chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning an approximately 42 month old caucasian male with no past medical history who on 07SEP2000 was vaccinated with a first dose of varicella virus vaccine live, in the left arm. There was no illness at the time of vaccination. In March 2003 the patient developed "<20 pink papular lesions on skin, no fever, no malaise: other than lesions child appears well (as per mother 09JUL2003 via telephone). There were no relevant diagnostic laboratory tests. It was reported that the patient recovered 5 days after onset of rash. It was also reported that up to nine other children in the patient's day care center had also developed chicken pox after being vaccinated with a dose of varicella virus vaccine live. No further information is expected.
After taking the vaccine on March 25th, 2021 1. Starting 04/04/21, Tinnitus became severe  in the right ear (7 on a scale of 10) . Also developed screeching metallic noise 24x7 (2 out of 10 severity). Masking with another sound also did not help. Hissing noise also started in the left year. Visited ENT doctor on 04/08/2021, got prescription for Medrol (Methyl prednisolone 4 mg) -- 6 day tapering dose. Medicine took starting 04/09/21, finished on 04/14/21. No change in symptoms.  2. Starting 04/10/2021 both knees started feeling very hot and painful. Also felt pressure in the back of the head. Unable to sleep.  3. On 04/12/2021 high blood pressure of 160/100 recorded by the primary care physician Dr.. 4. On 04/15/2021, pain and heat started in other joints (elbows and wrists). Pain in  knees continues. Tylonol 1000 mg did not give any relief.
Moderna vaccine booster given at a clinic and at this time we were unaware of the 20 dose limit for punctures of each vial.  The vial was punctured 28 times.  There were no reports of adverse events.
Shot received at 9:40. At 10:15 on my way to work my heart started to race, body got hot and got dizzy, felt like I was going to faint. Pulled over to get my breathing under control and turned my AC on high to cool body down. Symptoms still existed but got back on the road towards my work office. Throat started to feel like it had a gum all in it and felt like it was constricting. Chest started to hurt like there was a weight on it. 10:30am went to closet urgent care to where i was. Was there for 2 hours. They gave me IV fluids, steroid push through IV Oort, Benadryl through IV port and monitored the symptoms. They did not subside so they gave me a shot of epinephrine. When symptoms still did not go away they called EMS and I was transferred. They monitored my vitals and gave me lidocaine to drink and another liquid to relax my throat abs airway. Symptoms stated to subside but did not fully go away. Was discharged at 3:30 pm and a prescription for prednisone was called into my pharmacy. As of 9:40 on the same day vaccine was administered (4/6/21) throat is sore and chest is still tight, headache and sweats. Was advised to follow up with primary doctor.
received flublok after the vaccine experienced a temperature excursion that was not covered by the extended stability data with no reported adverse event; vaccine experienced a temperature excursion that was not covered by the extended stability data with no adverse event; Initial information received on 19-Oct-2022 regarding an unsolicited valid non-serious case from a nurse.  This case is linked to case 2022SA435204(CLUSTER).  This case involves 2 patients of unknown age and unknown gender who received influenza quadrivalent recombinant vaccine [Flublok] after the vaccine experienced a temperature excursion that was not covered by the extended stability data with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.    On an unknown date, the patients received suspect influenza quadrivalent recombinant vaccine at an unknown dose (lot UJ893AA, expiry date: 09-Jun-2023) via unknown route in unknown administration site for immunisation.  On an unknown date vaccine experienced a temperature excursion that was not covered by the extended stability data with no adverse event (product storage error) (unknown latency) and patients received flublok after the vaccine experienced a temperature excursion that was not covered by the extended stability data with no reported adverse event (poor quality product administered) same day latency.  Action taken: Not applicable.  Outcome: Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Rash, manageable but annoying, Is very itchy; This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of itchy rash in a 62-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 5th August 2021).   On 13th October 2021, the patient received the 2nd dose of Shingrix. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced itchy rash. The patient was treated with hydrocortisone (Hydrocortisone Topical Cream). On an unknown date, the outcome of the itchy rash was recovered/resolved.   It was unknown if the reporter considered the itchy rash to be related to Shingrix.  Additional details were reported as follows: The case was reported by the patient. The patient had received Shingrix and had now developed a rash in left knee and thigh that was very itchy for the last two weeks. The patient asked did this rash might be related to vaccine. The patient said it was manageable but annoying, controlling with topical hydrocortisone cream. Needed to rule out any other cause for this rash.
expired dose administered; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose administered) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 26-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose administered). On 26-Jul-2021, EXPIRED PRODUCT ADMINISTERED (expired dose administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Expired dose of the vaccine was administered on 26JUL2021 as 2nd doses. The lot number for the vaccine was 053C21A (expiration date on vial 09Nov2021). The date the vial was moved from freezer to refrigerator was 24Jun2021. The date the vial expired was 23Jul2021. The administration of the doses was 3 days after the vial expired.   This case was linked to MOD-2021-277219 (Patient Link).
Information has been received from a physician concerning a female with no known allergies or medical history who in October 2007, was vaccinated with her third dose of Gardasil.  Subsequently the patient had a positive HPV DNA test indicating high risk for human papillomavirus even though she received all three doses.  No further information was available.  Additional information has been requested.
Patient has extreme cramping in calves and feet. Patients forarm and trapezius muscle are painful to touch.
MD has seen an unusually high incidence of react following immu w/Td; 1 of 3 w/in 1 wk who exp extreme swelling (size of a small grapefruit) of inject site, fever to 103, & nausea;
had some soreness lt deltoid p/inj;awoke from sleep 11JAN w/itching;by PM arm warm to touch, large reddened area;pt to MD 13JAN ATB therapy;15JAN arm swollen from shoulder to elbow painful;adm to hosp IV ATB d/c 17JAN97;dx cellulitis;
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.  On 22-DEC-2016, the patient was vaccinated with an expired dose of M-M-R II lot # K021950, expiration date: 10-NOV-2016 (strenght, dose, frequency and route of administration were not reported ) for prophylaxis, by a physician. No adverse events were reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
3 days after my menstrual period ended, and 2 days after second dose of COVID vaccine, I saw a lot of bright red blood in the toilet after urinating around 10AM. I had spotting all day, then it suddenly stopped. Felt tired and a little bit of cramping.
pt recv vax & immed exp drowsiness;pt was still drowsy when seen by MD 4 days post vax;@ time of vax pt had a runny nose;MD stated may have been d/t a viral infect;pt also exp dec appetite;
Body aches, headache from early morning day after booster until late evening. Approximately 12 hours.
Moments after injection, left side of upper and lower lips began to tingle.  A minute later, they began to go numb.   After approximately 5 minutes, the left side of face went numb.   Left palm of hand became 'prickly' and very itchy.    Began cramping in the left foot, on the arch.    The foot cramping resolved within a half hour.   Face numbness resolved approximately 4 hours.  Palm of hand approximately 2 hours.   Numb lips resolved by noon the following day.
Case number PHEH2013US021574 is an initial spontaneous report received from a pharmacist on 15 Oct 2013 with a follow up information received from a pharmacist on 07 Nov 2013. This report refers to a female patient whose age was not reported. Her medical history and concomitant medications were not reported. She was vaccinated with seasonal influenza shot (manufacturer and batch number: not reported) subcutaneously on an unknown date. The pharmacist stated that the shot was not administered at his pharmacy, but at a clinic at a local school and he could not confirm if the vaccine was FLUVIRIN. No adverse event was reported following the maladministration. In the follow up information received on 07 Nov 2013, it was reported that the patient was administered ZOSTAVAX (other manufacturer, batch number: not reported) and reported an adverse event related to ZOSTAVAX and not FLUVIRIN and hence the case would be deactivated. No further information was provided. Follow up information received from a pharmacist on 07 Nov 2013: Patient reported an adverse event related to ZOSTAVAX and not FLUVIRIN and hence the case was deactivated.
Red, swollen hard lump occurred 4 hours after injection. Super painful and itchy later on. Redness, swelling, painful lump grew to about 3 inches in diameter. Urgent care told me to go to ER. Called  8 days post injection. Diagnosed with cellulitis. Prescribed clindamycin  1 tab q6hr and prednisone  1 tab for 2 days.
Headache, chills, body aches, stomach pain, nausea, weakness, pain at injection site.
Lungs closing up, trouble breathing, pulse ox drop.  Like an asthma attack but inhaler did not help.  It lasted about 4 hours.  Shooting nerve pain through my body for several days.   Overall sluggish for two days, body aches, exhaustion.
Child awoke with a rash that started on her trunk & spread to face & extremities. Her fever in the office was 101. She is slightly cranky but no meds given. The palms & soles do not have a rash.
hard to hear; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A 83 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPOACUSIS (non-serious), outcome "unknown", described as "hard to hear".  Additional information: She already got the two doses of Pfizer Covid-19 vaccine and then apart from the first and second dose it's more than 21 days and she mentioned about having health problems after taking the two doses.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
itching; severe pain in the arm; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration on 12Mar2021 as dose 1, single for COVID-19 immunisation. The patient medical history was not reported. The patient concomitant medication was not reported. PQC was not provided.  On an unspecified date the patient experienced severe pain in the arm and itching. Reporter stated that she knows some people have had different side effects. She wanted to know if there have been reports of itching and should she take Benadryl or go to HCP. Reporter wanted to know how long should the itching last/how long should that be before she goes to HCP. The clinical outcome of the events severe pain in the arm was resolved on an unspecified date and itching was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
started having itching on the 13th swelling red  hot to touch this has continued to get worse over time
A mother reported that by her 4-month-old son received an injection of Prevnar in Jul-2001 and subsequently developed an injection site reaction characterized by hardness, redness, and swelling. No further information was available at the date of this report.
I received the shot on Tuesday and did have side effects on Wednesday. They were moderate but I couldn't work. I had shaking/chills and fever from 100.4 to 101.7 all day. I feel much better today.
This spontaneous report was received from a certified medical assistant, on 14-JUL-2015, concerning to unspecified patients of unknown ages. Since 06-APR-2015, unspecified patients were vaccinated with VAQTA (dose, route, frequency and lot unknown), which had been exposed to temperatures outside of the recommended range. This is one of several reports received from the same source (1507USA006969 - 1507USA007091). Additional information has been requested.
Palpitations/PVC's constant for months (Starting 1 month after vaccine)  Atypical Hyperplasia bordering on Ductal Carcinoma (recent diagnosis)
administered expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 64-year-old male patient who received Herpes zoster (Shingrix) (batch number 29T59, expiry date 1st October 2021) for prophylaxis.   On 18th October 2021, the patient received the 1st dose of Shingrix. On 18th October 2021, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The patient was administered expired dose of Shingrix vaccine, which led to expired vaccine used. The reporter consented to follow up. This case was 1 of 5 linked cases reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021219382:same reporter US-GLAXOSMITHKLINE-US2021219379:same reporter US-GLAXOSMITHKLINE-US2021219378:same reporter US-GLAXOSMITHKLINE-US2021219375:same reporter
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 15-AUG-2014 the patient was vaccinated with expired dose of MMR II batch #J008882, lot# 0293AA with expiration date: 27-JUL-2014; route of administration dose and indication were not reported. No adverse effects reported. Additional information has been requested.
Very minor allergic reaction at the injection site (only appeared 7 days after injection). The area is swollen, warm, and itchy with a few small hives.
some rash in the neck area; This is a spontaneous report received from a contactable consumer (Patient's wife) reporting for husband (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 08Apr2021 as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter mentioned that her husband received the first dose of the Pfizer covid vaccine on Thursday, April 8th and after that he had some rash in the neck area on an unspecified date in 2021. She said that was unlikely related to the vaccine but she would like to know if he can take Benadryl or Claritin. She was recommended to consult their physician prior to taking the medication. The reporter mentions that she has heard that some people get fever after the second dose of the Pfizer covid vaccine and she wanted to know if it was ok to take acetaminophen if that was to happen to her husband. She was recommended to consult a physician prior to the taking of the medication. The outcome of event was unknown.  No follow up attempts are needed. No further information is expected.
Patient was given 0.25mL booster dose from a vial that was was out in room temperature past 25 hrs.; Patient was given 0.25mL booster dose from a vial that was was out in room temperature past 25 hrs.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was given 0.25mL booster dose from a vial that was was out in room temperature past 25 hrs.) and PRODUCT STORAGE ERROR (Patient was given 0.25mL booster dose from a vial that was was out in room temperature past 25 hrs.) in a 59-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 22-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was given 0.25mL booster dose from a vial that was was out in room temperature past 25 hrs.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient was given 0.25mL booster dose from a vial that was was out in room temperature past 25 hrs.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was given 0.25mL booster dose from a vial that was was out in room temperature past 25 hrs.) and PRODUCT STORAGE ERROR (Patient was given 0.25mL booster dose from a vial that was was out in room temperature past 25 hrs.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  The Dose administered after exposure to room temperature was more than 24 hours. The Number of doses reported was 1 dose. The vial was initially stored in the refrigerator on 13Apr2022. The vial had not undergone any temperature excursion. Total amount of time the vial was exposed to room temperature range was 25 hours. The patient had administered second booster dose.
Missing period, mensural cycle irregular since vaccination, worse fatigue, cramping. Horrible muscle locked arm. More concerned about the change of my menstrual cycle. Color, 2 weeks late, irregular, different color.  not pregnant.
This spontaneous report as received from other source as part of a marketing research-program, refers to unspecified patients of unknown demographics. The medical history and concurrent conditions of the patients were not reported. On an unknown date, the patient was vaccinated with GARDASIL of unknown strength (dose, frequency, lot number not reported). Concomitant medications were not reported. The reporter was sharing the experiences of some of the GARDASIL vaccine injury patients and stated that some patients who had GARDASIL have been in wheel chairs and bed bound. The outcome of the events was unknown. The reporter considered the events to be related to GARDASIL. The reporter considered the events to be disabling. Additional information has been requested.
extreme weakness, shaking extremities, diarrhea, loss of bowel/bladder control, mental disorientation, unable to walk
Pt received shot, normal soreness for five days, then on fifth day severe, severe pain at injection site. Pain described as "enough to make my arm fall off". Pt had difficulty moving arm at all. Relieved slightly by ibuprofen and alternating heat/cold packs. Some redness at site of injection remains. Pt is going to wait 2-3 days to see if issue resolves, then go to urgent care. As of time of reporting, issue still remains, although not as bad today (6/1/22) as it was yesterday.
Systemic: Fainting / Unresponsive-Mild, Additional Details: patient was recommended to rest for 15minutes after the vaccine.  patient ended up fainting while sitting and developed a rug burn on the forehead and a bloody nose.  patient was check on every 5 minutes and was okay after 30 minutes and left.
Pt c/o tingling sensation of tongue and throat after receiving 2nd vaccine dose. No facial edema or difficulty swallowing or breathing. States this also happened with the first dose and it lasted 4-5 days. She only reported that episode to her pcp who advised her to premedicate with Benadryl for 2nd dose which she did. Facility gave her an additional Benadryl 12.5 mg and monitored for 60 min without any worsening symptoms. Called pt next day and symptoms had improved somewhat. Denied facial swelling, difficulty swallowing or breathing .Advised to follow up with her pcp or call 911 if swelling or difficulty breathing occurred.
Positive Covid test after two moderna vaccines, and two boosters; took five day course of Paxlovid, prescribed by PCP.
On 2/2/2021, patient came in to clinic before scheduled appt.  Patient did not have his vaccination card so received new card at check-in with 2nd dose of Moderna written in the 1st dose section was provided. Nurse inquired to patient when was 1st dose so nurse can write down the information on the card. Patient did not know. "2nd" dose of Moderna was administered in right deltoid. Upon documentation, it was found that patient received the 2nd dose of Moderna vaccine at day 15 by nurse. Patient received 1st dose of Moderna 1/21/21.
01/19/2021 Fever- 102.0 F Headache Chills Sore arm  01/20/2021  Fever 100.1, sore arms, chills
Information has been received from a healthcare worker concerning multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not provided. On unknown dates, the patients were vaccinated with doses of improperly stored PROQUAD (strength, dose and frequency were unknown; subcutaneous, lot # L051101, expiration date 17-JUN-2017; lot # L040415, expiration date 13-APR-2017 and lot # reported as M015475 which was not valid, expiration date 01-SEP-2017). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.