chrisvoncsefalvay/vaers-outcomes huggingface dataset:
3 crazy rashes; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of RASH (3 crazy rashes) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and 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 RASH (3 crazy rashes). At the time of the report, RASH (3 crazy rashes) outcome was unknown.            No concomitant medications were reported.  No treatment information was reported.   This case was linked to MOD-2021-387460, MOD-2021-387097 (Patient Link).
Per telephone call - patient reported that area of injection on the upper arm has  a raised red area - now approximately size of a "softball" - initially after the injection. Pt. noted a red-raised area approx size of a small egg, but area continued to increase in size for the past 2 days. Reports now the area is approx size of a softball. Client encouraged to follow-up with primary Dr. and return call to clinic to report. Dr's recommendation - follow-up call to client for recommendation - client reported primary Dr encouraged use of CLARITIN during the day as well as use of probiotics. MD also encourage use of BENADRYL at night. Primary Dr. also suggested a titer to be drawn rather than receiving follow-up dose of Varicella. Pt. seen in clinic on 5/16/13 for follow-up Hepatitis B dose #2. Pt. reported redness, raised area resolved with use of CLARITIN and BENADRYL.
Chills; Nausea; Achy; Injection site is killing me; Headache; Temperature 99.8 F; Tired; This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE INCREASED (Temperature 99.8 F), NAUSEA (Nausea), FATIGUE (Tired), MYALGIA (Achy) and VACCINATION SITE PAIN (Injection site is killing me) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Mar-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced FATIGUE (Tired). On 10-Mar-2021, the patient experienced BODY TEMPERATURE INCREASED (Temperature 99.8 F), MYALGIA (Achy), VACCINATION SITE PAIN (Injection site is killing me) and HEADACHE (Headache). On an unknown date, the patient experienced NAUSEA (Nausea) and CHILLS (Chills). On 09-Mar-2021, FATIGUE (Tired) had resolved. At the time of the report, BODY TEMPERATURE INCREASED (Temperature 99.8 F), NAUSEA (Nausea), MYALGIA (Achy), VACCINATION SITE PAIN (Injection site is killing me), HEADACHE (Headache) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Body temperature increased: 99.8 (High) 99.8.         Concomitant medication list was not provided by the reporter. Treatment details was not reported by the reporter.
"Moderna" Adverse vaccine reaction S: Shingles appeared after patients initial vaccine. B: Patient and her spouse reported to the COVID-vaccine line to get her 2nd Moderna vaccine. Her husband inquired if Shingles had anything to do with the vaccine. He stated 7 to 12 days after he initial vaccine she got the Shingles A: SGP was asked and stated it didn't correlate however, there are a lot of unknowns. R: PSS talk to the patient in the holding area and retrieved her information to determine if the vaccine was the cause.
blood pressure to go up; This is a spontaneous report received from a contactable reporter (Consumer) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD PRESSURE INCREASED (non-serious), outcome "unknown", described as "blood pressure to go up". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller was querying if it was normal for her blood pressure to go up after getting the covid vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
instead of using sodium chloride to mix YF VACCINE with they mixed the vaccine with sterile water, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Agency (Reference number- 00688211) and transmitted to Sanofi on 19-Jul-2021.  This case involves a 47-year-old female patient who was administered YELLOW FEVER VACCINE - US [YF-VAX] in which instead of using sodium chloride to mix, they mixed the vaccine with sterile water (product preparation issue).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On 16-Jul-2021, the patient received 0.5 mL dose of suspect YELLOW FEVER VACCINE - (lot UJ372AA and expiry date: 22-Jul-2022) via a subcutaneous route in the left arm for prophylactic vaccination in which instead of using sodium chloride to mix, they mixed the vaccine with sterile water (product preparation issue).  It was reported that "She wanted to the implications as it has already been administered. Caller transferred. Caller asking how to proceed if Yellow Fever Vaccine was given to 2 patients mixed with the diluent that is used for MMR and Varicella vaccines, it is sterile water. Caller asking why do they need to revaccinate? Do you have any specific data showing that the sterile water that they used makes the vaccine not work or stable? She asked if this is a general CDC statement or specific to YF vaccine? Does Sanofi Pasteur have actual data showing why the specific diluent is the only one that can be used? Caller said they have to investigate more and therefore this doctor is not 100% verified as the person involved in this event) medical assistant (MA) who administered vaccine. Caller came back and said she gave all this information before she checked with her medical director and she would like to wait for the medical director to make the report after they have fully investigated what happened. Medical director will be back in the office next week."  It was a actual case of medication error due to Inappropriate reconstitution technique (latency same day).  At time of reporting, no adverse events were 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 the 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
Fever, Diarrhea, chills, fatigue Narrative:  Other Relevant History:
Fever, chills, headache, body aches lasted till 6:00 AM of next day.
Covid 19 Positive. Symptom onset 11/22/2021 included sore throat, cough, wheezing, shortness of breathe, nausea, vomiting, abdominal pain, diarrhea and congestion.
3 inch in diameter erythematous area with induration and increased temperature, mildly tender to palpation to the right forearm.
This spontaneous report was received from a registered nurse referring to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with a dose of M-M-R II for prophylaxis (dose, route, lot/batch # and expiration date were not reported) reconstituted with diluent MRK (STERILE DILUENT) (dose, lot/batch # and expiration date were not reported). It was reported that, on multiple unknown dates, the patients "had low titers when tested" M-M-R II (mumps antibody test negative and measles antibody negative) tested byan unspecified titer test. The primary reporter reported that an unspecified amount of the patients were treated by re-vaccinating with a dose of M-M-R II (dose, route, lot/batch # and expiration date were not reported) reconstituted with diluent MRK (STERILE DILUENT) (dose, lot/batch # and expiration date were not reported). The outcome of mumps antibody test negative and measles antibody negative was not reported. The causality between mumps antibody test negative and measles antibodynegative with M-M-R II was not reported. This is one of two reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1704USA003918:
Dizziness First symptom started right after vaccination and it was blurred vision, numbers and swelling of hands; dizziness. All resolved  Narrative:
HPV high risk; This spontaneous report as received from a physician assistant refers to a 30 year old female patient. The patient's pertinent medical history included anaemia. The patient's drug reactions or allergies were reported as none. Concomitant therapies included ethinyl estradiol, norgestimate(ORTHO TRI-CYCLEN). It was reported that the patient was not pregnant.  On an unknown date (reported as 15-16 years ago), the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) (strength, dose, anatomical location, lot/batch # and expiration date were not reported) via intramuscular route for prophylaxis. There was no overdose.  On 07-MAR-2018, a PAP SMEAR test was performed and the patient was diagnosed with HPV high risk (papilloma viral infection). The patient sought medical attention from a gynecologist, but there was no intervention to prevent the seriousness. The patient had not received any treatment. The outcome of papilloma viral infection was reported as not recovered. The reporter's causality assessment was not reported. There was no product quality complaint (PQC).
Sudden onset of severe SCIATICA - from Left hip down to toes.   PAIN, numbness, tingling.
Dose1 of Shingrix: given in left arm at Pharmacy on 9-20-19. Within 6 hours after the vaccine I had disabling arthralgias and myalgias and developed 102 temp. which lasted for four days.  On the second night after the vaccine I was awakened by a pounding migraine-like headache,which slowly responded to Tylenol.  My left arm became red and swollen over the deltoid muscle.  I could just barely getup to use the bathroom and had to collapse back into bed. I called the pharmacist, who reassured me that this could be a normal strong reaction. The pharmacy sent my vaccine information and lot number, etc. to my primary MD.   The second dose finally became available and we were called to our Pharmacy, off of their waiting list.  I discussed with the pharmacist my rather harsh first dose reaction, and he assured me that I should get the second dose.   Within 6 hours of gettin the second dose I felt like a truck had run me over again:  myalgias and arthralgias that sent me to bed; fever for two days; no horrible headache this time; huge swollen left deltoid muscle and blotchy redness below the deltoid to three inches above my elbow. Pharmacy also faxed the lot number and vaccine information to my primary MD.   Boy! if this vaccine were a three dose vaccine I certainly would NOT have appeared for a third dose!
Pt recvd vax & devel rashes, hives on face, neck & chest;
Nauseous; Headache; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nauseous) and HEADACHE (Headache) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.  No Medical History information was reported. In December 2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced NAUSEA (Nauseous) and HEADACHE (Headache). In February 2021, NAUSEA (Nauseous) and HEADACHE (Headache) had resolved. No concomitant medication information was reported. No treatment medication information was reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of an unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2008, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (exact dose, dose number, route and site of administration, lot# and expiration date were not reported), as prescribed and/or administered by a healthcare provider at a private doctor's office for the long-term prevention of shingles and zoster-related conditions. Subsequent to zoster vaccine live (ZOSTAVAX) vaccination, the patient was treated by a healthcare provider for shingles. As a direct and proximate result of use zoster vaccine live (ZOSTAVAX) use, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the event was unknown. The relatedness between the event and zoster vaccine live (ZOSTAVAX) was reported as related.
Information has been received from a registered nurse concerning a 20 month old female who on 06-JUN-2007 was vaccinated with a dose of MMR II (lot number 654897/1031F). On 25-JUN-2007 the patient experienced a fever of 103.1F, she passed out, vomited, stopped breathing, and had a seizure. The patient was taken to the emergency room the same day, 25-JUN-2007 and was diagnosed with a severe ear infection. She was prescribed antibiotics (unspecified). On 26-JUN-2007 her temperature went up to 103.8F and she vomited. On 27-JUN-2007 her temperature ranged from 99-101F and the ear infection continued. The patient's status at the time of the report was unknown. No product quality complaint was involved. The patient's convulsion and the event of stopped breathing were considered to be other important medical events and to be serious by the reporter. Additional information has been requested.
At 12 hours post injection (4am) I awoke with a profound headache, chills and severe joint pain. As the day progressed I had a fever to 101 degrees, headache, joint pain and profound fatigue. Headache was unrelieved by ibuprofen or Tylenol. Thought process has been fuzzy, difficulty typing and completing sentences  I also had vomitting x 2 on day one post vaccine but no diarrhea. Chills and fever persisted for approx 36 hours. Joint pain lasted x 36 hours. Headache continues now 5 days post vaccination. Per my employers request I was covid tested today 2/3 and my rapid results were negative. I continue to take ibuprofen and Tylenol for a continued headache. Thought process improved today.
Ears have not stopped ringing (tinnitus). Has caused dizziness, nauseousness, and paresthesia (right arm). Doctors prescribed meclizine to treat symptoms of vertigo.
Rash appeared on patient's stomach, arms, under breasts, behind one leg - one is 1/4 inch in diameter and raised, some are bright red splotches, some look like "carpet burn"; non-itchy; symptoms continue; patient's clothes with exception of bra were washed with clothes treated with Goo-Gone prior to rash appearing.
Patient experienced hives the night of the shot and the following night. Patient took BENADRYL to ease the itching.
10 min after shot was administered patient started feeling light headed and throat was closing. Pharmacist got an epi-pen and sat with patient. Patient said the breathing issue was coming and going. Staff called 911 while patient was observed. Patient then stated she felt it was closing again. Pharmacist asked if she was ready for the EpiPen and she nodded yes. Pharmacist administered EpiPen in left anterior thigh. Patient stated she could breath again shortly after. EMS arrived and checked vitals. Patient said she felt better and refused ambulance transport. Patient waited 30min after the vaccine and then purchased Benadryl and walked around the store to make sure she still felt ok. Patient said she would go to the ER if she felt an additional symptoms and would follow up with her MD>
7/10: Patient got a third shot of Pfizer vaccine (scheduled for 4th dose - told him to cancel it)  7/30: admitted for CVA (In ICU)
Developed cellulitis in the area the vaccine was administered.  Started ~7 days after vaccine was administered.  Developed fever, redness, induration at that site.  Started on oral antibiotics to treat it.
chills; body aches; presumed fever; This is an initial spontaneous report from a contactable consumer. A 26-year-old female patient received second dose of BNT162B2 (Solution for injection, Batch/Lot: unknown), via an unspecified route of administration on 13Jan2021 at single dose for an Covid-19 immunisation. Medical history and concomitant medications were not reported. Historical vaccine of BNT162B2 as first dose on 22Dec2020 for Covid-19 immunisation. The patient stated eleven hours after dose, person woke up with chills, body aches, and presumed fever (temp not taken at that time). Continued throughout the day. Next morning, temp taken by person and was 99. Still slightly chilled at the time. Estimating adverse event start date as not sure if it was on 13 or 14Jan. Only that adverse events started 11 hours after dose. The patient underwent lab tests and procedures which included body temperature: 99 on. The outcome of the events for chills and presumed fever was not recovered and for body aches was recovered on an unspecified date of 2021.  Information about Lot/Batch has been requested.
pt recv vax 28AUG97 & 29AUG97 & exp congestion, fever & chest pain;
Child immediately developed fever, rash and discomfort. Within 2 weeks behavior changed dramatically, language skills regressed, frequent fevers, seizures, loss of eye contact. 8 months out diagnosed with autism spectrum disorder. Has been diagnosed with Encephalitis.  3/4/09 MR received from PCP from 2/5/07 to 10/2008. DX: Autism Spectrum Disorder. Seen 10/19/07 with parental concerns re:  speech development.  No real progress since age 1.  Does not respond to name when called. Motor development WNL. More concerns with behavior reported 11/29/07 along with frequent fevers. Has episodes of stiffening and unresponsiveness and waking screaming. DX: Autism Spectrum D/O 12/2007.
First and important: my first two vaccines were Pfizer. This booster dose was Moderna. I was told the pharmacy had run out of Pfizer when I came for my appointment, so I asked if I could take  Moderna for the booster and was assured it was ok.   Woke up in night with severe case of dizziness, almost vertigo. Was able to walk holding on to walls, furniture. Dizziness somewhat improved with eyes open. When eyes were closed, everything was spinning. Went back to sleep, extremely careful with changing position. Was concerned about accompanying nausea. Wokes up again, same situation. Back to sleep for 4-5 hrs, woke up with no dizziness.  I also have been having  very tight right shoulder, right side of neck so this episode could be a result of that. I am still tight by midday on 17th and still feel a bit light in the head.
Flu vaccine received @ 10:30-within 15 minutes became itchy-rash began to developed and progressed seen in ER~12 and received IV Benadryl & Cenemet.
Dose administered after 30 day use by date or after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30 day use by date or after manufacturer date of expiry) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30 day use by date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30 day use by date or after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided. The vial was initially stored in the refrigerator was on 04 Nov 2021. The vial did not undergo any temperature excursions.It was reported that, some of the doses were administered on 05 Nov 2021 and the other doses on 12 Nov 2021.It was reported that the patient had no adverse event  and was monitored. No treatment medication information was provided.
Fatigue extreme; Terrible headache bordering on a migraine; Terrible headache bordering on a migraine; Muscle pain; Feeling unwell; Joint pain; bloody nose, a little bit of the bloody nose when she blew it; Some blisters on my lips; Nausea; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on the upper left arm, 28Jan2021 16:11 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, patient had extreme fatigue, terrible headache bordering on a migraine, muscle pain, joint pain, nausea and just feeling unwell and also had a bloody nose, a little bit of the bloody nose when she blew it and some blisters on her lips. Patient was just putting some Vaseline on her lips and to the migraine she took Imitrex. She have had a headache every single day, very bad. Outcome of the events was unknown.  Information on the lot/batch number has been requested.