chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient presented to the ED on 5/24/23 with shortness of breath. Tested positive for COVID. She was treated and discharged from the hospital on 5/28/23.
Soreness at injection site beginning approximately 5 hours after COVID-19 vaccination.; This is a spontaneous report from a contactable consumer.  A 62-year-old male patient received bnt162b2 (BNT162B2, Lot Number: EL 3247), via an unspecified route of administration on an unspecified date (at the age of 62 years) as a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced soreness at injection site beginning approximately 5 hours after COVID-19 vaccination on an unspecified date with outcome of unknown.    Information related to batch/lot number has been requested.
bad vertigo; dizziness; a lot of weakness in her knees; she doesn't feel good; nervous; This is a spontaneous report from a contactable consumer. A consumer reported for 84-year-old female patient (reporter's mother).  A 84-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number was not reported), dose 3 via an unspecified route of administration on 29Sep2021 as dose 3 (booster), single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that on 30Sep2021 patient experienced vertigo and dizziness a lot of weakness in her knees. She had complained about that last night but she did not have rash or fever and her breathing was good. She was asking if this was normal or if anybody had complained about this before. She was really nervous and upset. Stated she had it two days ago. Caller stated she spoke with her, she was in a different county and she was getting some side effects. Stated that last night she had bad vertigo, dizziness and weakness. Stated that she was 84 and never had this with the first or second doses but she got it with the booster. The outcome for the events was unknown.  Follow-up attempts completed. No further information is expected.
Information has been received from a health professional who was told by her sister in law that in October 2006, a 24 month old patient was vaccinated by mistake with HPV vaccine. It was reported that the patient became very ill and began vomiting and developed a high fever. It was reported that the patient recovered. Additional information has been requested.
Woke up 36 hours post vaccine with Headache, nausea dizziness
Pt recvd vax & 10 mins p/vax mom returned to clinc w/pt stating pt was coughing, red & swollen in face w/rash; on exam pt was noted to have periorbital edema-bilat erythematous rash on rt side of face & chest;
pt reported to clinic 10 days p/vax around inj site red, swollen, itchy sensation of warmth, warm to touch;presented to office on 30MAY97;3x4 cm red swollen area on rt deltoid @ inj site;
Vaccine Administration Error with No Adverse Event Reported by Patient  Patient was scheduled to receive their second dose of the Moderna COVID-19 vaccine (0.5ML) and instead received a Moderna COVID-19 booster dose (0.25ML).  Patient is deciding whether or not they want to receive additional vaccine to equal the "full" 0.5ML dose.
Baseball sized, red rash around injection site 8 days after injection. The rash doesn't itch or hurt in any way, just visibly noticable.
Nausea, occasional diarrhea, abdominal cramps, all still persisting currently at the time of this submission on 10/10/2011 8:45 pm.
Dizziness and anxious Complained injection was too fast Patient hasn't had any food until 18:10 Patient was given snacks and bottle of water and was observed for 30 minutes
Information has been received from a pharmacist, via a company representative, referring to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patient was vaccinated with the first and second doses of PNEUMOVAX 23 (anatomical location, administration route, lot number and expiration dates were not reported) both doses for prophylaxis. The pharmacist stated that the patient was "over the age of 65", when she received the second dose of PNEUMOVAX 23 and "before the age of 65" when she was vaccinated with the first dose. On unspecified dates, the patient experienced a "common injection site reaction" and also stated that the patient "experienced more pain and swelling at the injection site with the second dose" of PNEUMOVAX 23. The outcome of the common injection site reaction, the injection site swelling and injection site pain was unknown and the causality between these and the vaccination with PNEUMOVAX 23 was not reported.
Fever, Fatigue, Nausea, loss of appetite, muscle and joint aches and soreness, headache
MMR inject site RUOA sl local blister wheal rxn noted w/redness upon immediate needle withdrawal; applied ice pack & observed 10 mins; DTP inject site RAT 2-3 splotchy reddened area occurred p/running & playing in the park on day 3 or 4;
Emergency Use Authorization (EUA): injection Hard red swelling painful at injection site and migraine headache
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 49 years old patient of unknown gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 12-DEC-2013, the patient was administered the ZOSTAVAX vaccine. The patient was treated by a physician for the following injuries resulting from the patient's ZOSTAVAX use: Herpes Zoster. The patient claimed damages as a result of: Injury to themselves; Loss of consortium; Loss of services; Economic losses. The following claims were asserted: negligence; products liability - defective design; products liability - manufacturing defect; products liability-failure to warn; breach of express warranty; breach of implied warranty; fraudulent misrepresentation; fraudulent concealment; negligent misrepresentation; unjust enrichment; strict liability; consumer fraud; loss of consortium; punitive damages. The outcome of the event was unknown. Causality assessments were related.
The  patient received a Moderna dose approved for 6-11 years of age on 10/07. This vial was originally approved as a booster dose for patients 18+. So technically, they received a monovalent booster.
Our Child had a 103 degree fever at 7 PM.  Took over 17 hours to reduce to normal.  Treated with Acetaminophen every 4 hours and with Ibuprofen every 6 hours.  At injection site on arm is red and inflamed 27 hours later.
9/30/13 - received flu shot; shortly after had a ear ache - relieved by TYLENOL. 24 hours later discover swelling under (R) armpit - same arm she received the flu shot.
In April, I had two raised areas around my bumps which were thought to be lymph nodes. The CAT scan was done and it was not lymph nodes I was told that it could be Cushing's disease. I also had muscle fatigue and general fatigue just not feeling well.
Upper Left Quadrant Pain; Initial Report Received on 22-SEP-2022  This is a spontaneous report received from a pharmacist regarding a female patient who received HEPLISAV-B for hepatitis B immunization.   There was no medical history reported.  Concomitant medications were not reported.  On an unknown date, dose 1 of HEPLISAV B (Lot # not reported, expiration date not reported, NDC # not reported), route and site not specified, was administered for hepatitis B immunization.  On an unknown date, after having been vaccinated with the first dose of HEPLISAV B, the patient experienced upper left quadrant pain. The patient did follow through with finishing the vaccine series with a 2nd dose. The dates of the injections are unknown.  No further information was available at the time of the report.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Painful right lung; Coughing; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY PAIN (Painful right lung) and COUGH (Coughing) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PULMONARY PAIN (Painful right lung) and COUGH (Coughing). At the time of the report, PULMONARY PAIN (Painful right lung) and COUGH (Coughing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was provided by the reporter.   Reporter did not allow further contact
a 44 years old female patient was administered an expired dose of Fluzone Quadrivalent, No AE; Initial information received on 02-Oct-2020 regarding an unsolicited valid non-serious case received from the other health care professional.  This case involves a 44 years old female patient who was vaccinated with an expired dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (expired product administered).  Medical history, medical treatment, vaccination and family history were not provided.  No concomitant medications or vaccination given to the patient.   On 28-Sep-2020, the patient received a 0.5 mL (drug interval dosage : once) dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot U6655AA and expiry date: 30-Jun-2020) via an intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (latency on same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
While at the pharmacy patient reported tingling and swelling in her lips, as well as flushing in her face and chest. within 10 minutes of vaccination. Patient took 50mg of Benadryl and sat in the pharmacy for an hour with no worsening of reaction. For 3 days the patient reported continued swelling and tingling in her mouth and lips, flushing with feelings of hot and cold, fatigue, tingling in her left thigh, skin peeling on her face around eyes, and wheezing. Patient stayed home and slept and continued to take Benadryl. She spoke with her doctor and will be following up in the next week. She reported feeling better after 3 days.
covid like symptoms/ fever/ chills; unusual smell; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. Medical history included COVID-19 in the previous year (2020). The patient's concomitant medications were not reported. On an unspecified date, the patient got the first dose and became pretty sick. She was in bed for a few days - had COVID like symptoms - fever, chills - unusual smell. The patient wanted to know is she has to get the second dose. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 77-year-old, elderly patient of an unspecified gender. It was reported that, the FLUCELVAX QIVc vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6-degree Celsius. On 19-Oct-2018, the patient was administered FLUCELVAX QIVc [route of administration: intramuscular, anatomical location: left deltoid, batch number: 252230, expiry date: 31-May-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805441 was crossed linked to original case 201804863 due to same reporter.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN JAW (noticed a pain in the jaw), INFLUENZA (flu) and CONDITION AGGRAVATED (it was significantly worse than with the second shot) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 010M20A) for COVID-19 vaccination. Concurrent medical conditions included Hashimoto's disease, Hypothyroidism and Asthma. Concomitant products included COLECALCIFEROL (VITAMIN D3), THYROID (ARMOUR THYROID), SERTRALINE, ATOMOXETINE and OMEPRAZOLE for an unknown indication. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN JAW (noticed a pain in the jaw), INFLUENZA (flu) and CONDITION AGGRAVATED (it was significantly worst than with the second shot). At the time of the report, PAIN IN JAW (noticed a pain in the jaw), INFLUENZA (flu) and CONDITION AGGRAVATED (it was significantly worst than with the second shot) outcome was unknown. No treatment information was provided. This case was linked to MOD-2021-313599. This case was linked to MOD-2021-307971. See case MOD-2021-313599 for details regarding the child case.
Large area of swelling, erythema & warmth covering entire deltoid & 1/2 way down upper arm. Patient also c/o marked itching.
Patients mother reported site hot, red and painful after shot. started day of shot.  Picture was taken, look like possible cellulitis.  Told patients mother to take see MD to get course of anti-biotics.
Paroxysmal atrial fibrillation.  Less than 24 hours after the 3rd dose (booster) of Moderna vaccine atrial fibrillation began.  This continued for one one month, requiring a TEE Cardioversion to put me back in to a normal heartbeat rhythm.   The previous 2nd dose of Moderna (March 2020) had caused a similar atrial fibrillation, however the heart rhythm returned to normal within a five days of vaccination on its own, and did not require a Doctor's intervention.   I do not recall having heart rhythm issues after the initial (first) dose of Moderna in February 2020.
patient received COVID booster on 11/1/2021 and developed acute appendicitis on 11/3/2021
no adverse affects reported; patients received doses of improperly stored Varivax; This spontaneous report was received from a health professional and refers to a patient of unknown gender and age. The patient's concurrent conditions, medical history, concomitant therapies, drug reaction and allergies were not reported.   On an unknown date in April 2019 (reported as 25-APR-2019 or 26-APR-2019), the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) subcutaneously, lot # R034396, expiration date 27-NOV-2020, (dose was not reported) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of 38 degrees Fahrenheit for 72 hours. Sterile diluent was stored properly. There were no previous excursions reported. Data logger was not involved. No adverse effects was reported.  This is one of eleven reports from the same reporter.; Sender's Comments:  US-009507513-1904USA013268: US-009507513-1904USA013210: US-009507513-1904USA013272: US-009507513-1904USA013270: US-009507513-1904USA013275: US-009507513-1904USA013265: US-009507513-1904USA013269: US-009507513-1904USA013278: US-009507513-1904USA000187: US-009507513-1904USA000191:
Moderna COVID-19 Vaccine  Rash developed around 7-9 days after shot. Extends from torso to arms and legs, around a pimple/square inch. Some painful, many itchy. Prescribed triamcinolone 0.1% cream - not effective. Antihistamines, standard dose - somewhat helpful. No overall reduction in symptoms at time of reporting (10/4/2021).
C/o left arm discomfort & weakness with pain in the (L) scapula & chest. Also c/o twitching to left side of race. To see PCP.
Red hot half dollar size painful lump, went away came back as red itch half dollar size lump.
Myalgia, Arthralgia, Diarrhea & NauseaVomiting Narrative:
This spontaneous report as received from an office manager refers to a 57 year old patient of unknown gender. No pertinent medical history, concurrent conditions, drug reactions allergies or concomitant therapies were provided. On 30-JUN-2017, the patient was vaccinated with pediatric RECOMBIVAX HB 5/0.5 mcg/ml for prophylaxis (dose, route, indication, lot number and expiration date were not reported) due to a human error. No adverse effects were reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1707USA006672.
tested positive for Covid 19; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team for a Pfizer sponsored program (159558). The reporter is the parent.  A 5 year-old female patient received bnt162b2 (BNT162B2), administration date 08Jan2022 (Lot number: FK5618) at the age of 5 years as dose 1 (tris), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: COVID-19 (non-serious) with onset 13Jan2022, outcome "unknown", described as "tested positive for Covid 19". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Caller clarifies that it is his 5 year old daughter, stated she tested positive for Covid 13Jan2021, caller states she had symptoms during the day that she got the vaccine, states at the time it was just some sniffles so they went ahead with the vaccination. States it was followed up by a rapid test, states yesterday that test came back negative. States she got the paediatric dose. Investigation Assessment: No.; Sender's Comments: Based on limited information in the case , a possible causal association between all the reported event covid 19, and the suspect drug BNT162B2 cannot be excluded.,Linked Report(s) : US-PFIZER INC-202200101731 similar report from same reporter
Administered vaccine after 33 days in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications provided. No treatment medications provided.
The day of,  had arm soreness and fatigue, but had resolved after 4 days. However, after 10 days, had developed fatigue, tender lymph nodes in the axilla, and erythematous hive on the left arm where the vaccination was that resolved over the course of 4-5 days.
High fever 101-102, headache, nausea and vomiting for 48 hours
fever to 104.6 R; sz x 2 1st approx 60 sec 2nd approx 10 dex;
This case was reported by a healthcare professional and described the occurrence of a female subject of unknown age not responding to therapy following vaccination with hepatitis B vaccine recombinant (unknown manufacturer) for prophylaxis.  Approximately 10 to 15 years ago, the subject was vaccinated with an unspecified number of doses of hepatitis B vaccine.  At an unknown time, the subject was tested and the titer test showed to be non reactive.  The subject had not responded to therapy.  At the time of reporting the event was unresolved.
The patient had the shivers for over 8 hours and couldn't get warm; This is a spontaneous report from a non-contactable consumer. An unspecified aged male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date 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. It was unknown whether the patient had received any other vaccines within 4 weeks prior to the COVID-19 vaccine. On an unknown date in Feb2021, the patient experienced shivers for over 8 hours and could not get warm. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event shivers was recovered on an unknown date in 2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient reported off work today 09/29/2023.  I talked to patient today 09/29/2023 at 1145. He reported at 0600 severe headache N/V, and sore left arm, painful to raise arm.  He has stayed at home in bed, lights off, cool cloth for headache, sipping fluids. Slowly improving headache currently rated at 5-6/10, last emesis was at 1000. Donor ware to report to ER if having signs or symptoms of dehydration, or any other increased or new symptoms. verbalizes understanding.
DIED SUDDENLY; This spontaneous report received from a consumer via communication (other source) via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number, expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 19-OCT-2023, the patient  died suddenly from unknown cause of death. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20231149954-Died suddenly. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH