chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within two days of the vaccine I got a 101.9 fever, chills, and fatigue but all of that seemed normal, as did the pain in my arm where I received the vaccine.  However I have also developed dizziness, intermittent headaches, occasional fatigue, and vertigo(?) that has persisted for a week and I?m getting increasingly concerned.  I?ve also developed very intermittent sore throat and lost voice so I?ve been trying to deduce if I have a cold or the flu.  No fever and all Covid tests consistently come back negative.  But the issue is the dizziness and sporadic headaches are not getting better.  I?m growing increasingly concerned that it?s a lingering vaccine side effect and not a cold or flu.  When I had Covid in the past I developed serious ear pain and I worry that the Moderna MRNA vaccine has inflamed my inner ear, causing vertigo, which would make sense if it replicates the spike protein found in the virus.  It was my first dose of the Moderna MRNA vaccine, though I had two previous shots of the rudimentary Sinopharm or Sinovac vaccines in 2021 that only use dead virus cells to stimulate an immune response and I caught Covid in March 2022 here. I was reticent to get the vaccine after getting Covid due to concerns raised by others but finally opted for another shot when cases started to rise.  Now I fear I have some bigger problems than Covid if the vertigo doesn?t stop
Initial information received on 27-Jul-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a Four-years old female patient who was administered vaccine subcutaneously instead of IM, no AE. She received Quadracel. This was the case of actual medication error due to inappropriate route of vaccination. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other concomitant vaccination was given. On 24-Jul-2018, the patient received a dose of 0.5 ml of suspect Quadracel lot C5248AA, exp date not reported, via subcutaneous route in unknown administration site. The patient did not experience any event. Lab data and corrective treatment: not applicable. Event outcome: not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. Documents held by sender: none.
Per family pt had a good day and eve, no signs of allergic reaction or difficulty.  He failed to wake up the next morning. Time of death 10:37 AM.
Rash and fever at two hours after injection, followed by difficulty breathing. Two days later still have difficulty breathing. Doctor visit with prescription for epi-pen and stronger asthma medication.
Information has been received from a pharmacist referring to his or her 62 year old mother. The patient had drug reactions to sulfa, cephalosporins and sulfamethoxazole, BACTRIM with skin rash and hives. There was no pertinent medical history. On 08-OCT-2015, the patient was vaccinated with ZOSTAVAX (lot number, expiration date and dose unknown) intramuscularly (incorrect route of administration). There was no concomitant medication. After receiving ZOSTAVAX, the patient experienced soreness at the injection site. The patient did not seek medical attention. No treatment was given for the event. No lab diagnostics studies were performed. The outcome of the event was unknown. The causality between the injection site soreness and ZOSTAVAX was not provided. Additional information has been requested.
Fever, tiredness (expected) Chest pain. Variation in heart rate. Pain when breathing and only when taking deep breaths.
Arm is swelling; Knot that came up on top of wrist; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Mar2021 12:00 (Lot number: EN6205, Expiration Date: 30Mar2021) at the age of 72 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "COPD" (ongoing); "B carrier of hepatitis" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing); "A fib" (unspecified if ongoing); "Congestive heart failure" (unspecified if ongoing); "Blockage" (unspecified if ongoing); "Blood thinner" (unspecified if ongoing). Concomitant medication(s) included: SYMBICORT taken for chronic obstructive pulmonary disease (ongoing); ELIQUIS taken for atrial fibrillation, cardiac failure congestive, anticoagulant therapy, start date: Oct2019 (ongoing); SOTALOL taken for atrioventricular block (ongoing); CLOPIDOGREL (ongoing); ATORVASTATIN taken for blood cholesterol abnormal (ongoing); POTASSIUM (ongoing); MAGNESIUM OXIDE (ongoing). Past drug history included: Aspirin, reaction(s): "Allergy"; Codeine, reaction(s): "Allergy"; Sulfur, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (1st dose, Lot number: EN620C, Expiry date: 06Mar2021), administration date: 02Mar2021, when the patient was 72 years old, for COVID-19 immunisation. The following information was reported: NODULE (non-serious) with onset 29Mar2021, outcome "not recovered", described as "Knot that came up on top of wrist"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "Arm is swelling".  Additional information: The patient had no additional vaccines administered on same date of BNT162B2. The patient had not received any other vaccines within 4 weeks prior vaccination. The events did not require a visit to ER or Physician office.   No follow-up attempts are possible. No further information is expected.
Vaccine administration error-It was noticed after the vaccine was administered that the patient received Pfizer as his first dose COVID vaccine.
No additional AE; Pharmacist called to speak with agency regarding VERIVAX. On Friday (5/5/2023) a patient received VARIVAX, but the sterile diluent was not used to reconstitute, instead 0.9% sodium chloride was used to reconstitute. No additional information was provide; This spontaneous report was received from Consumer and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions included  prophylaxis. Concomitant therapies were not reported.  On 05-MAY-2023, the patient started therapy with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 1 dose, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided); and  sodium chloride (SODIUM CHLORIDE), unk (strength, formulation, lot #, expiry date, route of administration, and indication were not provided).  On unknown date, pharmacist called to speak with agency regarding varicella virus vaccine live (oka/merck) (VARIVAX). On 05-MAY-2023 (also reported as: Friday), a patient received varicella virus vaccine live (oka/merck) (VARIVAX), but the sterile diluent was not used to reconstitute, instead 0.9% sodium chloride was used to reconstitute (Vaccine incorrect diluent used). No additional information was provide.  Lot Number W031812 is valid for V210.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with improperly stored PNEUMOVAX 23 ON 04-SEP-2012. Lot# was reported as 0709AE, expiration date: 04-JAN-2014. Route was unspecified. No adverse events reported. The vaccine storage information was reported as "From 14-AUG-2012 to 28-AUG-2012, lowest temp excursions at -8.3C for total of 9 hours (2 excursions), -3.6C for total of 19 hours (2 excursions), -4.8C for total of 12 hours (4 excursions) and -5.7C for total of 9.5 hours (2 excursions). High temp excursions exposed to 18.4C for 1 hour and 10 minutes." This is one of several reports received from same source. 1209USA007525, 1209USA008597, 1209USA008598, 1209USA008599, 1209USA008600, 1209USA008601, 1209USA008602, 1209USA008603, 1209USA008604, 1209USA008605, 1209USA008606, 1209USA008607, 1209USA008608, 1209USA008609, 1209USA008610, 1209USA008611, 1209USA008612, 1209USA008613. Additional information has been requested.
2/14/2022 I had a tickle in my throat, dry cough, muscle aches and fatigue. I took an at home COVID test which was negative. 2/15/2022, I felt worse. That evening I took another at home COVID test and it was positive. I was coughing really hard. On 2/16/23 I had a telehealth visit. I was prescribed PAXLOIVD. I started PAXLOVID and capsules for my cough that day. By the next day, I began feeling better. The fatigue and cough lingered. I tested positive until Day 11. The next week, I got sick again, my COVID test was negative. I had congestion and a cough. I still have a little bit of a cough from that.
Received dose #1 and #2 at outside facility, unable to access lot #.  Cold symptoms starting on 11/17/21. Exposure to grandson who was COVID positive on 11/15
7-8 days after received 15 mo shots, MMR, Hib, Varicella, Flu pt. developed fever to approximately 100.5 degrees F and later that night was found in bed, seizing. 911 called and taken to ED where continued to seize despite anticonvulsant treatment. Became apneic - required intubation. Transferred to hospital. Seizures stopped but pt continued with fever up to 104 degrees F for few days. Then fever broke and developed hives on 11/27/10.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No medical history, current conditions and concomitant therapies were reported. On 29-MAY-2015, the patient was inadvertently vaccinated with 0.5 ml dose of PROQUAD (Merck) subcutaneously (lot # and expiration date were not reported) that had been improperly stored. No adverse effects were reported. Additional information is not expected, as the reporter did not wish any further contact.
Reaction to the Moderna booster COVID-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (Reaction to the Moderna booster COVID-19 vaccine) 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, the patient experienced VACCINATION COMPLICATION (Reaction to the Moderna booster COVID-19 vaccine). At the time of the report, VACCINATION COMPLICATION (Reaction to the Moderna booster COVID-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.    No treatment information provided.
Husband said that she started having muscle weakness in arms and legs 3 days after the vaccine. Went to hospital after she declined. Has since been put on a Vent to help her breathe. Has been on a vent for 3 days and they are starting to wean her off of the vent now.
Employee had already received 2 Moderna shots.  When he came for a J&J shot, employee documentation was not adequately reviewed to  catch that he should not have a 3rd COVID shot at this time with current recommendations.  Employee did not report any problems after receiving the 3rd COVID shot.
Pt called to say he broke out in a localized rash. Pt later went to urgent care for steroids. He "felt better" on follow up.
sore arm; feeling "achy"; This is a spontaneous report from a contactable consumer (patient). A male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Feb2021 as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Historical vaccine included flu shot for immunization and experienced sore arm and feeling "achy". The patient received his first dose of the Pfizer-BioNTech Covid19 vaccine this past Tuesday, 23Feb2021. He reported a sore arm and feeling "achy" on Feb2021 which was what he expected and wasn't any worse than what he experienced with the yearly flu shot. He wanted to know, since he's had a reaction, why he would need the second dose. Also would like to know if you need to get the vaccine if you've had Covid and how long does the vaccine protect you. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Ringing in the ears or tinnitus/more intense over time; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 79 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 20Feb2021 (Lot number: FN6201) at the age of 79 years as dose 2, single and administered in arm right, administration date 30Sep2021 (Lot number: FF2587) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Immunocompromised" (unspecified if ongoing); "Type I Diabetic" (unspecified if ongoing), notes: Type I Diabetic; "Type 1 insulin dependent diabetic" (unspecified if ongoing), notes: Type 1 insulin dependent diabetic, Diagnosed about 50 years ago. Concomitant medication(s) included: FLU VACCINE VII, administration date Aug2021. Vaccination history included: Bnt162b2 (Dose: 01, Batch/lot number: PL9265, Dosage text: Unknown strength/volume/dose injection to right upper arm , Pharmaceutical form (Dosage form): Injection, NDC/Expiry: Unknown, this is not on the CDC vaccine record card.), administration date: 30Jan2021, when the patient was 79 years old, for Covid-19 immunization; Insulin (She does take other medications but has taken those for years, including insulin.). The following information was reported: TINNITUS (non-serious) with onset 2021, outcome "not recovered", described as "Ringing in the ears or tinnitus/more intense over time".  Additional Information: Caller states she is immune compromised and wants the most protection available. States if she didn't have tinnitus she would get the shot and go on her way. Caller states the tinnitus started after the 1st shot and progressed. Caller does not recall the date it started. States it was in May and in June it was as intense as it is now. Caller states it depends on the day but it is mostly pretty intense and when she is more active she notices it less and when it's more quiet she notices it more. States when she is talking to people it seems ok. Caller states she thinks her 1st dose was 29Jan2021 and her 2nd dose was 20Feb2021, she tried to do them 3 weeks apart. Caller verified dose and anatomical location of all three doses were the same. Caller verified that there are no relevant concomitant products or other medical conditions aside from the Type I Diabetic to provide for this report. She does take other medications but has taken those for years, including insulin. She is pretty healthy, doesn't have high blood pressure, not obese and she exercised. For the past few years she has not seen people, she just stays at home, only her family comes around, and now since they are back at work if they come in she has them take a test before they come in. Caller verified she has had no relevant testing, treatment or medical interventions performed relative to this event. As far as she is aware there is no cure for tinnitus so she is not going to go down that road. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine  No follow-up attempts are possible. No further information is expected.
Client complaining of stiffness and achiness in back, neck, knuckles, and wrist that started 24 hours after vaccinations given. She reports she has dropped objects when trying to pick them up due to discomfort in hands.
Pt had immediate tingling and numbness down the arm and in the hand of the vaccinated arm (left side). Symptoms resolved within 3 hours. The follow up received on 12/23/03 states pt had tingling down the vaccinated rm starting w/in 10 minutes post vaccination lasting approx 2-3 hrs and resolved on its own.
BURNING ALL OVER BODY ESPECIALLY FACE, EYE PAIN/BLURRINESS,  RASH, EXTREME FATIGUE
Narrative:  Patient's COVID hospitalization did not require treatment for COVID itself. Monitoring O2 sat, spirometry, and trending inflammatory markers. Patient given throat spray for sore throat pain.
C/o of tingling down both arms. Notified at 225 pm. Stated tingling occurred shortly after returning to dept and persisted with swelling of hands sent & reported to ED/EH for evaluation. Denied any further symptoms following day.
Received flu vaccine in his doctor's office on 10/14/2005. No adverse effects described that evening. Found dead in bed the following morning. Autopsy was performed; results are pending. 3/30/06 Autopsy Report received which stated COD as undetermined.
Hand weakness and numbness beginning 8/5/06 after shot and resolving 8/13/06. Evaluated as mild neuritis by MD.
24 hours after vaccine was given the child's entire arm became swollen. The arm had fever and was hard. After that the skin blistered and bubbled around the area where shot was given.
Information has been received from a 70 year old female patient reporting on herself with no drug reactions/allergies and no pertinent medical history who in "2009", was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route, lot number not reported) to prevent shingles. There was no concomitant medication. On 14-FEB-2012, just recently the patient developed case of shingles. The shingles were on her neck and her hairline. Her physician, confirmed the diagnosis. VZV Packet faxed to Physician. VALTREX and unspecified antiviral medication were given for the treatment of shingles. At the time of the report the patient's outcome was not recovered. No laboratory tests were performed. The patient sought medical attention, office visit. Follow-up information has been received from a physician concerning a 70 year old female patient with no drug reactions/allergies, no birth defects and no illness at time of vaccination and unknown history of chicken pox who on 07-JAN-2009 at 13:00, was vaccinated with a first dose of ZOSTAVAX (Merck), into left arm (lot number 663333/1555X) (dose, route not reported). On 15-FEB-2012, the patient experienced Herpes Zoster, characterized as rash (vesicular) on right neck, multiple lesions. The patient had pain that was quantified as 10 (most). No recent exposure to chickenpox or Herpes Zoster was reported. At the time of the report the patient's outcome was unknown. No a direct fluorescent antibody was done, no specimen was collected for PCR, no photo was taken. It was unknown if the patient sought medical attention. Herpes zoster with rash (vesicular) on right neck was considered by physician to be disabling. Additional information has been requested.
Received AVA #6 on 15 Mar 07 with no untoward result except for the usual soreness with a small lump at the injection site. On 9 Apr 07 she had an HCG test which was positive. On 31 May she had a OB PAP test done which was positive for epithelium cell abnormalities. Atypical squamous cells of undetermined significance (ASCUS) with positive HPV, high risk. EDC 18 Dec 07.
Guillain-Barre Syndrome; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000002851.  A female patient received BNT162b2 (BNT162B2), in Apr2022 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer unknown, Dose 1), for Covid-19 immunization. The following information was reported: GUILLAIN-BARRE SYNDROME (medically significant), outcome "unknown". Therapeutic measures were taken as a result of guillain-barre syndrome.  Additional information: On 03Aug2022, it was reported that a patient started treatment on an unspecified date in Apr2022 with Pfizer-BioNTech COVID-19 Vaccine dose 2 for an unspecified indication. It was reported the patient developed Guillain-Barre Syndrome.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient reported redness, local swelling around site of injection (pt noted it felt like a lump underneath the skin) and pain
5x5 inch area of redness and warmth surrounding shot site which appeared about 24 hours after the administration of IPV, DTAP, HIB to that site.  No sign of infection.
Small raised bumps on lateral aspect of bilateral thighs covering 2/3 of area. 2 providers consulted and patient walked to allergy clinic where provider was expecting him.
Muscle ache, back and neck pain, fatigue and dehydration. Side effects started 10hrs after vaccine shot and lasted for around 20hrs
she lost her sense of taste and smell; she lost her sense of taste and smell; It was her Booster dose; Pharmacist seeking guidance for a dose of the Pfizer Covid-19 Vaccine administered to a patient undiluted.; Pfizer Covid-19 Vaccine administered to a patient undiluted.; Pharmacist seeking guidance for a dose of the Pfizer Covid-19 Vaccine administered to a patient undiluted.; This is a spontaneous report from a contactable pharmacist. A 69-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0150), via an unspecified route of administration on 05Oct2021 (at the age of 69-year-old) as DOSE 3 (BOOSTER), 0.3 ML SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 11Mar2021 as DOSE 1, SINGLE (Batch/Lot Number: EN6205) and received second dose of bnt162b2 on 01Apr2021 (Batch/Lot Number: ER2613) for covid-19 immunisation. The pharmacist reported that the female patient received a 0.3 mL undiluted Pfizer Covid-19 Vaccine on 05Oct2021 (Between 11:30-12:00) by a co-worker. It was her Booster dose. The patient lost her sense of taste and smell on an unspecified date. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Event: Age deviation in administration.  No adverse physical effects noted.  Case details: Minor child age was incorrectly entered into vaccine reservation system. Child appeared to be age 12 in our online appointment system. Clinic staff  failed to see age discrepancy between reservation and online immunization record in clinic.  Client (11 year old female) received 1st dose of Pfizer COVID-19 vaccine at age 11 years 9 months. Post clinic: state health department advised Public Health of error when data was in conflict. Mother notified of age deviation. 2nd dose appointment rescheduled for age 12 birthday or beyond.
10-16-12 patient received Hepatitis B vaccine, came into our office 11-7-12 with excessive thirst for couple weeks - dx with diabetes Type I. Onset of polydipsia, polyphagia, polyuria, onset after 10/23/12.
For over 3 weeks following the injection I have had injection site redness, soreness, area was hot to the touch, and a large lump at injection site. I have also been very fatigued, headaches, and body aches
Patient called pharmacy 1 hour after vaccine with fast heart rate and tight chest.  Pharmacist advised patient to take Benadryl and referred to urgent care for further monitoring.  Pharmacist called patient next day and patient reported they took Benadryl and did not go to urgent care.  They felt fine the next day.
Pt was given Morderna 6yr -11yr instead of Moderna Bivalent.