chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Breathing problems / Trouble breathing; This is a spontaneous report from a contactable consumer (Patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6207), via an unspecified route of administration on 15Mar2021 (at the age of 58-year-old), as 1st dose, single dose and received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0150), via an unspecified route of administration on 05Apr2021 (at the age of 58-year-old), as 2nd dose, single dose, for COVID-19 immunization. The patient's medical history included emphysema, Hashimoto's disease, hypopituitarism, chronic pain, and chronic severe calcification tendonitis. Concomitant medications included levothyroxine (LEVOTHYROXINE), metformin (METFORMIN), rosuvastatin calcium (CRESTOR), dhea (DHEA), fish oil (FISH OIL), magnesium (MAGNESIUM), ascorbic acid (VIT C), diclofenac sodium (NAC SR), nattokinase, olea europaea oil, phytosterols NOS, ubidecarenone (NATTOKINASE PLUS Q10), ergocalciferol (VIT D), ubidecarenone (COQ 10), cortisol (Hydrocortisol) all drugs taken for unspecified indications. On 15Mar2021, 15 minutes after the first shot, the patient experienced trouble in breathing. Doctor advised the patient to get the second dose. 10 minutes after the second shot, the patient again had breathing problems and 40 minutes after that, she really decompensated. Patient treated herself with her Ventolin inhaler, epi pen, and Benadryl for breathing problems started after the second dose and then 40 minutes later she was on the road decompensating. Patient had to take Benadryl for a few days and breathing problems lasted for a duration of 80 days. Patient was cortisol dependent and had to take an extra 20mg of cortisol and enquired whether this would affect the vaccine. Patient had to take Benadryl for a few days. After that, patient had a horrible rash her legs opened in whelps, on the entire back of her legs, which lasted a couple of weeks and treated with hydrocortisone cream that knocked down some itching. Patient stopped taking the generic for Crestor due to massive weight gain and CoQ10 to keep the muscle pain down from the statin, but it couldn't get rid of it. The clinical outcome of the event was resolved on 03Jun2021.
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: His fingers went numb; This is a spontaneous report from a contactable consumer or other non hcp. A 48-years-old male patient received bnt162b2 (BNT162B2, Solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as UNKNOWN, SINGLE DOSE for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MRNA 1273) via intramuscular on 28Apr2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE DOSE, intramuscular on 21May2021 (Batch/Lot number was not reported) to 21May2021, at 2ND DOSE, SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, after having the second dose of the vaccine on 28Apr2021 on the left, non dominant arm, side effects developed. It was reported that his fingers went numb on an unknown date. . Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021650409
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Swelling, Vaccination site pain
Clinical narrative: redness and soreness; redness and soreness; injection site pain; swelling; This is a spontaneous report from a contactable consumer or other non hcp.  A 65-years-old female patient received first dose of BNT162B2, (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number was not reported), via intramuscular on an unspecified date as single dose for COVID-19 immunization. Medical history included immune thrombocytopenia. The patient's concomitant medications were not reported. The patient experienced redness and soreness, injection site pain, swelling on an unspecified date. Outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on my left hand It has kind of spread over the back of my left hand; This is a spontaneous report received from a non-contactable consumer or other non hcp. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0167), via an unspecified route of administration on an unspecified date as 1st dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced rash on my left hand it has kind of spread over the back of my left hand on an unspecified date. The events were assessed as non-serious. Reporter stated, patient wants to check what level of protection if she don't get the second dose this June 5 which was this Saturday since she was experiencing rashes after getting the first dose on May 15. Consumer stated, about maybe four days after she got the shot or maybe 5 days, developed a rash on my left hand. She thought maybe something, ants or something they had bitten me or something, just didn't knew why because she didn't realize a rash could be a side effect from the Pfizer shot. But anyway it has kind of spread over the back of my left hand and about 4 or 5 or about 3 or 4 days after that, she noticed the same rash coming on my right hand as well. For about the last 2 weeks, it has been kind of progressive and then today for the first time, she noticed some rash around the lower part of neck. Further probing could not be done as consumer was unwilling to further answer the questions. Hence, other details are unknown and limited information was available over the call. The outcome of the events was reported as unknown.    Follow-up attempts are possible. further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Furuncle, Pain, Pruritus, Pyrexia
Clinical narrative: the area has become more red and itchy and is now swollen; the area has become more red and itchy and is now swollen; the area has become more red and itchy and is now swollen; he noticed 1 small boil under his left nipple; body aches and pain; fever; This is a spontaneous report from a contactable consumer.  A 51-years-old male patient received second dose of bnt162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot Number was not reported), via an unspecified route of administration, in Arm Left on 29May2021 as 2nd dose, single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient received fist dose of bnt162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot Number was not reported), via an unspecified route of administration, on unspecified date as 1st dose, single dose for covid-19 immunization. On 30May2021 the patient experienced fever (pyrexia) and on 31May2021 the patient experienced body aches and pain. On 02Jun2021(Wednesday) and into Thursday he noticed 1 small boil under his left nipple (noting that he received the vaccine dose in his left arm). And since Thursday the area has become more red and itchy and was now swollen. The patient asked if his symptoms are normal side effects or something he should be worried about. The patient do not know if it was lymph glands reacting. The patient was recovered from body aches and pain on 02Jun2021.The outcome of event fever, small boil under his left nipple and area has become more red and itchy and is now swollen was unknown.  No follow-up attempts are possible; information about lot/batch number was not reported.
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: the area has become more red and itchy and is now swollen; the area has become more red and itchy and is now swollen; the area has become more red and itchy and is now swollen; he noticed 1 small boil under his left nipple; body aches and pain; fever; This is a spontaneous report from a contactable consumer.  A 51-years-old male patient received second dose of bnt162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot Number was not reported), via an unspecified route of administration, in Arm Left on 29May2021 as 2nd dose, single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient received fist dose of bnt162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot Number was not reported), via an unspecified route of administration, on unspecified date as 1st dose, single dose for covid-19 immunization. On 30May2021 the patient experienced fever (pyrexia) and on 31May2021 the patient experienced body aches and pain. On 02Jun2021(Wednesday) and into Thursday he noticed 1 small boil under his left nipple (noting that he received the vaccine dose in his left arm). And since Thursday the area has become more red and itchy and was now swollen. The patient asked if his symptoms are normal side effects or something he should be worried about. The patient do not know if it was lymph glands reacting. The patient was recovered from body aches and pain on 02Jun2021.The outcome of event fever, small boil under his left nipple and area has become more red and itchy and is now swollen was unknown.  No follow-up attempts are possible; information about lot/batch number was not reported.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea; This is a spontaneous report from a contactable consumer (patient, self-reported). This 64-Year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number and expiry date was unknown) via an unspecified route of administration on 23Mar2021(age at the time 64-year-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient was not able to get the 2nd dose on time since he felt ill, mentioned he had "diarrhea" after the first dose. The patient had a word with nursing department. The patient wanted to know if he can still get the second dose given the timing. The outcome of the event was unknown.  Follow-up attempts not completed; information about lot/batch number cannot be obtained. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swelling of lymph nodes; This is a spontaneous report from a contactable consumer (the patient) via medical information team. A female patient of an unspecified age received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration in the left arm on 02Jun2021 as 2nd dose, single dose for COVID-19 immunisation. Medical history and Concomitant medications were not reported. Patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unknown date as 1st dose, single dose for COVID-19 immunisation. Patient got her 2nd dose of the Pfizer BioNTech Covid-19 Vaccine on 02Jun2021 and was experienced that swelling of lymph nodes up until today. The swollen lymph nodes were in the left arm just below her armpit, this was the same arm where she got the 1st and 2nd dose of the Pfizer BioNTech Covid-19 Vaccine. Patient wanted to know how long the swelling of the lymph nodes usually lasts. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: My arm is itching all over; This is a spontaneous report from a non-contactable consumer (Patient). A patient of unspecified age and gender received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot Number: Unknown; expiry date: unknown), via an unspecified route of administration on an unspecified date in 2021 as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient took a shot earlier today at Pfizer BioNTech shot and now the arm was itching all over. On an unspecified date in 2021 and when got too low left (Not sure as voice was not clear hence not captured as event) on each hour. The patient reported it was not on all the arm, not gonna itching bad under skin it is an hour ago. The clinical outcome of event was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Pruritus
Clinical narrative: itching; shortness of breath; This is a spontaneous report from a contactable consumer or other non hcp. A 72-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm on 28May2021 (Batch/Lot number was not reported) as 1st Dose, Single Dose for covid-19 immunization. The patient's medical history was reported as itch in her back (sometimes get this same itch back in the past). The patient's concomitant medications were not reported. On Wednesday, 02Jun2021,the patient experienced itching, no rash, shortness of breath. The case was assessed as non-serious by the reporter. The outcome for the events was Unknown.  Information on the lot/batch number has been requested
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anxiety, Condition aggravated, Pruritus, Rash, Vaccination complication
Clinical narrative: itching; shortness of breath; This is a spontaneous report from a contactable consumer or other non hcp. A 72-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm on 28May2021 (Batch/Lot number was not reported) as 1st Dose, Single Dose for covid-19 immunization. The patient's medical history was reported as itch in her back (sometimes get this same itch back in the past). The patient's concomitant medications were not reported. On Wednesday, 02Jun2021,the patient experienced itching, no rash, shortness of breath. The case was assessed as non-serious by the reporter. The outcome for the events was Unknown.  Information on the lot/batch number has been requested
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Peripheral swelling, Pruritus, Rash
Clinical narrative: itching; shortness of breath; This is a spontaneous report from a contactable consumer or other non hcp. A 72-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm on 28May2021 (Batch/Lot number was not reported) as 1st Dose, Single Dose for covid-19 immunization. The patient's medical history was reported as itch in her back (sometimes get this same itch back in the past). The patient's concomitant medications were not reported. On Wednesday, 02Jun2021,the patient experienced itching, no rash, shortness of breath. The case was assessed as non-serious by the reporter. The outcome for the events was Unknown.  Information on the lot/batch number has been requested
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy skin, Condition aggravated, Hypoaesthesia, Pain, Small fibre neuropathy
Clinical narrative: Small fiber neuropathy; worsening neuropathy; she has experienced increased pain and numbness over her body. This has been ongoing for six plus weeks; she has experienced increased pain and numbness over her body. This has been ongoing for six plus weeks; This is a spontaneous report from a contactable physician. A 64-years-old female patient received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient reported treating for small fiber neuropathy. Subsequently after the vaccine she had experienced increased pain and numbness over her body. This had been ongoing for six plus weeks. Patient had taken a 72-hour 5-day course of Ibuprofen, with no benefit. She had a skin biopsy to check for worsening neuropathy. Test results were pending at this time. The patient was asked to complete the biopsy prior to the vaccine; however, she was reluctant about coming out during the Pandemic. It was stated that there may be a possibility of a 5-day Medrol dose pack. Caller asked if there were reports of individuals with similar diagnosis who had experienced the same symptoms, if so, were there any treatment recommendations. Physician voiced he has had a couple patients with the same diagnosis that had been vaccinated report worsening symptoms also. The outcome of the events was unknown.  Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Constipation, Headache, Nausea, Vomiting
Clinical narrative: Vomiting; Constipation; Headache; Nausea; This is a spontaneous report from a contactable consumer(patient). A 55-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Lot number and Expiration date: Not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient constipated and also experienced headache, nausea and vomiting. Patient reported she can not use bathroom. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate decreased, Heart rate increased
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0169), via an unspecified route of administration, administered in Arm Right on 02Jun2021 (at the age of 67-year-old) as a single dose for COVID-19 immunization. The patient's medical history included high blood pressure, high cholesterol from 1980, irregular heartbeats started this year ago but had not been told by a doctor. The patient stated she was in her 40s and going through menopause when they diagnosed her. The patient's family history was reported as none. The patient's concomitant medications included metoprolol ER 25 mg every day taken for Blood Pressure abnormal, Duloxetine 30 mg a day and 60 mg a day, olanzapine 10 mg a day at bedtime, amlodipine besylate 5 mg day taken for Blood Pressure abnormal, Potassium 20 mg, acetylsalicylic acid (ASPIRIN) 81 mg and atorvastatin 80 mg taken for cholesterol abnormal. No AEs was reported prior vaccinations. The patient was not administered with vaccine at Military facility. The patient was not administered with any other vaccine on same date of the Pfizer suspect. The patient was not administered with any other vaccine 4 weeks prior to suspect vaccine. The patient stated that after receiving the Pfizer COVID-19 vaccine on 02Jun2021 (Wednesday) she was experiencing an elevated heart rate /noticed her heart rate was elevated this morning. She would like to know if this was a normal side effect. The patient stated her heart races when she gets up and when she sits it goes back down. She stated it has not worsened but it's scary. On 04Jun2021, the patient's heart rate a little faster than normal. After the COVID-19 vaccine her pulse was too low to take her blood pressure medication. The reporter stated this was yesterday (03Jun2021). She stated she does not know when she started taking any of her medications. She stated that, she didn't take her blood pressure medication yesterday as she can't take it if her pulse was below 60. This morning it was in the 90s. The patient had not visited emergency room/physician office. The patient's relevant medical tests were reported as none. The reporter stated that her next vaccine was scheduled for 26Jun2021. She stated that, she cannot find her card for the vaccine and it was in her purse and now she can't find it. She later clarifies that she found the card. The outcome of the events was unknown. Information on Lot/Batch number is available; Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: cramps in his legs in weird places; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 70-year-old male patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on 22Apr2021 as 1st dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On unspecified date of Apr2021 (reported as a day or two later), the patient experienced cramps in his legs in weird places. The outcome of the event was not recovered.  Information about batch no/lot no has been requested.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: Mild chills; Feel tired; This is a spontaneous report from a contactable consumer or other non hcp. A 87-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 01Jun2021 (at the age of 87-years-old) (Batch/Lot Number: EW0185) as single dose for covid-19 immunisation. Medical history included ongoing high blood pressure (10 years ago), ongoing anxiety (2 years ago), ongoing atrial fibrillation and hip surgery from an unknown date and unknown if ongoing (few years ago). The patient did not emergency room and physician office visit. Prior Vaccinations (within 4 weeks): None. Concomitant medication included warfarin taken for atrial fibrillation, start and stop date were not reported; olmesartan medoxomil (BENICAR) taken for blood pressure, start and stop date were not reported; nebivolol hydrochloride (BYSTOLIC) taken for blood pressure start and stop date were not reported; diltiazem hydrochloride (DILTIAZEM CD) taken for blood pressure, start and stop date were not reported; clonazepam taken for an unspecified indication, start and stop date were not reported. The patient previously took first dose of bnt162b2 on 04May2021 (Batch/lot number EW017) administered in, Left arm for covid-19 immunisation and experienced tired. The patient previously took Flu shot and experienced Sort of bothered my face (40-50 years ago). The reporter stated that second dose received 28 days after first dose. she had her second dose of the Pfizer COVID-19 vaccine 01Jun2021 and on 03Jun2021 started to feel tired she is stating to feel better. she didn't have a sore arm or anything and that the Covid-19 vaccine didn't seem to bother her. She stated she did notice having chills but realized it was because she had her air conditioning too high and was cold from the air temperature, does not think she had a fever. The patient experienced mild chills on 04Jun2021, but she was no longer having. Relevant tests was none. The outcome of the events feel tired was reported as recovering and mild chills was reported as recovered on 04Jun2021.   Follow-up attempts are completed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Heart rate increased
Clinical narrative: A fast heartbeat; Dizziness; Weakness; This is a spontaneous report from Medical information team. A contactable consumer (patient) reported that a 55-year-old (same age at vaccination) female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot: EW0191) intramuscularly on 22May2021 as single dose in arm left for COVID-19 immunization/ preventative. Medical history reported was ongoing knee disability, she does not take any prescription medication for this, once in a while takes ibuprofen for pain. Diagnosed when she was 2 years old, ongoing thyroid developed as an adult (her mother had a thyroid condition), at least 20 years ago or so, ongoing allergies, breathing difficulties and sarcoidosis in her lungs. Concomitant medications reported was levothyroxine sodium (SYNTHROID, Tablet) orally and ongoing at 25mcg daily for thyroid and fexofenadine hydrochloride (ALLEGRA) for allergies in the morning. She will sneeze a lot if she does not take it. There were none additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations within 4 weeks were reported. She explained since then, she has been experiencing a fast heartbeat, dizziness, and weakness. She asked if her symptoms, should continue for that long, now that it has been 13 days. Patient asked if she should get the second dose of the Pfizer-BioNTech COVID-19 vaccine if the side effects from the first dose persist. Around the day after the first dose, she thinks all the symptoms started, clarified all symptoms started Sunday 23May2021. It is not as much, but still enough that she can tell. For the first few days, almost first week even at night she was having it, at night she will still have the fast heartbeat. And now she was able to sleep through the night and when she wakes up the fast heartbeat will happen, it was not continuous but frequent enough during the day. She confirmed all the symptoms have slightly improved. Patient declined any treatment, she kept thinking it will go away. She takes two medications other supplements like vitamin b. In 2009 she was diagnosed with sarcoidosis in her lungs but was not given active treatment. They did tests and told her it was almost in remission and she would go in for check-ups. Two years ago, they told her she did not need any more check-ups, it is not active. The first year when she had breathing difficulties, she was given a medication and she was to take one puff of it and that was it. Stated it was not an inhaler or spray. It was a minimal dose that had a steroid in it, and she was concerned about the steroid. It was oral and she only used it as a precaution and to help with breathing. Her breathing issue went away as soon as she lost weight, so not sure if breathing issue was sarcoidosis or being overweight. The reporter assessed seriousness as non-serious. Outcome of the events was recovering.  No follow-up attempts possible. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymph node palpable
Clinical narrative: palpable node on her left collar bone; This is a spontaneous report from a contactable consumer (patient) via medical information team. A female patient of an unspecified age (age: 61, unit: unknown) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration administered in left arm on 02Jun2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient received her second dose of the Pfizer Covid 19 Vaccine on Wednesday 02June2021. On Thursday 03June2021, she experienced a palpable node on her left collar bone. The patient was asking if the symptom has been reported. The outcome of the event was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: severe nose bleed; This is a spontaneous report received from a contactable consumer (patient's fiance). A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 03Jun2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunisation. She stated patient got the second dose of Pfizer on 03Jun2021. It was almost 2 hours ago. Now he was having a severe nosebleed. It was not stopping. She states this never happened before. It didn't happen the first time he got a dose and he has never had a problem with bleeding through the nose. The outcome of the event was unknown.  Follow-up needed. Information about batch/lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain in the arm that he received the injection in; This is a spontaneous report from a contactable consumer (patient's wife). A 95-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in arm on 13Feb2021 (Batch/Lot number was not reported) as second dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter stated that on an unspecified date in 2021, the patient was still complaining of pain in the arm that he received the injection in. Outcome of event was not recovered.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Magnetic resonance imaging head
Clinical narrative: slight headache that never went away/ lot worse headache and had become a persistent.; This is a spontaneous report from a contactable Nurse (patient). A 72-year-old female Patient vaccine BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection), first dose via an unspecified route of administration on an unspecified date in Mar2021 as single dose and second dose via an unspecified route of administration on 11Apr2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Post vaccination of her first dose on an unspecified date in Mar2021, she experienced slight headache that never went away. And then post vaccination of her second dose on 11Apr2021, she experienced a lot worse headache and had become a persistent. Additionally, her doctor did some brain scans which came back with negative results indicating absence of abnormalities. And that he is scheduled to see his neurologist in 2 months. Patient was concerned about what to expect about this, or if there were any reports about this and how long this lasts and what she should do about this. The patient underwent lab tests and procedures which included magnetic resonance imaging head: negative on 2021 absence of abnormalities. Outcome of the event was not recovered.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia
Clinical narrative: She lost the sense of taste this morning; This is a spontaneous report received from a contactable consumer (Patient mother) via medical information team. A 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date in Jun2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. No adverse events reported with the first dose. On 04Jun2021, the patient had lost the sense of taste. The consumer stated that "My adult daughter received the second dose of the Pfizer COVID-19 vaccine two days ago. She lost the sense of taste this morning. I have seen people reported a loss of taste but along with a metallic taste in the mouth. But my daughter doesn't have a metallic taste in her mouth". The reporter has been reading some of the questions and articles and none of them talk about a loss of a sense of taste. They talk about a metallic taste, but her daughter doesn't have a metallic taste. The reporter wanted to know that if loss of a sense of taste was common after the Covid vaccine and if this was a side effect reported.  Information on lot/batch number has been requested.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever (100F); This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program. Follow-up (04Jun2021) was processed together with initial information.  A 71-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on 02Mar2021 (at age of 71-year-old) as single dose for covid-19 immunization. The patient medical history was not reported. The patient concomitant medications were not reported. The patient's historical vaccine included Methotrexate as immunosuppressant back in Dec2020 and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on 09Feb2021 (at age of 70-year-old), as single dose for covid-19 immunization. On 03Mar2021, the patient reported that experienced fever (100F) on the second day, after her 2nd dose of vaccination. Patient did experience a mild fever the second night of her second dose. She had a question about Methotrexate that was covered by Medical Information. she was just calling because she has been on Methotrexate for a year and gave it up in December. She didn't have the vaccine until February and March. Pfizer's research didn't begin with identifying immunosuppressed people. She may not be covered, so she called to find out what's new. Mild fever patient had the second dose of the vaccine on 02Mar2021, and it was 03Mar2021 in the evening that she had a fever. She took 2 Aspirin and went to bed. She was probably getting it as the evening wore on from earlier. It was only for a few hours that she was conscious of it and then she went to bed. She is trying to get out before traffic starts and she can't drive. Caller states that she would like to go now and that Pfizer can follow up with her and call any other time. The patient underwent laboratory tests and procedures which included body temperature showed 100 Fahrenheit (Mild fever), on 03Mar2021. The patient received treatment with Aspirin for fever. The outcome of the reported events was unknown.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Gait inability, Pain in extremity
Clinical narrative: Could not walk for a week; was like limping like from one place to another; Severe pain in both leg and the arm was like sore; could not really walk normally; arm was like sore; This is a spontaneous report received from a contactable consumer or other non hcp. A 14-years-old male patient received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, Batch/Lot Number: EW0167), dose 1 via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE for covid-19 immunization. Medical history included covid-19 in Apr2018 and recovered. The patient's concomitant medications were not reported. Patient did not had vaccination prior 4 weeks. The patient got the first shot and then he could not walk for a week, he was like he can walk but he was like limping like from one place to another, he had like severe pain in both leg and the arm was like sore a little bit at the first day, for hours then the next day and he was like he could not really walk normally he was like jumping with thorns for a whole week. The outcome of the events was unknown.  Information on lot/batch number was available. Additional information has been requested.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, HIBV, PNC13, RVX
Symptoms: Extra dose administered, No adverse event
Clinical narrative: 4 month old received Pentacel and Acthib at the same time, no AE; Initial information received on 17-May-2021 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 4 months old female patient who received 0.5 ml first dose of HIB (PRP/T) VACCINE [Act-HIB] (lot SO21458 and expiration date not reported) via intramuscular route in the right vastus lateralis and 0.5 ml first dose of suspect  DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (lot UJ412AA and expiration date not reported) via intramuscular route in the left vastus lateralis for prophylactic vaccination on 12-May-2021 (that is at the same time).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) (lot numbers, expiration date and other dosing details were not reported) for prophylactic vaccination.  It was a case of medication error due to extra dose administered (same day). It was also reported that caller wanted to know if there was any data on patient receiving too much medication or receiving the products at the same time. On 17-May-2021 - Confirmed pharmacist's questions about PENTACEL and ACTHIB being given at the same time.   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 the 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.  No further information was provided.
Age: 0.58
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: 7 month old female patient inadvertently administered an expired dose of Pentacel intramuscularly with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from a consumer via Agency (Reference number- 00609761) and transmitted to Sanofi on 20-May-2021.  This case involves a 7 month old female patient who was inadvertently administered an expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (expired product administered).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation.  On 18-May-2021, the patient received a 0.5 ml third dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ262AAA and expiry date: 14-May-2021) (Suspect formulation: single dose vials) via an intramuscular route in the right leg for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency on same day).  It was also reported that expire Pentacel was given to a baby and the vaccine was 4 days past the expiry date. Caller would like to know if they need to re-vaccinate. Reporter relationship: health care professional (HCP) Product used: used still using product: no   At the time of report 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 the 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: 3.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, PNC13
Symptoms: Expired product administered, No adverse event
Clinical narrative: An expired Act-Hib was administered to a patient/ NO AE; Initial information regarding an unsolicited valid non-serious case was received from a other health care professional via Agency (Reference number- 00609798) and transmitted to Sanofi on 20-May-2021.  This case involves a 3 years old male patient who received fourth dose 0.5 mL HAEMOPHILUS TYPE B (HIB) VACCINE [ACT-HIB] (frequency: once, batch number: UJ207AA and expiry date : 30-Apr-2021 via an intramuscular route at an right thigh administration site) (expired product administered) on 18-May-2021 for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination and family history were not provided.  It was an actual medication error case due to expired vaccine used (latency: same day).  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR), HEPATITIS A VACCINE (HEPATITIS A) and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for prophylactic vaccination.  Reporter want to know what need to know and which actions to take for the affected donors. Caller requested information to provide to mother of patient.   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 the 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: 13.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 13 year old patient had recieved MENACTRA vaccine 5 years early with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received on 20-May-2021 from other health care professional via Medical Information (Reference number- 00610012) and transmitted to Sanofi on 20-May-2021.  This case involves a 13 year-old female patient who was vaccinated with 0.5 mL MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] 5 years too early (batch number and expiry date not reported) via an intramuscular route at left deltoid on 20-May-2021 for prophylactic vaccination (inappropriate schedule of product administration)  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE for prophylactic vaccination.  It was also a case of an actual medication error due to inappropriate age at vaccine administration (latency was on same day).  It was reported that, would the patient be harmed, what should they do, would the patient need a booster?  Result of assessment was not 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 the 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.  There will be no information available on batch number for this case.
Sex: F
Vaccine: FLU4
Symptoms: Electrocardiogram T wave abnormal, Injection site pain, Musculoskeletal stiffness, Prolapse
Clinical narrative: pain at injection site; a really stiff arm for 3 days; Initial information regarding an unsolicited valid non-serious case was received from a consumer or non-health care professional via Medical Information (Reference number- 00613107) and transmitted to Sanofi on 24-May-2021.  This case involves an unknown age female patient who experienced really stiff arm for 3 days (musculoskeletal stiffness), pain at injection site (vaccination site pain), when received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical treatment included WITCH HAZEL [HAMAMELIS VIRGINIANA EXTRACT] having reaction of rash, KEFLEX [CEFALEXIN] with adverse reaction of egg allergy, arm swelling, VIOXX with vomiting, rash, LEVAQUIN with vomiting, rash, intravenous (IV), ANTIHISTAMINES which dries out eyes and mouth, MIDODRINE with edema, weight gain HCTZ having hypotension, PENICILLIN [PENICILLIN NOS], ERYTHROMYCIN and SULFA [SULFACETAMIDE SODIUM], , IVP dyes with hives, flushing, vomiting  The patient's past vaccination included INFLUENZA VACCINE with adverse reaction of egg allergy, arm swelling for prophylactic vaccination.  The patient's past medical history, concomitant medication and family history were not provided.  At the time of the event, the patient had ongoing allergy to COVID-19 vaccine and cardiac disorder.  In 2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot and expiry date not reported), via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious a really stiff arm (musculoskeletal stiffness) and pain at injection site (vaccination site pain) for 3 days (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Caller want to check ingredients in the flu shot to see if there are any of those ingredients as are in the Covid vaccine. Consumer who asks if sucrose, glycerin and glycerol are in Fluzone HD. She reports potential adverse event for Fluzone HD for multiple medicine  She also reported she has a T wave abnormality on ECG and valve prolapse.  It was not reported if the patient received a corrective treatment for the events.  On an unknown date, the patient recovered from both the events after 3 days.  Reporter does not relate both adverse event musculoskeletal stiffness and vaccination site pain to Fluzone HD, but to a general medical cardiac history.  There will be no information available on the batch number for this case.