chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe vomiting repeatedly the night/morning after injection; fever; body aches; This is a spontaneous report from a contactable consumer. A 69-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2, lot unknown as unable to locate, via an unspecified route of administration, administered in arm right on 18Feb2021 09:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  Medical history included asthma from an unknown date and unknown if ongoing. Historical vaccine information included BNT162B2, brand Pfizer , dose 1, administered 28Jan2021 13:30 in the right arm. Concomitant medication included escitalopram oxalate (LEXAPRO) taken for an unspecified indication, start and stop date were not reported; acyclovir [aciclovir] (ACYCLOVIR [ACICLOVIR]) taken for an unspecified indication, start and stop date were not reported; levothyroxine taken for an unspecified indication, start and stop date were not reported; vitamin d3 (VITAMIN D3) taken for an unspecified indication, start and stop date were not reported; cyanocobalamin (B12 [CYANOCOBALAMIN]) taken for an unspecified indication, start and stop date were not reported.  The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19.   On "19Feb2021 09:00 PM", the patient experienced severe vomiting repeatedly the night/morning after injection. Then 48hrs later (in Feb2021) developed fever and body aches again. No treatment was received. Outcome of the events was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.    Information on the lot/batch number has been requested.
Patient got the Shingles. This is the second time for this patient, the first occurrence of the Shingles was in March of 2020
Pt complained of flu shot given to high in left arm.  After leaving flu clinic, severe pain began with inability to move arm or use fingers also felt nauseated with pain.  Currently still having left shoulder pain, limiting use of left arm.
rash on at the site of the injection from the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash on at the site of the injection from the vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unkonwn) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (rash on at the site of the injection from the vaccine). At the time of the report, VACCINATION SITE RASH (rash on at the site of the injection from the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided. No treatment medications were provided.
2 days p/inject had stomach cramps constantly for 1 wk; noticeable but not severe; no n/v or diarrhea; 2nd shot given 11JUN91;
This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     no medical history was not provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On an unknown date, the patient experienced DYSGEUSIA (metallic taste). At the time of the report, DYSGEUSIA (metallic taste) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        relevant concomitant products usage were not reported by the reporter. Treatment details not included.   This case was linked to US-MODERNATX, INC.-MOD-2021-090205 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-090205:case for wife
Dizzy; Vertigo; This is a spontaneous report received from contactable reporter from medical information team.  A 51 year-old female patient received bnt162b2 (BNT162B2), administration date 25Apr2021 (Batch/Lot number: unknown) at the age of 51 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset 25Apr2021, outcome "recovering", described as "Dizzy"; VERTIGO (non-serious) with onset 25Apr2021, outcome "recovering", described as "Vertigo".  Additional information: Per reporter, his wife received her first Pfizer Covid 19 Vaccine on 25April2021. When she raised her head up or down to focus on anything she became dizzy. It's going on 3 weeks now. He reported symptom had improved about 65-70%. The reporter was asking if the symptom had been reported. TRANSMITING, POSSIBLE  Response: Spoke from the attached document. Spoke under Clinical Trials Experience,  Literature Search, and Post- Authorization Safety Reports. the reporter was asking how long the vertigo might last? If it might cause permanent brain complications?. Response: Spoke from the attached document under clinical data. "Information on onset and duration was not provided". Per reporter his wife didn't have any health insurance. Reporter was asking if Pfizer had any type of program that will assist with any medical experience related to complications from the Pfizer Covid 19 Vaccine?. During documentation this agent realized that the FACT sheet with the information couldn't be emailed. Outbound call made on 13May2021 1:23 p.m. ET, disclaimer noted. Reporter made aware that the information couldn't be emailed. Reporter asked if he could call back to obtain the contact information "he was in a important meeting"?. Response: Spoke from the attached document PI. is a federal program that has been created to help pay for related costs of medical care and other specific expenses to compensate people injured after use of certain medical countermeasures. Medical countermeasures are specific vaccines, medications, devices, or other items used to prevent, diagnose, or treat the public during a  health emergency or a security threat. For more information about  regarding the Pfizer-BioNTech COVID-19 Vaccine used to prevent COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I have a lump, it's like a size of a golf ball on my arm; I did get a tiny little lump smaller than the marble. But it's worst today.; it's red; it's warm to touch/ like hot to touch; Achiness; Upper respiratory infection/ kind of had a runny nose; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: ER8735; Expiration date: Jul2021), via unspecified route of administration in the left deltoid on 13May2021 (at the age of 41-years-old) as second dose, single dose for COVID-19 immunisation. The patient has no relevant medical history. Concomitant medications were not reported. The patient was preciously vaccinated with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number:  ER8735; Expiration date: 31Jul2021), via unspecified route of administration in the left arm, left deltoid on 22Apr2021 (at the age of 41-years-old) as first dose, single dose for COVID-19 immunisation. On an unspecified date in May2021, the patient experienced a tiny little lump smaller than the marble which became worst (reported as today) like a size of a golf ball on her arm and it was red and warm or like hot to touch, just kind of had a runny nose, achiness all day (reported as today) and upper respiratory infection that was not still bad. Treatment with Dayquil (2 tablets), Ibuprofen (800mg) and ice were taken as a result of the events.  The outcome of the events was unknown. The relatedness of events lump, like a size of a golf ball on her arm and it's red and warm to touch and achiness was reported to be related and causality of all the events was reported as yes by the reporter. There was no investigation assessment.  No follow-up attempts are needed. No further information is expected.
swelling was very large on the arm/swelling at the injection site is common; This is a spontaneous report from a contactable physician via a sales representative. A patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVENAR 13) on unknown date at single dose for immunisation on the arm. Medical history and concomitant drugs were not provided. This patient had an adverse event. The patient came back to see doctor and the swelling was very large on the arm. The reporter witnessed the adverse event with doctor and kind of went through the swelling at the injection site is common. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Generalized Vaccinia Day 4 developed severe malaise Day 6 develped vessicular rash throughout skin including gingiva and R ear Day 8 developed HA, Temp to 101.5, nausea Was treated with Percocet and 23 hr obs Day 9 marked improvement
Coughing; COVID-19; Felt bad; Face ache; Back ache; Headache; Felt tired; Shaking; Thought it was anxiety; Did not sleep well,  had awful night; Face was hot; Full of congestion; Racing heart rate; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), FEELING ABNORMAL (Felt bad), POOR QUALITY SLEEP (Did not sleep well,  had awful night), FEELING HOT (Face was hot) and NASAL CONGESTION (Full of congestion) in a 60-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Panic attack (Has had panic attacks in the past.).    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced POOR QUALITY SLEEP (Did not sleep well,  had awful night), FEELING HOT (Face was hot), NASAL CONGESTION (Full of congestion), HEART RATE INCREASED (Racing heart rate), TREMOR (Shaking) and ANXIETY (Thought it was anxiety). On 16-Mar-2021, the patient experienced FEELING ABNORMAL (Felt bad), FACIAL PAIN (Face ache), BACK PAIN (Back ache), HEADACHE (Headache) and FATIGUE (Felt tired). On 19-Mar-2021, the patient experienced COVID-19 (COVID-19). On 20-Mar-2021, the patient experienced COUGH (Coughing). The patient was treated with PARACETAMOL (TYNELOL) at an unspecified dose and frequency. On 16-Mar-2021, FEELING HOT (Face was hot), NASAL CONGESTION (Full of congestion), HEART RATE INCREASED (Racing heart rate) and TREMOR (Shaking) had resolved. On 17-Mar-2021, FATIGUE (Felt tired) had resolved. On 18-Mar-2021, FACIAL PAIN (Face ache), BACK PAIN (Back ache) and HEADACHE (Headache) had resolved. On 22-Mar-2021, COUGH (Coughing) was resolving. At the time of the report, COVID-19 (COVID-19), FEELING ABNORMAL (Felt bad), POOR QUALITY SLEEP (Did not sleep well,  had awful night) and ANXIETY (Thought it was anxiety) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Mar-2021, Oxygen saturation: 95 (Inconclusive) 95% Oxygen levels improving now.. On 19-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.  No relevant concomitant medications were reported.
Information has been received from a nurse practitioner concerning a 67 year old male with hypertension and penicillin allergy who on 14-APR-2008 was vaccinated with a 0.5 mL dose of ZOSTAVAX (Lot # 659763/18750), subcutaneously. Concomitant therapy included LOVASTATIN, INDOCIN, VITAMINS (unspecified) and omega-3. The nurse practitioner reported that on 27-MAY-2008, the patient returned to the office since he developed a generalized vesicular rash. The nurse practitioner diagnosed the patient with cellulitis and gave him an antibiotic. At the time of the report the patient was recovering. Follow-up information was received from the nurse practitioner. Concomitant therapy included CEPHALEXIN and CHLORPHENIRAMINE. The patient experienced pruritic rash, possibly post ZOSTAVAX reaction with mild cellulitis secondary to scratching. The patient spruritic rash with mild cellulitis resolved without further problems. No additional information is expected.
Patient was brought in by mother on Friday, May 10,2013 for rash on trunk and back.
Enlarged lymph nodes surrounding the area where it was injected, one of the lymph nodes is right on my clavicle bone in close proximity; I am also feeling swelling under my armpit and up my neck; This is a spontaneous report from a contactable consumer reported for self. This 38-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for covid-19 immunisation. Medical history included asthma. Concomitant product included vortioxetine hydrobromide (TRINTELLIX).  The patient previously the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for covid-19 immunisation. The patient got the COVID Vaccine second booster on Sunday and was having enlarged lymph nodes surrounding the area where it was injected. The patient stated, "No, it's not at the site of injection, I have one so it's on, I got the shot in my left shoulder and one of the lymph nodes is right on my clavicle bone in close proximity and I am also feeling swelling under my armpit and up my neck."  Treatments included Tylenol and Advil. Outcome of the events were unknown.  Information about lot/batch number has been requested.
CLEINT EXPERIENCED FEVER AND BODY ACHES ONE DAY FOLLOWING VACCINATION. IBUPROPHEN TAKEN FOR SYMPTOM RELIEF.  CLIENT PRESENTED FOR MENINGOCOCCAL ACWY VACCINATION ON 10.13.2022. PHARMACY STAFF ADMINISTERED FLUCELVAX IN ERROR. VACCINATION ERROR WAS DISCOVERD BY PARENT OF CLIENT. PHARMACY STAFF CONFIRMED INFLUENZA VACCINE WAS GIVEN TO CLIENT.
Severe joint pain. Knees and Elbows; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the arm right on 12Mar2021 at 10:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 22Mar2021 at 08:00, the patient experienced severe joint pain, knees and elbows. No therapeutic measures were taken as a result of the reported event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of severe joint pain, knees and elbows was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Large pericardial effusion found on 04/10/2021 with symptoms a few days prior, after receiving a 1st moderna vaccine
Fever; Headache; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (Body ache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012l20a) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (Body ache). On 14-Feb-2021, PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (Body ache) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication use was provided by the reporter. No treatment of events was reported.   This case was linked to MOD-2021-009108 (E2B Linked Report).; Sender's Comments:  MOD-2021-009108:First dose
Headache, onset evening of 11/05/2022, and daily after vaccination, with increased sinus pressure and pain over sinuses, including right temple and to teeth and jaw, with clear nasal drainage, on approx. 11/12/2022. on a.m. of 11/13/2022, oral temperature 99.6F. Initiated "e-visit" for care (virtual visit.) Assessed by MD for SINUS PAIN and SINUSITIS. Treatment: Doxycycline Monohydrate 100mg oral tabs, 1 q12 hours for SINUSITIS, started on 11/13/2022, completed 11/18/2022. Also, OTC Afrin nasal decongestant (one day) and acetaminophen 500mg oral tabs prn. As of 11/20 and 11/21/2022, temperature normal. Facial sinus pain and clear drainage continues as of 11/21/2022, somewhat improved.
WHOLE CLOTTING; CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via another pharmaceutical company (Moderna) concerned a male of an unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: penicillin allergy, and concurrent conditions included: blood pressure spikes up when in stress. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) 1 total, dose and start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. On an unspecified date, the patient experienced whole clotting (dose number in series 1) and had decided to take Moderna for his booster dose. The patient received Non-company suspect vaccine included: elasomeran (Moderna covid-19 vaccine) (dose number in series 2) (form of admin, route of admin were not reported, batch number: 022T(?)21A, expiry: unknown) dose was not reported, administered on 22-JAN-2022 for covid-19 prophylaxis. Concomitant medications included lisinopril for blood pressure spikes up when in stress. On 22-JAN-2022, the patient experienced revaccination with different covid-19 vaccine (dose number in series 2). On 27-AUG-2022, the patient had symptoms and tested positive for covid-19 and experienced confirmed covid-19 infection (dose number in series 2) and had confirmed clinical vaccination failure (dose number in series 1). On 06-SEP-2022 or 07-SEP-2022, Laboratory data included: COVID-19 virus test Negative. The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable. The patient recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure, revaccination with different covid-19 vaccine and whole clotting was not reported. This report was serious (Other Medically Important Condition). This report was associated with Product quality complaint: 90000254398. Sender's Comments: V0: 20221009696-covid-19 vaccine ad26.cov2.s- Confirmed Clinical Vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.  20221009696-covid-19 vaccine ad26.cov2.s-  Whole clotting- The event(s) has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable
covid; covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "leg inflammation" (unspecified if ongoing); "ACL surgery" (unspecified if ongoing). Concomitant medication(s) included: IRBESARTAN; METFORMIN; LIPITOR; OZEMPIC; ALLOPURINOL; CELECOXIB taken for ligament operation, inflammation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Caller is asking if he can still receive his 2nd booster of Pfizer covid vaccine even after having a covid infection and finishing Paxlovid treatment. Therapeutic measures were taken as a result of covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I was feeling a little out of it and I had surgery coming up. As a precautionary measure, I took a home test and I was positive. I was unsure of if it was a valid test because the liquid in the vile was not at the level described in the instructions. Because of that, I went to the urgent care and got another test and it came back positive. For treatment, I called my PCP Monday morning and let him know that I was positive for COVID-19. He prescribed Paxlovid just in case. I took that and I had no other symptoms. I just sat and waited until the necessary time frame and retested and came back negative.
Sore, swollen, and inflamed injection site for over 3 days, headache, muscle aches, fever, nausea/vomiting
**Pfizer-BioNTech COVID-19 Vaccine EUA** 1/25/2021 - was found unresponsive with left upward gaze deviation at midnight and admitted to hospital (last seen normal around 7 pm 1/24/2021).  Intubated in ED, ABG 6.98/17/186 on 40%, Bicarb <5, Scr 1.4, Lactate 1, Wbc 20.3, BP 101/45-- >95/41, Temp 94.3, RR 23-32.  Acidotic and initially required norepineprine for hypotension management (stopped 1/26/2021 0400 am) 1/26 to 2/1/2021 - supportive care for encephalopathy (anoxic vs. ischemic brain injury), ARF, HTN, MSSA growth in resp culture (no respiratory distress, on antibiotic) 1/28 GCS:E4VTM4; 1/29 GCS: EV4VTM4 with intact protective reflexes, extubated 2 pm 2/1 arousable, follows very simple commands, non verbal
2 hours after injection, started getting hoarse. Call physician who told her to go to ER. ER gave her a "steroid, BENADRYL and epi", felt better, then when that "wore off" later that evening she felt hot and cold and dev. a slight rash on abdomen and chest-next day felt tired but OK.
Breakthrough case admission after two Janssen vaccines Janssen 4/8/21 Lot# 042a21A;  Janssen 12/2/21 Lot# 213D21A;
7th Day after immunizations, temperature 100 - 100.5, light red bumps 5-10 on tummy and a few on face, slight lethargy. Light red bumps 30 on back, all of rash lasted only 4 days.