chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Severe vomiting and diarrhea 2 hours following vaccination; Severe vomiting and diarrhea 2 hours following vaccination; This is a spontaneous report from a contactable consumer (patient reported for herself). A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number and expiration date were not reported), via an unspecified route of administration at the left arm on 20Jan2021 at 16:00 (04:00 PM) at single dose for Covid-19 immunization, administered in a hospital. The patient was not pregnant at the time of vaccination. The patient's medical history included prior malignancy s/p chemo and targeted therapy (last dose approximately 3 years ago). The patient had no allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced severe vomiting and diarrhea 2 hours following vaccination on 20Jan2021 at 18:30 (06:30 PM). Therapeutic measures were taken as a result of the events which included ondansetron, oral fluids, and lorazepam. The outcome of the events was not recovered.    Information on the lot/batch number has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Myalgia, SARS-CoV-2 test
Clinical narrative: Dizziness; extreme fatigue (unable to drive and doze off during conversations); headache; muscle aches; vomiting still after 8 days.; This is a spontaneous report from a contactable healthcare professional (patient herself). A 40-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, expiry date not reported), via an unspecified route of administration in the right arm on 12Jan2021 09:00 at single dose for COVID-19 immunisation. Medical history included bipolar disorder and ovarian cyst. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has been tested for COVID-19. Concomitant medications included trazodone, desvenlafaxine succinate (PRISTIQ), and oxcarbazepine (TRILEPTAL). The patient previously took morphine sulfate and experienced allergies. On 12Jan2021 19:00, the patient experienced dizziness, extreme fatigue (unable to drive and doze off during conversations), headache, muscle aches and vomiting still after 8 days. The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative on 12Jan2021. No treatment was received for the adverse events. Clinical outcome of the events was not recovered.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Dizziness; extreme fatigue (unable to drive and doze off during conversations); headache; muscle aches; vomiting still after 8 days.; This is a spontaneous report from a contactable healthcare professional (patient herself). A 40-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, expiry date not reported), via an unspecified route of administration in the right arm on 12Jan2021 09:00 at single dose for COVID-19 immunisation. Medical history included bipolar disorder and ovarian cyst. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has been tested for COVID-19. Concomitant medications included trazodone, desvenlafaxine succinate (PRISTIQ), and oxcarbazepine (TRILEPTAL). The patient previously took morphine sulfate and experienced allergies. On 12Jan2021 19:00, the patient experienced dizziness, extreme fatigue (unable to drive and doze off during conversations), headache, muscle aches and vomiting still after 8 days. The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative on 12Jan2021. No treatment was received for the adverse events. Clinical outcome of the events was not recovered.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: A patient who has received the first dose, and then tests positive for COVID-19; A patient who has received the first dose, and then tests positive for COVID-19; This is a spontaneous report from a contactable pharmacist reported that a patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The pharmacist asked if there any information available for scheduling the second vaccine dose of the series in a patient who has received the first dose, and then tests positive for COVID-19 after already receiving the first dose. The outcome of the events was unknown.   Information about batch/lot number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 test positive and suspected LOE  due to temporal relationship.   There is limited information provided in this report.   This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Having some on and off pain like body aches; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer (patient). A female patient of an unspecified age received her first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; unknown lot number and expiration date), via an unspecified route of administration, on an unspecified date, at a single dose for COVID-19 immunization. Medical history included COVID-19 from Apr2020 to an unknown date as she had COVID in Apr2020 and she has had after effect symptoms long term, diabetes, blood pressures (blood pressure abnormal) and cholesterol (blood cholesterol abnormal). Concomitant medication included lisinopril for blood pressures, metformin for diabetes and simvastatin for cholesterol. The patient reported that she received the first dose of the COVID vaccine on Sunday (unspecified date). She mentioned that she has been having some on and off pain like body aches on an unspecified date. She added that she had COVID in Apr2020 and she has had after effect symptoms long term. She stated that she thought these symptoms would disappear after first dose of COVID vaccine, but this did not happen, and she is hoping it will happen after the second dose. She inquired if she can take ibuprofen (MOTRIN) for body aches. The outcome of the event was unknown.  The following information on the batch/lot number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ear discomfort, Lymphadenopathy, Pain, Pain assessment
Clinical narrative: swollen lymph node; Pain started on Sunday, 17Jan2021. 5/10 pain scale on Sunday.; felt a tickle behind his left ear; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age (reported age was 62 without unit) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date were not reported), via an unspecified route of administration on 16Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. During the injection on 16Jan2021, the patient felt a tickle behind his left ear. Pain started on Sunday, 17Jan2021. 5/10 pain scale on Sunday. He stated that "it hurts more after 8 hours of work, in the morning it is good." The patient believes it is a "swollen lymph node." Outcome of the events was unknown.   Information on the lot/ batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy
Clinical narrative: swollen lymph node; Pain started on Sunday, 17Jan2021. 5/10 pain scale on Sunday.; felt a tickle behind his left ear; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age (reported age was 62 without unit) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date were not reported), via an unspecified route of administration on 16Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. During the injection on 16Jan2021, the patient felt a tickle behind his left ear. Pain started on Sunday, 17Jan2021. 5/10 pain scale on Sunday. He stated that "it hurts more after 8 hours of work, in the morning it is good." The patient believes it is a "swollen lymph node." Outcome of the events was unknown.   Information on the lot/ batch number has been requested.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Gait disturbance, Groin pain, Pain in extremity
Clinical narrative: pain in right groin; difficulty walking; arm soreness; redness on the toe of his left foot; This is a spontaneous report from a contactable consumer (patient himself). An 86-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL1284, expiration date was unknown), via an unspecified route of administration on the left arm on 16Jan2021 at a single dose for COVID-19 immunization; it was offered to him and he was in the Phase 1B category. Relevant medical history included ongoing type 2 diabetes mellitus, which was diagnosed 10-15 years prior reporting, had a watchman procedure on an unspecified date, and had used a cane to walk before. Concomitant medication included clopidogrel as a blood thinner from 15Jan2021 and ongoing, which he would take for 6 months. The patient previously took apixaban (ELIQUIS). It was reported that he had a watchman procedure and they took him off of apixaban and started him on clopidogrel. In 6 months, he would not have to take any blood thinners and would make an appointment with his physician. On 18Jan2021, at noon, the patient was experiencing pain in his right groin. As the day progressed it got worse. By night (18Jan2021), he was in extreme pain and had difficulty walking. He had to use a walker to walk. It had let up, but he still had pain in the groin of his right leg. The patient was asking if there were certain doctors that could assist him with this problem. He was no longer using a walker. He was using a cane instead. He used a cane to walk with before this, but not for this reason. He never had any real serious aching. He had a little soreness in his arm on an unspecified date in Jan2021, but nothing out of the ordinary. He didn't know his arm was sore until he rubbed it. He though it might have been on Sunday when he noticed it. He was not sure. Prior to this, he had redness on the toe of his left foot on an unspecified date in Jan2021. He was prescribed an antibiotic that he was still taking. He was unable to provide the name of the antibiotic. Therapeutic measures were taken as a result of "difficulty walking and redness on the toe of his left foot. The patient had no investigation assessment. The patient was recovering from the event "pain in right groin," he was not recovered from the event "difficulty walking," while the outcome of the events "arm soreness and redness on the toe of his left foot" was unknown.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, SARS-CoV-2 test, Vasculitic rash
Clinical narrative: Headache; vascular rash on toes; This is a spontaneous report from a contactable consumer (patient). A 63 year-old female patient received first dose of BNT162B2 (lot number: 3246), via an unspecified route of administration on 16Jan2021 14:30 at single dose in the left arm for COVID-19 immunization. Medical history included chronic lymphocytic leukaemia from an unknown date. The patient has no known allergies. Concomitant medication included metformin extended release. On 16Jan2021, the patient experienced headache and vascular rash on toes. The events resulted in doctor or other healthcare professional office/clinic visit. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown if the patient received any treatment for the events. The patient underwent lab tests and procedures which included PCR and nasal swab: both unknown results on 20Jan2021. The outcome of the events was not recovered.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Hypotension, Presyncope
Clinical narrative: tends to have low blood pressure; Dizziness; she lies down and then gets up she is dizzy; tired; she might have almost fainted as the room was spinning; This is a spontaneous report from a contactable consumer, the patient.  A 72-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL1284, expiration date 0Apr2021), via an unspecified route of administration in the left arm on 18Jan2021 at 09:30 (at the age of 72-years-old) as a single dose for COVID-19 vaccination. Medical history included Reflux esophagitis, COPD and a root canal on 14Jan2021. Historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 28Dec2020. Past drug history includes sore arm after COVID-19 vaccination on 28Dec2020.  It was unknown if the patient has any allergies to medications, food, or other products. The patient's concomitant medications included oral famotidine (FAMOTIDINE) 20mg twice daily for reflux, (tiotropium bromide) SPIRIVA 2.5mcg, two puffs once daily by mouth for COPD, latanaprost (LATANAPROST)125mcg; one drop each eye at night for Glaucoma, (TIMOLOL)  5% one drop twice daily to each eye and (LORATADINE) 10mg; take once daily by mouth as needed for allergy. The patient did not receive any other vaccine within four (4) weeks prior to the vaccine. The vaccine was administered to the patient at the hospital. On 19Jan2021 the patient experienced dizziness and feeling tired. The patient further described that she had the vaccine on Monday and since yesterday, when she woke up, she has a lot of dizziness; and again this morning when she woke up. Also, when she lies down and then gets up she is dizzy. Mentions she didn't see dizziness on the list of side effects. She knows that is a side effect of COVID. She is asking is dizziness is a side effect of the vaccine wants to know if she should call her doctor. She continued and mentioned that she noticed when she was waking up on 19Jan2021 she was so dizzy that she couldn't get out of bed. Adds she thinks she might have almost fainted as the room was spinning. Mentions she tends to have low blood pressure but this is not typical. As far as side effects from the vaccine she mentions she is tired. The tiredness started after the second dose and has continued through today but not as bad. The clinical outcome of dizziness was reported as not recovered, the outcome of fatigue was recovering and the outcome of almost fainted and low blood pressure was unknown.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Feeling abnormal, Feeling cold
Clinical narrative: I was so faint/nearly passed out; so hot; very chilled for about 15 or 20 minutes; feeling sort "off"; weak; fatigued/very drained/exhausted; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK4176), via an unspecified route of administration on 19Jan2021 at 08:15 AM at single dose in right arm for COVID-19 immunisation. Patient age at time of vaccination was years 30 years. No other vaccine was given within 4 weeks prior to the COVID vaccine. The patient has no known allergies. The patient had no relevant medical history and received no concomitant medications. The patient reported the following: 'About 5 minutes after receiving the vaccine I was so faint I nearly passed out and was so hot I was given an ice pack to try and cool me down. It took about 45 minutes for me to be able walk across one room. I then was very chilled for about 15 or 20 minutes, and very drained. The rest of the day I was back and forth between feeling sort "off" and feeling like I was weak, exhausted, and fatigued'. Adverse events onset date was reported as 19Jan2021 at 08:15 AM. No treatment was received for the events other than ice pack for feeling hot. The patient was recovering from the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot
Clinical narrative: I was so faint/nearly passed out; so hot; very chilled for about 15 or 20 minutes; feeling sort "off"; weak; fatigued/very drained/exhausted; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK4176), via an unspecified route of administration on 19Jan2021 at 08:15 AM at single dose in right arm for COVID-19 immunisation. Patient age at time of vaccination was years 30 years. No other vaccine was given within 4 weeks prior to the COVID vaccine. The patient has no known allergies. The patient had no relevant medical history and received no concomitant medications. The patient reported the following: 'About 5 minutes after receiving the vaccine I was so faint I nearly passed out and was so hot I was given an ice pack to try and cool me down. It took about 45 minutes for me to be able walk across one room. I then was very chilled for about 15 or 20 minutes, and very drained. The rest of the day I was back and forth between feeling sort "off" and feeling like I was weak, exhausted, and fatigued'. Adverse events onset date was reported as 19Jan2021 at 08:15 AM. No treatment was received for the events other than ice pack for feeling hot. The patient was recovering from the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site discolouration
Clinical narrative: arm was a little blue after receiving injection; This is a spontaneous report from a contactable consumer, the patient.  A 66-year-old male patient received  BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EK9231, expiration date unknown), via an unspecified route of administration in the left arm on 12Jan2021 (at the age of 66-years-old) as a single dose for COVID-19 vaccination. Medical history included "cholesterol."  The patient's concomitant medications included rosuvastatin calcium (CRESTOR) 10 mg daily. It was unknown if the patient has any allergies to medications, food, or other products. It was unknown if the patient had received any other vaccines within four (4) weeks prior to the vaccine. On 13Jan2021 the patient added that his arm was "a little blue" after receiving the injection. Treatment information, if any, was not provided. The clinical outcome of vaccination site discoloration was reported as recovered on 13Jan2021.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash broke out all over my neck; This is a spontaneous report from a contactable physician (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231; expiration date not provided), via an unspecified route of administration in the left arm on 04Jan2021 12:30 at a single dose for COVID-19 immunization. Medical history included Mild anxiety, Sjogrens, Perimenopausal, and Allergies to tree nuts. The patient is not pregnant. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included escitalopram and estradiol (ESTROGEN). On 10Jan2021 06:00, 6 days after injection, the patient had rash broke out all over her neck which has not fully resolved after treatment with oral prednisone 20 mg for 10 days. The outcome of the event was not recovered. The patient has not been tested for COVID post vaccination.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Pyrexia, Vomiting
Clinical narrative: I felt as if I head a fever; sweats; needed to vomit; felt pretty dizzy; This is a spontaneous report from a contactable consumer. A 20-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 20Jan2021 18:45 at SINGLE DOSE at left arm for COVID-19 immunization. Medical history included ulcerative colitis. The patient was not pregnant at the time of vaccination. There were no concomitant medications. No other vaccine in four weeks. No other medications in two weeks. After my vaccine, on 20Jan2021 19:00, the patient felt as if I "head" a fever and sweats and needed to vomit I also felt pretty dizzy, I know this was in the side effects but just wanted to make sure I was going to be okay to receive my second dose. The patient did not receive treatment for the events. The patient recovered from the events on Jan2021.   Information about lot/batch number has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Erythema, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Bad cough; Trouble breathing; Tingling around mouth; Numbness in jaw and neck; Shaking; Red face and chest; Slight itching; This is a spontaneous report from a contactable healthcare professional (the patient).  A 38-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL8982), intramuscular in the left arm on 18Jan2021 at 10:30 (at the age of 38-years-old) as a single dose for Covid-19 immunization. Medical history was not reported. The patient was allergic to penicillin. The patient previously received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EJ1685) on 28Dec2020 in the left arm. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and cetirizine hydrochloride (ALERTEC), both for unknown indication from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Jan2021 at 11:00, the patient experienced bad cough, trouble breathing, tingling around mouth, numbness in jaw and neck, shaking, red face and chest, and slight itching. Treatment was given when seen by paramedics with an emergency room visit which included a second dose of allergy medication. The clinical outcome of the events bad cough, trouble breathing, tingling around mouth, numbness in jaw and neck, shaking, red face and chest, and slight itching was recovering. It was reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: The reported events were likely causally related to the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), considering the plausible temporal relationship and clinical course of the events.  The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Pruritus, Tremor
Clinical narrative: Bad cough; Trouble breathing; Tingling around mouth; Numbness in jaw and neck; Shaking; Red face and chest; Slight itching; This is a spontaneous report from a contactable healthcare professional (the patient).  A 38-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL8982), intramuscular in the left arm on 18Jan2021 at 10:30 (at the age of 38-years-old) as a single dose for Covid-19 immunization. Medical history was not reported. The patient was allergic to penicillin. The patient previously received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EJ1685) on 28Dec2020 in the left arm. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and cetirizine hydrochloride (ALERTEC), both for unknown indication from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Jan2021 at 11:00, the patient experienced bad cough, trouble breathing, tingling around mouth, numbness in jaw and neck, shaking, red face and chest, and slight itching. Treatment was given when seen by paramedics with an emergency room visit which included a second dose of allergy medication. The clinical outcome of the events bad cough, trouble breathing, tingling around mouth, numbness in jaw and neck, shaking, red face and chest, and slight itching was recovering. It was reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: The reported events were likely causally related to the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), considering the plausible temporal relationship and clinical course of the events.  The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swelling of left lymph node under left armpit; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration in the left arm on 19Jan2021 12:45 at a single dose for COVID-19 immunization. Medical history was none. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), colecalciferol (VITAMIN D), and ethinylestradiol, norgestimate (SPRINTEC). Historical vaccine included first dose of PFIZER BIONTECH COVID 19 VACCINE on 29Dec2020 12:30 PM in the left arm for COVID-19 immunization when the patient was 32 years old. The patient was not pregnant. The patient had not received any other vaccine prior to covid vaccine. The patient experienced swelling of left lymph node under left armpit on 20Jan2021 22:15 with outcome of not recovered. Therapeutic measure was taken as a result of swelling of left lymph node under left armpit (lymphadenopathy) with OTC ADVIL.The patient had no covid prior vaccination nor was he tested post vaccination.   Information on Lot/Batch number has been requested.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Scrotal disorder, Scrotal erythema, Scrotal inflammation, Scrotal pain
Clinical narrative: pain is very severe, includes all over the scrotum; includes all over the scrotum, with redness , induration , and kissing of the first layer of the skin; includes all over the scrotum, with redness , induration , and kissing of the first layer of the skin; kissing of the first layer of the skin all over the scrotum; inflammation of the scrotum; Got worse every day; This is a spontaneous report from a contactable physician. A 66-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL1284), via an unspecified route of administration on the Right arm on 07Jan2021 at a [SINGLE DOSE] for COVID-19 immunisation. Medical history included hyperlipidaemia from an unknown date and unknown if ongoing. There were no concomitant medications. The patient had the first dose on 19Dec2020. On 17Jan2021, the patient noticed inflammation of the scrotum which got worse every day. On 20Jan2021, the pain was very severe which included all over the scrotum, with redness and induration and kissing of the first layer of the skin. Therapeutic measures (Eli on ointment, triple antibiotic ointment Kenalog) were taken as a result of the events. The outcome of the events was not recovered.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dysstasia, Gait disturbance, Hypokinesia, Insomnia
Clinical narrative: felt a tinge of pain in my sacral area/It got worse each hour/ It worsen daily/It became painful; Became limited in movements such trying to picking up items from the floor; difficulty running or walking fast as I usually do; Lots of spasms in the sacral area; Difficulty sleeping; Difficulty sleeping and going from sitting to standing; This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiry date: unknown), via an unspecified route of administration in the left arm, on 09Jan2021 15:30, at single dose, for COVID-19 immunization, at the pharmacy. There was no medical history and no known allergies. Concomitant medication included acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN), diphenhydramine hydrochloride (BENADRYL), herbal nos, minerals nos, nutrients nos, vitamins nos (CATALYST) and "Muscle Strength". The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The patient did not have other vaccines in four weeks. The patient reported that on 12Jan2021 at 14:00, "I ardently felt a tinge of pain in my sacral area. Then it got worse each hour. Then I became limited in movements such trying to picking up items from the floor and difficulty running or walking fast as I usually do. It worsened daily. I would workout and then I experienced lots of spasms in the sacral area. It became painful. The patient experienced difficulty sleeping and going from sitting to standing." The events resulted to "Doctor or other healthcare professional office/clinic visit". Treatment for the events included prescription muscle relaxants (unspecified), ibuprofen and "topi". The patient was recovering from the events.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: felt a tinge of pain in my sacral area/It got worse each hour/ It worsen daily/It became painful; Became limited in movements such trying to picking up items from the floor; difficulty running or walking fast as I usually do; Lots of spasms in the sacral area; Difficulty sleeping; Difficulty sleeping and going from sitting to standing; This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiry date: unknown), via an unspecified route of administration in the left arm, on 09Jan2021 15:30, at single dose, for COVID-19 immunization, at the pharmacy. There was no medical history and no known allergies. Concomitant medication included acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN), diphenhydramine hydrochloride (BENADRYL), herbal nos, minerals nos, nutrients nos, vitamins nos (CATALYST) and "Muscle Strength". The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The patient did not have other vaccines in four weeks. The patient reported that on 12Jan2021 at 14:00, "I ardently felt a tinge of pain in my sacral area. Then it got worse each hour. Then I became limited in movements such trying to picking up items from the floor and difficulty running or walking fast as I usually do. It worsened daily. I would workout and then I experienced lots of spasms in the sacral area. It became painful. The patient experienced difficulty sleeping and going from sitting to standing." The events resulted to "Doctor or other healthcare professional office/clinic visit". Treatment for the events included prescription muscle relaxants (unspecified), ibuprofen and "topi". The patient was recovering from the events.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Pain in extremity, Tachycardia, Vision blurred
Clinical narrative: Blurred vision; fatigue; dizziness; tachycardia; arm soreness; This is a spontaneous report from a contactable nurse (patient). A 65-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EJ 1685), via an unspecified route of administration in the left arm on 20Dec2020 08:00 at a single dose for covid-19 immunization. Medical history included prediabetes, spinal stenosis of right back, allergies in penicillin, sulfa and yellow jacket venom. Concomitant medication included gabapentin, metformin, paracetamol (TYLENOL), diclofenac (DICLOFENAC), zinc and vitamins. On 20Dec2020 20:00, 12 hours after vaccine administration, the patient experienced blurred vision, fatigue, dizziness, tachycardia and arm soreness. The patient did not receive treatment for the events. The patient had not tested positive for COVID post vaccination. The outcome of the events was recovered on unspecified date.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pruritus, Urticaria
Clinical narrative: Administration date=13Jan2021, dose number=2/ administration date=21Dec2020, dose number=1; Starting 36 hr after 2nd dose had 4 days of whole body systemic hives, itching; Starting 36 hr after 2nd dose had 4 days of whole body systemic hives, itching; This is a spontaneous report from a contactable nurse. A 48-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration on the Right arm on 13Jan2021 07:45 at a SINGLE DOSE for covid-19 immunisation. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing, hypothyroidism from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (SYNTHROID). The patient had the first dose of BNT162B2 on 21Dec2020. On 15Jan2021 03:00 PM, starting 36 hours after 2nd dose, the patient had 4 days of whole body systemic hives and itching. There were no respiratory symptoms. Therapeutic measures (Pepcid, Zantac, Benadryl oral and cream) were taken as a result of hives and itching. The outcome of the events was recovered on an unspecified date.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle discomfort
Clinical narrative: Slight muscle discomfort; This is a spontaneous report from a contactable consumer (patient). An 82-year-old male patient received BNT162B2 (Lot number: EL3247), via an unspecified route of administration from 20Jan2021 11:15 to 20Jan2021 11:15 at single dose in the left arm for COVID-19 immunization. Medical history included blood pressure (BP) abnormal and high density lipoprotein abnormal (HDL). The patient has no known allergies. Concomitant medication included rosuvastatin calcium (CRESTOR), acetylsalicylic acid (ASP), losartan, ubidecarenone (COQ 10), ascorbic acid, tocopheryl acetate, xantofyl, zeaxanthin, zinc (AREDS) and isosorbide mononitrate (FLO). The patient experienced slight muscle discomfort on an unspecified date with outcome of unknown. The patient did not receive any treatment for the event. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Vaccination site pain, Vaccination site swelling
Clinical narrative: Moderate pain and swelling in the injection site; Moderate pain and swelling in the injection site; moderate headache; chills; This is a spontaneous report from a contactable consumer (patient). A 31-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EK4176), via an unspecified route of administration on 20Jan2021 at 14:00 at single dose on left arm for COVID-19 immunisation. Medical history and concomitant medications were none. No COVID prior vaccination. No COVID tested post vaccination. Known allergies: None. The patient experienced moderate pain and swelling in the injection site started abought 5 hours after receiving the vaccine and experienced moderate headache and chills as well, on 20Jan2021 at 21:00. No treatment was received for the events. Outcome of the events was resolving.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Joint range of motion decreased, Night sweats, Pain in extremity
Clinical narrative: Left arm soreness progressively increasing now 18 hours after injection difficulty raising arm; Left arm soreness progressively increasing now 18 hours after injection difficulty raising arm; Night sweats last night, soaked sheets/pillow/mattress; This is a spontaneous report from a non-contactable pharmacist who reported for self. A 39-year-old male patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL9261), via an unspecified route of administration on 20Jan2021 14:30 at single dose on left arm for COVID-19 immunisation. Medical history was none. No COVID prior vaccination. No COVID tested post vaccination. No known allergies. Concomitant medications included ascorbic acid (VIT C) at 1 g once daily, ubidecarenone (COQ10 [UBIDECARENONE]) at 100 mg once daily, valaciclovir hydrochloride (VALTREX) at 500 mg once daily, all from unknown date for unknown indication. On 20Jan2021 at 16:30, patient experienced left arm soreness progressively increasing 18 hours after injection difficulty raising arm and night sweats last night, soaked sheets/pillow/mattress. No treatment was received. Outcome of the events was not resolved.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Fatigue, Headache
Clinical narrative: fever 101; headache; chills; muscle pain; weakness; nausea; fatigue; This is a spontaneous report from a contactable nurse (patient). A 53-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular on an unspecified date at 10:00 at single dose on left arm for COVID-19 immunisation. Medical history included depression/anxiety, back pain, COVID prior vaccination and known allergies: sulfa and penicillin. Concomitant medication included naproxen, sertraline HCL (ZOLOFT), fish oil, ospemifene (OSPHENA) and docusate sodium (COLACE), all from unknown date for unknown indication. On 12Jan2021 at 17:00, patient experienced fever 101, headache, chills, muscle pain, weakness, nausea and fatigue. Events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received. Nasal Swab on 14Jan2021 was negative. Patient recovered in Jan2021.  Information on the lot/batch number has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, SARS-CoV-2 test
Clinical narrative: fever 101; headache; chills; muscle pain; weakness; nausea; fatigue; This is a spontaneous report from a contactable nurse (patient). A 53-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular on an unspecified date at 10:00 at single dose on left arm for COVID-19 immunisation. Medical history included depression/anxiety, back pain, COVID prior vaccination and known allergies: sulfa and penicillin. Concomitant medication included naproxen, sertraline HCL (ZOLOFT), fish oil, ospemifene (OSPHENA) and docusate sodium (COLACE), all from unknown date for unknown indication. On 12Jan2021 at 17:00, patient experienced fever 101, headache, chills, muscle pain, weakness, nausea and fatigue. Events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received. Nasal Swab on 14Jan2021 was negative. Patient recovered in Jan2021.  Information on the lot/batch number has been requested.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Asthma, Dizziness, Fatigue, Fibromyalgia, Headache
Clinical narrative: Triggered mild asthma attack; wheezing; Continued pain at injection site; Triggered a fibromyalgia episode; body pains; headache; fatigue; dizziness; This is a spontaneous report from a contactable consumer (patient himself). A 39-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247, expiry date not reported), via an unspecified route of administration in the left arm on 19Jan2021 08:45 at single dose for COVID-19 immunisation. Medical history included fibromyalgia and asthma. On 19Jan2021 16:00, the patient experienced triggered mild asthma attack, wheezing, continued pain at injection site, triggered a fibromyalgia episode, body pains, headache, fatigue, and dizziness. No therapeutic measure was taken as a result of the events. Clinical outcome of injection site pain was not recovered while for the other events was recovered on Jan2021.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Vaccination site pain, Wheezing
Clinical narrative: Triggered mild asthma attack; wheezing; Continued pain at injection site; Triggered a fibromyalgia episode; body pains; headache; fatigue; dizziness; This is a spontaneous report from a contactable consumer (patient himself). A 39-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247, expiry date not reported), via an unspecified route of administration in the left arm on 19Jan2021 08:45 at single dose for COVID-19 immunisation. Medical history included fibromyalgia and asthma. On 19Jan2021 16:00, the patient experienced triggered mild asthma attack, wheezing, continued pain at injection site, triggered a fibromyalgia episode, body pains, headache, fatigue, and dizziness. No therapeutic measure was taken as a result of the events. Clinical outcome of injection site pain was not recovered while for the other events was recovered on Jan2021.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: tested positive for Covid; tested positive for Covid; This is a spontaneous report from a contactable consumer(patient).  A male patient of an unspecified age first dose received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on 06Jan2021 at single dose for COVID-19 immunization .  The patient medical history and concomitant medications were not reported.  The patient experienced tested positive for COVID on 12Jan2021 with outcome of unknown. Patient was scheduled for second dose on 27Jan2021, while doctors can't agree on whether he should et that second dose or not.    Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Allergy to vaccine
Clinical narrative: allergic to the first dose; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter was asking if there was any desensitization protocol for a second dose for someone allergic to the first dose. The outcome of the event was unknown.   Information about Lot/Batch has been requested.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Fatigue; Pain at location of vaccine injection when pressing and lifting arm; This is a spontaneous report from a contactable Other Health Professional reported for herself. A 23-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL3247), via an unspecified route of administration on 19Jan2021 at 14:00 at single dose on left arm for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient was not diagnosed with COVID-19 prior to vaccination. Patient had not been tested for COVID-19 since the vaccination. Patient was not pregnant at the time of vaccination. The patient experienced pain at location of vaccine injection when pressing and lifting arm on 19Jan2021 15:00 with outcome of recovering. Fatigue and trouble getting out of bed the morning after the shot on 20Jan2021 with outcome of recovering. This case was reported as non-serious.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Myalgia, SARS-CoV-2 test
Clinical narrative: Continued total body myalgias; weakness; This is a spontaneous report from a contactable Other Health Professional, the patient.  A 43-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3246), via an unspecified route of administration in the left arm on 08Jan2021 at 13:00 PM (at the age of 43-year-old) as a single dose for COVID-19 immunization. Medical history included gastrooesophageal reflux disease. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient had sars-cov-2 test on 04Jan2021 which was negative. Concomitant medication taken within two weeks of vaccination included dexlansoprazole (DEXILANT). The patient did not receive any other vaccines within four weeks prior to the vaccination.  Historical vaccine included Dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EJ1685), left arm  on 19Dec2020 for COVID-19 immunization. The patient reported that he continued total body myalgias and weakness 11 days post injection. The events began on 11Jan2021. The events was reported as non serious. The patient did not receive treatment for the events. The clinical outcome of the events continued total body myalgias, and weakness was not recovered. It was also reported that since the vaccination, the patient had been tested for COVID-19.