chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Full blood count, Haematology test normal, Heart rate decreased, Leukopenia, Metabolic function test
Clinical narrative: [Moderna COVID-19 vaccine] treatment under Emergency Use Authorization(EUA): Moderna COVID-19 Vaccine Lot #039K20A; 70 yo physician with known normal blood counts prior and with no underlying medical conditions 17 days post first dose of vaccine noted to have leukopenia (WBC 3.4) and neutropenia (PMN 673). Also noted to have decreased HRV coincident. Simultaneous routine COVID PCR testing negative. Otherwise asymptomatic. Follow up CBC will be performed. All other hematologic and comprehensive metabolic profile values WNL
Sex: M
Vaccine: COVID19
Symptoms: Neutropenia, Neutrophil count, SARS-CoV-2 test negative
Clinical narrative: [Moderna COVID-19 vaccine] treatment under Emergency Use Authorization(EUA): Moderna COVID-19 Vaccine Lot #039K20A; 70 yo physician with known normal blood counts prior and with no underlying medical conditions 17 days post first dose of vaccine noted to have leukopenia (WBC 3.4) and neutropenia (PMN 673). Also noted to have decreased HRV coincident. Simultaneous routine COVID PCR testing negative. Otherwise asymptomatic. Follow up CBC will be performed. All other hematologic and comprehensive metabolic profile values WNL
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: [Pfizer Covid-19 vaccine] treatment under Emergency Use Authorization(EUA):received the Pzifer COVID vaccine on 12/18/20 at 10:50. I began experiencing numbness and tingling from my knees to my toes 40 minutes following the vaccine in both legs. I am still experiencing tingling and numbness in my legs at times.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: [Covid-19 vaccine] treatment under Emergency Use Authorization(EUA): drew 9 doses out of 1 vial
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Moderna COVID-19 vaccine EUA  Red, hard bump/knot raised , circle form , Warm to touch  Lasts about 3 days
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling hot, Headache, Hyperhidrosis, Nausea
Clinical narrative: 13:21 -vaccine administered 13:40-c/o HA, nausea, dizziness, "hot, sweaty," diaphoretic HR116 BP 135/80 13:45-HR 107 BP 126/74 with worsening HA, persistent nausea.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine administered > 6hrs after the beyond use time
Age: 90.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine administered > 6 hrs after the beyond use time.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: temperature excursion; This spontaneous report was received from a registered nurse and refers to a 4-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 18-DEC-2020, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD), lot# T021638, expiry date was reported as 21-FEB-2021, but upon internal validation established as 21-DEC-2021 (formulation, strength, dose, dose number, route of administration, anatomical location were not provided) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of -13.3 degrees Celsius for 4 hours 15 minutes. There were no previous excursions related. Data logger was involved.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: Caller informed the administration of improperly stored ROTATEQ.; No additional AE/PQC reported; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender (caller unable to provide patient and administration date information). Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On an unknown date, the patient was vaccinated with an improperly stored Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (unknown dosage regimen) orally, lot # S017642 with expiration date 28-FEB-2021, administered as prophylaxis.  The improperly stored dose of the suspect vaccine experienced a temperature excursion of 31 degree farenheit (°F) for 1 hour on 16-SEP-2020; a previous temperature excursion was reported of 47.7 °F, for 9 hours  This case was classified as non-valid due to no patient identifiers.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Anaphylactic shock, Choking, Hypersensitivity, Peripheral swelling
Clinical narrative: severe allergic reaction to it/and went into anaphylactic shock/started choking; severe allergic reaction to it/her arm swelled up; This spontaneous report was received from a 56 years old female patient, who was referring to herself. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. It was reported that she did not have any drug reactions or allergies in her life.  On 20-MAY-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) lot # J014566, expiration date was not reported but upon internal validation process it was established as 18-FEB-2015 (formulation, dose, route of administration and anatomical location were not reported) for prophylaxis.  On the same date, the patient experienced severe allergic reaction to zoster vaccine live (ZOSTAVAX). Her arm swelled up, she started choking, and went into anaphylactic shock. She was sent to an emergency room (ER) and they were waiting. They "pumped her with shot after shot", it was really bad, and finally was able to pull out. They told her if she received another vaccine they may not be able to save her. No laboratory diagnostics or studies were performed. She did not take any vaccines since then. The outcome of the events was reported as recovered.  The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of anaphylactic shock was determined to be medically significant.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Product administered to patient of inappropriate age
Clinical narrative: Arm soreness; Concerned about her age at the time of vaccination; A spontaneous report was received from a nurse concerning a 17-year-old, female patient who was participating in the mRNA-1273 Emergency Use Program and experienced arm soreness. This also resulted in the event, recipient of the vaccine who was younger than 18 years old.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the patient began to experience arm soreness, but no other symptoms, for 1-2 days. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The event recipient of vaccine who was younger than 18 years old, was considered resolved on 30 Dec 2020. The outcome of the event arm soreness was resolved on an unknown date.  The reporter did not provide an assessment for the events.; Reporter's Comments: This report refers to a case of 17- year-old female patient who experienced non-serious unexpected event of recipient of the vaccine was younger than 18 years old (product administered to patient of inappropriate age) for mRNA-1273, lot # unknown, Exp date-unknown. The patient experienced arm soreness, with no other associated adverse events. Based on temporal association and the known safety profile for the vaccine, a causal association with the event of arm soreness cannot be excluded.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: It all went down her arm; A spontaneous report was received from a consumer concerning an 84-year-old, female patient who was participating in the mRNA-1273 Emergency Use Program and the vaccine appeared to leak back out of her arm and it went all down her arm and 5 drips drained.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 12-Jan-2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the right arm for prophylaxis of COVID-19 infection.   Patient's daughter-in-law reported that patient received the Moderna vaccine on 12-Jan-2021 at a carside vaccination clinic.  She stated that after the vaccine was administered by injection to her right arm, it appeared to leak back out of her arm.  She said it all went down her arm and five drops drained. Patient was reportedly handed a paper towel to wipe up the fluid.  Caller reported wondering if her mother (the patient) received the full dose of the vaccine.  The patient had not had any symptoms or adverse events following vaccine administration.   No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The event the vaccine appeared to leak back out of her arm and it went all down her arm and 5 drips drained, was considered resolved.  The reporter did not provide an assessment for the event.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273.  There were no reported adverse events associated with this case.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site mass, Injection site warmth, Pain, Sleep disorder
Clinical narrative: 3in x 3in lump at injection site, red in color and hot to touch; 3in x 3in lump at injection site, red in color and hot to touch; 3in x 3in lump at injection site, red in color and hot to touch; his arm remains very tender to touch; Lost sleep due to pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number: EJ1686, expiry date unknown) intramuscular at the left arm on 07Jan2021 at a single dose for COVID-19 immunization. The patient's medical history included COVID-19 prior to vaccination; HTN, High cholesterol, and Asthma, all from an unknown date. The patient is not pregnant. Concomitant medications included ASA, carvedilol, ferrous sulfate, losartan potassium, magnesium, rosuvastatin, calcium carbonate, colecalciferol (CALCIUM + VITAMIN D, pantoprazole sodium sesquihydrate (PROTONIX), budesonide, and formoterol fumarate (SYMBICORT). The patient had previous allergies with Zocor, Prolia, Evista, Daypro, Amlodipine, and Lisinopril. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. Since the vaccination, the patient had not been tested for COVID-19. On 08Jan2021, 12:00 PM, the patient experienced 3in x 3in lump at the injection site, red in color and hot to touch. She lost sleep due to pain, his arm remains very tender to touch. No therapeutic measures were taken in response to the events. Outcome of the events at the time of last observation was recovering.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events vaccination site mass, vaccination site erythema, vaccination site warmth and vaccination site pain cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes 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: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: 3in x 3in lump at injection site, red in color and hot to touch; 3in x 3in lump at injection site, red in color and hot to touch; 3in x 3in lump at injection site, red in color and hot to touch; his arm remains very tender to touch; Lost sleep due to pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number: EJ1686, expiry date unknown) intramuscular at the left arm on 07Jan2021 at a single dose for COVID-19 immunization. The patient's medical history included COVID-19 prior to vaccination; HTN, High cholesterol, and Asthma, all from an unknown date. The patient is not pregnant. Concomitant medications included ASA, carvedilol, ferrous sulfate, losartan potassium, magnesium, rosuvastatin, calcium carbonate, colecalciferol (CALCIUM + VITAMIN D, pantoprazole sodium sesquihydrate (PROTONIX), budesonide, and formoterol fumarate (SYMBICORT). The patient had previous allergies with Zocor, Prolia, Evista, Daypro, Amlodipine, and Lisinopril. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. Since the vaccination, the patient had not been tested for COVID-19. On 08Jan2021, 12:00 PM, the patient experienced 3in x 3in lump at the injection site, red in color and hot to touch. She lost sleep due to pain, his arm remains very tender to touch. No therapeutic measures were taken in response to the events. Outcome of the events at the time of last observation was recovering.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events vaccination site mass, vaccination site erythema, vaccination site warmth and vaccination site pain cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes 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: Injection site bruising, Injection site nodule, Injection site swelling
Clinical narrative: injection she had a bruise like 1.5 inches long/ she had a knot as wide as a baseball now; injection she had a bruise like 1.5 inches long/ she had a knot as wide as a baseball now; This is a spontaneous report from a contactable consumer (patient herself).  A female patient of an unspecified age received her first dose of bnt162b2 (BNT162B2 also reported as Pfizer-BioNTech COVID-19 Vaccine, lot/batch number and expiry date not reported), via an unspecified route of administration on 11Jan2021 at single dose, for Covid-19 immunisation. The patient's medical history concomitant medications were not reported. On 11Jan2021 she received the vaccine and within hours of that injection she had a bruise like 1.5 inches long and had not seen that anywhere in the material. She knew it could swell, but she had a knot as wide as a baseball now. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Facial paralysis, Paraesthesia oral
Clinical narrative: suspect that it may be Bell's Palsy; tingling in the left side of her tongue; This is a spontaneous report from a contactable nurse. A 37-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), intramuscularly at 0.3ml single injection in the left arm on 22Dec2020 09:00 for covid-19 prophylaxis. Medical history included persimmon fruit allergy from an unknown date and unknown if ongoing. There were no concomitant medications. The patient experienced tingling in the left side of her tongue on 22Dec2020, the event was reported as serious per medically significant, suspect that it may be bell's palsy on an unspecified date. The adverse event was not required a visit to emergency room or physician office. Caller was an employee health nurse that reported that she had an employee that received the first dose Covid-19 vaccine on 22Dec2020 and as they were administering the vaccine, the patient developed tingling in the left side of her tongue. The caller said that the patient reported that the tingling was still there. She said that the patient was concerned that it might cause her to get bell's palsy. Caller wanted to know if this was this common and whether she could move forward with getting the 2nd dose of the vaccine. The caller said that the patient received the vaccine in her left arm. The caller said that the patient reported that the tingling in her tongue was mild and not stopping her from eating and she was not having any respiratory issues. Caller said that the only allergy that the patient has was to Persimmon fruit. The side effect mentioned is not necessarily Bell's palsy since the characteristic eye drooping is not present. The outcome of events for tingling in the left side of her tongue was not resolved, for suspect that it may be bell's palsy was unknown. Vaccination Facility Type was hospital. Vaccine Administered at Military Facility: No. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations within 4 weeks. No relevant tests. Drug result was related.; Sender's Comments: The causality between the reported tingling in the left side of her tongue, which was suspected that it may be Bell's Palsy and the administration of COVID-19 vaccine, BNT162B2, cannot be denied, based on the reasonable temporal association.   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 RA, IEC, as appropriate.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Chills, Dizziness, Eye pain
Clinical narrative: weakness; eye pain; headache/ head pain; back pain; chills; Nauseated; her arm was killing her more than a normal vaccine; She had a fever then; This is a spontaneous report from a contactable nurse. This 28-year-old female nurse (patient) reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3246) at single dose at left deltoid for COVID-19 immunisation on 11Jan2021 at 4:30 pm. Relevant history included contraception. Family Medical History Relevant to AE(s) was none. Concomitant drug included ongoing ethinylestradiol, etonogestrel (NUVARING) for contraception for years. The patient experienced a headache, back ache, nausea and was almost passing out. She had the first dose of the vaccine on the 11Jan2021 at 4:30 PM and was in bed around 10:00 that night.  She woke up at 5:00 AM on 12Jan2021 and didn't feel great, her arm was killing her more than a normal vaccine and she was nauseated at 5:30, which was not that horrible. She took some Tylenol. Then she got to work and around 9:00 she felt like she was going to get sick. She had horrendous nausea, chills, weakness, eye pain, headache/ head pain, and back pain. Her clothes hurt because the body aches were so bad. She felt like she was going to pass out, like a vasovagal. She went to urgent care because her manager didn't think it was side effect. She went and got swabbed (result unknown), whatever. She had a fever then. They told her it was a reaction to the vaccine. Her temperature was 101.6 degrees Fahrenheit when she went to Urgent care. She would say the fever started at 12:30PM on 12Jan2021. She did not know if fever would be ongoing because she was taking fever reducer and it was working. The events weakness, eye pain, head pain, and back pain were reported as serious since medically significant. The nausea was better around 2:00PM. The outcome of event nausea, Chills was and Weakness was resolved on 12Jan2021.  The outcome of events eye pain, head pain, and back pain was resolving. The outcome of event 'her arm was killing her more than a normal vaccine' was recovering. The outcome of fever was unknown. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. Prior Vaccinations (within 4 weeks) was none. AE(s) following prior vaccinations was none.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported events, weakness, eye pain, head pain, and back pain, and the administration the suspect vaccine, BNT162B2.   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 RA, IEC, as appropriate.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Nausea, Pain, Pain in extremity
Clinical narrative: weakness; eye pain; headache/ head pain; back pain; chills; Nauseated; her arm was killing her more than a normal vaccine; She had a fever then; This is a spontaneous report from a contactable nurse. This 28-year-old female nurse (patient) reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3246) at single dose at left deltoid for COVID-19 immunisation on 11Jan2021 at 4:30 pm. Relevant history included contraception. Family Medical History Relevant to AE(s) was none. Concomitant drug included ongoing ethinylestradiol, etonogestrel (NUVARING) for contraception for years. The patient experienced a headache, back ache, nausea and was almost passing out. She had the first dose of the vaccine on the 11Jan2021 at 4:30 PM and was in bed around 10:00 that night.  She woke up at 5:00 AM on 12Jan2021 and didn't feel great, her arm was killing her more than a normal vaccine and she was nauseated at 5:30, which was not that horrible. She took some Tylenol. Then she got to work and around 9:00 she felt like she was going to get sick. She had horrendous nausea, chills, weakness, eye pain, headache/ head pain, and back pain. Her clothes hurt because the body aches were so bad. She felt like she was going to pass out, like a vasovagal. She went to urgent care because her manager didn't think it was side effect. She went and got swabbed (result unknown), whatever. She had a fever then. They told her it was a reaction to the vaccine. Her temperature was 101.6 degrees Fahrenheit when she went to Urgent care. She would say the fever started at 12:30PM on 12Jan2021. She did not know if fever would be ongoing because she was taking fever reducer and it was working. The events weakness, eye pain, head pain, and back pain were reported as serious since medically significant. The nausea was better around 2:00PM. The outcome of event nausea, Chills was and Weakness was resolved on 12Jan2021.  The outcome of events eye pain, head pain, and back pain was resolving. The outcome of event 'her arm was killing her more than a normal vaccine' was recovering. The outcome of fever was unknown. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. Prior Vaccinations (within 4 weeks) was none. AE(s) following prior vaccinations was none.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported events, weakness, eye pain, head pain, and back pain, and the administration the suspect vaccine, BNT162B2.   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 RA, IEC, as appropriate.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination complication, Viral test
Clinical narrative: weakness; eye pain; headache/ head pain; back pain; chills; Nauseated; her arm was killing her more than a normal vaccine; She had a fever then; This is a spontaneous report from a contactable nurse. This 28-year-old female nurse (patient) reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3246) at single dose at left deltoid for COVID-19 immunisation on 11Jan2021 at 4:30 pm. Relevant history included contraception. Family Medical History Relevant to AE(s) was none. Concomitant drug included ongoing ethinylestradiol, etonogestrel (NUVARING) for contraception for years. The patient experienced a headache, back ache, nausea and was almost passing out. She had the first dose of the vaccine on the 11Jan2021 at 4:30 PM and was in bed around 10:00 that night.  She woke up at 5:00 AM on 12Jan2021 and didn't feel great, her arm was killing her more than a normal vaccine and she was nauseated at 5:30, which was not that horrible. She took some Tylenol. Then she got to work and around 9:00 she felt like she was going to get sick. She had horrendous nausea, chills, weakness, eye pain, headache/ head pain, and back pain. Her clothes hurt because the body aches were so bad. She felt like she was going to pass out, like a vasovagal. She went to urgent care because her manager didn't think it was side effect. She went and got swabbed (result unknown), whatever. She had a fever then. They told her it was a reaction to the vaccine. Her temperature was 101.6 degrees Fahrenheit when she went to Urgent care. She would say the fever started at 12:30PM on 12Jan2021. She did not know if fever would be ongoing because she was taking fever reducer and it was working. The events weakness, eye pain, head pain, and back pain were reported as serious since medically significant. The nausea was better around 2:00PM. The outcome of event nausea, Chills was and Weakness was resolved on 12Jan2021.  The outcome of events eye pain, head pain, and back pain was resolving. The outcome of event 'her arm was killing her more than a normal vaccine' was recovering. The outcome of fever was unknown. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. Prior Vaccinations (within 4 weeks) was none. AE(s) following prior vaccinations was none.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported events, weakness, eye pain, head pain, and back pain, and the administration the suspect vaccine, BNT162B2.   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 RA, IEC, as appropriate.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Dizziness, Erythema, Feeling hot, Hypertension
Clinical narrative: passed out briefly; a fruity taste in her mouth; turned "Beet red" on her neck/face; have an episode of hypertension; feeling hot; was "swaying"; had menstrual like cramps that radiated from her abdomen to her entire body; had menstrual like cramps that radiated from her abdomen to her entire body; This is a spontaneous report from a contactable pharmacist. A 33-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on 13Jan2021 at the first single dose for covid-19 immunisation .  The patient medical history was not reported.  The patient's concomitant medications were not reported.  Within in minutes of receiving the vaccine on 13Jan2021, the patient reported a fruity taste in her mouth, turned "Beet red" on her neck/face, and passed out briefly. When she regained consciousness, she was given Benadryl, and also was reported to have an episode of hypertension. She reported feeling hot and was "swaying" and had menstrual like cramps that radiated from her abdomen to her entire body.  The outcome of events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the compatible temporal association, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the event "passed out briefly". The impacts of this report on the benefit/risk profile of the 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.,Linked Report(s) : US-PFIZER INC-2021027150 same reporter/drug, similar event, different patient
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Muscle spasms, Taste disorder
Clinical narrative: passed out briefly; a fruity taste in her mouth; turned "Beet red" on her neck/face; have an episode of hypertension; feeling hot; was "swaying"; had menstrual like cramps that radiated from her abdomen to her entire body; had menstrual like cramps that radiated from her abdomen to her entire body; This is a spontaneous report from a contactable pharmacist. A 33-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on 13Jan2021 at the first single dose for covid-19 immunisation .  The patient medical history was not reported.  The patient's concomitant medications were not reported.  Within in minutes of receiving the vaccine on 13Jan2021, the patient reported a fruity taste in her mouth, turned "Beet red" on her neck/face, and passed out briefly. When she regained consciousness, she was given Benadryl, and also was reported to have an episode of hypertension. She reported feeling hot and was "swaying" and had menstrual like cramps that radiated from her abdomen to her entire body.  The outcome of events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the compatible temporal association, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the event "passed out briefly". The impacts of this report on the benefit/risk profile of the 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.,Linked Report(s) : US-PFIZER INC-2021027150 same reporter/drug, similar event, different patient
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Feeling abnormal, Headache, Lymphadenopathy
Clinical narrative: Mental fog; Chills; Dizziness sensation; Headache; Extremely large lymph nodes; Fevers; This is a spontaneous report from a contactable nurse reported for self. This 37-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) via unspecified route of administration on 08Jan2021 12:00 PM at single dose in right arm for COVID-19 immunization. The patient is not pregnant. The patient had no COVID prior vaccination. The patient had none known allergies. The patient medical history included hypertension/ gastric sleeve 2020. The patient concomitant mediations included metoprolol 100mg once a day. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) via unspecified route of administration on 18-Dec-2020 12:00 PM at single dose in right arm for COVID-19 immunization. The patient experienced extremely large lymph nodes, chills, fevers, Constant headache and dizziness sensation, mental fog. The events onset date was reported 08-Jan-2021 20:00 PM. The events resulted in doctor or other healthcare professional office/clinic visit. The COVID test post vaccination (COVID test type Nasal Swab, COVID test name COVID/flu AB by PCR) resulted Negative on 11-Jan-2021. The patient received no treatment. The outcome of events was recovering. Information on the Lot/batch number has been requested. Sender's Comments: Based on the reasonable temporal association, the Company cannot completely exclude the possible causality between the reported mental fog and the administration of the suspected vaccine, BNT162B2. 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 RA, IEC, as appropriate.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Mental fog; Chills; Dizziness sensation; Headache; Extremely large lymph nodes; Fevers; This is a spontaneous report from a contactable nurse reported for self. This 37-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) via unspecified route of administration on 08Jan2021 12:00 PM at single dose in right arm for COVID-19 immunization. The patient is not pregnant. The patient had no COVID prior vaccination. The patient had none known allergies. The patient medical history included hypertension/ gastric sleeve 2020. The patient concomitant mediations included metoprolol 100mg once a day. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) via unspecified route of administration on 18-Dec-2020 12:00 PM at single dose in right arm for COVID-19 immunization. The patient experienced extremely large lymph nodes, chills, fevers, Constant headache and dizziness sensation, mental fog. The events onset date was reported 08-Jan-2021 20:00 PM. The events resulted in doctor or other healthcare professional office/clinic visit. The COVID test post vaccination (COVID test type Nasal Swab, COVID test name COVID/flu AB by PCR) resulted Negative on 11-Jan-2021. The patient received no treatment. The outcome of events was recovering. Information on the Lot/batch number has been requested. Sender's Comments: Based on the reasonable temporal association, the Company cannot completely exclude the possible causality between the reported mental fog and the administration of the suspected vaccine, BNT162B2. 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 RA, IEC, as appropriate.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Loss of consciousness, Muscle spasms
Clinical narrative: lost consciousness; Severe cramping; diarrhea; This is a spontaneous report from a contactable other healthcare professional (patient). A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number: EL3249, expiry date unknown), via an unspecified route of administration on the left arm on 13Jan2021 13:30 at single dose for COVID-19 immunization. The patient's medical history included chronic fatigue syndrome from an unknown date and unknown if ongoing. The patient has no known allergies. Patient is not pregnant at the time of vaccination. Concomitant medications included cyanocobalamin (VITAMIN B-12), Iron, and Vitamin D (VITAMIN D NOS); patient received these medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 14Jan2021 04:00 AM, the patient experienced severe cramping, followed by episode of diarrhea. During the cramping, she lost consciousness for an unknown amount of time. No therapeutic measures were taken in response to the events. Outcome of the events at the time of last observation was recovering. The events were reported as non-serious.; Sender's Comments: A possible contribution role of the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of lost consciousness cannot be excluded due to temporal relationship.  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: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Pericarditis
Clinical narrative: 7 days after the vaccine-developed onset of Pericarditis; This is a spontaneous report from a contactable Other HCP reporting for a patient.   A 31-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Lot # EK9231) intramuscular at single dose at left arm on 28Dec2020 13:00 for Covid-19 immunisation, administered at Nursing Home/Senior Living Facility.  Medical history included recurrent idiopathic pericarditis, hypertension, pre-eclampsia, Covid-19. No known allergies. Patient was not pregnant. The patient had experienced Covid-19 prior vaccination. The patient's concomitant medications were not reported. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine.  The patient developed onset of pericarditis 7 days after the vaccine on 04Jan2021. AE resulted in doctor or other healthcare professional office/clinic visit. Patient received Colchicine and Ibuprofen as treatment. Post vaccination, the patient has not been tested for COVID-19. The outcome of event was not recovered.; Sender's Comments: Based on the temporal relationship, the association between the event pericarditis with BNT162b2 can not be completely excluded.  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: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure decreased, Cold sweat, Cyanosis, Discomfort
Clinical narrative: WBCs and neutrophils and platelets elevated 3 hours later; WBCs and neutrophils and platelets elevated 3 hours later; WBCs and neutrophils and platelets elevated 3 hours later; Coat hanger neck/ shoulder pain; Coat hanger neck/ shoulder pain; flushed; felt uncomfortable; couldn't sit still; feeling clammy; saw spots; BP dropped to 60s/30s; felt like throat was closing; couldn't breathe well; hands were numb; lips were white/ blue; This is a spontaneous report from a contactable nurse (patient). A 25-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, LOT# EL1283), via an unspecified route of administration in right arm on 07Jan2021 13:30 at first single dose for COVID-19 immunization. Medical history included asthma, fibromyalgia, idiopathic hypersomnia, seasonal allergies (dust, ragweed, pollen, dander), covid-19. Concomitant medication in two weeks included duloxetine hydrochloride (CYMBALTA), modafinil, montelukast sodium (SINGULAIR), cetirizine hydrochloride (ZYRTEC), ergocalciferol (VIT D). No other vaccine in four weeks. 1-2 min after shot the patient became flushed and felt uncomfortable/ couldn't sit still, began feeling clammy, saw spots, BP dropped to 60s/30s, all other vitals stable, felt like throat was closing and couldn't breathe well, hands were numb, lips were white/ blue. No itching or hives. Resolved with trendelenburg and rest, fluids given in ED. WBCs and neutrophils and platelets elevated 3 hours later. Coat hanger neck/ shoulder pain for the next few days. Adverse event start date was 07Jan2021 01:30. Event resulted in emergency room/department or urgent care. Covid was not tested post vaccination. Outcome of the event was recovering.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the reported events cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes 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: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Flushing, Hypoaesthesia, Neck pain, Neutrophil count increased
Clinical narrative: WBCs and neutrophils and platelets elevated 3 hours later; WBCs and neutrophils and platelets elevated 3 hours later; WBCs and neutrophils and platelets elevated 3 hours later; Coat hanger neck/ shoulder pain; Coat hanger neck/ shoulder pain; flushed; felt uncomfortable; couldn't sit still; feeling clammy; saw spots; BP dropped to 60s/30s; felt like throat was closing; couldn't breathe well; hands were numb; lips were white/ blue; This is a spontaneous report from a contactable nurse (patient). A 25-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, LOT# EL1283), via an unspecified route of administration in right arm on 07Jan2021 13:30 at first single dose for COVID-19 immunization. Medical history included asthma, fibromyalgia, idiopathic hypersomnia, seasonal allergies (dust, ragweed, pollen, dander), covid-19. Concomitant medication in two weeks included duloxetine hydrochloride (CYMBALTA), modafinil, montelukast sodium (SINGULAIR), cetirizine hydrochloride (ZYRTEC), ergocalciferol (VIT D). No other vaccine in four weeks. 1-2 min after shot the patient became flushed and felt uncomfortable/ couldn't sit still, began feeling clammy, saw spots, BP dropped to 60s/30s, all other vitals stable, felt like throat was closing and couldn't breathe well, hands were numb, lips were white/ blue. No itching or hives. Resolved with trendelenburg and rest, fluids given in ED. WBCs and neutrophils and platelets elevated 3 hours later. Coat hanger neck/ shoulder pain for the next few days. Adverse event start date was 07Jan2021 01:30. Event resulted in emergency room/department or urgent care. Covid was not tested post vaccination. Outcome of the event was recovering.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the reported events cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes 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: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pallor, Platelet count increased, Restlessness, Throat tightness, Visual impairment
Clinical narrative: WBCs and neutrophils and platelets elevated 3 hours later; WBCs and neutrophils and platelets elevated 3 hours later; WBCs and neutrophils and platelets elevated 3 hours later; Coat hanger neck/ shoulder pain; Coat hanger neck/ shoulder pain; flushed; felt uncomfortable; couldn't sit still; feeling clammy; saw spots; BP dropped to 60s/30s; felt like throat was closing; couldn't breathe well; hands were numb; lips were white/ blue; This is a spontaneous report from a contactable nurse (patient). A 25-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, LOT# EL1283), via an unspecified route of administration in right arm on 07Jan2021 13:30 at first single dose for COVID-19 immunization. Medical history included asthma, fibromyalgia, idiopathic hypersomnia, seasonal allergies (dust, ragweed, pollen, dander), covid-19. Concomitant medication in two weeks included duloxetine hydrochloride (CYMBALTA), modafinil, montelukast sodium (SINGULAIR), cetirizine hydrochloride (ZYRTEC), ergocalciferol (VIT D). No other vaccine in four weeks. 1-2 min after shot the patient became flushed and felt uncomfortable/ couldn't sit still, began feeling clammy, saw spots, BP dropped to 60s/30s, all other vitals stable, felt like throat was closing and couldn't breathe well, hands were numb, lips were white/ blue. No itching or hives. Resolved with trendelenburg and rest, fluids given in ED. WBCs and neutrophils and platelets elevated 3 hours later. Coat hanger neck/ shoulder pain for the next few days. Adverse event start date was 07Jan2021 01:30. Event resulted in emergency room/department or urgent care. Covid was not tested post vaccination. Outcome of the event was recovering.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the reported events cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes 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.