chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received their first dose on Jan 2020; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in January 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow up. This case was linked with case US2021137206, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021137206:Same reporter
Pain and burning  during injection which did not go away.  Extreme tenderness the rest of the day with accompanying body aches and exhaustion. Next morning a reddish, swollen area about 2cm appeared, extremely tender and hot to touch. Arm ached all day, exhaustion the next afternoon. For 7 days after, site was tender, swollen, and pink. 48 hours after injection the raised reddish area was approximately 6cm in diameter, round. Always felt a little better in the morning, with exhaustion in afternoons. By 7th day area was 9cm x 6cm. Surface of raised area burned and tingled, with muscle pain underneath, whether or not it was touched. Arm ached when leaning on elbow. Today is day 8; area still burns, but is no longer visible.
Received the flu (left arm)and pneumonia immunication (right arm)injection around 11 A.M. on 11/14/03.  Later, around 3 PM., after working out, did not feel well.  Took a nap.  Up and fixed dinner for husband & I.  About 8 P.M., just finishing eating, felt faint.  Husband helped me back to bedroom.  Very short of breath.  Noticed right arm very swollen, red, warm.  Very weak.  This lasted about 20-30 minutes.  Then gradually began to feel better.  The next 3 days, drank lots of water, took long afternoon naps, and used cold compresses to arm. Right arm about 1" larger than left.  No residual effects noted.  On Nordic track yesterday for 20 minutes and plan to workout today as well as go to Yoga class tonight.  Will be teaching classes in AM. I seem to be fine, but just think this needs to be reported for the record. I have taken the flu shots annually, but this is the first time I took the pneumonia shot, so I think that is the one that caused the problem.
Behavioral changes, agitation, obsessive compulsive behavior starting within 2-3 days of receiving DAPTACEL #5, MMR II #2, IPOL #4, Varivax #2. These behavior changes, although improving, have persisted 3 weeks after vaccinations. Pt had completed a course of ZITHROMAX for pertussis exposure 5 days prior to shots.
sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  An 84-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "allergic to Polyethylene glycol (PEG)" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization, reaction(s): "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional information: Patient Age: Almost 85 years old. The patient mentioned that she called like year and a half ago regarding the ingredients of the vaccine. She was allergic to Polyethylene glycol (PEG) and remembered that when she called, someone told her that it contains 53 mg. However, she stated that she never had an adverse event when she received her first doses of the Pfizer-BioNTech COVID 19 Vaccine. Later, she mentioned that she only had a sore arm but that was all. She was allergic to PEG on quantities greater than 1000mg. She waited between 4 to 5 months to receive her next dose of the COVID Vaccine, but in her area, someone told her that the new formulation is only available. She wanted to know if the amount of PEG is still the 53 mg. After hearing the response, patient complained that that it was a small quantity of PEG and it should contain more. The patient who was in her 80s took three shots of the COVID-19 vaccine and would like to know more regarding the new booster vaccine because she had an allergic reaction with one of the ingredients in it. She got information and found out it was safe for her to take the vaccines which she had. She didn't have any problem with the vaccines she took. She also mentioned she was allergic to high doses.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201304036 Same reporter/patient/vaccine/events, different dose;
Patient described herself of having severe flu-like symptoms for 24-48 hours immunization...recovered okay.
I began experiencing numbness on the side of my left hand as well as a little blood flow last week. One week before that I begin experiencing numbness in my left shin muscle. I have also experienced dizziness for the last week.
FATIGUE EXTREME; This spontaneous report received from a patient concerned a 6 decade old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis, and other pre-existing medical conditions included: The patient has no reported medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 15-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled syringe, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. Age at time of vaccination 56 years old. No concomitant medications were reported. On an unspecified date, the patient experienced fatigue extreme. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of adalimumab was not changed. The patient had not recovered from fatigue extreme. This report was non-serious.
No adverse event; Patient given expired dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient given expired dose) and NO ADVERSE EVENT (No adverse event) in a 30-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Mar-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 09-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient given expired dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient given expired dose) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient given expired dose).    Concomitant medication was not reported. Patient given expired dose, contacted Moderna, lot analysis determined vaccine maintained the activity necessary to protect. It was unknown if the patient experienced any additional symptoms/events. Treatment medication was not reported.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies, drug reactions and allergies were not provided. On 30-JAN-2019, the patient was vaccinated with improperly stored LIQUID PEDVAXHIB intramuscularly, lot # R021076, expiry date: 11-JUN-2021 (dose and anatomical location were not provided) for prophylaxis. The vaccine was stored in temperature above 47 degrees Fahrenheit (47.3) for 18 minutes. On unknown date in the past, there was one more temperature excursion, the vaccine was stored in temperature above 47 degrees Fahrenheit for 4 minutes. Digital data logger was involved in this case. No adverse effects were reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1902USA001383.
Area of shot site red, swollen, & warm to touch.  Pain in armpit when lifting arm.  Onset @6:00pm, worst @8:00pm.  Swelling, redness, & pain decreased by 8:00 am on 02/11/2013.
Information has been received from a nurse concerning a 31 year old female who on 22-APR-2008 was vaccinated with zoster vaccine live (Oka/Merck) (Lot # 658325/1429U) rather than varicella virus vaccine live (Oka/Merck). The nurse researched zoster vaccine live (Oka/Merck) and varicella virus vaccine live (Oka/Merck) and was not clear about the differences, and thought that they could be used interchangeably. No other problems were reported. No other information was available at the time of this report. Additional information has been requested.
expired fluzone high dose was administered to a patient with no reported adverse event; Initial information was received on 27-Oct-2021 regarding an unsolicited valid non-serious case received from other health care professional, non-healthcare professional and physician via GMI (Global Medical Information- 00830761).  This case involves a 83-years old male patient who was vaccinated with expired dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (Expired product administered).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  No other concomitant vaccines were not provided.   On 26-Oct-2021, the patient received 0.7ml {total} dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number UJ482AA and expiry date 31-Jun-2021 was reported) via intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (latency was on same day).  At the time of report, no adverse event reported.  Event outcome was 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 by the regulatory authority. 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.
Intussusception surgery and appendectomy 2/22/08.  Doctor thought 1st diagnosis related to Appendicitis.  4/8/08 Reviewed hospital medical records of 2/22-2/25/2008. FINAL DX: Ileocolic intussusception, exp lap w/reduction of IS & appendectomy. Records reveal patient experienced screaming, pain, bloody/mucousy stools, emesis.  Seen at outlying ER where BE c/w IS to transverse colon, not able to reduce.  Transferred to higher level of care for peds surgery.  Progressed well s/p surgery & d/c to home.
12 hours after vaccination, had fever, chills, headache, muscle aches. 24 hours after vaccination, still had headache and muscle aches. Experienced nausea and vomiting 24 hours after vaccination. Missed work as a result of these side effects.
LOCAL REACTION LEFT ARM, CELLULITIS - POSSIBLE ABSCESS STAT FOLLOW UP RX KEFLEX (500 MG) X 10 DAYS
On 8/21/09 Mother reported child had extreme dizziness- Felt dizzy a short time after vaccine and during day and night had difficulty standing due to dizziness- Did not seek medical care- vaccine date was 4/14/08- No previous report.
hives were localized to the right arm; Initial information was received on 15-Jan-2020 regarding an unsolicited valid non-serious case from a consumer or non-healthcare professional (pharmacy intern).  This case involves a 36 year old male patient who experienced hives were localized to the right arm (vaccination site urticaria), while he received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE POLYSACCH 23V (PNEUMOVAX 23) in left arm for immunisation; nicotine (Nicoderm); Thiamine; calcium pantothenate, folic acid, vitamins (Multi-Vitamins Vitafit); trazodone hydrochloride (Desyrel); buprenorphine hydrochloride, naloxone hydrochloride (Suboxone) 2 mg; and Prednisone.  On 19-Nov-2019, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT66861A, expiry date - 20-Jun-2030, formulation - prefilled syringe) via intramuscular route in the right arm.  On an unknown date, the patient developed non-serious hives were localized to the right arm (vaccination site urticaria) (unknown latency), following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Laboratory data was not provided.  Final diagnosis was vaccination site urticaria.   The patient was treated with diphenhydramine.  The outcome of the event was unknown.
Patient was administered with a second dose of Bivalent vaccine. Patient did not present at the time of administration and has not reported to the pharmacy adverse or secondary event.
Pt recvd 3 doses of Hep B vax & following vax; lab eval revealed that SGPT level was 400;
Swelling, pain in arm. Throat pain, swelling feeling. That evening, symptoms started getting worse 3 hours after injection. Continued with flu like symptoms for days & was told it was normal reaction.
Large red hot patch at injection site 30 hours after injection . Irregular edges. Heart palpitations started 3 days later, shortness of breath, exhaustion from normal activities, fatigue.
Five hrs after receiving flu vaccine I began to tremor extensively (entire body) and could not control my hands to use telephone. Tremors lasted approx two hours, then subsided. the identical adverse event occurred with last years vaccine.
Patient turned ghost white, spiked a fever and his blood pressure went sky high, something like 186 over 116. He was completely calm and unafraid of the shot so I don?t think it was a visceral reaction that is common. The high blood pressure was most concerning.  An ambulance was called but they didn?t retake his blood pressure and just sent us on our way once he said he felt better.
Headache - (18-22 hrs). Nausea - beginning a.m. 1/1/14 until noon. Chills, tiredness - all day 1/1/14.
Fever 103 1/12/07, Rash 1/13/07.
his wife experienced a minor one day reaction after a Moderna COVID-19 vaccine but he did not remember which one it was; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (his wife experienced a minor one day reaction after a Moderna COVID-19 vaccine but he did not remember which one it was) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A, 021B21A, 27C21A and 002M21A) for COVID-19 vaccination.     Concurrent medical conditions included High cholesterol, Seizures and Epileptic seizure. Concomitant products included PRAVASTATIN, SERTRALINE and LEVETIRACETAM for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (his wife experienced a minor one day reaction after a Moderna COVID-19 vaccine but he did not remember which one it was). At the time of the report, IMMUNISATION REACTION (his wife experienced a minor one day reaction after a Moderna COVID-19 vaccine but he did not remember which one it was) had resolved.            On 14Nov2022 a HCP from their vaccination site called and told him he and his wife needed to be revaccinated with half of a dose since they only received half of a dose on 12Sep2022. No Allergies were reported by reporter. Patient had never done COVID positive test or diagnosis. No Treatment information was provided by reporter.   This case was linked to MOD-2022-672845 (Patient Link).
Fever and coughing and irritable. 3/14/02 ear and eye infection green mucous in eye. 4/8/02 ear and eye infection.
Pain in the arm/sore arm; The pain was in the Injection site in Left arm.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 72 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Aug2021 11:30 (Batch/Lot number: unknown) at the age of 72 years 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: PAIN IN EXTREMITY (non-serious) with onset 05Aug2021, outcome "recovered" (05Aug2021), described as "Pain in the arm/sore arm"; VACCINATION SITE PAIN (non-serious) with onset 05Aug2021, outcome "recovered" (05Aug2021), described as "The pain was in the Injection site in Left arm.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Vaccination failure; COVID-19; This is a spontaneous report from a non-contactable other hcp. A 47-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN5318, Expiration date: not reported) via an unspecified route of administration at workplace clinic on 17Feb2021(at the age of 47-years-old) as dose 2, single and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN5318, Expiration date: not reported) via an unspecified route of administration on 26Jan2021 as dose 1, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 08Oct2021, patient experienced vaccination failure and covid-19 which were medically significant. On 08Oct2021, patient underwent lab tests and procedures which included SARS-CoV-2 test: positive. Prior to the vaccination, unknown if the patient was diagnosed with COVID-19. Post the vaccination, the patient had been tested for COVID-19. The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a health professional refers to a 18 month old patient. On 17-JUN-2014 the patient was vaccinated with a dose of VARIVAX (Merck) (lot # J009728, expiration date: 07-AUG-2015) (dose and route not reported) which was stored improperly. There was no adverse effect reported. This is one of several reports received from the same source. Additional information is not expected.
Pt received PREVNAR 13 on 10/17!6 came into pharmacy with red arm on 10/23/16. Told pt it may be allergic rxn and referred her to PCP.
Patient states that on 9/6/10 approx. 72 hrs after vaccine given, the vaccine site started to become red and swollen.  Over the course of a few days the area became red, warm, and swollen.  She states the area of induration is about the size of an egg.  Also stated that she does not feel "well".  Does not think she is running a fever, but feels tired and not herself.  Works in a physician's office and they looked at her vaccine site and felt it was a normal reaction.
The patient was given combo Pediavax with Hep B and also an individual Hep B vaccine. There were no adverse events. The patient was observed closely and notified immediately at time of event. We have separated vaccine fridge and implemented second check to avoid this error in the future.
1:30 PM Patient was given Tdap in left deltoid via IM. Pt attentive and proceeded to walk out of clinic room and into waiting area with Mother.  1:45 PM While standing at the front desk in the waiting room, patient's color appeared pale and stated he felt dizzy. Pt was guided to chair and sat down. Pt's feet were propped up on second chair. Pt was given water to drink and a snack to eat. 02:00 PM Pt stated feeling better and guided back to clinic room to lay down. 2:40 PM Pt assisted into sitting position  with no complaints. Pt then assisted to standing position and states feeling "better".
Awoke 2/14/22 with vertigo that mostly resolved within 48 hours.  2/16/22 awoke with tinnitus. 2/17/22 awoke with right sided eye brow paralysis and lid drooping. Seen by ENT and sent for MRI. 3/08/2022 experienced nystagmus bilaterally with 3-4 recurrent episodes. Seen by neuro and multiple follow-ups with ENT. Diagnosed with  involvement of Cranial nerves 6 and 7. Suspected reactivation of existing virus.  Has been nearly one year and the tinnitus persists. Balance issues mostly resolved. Rare instances of nystagmus with repetitive change of positions (bending and raising back  up.)
37-year-old foreign-speaking patient walked into the vaccination site accompanied by wife at about 11:45am. They requested the Janssen Covid-19 vaccines for the both of them. Patient signed all necessary consent forms and pre-vaccination checklist requirements, and entered the vaccination section at around 11:50am. The Janssen vaccine was administered at 11:57am. At 12pm patient started to experience light-headedness, dizziness, and change of LOC. At 12:01pm charge nurse  called 911. Patient?s wife and observation nurse asked patient how he was feeling but patient was unresponsive and disoriented for about 30-60 seconds. Soon after patient was able to speak and started complaining of being nauseous and observation nurse handed patient a garbage bag to throw up. Charge nurse hooked up patient with pulse oximetry at 12:02pm with a reading of 98. Nurse assessed if patient is experiencing any symptoms of hives or redness, shortness of breath or any difficulty breathing or swallowing, and patient denied any symptoms. Administering RN hooked up patient with the blood pressure machine and BP reading was 167/156 with a pulse of 56. At 12:03pm BP reading was 139/75 with a pulse of 62 and pulse ox reading of 95. At 12:06pm BP reading was 153/115 with a pulse of 67 and pulse ox of 95. Patient also stated that his left arm started to get numb and tingly feeling. At 12:07pm first responder 911 came and took over. Patient was hooked up to EKG and found some arrhythmia and was advised to go to the hospital to further evaluate. Patient agreed and was taken to the nearest hospital at about 12:20pm. Action taken: Charge nurse called 911 for help and hooked up patient with pulse oximetry and assessed patient for any sign and symptoms of any allergic reactions to Janssen Covid-19 vaccine. Administering RN and observation nurse continuously monitored patient?s B/P, Pulse, Pulse oximetry, and LOC until first responder paramedics came.
Client vaccinated with Moderna vaccines x 2 in Jan and Feb 2021.  Boosted in November 2021 with Moderna.  Symptoms started on 12/27/2021 - runny nose, cough, fatigue, headache, myalgia, sore throat.