chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rheumatoid arthritis flare up; sore arm; Upset stomach; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4389748-00.  A 44-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous for rheumatoid arthritis; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Vaccine dose number=3 Pfizer, vaccine dose number=1,2 Moderna" (unspecified if ongoing), notes: Vaccine dose number=3 Pfizer, vaccine dose number=1,2 Moderna. The patient's concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant) with onset 2022, outcome "recovered" (2022), described as "Rheumatoid arthritis flare up"; ABDOMINAL DISCOMFORT (non-serious) with onset 2022, outcome "recovered", described as "Upset stomach"; PAIN IN EXTREMITY (non-serious) with onset 2022, outcome "recovered", described as "sore arm". The action taken for adalimumab was unknown.  The reporter considered "rheumatoid arthritis flare up", "sore arm" and "upset stomach" related to BNT162b2.  The reporter causality between the events rheumatoid arthritis flares up, sore arm and upset stomach for BNT162b2 and MODERNA COVID-19 VACCINE was reported as possible and for HUMIRA was not reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Amendment: This follow-up report is being submitted to amend previous information: To amend to update event causality result.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events rheumatoid arthritis, abdominal discomfort and pain in extremity cannot be excluded.
Reaction to vaccine area is warm, itchy and hard. Pt. advised to apply ice to area.
Patient hospitalized for normal labor and delivery within 6 weeks of receiving covid booster. postpartum course uneventful. APGAR scores were 8 and 9.  No other information available for baby.
Shortness of breath in left lung developed after 2nd shot and has continued several weeks after.
the soreness is quite evident; swelling at the injection site; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9267 and expiration date was unknown) via an unspecified route of administration on left arm on 15Feb2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced swelling at the injection site on 16Feb2021 and the soreness is quite evident on an unspecified date. The outcome of swelling at the injection site was not recovered and soreness is quite evident was unknown.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 55-year-old male patient received BNT162b2 (BNT162B2), on 23Apr2021 as dose 2, single (Lot number: ER8796), in left arm and on 23Nov2021 as dose 3 (booster), single (Lot number: FJ8757) at the age of 54 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: VALSARTAN, start date: 01Sep2021; VERAPAMIL, start date: 15Mar2022; ATORVASTATIN, start date: 01Jan2018. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: indication=Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: vaccine was received and patient received other medication in 2weeks.
The patient has received the J&J Covid vaccine according  to database and said they did not receive any COVID Vaccine before, so we administered  a dose of MODERNA Vaccine per patient request on 08/17/2021. Patient stated on the screening form that has not received another Covid vaccine.
Guillain Barre and ADEM. Respiratory failure, altered mental status, muscle weakness.
Subsequent to receiving the first dose of varicella virus vaccine live, the pt developed approximately 5-10 lesions on her face and forehead.
Patient was given MMR and Depoprovera at approximately 10:16am. Within three to four minutes patient became pale, complained of being hot, then fainted. Had Gran mal Seizure lasting approximately ten seconds. Patient has been on Depo since 8/01. This was first known MMR.
Using Pentacel off Label with Pediarix/prophylactic vaccination (Immunisation); This case was reported by a consumer via other manufacturer and described the occurrence of off label use in a patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis and PENTACEL (DTAP + HIB + IPV) for prophylaxis.   On an unknown date, the patient received Pediarix, Pediarix Pre-Filled Syringe Device and PENTACEL (DTAP + HIB + IPV). On an unknown date, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced off label use. On an unknown date, the outcome of the off label use 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 patient received Pentacel off label with Pediarix, which led to off label use of product. At the time of report, no adverse event reported. There will be no information available on batch number for this case. The reporter did not consented to follow up
This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Adverse reaction after second dose) in a male 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 an unknown date, the patient experienced ADVERSE REACTION (Adverse reaction after second dose). At the time of the report, ADVERSE REACTION (Adverse reaction after second dose) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided. No concomitant medication was provided.
My daughter got vaccinated and immediately got the shingles.; This case was reported by a consumer via interactive and described the occurrence of shingles in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows The case was reported by the patient's parent. The age at vaccination was not reported. Immediately after receiving Shingles vaccine, the patient got shingles.
Patient began with a rash on her face that moved to her torso. Began with palpitations and then went to the emergency room to be evaluated. By that point in time the provider reports that the rash was not visible.
Patient received Prevnar 13 vaccine on 7/31/18 in Left Deltoid.  Unknown specific date when patient's symptoms started, however, patient stated erythema, warmth, and itching of left upper arm worsened over the weekend, and became stable on 8/6/18.  Patient presented to PCP office on 8/6 with above complaints.  MD noted "17 by 12 cm in diameter left upper arm erythematous, mildly warm and raised.  No other apparent skin lesions".  Patient did not use antihistamines or topicals.  MD recommended cetirizine 5mg daily, hydrocortisone 1% topical, and ice packs.  On 8/7, patient presented to PCP again with worsening symptoms.  MD prescribed cephalexin 500mg BID and prednisone 20mg daily x 4 days.
Patient received flu vaccine at this facility during a flu clinic open to the public.  Three days later he experienced fever, headache, nausea/vomiting, diarrhea, muscle aches.
Patient recieved first dose of the Moderna vaccination and about five minutes after recieving the vaccine, started to feel lightheaded, dizzy, and tingling of the tounge. Patient was assesed by onsite medical staff and ALS resources were called. The patient was transported by local EMS to Hospital.
Patient developed redness, inflammation and pain around the injection site on 8/2/12. She called her doctor on 8/3/12, and he recommended to use ice and TYLENOL. She applied ice and only had to take one TYLENOL. The rash was gone by 8/5/12. She still has a small knot on 8/7 at the injection site.
Day one immediate soreness. By day two redness, swollen, by day three swelling spread to entire upper arm, still red, by fourth day swelling decreasing, but still swollen and very hard bump 2-3" in diameter, some fatigue. Took once dose ADVIL Day 2 and Day 3. Not recovered yet. It is day 4 today. Reported to doctor but it's the weekend, so don't know if doctor visit or follow up needed yet.
Complete body muscle rigidity and cramping, lasting about 4-5 hours. I am not able to walk or ride in the car, so I just tried to stay calm, drink water, and wait for the symptoms to go away.
2/25/15-C/o fatigue, body aches and chills. 2/26/15-C/0 with these symptoms and rash to hand-rash worsening both hands/chest. 2/27/15-rash worsening and took BENADRYL x 3. Rash "burned" no itch. 2/28/15-went to urgent care-rx steroids.
5 days after vaccine given , patients started having chills for very short time twice, some chest pain, extreme fatigue , loss  of equilibrium
Headache, NauseaVomiting, chills Narrative:  Other Relevant History:
vaccinate past its expiration date/Vaccine that had been more than 30 days in the refrigerator; vaccinate past its expiration date/Vaccine that had been more than 30 days in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccinate past its expiration date/Vaccine that had been more than 30 days in the refrigerator) and PRODUCT STORAGE ERROR (vaccinate past its expiration date/Vaccine that had been more than 30 days in the refrigerator) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccinate past its expiration date/Vaccine that had been more than 30 days in the refrigerator) and PRODUCT STORAGE ERROR (vaccinate past its expiration date/Vaccine that had been more than 30 days in the refrigerator). On 08-Oct-2021, EXPIRED PRODUCT ADMINISTERED (vaccinate past its expiration date/Vaccine that had been more than 30 days in the refrigerator) and PRODUCT STORAGE ERROR (vaccinate past its expiration date/Vaccine that had been more than 30 days in the refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant information was reported. No treatment information was reported.   This case was linked to MOD-2021-352843 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Oct-2021: Added patient initials, DOB and gender. Added suspect product start date, expiration date.
This case was reported by a physician via sales rep and described the occurrence of pain in arm in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced pain in arm, muscle pain, influenza like illness, headache, exhaustion and feeling abnormal. On an unknown date, the outcome of the pain in arm, influenza like illness, headache, exhaustion and feeling abnormal were recovering/resolving and the outcome of the muscle pain was unknown. It was unknown if the reporter considered the pain in arm, muscle pain, influenza like illness, headache, exhaustion and feeling abnormal to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. On Friday afternoon, the patient received a dose of SHINGRIX correctly in the deltoid. Within a few hours after vaccination, the patient experienced arm soreness in the vaccinated arm. At that night, the patient's arms ached and she had difficulty in sleeping due to not being able to get comfortable. On Saturday, the patient had muscle aches, headache, felt like flu-without the fever, exhausted and just felt eh. On Sunday the patient felt better and was pretty much back to normal on Monday. The reporter agreed to follow up from the GlaxoSmithKline. This case has been linked with case US2019GSK017834 (wife's case), reported by the same reporter.
Arm swollen, red & hot from injection site to below elbow, headache, nausea,  weakness, body aches, dizziness,  GI cramping  & very loose stools. I'm on day 9 & still have weakness, dizziness, GI cramping & very loose stools.
Tendons inflammation. Damaged and became thicker. Weak and ache like a 70 yes old person who has abused the joints for decades. Went to see the rhaumatologist and she concluded that this is cause by Pfizer vaccine and not a disease or disorder of rhaumatoid and cannot treat me. Blood test in Oct 2021 and Jan 2022 show autoimmune is normal. So the inflammation is cause by the chemical in pfizer. Blood tests show the body autoimmune  doesn't not elevate and did nothing or has any reaction. Concluded by me that vaccine has a chemical that is design and execute by itself to cause inflammation and damage the tendons. Maybe down the future more people will buy pfizer arthritis product line.
This case was reported by a healthcare professional and described the occurrence of low grade fever in a 10-month-old male subject who was vaccinated with Fluarix, GlaxoSmithKline for prophylaxis.  Concurrent medical conditions included healthy baby.  No concurrent medications.  The subject had experienced no adverse events following previous vaccinations.  On 27 November 2007 the subject received unspecified dose of Fluarix (.5 unknown) and experienced a vaccination error.  On 29 November 2007, 2 days after vaccination with Fluarix, the subject experienced low grade fever, diarrhea and runny nose.  No other vaccinations were given on 27 November 2007.  Medical attention was not required.  At the time of reporting the runny nose had improved and the fever and diarrhea were unresolved. Follow-up information was received on 17 December 2007, via healthcare professional, who reported the subject received the wrong dose and wrong drug. One day later on 28 November 2007, the subject experienced the previously reported events that resolved 04 December 2007. The healthcare professional considered the events related to erroneous administration. The reporter was "positive the baby was given to much and not the correct dose".
Client developed redness in face particularly cheeks. Reportedly warm to touch.  No other symptoms until 9/22 when developed rash on right forearm and chest.  Experienced some swelling in cheeks and below eyes. Mother reports she was also exposed to neighbor's rabbit on 9/19 and 9/20. Mother reports she gave dose of Benadryl on 9/22 and the swelling improved.  Sought medical advice on 9/22 at local FQHC.
No additional AEs; VARlVAX by the intramuscular route instead of subcutaneous; This non-valid spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 29-APR-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 milliliter, lot number T012552, expiration date 10-APR-2021 for prophylaxis. The vaccine was administered intramuscularly instead of subcutaneously (incorrect route of product administration). No adverse event was reported.  This is a non-valid case due to the lack of patient identifiers.  Follow-up information was received from a nurse on 12-MAY-2021. The patient's identifiers were provided: the patient was a 21-year-old male. He was vaccinated in the right deltoid.
Drug ineffective; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 27Sep2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 70 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown", described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: After 7 days I tested negative on an antigen test; Positive, notes: Day 12. That day the symptoms returned and I tested positive on an Antigen test; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.  Additional information: He was prescribed with Paxlovid in a timely fashion, and it relieved the symptoms very quickly. Thank you. After the 5 days and 5 doses, he felt great. After 7 days he tested negative on an antigen test. he was symptom free and felt great until day 12. That day the symptoms returned and he tested positive on an Antigen test. So he want to alert you to the possibility of a virus resurgence like this. Perhaps the 5 day treatment was not enough. It still did its primary duty as his symptoms are mild and he certainly do not expect to be hospitalized. But perhaps there needs to be a warning about the possibility of resurgence after a course of a Paxlovid treatment. He was recovered on 03Apr2022. He did not receive any other vaccine within 2 weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
8:30pm 9/14 Body was sore all over esp. neck stiff, couldn't turn head. (Injection site not sore). Rapid sneezing 6-10 times in a row from 8:30-9:30pm. 9/15 Sweating & chills (alternating) began. 9/16 3:30 pm symptoms resolved completely.
From initial information received on 19Nov04 from a health care professional regarding an adverse event occurring, it was reported that an 18 month old male pt received his third dose of Daptacel, lot number C1700AA, administered in the left thigh, a dose of Ipol, lot X1212, administered in the right thigh and a dose of Fluzone SV 2004-2005 Pediatric dose, lot number U1389AB, administered in the right thigh on 18Nov04. Routes of administration were not reported. That same day, the pt developed a diffuse, red, and warm reaction on his thigh. Reportedly, he was able to walk but the thigh was very swollen. The pt previously received a dose of Acthib,lot number UE443AA, administered in the left thigh, a dose of Fluzone SV 2004-2005 Pediatric dose, lot number U1389AB, administered in the left thigh and a dose of Varivax, lot number 0278P, manf Merck, administered in the right thigh on 18Oct04. Routes of admin of these vaccines were not reported. Concomitant medication at the time of vaccination included Pulmicort and Singulair. Pt's pre-existing medical conditions include Alpha Anti-Trypsin Deficit, Reactive Airways Disease and chronic otitis media. He has no known allergies. It is unk whether the pt recovered from these events. The reporter of this case is the same reporter as cases 200403769, 200403771, 200403772, 200403773 and 200403774.
2 days p/vax pt devel an inj site rxn characterized by 45mm by 40mm area of erythema & induration;pt recovered @ the date of this report;this is 1 of 4 pt from this site to devel an inj site rxn following the vax;
Patient received Janssen vaccine at the jail on 7/9/2021 and 2 weeks later he started having neurologic symptoms (could only smile on the L side of his lip, could not his eye on the R side, difficulty chewing and swallowing, and eventually the R side of his face became numb). He was subsequently diagnosed with Bells Palsy by the physician at the jail. He came to get booster doses for COVID and at the time of our visit he stated that he feels he has fully recovered except that he his R eye does not blink as often as the L eye. I told him to refer to his primary care provider and never to get the Janssen vaccine again--he confirmed understanding.
Very minor side effects; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (Very minor side effects) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced ADVERSE DRUG REACTION (Very minor side effects). The patient was treated with ACETAMINOPHEN ongoing from 19-Jan-2021 for Adverse event following immunisation, at a dose of UNK dosage form. At the time of the report, ADVERSE DRUG REACTION (Very minor side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Patient took preventatively a dose of acetaminophen in the morning of vaccination.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
This spontaneous report as received from a registered pharmacist refers to an unspecified patient of unknown age and gender. No concurrent condition or medical history was reported. On 04-JUN-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) (dose, route of administration, anatomical location, lot # and expiration date were not reported). No adverse effect were reported. It was unknown if the patient sought medical attention. Additional information has been requested.
Mom described pt turning limp & pale in approx 1 hr p/shot did not respond to touch, finally "woke up" p/shaking-then seemed nl;