chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19 Breakthrough. It started as a scratchy sore throat on Wednesday night. The next morning I started to get a tingling in my thighs that turned to aches and pains through my entire body. I assume that when my body was producing spike protein response because of the aggressiveness. I had aches, pains, and fever that fluctuated often. I also had cranial pressure in my frontal bone. I took NSAIDS around 4:30 pm that Friday by 6:30 pm the fever and pains reduced. The pressure moved to my temples. Then I started to get the head cold nasal drip. On Sunday for about 4 hours my taste and smell was weaker. My symptoms went away by May 17th and since then I have had a low grade post nasal drip all day everyday that comes and goes. There was fatigue for about 4 weeks after my symptoms ended and has since gotten better as of this week.
6 hours after receiving 2nd dose of Pfizer COVID-19 vaccine I began experiencing palpitations. Using mobile device it appears to be PACS. Sustained.
Suspected vaccination failure; Shingles; This case was reported by a consumer and described the occurrence of Suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group of patient was not reported but was captured as an adult as per vaccine indication. The patient had Shingles after vaccination. This case was considered as suspected vaccination failure as completion of primary vaccination schedule, time to onset and laboratory confirmation test were unknown at the time of reporting.
While standing behind her mother at the nurses desk with her winter jacket on - patient fell to the ground and passed out. This occurred approx. 10 - 15 minutes after her injection. She reported feeling fine and refused a chair when offered. She was unresponsive for a minute or two during which time her arms became stiff and wrist turned outward. Face was flush.
No more menstrual periods, hot flashes several times a day, thirsty, head "feels tingly".
This case was reported by a healthcare professional and described the occurrence of injection site soreness in a 23-year-old female subject who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. The subject had experienced soreness in the arm without any rash following receipt of prior immunizations of influenza virus vaccine. On 26 October 2006 the subject received a dose of Fluarix in the left arm. On 27 October 2006, 1 day after vaccination with Fluarix, the subject experienced injection site soreness, "a rash in a ring around the injection site", and body aches. The outcome of the events was not reported. The healthcare professional considered the events were probably related to vaccination with Fluarix. Follow-up received on 10 November 2006 indicated that on 28 October 2006 the subject was evaluated on 28 October 2006 to rule out underlying pain issues. The reporter stated that the subject experienced a "halo type rash around the site of injection,a arm pain and generalized body aches. The subject was in no distress and denied any difficulty breathing, swallowing, fever or swelling. At the time of this report, the healthcare professional considered the events were possibly related to vaccination with Fluarix.
Approx 15 days post receipt SPV pt developed substernal pressure accompanied by dyspnea, described as like someone sitting my chest and significantly increased with lying and sitting and reduced when standing up - See VHC clinical summary. Symptoms Dyspnea (shortness of breath), chest pain felt like someone sitting on my chest, fever nasal drainage (runny nose, also reports sore throat), headache, malaise (<60 days).
Joint rash (ankle, knees, hips, elbows, wrists) days 4-6 post vaccine, tired/tight/weak calves with occasional spasm in left calf (days 2 - 16/ ongoing)
The next morning, 9-1-2021, on my left arm was a rash. I called the doctors office and they could not see me until the following day. I went to the appointment the next day on 9-2-2021, and they did a culture swab and stated that it looked like a shingles outbreak.
Pt. states that after receiving the 2nd dose of Moderna 08/2021, started experiencing symptoms mid 08/2021 of intense arm pain and loss of motor skills throughout the hands. Still continuing to experience symptoms.
Patient reported developing intermittent but persistent substernal chest pain/discomfort following his second dose of Pfizer vaccine on 4/30/2021. Pain was aggravated by leaning forward, deep inspiration, sitting up from supine position, coughing/sneezing and had not been improving following onset. No dyspnea on exertion or other systemic symptoms. Denied any other inciting factors prior to onset including injuries or change in his physical activity. EKG in office appeared consistent with pericarditis. He was advised to present to hospital to confirm diagnosis and initiate treatment if confirmed.
Patient presented to clinic for second dose of COVID Vaccine. Patient originally received Moderna 6m -5y vaccine as first dose. Pfizer 6m - 4y was administered today 10/08 as second dose, instead of Moderna. Followed CDC's Interim Clinical Considerations for administration errors: "Children ages 6 months to 4 years who receive different mRNA products for the first 2 doses of an mRNA COVID-19 vaccine series should follow a 3-dose schedule. A third dose of either mRNA vaccine should be administered 8 weeks after the second dose to complete the 3-dose primary series." https://www.cdc.gov/vaccines/covid-19/clinical-considerations/interim-considerations-us-appendix.html. Patient's mother was contacted around 11:30 am and informed of error and CDC recommendations. Patient's mother verbalized understanding of situation, willingness to administer a third dose, and stated no further questions. Per patient's mother patient was doing good and had no symptoms at the time of call.
According to patient,, The inject site is itchy and there is a tingling sensation on the left arm. The left arm is weak
Pediatric dose was given to adults mistakenly; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly).    This case included information of patient 34 out of 104 patients.  No concomitant product reported by reporter.  051B22A was kept in the freezer upon receipt of shipment on 01-Aug-2022 and individual vials were put in the refrigerator on the day of use. AR5186C was previously reported. Pediatric dose was given to adults mistakenly and each patient received the error dose, with instructions to re-vaccinate 2 months from the initial error dose.  No treatment medication reported by reporter.
I am 54 and post menopause (last period over 14 months ago.)  After first shot I began to experience some PMS symptoms.  They became significantly more pronounced after the 2nd shot, and today, 9 days post 2nd shot, I woke up to menstrual bleeding.  I have not had a period in well over a year and the timing is troubling.
HPV (Gardisil) and FLu vaccines given 9/19/19. Fever to 102 degrees over next 24 hours - 36 hours. Had resolved by the morning of Saturday 9/21. (It was her 2nd Gardisil, and she receives flu vaccines yearly)
Swelling around (L) eye and upper lip. Swelling and redness (L) upper arm at site immunization and (L) thigh at site immunization. Does not appear to have urticaria. Will refer to allergist for testing parent prefers to hold on antihistamines.
nausea; vomiting; chills; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea), VOMITING (vomiting) and CHILLS (chills) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Nov-2021, the patient experienced NAUSEA (nausea), VOMITING (vomiting) and CHILLS (chills). At the time of the report, NAUSEA (nausea), VOMITING (vomiting) and CHILLS (chills) outcome was unknown.            Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-546661, MOD-2022-546695, MOD-2022-546699 (Patient Link).
Brachial plexopathy, bilateral diagnosed as being due to Zostavax most likely by neurology consultant.  5/6/08 Reviewed PCP medical records which included neuro consult.  PCP note of 11/20 indicates patient had arthroscopic right shoulder surgery for bone spur & torn rotator cuff also noted but not repaired.  Afterward developed left arm pain for past 2 weeks which was worse when lying down, better w/sitting up.  Sleep had been difficult.  Right hip discomfort made walking difficult. Labs ordered & referred to neurology.    12/14/2007 Neuro consult for RUE shoulder & arm pain w/abrupt onset s/p vaccination into left arm & self-resolution.  Mid October developed left shoulder/arm pain w/o trauma.  Testing revealed mild weakness of right shoulder girdle, limited left shoulder ROM w/decreased left biceps reflexes. FINAL NEURO DX: strongly suspicious for bilateral sequential idiopathic/inflammatory brachial plexus neuropathies possibly assoc w/DJD or immune reaction; asymptomatic cervical spondylosis.
pt recv vax 8SEP98 & pt devel sl redness @ the vax site;
25 min after the vaccine I had left the hospital and was already home. I was unable to swallow. I could breathe and talk, but could not feel the Babcock of my throat. My tongue felt like it was swelling but it wasn?t! I tried to drink but couldn?t.  This lasted approx 5 minutes and started to subside. All effects cleared 45 -50 min later.  The following day I nauseous, throwing up, headache, tired, body aches.  Today is totally fine!
Patient received an initial dose of Varicella vaccine on 05/13/2022 and later received a Proquad dose on 05/24/22.  Proquad dose was not valid due to being administered less than 4 weeks after initial dose.
A few days after getting the second COVID vaccination, I woke up with severe pain in both shoulders that eventually started to radiate down to the biceps. Both shoulders appear to be frozen with limited mobility. This condition got progressively worse over the next few weeks and mobility and strength were getting worse quickly.
Initial information received on 26-Sep-2018 regarding an unsolicited valid non-serious case received from a physician. This case is linked to case 2018SA272032 and 2018SA271978 (same reporter). This case involves unknown age of 24 patients who received vaccine IPOL (lot N1G511M and N1D451M) via unknown route (expiry date and site of administration were not reported) on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to incorrect product storage. It was reported that three temperature excursions on 2/14/18, 3/8/18, 4/11/18 of 1-degree C. for approx 14 hours. Vaccines included two open MDV of IPOL, and unopened other products. States that 24 children received IPOL after the temp excursion. It was not reported if any adverse event occurred. 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 and Module VI of the 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. Documents held by sender: none.
per patient's family report:  patient complained severe leg pain a few days before she was found dead in her apartment on 2/18./2021. It was likely she had sudden death as she did not activate her neck alert or call button in her apartment.  Family request we report the incident, she was last seen on 12/15/2020 for pacemaker check, she also had medical message communication with me on 2/8 to request refill on her Percocet that she takes occ for her joint pain only at bed time.  family suspect possible DVT with PE after getting more informed about vaccine side effects. however no autopsy was done.
I conceived baby 1 month after receiving this vaccine and fetus was diagnosed with birth defect of severe hydrocephalus and stunted cerebellum at 18 week ultrasound.  Amniocentesis shows no genetic defect and no other explanation as to what caused this birth defect can be accounted for.  I suspect it may have had something to do with getting the vaccine so close to conception.
Had a problem in her left knee that she stated she never had before. It was like a painful tear and she couldn't walk. Her right foot also became very painful.  Went to see an Orthopedic  and they dx her with having arthritis.
A low fever; This is a spontaneous report from a contactable consumer.   An 18-months-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) on an unspecified date, at single dose, for immunization. It was reported that the patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) and 2 other shots (unspecified). Relevant medical history and concomitant medications were unknown. On an unspecified date, at night, after the vaccination, the patient experienced low fever. Clinical outcome of the adverse event was unknown at time of this report.   No follow-up attempts are needed, information about lot number cannot be obtained.
This spontaneous report as received from a consumer refers to a female patient of unknown age. Patient history or concomitant medications not reported. On 01-DEC-2015 the patient was vaccinated with ZOSTAVAX. The patient claims to have experienced a reaction to ZOSTAVAX, which resulted in her being admitted to the hospital. No further information was reported. Additional information has been requested.
Patient is fully vaccinated. A retired Octogenarian, whose symptoms started on 07/28/21. In addition to the symptoms checked off, she also experienced chest congestion and weakness. Symptoms resolved on 08/09/21. She was hospitalized for 5 days.
Dizziness; Redness; Pain; Dizziness; Redness; Pain; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of DIZZINESS (Dizziness), the first episode of ERYTHEMA (Redness), the first episode of PAIN (Pain), the second episode of DIZZINESS (Dizziness) and the second episode of ERYTHEMA (Redness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced the first episode of DIZZINESS (Dizziness), the first episode of ERYTHEMA (Redness) and the first episode of PAIN (Pain). On 17-Feb-2021, the patient experienced the second episode of DIZZINESS (Dizziness), the second episode of ERYTHEMA (Redness) and the second episode of PAIN (Pain). At the time of the report, last episode of DIZZINESS (Dizziness), the last episode of ERYTHEMA (Redness) and the last episode of PAIN (Pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Upon in internal review on 21 May 2021, the age was corrected to unknown age.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 22-Feb-2021: Upon internal review on 07 Jun 2021, it was discovered that the patient age was incorrectly captured as 121 years and DOB mentioned in source document was incorrect, which was a MI error. The patient age and narrative has been updated to unknown age with reports re-submission and significant amendment is performed for the correction.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
left leg pain and swelling developed on 5/26/2021, did not seek treatment until 6/9/2021 as not resolving. Evaluated in ER 6/9/21, identified on ultrasound left popliteal and calf deep vein thrombosis. Started on anticoagulation therapy, Eliquis 10mg BID, ongoing treatment, reduced to  5mg BID after 7 days and will continue to monitor renal function.
When patient left the facility in her car, she passed out at the wheel.  Regained consciousness after a few minutes.  Husband came in today, 3 weeks later and said "she is still not herself, dizzy, etc"
Nausea and decreased blood pressure per EMS. Transported to local ER via ambulance. Patient transported to ER via ambulance for evaluation before staff could asses the patient.  Evaluation done by MD. (Name) noted 4/13/202 @  2:45 PM:  No telephone number to contact patient for f/u.   Sent email requesting a call back.
Arm is really sore; Bruise; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm is really sore) and CONTUSION (Bruise) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm is really sore) and CONTUSION (Bruise). At the time of the report, PAIN IN EXTREMITY (Arm is really sore) and CONTUSION (Bruise) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  No relevant concomitant medications were provided Treatment for the events, were not provided
Patient received a Pfizer BioNTech Adolescent/Adult Vaccine (Lot# 301458A) that was stored in the regular freezer (-25 to  -15 oC) beyond 14 days. On 22JAN22 Pfizer responded to the clinic that stability data does not support the use of the Pfizer Vaccine (Lot# 301458A). Pfizer further states decision to release or dispose of the product is the responsibility of clinic. The CDC website states that if the manufacturer does not have the information to support the stability of the vaccine, repeat the dose immediately with no minimum interval.
"Foggy Headiness; Trouble with word recall; experience a headache; soreness; A spontaneous report was received from a consumer concerning a 71-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events soreness,/general body pain, headache, foggy headiness/feeling abnormal, trouble with word recall/aphasia.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 8 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 013M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 8 Feb 2021, the patient experienced the event(s) soreness, headache, foggy headiness, trouble with word recall.  Treatment details included Ibuprofen, Electrolytes.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), soreness, headache, foggy headiness, trouble with word recall,  was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This spontaneous report as received from a healthcare worker refers to a 23 year old female patient. On an unknown date in 2009, the patient was vaccinated with her first dose of GARDASIL. On 21-MAR-2016 (reported as today), the patient will get her second dose of GARDASIL 9. No adverse effects were reported. No product quality complaints (PQC) was involved. Additional information is not expected as the reporter did not wish further contact.
This case was reported by a pharmacist via call center representative and described the occurrence of antinuclear antibody positive in a 65-year-old female patient who received Shingrix for prophylaxis. Concurrent medical conditions included fibromyalgia (had a long standing history of fibromyalgia that the patient believed was diagnosed incorrectly 15 years before the date of reporting). Concomitant products included prednisone. In July 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced antinuclear antibody positive. On 11th September 2018, the outcome of the antinuclear antibody positive was recovered/resolved. The reporter considered the antinuclear antibody positive to be unrelated to Shingrix. Additional information was reported as follows: The reporting pharmacist was the patient herself, she was a retired pharmacist. The batch number and expiry date for Shingrix was not reported. The patient used to work in a safety department so she understood she had to report the events experienced by her. On the date of reporting, after vaccination with Shingrix, the patient received her lab results, that showed positive results for antinuclear antibody (an autoimmune disorder). At the time of reporting, the patient was prescribed Prednisone for a period of about 12 days. The pharmacist believed that the event experienced by the patient was not related to Shingrix. The pharmacist also stated that if the lab test samples were withdrawn prior to vaccination with Shingrix, they would still had shown positive results. The pharmacist believed that the events experienced by her were not due to the vaccine as she had a long-standing history.