chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Same day post vax, pt called in reaction, swollen tongue, welts, and was referred to ER.
Injection site soreness and headache started on the evening of the day shot was given.  The injection site pain was worse the next morning but Tylenol took care of the pain.   The headache continued on despite tylenol & ibuprofen, and accompanied by nausea for 4 days, went away for 3 days then came back again until present.
Pfizer-biotech COVID-19 Vaccine EAU Expected extreme sleepiness, could only stay awake for 20 minutes at a time for next 24 hours. O2 saturation went down as low as 91 but mostly was at 93, heart rate 112 on Jan 13, along with a 100.1 oral temp. I did not Check on Jan 12.    Morning of Jan 14: 99 oral temp and 95 O2 saturation.  By evening temp and O2 were back to normal: 98°  and 98%.   Jan 17 I experienced some wheezing.    I did have COVID with pneumonia Sept 2020.
Vaccine given to a 16 year old; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine given to a 16 year old) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 27-Jul-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine given to a 16 year old). On 27-Jul-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine given to a 16 year old) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was reported.
swelling in her fingers; fever; chills; nausea/nausea; felt weak/weakness; lethargic/lethargy; pounding headaches/pounding headaches; tingling in her left hand got worse; 5 -10 bruises (looked like little broken blood vessels) popped up on both upper thighs; appetite was affected; tingling in left hand (ulnar distribution); This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling in left hand (ulnar distribution)), PERIPHERAL SWELLING (swelling in her fingers), PYREXIA (fever), CHILLS (chills) and NAUSEA (nausea/nausea) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036C21A and 016C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: FLU. Concomitant products included ETHINYLESTRADIOL, FERROUS FUMARATE, NORETHISTERONE ACETATE (MIBELAS 24 FE) for an unknown indication.   On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5. On 31-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-May-2021, the patient experienced PARAESTHESIA (tingling in left hand (ulnar distribution)). On 01-Jun-2021, the patient experienced PERIPHERAL SWELLING (swelling in her fingers), PYREXIA (fever), CHILLS (chills), NAUSEA (nausea/nausea), ASTHENIA (felt weak/weakness), LETHARGY (lethargic/lethargy), HEADACHE (pounding headaches/pounding headaches), PARAESTHESIA (tingling in her left hand got worse), CONTUSION (5 -10 bruises (looked like little broken blood vessels) popped up on both upper thighs) and APPETITE DISORDER (appetite was affected). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) ongoing since an unknown date at a dose of 1 dosage form. On 02-Jun-2021, PYREXIA (fever) and CHILLS (chills) had resolved. On 04-Jun-2021, APPETITE DISORDER (appetite was affected) had resolved. At the time of the report, PARAESTHESIA (tingling in left hand (ulnar distribution)), PERIPHERAL SWELLING (swelling in her fingers), NAUSEA (nausea/nausea), ASTHENIA (felt weak/weakness), LETHARGY (lethargic/lethargy), HEADACHE (pounding headaches/pounding headaches) and PARAESTHESIA (tingling in her left hand got worse) had resolved and CONTUSION (5 -10 bruises (looked like little broken blood vessels) popped up on both upper thighs) outcome was unknown.            This case was linked to MOD-2021-209181 (Patient Link).
Pt received first dose 1/5/2021.  Pt received second dose 02/01/2021.  Pt started to have SOB and tachycardia 2/2/20201.  She presented to Hospital and was diagnosed and admitted with a pulmonary embolism.  She is a paramedic in our EMS system.  It is not known to me whether she had other risk factors for a pulmonary embolism.
Information has been received from a nurse referring to unspecified number of patients of unknown age and gender. Since 31-DEC-2015 the patients were vaccinated with improperly stored M-M-R II (lot # L000458 with expiration date of 06-JAN-2018, lot # L015282 with expiration date of 30-APR-2017, dose, strength and route unknown). The vaccines were stored at 10 Celsius degree for 36 minutes. There was no previous temperature excursion. No adverse effects had been reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Patient reported left arm Covid arm. She has an area 3 in by 3 in towards front of arm near injection site that is itchy, and slightly burning, doesn?t hurt but definitely feels like something is wrong there. Injection was 06/08/2021 4 pm on 6/09/2021 pt notice rash & called to report on 6/10/2921 4 pm. I suggested Benadryl every 4-6 hours watch for drowsiness, topical cortaid, baking soda paste may help with the itching. Told patient to contact us if it gets worse or she experiences anything else so that can also be reported   Moderne Covid 19 vaccine EUA
Flushing, history of anxiety. BPs 148/80 (pulse 84), 140/90 (pulse 74). O2 sat 97%.
I first started noticing a discomfort when I was removing my bra in the evening on the right side of my breast. This lasted for a week, this then started on my left side and continued for a while. I contacted my doctor through my patient portal about coming in for a mammography. He advised me that it was too soon for me to come in for another mammography. The pain has lessened but is still there.
I noticed bumps on my legs and I started itching, and noticed it on my wrist too; I noticed bumps on my legs and I started itching, and noticed it on my wrist too; the one on my wrist .looks like a mosquito bit you, and hot; hives; This is a spontaneous report from a contactable consumer (patient) reported for himself. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 20Aug2021 at around 12:30 (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received 1st shot on 20Aug2021 around 12:30 and 2:00 when it began. The patient went to the restroom and he noticed bumps on his legs and he started itching and noticed it on his wrist too on an unspecified date. The one on his wrist. Looked like a mosquito bit and hot. He had no fever or head ache or nothing like that, he had like 6 of those bumps or hives and itchy on an unspecified date, but the ones on his leg were going away. The patient asked if these were common side effects of the Pfizer COVID vaccine. The case was reported as non-serious. The outcome of the events was unknown.   The lot number for BNT162B2 was not provided and will be requested during follow up.
lot of pain in the arm where they gave me the vaccine; There was pain; temperature; vomiting; Diarrhea; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine (unknown arm). On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced injection site pain (Verbatim: lot of pain in the arm where they gave me the vaccine), pain (Verbatim: There was pain), fever (Verbatim: temperature), vomiting (Verbatim: vomiting) and diarrhea (Verbatim: Diarrhea). The outcome of the injection site pain, pain, fever, vomiting and diarrhea were not reported.   It was unknown if the reporter considered the injection site pain, pain, fever, vomiting and diarrhea to be related to Shingles vaccine.     It was unknown if the company considered the injection site pain, pain, fever, vomiting and diarrhea to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 11-JUN-2023 This case was reported by patient via interactive digital media. The patient reported that there was pain, temperature, vomiting, diarrhea along with a lot of pain in the arm where they gave him or her the vaccine. The patient also stated that the reaction was strong for his/her body and not all people feel the same reaction as others hardly feel anything after vaccination. Follow up was not possible, as no contact details were available.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter (other HCP) and from Product Quality Group. The reporter is the patient. A 53-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection), on 14Jan2021 as dose 1, single (lot number EL3247), in left arm; on 04Feb2021 (also reported as 04Feb2022) as dose 2, single (lot number EL3247), in left arm and; on 03Dec2021 as dose 3 (booster), single (lot number FJ8757) at the age of 53 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medications included: MAGNESIUM ACETATE start date: 01Feb2019, stop date: 25May2022; VITAMIN D3 start date: 01Jun2019, stop date: 25May2022; BAYER ASPIRIN stop date: 25May2022 and; multivitamin stop date: 25May2022. The following information was reported: VACCINATION FAILURE (medically significant) and COVID-19 (medically significant), outcome "unknown" and described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure and covid-19 which included Paxlovid taken since 25May2022.  Product Quality Group provided investigational results on 31May2022 for BNT162b2. Conclusion: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot FJ8757 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot FJ8757, fill lot FJ1608, and formulated drug product lot FK2442. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  Product Quality Group provided investigational results on 31May2022 for BNT162b2. Conclusion: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot EL3247 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EL3247, fill lot EL3230, and the formulated drug product lot EL3223. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.
Patient developed induration and erythema at injection site and required doctors visit 5 days after injection. Antibiotics were prescribed.
03/10/2023 I started feeling very tired, sore and achy. Overnight my symptoms increased I had lost sense of taste and smell, having a hard time swallowing and was coughing up yellow mucus. 03/11/2023 I went to the ER and was prescribed a course of Paxlovid. I was also prescribed Prednisone and Antibiotics. I still have not recovered my sense of taste and smell several weeks later. And I still don't feel better, I continue to have sinus pain and headaches.
doses administered past the published expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021 at 8:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date). On 15-Oct-2021 at 8:00 AM, EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant drugs were reported. no treatment drugs were reported.
8-03-07 pt Mom brought in right upper outer deltoid area 2 1/2-3 in circumference, red, hot, swollen and tender to touch. Advised ice to arm, Tylenol or Motrin for discomfort and Benadryl PRN. Dr. confirmed reaction to tetanus was allergic. 8-7-07 checked arm - no redness, swelling or pain.
first shot, shingles in my ear; This serious case was reported by a consumer via interactive digital media and described the occurrence of herpes zoster otitis externa in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Family history included shingles (patient's aunt and uncles had shingles).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced herpes zoster otitis externa (Verbatim: first shot, shingles in my ear) (serious criteria GSK medically significant). In FEB-2023, the outcome of the herpes zoster otitis externa was recovered/resolved.   It was unknown if the reporter considered the herpes zoster otitis externa to be related to Shingles vaccine.     It was unknown if the company considered the herpes zoster otitis externa to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 28-FEB-2023 Reporter's Comment: This case was reported by the patient via interactive digital media. The patient reported that he/she never had shingles, but he/she took the first shot of Shingles vaccine and it threw into shingles in ear, so he/she took some medicine, and on the last week for the shot, it cleared up and he/she got the other shot and reported never was bothered again. The patient reported that his/her aunt and uncles had shingles and his/her dad gave them a supply of Golden seal, also called yellow root or yellow pecoon. Additional Supportive Information: Follow-up would not possible as no contact details were available.
This spontaneous report was received from a Registered Nurse referring to multiple unspecified patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapy were not provided. On multiple unspecified dates, patients were vaccinated with improperly stored dose of VARIVAX lot# M035140 expiration date 03-AUG-2018) and PROQUAD Lot # L040411 expiration 13-APR-2017; lot# M034692 expiration 24-JAN-2018 and properly stored DILUENT MRK lot number unknown. No adverse events reported. The vaccines were exposed to a temperature excursion minus 8.8 degrees Celsius for 1 hour 14 minutes. The call was placed because of a Digital data logger. Previous temperature excursions on 23-MAR-2017 (- 11.3 degrees Celsius) for 1 hour 43 minutes; 22-MAR-2017 (-11.9  degrees Celsius) for 1 hour 15 minutes and on 26-JAN-2017 2017 (- 11.2 degrees Celsius) for 1 hour 23 minutes. No further information was provided. Additional information has been requested.
Immature granulocytes noted on CBC 5/25/2022 & 8/30/2022 and increased monocytes also noted on both
On Thursday 11/5 I administered a flu shot to the patient and shortly after administering it I discovered that he was not feeling well. By the time I was made aware of the situation and made it to the patient a member of management was already on scene and EMT's had already been called. I spoke with the patient's mother and the patient to try to determine how he was feeling and what his complaint was when EMT's arrived. They checked his blood pressure and O2 sats and determined that the child was likely hypoglycemic due to not eating much that day and the previous day. The child was likely not feeling well due to his low blood sugar and the nerves he experienced while getting a flu shot. The EMT's determined that he did not need further evaluation at a hospital he just needed to eat lunch and was sent home with his mother. Before he left he was given an ICEE from the cafe to help him get some sugar in his system.
Shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Shingles). The outcome of the shingles was not resolved.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.   It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 19-MAR-2023 This case was reported by a patient via interactive digital media. The patient never had shingles. The patient went to the facility and got the shingles shot and had the shingles the next day. The patient still had shingles 7 weeks later. The follow up would not possible as no contact details were available.
I've had both moderna doses properly spaced. No anaphylaxis at either time given. About 5 days after both doses I started breaking out with a itchy full body rash that looks like the measles. I'm currently on the second dose breakout it started 5 days after dose it has been 11 days and I still have a full body itchy rash. Im 25 I don't have healthcare and I can't afford to go to the doctor.
REDNESS NOTED YESTERDAY  AT INJECTION SITE AND IS SPREADING.AREA RAISED AND WARM TO TOUCH.
Vaccine high up in left shoulder joint area & sideways towards body. Immediate severe burning pain, flushing, dizziness, faintness, chest pain, BP 180/115.  Incident report was filed by nurses. Paramedics onsite attended patient; documentation was signed by patient. Felt like arm ripped off and put back on.  Severe pain left shoulder to elbow, neck, scapula: continunous for 6 weeks, no sleep. Moderate pain at 8 weeks. Pins & needles top-trunk 4wks. 2 weeks out: lump on top of L shoulder for 1 week. 2.5 weeks out: burning rash in armpit for 1 week. 8+ wks of numb/tingling in L hand pinky & ring fingers, limited range of motion w/popping, crunching in shoulder when move left arm. Headache, nausea, muscle aches for 5 days post vaccine. On 3/29/21, 3/30/21, 4/16, 4/19, 4/30/21 sought medical attention @ internal med. doctor & orthopedic doctor.
Pt recvd vax & exp lipodystrophy (deltoid) & hypopigmentation (scaring);
?Covid arm? in which my injection site swelled, itches, and turned red a week after receiving the vaccine.
This spontaneous report as received from a consumer refers to her friend's child of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On an unknown date in October 2017, the patient was vaccinated with an expired dose of ROTATEQ (orally; expiration date: 02-OCT-2017; dose and lot# were not provided).
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a female patient who received SHINGRIX (batch number 5544H, expiry date 15th May 2021) for prophylaxis. On 13th December 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In December 2018, less than a week after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling and injection site itching. The patient was treated with antibiotics nos (Antibiotic (Drug Name Unknown)) and antihistamine. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site itching were unknown. It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site itching to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The reporter did not provide patient's initials or date of birth. The patient received SHINGRIX on the left deltoid. After vaccination, the patient experienced redness, swelling and severe itchiness on her left deltoid. The patient went to the emergency room to had it checked out and treated with an antibiotic and an antihistamine for the reaction.
Patient presented to emergency department with right sided swelling of face and lips the morning after receiving his first SHINGRIX vaccine. Patient did not report any difficulty breathing, swelling of tongue or difficulty swallowing. Patient received Benadryl and solumedrol IV.
Concern for MISC. 5 yo with 11 days of fever in association with conjunctivitis diarrhea and emesis; labs showing systemic inflammation and COVID Ab positive, PCR negative. He had one dose of COVID vaccine; our antibody test does not distinguish between antibodies from environmental infection and those from vaccination. The source of his prolonged fevers was unclear. Infection, malignancy, incomplete KD, MIS-C were possibilities. Given continued fever showing continued active inflammation we treated for MIS-C with IVIG and IV steroids. ECHO was reassuring to cardiac function but views of the coronary arteries were technically limited. He had good clinical response with cessation of fevers.
Patient received undiluted dose of Pfizer, 150mcg. This was dose 2 in series. Have made multiple attempts to reach patient and HCP without success. Sent certified letter to patient, without response.
Pt presenting today for evaluation of Left shoulder pain after receiving last Hep B vax.  States her vaccine was given higher than usual and hurt really bad going in.  In so much pain, she is unable to lay on her left side.  This has never happened to her before.  Diagnosed with shoulder bursitis. Recommended 400-600mg ibuprofen every 6 hours for 2 weeks, diclofenac gel and ice