chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administered past published expiration date. Contacted Moderna, received this communication: ?The vaccine administered on November 10, 2021 and November 15, 2021 from lot number 046C21A maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration,? therefore there is no need for revaccination.
This spontaneous report was received from a physician refers to a 1 year old male patient (presently 9 years of age). Patient has no drug reactions or allergies. On an unknown date approximately 8 years ago in October 2005, the patient was vaccinated with a dose of M-M-R II (lot #, expiry not reported). On an unknown date, the patient developed anaphylaxis, urticaria and chest congestion. The patient was found to be negative for mumps antibodies when a titer was performed on an unspecified date. The outcome of negative for mumps antibodies when a titer was performed was unknown. The patient recovered from anaphylaxis, urticaria and chest congestion on an unknown date. The reporter considered the events anaphylaxis, urticaria, chest congestion and negative for mumps antibodies when a titer was performed as life threatening. Additional information has been requested.
pt had red bumps all over body;low grade fever;mom told to try DPH for allerg rxn-if gets any worse to call MD;
Anterior L thigh with two areas of erythema. More proximal had two small papules within it, no pustules. Both had firm nodules underlying them. No warmth or discharge.
Per mother, slight rash and swelling began a few hours after vaccination. Next day, left upper arm was swollen, red, and itchy. Patient was taken to ER and diagnosed with allergic reaction to  vaccination. Instructed to follow up with PCP. Pt seen in office 8/3/18 and confirmed diagnosis of allergic reaction by MD. Prescribed following medications: triamcinolone acetonide 0.1 % topical cream Benadryl Allergy 12.5 mg/5 mL oral liquid prednisolone 15 mg/5 mL oral solution.
Information has been received from a physician concerning a 24 year old female on birth control who on 25-JUN-2009 was vaccinated with first 0.5mL dose of GARDASIL (route and lot number not reported).  Concomitant therapy included NUVARING. On 28-JUN-2009, the patient experienced tiredness and fatigue. On 29-JUN-2009, the patient called the physician's office and reported that she was exhausted and was still experiencing tiredness. No lab studies were performed. The patient sought unspecified medical attention. Additional information has been requested.
Increased blood pressure; Rapid heart rate; Chills( shaking); Chills( shaking); Chest and neck tightness; Chest and neck tightness; Teeth tingling; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient (not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek5730), via an unspecified route of administration on 19Dec2020 12:30 at single dose on left arm for COVID-19 immunization. Medical history included known allergies: Latex. Concomitant medications received within received within 2 weeks of vaccination included acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN [ACETYLSALICYLIC ACID; CAFFEINE; PARACETAMOL]); ibuprofen. The most recent COVID-19 vaccine was administered at Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19Dec2020 13:00 (01:00 PM), the patient experienced rapid heart rate, Increased blood pressure, Chills (shaking), Chest and neck tightness, Teeth tingling. The adverse events result in Emergency room/department or urgent care. The patient received ER monitoring, EKG (reported as "AE treatment") for the adverse events. The events were non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was recovering.
Pt presented to the ED in acute anaphylaxis 20 minutes after receiving vaccine dose, in respiratory distress with stridor, wheezing, and difficulty breathing, as well as hives across her chest and arms. Pt had Epipen with her and ED staff assisted her in administering it. Pt received solu-medrol, pepcid, benadryl, and albuterol in the ED. Pt significantly improved within 1 hour and was admitted to the hospital to be monitored overnight.
Status epileptic/focal seizures on 03/15/04. The hospital record and medical record received on 4/2/04 states encephalitis.  Discharge summary on 05/07/04 states viral encephalitis. Follow up with mom 3/30/04: Eating well, positive walking, no further seizures. Unable to reach patient or family. 05/27/2005:  One month after reaction reported child removed from home and placed in custody of court system, unable to locate, recovery status unknown.
I had no symptoms until a week before my second shot. I woke up with Tinnitus in my left ear. That has continued to this day. I was going to report this to your site before when it happened, but I spoke to my family doctor who sent me t an ENT, both didn't feel the onset of Tinnitus didn't have anything to do with the vaccine. My hearing test was normal, with no hearing loss.
p/recvd vax c/o warm feeling on the rt side of head & neck; also c/o sl dizzy feeling about 2 hrs later got a h/a in the back of head & rt side, that lasted until mid AM; woke up several times through the noc w/same h/a;
pt arrived at hospital and was admitted for COVID pneumonia and respiratory failure; started on antibiotics, Decadron, Remdesivir; O2 supplementation with Vapotherm; eventually requiring BiPAP; pt's respiratory condition worsened requiring intubation with mechanical ventilation; developed severe hypoxia with inability to ventilate; no evidence of pneumothoraces; suffered cardiac arrest; CPR started but family opted to stop CPR; pt died in the hospital
had poor appetite; 4 month old patient received Kinrix; received Kinrix instead of dose 2 of Pentacel; This case was reported by a nurse via call center representative and described the occurrence of appetite impaired in a 4-month-old female patient who received DTPa-IPV (Kinrix) (batch number PP9L5, expiry date 16th October 2021) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, less than 5 months after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced appetite impaired, inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the appetite impaired was recovered/resolved and the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   It was unknown if the reporter considered the appetite impaired to be related to Kinrix and Kinrix Pre-Filled Syringe Device.   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: Nurse practitioner reported a 4 month old patient received Kinrix instead of dose 2 of Pentacel and the patient had poor appetite for a couple days but it had resolved, which led to inappropriate age at vaccine administration and wrong vaccine administered. The reporter consented to follow up.
1327: received injection - patient said it hurt much more than 1st injection 1337: Felt dizzy, HR 79, 125/78, O2 Sat 100%, placed supine position 1343: Felt shakey like low BG - got cookies, water, 80 HR, 128/88, 100% O2 1348: Felt like she wanted to sit up. 66 HR, 107/72, 100%, wave of dizziness and nausea 1349: HR 82, 123/86, 100% applied O2 8L Mask 1353: 92 HR 128/84, 100%, nauseated - coolw ash clothes applied - needed to transfer to a better chair that would lay back 1400: HR 72, 120/80, 100%, 36.7 - Felt warm but cool, wanted warm blankets - said she feels like she is sinking into the chair. HR 73, 118/78, 100% feeling better.  1409: 70 HR, 115/76, 100%, orthostatics taken.  1411: 69 HR 118/77, 100%, sat up 1414: 79 HR 123/87 99% took O2 off - felt ok. 1419 67 HR 121/83 100% standing felt okay, not dizzy.
pt recvd vax & had anaphylaxis rxn; urticaria; angioedema; laryngeal edema; to hosp, tx iv atb;
This spontaneous report as received from a pharmacist refers to a multiple unspecified patient of unknown age with prophylaxis. On an unknown date, the patients were vaccinated with an improperly stored dose of ZOSTAVAX for prophylaxis. The ZOSTAVAX was reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT). No adverse effects were reported with any patients. The digital data logger was involved in recording the excursion. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1707USA007049:
The patient was seen in the cardiology clinic on 5/4/22 and referred to follow up in the ED for further workup of dyspnea and orthopnea.  He was evaluated by cardiology upon admission and was thought to be having a heart failure exacerbation, managed with diuretics while admitted.
tested positive for Covid; Started having flu symptoms; 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 female patient received bnt162b2 (BNT162B2), administration date 23Apr2021 (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: INFLUENZA (non-serious) with onset 2021, outcome "unknown", described as "Started having flu symptoms"; COVID-19 (non-serious) with onset 01May2021, outcome "unknown", described as "tested positive for Covid". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that, patient received first dose of the Pfizer BioNTech Covid 19 on 23Apr2021. That Wednesday she started having flu symptoms and tested positive for Covid on 1May2021. She was due for her second dose 14May2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Moderna vaccine (NDC 80777-0273-98) lot # 039D21A + GTiH 00380777273983 was administered after the beyond date of 10/23/2021.  Contacted manufacturer Moderna = no need to repeat the dose.
Slightly raised area on left deltoid. No increase in warmth. No drainage. 4 cm x 2 cm erythematic. Instructed to take diphenhydramine orally and hydrocortisone cream topically. Ice. Erythema multiform and urticaria pruritus.
Pimple like lesions began eve of 11/26/2001 and more noticed next morning. Seen in office 11/27/2001 and had 10-12 lesions that were papular with central puncta on face, trunk, back, LLE that were itchy and painful. Seen 2 days later with 20-30 lesions, a few crusted over. Diagnosed with Varicella. Family found exposure at day care. Recovered within 7 days.
Information has been received from a 41 year old male HIV and HPV positive (prior to vaccine) with an allergy/reaction to fluoroquinolone antibiotics who in "early 2008" was vaccinated with GARDASIL. Concomitant therapy included LIPITOR and allopurinol. The consumer reported that since "Spring 2009" he had 2 warts on his back and 13 warts on his chest after administration of GARDASIL. The patient stated that he never had warts in either area prior to receiving GARDASIL. At the time of the report the patient had not recovered. The consumer wanted to note that he was advised by his physician to receive the vaccine because he was a "gay man". The patient sought unspecified medical attention. On an unspecified date a skin biopsy with diagnosis of wart was performed. No further information is available.
No additional adverse events; administered doses of vaccines to 5 patients following temperature excursion; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding patient's medical history, concurrent conditions or concomitant therapies was provided.  On 20-JUN-2022, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 1 dose, lot #U007505, expiration date: 04-SEP-2022, albumin status verified to be rHA (strength and route of administration were not provided) for prophylaxis (Product storage error). No adverse events were reported (No adverse event).  This is one of several reports from the same reporter.
pt reported 14JAN c/o pain in back & neck;no rash but sore arm;pt recv vax 13JAN98;c/o chills no fever;sx lasting 2-3 days;As of 16JAN neck & back still sore, h/a also;went to hosp ER 14JAN98
Patient's sister reports patient started "seizing" in the car after they left pharmacy, so they came back. Approximately 30 minutes after patient received the vaccine, patient looked pale, but was alert and coherently speaking.
Received the vaccine January 27, 2021 with no adverse events. Ten days later I woke up with bright  red upper arm around injection site - about the size of an orange. There was no pain, it was a bit itchy.
Starting at 0300 5/16/21 Pt was awoken with pain in R arm, R arm pit, and along back.  Pain kept waking Pt up, she slept fitfully. Pt stayed in bed until around 1300 5/16/21.  She had a project for school due- had to video tape making a recipe.  She was standing up videotaping the ingredients when she felt very dizzy. Pt then reported that she lost her vision- everything turned black.  I had to rush to her to catch her- she had loss of consciousness for about a minute.  She was very pale- lips turned blue.  She had a pulse the whole time, BP was 117/60- when I checked it about 5 min later.  Her temperature on a ear thermometer was 99.7.   After she awoke,  she was still very dizzy and stayed in bed most of the day.  5/17/21 AM- she woke up for school 0600- and was feeling better.  No more dizziness, color was back in her cheeks, was able to eat and left for school.
15 seconds after administration I felt tingling in my mouth and felt warmth come over my body from my feet to my head. I then experienced a sudden increase in heart rate. I was tachycardia to the 140s and BP 140/90s (high for me). This lasted for about 1 hour then resolved. The same event occurred 3 additional times, resolving in between episodes with a heart rate in the low 100s.. I was taken to my workplace Emergency Department. The entire even lasted over 4 hours.
Patient Received her second dose Pfizer vaccine (LOT#: EW0185 EXP: 8/2021) at 1418 on 5/25/21. Patient alerted EMT at 1440. Patient stated that she felt slightly dizzy and sleepy. PHN asked patient to stay 30 minutes for further observation. Patient agreed. EMT took patients vital signs. BP: 130/70, pulse: 81, O2: 99%. Patient received two waters. EMT reassessed and retook patients vital signs. Patient stated that she no longer had any symptoms. BP: 120/75, pulse: 77, O2: 99%. Patient completed observation time. Patient was educated on worsening signs and symptoms of side effects from vaccine and when to call EMS or go to the ED/urgent care. Patient verbalized understanding of education. Patient left vaccination site unassisted with a steady gait at 1510.
Pt recv vax on 10/23/98; on same day pt exp angioedema of left eyelid.
got real bad chills; was shaking so bad I couldn't get warm not matter how many blankets; Headache; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient reported for herself). A 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: FD8448), first dose via intramuscular, administered in upper left arm on 14Aug2021 (at the age of 64-year-old) as dose 2, single for COVID-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing Verbatim: Asthma, neuropathy peripheral from an unknown date and unknown if ongoing Verbatim: Neuropathy, migraine from an unknown date and unknown if ongoing Verbatim: Migraine, hypersensitivity from an unknown date and unknown if ongoing, neuropathy peripheral from an unknown date and unknown if ongoing. No investigation assessment was reported. Concomitant medications included pregabalin (LYRICA) taken for neuropathy peripheral, start and stop date were not reported; atenolol (ATANOL) taken for an unspecified indication, start and stop date were not reported; cetirizine hydrochloride (ZYRTEC) taken for hypersensitivity, start and stop date were not reported. Historical vaccine given to patient previously was bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), first dose via intramuscular, administered in left arm on 24Jul2021 (at the age of 64-year-old) as dose 1, single for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date, the patient experienced got real bad chills, was shaking so bad I could not get warm not matter how many blankets, headache. Therapeutic measures were taken as a result of got real bad chills, was shaking so bad I could not get warm not matter how many blankets, headache. Consumer stated, "I got the second dose yesterday and around midnight I got real bad chills, I was shaking so bad I couldn't get warm not matter how many blankets, I am not running a fever and I actually couldn't even read the paper that I was given. I had to get my niece up to see what to do, and she said just try Tylenol (Treatment), that help but the chills are starting back now. And also, I have a headache, so I was wondering how long should this side effects last." Consumer stated, "No it just started last night I took Tylenol, that's it." Consumer stated, "From the Tylenol it improved, and it's started back so I took more Tylenol." The outcome of the events was reported as unknown.  Follow-up attempts are completed. No further information is expected.
Parent contacted Health Department on 09/13/07 and stated that child had red blotches on top of both thighs, starting 09/12. These never became bumpy, were more reddened after bath, and never became itchy. No new foods eaten, no new detergents, soaps or fabric softeners being used. No fever. She is quite certain that rash caused by shots given on 09/04. Spoke again on 09/14. Contacted medical provider on 9/13 but did not take her in. They recommended that she use Benedryl cream on the rash, which she did. Rash is now resolved.
This spontaneous report as received from a healthcare worker refers to unknown number of patients of unknown age. The unknown number of patients had received ZOSTAVAX (lot number not provided) and VARIVAX (Merck) (Lot number not provided) doses which were exposed to -6.8C for 1.5 hours every 24 hours due to defrost cycle every day. No adverse effect reported. It was unspecified if the patients had sought medical attention. The health care professional contacted during telephone follow-up did not remember which patient might have received these vaccines and could not supply the following information: patient name, date of birth, dates of vaccination, or lot number. She also stated that the vaccines have been moved to a proper storage unit. Follow-up information received from the healthcare worker. Patient information was updated. On 27-AUG-2013 the patient was vaccinated with a dose of improperly stored ZOSTAVAX (lot #, expiration date and route not reported). This report is one of the several reports received from the same source. Additional information has been requested.
Patient received second dose of Pfizer vaccine on 5/12/2021 at 09:49am.  Medication had a manufacturer's expiration date of 8/2021.  Dose expired on 5/12/2021 at expired at 09:30 am on 5/12/2021.  No adverse reactions.  MD made aware.
On August 26th at 0949 a RN went to obtain a Menveo vaccination. She noted one bottle of diluent without a powder to go with the diluent.  Staff interviewed involving the 5 previous patient administrations.  They all confirm they did not drop or break an orange vial of powder.  Unable to determine which patient received the incorrect diluent for the Menveo powder.  No adverse events.  All 5 patients are being contacted for re-vaccination of Menveo vaccine.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 05-DEC-2014, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 26-JAN-2015, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the 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 has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Resident complained to nurse that "I can't breathe" and that he was feeling discomfort when breathing. Upon assessment resident found to be shaking and sob. o2 stat 94 on RA, BP 156/82 P 102 T97.2. 2L oxygen and all due medications were administered.
Acute cholangitis following mRNA COVID-19 vaccine booster in a patient; This is a literature report for the following literature source(s).  A patient (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Alzheimer's disease" (ongoing). The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1 single, Unknown manufacturer), for Covid-19 Immunisation; Covid-19 vaccine (Dose 2 single, Unknown manufacturer), for Covid-19 Immunisation. The following information was reported: CHOLANGITIS ACUTE (medically significant), outcome "unknown", described as "Acute cholangitis following mRNA COVID-19 vaccine booster in a patient".; Sender's Comments: Based on the available information and the temporal association, a causal relationship between the reported event  acute cholangitis and BNT162B2 is considered possible. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Had vaccine 7/17/07. Rash appeared 7/24/07 with fever. Highest temp. 105.3 R. Not eating well, fussy. Treating with Ibuprofen and Benadryl. Plenty of fluids. Seen in office 7/26/07 for RXN.
I experienced hair loss following the Pfizer Covid series, including two shots and two boosters, which I had beginning in January 2021 and ending in early April 2022. The hair loss began in winter 2021-2022 and became serious following the 2nd booster. I am now mostly bald and diagnosed with alopecia areata.