chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient developed right thigh pain and refusal to bear weight (started walking one week prior to vaccine administration). Parent brought patient to clinic on 3.30.2023 due to concerns for persistent thigh pain. Patient had started to partially bear weight until 3.29.2023 and was not yet fully bearing weight when evaluated on 3.30.2023. Patient with mild TTP along R anterolateral thigh but no overlying skin changes. Per phone follow up with parent on 4.5.2023, patient's pain resolved and she started walking again approx 2-3 days ago.
Covid arm symptoms appeared at injection site around 4:00am just over a week after injection. Currently have two small-medium sized welts on left arm at injection site (typing this 7 hours after symptoms started)
warm to the touch/her left arm was hurting and very warm and hot to the touch and her thighs were hot; nauseated; fever; didn't feel like herself/feeling bad; mild headache; her left arm was hurting/sore left arm; arm hurt at the injection site; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number/expiry date: unknown) (age at the time of vaccination was 62 years), administered in arm left on 05Mar2021 as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history included pulmonary embolism from 2012 and unknown if ongoing. Concomitant medications were not reported. On 05Mar2021, the patient received first dose of Pfizer BioNTech Covid vaccine. On 06Mar2021, patient had sore left arm on second and third day after vaccine. On 12Mar2021, the patient had a little bit of a headache. On 13Mar2021, after receiving vaccine the patient arms and thighs were warm to the touch, felt hot and arm hurt at the injection site. The felt nauseated, arm continued to hurt and a mild headache. This lasted 2-4 days where she did not feel like herself. Caller states that she had a side effect starting later on the first or second day. She states on the 8th day after, her left arm was hurting and very warm and hot to the touch and her thighs were hot and she was feeling nauseated. She states on the 11th day after the vaccine she was still feeling nauseated. She states that she had a headache. She states her arm has been hurting for at least a good 10 days. She states that she does not know if she should get second vaccine because they say that people only get side effects the first and second day. States that she was calling because she was due for second one on Friday but she was afraid. No treatment was received, states she was afraid that it would interact with the vaccine. The outcome of the events warm to the touch/her left arm was hurting and very warm and hot to the touch and her thighs were hot was recovered on 14Mar2021, mild headache and nauseated resolved on 17Mar2021, fever resolved on 15Mar2021, didn't feel like herself/feeling bad resolved on 17Mar2021, arm hurt at the injection site, her left arm was hurting/sore left arm not resolved.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
FAINTING; NUMBNESS; SORENESS; FEELING EXTREMELY HOT; SOAKING WET; HEADACHE ON THE RIGHT SIDE; This spontaneous report received from a patient unspecified age. The patient's height, and weight were not reported. The patient's past medical history included miscarriage, and concurrent conditions included anxiety, fainting, hazelnut allergy, Ceftin allergy, Alcoholic (drinks once a week), and non-smoker. The patient has no history of drug abuse or illicit drug usage. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: UNKNOWN) dose was not reported, one total, administered on 08-APR-2021 to the left arm for prophylactic vaccination. No concomitant medications were reported. She fainted on occasion per her history. She felt numbness and felt hot and fainted 5 minutes after she received the vaccine. She experienced headaches on the right side, soreness, and soaking wet. She took ibuprofen and switch to aspirin yesterday. She still has the headaches come and go. She spoke with her doctor and was advised to go to the emergency room (ER) if symptoms continued. On 14-APR-2021, treatment medications included: Acetylsalicylic acid (Aspirin). Additional treatment medications (dates unspecified) included: Ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fainting, numbness, soreness, feeling extremely hot, and soaking wet, and had not recovered from headache on the right side. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210432537-Covid-19 vaccine ad26.cov2.s -Fainting. This event(s) is considered not related. 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: MEDICAL HISTORY, UNDERLYING DISEASE
itchiness; hot; sore; welt uncomfortable; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Feb-2021 and was forwarded to Moderna on 23-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (hot), PAIN (sore) and URTICARIA (welt uncomfortable) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypercholesterolaemia (Medical history reported as high cholesterol) and Arrhythmia (Medical history reported as heart arrhythmia.). Concomitant products included CORTISONE for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING HOT (hot), PAIN (sore) and URTICARIA (welt uncomfortable). At the time of the report, FEELING HOT (hot), PAIN (sore) and URTICARIA (welt uncomfortable) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood cholesterol increased: (High) Blood cholesterol increased..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Pt received her 1st vax on 13feb2021 and recently develop itchiness, hot, sore, a welt uncomfortable, around injection site. She said that is hard, a good size and flatchines.    Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: TCR Received: Patient feeling fine and requested no further follow up.
Narrative: 65yo male patient with a history of HTN, HLD, atherosclerosis of coronaries, cerebral aneurysm and chronic low back pain died on 11/12/2021 at outside facility place. Place & circumstances of death not provided. Pt had received covid vaccines on 3/29/21 & 4/28/21. This death is likely not related to the vaccinations due to patient's comorbidities, advanced age, and length of time from vaccine administration.
patient states he woke up at 0200 following vaccine with severe SOB, wheezing, body aches and fever; he had metallic taste in mouth and dark urine  - lasted 4 days; spoke with patient on 4/1/2021 and he feels totally normal and back to baseline
12 hours after receiving vaccinations, my daughter developed a case of hives, which completely covered her body from neck to toes. (It was almost like one giant connecting hive). I called the doctors office and they wanted to see her right away.  I was told that they had never seen a case of hives like that as a reaction to the vaccinations.  Exactly 72 hours later, her hives went completely away.
Patient fainted after her first immunization. Patient was sitting down, said she was feeling nauseous, and then fainted. She regained consciousness immediately. Provided patient with water, Patient said she felt fine and declined any additional treatment.
temperature excursion; This spontaneous report was received from a registered nurse and refers to a 5-month-old patient of an unknown gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications. On 09-FEB-2020, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 milliliter (lot # T017688, expiration date: 21-MAY-2022) (strength and route of administration were not reported) for prophylaxis. According to the reporter, the temperature excursion was -13.3 degrees Celsius for a time frame of 4 hours and 15 minutes on an unspecified date, without any previous temperature excursion; which was detected by a digital data logger.
Muscle pain in shoulders, hips, back, balance problems leg weakness, incoordination, persistent frontal headache, fatigueMRI,
I broke my toe; My whole foot is black and blue and swollen up; My whole foot is black and blue and swollen up; This is a spontaneous report received from a contactable consumer (patient). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiry not reported) via unspecified route of administration on 06Apr2021 as single dose for COVID-19 immunization. Medical history, concomitant medications and past drug history were not reported. On an unspecified date in Apr2021, the patient reported that she broke her toe. Her whole foot was black and blue and swollen up. Also reported that it had nothing to do with her vaccine though. She provided no further information. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the limited information in the case report, a possible causal relationship reported events and suspect drug BNT162B2 cannot be 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.
I had it 7 times, Had shots after 3 times, shingles/suspected vaccination failure; shingles; pain; burning sensation; nerve pain; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain, burning sensation and post herpetic neuralgia. The patient was treated with valaciclovir (Valacyclovir). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, pain, burning sensation and post herpetic neuralgia were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain, burning sensation and post herpetic neuralgia to be related to Shingles vaccine.  Linked case(s) involving the same patient: US2022AMR100425   Additional Information: GSK Receipt Date: 28-JUN-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient had shingles 7 times. The patient stated that, he/she thought others could only get shingles vaccine once.  The patient had shots after 3 times got shingles.  The patient never got a rash he/she guessed that's what people were saying were internal they give him/her Valacyclovir medication it took the pain and burning away last November. The patient had it and took the medication it went away 3 weeks later, he/she got it again now he/she thinking was it really shingles  he/she get nerve pain with it. The patient had it 3 times on his/her left side on the side, two times on his/her right side and 2 times in his/her left leg on top by waist.  The patient doctor sent him/her to a nerve specialist.  The patient said that, he couldn't test for shingles because he/she had gotten the shingles shot. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR100425:same patient
11: 24 -Itchy, red rash all over my body, and my heart was racing took 25mg of Benadryl. Itching and rash continued and I started to have to clear my throat it was feeling very irritated, a shot of Epi was give to me and symptoms started to clear up. I was taken by ambulance to the Emergency Department for my symptoms to be monitored. While at the Emergency Department I began to get itchy and a red rash , I felt my heart rate increasing again, I was starting to have to clear my throat. A minute or two later I started to have  difficultly swallowing. I was given another shot of Epi and  Benadryl. Symptoms started to clear up shortly after medicine was given.
Patient received 2nd dose on day 13:  Booked 2nd appointment early and was not caught until after injections
Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness) in a female patient of an unknown age 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 FATIGUE (Tiredness). At the time of the report, FATIGUE (Tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment information was provided by the reporter.   Reporter did not allow further contact
Fever, body aches, injection soreness-redness-hot, axillary lymph node pain and swelling, fatigue, sweating, chills, weakness, slight headache, excess sleeping
A week after the 1st and about 10 days after the 2nd I had a terrible flare up of my rheumatoid arthritis i felt fine, other than pain in all my joints. Down on couch pain with pain pills I rarely take. Just thought to let you know. I am fine now. Thanks for doing what you do.
Patient presented to doctor for abdominal pain in September.  Workup revealed: lymphoma and LE weakness. Went to MD for treatment and found to have CMV infection,  guillain barre, elevated liver enzymes
The patient reports that almost immediately following the vaccination, she experienced her throat starting to feel scratchy and felt like it was swelling. It quickly stopped swelling and did not block her airway.
Administration Error - Tetanus vaccine seperately because of age (4-6mos) instead of 4-6 yrs of age.
DX COVID: Presented to ED with dizziness and light headedness.  Known to be COVID 19 positive.  Fatigue.  No SOB.  Treatment:  monoclonal antibody treatment day before the ED visit. Supportive care
lack of drug effect; Additional dose of Moderna after 2 pfizer; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Additional dose of Moderna after 2 pfizer) and DRUG INEFFECTIVE (lack of drug effect) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E21A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 14-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) at an unspecified dose. On 14-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Additional dose of Moderna after 2 pfizer). On an unknown date, the patient experienced DRUG INEFFECTIVE (lack of drug effect). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Additional dose of Moderna after 2 pfizer) and DRUG INEFFECTIVE (lack of drug effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported. Treatment information was not reported.; Sender's Comments: This case concerns an 80 year old male who had a complete series of Pfizer COVID-19 vaccine but did not develop antibodies. On the advice of this HCP he then received both doses of Moderna COVID-19 vaccine without apparent problems. There are no adverse events due to MODERNA COVID-19 vaccine associated with this case.
itch; The booster dose, was not a half dose but a full dose; she got an acute urticaria; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itch), URTICARIA (she got an acute urticaria) and ACCIDENTAL OVERDOSE (The booster dose, was not a half dose but a full dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Aug-2021, the patient experienced ACCIDENTAL OVERDOSE (The booster dose, was not a half dose but a full dose). On an unknown date, the patient experienced PRURITUS (itch) and URTICARIA (she got an acute urticaria). On 26-Aug-2021, ACCIDENTAL OVERDOSE (The booster dose, was not a half dose but a full dose) had resolved. At the time of the report, PRURITUS (itch) and URTICARIA (she got an acute urticaria) outcome was unknown.            No concomitant medications were reported.  Patient was taking an antihistaminic and a cream for the itch.
Dizziness that lasted 20 minutes; This is a spontaneous report from a non-contactable pharmacist. A 67-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an intramuscular route of administration in the left arm on 12Mar2021 (at the age of 67-year-old) as a single dose for COVID-19 immunisation. Medical history AND concomitant medications were not reported. Prior to the vaccination, it was unknown if the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Mar2021, the patient experienced dizziness that lasted for 20 minutes. Since the vaccination, it was unknown if the patient had been tested for COVID-19. No therapeutic measures were taken as a result of the event. The clinical outcome of the event dizziness was resolved on 12Mar2021, after the duration of 20 minutes.  No follow-up attempts are possible. No further information is expected.
This is a spontaneous report from a contactable physician via a Pfizer sales representative and from a contactable Certified Medical Assistant (other healthcare professional) reporting on behalf of the physician. A 72-year-old, female patient received first dose of PREVNAR 13 (Lot G68911; Expiration date Oct2014) on 08Apr2013 at 04:00 PM, 0.5 ml single dose IM (deltoid left). Medical history included hypertension and allergy to contrast dye and Codeine. Relevant concomitant medications of the patient were none. No administration of any antipyretic prior to vaccination and no vaccinations within four weeks. After administration of PREVNAR 13, on an unspecified date in apr2013, the patient experienced chills, redness and inflammation (injection site reaction). On 08Apr2013 the patient experienced left arm swollen and rash and pain at site. She was given ice and prescribed Medrol dose pak to bring down the inflammation and help with the pain. No cultures or other diagnostic tests performed. Events did not result in an emergency room or doctor visit. Left arm swollen, rash and pain at site recovered all on 15Apr2013. Clinical outcome of the other events was unknown at the time of the report. Reporter assessed there was a reasonable possibility that the events were related to PREVNAR 13. Follow-up (24May2013): Follow-up attempts completed. No further information expected. Follow-up (03Jun2013): New information received from a contactable Certified Medical Assistant (other healthcare professional) reporting on behalf of the physician includes: PREVNAR 13 details (Lot #, expiration date, administered date, route, dose and dose number); events updated (left arm swollen, rash, pain at site added), treatment, reporter assessment, patient details (age, medical history). Follow-up attempts completed. No further information expected.
Fatigue bad enough to miss 2 days off work.  Strong muscle soreness at injection site.
I was overwhelmingly tired with throwing up and head congestion. Some muscles aches. My left ear became inflamed from the congestion. Still to this day I am struggling to hear out of my left ear.
This case was reported by a other health professional via call center representative and described the occurrence of injection site discoloration in a 2-month-old female patient who received HIBERIX (batch number 4XD9P, expiry date 20th January 2018). Concomitant products included PEDIARIX, PREVNAR and ROTATEQ. On 14th July 2017, the patient received the 1st dose of HIBERIX (intramuscular) .5 ml. On 14th July 2017, immediately after receiving HIBERIX, the patient experienced injection site discoloration. On an unknown date, the outcome of the injection site discoloration was not recovered/not resolved. The reporter considered the injection site discoloration to be probably related to HIBERIX. Additional details were provided as follows: The case was reported by Medical assistants. The patient's birth weight was reported as 6 pound and 7 ounce. On 14th July 2017, the patient received PREVNAR, PEDIATRIX and ROTATEQ concomitantly. On the same day, a black dot appeared at the injection site immediately following vaccination with HIBERIX. It was reported that, several hours later, the black dot did not went away. The batch number reported for HIBERIX (4XDNP) did not exist and was updated to 4XD9P, as per sales database.
Expired dose of Twinrix administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HAB (Twinrix) (batch number unknown, expiry date 8th February 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   In February 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. In February 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that an expired dose of Twinrix was administered to the patient, which led to expired vaccine used. The reporter was unable to provide date of administration, further reported that the vaccine expired last week. The reporter consented to follow up.