chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal sensation in eye, Feeling hot, SARS-CoV-2 test
Clinical narrative: Sensation of heating or warming eyeballs; Sensation of heating or warming eyeballs; This is a spontaneous report from a contactable consumer (patient). A 40-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration in left arm on 06May2021 at 14:00 (at the age of 40-years-old) as dose 1, single for covid-19 immunization at doctor's office/urgent care facility. Patient reported that she was healthy, other medical history and concomitant medications was not reported. No known allergies were reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, patient was not diagnosed with Covid-19. Post vaccination, patient was tested for Covid-19. The patient was not pregnant at time of vaccination. On 06May2021 at 17:00, patient experienced sensation of heating or warming eyeballs. It was notable since she never experienced the sensation ever before. On 16Jul2021, patient underwent lab tests and procedures which included nasal swab polymerase chain reaction (PCR) test with negative result. No therapeutic measures were taken. The outcome of the events was reported as recovered on an unspecified date in 2021.  The lot/batch number was not available despite the follow-up attempts made. Follow-up attempts completed. No further information was expected.
Sex: U
Vaccine: COVID19
Symptoms: Blood cholesterol increased, Low density lipoprotein increased
Clinical narrative: This is a spontaneous report from a contactable consumer (pharmacist), reported for a consumer (patient). A patient, of unspecified age and gender, received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, pre-filled syringe, batch/lot# unknown), via an unspecified route of administration, single dose, for COVID-19 immunization. The patient's medical history and patient's concomitant medications not reported. On an unknown date, it was reported two of his patients had a significant increase in their total cholesterol and LDL levels a few days after receiving the Comirnaty vaccine. Pharmacist also added these patients had no other change whether in their exercise routine or their dietary habits. They had not consumed food with large amounts of cholesterol. Caller would like to know if Pfizer has any reports of increased total cholesterol and LDL (low density lipoprotein) values after taking Comirnaty/Pfizer-BioNTech COVID-19 vaccine. Lab data included significant increase in total cholesterol and LDL values. The outcome of significant increase in their total cholesterol and LDL values: unknown. The lot number for the vaccine, (BNT162B2), not provided and will be requested during follow-up. Sender's comments: Linked report(s): US-PFIZER INC-202101106284 same drug/AE/reporter, different patient.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fibromyalgia, SARS-CoV-2 test
Clinical narrative: After my 2nd dose of Covid Vaccine, I have experienced weekly flare ups of my fibromyalgia. It had been over 10 years since I had experienced any symptoms.; This is a spontaneous report from a contactable consumer (patient) and other HCP. A 57-year-old non pregnant female patient received bnt162b2 (BNT162B2, solution for injection, Lot number was not reported) dose 2 via an unspecified route of administration on an unspecified date (at the age of 57-year-old) as dose 2, single for COVID-19 immunisation. Patient was not pregnant at the time of vaccination. The facility in which the vaccination was administered was other. Medical history included fibromyalgia (It had been over 10 years since I had experienced any symptoms), intervertebral disc degeneration. Patient had known allergies. Historical vaccine includes bnt162b2 (Lot number: EP7534) dose 1 via an unspecified route of administration, administered in the left arm on 01Apr2021 (at the age of 57-years-old) as dose 1, single for COVID-19 immunisation. No other vaccines were given within 4 weeks. Patient administered other medications in 2 weeks. Concomitant medication was not reported. Post vaccination, the patient was tested positive for COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 26Apr2021 the patient experienced after my 2nd dose of covid vaccine, I have experienced weekly flare ups of my fibromyalgia, it had been over 10 years since I had experienced any symptoms. No treatment was given for the events. The patient underwent lab tests and procedures which included sars-cov-2 test resulted negative on 20Aug2021. The clinical outcome of the event was reported as not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: broke out with psoriasis really bad/ had a little bit of psoriasis on the back of her neck; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient's husband). A 36-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, Expiry date was not reported), via an unspecified route of administration, administered in left arm, on an unspecified date sometime in Jun2021 10:00 (at the age of 36-year-old) as dose 2, single for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported, Expiry date was not reported), via an unspecified route of administration, administered anatomical location was not reported, on an unspecified date at the end of May2021 (at the age of 36-year-old) as dose 1, single for COVID-19 immunization. The patient does not receive additional vaccines administered on same date of the Pfizer suspect. The patient visited Physician office (dermatologist) because of adverse event. The patient does not receive any vaccination aside from COVID-19 vaccine within 4 weeks. The patient never had any issues with any type of vaccine. The patient received Pfizer COVID-19 vaccine for travel purpose. On unspecified date in 2021, the patient was broke out really bad with psoriasis and is covered with it now. The patient went to the dermatologist and the dermatologist asked her if she got the vaccine. The dermatologist told her that because she had a little bit of psoriasis on the back of her neck, the vaccine is the reason that she is now covered with psoriasis. The reporter does not have her vaccination card to provide dates of doses, lot numbers, expiration date or NDC. Two weeks after her second dose she noticed the psoriasis starting to spread. It is getting a lot worse. The patient had been to the doctor and was given one type of pill and it does not work and then she was switched to another pill and that did not work either, the psoriasis is getting worse. The reporter does not have the names of the pills she took that did not work. The outcome of the event was not recovered.  No follow up attempts are needed, information about batch/lot number cannot be obtained.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Fatigue, Headache, Illness, Nausea
Clinical narrative: her husband is really sick; He has been nauseous; really tired; sleeping a whole lot; Shaking; had a headache; Left arm is really sore; Cold sweat; This is a spontaneous report from a contactable consumer (patient's wife) reporting for a 59-year-old male patient (reporter's husband). A 59-year-old male patient received bnt162b2 (PFIZER BIONETCH COVID-19 MRNA VACCINE Solution for injection Lot number was not reported) via intramuscularly in arm left on 23Aug2021 14:00 as dose 1, single (age at vaccination: 59 years) for COVID-19 immunisation. Medical history included pain, anxiety disorder, neuropathy, all from an unknown date and unknown if ongoing. Concomitant medications included alprazolam (XANAX) 4 mg, daily taken for anxiety disorder Started taking 10 years ago, start and stop date were not reported; gabapentin (NEURONTIN) either 350mg or 400 mg three times daily started 8 years ago, taken for neuropathy, start and stop date were not reported; buprenorphine hydrochloride (SUBUTEX) taken for pain 8mg 3 times sublingual daily started taking it 18 years ago, start and stop date were not reported. Prior Vaccinations (within 4 weeks), other vaccinations within four weeks prior to the first administration date of the suspect vaccines was none. The adverse events following prior vaccinations was none. Additional vaccines administered on same date of the Pfizer suspect was none. On 24Aug2021, the patient experienced cold sweat, sleeping a whole lot, Shaking and had a headache, left arm is really sore. It was reported by the reported that her husband is really sick. She feels like someone is squeezing her throat and it hurts really bad and had a hard time swallowing and is sick. Her throat hurts so bad and feels like it is closing. He is sick from the shot too. He had cold sweats and has been sleeping a whole lot. He has been nauseous. He was shaking and had a headache. He tried to work yesterday and the boss sent him home because he was in a daze and really out of it and really tired. It all started on 24Aug2021, she does not know outcome because he is still sleeping, she would like to know if this is a normal reaction. Both received it at the same time and place, he got his after hers, they were not even going to get it and dont know about getting second one. The adverse events did not require a visit to emergency room/physician office. Treatment was received. The pharmacist told him to take Tylenol and if it is not better by the end of the day, he wants her to report back to the pharmacist. The clinical outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Somnolence, Tremor
Clinical narrative: her husband is really sick; He has been nauseous; really tired; sleeping a whole lot; Shaking; had a headache; Left arm is really sore; Cold sweat; This is a spontaneous report from a contactable consumer (patient's wife) reporting for a 59-year-old male patient (reporter's husband). A 59-year-old male patient received bnt162b2 (PFIZER BIONETCH COVID-19 MRNA VACCINE Solution for injection Lot number was not reported) via intramuscularly in arm left on 23Aug2021 14:00 as dose 1, single (age at vaccination: 59 years) for COVID-19 immunisation. Medical history included pain, anxiety disorder, neuropathy, all from an unknown date and unknown if ongoing. Concomitant medications included alprazolam (XANAX) 4 mg, daily taken for anxiety disorder Started taking 10 years ago, start and stop date were not reported; gabapentin (NEURONTIN) either 350mg or 400 mg three times daily started 8 years ago, taken for neuropathy, start and stop date were not reported; buprenorphine hydrochloride (SUBUTEX) taken for pain 8mg 3 times sublingual daily started taking it 18 years ago, start and stop date were not reported. Prior Vaccinations (within 4 weeks), other vaccinations within four weeks prior to the first administration date of the suspect vaccines was none. The adverse events following prior vaccinations was none. Additional vaccines administered on same date of the Pfizer suspect was none. On 24Aug2021, the patient experienced cold sweat, sleeping a whole lot, Shaking and had a headache, left arm is really sore. It was reported by the reported that her husband is really sick. She feels like someone is squeezing her throat and it hurts really bad and had a hard time swallowing and is sick. Her throat hurts so bad and feels like it is closing. He is sick from the shot too. He had cold sweats and has been sleeping a whole lot. He has been nauseous. He was shaking and had a headache. He tried to work yesterday and the boss sent him home because he was in a daze and really out of it and really tired. It all started on 24Aug2021, she does not know outcome because he is still sleeping, she would like to know if this is a normal reaction. Both received it at the same time and place, he got his after hers, they were not even going to get it and dont know about getting second one. The adverse events did not require a visit to emergency room/physician office. Treatment was received. The pharmacist told him to take Tylenol and if it is not better by the end of the day, he wants her to report back to the pharmacist. The clinical outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A patient, of unspecified age and gender, received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. The patient received the first of the two COVID-19 vaccines and had an immediate allergic reaction. The patient mentioned a recommendation of not getting a second dose of this vaccine. The patient queried about level of protection would that they'd have long-term after just receiving one dose of this vaccine. Patient asked where would they be able to obtain samples of the ingredients in the vaccine to tell what exactly they are allergic to. The patient went to the allergist. He was at a loss for where to obtain the ingredients. The outcome of event: unknown. The lot number for the vaccine, (BNT162B2), not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Depression, Mood altered, Pruritus, Rash macular, Renal disorder
Clinical narrative: This is a spontaneous report from a contactable consumer. A female patient, of unspecified age,  received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# and expiry date: unknown), via unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. Historical vaccine included the first dose of BNT162B2, via unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. Patient's medical history and concomitant medications not reported. Patient was going through a horrible experience since she her second dose of the Pfizer vaccine. She has seen more than 8 doctors so far. Her whole body was full of red dots that were extremely itchy. She gained over 40 pounds on prednisone. She was overly depressed. She tried all sorts of allergy medication. They even gave her ivermectin; she had no more itch for the first 9 days; then the effects came back. Taking all sort of medications was ruining her kidneys. She doesn't sleep and her mood was extremely bad. She was also getting very anxious and thus definitely affecting her daily life. The outcome of "her whole body is full of red dots that are extremely itchy:" not recovered; the rest: unknown. Follow-up attempts  completed. Batch/lot number not available for BNT162B2. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: This is a spontaneous report from a contactable consumer. A female patient, of unspecified age,  received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# and expiry date: unknown), via unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. Historical vaccine included the first dose of BNT162B2, via unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. Patient's medical history and concomitant medications not reported. Patient was going through a horrible experience since she her second dose of the Pfizer vaccine. She has seen more than 8 doctors so far. Her whole body was full of red dots that were extremely itchy. She gained over 40 pounds on prednisone. She was overly depressed. She tried all sorts of allergy medication. They even gave her ivermectin; she had no more itch for the first 9 days; then the effects came back. Taking all sort of medications was ruining her kidneys. She doesn't sleep and her mood was extremely bad. She was also getting very anxious and thus definitely affecting her daily life. The outcome of "her whole body is full of red dots that are extremely itchy:" not recovered; the rest: unknown. Follow-up attempts  completed. Batch/lot number not available for BNT162B2. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A female patient, of an unspecified age, received the 1st dose of BNTBNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# and expiration date not reported), via an unspecified route of administration, on Aug 19, 2021, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. The patient experienced dizziness on an unspecified date. Patient wanted to know more about the side effects of the Pfizer COVID-19 vaccine. Her second dose is scheduled on Sep 9, 2021. The outcome of the events: unknown. The lot number for the vaccine, (BNT162B2), not provided and will be requested during follow-up. No follow-up attempts needed. Information about lot/batch number cannot be obtained. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: This is a spontaneous report from a contactable consumer. A patient, of unspecified age and gender, received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# unknown), via an unspecified route of administration, on an unspecified date (Saturday), single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. On an unspecified date (Tuesday and on that day), patient broke-out in rashes on legs, thighs, buttocks and on arm; with outcome of unknown. Information on the lot/batch number requested.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Blood test, Fatigue, Heart rate, Heart rate increased
Clinical narrative: Extreme fatigue; Extreme thirst; Anxiety; Insomnia; Rapid heartbeat; heart palpitations; This is a spontaneous report from a contactable Consumer or other non-HCP (Patient). A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: not reported) via an unspecified route of administration, administered on Left arm on 23Jul2021 11:00 (at the age of 46-year-old) as dose 1, single for COVID-19 immunization. The patient medical history not reported and concomitant medications (in two weeks) were none. Patient has no Known allergies. The patient had not received any other vaccine within 4 weeks. Prior to vaccination, patient was not diagnosed with COVID-19. Post vaccination, the patient has been tested for COVID-19. It was reported that on 23Jul2021 11:00 patient experienced Extreme fatigue, Extreme thirst, Anxiety, Insomnia, Rapid heartbeat and heart palpitations. The clinical course reported as follows, the patient stated that, this has been going on for nearly five weeks. The patient had two trips to the doctor's office for bloodwork. All were normal except for elevated calcium and hemoglobin conducive with dehydration. His doctor was unconcerned. A second doctor who I followed up with recommended a cardiologist. He was previously healthy. Patient underwent lab test and procedures which included on an unspecified date blood work- All are normal except for elevated calcium and haemoglobin conducive with dehydration and Heart Beat rapid whereas on 26Jul2021 Binax Nasal Swab-negative. Patient did not receive any treatment for the event. Outcome of the events was not recovered.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Palpitations, SARS-CoV-2 test, Thirst
Clinical narrative: Extreme fatigue; Extreme thirst; Anxiety; Insomnia; Rapid heartbeat; heart palpitations; This is a spontaneous report from a contactable Consumer or other non-HCP (Patient). A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: not reported) via an unspecified route of administration, administered on Left arm on 23Jul2021 11:00 (at the age of 46-year-old) as dose 1, single for COVID-19 immunization. The patient medical history not reported and concomitant medications (in two weeks) were none. Patient has no Known allergies. The patient had not received any other vaccine within 4 weeks. Prior to vaccination, patient was not diagnosed with COVID-19. Post vaccination, the patient has been tested for COVID-19. It was reported that on 23Jul2021 11:00 patient experienced Extreme fatigue, Extreme thirst, Anxiety, Insomnia, Rapid heartbeat and heart palpitations. The clinical course reported as follows, the patient stated that, this has been going on for nearly five weeks. The patient had two trips to the doctor's office for bloodwork. All were normal except for elevated calcium and hemoglobin conducive with dehydration. His doctor was unconcerned. A second doctor who I followed up with recommended a cardiologist. He was previously healthy. Patient underwent lab test and procedures which included on an unspecified date blood work- All are normal except for elevated calcium and haemoglobin conducive with dehydration and Heart Beat rapid whereas on 26Jul2021 Binax Nasal Swab-negative. Patient did not receive any treatment for the event. Outcome of the events was not recovered.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test
Clinical narrative: Left arm is still sore primarily when I am lifting weights; This is a spontaneous report from a contactable consumer or other non hcp (Patient herself). A 51-years-old female (Non pregnant) patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection), via an unspecified route of administration, administered in Arm Left (Age at the time of vaccination 51-year-old) on 05Aug2021, at 17:30 as dose 1, single for covid-19 immunization. The patient did not receive other vaccine in four weeks. The patient medical history was not reported. Concomitant medications included in two weeks as vitamin d3 (VITAMIN D3), angelica sinensis, cimicifuga racemosa, hesperidin, oryzanol, vitex agnus-castus (MENOSENSE), turmeric [curcuma longa rhizome] (TURMERIC [CURCUMA LONGA RHIZOME]), diloxanide furoate, metronidazole (DIMET-PLUS) and ascorbic acid (VIT C). On 07Aug2021 at 09:45, in timeframe between vaccination and starting of symptoms was 2 days 9 hrs 45 min,  the patient experienced left arm is still sore primarily when she lifting weights. The patient underwent lab tests and procedures which included Binax (Nasal Swab) test was negative on 18Aug2021. The patient not had covid prior vaccination; tested for covid post vaccination. The patient did not receive any treatment for AE. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Ocular hyperaemia, Swelling of eyelid
Clinical narrative: This is a spontaneous report from a contactable consumer (the patient). A 27-year-old female patient (non-pregnant) received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), at the vaccination age of 27, via an unspecified route of administration, left arm, on Aug 28, 2021, at 11:45, single dose, for COVID-19 immunisation. Medical history reported as none. The patient did not have any known allergies. There were no concomitant medications. The patient had swollen eyelids and red eyes about 8 hours post injection on Aug 28, 2021, at 20:15. The patient did not take other medications in two weeks. No other vaccines were taken in four weeks. No therapeutic measures taken in response to the events. The patient did not have COVID-19 prior to the vaccination. The patient did not get COVID-19 tested post vaccination. The outcome of the events: not recovered. The lot number for the vaccine (BNT162B2), not provided and will be requested during follow-up.
Sex: M
Vaccine: COVID19
Symptoms: Fall, Fatigue, Somnolence
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-HCP (patient's wife), for a male patient (reporter's husband). A male patient, of an unspecified age, received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. Medical history included neuropathy from diabetes. Concomitant medications not reported. Additional Context: The report is cross referenced to report ID: 2T5JQW1M. Caller also called to report adverse reaction for herself with COVID-19 vaccine. Reporter consented to do a report for her husband. This report is for her husband. Reporter's husband was just tired after it. He also got Pfizer COVID-19 vaccine. He is always tired. He is in a walker because he fell when he was in a hurry to get to the bathroom (not related to the vaccine). He has neuropathy from diabetes. His feet are messed up. He cannot walk without the walker. Reporter stated he was sleeping, and he sleeps a lot. The outcome of the events: unknown. The lot number for the vaccine, (BNT162B2), not provided and will be requested during follow-up. Follow-up attempts completed. No further information expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Palms and soles of feet itch, no rash, blister, or blemishes on hands or feet; This is a spontaneous report from a contactable consumer. This 34-year-old female consumer (patient) reported.  A 34-years-old non-pregnant female patient (not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FD8448), via an unspecified route of administration, administered in Right arm on 18Aug2021 08:30 (34-years-old at the time of vaccination) as dose 1, single for covid-19 immunisation. The patient medical history included Environmental allergies, PCOS (polycystic ovaries), Von Wille brands from an unknown date and unknown if ongoing. The patient's concomitant medications in two weeks included Multivitamin. The patient had not taken other vaccine in four weeks. The patient had not been tested for covid prior vaccination. The patient had not been tested for covid post vaccination. On 19Aug2021 at 12 pm, the patient experienced palms and soles of feet itch, no rash, blister, or blemishes on hands or feet. The patient not received any treatment. The outcome of event was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated
Clinical narrative: receiving her Covid-19 vaccine and is unfortunately having a flare from that; This is a spontaneous report from a contactable other health professional. A 21-years-old female patient 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 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and medications were not reported. Previously, the patient took XELJANZ XR (tab 11mg) and had no adverse events; and took HUMIRA and had side effects that had gone away. Reportedly, the reporter spoke with patient's mother, and it was reported that the patient reported no adverse events from XELJANZ, and she reported that her HUMIRA side effects had gone away. The patient had received her Covid-19 vaccine and was unfortunately having a flare from that on an unspecified date. The outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Angiogram, Computerised tomogram, Feeling abnormal, Headache, Influenza like illness
Clinical narrative: Flu like symptoms that last for 3 days; headache; I wake with what feels like a hangover and typically it gets worse from there; Tension level headache; Patient could only imagine is what a migraine may feel like; This is a spontaneous report from a contactable consumer or other non-HCP (patient). A patient of an unspecified age and gender received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKOWN) via an unspecified route of administration on 15Feb2021 as dose 1, single for COVID-19 immunization. Patient medical history included COVID-19 in Jan2021, was hospitalized from 18Jan2021 to 23Jan2021. Received the Remdesivir injections for 5 days and was discharged on an unspecified date in Jan2021. On 15Feb2021, patient received the first of 2 Pfizer covid-19 injections (the second on 10Mar2021). The next day, 16Feb2021 developed flu like symptoms that lasted 3 days. At the end of the 3 days most symptoms had gone away but still had daily reoccurring headaches on an unspecified date in Feb2021. It was now 6 months later and still had daily headaches. Many days the headache was almost debilitating. At best wake with what felt like a hangover and typically it got worse from there on an unspecified date in Feb2021. At best many of the hours in a day it felt like a bad hangover, progressing to what may be a tension level headache and maybe finishing with what patient could only imagine is what a migraine may feel like on an unspecified date in 2021. The treatment medications included Nortriptyline at bedtime, Nurtec, Zipsor, Ubrelvy and Ajovy injections. Zipsor when Nurtec or Ubrelvy did not help. Patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKOWN) via an unspecified route of administration on 10Mar2021 as dose 2, single for COVID-19 immunization. Patient had an MRI, MRA and MRV of the brain with results as unspecified. Had MRI of the neck and spine with result as unspecified. A TMJ CT scan with result as unspecified and COVID-19 on an unspecified date in Jan2021. Seeing a neurologist but to date still had issues and did not see any light at the end of a very dark tunnel. The outcome of the events headache and feeling abnormal was not recovered, of the events tension headache and migraine was unknown, while of the event flu like symptoms was resolved on 19Feb2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Information about lot/batch number cannot be obtained. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Magnetic resonance imaging head, Migraine, SARS-CoV-2 test, Tension headache
Clinical narrative: Flu like symptoms that last for 3 days; headache; I wake with what feels like a hangover and typically it gets worse from there; Tension level headache; Patient could only imagine is what a migraine may feel like; This is a spontaneous report from a contactable consumer or other non-HCP (patient). A patient of an unspecified age and gender received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKOWN) via an unspecified route of administration on 15Feb2021 as dose 1, single for COVID-19 immunization. Patient medical history included COVID-19 in Jan2021, was hospitalized from 18Jan2021 to 23Jan2021. Received the Remdesivir injections for 5 days and was discharged on an unspecified date in Jan2021. On 15Feb2021, patient received the first of 2 Pfizer covid-19 injections (the second on 10Mar2021). The next day, 16Feb2021 developed flu like symptoms that lasted 3 days. At the end of the 3 days most symptoms had gone away but still had daily reoccurring headaches on an unspecified date in Feb2021. It was now 6 months later and still had daily headaches. Many days the headache was almost debilitating. At best wake with what felt like a hangover and typically it got worse from there on an unspecified date in Feb2021. At best many of the hours in a day it felt like a bad hangover, progressing to what may be a tension level headache and maybe finishing with what patient could only imagine is what a migraine may feel like on an unspecified date in 2021. The treatment medications included Nortriptyline at bedtime, Nurtec, Zipsor, Ubrelvy and Ajovy injections. Zipsor when Nurtec or Ubrelvy did not help. Patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKOWN) via an unspecified route of administration on 10Mar2021 as dose 2, single for COVID-19 immunization. Patient had an MRI, MRA and MRV of the brain with results as unspecified. Had MRI of the neck and spine with result as unspecified. A TMJ CT scan with result as unspecified and COVID-19 on an unspecified date in Jan2021. Seeing a neurologist but to date still had issues and did not see any light at the end of a very dark tunnel. The outcome of the events headache and feeling abnormal was not recovered, of the events tension headache and migraine was unknown, while of the event flu like symptoms was resolved on 19Feb2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Information about lot/batch number cannot be obtained. No further information expected.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Nasal congestion, Pruritus, Pyrexia, Rash
Clinical narrative: Itchy; rash like hives on face, eyes, arms, back, legs, mouth; Stuffy nose; 99.5 fever; rash like hives on face, eyes, arms, back, legs, mouth; This is a spontaneous report from a contactable Consumer. A 14-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 25Aug2021 15:00 (age at vaccination 14-years-old) as dose 2, single for covid-19 immunisation. Medical history included ADHD from an unknown date and unknown if ongoing. Concomitant medication included methylphenidate hydrochloride (CONCERTA) in two weeks. The patient historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 04Aug2021 12:00 (age at vaccination 14-years-old) as dose 1, single for covid-19 immunisation. Patient was not taken any other vaccine in four weeks. On 27Aug2021 17:00, patient experienced Itchy, rash like hives on face, eyes, arms, back, legs, mouth. Stuffy nose, 99.5 fever. Ae resulted in physician office visit. Treatment received with Benadryl, Prednisone RX. Patient has stated that she had not been diagnosed with COVID -19 prior to vaccination and not been tested since the vaccination. Outcome of the events was recovering.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Itchy; rash like hives on face, eyes, arms, back, legs, mouth; Stuffy nose; 99.5 fever; rash like hives on face, eyes, arms, back, legs, mouth; This is a spontaneous report from a contactable Consumer. A 14-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 25Aug2021 15:00 (age at vaccination 14-years-old) as dose 2, single for covid-19 immunisation. Medical history included ADHD from an unknown date and unknown if ongoing. Concomitant medication included methylphenidate hydrochloride (CONCERTA) in two weeks. The patient historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 04Aug2021 12:00 (age at vaccination 14-years-old) as dose 1, single for covid-19 immunisation. Patient was not taken any other vaccine in four weeks. On 27Aug2021 17:00, patient experienced Itchy, rash like hives on face, eyes, arms, back, legs, mouth. Stuffy nose, 99.5 fever. Ae resulted in physician office visit. Treatment received with Benadryl, Prednisone RX. Patient has stated that she had not been diagnosed with COVID -19 prior to vaccination and not been tested since the vaccination. Outcome of the events was recovering.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 0.17
Sex: M
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 2month old was given Havrix; accidentally given Havrix instead of Engerix-B; This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-month-old male patient who received HAV (Havrix) (batch number 2JD3Y, expiry date 4th December 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th September 2021, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 30th September 2021, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were 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 as follows: The 2 month old patient was accidentally given Havrix instead of Engerix-B, which led to inappropriate age at vaccine administration and wrong vaccine administered. No symptoms reported.  The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Inappropriate Schedule of SHINGRIX/received the first dose on 2019 but not the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 16th August 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of the Shingrix, which led to incomplete course of vaccination. The VAERS details reported for 1st dose of Shingrix. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Inappropriate schedule of Vaccine/has not received the second dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in November 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient had not received the second dose of Shingrix till the time of reporting, which led to incomplete course of vaccination. The reporter had nothing else to report.
Age: 0.5
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: inappropriate age/ 6 month old received Kinrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 6-month-old male patient who received DTPa-IPV (Kinrix) (batch number 7P5J5, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 27th September 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 27th September 2021, 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 as follows: The Medical assistant reported the case. The patient received a dose of Kinrix at 6 months of age, which led to inappropriate age at vaccine administration. No symptoms reported.  The reporter consented to follow up.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Therapeutic response unexpected
Clinical narrative: felt so good that she has never been more energetic in her life; she felt like she was coming down with the flu; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (she felt like she was coming down with the flu) and THERAPEUTIC RESPONSE UNEXPECTED (felt so good that she has never been more energetic in her life) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (she felt like she was coming down with the flu). On 27-Jan-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (felt so good that she has never been more energetic in her life). On 27-Jan-2021, INFLUENZA LIKE ILLNESS (she felt like she was coming down with the flu) had resolved. At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (felt so good that she has never been more energetic in her life) outcome was unknown.            No concomitant medication information were provided. No treatment information were provided.   This case was linked to MOD-2021-335962, MOD-2021-335982 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Blood glucose, Hyperglycaemia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of hyperglycemia (increased blood sugar levels after getting the booster) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Feb 4, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 4, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Aug 24, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced hyperglycemia (increased blood sugar levels after getting the booster). At the time of the report, hyperglycemia (increased blood sugar levels after getting the booster) outcome: unknown. Diagnostic results: On an unknown date, blood glucose: increased (high)/increased blood glucose. No concomitant medication or treatment information provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE USED; This spontaneous report received from a health care professional concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A expiry: 21-SEP-2021) dose was not reported, administered on 04-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-OCT-2021, the patient experienced expired vaccine used. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine used was not reported. This report was non-serious. This case, from the same reporter is linked to 20211006668, 20211006798, 20211009653 and 20211009632.
Sex: F
Vaccine: COVID19
Symptoms: Pneumonia, Throat irritation
Clinical narrative: PNEUMONIA; TICKLE IN THE BACK OF HER THROAT; This spontaneous report received from a consumer concerned a female of unspecified age of unknown race and ethnicity.. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient had tickle in the back of her throat and according to reporter patient was positive because patient work from home. Patient got hit hard and went to the doctor and had the start of pneumonia and almost ended up in the hospital. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pneumonia and tickle in the back of her throat was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20211007273.; Sender's Comments: V0;20211007486; -covid-19 vaccine ad26.cov2.s Pneumonia. This event is considered unassessable. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.