chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 6-26-08, pt presented for immunizations as follows: GARDASIL #1, Tdap #1, MENACTRA #1, and Hepatitis A #1. She was seen in the ER on 6-30-08 after experiencing chest pains, shakiness and tremors. At the time her symptoms began, she was lying on a couch, watching TV. Earlier that day, she had been working in the hot sun and symptoms were attributed to dehydration and anxiety accompanied by hyperventilation. The tremors continued in her legs and to a lesser extent in her arms intermittently for several days. She was seen at clinic on 7-01-08 due to the continued tremors. Doctor agreed with the Emergency Room physician's assessment, that the symptoms were due to dehydration, anxiety and hyperventilation. Pt returned for her second GARDASIL on 9-03-08. That evening, she experienced tremors in her legs and to a lesser extent in her arms throughout the following day. These symptoms were not reported at that time since they had not lasted as long and since the family had not connected the two episodes with the GARDASIL vaccine. When the family called to schedule her third GARDASIL vaccine, it was brought to our attention that she had a similar experience following the first two vaccines. With this information being brought to light, the third GARDASIL will not be given.  12/17/2008 ER record received for 7/1/08 with Impression Esophagitis, Tremors. Pt presented with c/o leg shaking and burning in chest. PE WNL. D/C to f/u with PCP.
NEUROSIS; This spontaneous report received from a consumer concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch numbers were not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced neurosis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of neurosis was not reported. This report was non-serious.
Fever; coldorflu; Cold or Flu; chill; dizziness; not feeling the best/not feeling well; headache; Nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the parent. Other Case identifier(s): PFIZER INC-2021405777 .  A 16 year-old male patient received bnt162b2 (BNT162B2), administration date 24Mar2021 (Batch/Lot number: unknown) as dose1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Fever"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "cold or flu"; INFLUENZA (non-serious), outcome "unknown", described as "Cold or Flu"; CHILLS (non-serious), outcome "unknown", described as "chill"; DIZZINESS (non-serious), outcome "unknown", described as "dizziness"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "not feeling the best/not feeling well"; HEADACHE (non-serious), outcome "unknown", described as "headache"; NAUSEA (non-serious), outcome "unknown", described as "Nausea".  Additional information: reporter stated her son (patient) was due for the second dose tomorrow (as reported). he has been experiencing chill, dizziness, nausea , fever, headache, and not feeling well. reporter thinks that he may have some cold or flu and its nothing to do with the vaccine. Reporter  wanted to know is it ok take the second dose. Reporter wanted to know about the timing for the second dose. Response: Spoke from the attached document. Reporter  was wondering if he can still receive the 2nd vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
76 yo female with onset pain left back and arm 4 days ago followed by redness and blisters.  Pain is 8/10 constant with new blisters arising.  No systemic symptoms, no HX of Immunosuppression.  Had Zoster vaccine 4/10/2007.  No relief with Tylenol.  Exam: Skin with grouped vesicles on erythematous base in linear distribution over left upper back, medial upper arm and left upper chest; right upper back with unassociated linear crusts attributed to scratch trauma by patient.  Face and hands clear.  Herpes Zoster (Shingles).
I lost my sense of smell three days after I had gotten my first shot, it has not returned.; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the right arm on 12Apr2021 at 18:15 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. The patient had no other medical history. The patient had no known allergies to medications, food, or other products. Concomitant medications were not taken within two weeks of vaccination. The patient had received other vaccines within four weeks prior to the vaccination which included measles vaccine, mumps vaccine, rubella vaccine (MMR) on 29Mar2021 in the left arm for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient lost his sense of smell on 15Apr2021 at 12:00, three days after he had gotten his first shot, it had not returned. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. On 19Apr2021, the patient underwent LUMIRADX SARS-COV-2 AG test for COVID- 19 via nasal swab and the result was negative. The clinical outcome of the event lost sense of smell three days after the patient had gotten his first shot, it had not returned was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
had the shingles vaccine, then ended up with shingles in her eye\ Suspected vaccination failure; shingles in her eye; This case was reported by a consumer  and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and ophthalmic herpes zoster (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and ophthalmic herpes zoster were unknown.   It was unknown if the reporter considered the vaccination failure and ophthalmic herpes zoster to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received shingles vaccine, then ended up with shingles in eye. This case was considered as suspected vaccination failure since details regarding completion of primary vaccination schedule, time to onset and laboratoy test confirming shingles were not provided.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. Between 03-SEP-2017 and 11-SEP-2017, the patient was vaccinated with an improperly stored dose of VAQTA (lot # N005796, expiration date 26-MAY-2018) (dose and route were not reported) for prophylaxis. The vaccine was exposed to 8.5 Celsius degrees (°C) for 1 hour. There was no previous temperature excursion and also there was no "data logger". No adverse effects were reported. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA009437: US-009507513-1709USA009443: US-009507513-1709USA009439: US-009507513-1709USA009440: US-009507513-1709USA009441: US-009507513-1709USA005606: US-009507513-1709USA009436: US-009507513-1709USA009435: US-009507513-1709USA009438.
Arthritis throughout body in joints. A large red spot at injection site, growing larger, that itches, intermittently. Arm is sensitive to touch, starting 2 days, post vax.
Patient requested COVID 19 Moderna Updated Booster 12+ and by error the pharmacist administered the COVID 19 Moderna Pediatric Age 6-11
Gave Moderna vaccine in error instead of PFizer since pt's first 2 vaccines were Pfizer. NO SIDE EFFECTS
Pt had signs of alternating lethargy, fussiness and a bloody stool. Diagnosed with intussusception by BE which failed to reduce it. Went to surgery and his appendix was lead point. Doubt due to Rotateq 2 mos after dose and appendix lead point. 05/15/07-records received for DOS 2/26-3/2/07. DC DX: Intussusception.Several hour history of sleeping a lot waking up crying not eating well. Vomited once. No diarrhea. Rectal exam revealed hempositive secretions. Barium enema revealed intussusception. Unsuccessful in reduction. Surgical reduction revealed appendix in the middle of the intussusception.
My first Covid shot on 16 Feb 21 (previously submitted to VAERS) developed a rash on my left arm.  It showed up 9 days after the first vaccination. It itched and was about 2.5" by 2.5" inches and 2.5" below the injection site. It  lingered for about 3 days and I had no other reactions.   My second Covid shot ( 11:30 hours on 16 Mar 21) developed a rash less than 24 hours later. The rash was present on my arm at 0530 hrs on 17 Mar 21.  It didn't itch as much but was much larger than the first rash.  It is about 3 inches by 3 inches and is in the same spot (about 2 to 3 inches below the injection site). In addition, after the second shot I had a headache and general malaise and fatigue the next day, but that wore off late on the 17th.
Chills; Fever; Body ache; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 as dose number unknown (booster), 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 (Primary Immunization series completed, unknown manufacturer), for Covid-19 Immunization. The following information was reported: PAIN (non-serious) with onset 2022, outcome "unknown", described as "Body ache"; CHILLS (non-serious) with onset 2022, outcome "unknown"; PYREXIA (non-serious) with onset 2022, outcome "unknown", described as "Fever"; HEADACHE (non-serious) with onset 2022, outcome "unknown".  Additional information: patient wanted to report the following side effects that experienced after receiving the Pfizer Omicron booster shot for COVID 19: Chills, Fever, Body ache, Headache.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Narrative:  PATIENT WAS VACCINATED IN TIMELY MANNER 3-12-21 AND 4-2-21 AND TESTED POSITIVE FOR COVID 9-28-21. PATIENT WAS ADMITTED 10-4-21 AFTER ED VISIT PRESENTING WITH FEVER, CHILLS, FATIGUE, PRODUCTIVE COUGH, DIARRHEA, LOSS OF APPETITE. PATIENT WAS MILDLY HYPOXIC--WAS ON 2 L O2 AND DEXAMETHASONE.
10SEP93 225PM administered MMR 230PM diaphoretic, syncope, hypotension; BP 70/0, BP 80/0, Pulse thready @ 60 min - pale; not responding too well;
Received vaccination 0830 and within 10 hrs  patient experienced irritation in and around the right eye. Swelling, tender to touch, discoloration (red/black), and blurry vision. Other symptoms included fatigue, headache, body aches, and feverish. Patient has experienced swelling of the eye for 5 consecutive days. No discharge of fluid from the eye or crustiness ruled out pink eye from the clinic. Was advised to take a wait and see approach, schedule a follow up within 72 hrs from day 5 of symptoms.
patient received what we thought was covid bivalent vaccine, but it was determined that it was the standard dose that patient received.  patient has been notified after risk management, clinic manager and rn's determined there was no hard in patient receiving another standard dose.
Vaccine administered after temperature excursion/frozen vaccine 47 minutes -13.79 C/refrigerator 59 minutes 12 C; Vaccine administered after temperature excursion/frozen vaccine 47 minutes -13.79 C/refrigerator 59 minutes 12 C; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/frozen vaccine 47 minutes -13.79 C/refrigerator 59 minutes 12 C) and EXPIRED PRODUCT ADMINISTERED (Vaccine administered after temperature excursion/frozen vaccine 47 minutes -13.79 C/refrigerator 59 minutes 12 C) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/frozen vaccine 47 minutes -13.79 C/refrigerator 59 minutes 12 C) and EXPIRED PRODUCT ADMINISTERED (Vaccine administered after temperature excursion/frozen vaccine 47 minutes -13.79 C/refrigerator 59 minutes 12 C). On 02-Apr-2021, PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/frozen vaccine 47 minutes -13.79 C/refrigerator 59 minutes 12 C) and EXPIRED PRODUCT ADMINISTERED (Vaccine administered after temperature excursion/frozen vaccine 47 minutes -13.79 C/refrigerator 59 minutes 12 C) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment information was provided.  This report refers to a case of Product storage error and expired product administered for mRNA-1273, lot # 003B21A, with no associated AEs.   This case was linked to MOD21-068620 (E2B Linked Report).; Sender's Comments: This report refers to a case of Product storage error and expired product administered for mRNA-1273, lot # 003B21A, with no associated AEs. MOD21-068620:crosslinked
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX vaccine on or about 23-APR-2013 as recommended for routine adult health maintenance and for the prevention of shingles (lot number, dosage, and route of administration not provided). The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent and chronic strain of herpes zoster. On or about 22-MAR-2016, the patient was treated by a physician assistant for a blistering vesicular outbreak which was diagnosed as severe herpes zoster, or shingles. The patient has been prescribed VALTREX to attempt to manage and relieve her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Very sore arm. Swelling, redness - increasing in size overnight. Headache. Slightly feverish. Ibuprofen.  Ice.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On an unknown date in 2013, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. Later on an unknown date in 2013, the patient was treated for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient had suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
pt recv vax; fever of 101 p/ DTP; slept  for 9 1/2 hr; would not eat; pt cried all day;  1 lb weight loss over 2 days;
Left sided facial numbness, right sided facial weakness, lip numbness and loss of taste x 1/5 months.  Treated with oral prednisone.
20 minutes after recieving vacinnes, patient fell onto padded matting with tachypneic respirations in apparent respiratory distress with hives only on forehead, awake and responsive with generalized twiching of upper extremities, C/O chest pain.  50mg Benadryl IM and 0.3mg Epinephrine IM given, place on O2 10L NRB.  Lungs with diffuse wheezes but moving air with patent airway.  Code Blue called, placed on monitor-NSR with sinus tach. Vitals 135/97, P-100, R-75, SAO2 99% NRB, with strong pulses. IV started.  Patient given 5 mg valium IVP and 5mg albuterol via HHN.  Taken to hospital ER via ACLS.  Admitted overnight for observation.  Discharged 1200 the following day.
PAIN THE 1ST AND SECOND DAY, RED BAND AROUND LEFT ARM WITH SOME SWELLING THIS MORNING 09/29/2016.
I am in my 4th week of reaction. Full body muscular aches, exhaustion, diarrhea, brain fog. Blood test showed elevated liver function.
Patient lived in a nursing home. The following was reported to our on-call MD.  Nurse from home called to report Pt is lethargic.  BP this morning 139/57, HR60.  BP now 86/42.  O2 sats RA 85-86%; O2 @ 1.5L applied and sats went up to 95%, temp 99.4.  Pt had covid booster on 10/12/2021.     At around 1:40pm, nurse found him very lethargy, can't lift his arms but responding and able to talk. He was hypotensive and hypoxia with low grade fever. He is DNR/DNI/DNH. Ambulance was called, while trying to get hold of HCP. At ~2:25pm, Patient passed away.
Throughout the day on Sunday, November 4th, I experienced the following: 1. chills 2. entire body, joint and neck soreness including stomach soreness (not stomache) but soreness that one would feel as if they had vomitted many times. 3. headache 4.  muscle pain 5. extreme lethargy and tiredness
ARM BEGAN TO ACHE, THOUGHT IT WAS JUST A SIDE AFFECT FROM JUST RECENTLY HAVING THE INJECTION AS THIS USUALLY OCCURS EVERY YEAR THAT I RECEIVE FLU INJECTION. THIS TIME THE PAIN HAS NOT SUBSIDED.
Day after flu vaccine administration in (L) deltoid, pt developed pain in (L) shoulder joint & decreased ROM, consistent with bursitis. Sx persisted for 2 wks before she came in for evaluation. Ortho MD eval already scheduled day after our ofc eval.
5/9/23 I had an ordinary cold, stuffy sinuses and cough. I had an intense sore throat that lingered longer than normal.  I had a productive cough that lasted for 3-4 weeks which is not common for me. I had an appointment with my doctor and was prescribed an antibiotic and steroids. This went away after I completed the two medications and now all is good.
Swelling, rash, next day sl. better day next day was referred to covering MD. Was seen, 5-1-15 by dr. Treated with AUGMENTIN 875-125 mg 2 times daily/or 10.
Graves' Disease; bulging eyes; polygenetic granuloma in her nose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 44-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, 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: BASEDOW'S DISEASE (medically significant), outcome "unknown", described as "Graves' Disease"; EXOPHTHALMOS (medically significant), outcome "unknown", described as "bulging eyes"; GRANULOMA (non-serious), outcome "unknown", described as "polygenetic granuloma in her nose".  Clinical course: It was reported that reporter's friend was forced to get the shot as a healthcare worker, and previously has never had a problem in her life. Last week, this friend was diagnosed with Graves' disease, Thyroid eye disease (TED), and polygenetic granuloma in her nose. Reporter states that the internet, the doctors, and the pharmacists all say it was definitely the Covid (vaccine). Million people got graves' disease from the shot; a million people have their thyroids messed up. Caller is seeking information as to these side effects. Reporter said that she was trying get some information on side effects. It seems like her friend has every side effect she can have from the vaccine. The caller reported that her friend got Grave's disease and bulging eyes from it, she got a polygenetic granuloma in their nose, and they were told that it came from the shot. Reporter wants to know is it is related to the shot. Her friend's body doesn't like the shot and she was forced to get it because her friend is in the medical field.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (23May2022): Follow-up attempts completed. No further information expected.
Vaccination after a temperature excursion; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 6-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number 2KB4B, expiry date 8th May 2022) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th February 2022, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter stated that the patient received a pediarix vaccine after a temperature excursion in the right thigh, which led to incorrect storage of drug. The reporter consented to follow up. This is 1 of the 6 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022039273:same reporter US-GLAXOSMITHKLINE-US2022039274:Same reporter US-GLAXOSMITHKLINE-US2022039271:same reporter US-GLAXOSMITHKLINE-US2022039278:Same reporter. US-GLAXOSMITHKLINE-US2022039275:same reporter
Woozy, double-vision, hot, tipsy. Vital signs 162/104, pulse 79,(8:15am), bp 163/104, p 85 (8:20am), bp 135/91, pulse 77 at 08:48. Pt still feels slight wooziness.
Pain at the injection site, headache, fever, fatigue, chills, nausea, weakness.