chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician assistant, via a company representative, concerning a female age unknown, with asthma, who in 1985 was vaccinated route unknown with a dose of Pneumococcal 23v polysaccharide vaccine (lot unknown). Concomitant therapies included unspecified medications therapy unspecified, for asthma. About 20 years ago, in 1985, the pt developed swelling from elbow to neck after being vaccinated. Symptoms were treated with cold compresses. After a week symptoms resolved. No product quality complaint was involved. Additional information has been requested.
Information has been received from a health professional concerning a 30 year old female who on 16, Aug 2006 was inadvertently vaccinated with a dose of varicella-zoster virus vaccine live (Oka/Merck) (lot # 652925/0621F) instead of a second dose of varicella virus vaccine live (Oka/Merck) (MSD). It was reported that the patient was previously vaccinated with a first dose of varicella virus vaccine live (Oka/Merck) (MSD) on an unspecified date. The patient was seeing a fertility doctor, however she was not pregnant at the time of vaccination. No symptoms have been reported. Unspecified medical attention was sought. Additional information from the nurse indicated that the patient did not suffer any adverse experiences. The nurse reported that the error was an internal error. No other information was provided. No further information is expected.
Pt had no adverse events at time. Pt was given KINRIX instead of Hep A.
I had Covid in July 2020 and was hospitalized for 6 days and received remdesivir.  Since having Covid I had more frequent headaches 3-5 days per week.  After the second vaccine dose the headaches worsened to 4-6 days per week and increased in intensity from 2/10 to 5/10 and Tylenol no longer relieves them.
Arm pain that initially went away and then worsened and travelled down the arm. Disrupting sleep and daily functioning.
Redness, warm to touch, "bump" on (L) arm. Redness has increased in size over the next 24 hours. Recommend BENADRYL 25 mg q 4-6 hr x 24 hr.
25 patients were given the Pfizer Covid vaccine after June 2nd, due to the vaccines being kept in a freezer after the initial  delivery date of May 19th 2021 (after 2  weeks) They  remained in the same freezer up until July 20th. Per Pfizer and the State the vaccines are to be Voided and all 25 patients are needing to be re vaccinated elsewhere.  Vaccines are being voided due to incorrect temperature storage
Shot given in R upper thigh. Red and hot to the touch-very swollen leg/foot and pt refuses to walk on. Was told to apply cool packs and use Tylenol and call with worsening. Called back and was given Benadryl and started on Keflex.
PATIENT CALLED  ABOUT MONTH AFTER VACCINATION AND INFORMED US THAT HER ARM WAS STILL REALY SORE. SHE WAS GOING TO SEE HER DOCTOR. SHE CALLED TODAY (01/28/2020), ABOUT 5 MONTHS AFTER IMMUNIZATION TO INFORM US THAT HER MD REFERRED HER TO A SURGEON, WHO REFERRED HER TO AN ONCOLOGIST AND THAT A SURGERY WAS PERFORMED FOR CANCEROUS MASS AT THE SPOT OF VACCINATION OF HER LEFT ARM.
Breakthrough case admission after 3 vaccines Pfizer 2/11/21 Lot# EM9810;  Pfizer 3/4/2 Lot# En6201;  Pfizer 11/2/21 Lot# 30155BA
Very red rash, lower then injection site. Told patient to take some Benadryl and use ICE topically & come back tomorrow.
Seasonal depression; Not feel well; This spontaneous case was reported by a consumer and describes the occurrence of SEASONAL AFFECTIVE DISORDER (Seasonal depression) and MALAISE (Not feel well) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On 07-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced SEASONAL AFFECTIVE DISORDER (Seasonal depression) and MALAISE (Not feel well). At the time of the report, SEASONAL AFFECTIVE DISORDER (Seasonal depression) and MALAISE (Not feel well) outcome was unknown.            No concomitant medications were reported. No treatment medications were 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.
Moderna vaccine was thawed on 5/17 and administered on 6/26/23 (10 days past the 30-day stability date). When outreaching Moderna for extended stability data, a lot assessment was conducted and it was determined the lot was active against COVID-19 at this time interval. Patient has not reported any adverse effects to date.
The morning after the vaccine I woke up with a  headache, took some Advil and it helped. On Monday I had the majority of other symptoms: chills, headache, nausea, mild abdominal discomfort, sore throat, congestion, muscle ache, joint pains.  No fever.
Developed bilateral uveitis, confirmed by ophthalmologist. Treated with Durezol (difluprednate) eye drops. Improving
77 patients received Moderna bivalent booster doses that had undergone a temperature excursion; Poor quality vaccine administered; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered).    No concomitant medication was reported.  On an unknown date, approximately 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion. The doses were administered before it was known if the vaccine was ok to use after the excursion.  No treatment medication was reported.  This case contains information for 63th of 77 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:Master case
Fractured her knee; Developed pneumonia; Developed pneumonia; In 07Jul2017 she had the pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) and in 03Aug2018 she got the PCV13.; This is a spontaneous report from a contactable consumer who reported for herself, a 68-year-old female patient who received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), also reported as PCV 13, first dose on 07Jul2017 at 66 years of age, and a second dose on 03Aug2018 at 67 years of age, both via an unspecified route of administration at a single dose for prevention. The patient's medical history was not reported. There were no concomitant medications. The patient previously took pneumococcal polysaccharide vaccine, 23-valent for immunization, which was read from her shot record. In 07Jul2017 she had the pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) and in 03Aug2018 she got the PCV13. Patient stated that in 01Jan2020, she developed pneumonia. Patient was told the pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) would protect her up to 2017. She stated that she didn't have a need to have the shot but she got it anyway because she was somewhere and she had to go to rehab. Before she could go to rehab, either her surgeon or her regular doctor told her she had to get the pneumonia shot. Patient stated got her second one at a pharmacy. When she was at the hospital, they told her she would need to get a second pneumonia shot. She decided to just go to pharmacy for the second one a year later. Patient stated she had to call in sick to work on holiday, which was unthinkable, but she wasn't able to go. She did not make it to the doctor until 07Jan2020 because of the holidays and the clinic was too full to see her. She finally contacted her doctor around 07Jan2020 and he did X-rays and that's when they discovered the pneumonia. Patient stated that her having to go to a care home happened before having to get shots. She also stated that she had fractured her knee and she lives by herself and they wouldn't let her go home. The outcome of the events "developed pneumonia" coded to drug ineffective and pneumonia was recovered on Jan2020; while outcome of the remaining events was unknown.  information on the lot/Batch number has been requested.
Tinnitus: First noticed on 12/7/2021.  Mild at first.  Has progressively worsened over the past eight months.  Would grade as moderate to severe at this time.  Interferes with sleep unless moderately loud white noise is present in background.
Headache, vomiting so severe it was associated with a troponin elevation despite coronary arteries having no significant coronary artery disease on cardiac catheterization.
Patient became ill, chest tight, harder to breathe. Tested + for COVID 1/19/21. Had Regeneron on Fri. Started running 104-105 fevers several hours later. Entered ER Wed night was held in ER. IV infusions of antibiotic started & we were informed his kidneys were shutting down & he had the COVID  white lung. Patient went to the floor in am. After no food for 8 hrs on floor, no meds for 10hr or so he was now in a bad way.  Started high flow oxygen that evening.At some point they intubated him without notifying me. On Fri I believe care startled him & he was losing me ration. Staff sedated him & didn?t even begin to discuss tube feedings until sun after I refused a pic line when he had a central line. Patient had CPR performed on him but heart never responded.
This spontaneous report as received from a registered nurse refers to a patient of unknown gender and age, but possibly a newborn. The patient's medical history and past drug history were unknown. On either 05-MAY-2016 or 06-MAY-2016, the patient was vaccinated with the first dose of RECOMBIVAX HB (lot # L039660 with expiration date 04-FEB-2018), via injection (dose and exact route were not reported), which had previously undergone a supported temperature excursion. Concomitant medication was not reported. As of 06-MAY-2016, it was unknown if the patient continued to take RECOMBIVAX HB. The outcome of receiving the RECOMBIVAX HB that had undergone a temperature excursion was unknown. This is one of several reports from the same reporter. Additional information has been requested.
This spontaneous case was reported by a consumer and describes the occurrence of DIARRHEA (Diarrhea), MALAISE (Feeling sick) and PRODUCT DOSE OMISSION ISSUE (Not yet taken her second shot of Moderna Covid-19 Vaccine since 6Apr2021) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. Concurrent medical conditions included Food allergy and Drug allergy. On 06-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Not yet taken her second shot of Moderna Covid-19 Vaccine since 6Apr2021). On 10-Apr-2021, the patient experienced DIARRHEA (Diarrhea) and MALAISE (Feeling sick). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO-BISMOL) for Diarrhea, at an unspecified dose and frequency. At the time of the report, DIARRHEA (Diarrhea) and MALAISE (Feeling sick) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Not yet taken her second shot of Moderna Covid-19 Vaccine since 6Apr2021) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment information was reported. The patient took Pepto-Bismol and Kaopectate for the diarrhea, and an allergy pill. Side effects that were reported post vaccination were diarrhea and feeling sick for three weeks started 10-Apr-2021.
First dose of the Moderna COVID-19 vaccine on 11Mar2021 and the second dose on 16 APR 2021; Second dose of vaccine administered after excursion; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Second dose of vaccine administered after excursion) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose of the Moderna COVID-19 vaccine on 11Mar2021 and the second dose on 16 APR 2021) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Second dose of vaccine administered after excursion). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose of the Moderna COVID-19 vaccine on 11Mar2021 and the second dose on 16 APR 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Second dose of vaccine administered after excursion) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose of the Moderna COVID-19 vaccine on 11Mar2021 and the second dose on 16 APR 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter.  No treatment medication was provided.  The action taken with mRNA-1273 in response to the events were not applicable.   This case was linked to MOD-2021-250456 (Patient Link).
increased injection site swelling daily, extreme nausea, severe body aches, severe headaches with blurred vision, hair loss
Caregiver tested positive on 4/30/21, sx starting on 4/28/21, after completing the Moderna vaccine series on 1/4/21 and 2/2/21
Nightmares  Fatigue all week,   itchy and sore arm on day  9 still present
Patient made appointment on line and did not reveal she already received a Covid J&J from another pharmacy, from another town. We found out after her sister came and wanted " 2nd  dose" of J&J , and we got a reject from her insurance claim. When we tried to contact the patient for confirmation, her phone went unanswer.
Within 1 hour post vax, the pt developed generalized swelling of whole body including face and eyelids. Was seen at the ER on 9/14.
101 Deg F Fever, Sore Arm, Muscle Aches and chills. Fever, Muscle Aches and Chills lasted for roughly 24 hours from symptom onset.
4/29/09 (Telephone consult) rash on face and back of neck, no respiratory distress per mother. Atarax q6 hours as needed. Mother instructed to schedule follow up in 4 to 5 days if rash does not resolve. 5/6/09 (Telephone consult) rash on face and neck, no respiratory distress per mother. 5/7/09 (Clinic appointment) Itchy/Irritated rash to face/neck/back/wrist. No further MMR vaccines to be given to child.
Patient developed signs of syncope within five minutes of receiving the second dose of the Phizer COVID-19 vaccine. Patient stated he ate little that day and often has similar episodes after giving blood. The patient also stated a fear or needles and taking a look at the needle today caused anxiety.
This case was reported by a healthcare professional and described the occurrence of joint pain in an adult female subject who was vaccinated with BOOSTRIX, GlaxoSmithKline.  On an unspecified date the subject received unspecified dose of BOOSTRIX (details unknown).  At an unspecified time after vaccination with BOOSTRIX, the subject experienced joint pain.  The subject was seen by her primary care physician.  At the time of reporting the outcome of the event was unspecified.  Follow-up received from reporting healthcare professional on 22 May 2009: The subject was 28-years-old.  The subject's alcohol use was social and she was a non-smoker.  Past medical history included migraines.  Concurrent medications included Yaz, Fioricet and Prenatal vitamins (for lactation).  On 29 April 2009, the subject received a dose of BOOSTRIX (0.5 mL, intramuscular, left deltoid).  Two days after vaccination with BOOSTRIX, the subject experienced joint pain and redness at injection site.  It was reported that blood tests may have been performed for possible rheumatoid arthritis.  This case was assessed as medically serious by GSK.  The outcome of the events was unknown.  The healthcare professional considered the events were possibly related to vaccination with BOOSTRIX.  The healthcare professional considered that the events could also have been associated with medical history or a concurrent condition, and the subject's physician was performing tests for rheumatoid arthritis.
Severe redness, swelling induration left deltoid after 24 hours. Treated with Benadryl and Ibuprofen
missed period with confirmed negative pregnancy tests x2. course has not ended as period has yet to return.
Death Narrative: On 3/3/21 an MSA from the Decedent Affairs Office received a call from the Office of the Chief Medical Examiner. The ME office informed the MSA that an autopsy was conducted on 3/2/21 and is pending results. No further information was given. A clinical review was conducted by the PCP but no conclusions could be made until autopsy results are received. The Office of Decedent Affairs will be reaching out periodically to the ME's office to retrieve these results. This Issue Brief will be updated by 3/17/21.
The night of vaccination I felt awful like I had the flu and got hives up and down my legs. Since then I have felt malaise and general soreness as well as intermittent headaches etc. none of this is uncommon in my body (as I have autoimmune issues). But I am concerned it?s triggered an autoimmune flare. I no longer have hives (so I will check recovered) but still feel unwell.
Only after my third shot, the booster, did I start experiencing heart palpitations. They occurred 2-3 times a day for the 2-3 weeks following my vaccination, and have now started to taper off.
Starting a few hours after injection, soreness, red and warm to touch began. Couldn't lift arm by bedtime. Still sore in the morning and still hot to touch, no redness still feels swollen. Told to put on ice on and keep muscles active to get serum out of muscles faster. He took a tramadol at bedtime the night before.
pt recvd vax;fever about 101;apap given;about 1pm sz; to hosp about 6pm;IV given w/ atb,motrin,apap;pt released when fever went down at about 12:30am;next day pt was fine
CHILLS; SLIGHT FEVER; DULL ACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case requested for this case. No concomitant medications were reported. On APR-2021, the subject experienced dull ache. On 28-APR-2021, the subject experienced chills. On 28-APR-2021, the subject experienced slight fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and slight fever, and had not recovered from dull ache. This report was non-serious.
August 20 or 21st, I woke up in the morning, with a loud snap in my head. Like a firecracker went off. I grabbed my husband to wake him up. I felt fine after. I go up and made some coffee. I went online to see if anyone else has had this. I found a couple of websites; EHS, Exploding Head Syndrome. I read about it and it said many people, especially women over 50 do. It doesn't cause adverse affects or any problems. They sited four things that might cause it: stress (I don't have); lack of sleep (that's not me either); inner ear problem (I had just finished an antibiotic for an earache, a few days to a week before, I had finished that medicine). I can't think of what the fourth cause was. I haven't had it again. Three or four days later, I went to the doctor for my annual check-up. My doctor was very concerned. He said there could be a possible brain bleed. He wanted me to go to ER to schedule a CT scan. So I got the orders and said I would do it. A couple of days later, he called me again (the doctor did) and said to get into the ER. I went Friday to the hospital for the CT scan. Also, my blood sugar was high. I had had bloodwork done on 8/23/2021. The doctor said he wanted to increase my dose of Metformin to 3 pills a day, along with type two diabetes there is higher cholesterol and blood pressure. He put me on two medications: lisinopril, 1 tab a day 5mg; atorvastatin calcium, 20mg one a day.
Admitted to hospital on 10/6/11 with 12-13 day history of neurologic disorder beginning with tingling in limbs first involving the thighs, progression to fairly acute weakness of proximal upper and lower extremity muscles around 10/2/11, falling near her bed while trying to do her laundry.  She has progressed so far has bilateral facial palsy.  There was no viral prodrome or recent febrile illness.  She is currently hospitalized with a presumptive diagnosis of Guillain Barre Syndrome for which she is receiving IVIG.  She has a marked neuropathy and cannot bend her knees while lying in bed and cannot lift her forearms to the height of her shoulders.  She has an incomplete right facial palsy and a complete left faical palsy.