chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pain in extremity, Suspected COVID-19
Clinical narrative: I tried to think maybe I am infected with covid, see if I got it or; I got sourness in my arms.; I got soreness and I am sick ever since; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 51-year-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EW0191), via an unspecified route of administration on 10Jun2021 (at the age of 51-years-old) as dose 1, single for COVID-19 immunisation. The medical history of the patient included hypersensitivity from an unknown date and unknown if ongoing. The concomitant medications of the patient included paracetamol, pseudoephedrine hydrochloride, triprolidine hydrochloride (SUDAFED SINUS PAIN & ALLERGY RELIEF) taken for hypersensitivity, start and stop date were not reported, dextromethorphan hydrobromide, doxylamine succinate, ephedrine sulfate, ethanol, paracetamol (NYQUIL) taken for an unspecified indication, start and stop date were not reported and mesna (MESNEX) taken for an unspecified indication, start and stop date were not reported. It was reported that patient had been taking some allergy medicines (unspecified medication), It never worked it never working, he was taking over the counter cold medicines like Sudafed, NyQuil, mesnex and he took two pills every four hours, 10 mg (unspecified pills) he donot know it was confusing. On 13Jun2021 the patient reported i tried to think maybe i am infected with covid, see if i got it or, i got sourness in my arms, i got soreness and i am sick ever since and just have been taking some allergy medicines. The patient stated he donot know what the shot did to him but he was sick that he wanted to report what kind of medical guidance can he get, do his event and asked to inform him if is there anything else he can visit to hospital. Therapeutic measures were taken as a result of AE. The outcome of the events was reported as unknown.  Follow up attempts are needed; Additional information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Epistaxis, Pain
Clinical narrative: feels dizzy and has trouble breathing; feels dizzy and has trouble breathing; had nosebleed by morning; has pain in forehead and nose; This is a spontaneous report from a non-contactable consumer, reported for co-worker via Pfizer colleague. A 27-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: not reported), via an unspecified route of administration on an unspecified date, dose 2, single for COVID-19 immunisation. No patient medical history and concomitant medications were reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: not reported), via unspecified route of administrated on an unspecified date, as dose 1, single for COVID-19 immunisation and had no reaction on previous exposure to drug. On an unspecified date after second dose, the patient had nosebleed by morning, had pain in forehead and nose, feels dizzy and has trouble breathing. Reporter wanted to know what to do and stated that after the vaccination, the patient drank 3 beers, and he wants to know if this had any consequence. The reporter wanted to know if there was a problem consuming alcohol after administration of Pfizer COVID-19 vaccine. Reporter commented that Pfizer was playing with their lives because vaccine was not approved by FDA. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 80.0
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Dyspnoea, Eructation, Weight decreased
Clinical narrative: Having shortness of breath; back aches; constant burping; sudden weight loss; This is a spontaneous report from a contactable consumer (Patient). A 80-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EP7534), via an unspecified route of administration, administered in Arm Left on 17Mar2021 (at the age of 80-year-old) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medications taken in two weeks included amlodipine; atorvastatin; pantoprazole; metoprolol. The patient previously took percocet [oxycodone hydrochloride;paracetamol] and experienced allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. on 19Mar2021, the patient experienced having shortness of breath, back aches, constant burping, sudden weight loss. The events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. It was unknown that, treatment was received as a result of events. The outcome of the events were not resolved.
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: Experienced Fever,Hot sensation to the right ear lobe,fever,Loss of appetite,back pain,felt strange,Figure out if it is Covid; This is a spontaneous report from a non-contactable consumer or other non health care professional (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE solution for injection), via an unspecified route of administration on 11Jun2021 (Batch/Lot Number: EW0196) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced that his right ear lobe started to get very hot. Then on 21Jun2021 when he woke up and he started a high fever on his head. He bought a forehead thermometer and it said 102. He took an Advil, and it went down to 98 or 99. side effects like that to happen 10 days after or a week after receiving vaccine. he did not feel right. He also had a backache and he never had a backache. He also had loss of appetite. he woke up he had a strange ache in his back. Also, he usually woke up very hungry, but when he woke up, he was not hungry. He did eat and he still had his senses like smell and taste, and he was just wondering and trying to figure out if it was Covid or was it some side effect of the drug. Patient has never had a fever for years and all the sudden he takes this shot and then he was getting all this events. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: he had a stroke late week and is 99% percent sure it was due to the COVID vaccine.; This is a spontaneous report from a contactable male consumer reported for himself. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date were not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single, for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced stroke on an unspecified date patient stated, he had a stroke late week and was 99% percent sure it was due to the covid vaccine. The outcome of event was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Hypoaesthesia, Paraesthesia, Product use issue
Clinical narrative: had a similar reaction/numbness and tingling/felt prickliness; had a similar reaction/numbness and tingling/felt prickliness; After the second shot the symptoms got worse; Received her 1st dose of the Moderna vaccine 2 weeks before she got her 1st dose of the Pfizer-BioNTech Covid-19 Vaccine; This is a spontaneous report from a contactable consumer (patient's parent). A 31-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation; COVID-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), via an unspecified route of administration from an unspecified date (Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The consumer reported that her daughter (patient) received her 1st dose of the Moderna vaccine 2 weeks before she got her 1st dose of the Pfizer-BioNTech COVID-19 Vaccine. She further reported that at the 1-week mark after receiving the 1st dose, the patient had a similar reaction/numbness and tingling/felt prickliness, as she had. The patient's doctor still told  her to receive the second shot. After the second shot, the symptoms got worse and continued. The consumer stated that there must be something the vaccines have in common that she and the patient reacted to. The outcome of all the events was unknown.  Follow-up attempts are needed. Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash; This is a spontaneous report from a non-contactable consumer (patient) via a Pfizer sponsored program Pfizer First Connect. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number and expiration date was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced rash on an unspecified date. The outcome of event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Loose stool/diarrhea; This is a spontaneous report from a contactable consumer (patient herself). A 74-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as dose 2, single for COVID-19 immunization. Patient medical history included cholesterol and constipation (patient was mostly a constipated person). The concomitant medication included Simvastatin at a dose of 20 mg taken for cholesterol from 20 years ago. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as dose 1, single for COVID-19 immunization. Patient had a reaction from taking Lipitor and simvastatin. Adverse event did not result in hospitalization and no treatment was received for the adverse events. First shot just fatigue for 2 days. Second diarrhea. I am usually a constipated person but now have more loose stool and diarrhea. Patient was now taking probiotics and anti-diarrheal pills will have colonoscopy beginning of 2022. If anything was shown on the colon he will contact us. He did think there was any problem with shot and simvastatin for cholesterol. The outcome of the event was unknown.   Follow-up attempts are needed; Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: was administered to a patient was from the refrigerator and the temperature is 41 degrees F; This is a spontaneous report from a Pfizer sponsored program. A contactable Pharmacist reported for a male patient.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. The reporter reported that a Pharmacist called with regards to the stability. She wanted to know if there was any flexibility with the previous information on the website, that the COVID-19 vaccines should be used after reconstitution before 6hrs at room temperature. At the onset of the call, she also mentioned that morning, a patient was administered with a vaccine that was already 1hr and 40 mins expired. After clarification, the caller said that there was no temperature excursion. The Pfizer Covid-19 vaccine that was administered to a patient was from the refrigerator and the temperature is 41 degrees F. Outcome of the events was reported as Unknown.  No follow up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Dehydration, Fatigue
Clinical narrative: She is drinking juices and sprite to keep from getting dehydrated; she has been feeling horrible; Has been sick; Chills; Can't eat; No appetite; Tired; No energy; Body aches; When she tries to eat her gums are sore; The physician she works for says flu like symptoms; This is a spontaneous report received from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONECH COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration on Jun2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Jun2021, the patient had been sick, chills, can't eat, no appetite, tired, no energy, body aches, when she tried to eat her gums are sore, the physician she worked for said flu like symptoms, she was drinking juices and sprite to keep from getting dehydrated, she had been feeling horrible. Got first dose of vaccine on Thursday and had been sick, chills, can't eat, no appetite, tired and no energy. Patient wanted to know, if this was normal. Patient also reported body aches, when she tried to eat her gums were sore, and no appetite. She was drinking juices and sprite to keep from getting dehydrated. The physician she worked for said flu like symptoms. She asked, should it be going on this long? She stated she will have to ask about the second dose because she may not take it if she was still sick then. The outcome of events was unknown.   Information on batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Feeding disorder, Feeling abnormal, Gingival pain, Illness, Influenza like illness
Clinical narrative: She is drinking juices and sprite to keep from getting dehydrated; she has been feeling horrible; Has been sick; Chills; Can't eat; No appetite; Tired; No energy; Body aches; When she tries to eat her gums are sore; The physician she works for says flu like symptoms; This is a spontaneous report received from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONECH COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration on Jun2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Jun2021, the patient had been sick, chills, can't eat, no appetite, tired, no energy, body aches, when she tried to eat her gums are sore, the physician she worked for said flu like symptoms, she was drinking juices and sprite to keep from getting dehydrated, she had been feeling horrible. Got first dose of vaccine on Thursday and had been sick, chills, can't eat, no appetite, tired and no energy. Patient wanted to know, if this was normal. Patient also reported body aches, when she tried to eat her gums were sore, and no appetite. She was drinking juices and sprite to keep from getting dehydrated. The physician she worked for said flu like symptoms. She asked, should it be going on this long? She stated she will have to ask about the second dose because she may not take it if she was still sick then. The outcome of events was unknown.   Information on batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: She is drinking juices and sprite to keep from getting dehydrated; she has been feeling horrible; Has been sick; Chills; Can't eat; No appetite; Tired; No energy; Body aches; When she tries to eat her gums are sore; The physician she works for says flu like symptoms; This is a spontaneous report received from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONECH COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration on Jun2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Jun2021, the patient had been sick, chills, can't eat, no appetite, tired, no energy, body aches, when she tried to eat her gums are sore, the physician she worked for said flu like symptoms, she was drinking juices and sprite to keep from getting dehydrated, she had been feeling horrible. Got first dose of vaccine on Thursday and had been sick, chills, can't eat, no appetite, tired and no energy. Patient wanted to know, if this was normal. Patient also reported body aches, when she tried to eat her gums were sore, and no appetite. She was drinking juices and sprite to keep from getting dehydrated. The physician she worked for said flu like symptoms. She asked, should it be going on this long? She stated she will have to ask about the second dose because she may not take it if she was still sick then. The outcome of events was unknown.   Information on batch/lot number has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dyspnoea, Headache, Pain
Clinical narrative: Pain; Diarrhea; difficulty breathing; headache; This is a spontaneous report from a contactable consumer or other non hcp (patient boyfriend). A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number and Expiration Date not reported), via an unspecified route of administration on 15Jun2021 (at the age of 47-years-old) as dose number unknown, single for COVID-19 immunisation. The medical history and concomitant medications of the patient were not reported. The investigation assessment was not provided. The patient experienced pain, diarrhea, difficulty breathing and headache on an unspecified date in Jun2021. Reporter stated that he does not know if these are typical side effects, but the patient got the Covid-19 shot last Tuesday, 15Jun2021, and started getting side effects 3 days ago. The seriousness of the events was reported as non-serious. Reporter questioned if these are common side effects and was it normal for side effects to start up to 7 days after the vaccine and how long would they last. The report was not related to a study or program. The outcome of all the events was reported as unknown.  Information on the lot/batch number has been requested.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Breast cyst, Heavy menstrual bleeding, Muscle spasms, Ovarian cyst
Clinical narrative: Heavier period, longer period; More intense cramps; Lower back pain; Significantly higher ovarian cyst pain; Increase cyst pain in left breast; This is a spontaneous report received from a contactable consumer (patient herself). A 29-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0167, at the age of 29-year-old), dose 2 via an unspecified route of administration, administered in arm left on 08Apr2021 as single for covid-19 immunisation in pharmacy or drug Store. Medical history and concomitant medications were not reported. The patient had no known allergies sulfa. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on unknown date 13:45 (Batch/Lot Number: EW0153) as single for covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any medications the patient received within 2 weeks of vaccination. On 17May2021, the patient experienced heavier period, longer period, more intense cramps, lower back pain, significantly higher ovarian cyst pain (on both sides now instead of just one) and increase cyst pain in left breast more frequent and intense. The patient did not receive the treatment. Post vaccination, the patient had not tested for COVID-19. The outcome of the events was not resolved.
Age: 63.0
Sex: U
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, SARS-CoV-2 test
Clinical narrative: swollen lymph nodes, really bad that they hurt so bad under my armpit and every day it hurts like really bad; painful lymph nodes; This is a spontaneous report from a contactable consumer (patient). A 63-year-old patient of an unspecified gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 27Mar2021 (Lot Number: EP6955) at the age of 63-year-old as a single dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 17Apr2021 (Lot Number: ER8731) at the age of 63-year-old as a single dose for covid-19 immunisation. The patient has no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and not any other medications the patient received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. On 27Mar2021 12:00, patient had very painful lymph nodes started immediately after the received first dose vaccine. Patient constantly feel the pain and it is interfering with patients life. Patient had a horrible swollen lymph nodes, really bad that they hurt so bad under the armpit and every day it hurts like really bad. The patient underwent lab tests on 06Jun2021 which included COVID test, Nasal Swab was negative. The outcome of event painful lymph nodes was not recovered with no treatment received and event swollen lymph nodes, really bad that they hurt so bad under my armpit and every day it hurts like really bad was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Patient received the Pfizer covid vaccine, and had no symptoms but a sore arm.; This is a spontaneous report from a contactable consumer. A contactable consumer reported different events for 5 patients. This is 4 of 5 reports. This consumer reported for a male patient (reporter's brother) that:  A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: Not reported), via unspecified route of administration on an unspecified date in 2021 as dose number unknown, single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient received the Pfizer covid vaccine, and had no symptoms but a sore arm on an unspecified date. The reporter stated that the patient had received the Pfizer covid vaccine within the last two months. The outcome of the event sore arm was unknown.  Information on the lot/batch number has been requested.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pallor
Clinical narrative: whiteness on both hands, specifically on the fingers.; a sore arm down to her hand; This is a report from a Pfizer sponsored program received via a contactable consumer (patient's mother). A 15-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19  VACCINE, Solution for injection; lot number and expiration date: not reported), via an unspecified route of administration, on 22Jun2021 (at the age of 15-year-old), as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization .The patient's medical history and concomitant medications were not reported. After the vaccination, the patient experienced sore arm down to her hand and whiteness on both hands, specifically on the fingers on Jun2021. Reporter would like to know, what that is. The outcome of the events was unknown.  Information on the lot/batch number has been requested
Sex: M
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: Coughed 5 different times; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot number and expiration date was not reported) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced coughed 5 different times on 23Jun2021. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headaches; This is a spontaneous report from a contactable consumer (patient). A 15-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Jun2021 13:00 (Lot number and expiration date was not reported) as dose number unknown, single for COVID-19 immunization at the age of 15-year-old. The patient medical history was not reported. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient experienced headaches on 21Jun2021. The outcome of the event was not recovered. The patient did not receive treatment for the event. The event was reported as non-serious.  Information on lot/batch number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 10Jun2021 10:30 (Lot Number: EW0186; Expiration Date: Aug2021) as dose 1, single for COVID-19 immunization at the age of 65-year-old. The patient received the COVID-19 vaccine in hospital. Medical history and concomitant medications were none. No family history. The patient did not receive any vaccinations prior to COVID vaccine. The patient did not undergo any relevant tests. The patient experienced diarrhea and stated that its looks like it is water on an unspecified date of Jun2021 (reported as about 4 days ago). The event did not result in any emergency room or physician office visit. It was reported the event was persisting (not recovered). She is scheduled for the second dose on 01Jul2021.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiac failure, Computerised tomogram
Clinical narrative: My heart stopped; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received bnt162b2, second single dose via an unspecified route of administration, administered in arm right on 06Apr2021 (Batch/Lot number was not reported) for covid-19 immunisation at age of 40-year-old. Medical history was none. The patient had first dose of bnt162b2 on 06Mar2021 at right arm at age of 40-year-old. Concomitant medication in two weeks included omeprazole (PRILOSEC). No other vaccine took in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient heart stopped on 10Apr2021and she died at home, her husband brought her back to life, then she died in the ambulance they brought her back to life. Then in the Hospital trauma room they sent her to CT scan she died again for 5 minutes they saved her again. The patient was admitted for 6 days and received treatment for the event. The event resulted in: Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. The patient was recovered with lasting effects.  Information regarding the Lot/Batch number has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram, Intensive care, Mechanical ventilation, Medical induction of coma, Resuscitation
Clinical narrative: My heart stopped; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received bnt162b2, second single dose via an unspecified route of administration, administered in arm right on 06Apr2021 (Batch/Lot number was not reported) for covid-19 immunisation at age of 40-year-old. Medical history was none. The patient had first dose of bnt162b2 on 06Mar2021 at right arm at age of 40-year-old. Concomitant medication in two weeks included omeprazole (PRILOSEC). No other vaccine took in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient heart stopped on 10Apr2021and she died at home, her husband brought her back to life, then she died in the ambulance they brought her back to life. Then in the Hospital trauma room they sent her to CT scan she died again for 5 minutes they saved her again. The patient was admitted for 6 days and received treatment for the event. The event resulted in: Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. The patient was recovered with lasting effects.  Information regarding the Lot/Batch number has been requested.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebral venous thrombosis, Computerised tomogram, SARS-CoV-2 test
Clinical narrative: I formed a series of blood clots in the sinus veins on the surface of my brain.; This is a spontaneous report from a contactable consumer (patient). This 25-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose in left arm in 2021 at the age of 25-year-old for COVID-19 immunization. The first dose was on 27Feb2021 04:00 PM in left arm at the age of 25-year-old. Patient had allergies to hydromorphone hydrochloride (DILAUDID) in the past. Medical history was not reported. Concomitant medications received within 2 weeks of vaccination included omeprazole; drospirenone/ethinylestradiol (LORYNA). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Nasal Swab SARS-CoV-2 RT-PCR was negative on 31Mar2021. The patient formed a series of blood clots in the sinus veins on the surface of her brain on 28Apr2021 08:00. She began having headaches on 28Apr2021 08:00 and was admitted to the hospital on 04May2021 after the headaches wouldn't subside and a CT scan revealed the blood clots on 04May2021. She was treated with anti-coagulants during a 9-day ICU stay. A thrombectomy was performed on 11May2021 to relieve the pressure on her brain and prevent a brain bleed. The adverse event resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The seriousness criteria were hospitalization and life-threatening illness (immediate risk of death from the event), not results in death, not disabling/incapacitating, not congenital anomaly/birth defect. Hospitalization duration was 9 days. The treatments were anti-coagulants and thrombectomy. The outcome of event was not recovered.  The information on the lot/batch number has been requested.
Age: 3.0
Sex: M
Vaccine: DTAPIPVHIB, IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received both IPOL and PENTACEL expired doses/ NO AE; Initial information received on 22-Jun-2021 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional and physician via call center via Medical Information (reference number- 00651323).  This case involves a 3-years-old male patient who was vaccinated with an 0.5 mL expired dose of IPOL (frequency: once, strength: standard, lot number : R1B251M and expiry date : 13-Mar-2021, via an intramuscular route in right arm) and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (frequency: once, strength: standard, lot number and expiry date not reported, via an unknown route at an unknown administration site) (expired product administered) on 21-Jun-2021 for prophylactic vaccination.  The patient's past medical history, medical treatments, vaccinations and family history were not provided.    Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency: same day).  Caller with question on whether doses are viable or whether dose needs repeating. Caller also with question on any adverse reactions to expect due to dose of IPOL in addition to dose received with PENTACEL.   At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chiropractic, Pain, Pain in extremity
Clinical narrative: It started when I lifted my arms to change my cloths I felt pain on the back of my upper arms, the pain has been growing and now , is extending to my legs and my whole body
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Eustachian tube dysfunction, Fatigue, Hypoacusis
Clinical narrative: been fatigued for over a week; with some Eustachian Tube Disfunction; fluid on the ear; Some associated dizziness; muffled hearing; about 24 hours post injection, I did run a slight fever; about 24 hours post injection / had some chills; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 50-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fatigue, eustachian tube dysfunction, fluid in middle ear, dizziness, muffled hearing in both ears, fever and chills. On an unknown date, the outcome of the fatigue, eustachian tube dysfunction, fluid in middle ear, dizziness and muffled hearing in both ears were not recovered/not resolved and the outcome of the fever and chills were unknown.   It was unknown if the reporter considered the fatigue, eustachian tube dysfunction, fluid in middle ear, dizziness, muffled hearing in both ears, fever and chills to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient himself/ herself. The patient reported that she had received Shingrix vaccine. About 24 hours post injection, she had a slight fever, and had some chills. She had been fatigued for over a week, with some Eustachian tube disfunction and fluid on the ear. She also experienced some associated dizziness and muffled hearing.  She knew that these were not listed among the side effects, and wanted to check. The reporter wanted to know how long do the side effects from the first vaccination typically last.
Sex: U
Vaccine: VARZOS
Symptoms: Middle ear effusion, Pyrexia
Clinical narrative: been fatigued for over a week; with some Eustachian Tube Disfunction; fluid on the ear; Some associated dizziness; muffled hearing; about 24 hours post injection, I did run a slight fever; about 24 hours post injection / had some chills; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 50-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fatigue, eustachian tube dysfunction, fluid in middle ear, dizziness, muffled hearing in both ears, fever and chills. On an unknown date, the outcome of the fatigue, eustachian tube dysfunction, fluid in middle ear, dizziness and muffled hearing in both ears were not recovered/not resolved and the outcome of the fever and chills were unknown.   It was unknown if the reporter considered the fatigue, eustachian tube dysfunction, fluid in middle ear, dizziness, muffled hearing in both ears, fever and chills to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient himself/ herself. The patient reported that she had received Shingrix vaccine. About 24 hours post injection, she had a slight fever, and had some chills. She had been fatigued for over a week, with some Eustachian tube disfunction and fluid on the ear. She also experienced some associated dizziness and muffled hearing.  She knew that these were not listed among the side effects, and wanted to check. The reporter wanted to know how long do the side effects from the first vaccination typically last.
Age: 10.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Kinrix that was administered to a 10 year old; This case was reported by a other health professional via interactive digital media and described the occurrence of inappropriate age at vaccine administration in a 10-year-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided are as follows: The patient who was 10 years old, received Kinrix, which led to inappropriate age at vaccine administration. The reporter wanted to know if a Kinrix that was administered, count as a valid dose for tdap. No further details were provided.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had the vaccine and still got the shingles/ suspected vaccination failure; got the shingles; This case was reported by a consumer via (Facebook) interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient's wife. The age at vaccination was not reported. The reporter stated that, the patient had vaccine and still got the shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the shot it didn't work/ suspected vaccination failure; got the shot it didn't work; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The reporter stated that, got the shot but it did not work. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia, Skin ulcer, Vaccination failure
Clinical narrative: Suspected vaccination failure; Still got shingles / just getting back to normal; The sores dried up / just getting back to normal; But still had residual nerve pain for a while after / just getting back to normal; This case was reported by a consumer via (Facebook) interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, skin ulcer and nerve pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and skin ulcer were recovering/resolving and the outcome of the nerve pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, skin ulcer and nerve pain to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient had shot still got shingles. The sores dried up but still had residual nerve pain for a while after. The patient was getting back to normal. The reporter stated that vaccine might make your case lighter but it won't prevent it. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I have had 2 shots for shots for shingles and I still get shingles!/ suspected vaccination failure; I have had 2 shots for shots for shingles and I still get shingles!; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient got 2 shots for shots for shingles and still get shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling hot, Herpes zoster, Pruritus, Vaccination failure
Clinical narrative: suspected vaccination failure; I have had the shot! But I have had shingles! , I also have it again!!; It's like fire; It's like/ itching!; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, feeling of warmth and pruritus. On an unknown date, the outcome of the vaccination failure, shingles, feeling of warmth and pruritus were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, feeling of warmth and pruritus to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The reporter stated that, had shot and had shingles. The patient had shingles again and stated it was like fire and itching. The patient would call physician. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Powder component was expired in March 2021 / Lot / expired on March 31st, 2021; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 18-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA354A, expiry date 31st March 2021) and (batch number unknown, expiry date June 2022) for prophylaxis.   On 24th June 2021, the patient received Menveo. On an unknown date, the dose was an unknown dose. On 24th June 2021, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided are as follows: A patient received a dose Menveo on June 24th, 2021, which the diluent component expires in June 2022 and the powder component was expired in March 2021 which led to expired vaccine used. Health care professional  mentioned that she believed that both vials were in the same box but she was not sure about it.  Health care professional declined reported as a Product Quality Complaint. The reporter consented to follow-up.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Administered an expired dose of Menveo; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA259A, expiry date 31st March 2021) for prophylaxis.   On 25th June 2021, the patient received Menveo. On 25th June 2021, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows:  The coworker administered an expired dose of Menveo to the patient, which led to expired vaccine used. No further events were reported at the time of the call. The reporter did not consent to follow up.