chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My entire body felt heavy, like lead filled my body and it was difficult to lift my arms and legs. My legs were so heavy and I was so weak so I had to crawl and there is an aching from my bones out similar to what one experiences with the flu that has left me suicidal in order to escape the pain! It is managed with narcotics now, but I remain at all times. I had a sore throat that has not gone away in the past six years. My white blood cell count was down at 2 to 3 verses normal 5 to 12. I remain unable to process information or recall things from my short-term memory, I could not watch a television show, read or do math. I was incapable of any complex activities like paying bills or filling my pillbox and had no strength to even get up and do my own toileting and hygiene. I had photophobia and difficulty regulating my body temperature with my hands and feet becoming extremely cold and purplish colored intermittently. I developed interstitial cystitis. My doctor later told me I had post viral syndrome also known as chronic fatigue syndrome and to remain hopeful but as the years passed she explained some people never get well.
The patient's partner called on 4/19/22 and stated that the patient was unable to move and asked if that was normal after getting the typhoid vaccine.  I gathered more information from her and found out the patient had no trouble breathing, was able to move with help, however very lethargic.  I called the patient on 4/20/22 and the patient said he felt fine today.  He said he was very groggy the prior day and said it may have been due to two things put together: receiving the vaccine and also him not getting enough sleep in the last few weeks due to being busy moving and traveling.
Patient experienced swelling, malaise, fever, inflammation. Swelling and inflammation spread out from site of injection. MD treated with BENADRYL, AMOX, as well as MEDROL.
Patient reported an anaphylactic reaction to her first vaccine (Janssen) on April 10, 2021.  Patient went to the ED and was treated with Prednisone, Benadryl and Pepcid.   Patient was given Benadryl and Pepcid at 4:08 PM, monitored for 30 minutes and given her Pfizer vaccine at 4:38PM and monitored again for 30 minutes.  At the 25 minute mark she complained of throat tightness but not as bad as the first vaccine.  Consulted with NP and additional Benadryl 25mg given.  Patient was monitored for an additional 30 minutes.  She denied shortness of breath and her vital signs remained stable.  At 5:40 she said she was almost back to normal but felt a little drowsy from the medications.  At 5:45 she left the clinic with her father.
Patient came to get a covid 19 shot of Johnson and Johnson and realized after the shot was given that she was not 18 years old until 3 more months. She was currently 17 years and 9 months old when receiving the shot. No adverse side effects have been reported to the pharmacy since the shot was given and tried to follow up with the patient as well.
Patient was admitted for myocarditis. He developed chest pain, fatigue and intermittent shortness of breath.
Rash to (L) arm, fatigue, sinus symptoms. ZYRTEC daily and OTC ibuprofen (MOTRIN).
No additional AE reported; Patient was administered expired MMR II; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided.  On 04-FEB-2022, the patient was vaccinated with expired dose (expired product administered) of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot #: T001213, expiration date: 12-JAN-2022, status albumin: recombinant human albumin (rHA) (exact dose, strength, site and route of administration were not provided) for prophylaxis. There was no additional adverse event reported.
On 07/06/2021, I was given an allergy shot and I had an allergy reaction. I coughed uncontrollably about 45 minutes after the shot. I had to pull over as I was driving and took a Benadryl and an aspirin immediately .
(R) thigh 3.5 x 2.5 in red, warm area of skin 3-4 papulo/vesicular lesions within the red area. Varicella and Hep A given in this leg. (R thigh cellulitis).
9 days p/vax small lump devel @ inj site;next day turned red & swolle;inc redness to 2in x 3in;devel swelling under arm;lymph nodes in axilla enlarged;saw FNP on day 12; felt related-given Deltasone & all sxs gone w/in 24hrs x/small lump
Vaccine administered after being punctured and left at room temp over 2 hours.  Pt received vaccine about 4&1/4 hours after initial puncture.
Patient became developed COVID symptoms 5/7/21, tested 5/13/21 positive after completing vaccination
Patient requested booster covid-19 vaccine.  The pharmacy technician misunderstood that the patient had previously received 2 doses of ModernaC COvid-19 vaccine in the spring.  She thought the patient had received Pfizer.  Pharmacist administered Pfizer Vaccine for Covid-19 and then after administration discovered that patient had previously received Moderna.
This case was reported by a nurse via sales rep and described the occurrence of blister in patient who received FLUARIX QUADRIVALENT. On an unknown date, the patient received FLUARIX QUADRIVALENT .5 ml. On an unknown date, an unknown time after receiving FLUARIX QUADRIVALENT, the patient experienced blister and swelling. On an unknown date, the outcome of the blister and swelling were unknown. It was unknown if the reporter considered the blister and swelling to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The other healthcare professional called to report that she did not like the FLUARIX QUADRIVALENT vaccine because 3 patients received the vaccine in 2014 and experienced blisters and swelling. The sales representative did not have any further information. This case has been linked to cases US2016GSK034531 and US2016GSK034532, reported by the same reporter.
31AUG92 call from mom states pt has been running fever since PM p/shots given 25AUG92; pt has felt hot but temp not taken; has been weak & not drank over an ounce in last 2 days; vomited 30AUG again 31AUG; instructed to take to MD;
No sings or symptoms reported; Temperature excursion; This spontaneous report was received from an administrator referring to a patient of unknown age and gender. The patient's medical history, concomitant medications, drug allergies, or reactions were not reported.   On 09-APR-2021 and 23-APR-2021, a Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) (lot # T035379 has been verified to be a valid lot number for Pneumococcal Vaccine, Polyvalent (23-valent), expiration date 31-MAY-2022) was exposed to a temperature of 49.0 to 48.7 Fahrenheit degrees respectively  for a time frame of 1 hours and 15 minutes cumulative.  On an unspecified day between 09-APR-2021 and 12-MAY-2021, the  patient was vaccinated with 1 single dose of  the previous mention Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (strength and administration route were not provided) (product storage error). No digital data logger was involved, non previous excursions were reports and no sing or symptoms were reported (no adverse event).  This case is linked with several same reporter cases. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck; devicelotnumber: T035379; expirationdate: 31-MAY-2022; deviceage and unit: 0 ; operatorofdevice: Unknown; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2105USA002866: US-009507513-2105USA002935: US-009507513-2105USA002943: US-009507513-2105USA002937: US-009507513-2105USA002938: US-009507513-2105USA002939: US-009507513-2105USA002941: US-009507513-2105USA002942: US-009507513-2105USA002934: US-009507513-2105USA002933: US-009507513-2105USA002936: US-009507513-2105USA002932:
I had a significant pain my arm. I woke up in the morning with an extremely high fever. After checking my fever it went higher the Next  day but slowly digressed over the span of 4days.
Mom noticed site of injection red, swollen and hard to the touch. Gave Septra Surp 2.5 ml G 12h x 2wks.
This case was reported by a consumer via call center representative and described the occurrence of groin pain in a 79-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included leg cramps (relieved pressure spot on back /waist / buttock area) and sciatica (10 year before the time of reporting on left due to medical procedure and placement on a medical table caused the pain). On 1st October 2018, the patient received the 1st dose of SHINGRIX (intramuscular) 50 µg. On 1st October 2018, less than a day after receiving SHINGRIX, the patient experienced groin pain and discomfort. On 7th October 2018, the patient experienced sleeplessness. On 8th October 2018, the patient experienced leg pain and knee pain. In October 2018, the patient experienced pain in spine. On an unknown date, the outcome of the groin pain was recovering/resolving and the outcome of the discomfort, knee pain and pain in spine were unknown and the outcome of the leg pain and sleeplessness were not recovered/not resolved. It was unknown if the reporter considered the groin pain, discomfort, leg pain, sleeplessness, knee pain and pain in spine to be related to SHINGRIX. Additional details were provided as follows: The patient previously experienced sciatica pain due to medical procedure and placement on a medical table caused the pain. The patient received SHINGRIX in the left arm. The patient was experiencing pain in his right groin area that began sometime after the injection. He stated the pain had been so uncomfortable that was unable to sleep. From 7th October 2018, 6 days receiving SHINGRIX, he noted that he was unable to sleep beginning. At the time of reporting, he was still not able to sleep at night, but noted the severity of the pain was not as bad. On 8th October 2018, 7 days receiving SHINGRIX, the patient also noted the soreness had traveled down the inner right leg to the knee. He also noted the knee cap was painful. He stated there was an area on his buttocks between the buttocks and waist that he can press on and it is slightly sore. The patient noted that it was to the right of the spine. The patient did not have difficulty walking with these events. He stated the traveling soreness down the leg began 2 days before the time of reporting.
Red, blotchy rash all over body, hot, itching. Then given 50ml oral BENADRYL per v/o Dr. Pt then became cold all over body. Pt felt better within 45 mins and was driven home by spouse. Prednisone prescribed.
left thigh at injection site without redness or swelling but redness and swelling generalized medially left leg extends thigh to knee, non fluctuant, no abscess seen TREATED WITH PREDNISOLONE 15MG/5ML 1/2 TSP BID
On the clinic day, the vaccine was transported out from the pharmacy to the facility without a digital data logger. The packing used for transport was  refrigerated packaging tote to maintain a temperature of 36 F - 46 F.  However, that is not approved by State of  for COVID-19 vaccine transportation. The total time (from when vaccine left the pharmacy to the clinic completion) was less than 6 hours. There were no adverse events.
10 hours after injection I had a short ringing in right ear first, then about 10 minutes later ringing inert ear and it lasted for less than 30 seconds for both ears. Tenderness in arm at injection area about 8 hours after shot.  Slight headache 10 hours after injection.
No adverse event; Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated.; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated.) and NO ADVERSE EVENT (No adverse event) in a 6-month-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 214K22A and 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 21-Apr-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 10 microgram. On 20-May-2023, received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 10 microgram. On 21-Apr-2023, the patient experienced WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated.) 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 WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated.).    The route of administration of suspect Moderna bivalent dose 1 and 2 was reported as. Concomitant medication was not reported. No adverse effects noted. Treatment medication was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-730780 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730780:Master case
High fever during night of vaccine (did not check with thermometer). Felt dizzy next morning and fainted twice. Felt better by that afternoon.
Hypoglycemia following swimming. Lethargy, unbalanced. Given sugary snack and felt better.
Mom called to report shot site very swollen, hot to touch and extremely red.  Patient had pain when arm was touched at all.  Given Ibuprofen for pain and swelling.  Mom reported on 08/13/2003 that arm almost normal size and small hard spot at injection site but pretty much cleared up.
Swollen, red, hot to touch, fever 101.4, irritable, painful.
Initial unsolicited report received from Pfizer via health care professional on 06-Dec-2016. This case involves a (age was not reported) female patient who was vaccinated with a dose of TETANUS TOXOID (batch number, expiry date, dose in series, dose, route and site of administration was not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient had experienced rash, shortness of breath and also experienced allergy to vaccine. Relevant laboratory data and corrective treatment was not reported. The outcome of the event was unknown. List of documents held by sender: none.
Presented to office day 14 post MMR with resolving maculopapular rash chest, shoulders - stated she had fever, headache, body aches stiff neck 9/3 - 9/6 (day 10 - day 13), afebrile now.
This spontaneous case, received from a pharmacist on 15-Oct-2018, (initial and follow-up 1 combinedly processed), concerns a 33-year-old, adult male patient. On an unspecified date, FLUCELVAX QIVc was stored at a maximum temperature of 56F for 8 hours following a power outage. On 14-Oct-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252668 and expiry date: 30-Jun-2019] which was stored inappropriately. At the time of this report, no adverse events were reported. The reporter assessed this case as non-serious. This case 201804538 was cross-linked to the case 201804533 reported by the same reporter.
After a few months of getting my booster shot I tested positive for COVID. I felt really different and just decided to do a home test. I quarantined for 10 days and after that I felt normal again and went back to doing my normal daily activities.
Exhaustion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 16Oct2023 as dose 1, 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 (DOSE NUMBER UNKNOWN; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 17Oct2023, outcome "not recovered", described as "Exhaustion".  Additional information: Reporter stated he got Pfizer booster Covid shot yesterday (16Oct2023). Patient was having exhaustion on the day of report. Reporter wanted to know what to do.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
administered an expired menactra to a patient with no reported adverse event; Initial information received on 10-Oct-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 17 years old male patient who was administered an expired MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient was administered expired MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE at dose of 0.5mL, once (lot number not reported) with no reported adverse event (expired product administered) (unknown latency) via unknown route in unknown administration site for immunization.  First time product used : No Still using product : No  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event administered an expired menactra to a patient with no reported adverse event.  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.
2 days after receiving Zostavax vaccine, patient noticed the site was red, swollen and hot.  She circled the site and waited until the next morning.  When she saw it expanded beyond the circle she proceeded to the emergency room.  According to the patient she was diagnosed with cellulitis and treated with a 7 day course of clindamycin.  The swelling is gone and guest has no symptoms at this time.
Headaches, sore arm at sight, extremely tiredness for about two weeks, swelling in arm.  Pain and swelling in the arm is still there.  It has became increasingly hard to raise her left arm.
MMR given approximately 3:30 6/24/04. Complained of throat pain, bilateral, intense feet itch and swelling, ears swelling and tachycardia. 0.5 tsp oral Benadryl + 0.1 1:100 epi SQ given. Transfer to ER via ambulance. Had steroids at hospital. Discharged at home 8pm 6/24/04.
11/11/21 presents to local ED "at the request of her pediatrician for elevated transaminases" with "no past medical history".
Pt. reported to our Urgent Care Center complaining of a rash. He received a Zostavax about 1 month ago. His rash is clinically consistent with Varicella. Viral culture was taken
sudden onset of sneezing, coughing, runny nose (clear discharge) with excoriation of nasal folds from constant use of facial tissues to cover sneezes.
Dizziness, ataxia, nystagmus, possible chill, temp no measured; Occurred 15 hrs post inject; MRI showed cerabellar inflam, CSF inc Protein; Better now;
Patient received immunization in a seated position. After the immunization, patient stood around the immunization area for approximately 10 minutes when the patient experienced syncope and collapse. Patient was caught prior to making contact with the floor. No apparent physical injuries were present.
got tested she is positive with Covid; got tested she is positive with Covid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (004756). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "got tested she is positive with Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Clinical course: The patient was vaccinated with Pfizer Covid 19 vaccine but had symptoms and side effects (headache ,diarrhea, fever, chills, upset stomach, cough) when she got tested she was positive with Covid. The patient wanted to know if it was normal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Red, hot, and itchy bump near injection site. Itchiness and red bumps along arms.
This spontaneous report as received from a nurse refers to a patient of unknown age. On 27-JUN-2014 the patient was inadvertently vaccinated with a does of expired (Oka/Merck) VARIVAX lot # H011232, expiration date: 06-JUN-2014, 0.5 ml, subcutaneous. No adverse reactions reported. The outcome of the event was unknown. Additional information has been requested.
7 1/2 hrs post vaccine pt developed hives on body, vomiting,difficulty swallowing. ER visit times 2, treated with Benadryl.
Soon after the Pfizer, 2nd Covid booster vaccination, around 4:00pm (15 minutes), I began smelling an intense acrid smoke-like smell. I could detect no source for the smell. I thought someone might have been smoking  nearby. It grew stronger through the evening even though I was at home. There was no source of the smoke smell anywhere near. As of 6:30am the following morning, the sense is still present, though diminished from the prior evening.
1. Adverse effect of vaccine, initial encounter - skin reaction at Varicella injection site - no overt vesicles noted - no systemic signs of varicella infection - reviewed partially live vaccine complications - may be local skin reaction, early cellulitis or vaccine reaction - images in System - mom to update office in 48 hours  - take pictures daily - consider VAERS report   2. Skin lesion - at varicella site - no varicella infection noted - may be cellulitis from injection-  - site borders marked to track progress - mom to take images daily  - if redness spreading, would start keflex - mom aware to contact office in 2 days with update and send images in System prn