chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a contactable consumer (patient). This 51-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 08Apr2021 15:45 as single dose for COVID-19 immunization. Medical history included prior to vaccination, the patient was diagnosed with COVID-19. No known allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. No other medications the patient received within 2 weeks of vaccination. On 09Apr2021 at 07:30 PM, patient experienced left leg went numb (also reported as 3 hrs after shot), next day felt slightly better, by day 4 ended up in ER (emergency room) and was admitted for legs not working correctly and weakness in left leg. The events resulted in hospitalization for three days. Patient underwent COVID-19 (Nasal Swab) tested post vaccination on 11Apr2021, COVID-19 test result: Negative. Patient received treatment included medication, physical therapy for the adverse events. Outcome of the events was recovering. Follow-up attempts are needed; information about lot/batch number is requested.
Patient developed a rash 2 days after vaccination in the same are that extended down to wrist, shoulder, and middle back. Rash is raised, erythematous, painful, and burning. Rash continues to spread on day 4 post vaccination. Labs have been ordered (CBC, CRP, ESR, CMP, and UA).
Bout of Diarrhea on Thursday and Friday.  Maybe a little fatigue for a couple of days.  Otherwise - no other problems.
Along with fever, she has had associated body aches.  She has had a mild headache.  She denies any neck pain.  She has had no rash. She does report some lymphadenopathy of her neck. She denies any sore throat, upper respiratory infection symptoms or cough.  She received MMR, her first 1 about 10 days ago.
Acute myocarditis, admitted for 3 days, discharged home on NSAIDs with pediatric cardiology follow-up
BlurredVision,Dizziness, Headache, Fever, Rash, UrticariaPruritus, Diarrhea, bloating, feet edema, loss of appetite, neuropathy pain in hands, arms, feet and legs Presented to ER due to Adverse reaction occurring within minutes after receiving the 1st dose of Pfizer COVID vaccine. Pt states he pre-medicated with Benadryl 50mg early am, then 50mg two hours before vaccine administration. Pt with a history of allergies to shellfish and latex. Pt reports anaphylactic reaction, but MD documented that airway was never compromised. Severe raised rash still present.
runny nose; This spontaneous case was reported by an other health care professional and describes the occurrence of RHINORRHOEA (runny nose) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product SELEXIPAG tablet for Primary pulmonary hypertension.    Concurrent medical conditions included Primary pulmonary hypertension. Concomitant products included RIVAROXABAN and SILDENAFIL CITRATE for an unknown indication.   On 07-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started SELEXIPAG (Oral) 200 microgram twice a day. On 07-Apr-2022, the patient experienced RHINORRHOEA (runny nose). At the time of the report, RHINORRHOEA (runny nose) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On an unspecified date, the patient experienced seasonal allergies, sinusitis and runny nose when she bends over her legs are shaky so she had to use her walker in the house. She also had swollen legs which have resolved with diuretics and bottom of left foot was dark like she has walked in dirt. The patient received her second Moderna COVID booster shot on Thursday 07-APR-2022 and has had a runny nose ever since. She was taking some over the counter medication for it.   The action taken with selexipag, and elasomeran was not reported. The patient recovered from swollen legs, had not recovered from runny nose, and the outcome of seasonal allergies, sinusitis, legs are shaky and bottom of left foot is dark like she has walked in dirt was not reported. The reporter provided no causality assessment. Company causality between selexipag, and seasonal allergies, sinusitis, legs are shaky, swollen legs, bottom of left foot is dark like she has walked in dirt, and runny nose was not related.  She was taking some over the counter medication for runny nose as treatment.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
I got sick and was nauseous threw up multiple times felt generally unwell with flu like symptoms. two months later in december felt fatigue and brain fog. a spike in anxiety as well, with shortness of breath and light headedness' Has also be seeing a hematologist
After the first injection I had mild eye issues which I went to my PCP and they cleared up within a week. The symptoms were dry eyes which was uncomfortable.  The second injection dry eye issue has been excruciating and still problematic to where I can?t even open my eyes.  I am seeing my PCP and an ophthalmologist to treat this.
mild diarrhea, vomiting, t103 starting @ approx 2PM on 2FEB94-advised by MD @ clinic inc fluids-APAP
p/in 1hr of vax pt exp anaphylaxis characterized by wheezing & laryngeal edema;tx w/epi & dph, decadron & oral steroids;2 days later became lethargic;it it no known when DPH administration was discontinued;
While injecting, DTP into rt thigh, pt screamed, held breath until pt passed, then pt breathed & appeared to have a sz & go limp w/o breathing 3 times; started to breath p/chest massage; color, respirations returned quickly;
Migraines 3 days, vomiting 1day, nausea 4 days. Muscle aches 4 days, joint pain 5 days. Exhaustion 5 days
This spontaneous report as received from a medical assistant regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 30-SEP-2015 the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # L004754, expiry date- 10-NOV-2016) (dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
Pain in arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and PAIN IN EXTREMITY (Pain in arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis and Migraine headache. Concomitant products included METHOTREXATE SODIUM, SULFASALAZINE and INFLIXIMAB DYYB (INFLECTRA [INFLIXIMAB DYYB]) for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (Headache). On 27-Jan-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm). At the time of the report, HEADACHE (Headache) and PAIN IN EXTREMITY (Pain in arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment medication were provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-062187 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Follow-up information received on 05-May-2021 included no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-062187:Case for second dose
The batch was administered to patient after 12-Jan-2023, last dose given was 13-Apr-2023; Vial was expired 30 days after being in the fridge; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The batch was administered to patient after 12-Jan-2023, last dose given was 13-Apr-2023), PRODUCT STORAGE ERROR (Vial was expired 30 days after being in the fridge) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1417B) for COVID-19 prophylaxis.     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 EXPIRED PRODUCT ADMINISTERED (The batch was administered to patient after 12-Jan-2023, last dose given was 13-Apr-2023), PRODUCT STORAGE ERROR (Vial was expired 30 days after being in the fridge) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The batch was administered to patient after 12-Jan-2023, last dose given was 13-Apr-2023), PRODUCT STORAGE ERROR (Vial was expired 30 days after being in the fridge) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (The batch was administered to patient after 12-Jan-2023, last dose given was 13-Apr-2023) and PRODUCT STORAGE ERROR (Vial was expired 30 days after being in the fridge).    No concomitant medications were reported.  The vaccine was delivered on 12-Dec-2022 and they have had them in the refrigerator since. The reporter stated that it was their understanding that it expires 30 days after being in the fridge but they were getting notices from the department of health that the expiration date of the said batch were extended, the last one they received said that expiration date was 14-May-2023. The batch was administered to 6 patients after 12-Jan-2023, last dose was given on 13-Apr-2023.  No treatment medications were reported.  This case contains information for the 3 of 6th child patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-721723 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721723:1st patient case (Master case)
Arm injection site soreness did not resolve and spread into arm resulting in continued pain for a month after. On May 3 I went to see the orthopedic doctor to discuss the continuing pain from injection. Doctor noted swelling, loss of mobility and administered a cortisone shot to help heal the inflammation. I have started physical therapy on doctors recommendation to regain the lost mobility.
Saturday, April 24th (4/24/21) 11:00am initial dizziness and vertigo. Same day 11pm extreme dizziness/vertigo, vomiting. Now continual dizziness/vertigo through the day and some naseau.....lasting a week now.  Missed this menstrual cycle
p/vax had some internal problems; full/hard stomach feeling x 2.5 days; also unable to pass anything (b/m wise)
kidney transplant; flu like symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RENAL TRANSPLANT (medically significant), outcome "unknown", described as "kidney transplant"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "flu like symptoms". Clinical course: Caller was calling in mentioned that after they take the Pfizer vaccine and her husband experienced a flu like symptoms. Asking if it was normal. Created manual AE form because the caller's husband developed a flu like symptoms after getting a vaccine shot and caller mentioned that her husband had a kidney transplant.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient completed 15 minute observation after administration of both Flucelvax and Moderna Bivalent Booster and proceeded to leave clinic with daughter. Still near the clinic, patient started to feel itchiness in throat and swelling in both eyelids and came back to clinic. EMS evaluated patient - initial blood pressure 120/66, HR 64, Sp02 100%, respirations, lungs diminished. This RN administered Benadryl 25mg orally as per standing order. Kept patient for additional 30 minutes after administration of Benadryl. Patient's symptoms improved, signed refusal of medical assistance (RMA) with EMS and left clinic feeling better.
This spontaneous report received from a patient concerned an 81-year-old white female of unspecified ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: kidney infections and kidney stone (at the age of 27). The patient had anaphylaxis to several antibiotics (too many for her to list) (captured as antibiotic allergy) and a chlorine allergy. The patient is on medication for the rest of her life for kidney stone. The patient did not have drug abuse or illicit drug usage and does not consume alcohol or smoke. The patient was previously treated with chlorine. The patient received covid-19 vaccine (unspecified manufacturer) (suspension for injection, route of administration batch number and expiration date were not reported) 1 total, dose was not reported administered on unspecified day for prophylactic vaccination (dose number in series 1). The batch number was not reported and has been requested. Patient went to urologist on 09-DEC-2021 (Thursday) and confirmed diagnosis of kidney infection (on dose number in series 1) on the 13-DEC-2021. The patient reported that, she was on antibiotics after being diagnosed with kidney infection. The patient received covid-19 vaccine (suspension for injection, route of administration not reported, batch number: 1822811 and expiry: 20-MAR-2022) 1 total, dose was not reported, administered on right arm 13-DEC-2021 at about 10:00 for prophylactic vaccination (Dose number in series 2).  No concomitant medications were reported. The action taken with covid-19 vaccine was not applicable. The patient was recovering from kidney infection. This report was serious (other medically important condition).; Sender's Comments: V0- 20211233134- covid-19 vaccine Kidney Infection. This event(s) is considered not related. The event(s) has an unknown/unclear 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: MEDICAL HISTORY, UNDERLYING DISEASE.
Fever >100F, chills, hot/cold flashes, body aches, and head aches.
I was sick for 16 days following the 2nd dose.  I had a lot of stomach issues.  I had a rolling temperature.  My lungs hurt. I was light headed and had the bad brain fog.  My doctor told me to take Tylenol regular every 4 hours and we would have to wait it out.  The light headiness was to the point I felt I was going to pass out and I was having trouble walking.
Pt recvd vax on 5FEB93 & on 19FEB93 pt devel a fever of 103, polyarthralgias, macular rash & submandibular lymph node enlargement w/stiff, swollen neck; 22FEB93 hospitalized w/dx acute cholestatic hepatitis; devel jaundice; dx serum sicknes
This spontaneous report as received from a nurse practitioner (patient's mother) via company representative refers to a 9 year old male patient. Patient's pertinent medical history, concurrent condition and concomitant medication were not known. No previous drug reactions/allergies were reported. On 19-AUG-2016, the patient was vaccinated with PROQUAD (lot # L037968, expiry date 29-MAR-2017) via injection in the upper right arm (strength and dosing details were unknown). About one week after the vaccination (approximately on 26-AUG-2016), the patient experienced red bumps on his face and forehead. The patient was seen by an unspecified eye doctor. The outcome of the events were unknown. Causality assessment was not provided. No product quality complaint was involved. Additional information has been requested.
Fever; Chills; Body aches; Lethargic; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN), via an unspecified route of administration on unknown date in 2021 (at the age of 46-years-old), as a single dose for COVID-19 immunisation and a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: Ev6204), via an unspecified route of administration on unknown date in 2021 (at the age of 46-years-old), as single dose for COVID-19 immunisation. Medical history included Graves disease and penicillin allergy. The patient previously took clindamycin and experienced allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. Concomitant medication was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 18Mar2021, the patient experienced, fever, chills, body ache and lethargic Therapeutic measure and treatments were not taken in response to the events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events fever, chills, body ache and lethargic was resolved on an unspecified date in Mar2021 at the time of this report.   No follow-up attempts are possible; Information about the lot/batch number cannot be obtained.
Red rash in her injection arm; Red rash in her injection arm; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PRURITUS (Red rash in her injection arm) and VACCINATION SITE ERYTHEMA (Red rash in her injection arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Red rash in her injection arm) and VACCINATION SITE ERYTHEMA (Red rash in her injection arm). At the time of the report, VACCINATION SITE PRURITUS (Red rash in her injection arm) and VACCINATION SITE ERYTHEMA (Red rash in her injection arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant Concomitant medications were reported. No Treatment for the event was provided.
5cm x 7.5cm area of erythema, induration, heat and tenderness.
Fever; Swelling at injection side; Pain and tenderness at injection side; Extremely difficult to sleep or rest in any manner; Side effects impacted daily activity; On 27AUG2021, a spontaneous report was received from a patient.  On an unknown date, an adult male (age unknown) experienced "swelling at injection side" (PT: Injection site swelling), "pain and tenderness at injection side" (PT: Injection site pain), and "fever" (PT: Pyrexia) after receiving a second dose (date unknown) of BioThrax (anthrax vaccine adsorbed). The patient, who was also a company representative, reported that "all of these side effects lasted for a couple days and impacted daily activity and made it extremely difficult to sleep or rest in any manner" (PT: Loss of personal independence in daily activities, PT: Insomnia). The reporter stated that he was under the impression that the events he experienced were "standard side effects" of the product, but was advised to report these events. The outcome of the events swelling at injection site, pain and tenderness at injection site and fever were reported as recovered/resolved. The outcome of the events impacted daily activity and difficult to sleep or rest was unknown.  The patient's medical history and concomitant medication use was unknown.  No additional information was provided regarding these event.  Company Comment:  The injection site reaction and fever are known phenomenon caused by BioThrax and considered "probable" related. Difficulty sleeping and impaired daily activities were a consequence of the injection site reaction but not due to the vaccine. The Company considers that these events are not related.
Every joint and bone in his body hurt; every joint and bone in his body hurt; muscle aches; cramps; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, administered in the right arm, on 02Aug2021 10:30 (Batch/Lot number unknown), at age 60 years old, as dose 2, single, for COVID-19 immunisation, at a pharmacy/drug store. Relevant medical history and concomitant medications were not reported. The patient has no known allergies. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection) administered in the left arm, on an unspecified date (Batch/Lot number unknown), as dose 1, single, for COVID-19 immunisation. The patient did not receive other vaccines in four weeks. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. On 02Aug2021 11:30, the patient experienced every joint and bone in his body hurt, had constant muscle aches and cramps. The events resulted to disability or permanent damage. It was unknown if the patient received treatment for the events. The outcome of the events was not resolved.  The lot number for BNT162B2 was not provided and will be requested during follow up.
Administration Error. Patient received 2nd flu shot for the year. Patient received one in the pharmacy and then a second at a walk-in clinic at local community center.   Patient had no adverse reaction to either injections.
Vaccine administered 8/22/14, reports soreness (L) arm. By Saturday reports swelling and redness to elbow and temp of 100 degrees, flu-like symptoms (fatigue, body aches), lightheaded, upset stomach. 8/29/14 into office to report side effects - fever, swelling and redness has gone but continues to feel weak and lightheaded.
several days of heart palpitations over the course of a few days. on 2/11/21 palpitations were constant and strong. went to urgent care. received EKG, chest Xray, cat scan,  was transfered to Hospital, to be seen by a cardiologist. He did a nuclear cat scan, stress test, and an echo cardiogram.  No definite diagnosis. tests were all negative.  will now have a heart monitor for two weeks to see if episodes reoccur.
Between the 3rd and 4th day after the shot, patient developed  acute onset of excruciating back pain, acute onset of paresthesias and numbness in the right 3rd middle and  distal phalanx on palmar aspect. He also developed midsternal chest pain, worsened with lying down and improved slightly with sitting up. It is now 1.5 weeks after the 1st dose, and he continues to have chest pain, which is worsened with lying down and improved with sitting up, which are typical of pericarditis. He has been sitting up to sleep every night since the first dose. The numbness is slightly improved but still present. The back pain and chest pain persist.
Chest pain - Shortness of breath- Fast beating, fluttering & pounding of heart- Dizziness and weakness- Shaking uncontrollably.