chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 211A21A expiry: UNKNOWN) dose was not reported, administered on 14-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-DEC-2021, the patient experienced body aches. On 15-DEC-2021, the patient experienced chills. On 15-DEC-2021, the patient experienced headache. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from headache, chills, and body aches. This report was non-serious.
Patient reports almost immediately after receiving the vaccine on 3/3/2021 she developed a rash to her chest, axilla, arms, neck.  She also developed body aches and joint pain which have persisted over a month.  She developed diarrhea starting on 4/2/2021 which is ongoing to present.  She developed nausea and vomiting starting yesterday 4/13/2021.
BLACKED OUT MOMENTARILY; CHILLS; MUSCLE SORENESS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included radiation treatment for an unspecified cancer. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 03-APR-2021, at 7 pm the patient experienced chills, muscle soreness.  On 04-APR-2021, around 08:00 AM the patient was blacked out momentarily and visited an emergency room for the same. Treatment medications (dates unspecified) included: paracetamol used for chills, muscle soreness.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blacked out, and the outcome of chills and muscle soreness was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210408864-covid-19 vaccine ad26.cov2.s -black out. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Prolonged amennorhea diagnosis. Daughter has had only only period in her whole life on her own. She is now 22 and seeing fertility doctors.
pneumonia; afib; Flu; Initial information received on 04-Jan-2023 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves patient of an unknown age and gender who experienced pneumonia, afib (atrial fibrillation) and flu after receiving vaccine influenza vaccine.  It was unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date in October, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (formulation; strength; lot number; expiry date not reported) via unknown route in unknown administration site for flu.  On an unknown date the patient experienced a serious event of pneumonia, afib (atrial fibrillation) and flu (influenza) (unknown latency) following the administration of influenza vaccine.   It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for all the events.  At time of reporting, the outcome was Unknown for all the events.  The events pneumonia, afib were assessed as medically significant while the patient was hospitalized for all the events.; Sender's Comments: Sanofi company comment for information received on 09-Jan-2023: This case involves patient of an unknown age and gender who experienced pneumonia, afib (atrial fibrillation) and flu after receiving vaccine influenza vaccine. The causal role of the company suspect vaccine cannot be assessed based on the temporal relevance. Further information regarding concurrent condition during vaccination, previous vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based on the data provided, the role of vaccine(s) cannot be assessed.
dose to a 16 year old; A spontaneous report was received from a healthcare professional (HCP) concerning a 16-year-old, male consumer who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 14 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 013L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 14 Jan 2021, a 16-year-old patient was administered the first dose of the Moderna vaccine.  No other information was received. No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was unknown.  The event, vaccine given to a patient less than 18-years-old, was considered resolved.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (16 year old male) for mRNA-1273 (lot number 013L20A) with no associated AEs reported.
Case number PHEH2014US014998, is an initial spontaneous report from a medical assistant received on 24 Jul 2014 with a follow-up from a medical assistant received on 21 Oct 2014. This report refers to a 17-year-old female patient. Past medical history and concomitant medications were not provided. Her vaccination status was up-to-date. She was vaccinated with 0.5 ml of expired MENVEO (batch number: M11075) intramuscularly into left arm on 14 Jul 2014. No adverse reactions have occurred following this medication error. She was administered with another dose of MENVEO on an unknown date. No further information was provided. Follow-up information received from the medical assistant on 21 Oct 2014: Patient demographics (height and weight), site of vaccination (left arm) and narrative (revaccination details) were updated.
No additional AE reported; dose of VARIVAX that experienced a temperautre excursion was administered to the patient after the excursion occured; This spontaneous report was received from medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 24-MAY-2022,, improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter lot #U029496 expiration date: 21-SEP-2023 (route of administration and anatomical location were not provided) was administered for prophylaxis. The vaccine experienced a temperature excursion of 7.3 degree Fahrenheit four 2 hours (product storage error). There was previous temperature excursion. No additional adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA007855: US-009507513-2206USA007845: US-009507513-2206USA007717: US-009507513-2206USA007710: US-009507513-2206USA007839: US-009507513-2206USA007547: US-009507513-2206USA007894: US-009507513-2206USA007527: US-009507513-2206USA007706: US-009507513-2206USA007910: US-009507513-2206USA007693:
never received second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose of Shingrix more than 6 months ago from reporting date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The reporter was patient's sister. The age at vaccination was not applicable for this report. Till the time of reporting, the patient had not received the second dose of Shingrix, which led to incomplete course of vaccination. The reporter did not provide any additional information. The reporter did not consent to follow up.
Pt was very frightened about immun; p/receiving vax (approx 5 min) pt c/o not feeling well & became very pale & passed out; HR 60 irregular;
Sick; Felt horrible; This case was reported by a pharmacist via call center representative and described the occurrence of sickness in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced sickness and feels awful. On an unknown date, the outcome of the sickness and feels awful were unknown.   It was unknown if the reporter considered the sickness and feels awful to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and felt horrible and sick after the vaccination.The specific symptoms were unknown.  The reporter consented to follow up. The health care professional did not had the patient's initials, age, or exact date of vaccination as it was a random customer at the pharmacy from earlier in the day that mentioned the event. This case linked with US2019203796, reported by same reporter.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 23-JUN-2016, the patient was vaccinated with improperly stored ROTATEQ (lot # L008053 and expiry date: 30-NOV-2016) following a temperature excursion. No adverse effects were reported. The vaccine was stored at a temperature of 1.1 Celsius for 15 minutes (3 cycles). There was no previous temperature excursion and data logger was reported as yes. No product quality complaint (PQC) was reported for ROTATEQ. Additional information has been requested.
This is a spontaneous report from a contactable pharmacist via Pfizer sales representative. This pharmacist reported similar event for 3 patients. This is the third of 3 reports. A patient of unspecified age ethnicity and gender received on the same unspecified day PREVNAR 13, at single dose and influenza vaccine both for immunisation. The patient medical history and concomitant medications were not reported. The patient previously received flu shot for immunization. The patient was sick after getting the flu shot plus PREVNAR 13 on an unspecified date with outcome of unknown. Information on the batch number has been requested. Sender's Comments: Linked Report(s): US-PFIZER INC-2018080773 same drug/ event, different patients; US-PFIZER INC-2018080772 same drug/ event, different patients.
Swelling, pain, tingling down arm x 2 plus days and still painful/tender.
Fatigue, severe injection site pain, significant myalgias  throughout my body (neck, back, thighs). Some relief after taking ibuprofen 400 mg, but myalgias are not completely resolved.
pt recv 1st vax,no problems noted;recv 2nd dose,following day,devel drowsiness,weakness,arthralgia,muscular aches,myalgia,mild d;low grade fever & sl pruritic rash on upper extremities;tx w/ ASA & apap;sx resolved w/in 24 hr;
Woke up in middle of night with shortness of breath, had to use home nebulizer, every 3 hours and developed migraine headache, left eye pain, twitching, joint pain, fever, 101.3, lasted for 4 days, rash 48 hours, migraine headache continued for 5 days, left eye twitching 20 days as well as the joint pain.  Became sick had to see provider and antibiotic Z pack.
Reporting administration error as per Agency.  We contacted Pfizer for expiration dates, Pfizer vaccine specialist advised that the expiration dates were deemed viable at the time of vaccine administration. Pfizer vaccine vials only include manufacturer dates on the box and vials. Therefore, we contacted Pfizer to obtained expiration dates directly from them.  No adverse reactions were reported from the patient at the time of vaccination. No adverse reactions were reported since the administration of vaccination.
Itchy rash/rash and itching around the surgical wound that extended to other parts of her body, including her forearm (same arm where she received the vaccine), ribcage, and gluteal area; This is a spontaneous report from a contactable consumer(patient). A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN9581) via unspecified route, administration on right arm on 29Jan2021 as a 1st dose single dose for COVID-19 immunization. Medical history included hip, knee, and thigh surgery all on that one side of her body over the past 3 years. The patient underwent 5 surgical procedures. The patient's concomitant medications were not reported. The patient was not on any other products. No investigation assessment was performed. 02Feb2021, the patient underwent surgery (last surgery after vaccination) on her IT (Iliotibial) band, releasing a tendon on the outside of her thigh. She knew that she would go for surgery as it was scheduled prior to the vaccination. On 05Feb2021(a week after vaccination) the patient experienced rash/an itchy rash, itching around the surgical wound that extended to other parts of her body, including her forearm (same arm where she received the vaccine), ribcage, and gluteal area. Rash apparently improved today (date of reporting) she did not find any new spots and it was not as itchy. The patient was treating rash with an over-the-counter salve per her doctor's recommendation, and it was now subsiding, but that it was jumping from body part to body part. She wanted to know if she should still get the second dose considering she had the rash as the dose was due on Friday or Saturday next week. The outcome of the event itchy rash was recovering and unknown for another event.  Follow-up attempts are completed. No further information was expected.
Information has been received from a physician referring to a 4 and a half years old male patient. On an unknown date the patient was vaccinated with a first dose of M-M-R II (dose, frequency, lot# were not reported) with no problem and at the reporting time he was ready for his booster dose, but patient currently had mild egg allergy (patient could tolerate well-cooked egg). The physician wanted to make sure if patient would be able to tolerate M-M-R II booster dose. It was unknown at this time when patient developed egg allergy, either before or after the first dose of M-M-R II. No treatment was given for the event. The outcome of the event was reported as not recovered. Causality was not reported. The patient sought medical attention via office visit. Additional information has been requested.
2wk p/vax pt devel high fever of 104 & generalized convuls;fever persisted 3 days;pt had 2 episodes of sz on different occasion;
Patient received dose outside of manufacture recommended storage conditions.  Patient did not/has not shown any signs of issues.
My reaction included ?covid arm? a large, red, swollen area at the injection site along with a severe rash that was blistered, itchy, very painful and red on my feet, hands, lower and upper legs and minimally on my arms. The rash first presented mildly 7 days post vaccine along with ?covid arm? and progressed with day 4 of the outbreak being the worst and subsequently fading-with mostly being completely gone on day 7. I still have some small bumps on my hands along with discolored skin in all the areas where the rash was present. I received steroids (both oral and injection), pain medicine and a biopsy.
Shortness of breath, chest pains, migraines, fatigue, admitted to the ER on 07/31/2021, suffered from a slight heart attack. Healthcare provider confirmed inflammation around the heart.
This spontaneous report was received from a licensed vocational nurse referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions, or concomitant medications. On unspecified dates, the patients were vaccinated with an improperly stored dose of RECOMBIVAX HB (lot number reported as M044031, expiration date 21-FEB-2019 and lot number M031574, expiration date 11-NOV-2018) for prophylaxis (dose and route of administration were not reported). The administered dose of the vaccine experienced a temperature excursion 57 degrees Farenheit for 15 minutes. A previous temperature excursion of 48 degrees Farenheit for 15 minutes was also reported. The temperature excursions were recorded by a data logger. There was no adverse effect reported. No product quality complaint was involved. This is one of several reports from the same reported (MARRS No. 1703USA013299, 1704USA001639 and 1704USA001640). Additional information has been requested. Sender's Comments: US-009507513-1704USA001639: US-009507513-1704USA001640: US-009507513-1703USA013299.
ON 1/1/21, DEVELOPED SORE THROAT LASTING 2 DAYS. LOW GRADE FEVER (99.3 ON 12/31 AND 1/1. MUSCLES ACHES 1/1/21-1/3/21.
Three hours later fever, body aches and major fatigue lasted three days, really bad. It lessened but I still had a lot of nausea and triggered my migraine. For ten days to two weeks, I developed severe pain in spine, neck and had vision disturbance. Went into my arms and legs and I can't stand. I can't hold things well, constipation really bad, bouts of urinary incontinence. Same symptoms for 2nd dose. Guillain-Barré Syndrome since 20s after the vaccine and was ok with flu vaccines and did the COVID-19 vaccines. Went to Urgent Care around November 2, 2021. It was not a UTI. Went to primary again, yesterday it was worse than ever, and now I need a walker to walk.
tested positive for COVID; unintended benefit from the vaccine; This is a spontaneous report from a contactable consumer. An 84-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), dose 1 via an unspecified route of administration on 04Jan2021 as SINGLE DOSE for covid-19 immunisation. Medical history included general physical health deterioration, cardiac effusion from an unknown date and unknown if ongoing. The patient is not pregnant at the time. The patient was vaccinated at a Nursing Home/Senior Living Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was recovering from a cardiac effusion prior to being administered the vaccine, was extremely weak and on 2 liters of oxygen. Within a month of receiving her first vaccine on 04Jan2021, she has significantly improved. She also tested positive for COVID on 08Jan2021 we believe she was exposed prior to receiving the vaccine. She did not have serious symptoms. She received her second dose of the vaccine on 15Feb2021, after testing negative for the virus. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 04Feb2021. The outcome of the event Unexpected therapeutic benefit was unknown, and another event SARS-CoV-2 infection was recovered. No treatment was received for the adverse events.   Information on the lot/batch number has been requested.
Patient felt significant whole body muscle weakness and has not improved after a month. Also have double-vision.
Information has been received from a medical assistant referring to a 2 year old patient of unknown gender. Information about medical history, concurrent condition and concomitant medication was unknown. On 13-NOV-2018 the patient received an improperly stored dose of PROQUAD (lot # R012417, expiry date: 28-OCT-2019; dose, frequency and route were not reported) for prophylaxis, which was reconstituted with properly stored sterile diluent. No adverse effects were reported. There was no previous temperature excursion. It was also reported that temperature was from 15 Fahrenheit to 46 Fahrenheit for 8 hours and the data logger was involved. Sender's Comments: US-009507513-1902USA007542: US-009507513-1902USA007540: US-009507513-1902USA007543: US-009507513-1902USA007545: US-009507513-1902USA007539: US-009507513-1902USA007538: US-009507513-1902USA007536: US-009507513-1902USA007541: US-009507513-1902USA007537: US-009507513-1902USA007544: US-009507513-1902USA007547: US-009507513-1902USA007548: US-009507513-1902USA007549: US-009507513-1902USA007550: US-009507513-1901USA008772.
I broke out in hives on my back. It is extremely itchy with red bumps. It has spread up to the back of my neck. I contacted my doctor, and they recommended taking antihistamines. I am taking XYZAL currently. I feel like my pravastatin medication contributes to it, so I have stopped taking it at this time to see if it helps. I am still dealing with this at this time.
Marked swelling of his right arm from shoulder to fingertips his third dose of AVA in 2007. 8 hours after receiving AVA his arm was swollen as above with his hand "10 times bigger than the other". His fingertips were red and tingling. There was some difficulty with movement; his arm felt heavy. No systemic symptoms; well otherwise. The symptoms lasted 24 hours then totally resolved.
Left arm was sore; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 43-year-old male patient BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 11Mar2021 15:00 (Batch/Lot number: unknown) at the age of 43 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Sulfonamide allergy" (unspecified if ongoing), notes: known allergies: sulfa drugs; "Liver transplant" (unspecified if ongoing), notes: Recent liver transplant recipient. Concomitant medication(s) included: CYCLOSPORINE; MYCOPHENOLIC ACID; DESCOVY; TIVICAY. Past drug history included: Sustiva, reaction(s): "Allergy", notes: known allergies: Sustiva; Viramune, reaction(s): "Allergy", notes: known allergies: Viraumune. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "Left arm was sore". Therapeutic measures were not taken as a result of vaccination site pain. Additional Information: 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 vaccines within four weeks prior to the COVID vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021404535 same drug/reporter/patient, different dose
cold symptoms for about 5 days starting on 9/11/21 (sore throat, sinus congestion, nasal congestion). Note wife also tested positive for COVID same day he did
Swelling/erythema right upper arm and elbow two days after receiving pneumonia vaccine in right deltoid.
Developed low grade reaction 24 hours following Hep B and MMR immunization. Reaction consisted of headache, flushed face and fever ranging from 99 to 100.9. Pt's mother reported she began to feel better on the evening of 11/09/2001.
I began with a very light cough on Tuesday evening, October 18.  On Wednesday, I woke up and felt a high fever (101.5) and extreme fatigue.  I also had a more severe cough and sore throat.   I tested positive for COVID 19 on Wednnesday, October 19, 2022.   I received Monlupiravir on Wednesday, as well.    The sore throat resolved almost immediately.  However, the cough remained.  The most severe symptom was the extreme fatigue.  I had a fever from Wednesday through Saturday.  On Sunday, I began to feel a little bit better.    On Tuesday morning, although I didn't feel much better, I did test negative.