chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a licensed practical nurse (LPN), referring to an unknown number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored dose of RECOMBIVAX HB lot number N002914, expiration date 04-NOV-2019, for prophylaxis. The data logger registered a temperature excursion of 47.49 Fahrenheit (F) for 13 minutes. There was not previous temperature excursion. No adverse effects were reported in any patients. This is one of two cases from the same reporter. Sender's Comments: US-009507513-1708USA007603.
Pt recvd 1st dose of hep B vax 22JAN91 & exp diffuse arthralgia & malaise.Tx w/ meds.MD feels events related to MMR vax & not Hep B vax.
symptomatic, mild hypoxia, testrd positive for COVID on 12/31/2021
urticarial rash with no other likely precipitating cause.  Treated with benedryl.  No respiratory or GI symptoms.
The vial was initially stored in refrigerator was on 04-Jun-2022 and vaccine administered on 16-Jul-2022; No adverse event; Patient administered the vaccine after the 30 days by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 days by used), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator was on 04-Jun-2022 and vaccine administered on 16-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 days by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator was on 04-Jun-2022 and vaccine administered on 16-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 days by used), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator was on 04-Jun-2022 and vaccine administered on 16-Jul-2022) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 days by used) and PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator was on 04-Jun-2022 and vaccine administered on 16-Jul-2022).    No concomitant medication was reported.  Patient received half dose of vaccine.  On 04-Jun-2022, the vials were initially stored in the refrigerator.  The vial did not undergo any temperature excursions.  No treatment information was provided.
16 year old patient was given an extra dose of ADACEL with no reported adverse event; Initial information received on 13-Nov-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 16 years old female patient was given an extra dose of Diphtheria-2/Tetanus/5 AC Pertussis vaccine [Adacel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Meningococcal vaccine A/C/Y/W CONJ (TET TOX) (Menquadfi) for Prophylactic vaccination.  On 10-Nov-2023, the patient received an unknown extra dose of suspect Diphtheria-2/Tetanus/5 AC Pertussis vaccine Suspension for injection of lot U7648AA and expiry: 15-Feb-2025 via unknown route in unknown administration site for immunization; with no reported adverse event (extra dose administered) (latency: same day).  No lab data was 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 and Regulatory Authority 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.
Patient went into Atrial Fibrulation sometime between March 15th and April 5th when it was discovered during a visit to Dr.
Mild swelling, redness, tenderness, itching covering about 12cm area on the arm.
Patient reported difficulty breathing and swelling of the tongue approximately 5 minutes after administration of vaccine.  Epipen administered and patient monitored afterward until resolution of symptoms and vitals stable.  She was also given 4mg of decadron (approximately 1 hour in total).  Sent home with epipen and benadryl.
Tired after COVID booster dose; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tired after COVID booster dose) in an elderly 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 Ankylosing spondylitis and Panuveitis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced FATIGUE (Tired after COVID booster dose). At the time of the report, FATIGUE (Tired after COVID booster dose) had resolved.            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.
Day following injection, pt reports feelings of "pounding heart" and shortness of breath. This symptoms resolved same day. When seen in office on 12/8 reporting: no pain but some residual feelings of L arm numbness/tingling  radiating down to fingers - feeling "like her finger are falling asleep."
No adverse event; 5 patients received expired Moderna Bivalent Covid-19 vaccine. 4 of the patients are included in this source document; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 patients received expired Moderna Bivalent Covid-19 vaccine. 4 of the patients are included in this source document) 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. 044H22A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 15-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 15-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 patients received expired Moderna Bivalent Covid-19 vaccine. 4 of the patients are included in this source document). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 patients received expired Moderna Bivalent Covid-19 vaccine. 4 of the patients are included in this source document) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (5 patients received expired Moderna Bivalent Covid-19 vaccine. 4 of the patients are included in this source document).    Concomitant product use was not provided by the reporter.  Treatment information was not provided.  This case contains information for the 3rd patient out of 4 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-732810 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732810:Master case (Patient 3)
Information regarding PREVNAR 13 was received from a healthcare professional regarding a patient who experienced injection site pain, swelling and excessive redness. The patient received a dose on an unspecified date. MEDICAL HISTORY: Relevant medical history was not provided. PRODUCT DETAILS: Indication for PREVNAR 13 was immunisation. Product was administered on an unspecified date. Dose regimen was 1 dose. CONCOMITANT THERAPY: Concomitant medications were not reported. EVENT DETAILS: The patient experienced injection site pain, swelling and excessive redness. Outcome was unknown. No additional information was available at the time of this report. MANUFACTURER'S COMMENT: The reporter was unable to specify the number of patients who experienced this event. Additional reports will be generated when identifying information is provided.
Severe intermittent chest pains on the 17th January.  Followed by a wave of cold sweats and clammy feeling yuk. I was driving a car when this came on. Not stressed not doing physical activity.   I was at work mine where it's mandatory to be vaccinated or I loose my job)  I went to the paramedics,  by the time I got there the pain had stopped so of course the checks came up fine.    3 days later I was driving my car on the highway... I experienced Severe chest pains again and shortness of breath.  I called 000 and an ambulance came to meet me at the side of the road.  By the time they came the pain had passed. I asked her to listen to my heart to make sure is ok.. she said ohhh I can't listen to your heart I don't have the things.. :/ ?   I went to see my doctor yesterday as I'm extremely concerned to have the 2nd does of vaccine!! I have a heart specialist appointment on the 2nd of Feb.    My chest is tight and feels uncomfortable,  it's definitely done something to me!!  A man just died last week at a neighboring mine from a heart attack,  his co workers said he just had the vax the day before!!?
Case number PHEH2014US025321, is an initial spontaneous report from a medical assistant received on 16 Dec 2014. This report refers to a 71-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient had tolerated vaccines (no further details provided) well in the past. On 16 Oct 2014, the patient was vaccinated with 0.5 ml of FLUVIRIN (batch number: 145701, expiry date: Mar 2015) into left deltoid muscle that was stored at minus 0.6 degrees Celsius for 2 hours and 50 minutes. No adverse reaction was reported following this medication error (incorrect storage of drug).
Acute chest pain around 36 hours after receiving 2nd dose. Likely Myocarditis, but i?m not a doctor.
SLIGHT FEVER, LEFT UPPER SHOULDER WARM, TENDER, AND SWOLLEN. MOM GAVE TYLENOL AND APPLIED COLD PACKS TO AREA.
Jan 16 received vaccine (Anthrax) in L arm.  No pain or erythema.  Pt woke up Jan 18 with  inability to left arm and paresthesia over the lateral aspect of the arm. No pain.
Full body itchy rash, started about 4-8 hours after vaccines, continued spreading the next day. Treatment: BENADRYL.
Severe arm pain, inability to lift arm. Joint pain, especially knees. Chills.
Dizziness; Feel shaky; Numb almost like I took a Lortab; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), NERVOUSNESS (Feel shaky) and HYPOAESTHESIA (Numb almost like I took a Lortab) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced DIZZINESS (Dizziness), NERVOUSNESS (Feel shaky) and HYPOAESTHESIA (Numb almost like I took a Lortab). At the time of the report, DIZZINESS (Dizziness), NERVOUSNESS (Feel shaky) and HYPOAESTHESIA (Numb almost like I took a Lortab) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment was received by the patient.  She got the Moderna COVID-19 vaccine at 9am this morning.  Two hours later she started to feel dizziness and shaky.  The same day she started to feel numb stating that it "almost felt like I took a Lortab."  Reporter allowed further contact with her and consent for Safety to follow-up with her health care provider was denied  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.   Reporter did not allow further contact; 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.
Initial reaction was normal,  slight fever,  body aches,  arm soreness,  fatigue.  By later the next day,  extreme fatigue,  vomiting for 30 hours, unable to take in food or liquid.  Transported by ambulance to Hospital 4/21/2021 diagnosed with diabetic ketoacidosis, dehydration, and slightly elevated troponin levels. Hospitalized overnight.  Took nearly 3 weeks to feel normal.  2 weeks before I could eat an actual meal.
Pt received her booster dose of Moderna on 12/1/21. She called Health Department on 12/3/21 to report a few hours after her booster shot she started experiencing some numbness and tingling around her left eye and left side of her mouth. Pt reports she did not notify her primary care doctor or seek emergency evaluation. Pt reports she still feels like she had lidocaine around the left side of her face.  Public Health Nurse advised pt she needs to seek urgent evaluation right away. Pt verbalized understanding and agreed to the plan of care.   Public Health Nurse tried to call pt back on 12/7 for follow up however while on the phone the pt said she had to go abruptly since she was at work. Pt did state was still experiencing some of the same symptoms but they seemed to be improving.
FAINTED; QUALITY OF SLEEP WAS LOW/DID NOT SLEEP WELL; FELT VERY RESTLESS; CHILLS; FEVER (UNKNOWN TEMPERATURE); EXTREME NAUSEA; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight, height, and medical history included the patient had several comorbidities. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978) dose was not reported, frequency 1 total, administered on 03-APR-2021 at left Arm for prophylactic vaccination. No concomitant medications were reported. It was reported that, On 04-APR-2021 at approximately 04:00 a.m. in the morning, the patient experienced chills, extreme nausea, fever (unknown temperature, felt like she had a fever, hot) and she fainted. She also stated that when she went to sleep her quality of sleep was low and poor as she felt very restless. She stated that before fainting she called out to her husband who then carried her back to her bed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the quality of sleep was low/ did not sleep well, chills, fever (unknown temperature), fainted, extreme nausea and felt very restless was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210408190-Covid-19 Vaccine ad26. cov2.s-Fainted. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
2 Hives left check, lower left lip, hydrocortisone cream 25 mg Benadryl.
This spontaneous report was received from a medical assistant refers to an unspecified number of patients of unknown age. On an unknown date, the patients may have been vaccinated with M-M-R II, lot # K022284, expiry date 12-NOV-2016, lot # K011188, expiry date 12-AUG-2016 that may have been exposed to temperatures outside of the recommended range. No adverse experiences were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a nurse refers to a patient of unknown demographics. The patient's medical history was not reported. On 16-OCT-2013 the patient was vaccinated intramuscularly with VAQTA (dose, lot number and expiration date were not reported). No concomitant medications were reported. It was reported that on 16-DEC-2013 the patient received again VAQTA. There were not known adverse effects or product quality complaints. Additional information has been requested.
Received Hep A #1 R thigh, cried; Received FLUZONE 0.25 ml IM 6-35 mo cried - held breath - went limp; Baby in mom's arm, mom ran out of room for addenenal abreaction.
Became allergic to Advil and Aleve (numbness in entire mouth, couldn't tell if throat was closing). Previously, I would take Advil once a month over the course of a week. Developed sciatica. Woke up with intense pain 12/28/2021 in lower back. Couldn't bend over, sitting was very uncomfortable. Continued until 1/15/2022, at which point the pain became severe with no relief. Loss of mobility due to pain. Pain started to become less severe on 1/19/2022. Still have pain and mobility issues related to the pain to this day (can't walk for very long or sit/lie down in one position, bend, move certain ways), but it seems to be getting better. I was prescribed muscle relaxers for treatment but only took it once. Have been stretching and walking to treat.
Pt fever shortly after vaccine. Pt experienced seizure was taken to ER and dx'd with febrile seizure. Pt positive for strep throat the following day 6/30/11.
a sore arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (a sore arm) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced PAIN IN EXTREMITY (a sore arm) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (a sore arm) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.
After MMR and Chicken Pox vaccines, 100.7 fever for 5 days, moody and lethargic.  Tired and clumsy and excessive falling over for two weeks.  Bumpy rash on stomach and legs for two weeks.  Refusing to eat, change in happy demeaner to melancholy and cranky.  No other reactions to any of the other previously routine vaccines he had received until then.
This spontaneous report was received from a consumer who posted on Facebook an information identified on the Facebook page and refers to an unknown number of patients of unknown age and gender. The patients' pertinent medical history, allergies or drug reactions and concomitant therapy were not reported. On an unknown date, the patients were vaccinated with a dose of unspecified HPV (quadrivalent HPV (types 6, 11, 16, 18) recomb. vaccine (GARDASIL) or HPV rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) could not be ruled out) (manufacturer, dose, frequency, route of administration, lot # and expiration date were not reported). The consumer reported that just a one minute internet search showed an article by pediatrician group saying it might have profound long term side effects on kids reproductive systems. The outcome of adverse events was not reported. This is one of two reports from the same reporter (MARRS # 1609USA014668). Additional information is not expected, as no consent was given to follow up.
Severe localized reaction - "cellulitis" treated with KEFLEX fever 104 - diffuse myalgias - right arm.
Light headedness, tingling feeling all over body and excessive vomiting (in this progressive order). All of this occurred within 2 hours of receiving the vaccine.
Subsequent to receiving first and second doses if varicella virus vaccine live a serum VZV antibody test revealed negative titers.
This spontaneous report as received from a nurse refers to a 21 month old patient (gender was not reported). On 02-SEP-2014 the patient was vaccinated with improperly stored M-M-R II (lot # J008153 with expiration date: 08-JUL-2015; dose, frequency and indication were not reported). Lot # J008153 with expiration date: 08-JUL-2015. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Chills and overheating, exhaustion, muscles aches, headaches. It began 7 hours after the shot, rendering me bedridden, and continued until I woke up the next morning.
p/vax pt arm where got the shot is red, tender & hot;this size of grapefruit;child seen by MD;9cm local rxn rt upper arms-indurated area;cefzil given;
starting on 1/19: headache; burning behind eyes and sore throat; x 3 days which have now resolved  - now dizzy when standing;  fatigue - arms feels heavy when taking shower;  pale; remains very weak and tired; dizzy - feels like anemia - tried to work last night but broke out in cold sweat and pale so sent home from work last night - sxs are not worsening
I am freaking out and don't want to be permanently paralyzed.; 25 min ago my left eye became slightly blurred; left side of my face and left my eye were/are tingling/the  left side of my forehead/temple area started tingling; I am freaking out and don't want to be permanently paralyzed.; This is a spontaneous report from a contactable consumer (patient).  A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in arm left on 19May2021 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 dose 1 on an unspecified date for Covid-19 immunization. It was reported that the patient received her 2nd Pfizer dose, in her left arm 2 hours ago (on 19May2021) and then she noticed the left side of her face and left her eye were tingling. She stated this started about 1 hour and 40 min after receiving her 2nd vaccine dose, 25 min ago her left eye became slightly blurred and the left side of her forehead/temple area started tingling. She was freaking out and doesn't want to be permanently paralyzed. She asked if these are expected side effects and what she should do. The outcome of the events was unknown.  Information on the lot/batch number has been requested. Further information has been requested.
Vasovagal response 5 minutes after injection. Blood pressure below 80. Patient drank water and orange juice then reported feeling better and vitals improved to in-range levels.