chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hives; Extreme itching; This is a spontaneous report from a contactable healthcare professional, the patient.  A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613), via an intramuscular route of administration in the left arm on 19Mar2021 at 10:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included thyroid and anemia. The patient was allergic to latex and venom (wasp/bee). Concomitant medications included amoxicillin (MANUFACTURER UNKNOWN) and azelastine (MANUFACTURER UNKNOWN) for unknown indications from unknown dates. Prior to 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. On 23Mar2021, the patient was experiencing hives and extreme itching. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment with methylprednisolone (MANUFACTURER UNKNOWN) for the events hives and itching. The clinical outcomes of the events hives and itching were not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
Only two doses Pfizer Monovalent listed, Pfizer Monovalent given 11-09-2021 & 11-29-2021. Pfizer Bivalent was given 05-01-2023. After review of chart patient had previously received 3 doses Pfizer Monovalent 11-09-2021, 11-29-2021, 06-20-2022 and received Pfizer Bivalent 10-31-2022.  Physician was made aware of extra dose given.  Mom was informed as well. Mom denies any issues after receiving additional vaccine on 05-01-2023.
Pt recvd Hep B vax on 25NOV87,23DEC87 & 24JAN88.Titers drawn 4 mo p/ 3rd dose showed no immunity.4th dose given & satisfactory titer achieved.
Information has been received from an RN concerning a medical intern who was vaccinated with 1 dose of Hep-B. On an unspecified date, the pt was dx'd with active Hepatitis B. The pt sought unspecified medical attention. Also, reported was a female intern (WAES00060043) and 1 male intern (WAES00060055) who were vaccinated and developed a similar event. Additional information has been requested.
Bleeding at injection site and hematoma the size of approx. 6mm.  Patient returned 10/02/2015 and had a bruise at injection site, swelling and redness approx 2-3 inches around injection site.  Patient has applied a cold pack and Pharmacist recomended chlorphineramine.  Patient was advised to watch for any worsening of symptoms and seek medical attention if needed.
Pt recv vax on 10/20/98; 20 min later pt exp numbness & tingling of tongue x 15 min; shortness of breath & wheezing; 10/21/98 pt imp
On March 30, did shore excursion in tropical Islands - snorkeling using the tour operator's equipment.  Swallowed some sea water while snorkeling. Upon return to ship, developed scratchy throat and cough. Tested positive onboard cruise ship on March 31, 2023 @1830 after vomiting at dinner. Experienced dry scratchy throat and coughing earlier in the day.  Medical staff took vitals - no fever, BP within norm.  Given cough syrup for the cough.
Injection site reaction (redness, swelling) possible infection. Given Rx for antibiotic and prednisone 10/2/14.
Patient received Pediatric dose of Pfizer (orange cap; ages 5-11) instead of regular Pfizer (purple cap; ages 12+). Parents are aware and were told to contact the pediatrician if any unexpected adverse events occur. Patient is scheduled to receive regular Pfizer as second dose per CDC guidelines.
12/05/21 presents to EC ED for "decreased appetite, fatigue, productive cough, shortness of breath, intermittent nonbloody diarrhea and vomiting". PMHx of "COPD, lymphoma, 3rd degree heart block s/p ppm 7/2021, a fib on eliquis, AAA s/p repair, HLD"
had vax 15JUL94 & over the weekend devel redness, pain & swelling to elbow of lt arm site of SC inject
Admitted for acute hypoxic respiratory failure /Pneumonia due to COVID-19.  Received all treatments including tocilizumab, Remdesivir, high-dose steroids. Did not improve despite efforts. Pt dc'd to hospice.
Tired; Sluggish; Fever; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 23Apr2021 at 12:30 (at the age of 41-year-old), as a single dose for COVID-19 immunisation. Medical history included attention deficit hyperactivity disorder (ADHD) and anxiety. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included lisdexamfetamine mesilate (VYVANSE) and venlafaxine hydrochloride (EFFEXOR); both for unknown indication from unknown date and unknown if ongoing. The patient previously received ciprofloxacin (CIPRO) and morphine (MANUFACTURER UNKNOWN); both for unspecified indication from unknown date and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 02Apr2021 at 12:30 (at the age of 41-year-old), as a single dose for COVID-19 immunisation. On 24Apr2021 at 10:30, the patient felt tired, sluggish and had fever. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tired, sluggish, fever was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
A nurse reported that a 49 year old female received an injection of TD Toxoids Adsorbed, Purogenated on 7/26/00. Subsequently, she developed an injection site reaction characterized by "extreme" soreness and a "9cm line of discoloration down dorsi-lateral aspect" of upper arm. This is 1 of 4 pts from this facility who had an adverse experience following receipt of TD Toxoids Adsorbed, Purogenated lot 471038.
inappropriate schedule of vaccine; shingles; This case was reported by a physician via call center representative and described the occurrence of shingles in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In May 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 28th June 2019, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced drug dose administration interval too long. The patient was treated with acyclovir. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows:  At the time of reporting, the patient developed shingles. The shingles was treated with acyclovir. It was also over 6 months since 1st dose and the patient was considering getting the 2nd dose, which led to lengthening of vaccination schedule.
Pt received dose #1 of COVID-19 vaccine (Pfizer-BioNTech) on 12/18/20 and dose #2 ( Pfizer-BioNTech) on 1/8/21. On 1/30, patient was evaluated at urgent care due to back pain. No bloodwork done; metronidazole prescribed for 7 days. On 2/8, patient was admitted to outside hospital due to ongoing symptom progression. At time of admission, hgb 5 g/dL and plt 9k. Per Dr. (hematology/oncology), pt with schistocytes, LDH 1500, and elevated reticulocyte count consistent with thrombotic thrombocytopenic purpura (TTP). SCr >2 mg/dL. Patient immediately treated with plasma exchange and steroids, however continued to decline. Patient expired on 2/14/21.
Shot lt arm red, the day /p red streak from shot to elbow, throwing up. Won't eat or anything. Real cranky, erythematous skin, Rxn to MMR
Moderna vial does not have an expiration date on the vial.  Nursing scans vial NDC auto fills.In lot # field click on magnifying glass for drop down of lot numbers.  Normally when lot number is chosen expiration date auto fills. The lot number of this vaccine was not found. So lot number was manually entered and beyond use date (BUD) that was written by pharmacy on packaging was entered in as expiration date because patient was waiting. Vaccine was administered and message sent for a lot # to be entered into Epic system. Recieved reply back that this lot was expired on 3/25/22. Imm. coordinator notified and Moderna contacted for advice.
One lymph node under left armpit, mild ttp, present since 3/25/21
I was 5.5 weeks pregnant when I revived the Pfizer Covid Vaccine. Everything was seemingly going fine with my pregnancy until about 4 hours after receiving the vaccine when I went to the bathroom nd wiped and saw pink discharge on the toilet paper. I then began to have mild low abdominal cramping. The abdominal cramping and vaginal bleeding steadily increased in severity over the next 24 hours until I eventually had an obvious miscarriage the evening of  12/31/2020.  I cant help but think the vaccine in some way caused my body to reject the pregnancy.    Along  with the miscarriage, I also had extreme tiredness with GI upset 12/31/20 - 1/02/2021.
Site of vaccination was sore x first few days.  Limited ROM started on June 22nd and continued into June 23rd.  Woken up by left shoulder pain on the night of June 23rd.  Went to the ER, where a "moderate sprain" of the shoulder was diagnosed.  Was given an injection of Toradol in the ER with some relief of pain.  Left arm was placed in a sling which helped with pain relief.   Continued to have limited ROM and pain of the left shoulder, and upper left arm with feeling of "big bruise" around upper left arm.  Was taking Advil every 4 hours and using ice to the shoulder every 2 hours.  ROM slowly returned.  Took off work the week of June 29th due to limited ROM. ROM returned on July 2nd or 3rd, but left shoulder is still sore.  Also, gets achiness in left elbow (started at the beginning of June 29th).  Had left elbow injury about 10 years ago. Came back to work on July 6th. Able to perform duties without problems. Following up with pcp on July 8th.
Rash started 2 days ago, spreading and itchy.  Some headache and abdominal pain on and off for past few weeks.
This report came to the HD via the patient's son "A summary of this incident: The caller?s mother was a resident of Retirement Community, and she got the Pfizer vaccine on 1/26 and 2/18. Patient was then transferred to Residential Home Care, where she was given one dose of Moderna on 4/17. The caller was alerted to this situation because he received a insurance statement that indicated that a vaccine was administered and he knew she had already been fully vaccinated earlier in the year. The son stated that while his mother has dementia, she seemed a little more out of it and had been vomiting around the time that this second dose was administered. "
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 SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not reported. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient commented that, when he received SHINGRIX, it hurt. This case has been linked with case US2019GSK062708, reported by the same reporter.
Patient reported sore arm, swelling, pain, redness and red blotches on right arm at injection site.
Patient presented to clinic with R shoulder pain and eye swelling that occurred yesterday for about 10-12 hours which has now resolved (has pictures). Member received the anthrax vaccine yesterday. He had shoulder pain following the injection and yesterday pain, swelling, and redness increased. States redness and swelling have improved today. Pt describes the pain in his shoulder as a constant dull ache, 4:10 that causes numbness in 3rd-4th fingers on his right hand. Pt gets mild relief after trying to stretch and move his arm around. Also notes that yesterday he was feeling tired and had generalized aches and pains. He reports that he still feels less energetic than normal but better than yesterday. Patient treated with 800mg ibuprofen and 325mg TYLENOL.
Nurse administered too much vaccine.  Attempted to reach patient unsuccessful.  Will contact again tomorrow.
Pt. previously received 2 month vaccine on 4/24/18 and 4 month vaccines on 6/25/18. Website recommendations showed pt. only received 2 month vaccines. 4 month vaccines were given again on 8/27/18. So pt. received an extra dose of PEDVAXHIB and ROTARIX. No adverse reactions noted.
Chills, fever (101); arm sore all night; could not sleep; took Tylenol to bring temp down; nose was running; did not feel like eating;  feeling much better today; no fever, chills, temp normal
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE FOCAL MOTOR SEIZURE HYPOTENSION  1/16/2023 &  1/14/2023  --  RECURRENCE OF SAME SYMPTOMS
PT ALLEGES SHE EXPERIENCED PAIN TO THE LEFT SHOULDER AND BACK 7 DAYS AFTER RECEIVING HER FIRST DOSE OF COVID PFIZER VACCINE.
Patient received dose of a vaccine from an expired vial; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Patient received dose of a vaccine from an expired vial) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 11-May-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Patient received dose of a vaccine from an expired vial). On 11-May-2021, PRODUCT ADMINISTRATION ERROR (Patient received dose of a vaccine from an expired vial) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Pharmacist and Physician called to report ten patients receiving doses of Moderna COVID-19 vaccine from an expired vial. The vial was stored at the facility on 07Apr2021 and kept in their fridge past the expiration date of 07May2021. The doses were received on 11May2021   This case was linked to, INC.-MOD-2021-122517, INC.-MOD-2021-122422, US-MODERNATX, INC.-MOD-2021-122588 (E2B Linked Report).; Sender's Comments: INC.-MOD-2021-122422: INC.-MOD-2021-122588:
Phlebitis, Fever, NauseaVomiting, Developed new DVT five days after had vaccine Narrative:  Patient had COVID late December, had the COVID vaccine 1/5/21 and within a few days developed N/V and fever, presented 1/10/21 to ER and diagnosed with new DVT
At 10:49 am, writer was called to school nurse office by school nurse and POD manager.  School nurse stated that at 10:30 am client arrived at clinic stated that her lungs is bothering her.  Received client sitting on a cot in clinic.  Alert and responsive without any signs of acute distress.  Mucosa pink and moist.  Vital signs as follows-Pulse OX on room air 100%, Pulse 89, Resp 20 and unlabored and Temp 97.5.  Per school nurse and client, client has a hx of asthma.  Last attack about 3 years ago.  School nurse communicated with parents and client will be released in the care of her dad by the school and school nurse.  No acute distreee and client stated, "I am feeling better" when asked how she was feeling.  Client is in the care of school and school nurse.  Notified via POD Manager and Lead.
Shingrix second dose given less than the minimum recommended interval; This case was reported by a pharmacist and described the occurrence of drug dose administration interval too short in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included memory impairment. Concomitant products included Herpes zoster (Shingrix).   On 15th October 2020, the patient received the 2nd dose of Shingrix. On 15th October 2020, unknown after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient with bad memory had received first dose of Shingrix on 15th September 2020 (batch number 75P7G and expiry date 17th April 2022) but the patient was not sure if she got second shot on 15th October 2020, which led to shortening of vaccination schedule. The pharmacist was looking for some guidance for the patient and also asked about what would happen if patient received a third dose of Shingrix. The reporter consented to follow up. This case was processed conservatively considering that there was shortening of vaccination schedule as it was unknown if the patient indeed received the 2nd dose.
Initial unsolicited report received from an other health professional on 31-Jul-2018. This case involves a six-years-old female patient who was vaccinated with a 0.5 ml dose of ADACEL lot U5792AA via intramuscular route in left thigh on 08-Jun-2018 instead of DTaP. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PROQUAD. It was an actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration. It was reported that the patient tolerated vaccine well, without notice of adverse reaction. 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. List of documents held by sender: none.
A week and a day exactly after the vaccine I woke up and was sitting on the couch and starting having chest pain on my the right side even more so when I breathe in more so  Throughout the day it progressed but was bearable.  It continued to persist and get worse the next day so I was transported to the Urgent Care. There various tests were performed and I was advised to lay down to do an EKG done, but when I laid down the pain got so intense and hurt so bad I could not even sit up. I had to lay there for a while to try to let the pain subside.  Finally I was able to sit up after about 30 minutes.  The pain was so severe a CT scan couldn't be performed and was advised to go the hospital.  At the hospital various blood work and and a Chest X-ray was performed but nothing still was seen as to cause the pain.  I was monitored and released later and was advised to F/U with my PCP. My PCP referred me to my Rheumatologist who ordered another CT Scan and everything on it came back normal as well.   Since the pain has come and goes off and on periodically since, but the pain is not as intense or hurt as bad as originally
Left upper arm (Deltoid area) red and swollen. 4 1/2" long and 2 1/2" wide.
I tested positive for COVID-19 in July and had difficulty breathing, coughing, very tired, fever, body aches. I went to the clinic and was tested for COVID-19 and the Flu and I was given Teflalon pearls for the cough. I was not able to work for 2 days.
improperly stored temperature excursion - 08/05/2020; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported.   On 05-AUG-2020, the patient was vaccinated with an improperly stored dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) lot# S020160, expiration date 30-JUN-2021 ,for prophylaxis (strength, dose, route and frequency were not reported) and varicella virus vaccine live (Oka/Merck)(VARIVAX) lot# S038175, expiration date 26-NOV-2021, for prophylaxis (strength, dose, route and frequency were not reported).    The temperature excursion was of -50 Fahrenheit degrees (°F), time frame -6°F (10°F) for 1 hour and 15 minutes; 15°C to 46°F (44.8°F) for 1 hour and 30 minutes; 47°F to 77°F (50°F) for 2 hours and 30 minutes. A previous temperature excursion was not reported. A digital data logger was involved. No adverse effects were reported.
On 9-14-16, pt. reported this reaction to us: Pt. states on 7-27-16, left arm pain began soon after shot administered. Says 'it felt like my arm was broken'. Had difficulty moving and raising her arm. States pain lasted approximately 3 weeks. At worse, pain was 10/10. Denied any other symptoms. Denied discomfort on 9-14-16. Decision was made not to administer vaccine #2 (Men B).
blood pressure issues; burning in the stomach; has a lot of gas in the stomach; This spontaneous case was reported by a patient family member or friend and describes the occurrence of BLOOD PRESSURE ABNORMAL (blood pressure issues), DYSPEPSIA (burning in the stomach) and FLATULENCE (has a lot of gas in the stomach) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLOOD PRESSURE ABNORMAL (blood pressure issues), DYSPEPSIA (burning in the stomach) and FLATULENCE (has a lot of gas in the stomach). At the time of the report, BLOOD PRESSURE ABNORMAL (blood pressure issues) and DYSPEPSIA (burning in the stomach) had not resolved and FLATULENCE (has a lot of gas in the stomach) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood cholesterol: 140 - 230 (High) 140 to 230 something. On an unknown date, Blood triglycerides: high (High) borderline to be consider diabetic..         Patient had a previous blood test showed that their cholesterol and sugar triglyceride levels were good (this was a month ago). No concomitant and no treatment information was provided .   This case was linked to MOD-2021-380122 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Nov-2021: Significant Follow-up received contain patients  lab text  information . Event was added, 'Has a lot of gas in the stomach'.; Sender's Comments: This case concerns a 58-year-old, male patient, with no disclosed medical history, who experienced the non-serious, unexpected events of blood pressure abnormal, dyspepsia and flatulence. The events occurred  on unknown date after second dose of mRNA 1273 vaccine. On unknown date, patient had blood tests, blood cholesterol and blood triglycerides done, which were high, borderline, no treatment was mentioned. The rechallenge is not applicable as there is no information regarding a third dose. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
pt had 3rd dose pfizer vaccine at 5:15pm, pt had hives at 05:35pm. called 911 and they had her do an epi pen at 5:40pm. pt left with emergency personal.