chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 07Jul2022; Administered the vaccine to 346 patients after the 30 day by used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), NO ADVERSE EVENT (No adverse event) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 07Jul2022) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 07-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 07Jul2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), NO ADVERSE EVENT (No adverse event) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 07Jul2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 07Jul2022).    Concomitant medications were not reported.  Patient received half dose. They administered the vaccine to 346 patients after the 30 day by used and total Number of vials was 35. The vial did not undergo any temperature excursions. Treatment medications were not reported.
TEMP 102.5, REDNESS, SWELLING, WARMTH OF RIGHT UPPER ARM INJECTION SITE.
At 13:45, 15 minutes after vaccination developed tingling and numbness of sore with itching at ear itching.  No shortness of breath or wheeze.  Benadryl, Prednisone.  At 15:15, developed several papules of arms, otherwise no new symptoms.
approx 1day p/vax pt exp painful, erythematous butterfly rash, w/some vesicles, some itching of eyes. max temp 99f. also frequent sweating, achiness, awakenings during the nigh. MD dx w/atypical herpes zoster. treated w/acyclovir & benadryl
Adverse reaction next day after Moderna. I received 2nd dose 04/15/2021. On 04/16/2021 at night my Left eye started swelling, 04/17/2021 that morning my Left eye swelled shut, I sent a picture to my administrators cell phone of my left eye. on 04/19/2022 seen by my PCP.
large area of erythema & induration (w/little warmth) over entire deltoid area; pruritus, approx 12 hrs p/vax; resolved rapidly w/IM streoid & po DPH; was already on ATB @ time of incident;
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 14Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 53 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes T2" (unspecified if ongoing), notes: other medical history: Diabetes T2; "Hypothyroid" (unspecified if ongoing), notes: other medical history: Hypothyroid; "obesity" (unspecified if ongoing); "known allergies: Yes. Penicillin" (unspecified if ongoing), notes: known allergies: Yes. Penicillin. The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient experienced body shaking, sweating, and a fever-feeling 10-12 hours after getting the vaccine. She consulted her doctor and he advised that she still get the second dose and she pre-medicate with ibuprofen before she gets it.
This case was reported by a healthcare professional (medical assistant) via a sales representative and described the occurrence of injection site induration in a 15-month-old subject of unspecified gender who was vaccinated with INFANRIX (GlaxoSmithKline). In 2014 the subject received a dose of INFANRIX (unknown details). In 2014, within weeks of vaccination with INFANRIX, the subject experienced injection site induration (described as "knots at injection site") and injection site redness. The reporter noted that "the timeframe was is the past 2 weeks." The reporter stated that after the subject received INFANRIX, the subject "developed huge red knots at the injection site." No other events were reported. It was unknown if the immunization series was discontinued. At the time of reporting the outcome of the events were unknown. The healthcare professional considered the events were probably related to vaccination with INFANRIX. The medical assistant reported 4 other cases with INFANRIX. See A1060686A, A1060689A, A1060690A and A1060692A.
very tired; feel unstable; This non-serious case was reported by a consumer and described the occurrence of tiredness in a 78-year-old male patient who received Herpes zoster (Shingrix) (batch number 3A3TC) for prophylaxis.   Concurrent medical conditions included blood pressure high and type ii diabetes mellitus. Concomitant products included metformin and lisinopril.   On 26-MAY-2023, the patient received Shingrix. On 30-MAY-2023, 4 days after receiving Shingrix, the patient experienced tiredness (Verbatim: very tired) and unstable feeling (Verbatim: feel unstable). The outcome of the tiredness and unstable feeling were not reported.   It was unknown if the reporter considered the tiredness and unstable feeling to be related to Shingrix.     It was unknown if the company considered the tiredness and unstable feeling to be related to Shingrix.   Additional Information: GSK Receipt Date: 05-JUN-2023 The patient felt very tired and unstable, especially in morning and slept good at night, had to function. The reporter consented to follow up.
Received Td and Hep B vaccines (vaso vagal episode) and passed out onto the floor face down, vital signs q 5 mins, ice packs applied to left forehead (20mm raised area; palpable). EMS called for transport to local hospital for follow up of head injury.
painless swelling of submandibular glands onset 15AUG97 (3cm) non-tender;suspect mumps vax rxn;t97.2;
Headache, shivers, arm pain, malaise, slight troubled breathing within 24 hours which subsided
I received the first dose of Pfizer vaccination #1 on April 8 at 9:15am.  Almost immediately the hearing in my right ear started to shut down/muffle.  Today is April 22 and the problem persists.  After researching online I will not take the second dose, scheduled for April 29 at 12:30pm, for fear of worsened and/or permanent damage.
Fatigue, chills on 4/15 and 4/16 - treated with Tylenol. Swollen lymph node in left arm pit area beginning around 4/20. Unusually heavy menstrual period beginning 4/17 through 4/20 then tapering off.  Breakthrough menstrual bleeding on 4/28.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown dates the patient were vaccinated with a dose of GARDASIL (lot#, strength, dose, route and frequency were not reported). The doses of GARDASIL were exposed to temperatures below the recommended storage temperature. No adverse experience had been observed or reported. The outcome of event was not reported. This is one of two reports from the same reporter. Additional information has been requested.
Day of injection- sore arm at injection site Aug 30 - Sept 13 - feverish/ hot flashes Sept 20 to present - hives and dark splotches on upper right and left arm
Info has been received from a health care professional concerning a 13 year old female pt with a neurogenic bladder and no known drug allergies who was vaccinated with a 2nd dose of Hep-B. The pt developed a rash 3-4 days after administration of the vaccine. The rash was located on her hands, arms, legs and trunk. The rash was described as a monomorphus, 2-3mm, generalized papular eruption, non-blanching and pruritic. A skin biopsy was performed to rule out Giacotti-Crosi and vasculitis. No vasculitis was identified. The pt was treated with Triamcinolone cream and Camphor + Menthol + Phenol (Sarna) lotion. The pt's condition did improve and the physician thought it could be related to the vaccine. Additional info has been requested.
Pain in BOTH arms, elbows to fingertips, unrelenting. Worse when pressure applied (such as when resting arms on desk). Significantly impacting my ability to be on the computer (and I work on a computer.) Continuous.
I went home, and exactly 5 hours after the shot, I started getting really loud ringing in my ears, the left was always louder. About 26 hours afterwards, I started vomiting, diarrhea, and a bloody nose. About a week later, I developed jaw pain. I went to my Doctor and she said it was Bels Palsy and she told me to take an anti-inflammatory OTC medicine, I think I took a Motrin for it. About two weeks later, the tightening of the jaw got better. April 13th, I developed very strong dizziness that lasted for a few days. I waited a few months for the ringing to go away, but The tinnitus persisted and I saw an ENT who couldn't find anything and sent me to an audiologist on 10/26/21. Audiologist that there was a part of my left inner ear was missing the acoustic reflex threshold. Said I needed to return every 3-6 month to monitor.
Symptoms: "COVID Arm" redness, swelling, tenderness, hot to the touch, itchy, hives, rash - from shoulder to elbow. Headache, nausea, fever 103.1, body aches, joint pain.  Duration: symptoms have not yet resolved.
Received Anthrax vaccine, it was administered to the upper left tricep area subcutaneously, within 48 hours patient had a fever of 102 degrees F, a 6cm X 9 cm area of erythema with tenderness, was feeling dizzy and nauseous with a headache, she was given naprosyn 500 mg for the swelling and tenderness, and to apply a cold compress to site
About 3hrs after shot I had elevated heart rate sitting in my chair it was 124 bpm with bp of 124 over 107 I usually have normal bp .this lasted several hours then in the morning I had chills and head acke arm was sore bp normal hand heart rate was 71bpm
Case number PHHY2014US022268, is an initial spontaneous report received from a pharmacist on 05 Nov 2014. This report refers to a patient of unknown age and gender. Medical history and concomitant medication was not reported. It was reported that the pharmacist unintentionally vaccinated the patient with FLUVIRIN (batch number: unknown) PFS intramuscular which was stored at room temperature fpr 45 minutes on 04 Nov 2014. No adverse event was reported. No further information was provided.
In summary, the vaccines haven't stolen my vocal power completely, but the second administration of the Moderna shot and the Pfizer-BIONTech shots seemed to be hard on my thyroidal/esophageal organs, whichever organs, tissue and muscles involves a singing voice. It seems that it reset my vocal power to a time of my voice while it was developing. Also, on 6/4/2021 it could've been the combination of the vaccine, some cheap, powdery sugar-free candy and dehydration from walking a distance from dowtown to the Pharmacy. As for the Pfizer vaccine, it seems to be effective, but again, without the presence of any questionable consumables, it took a toll on my vocal power. It's restoring, but it's almost as if my voice has been stolen.
Arm hurts; Flu like symptoms; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 10-JAN-2023, the patient received the 2nd dose of Shingles vaccine. On 10-JAN-2023, less than a day after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: Arm hurts). In JAN-2023, the patient experienced influenza-like symptoms (Verbatim: Flu like symptoms). In JAN-2023, the outcome of the influenza-like symptoms was resolved (duration 1 day). The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm and influenza-like symptoms to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm and influenza-like symptoms to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received Shingles vaccine and experienced his or her arm hurts but he or she was glad that he or she received the vaccine. The patient experienced flu like symptoms for a day after received shingles vaccine and he or she was fine by the next day and now he or she did not had worries of getting the shingles. Follow-up would not possible as no contact details were available.
local rxn same day-erythema, swelling & soreness;numbness tingling in arm & fingers next day, cont @ least 4 days;
Does not monitor freezer temperatures/Possible freezer temperature excursion but unknown; Potential subpotent dose; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Does not monitor freezer temperatures/Possible freezer temperature excursion but unknown) and PRODUCT MEASURED POTENCY ISSUE (Potential subpotent dose) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 prophylaxis.     It was unknown patient had ever been diagnosed with or tested positive for COVID-19.     On 17-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 17-May-2022, the patient experienced PRODUCT MEASURED POTENCY ISSUE (Potential subpotent dose). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Does not monitor freezer temperatures/Possible freezer temperature excursion but unknown). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Does not monitor freezer temperatures/Possible freezer temperature excursion but unknown) and PRODUCT MEASURED POTENCY ISSUE (Potential subpotent dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PRODUCT MEASURED POTENCY ISSUE (Potential subpotent dose) to be not related. No further causality assessment was provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Does not monitor freezer temperatures/Possible freezer temperature excursion but unknown).    Concomitant medications details were not reported by the reporter.  It was reported that vaccines were stored, there was no monitoring of the freezer temperature, and those vaccines was administered to patients. Vaccination site has a data logger, but it was not set up to record.  The HCP stated that there was no freezer minimum and maximum temperatures to report as the temperatures were not recorded by the site.  There was no adverse event, only the potential of a subtherapeutic dose due to poor freezer documentation following a freezer changeover.  Treatment details were not reported by the reporter.    Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2022: Follow up received and Quality Complaint number added.
Anaphylactic reaction requiring two doses of Epinephren to control. Still having issues; other vaccine same date product received; This is a spontaneous report from a contactable nurse (patient). A 54-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on right arm at 12:30 PM on 18Dec2020 at single dose for COVID-19 immunization, and first dose of other Pfizer vaccine same date product (other vaccine same date lot number: elt9899) on right deltoid on 18Dec2020 for unknown indication. Medical history reported as none. Concomitant medication included vitamin C and colecalciferol (VITAMIN D). The patient experienced anaphylactic reaction at 12:30 PM on 18Dec2020 requiring two doses of epinephren to control. still having issues, resulted in: Doctor or other healthcare professional office/clinic visit, Hospitalization in Dec2020. days hospitalization: 1. The patient received treatment: 2 doses of epinephrine, solumedrol, benadryl, IV and O2 for event anaphylactic reaction to vaccine. The outcome of anaphylactic reaction was not recovered. Lot/Batch and Expiration date has been requested.; Sender's Comments: The information available in this report is limited and anecdotal and does not allow a medically meaningful assessment of the case. There is a plausible temporal association between vaccines administration and onset of the reported event. It is unclear what is the nature of the vaccine co-administered with BNT162b2. Currently no information is available on the co-administration of the Pfizer-BioNTech COVID-19 Vaccine with other vaccines.
Allergic reaction- hives, swelling of eyes and lips. Prescribed steroids and epi pen
Information has been received from a Licensed Vocational Nurse (LVN) referring to a patient of unknown age and gender. There was no medical history or concurrent condition reported. On 18-AUG-2015 the patient was vaccinated with a dose of expired M-M-R II (lot # J006140, expiry date 17-APR-2015) (dosage, strength and route were not reported). There was no concomitant medication reported. At the time of the report, no symptoms was reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a currently 34 year old female consumer regarding herself. On unspecified date in 1999 (also reported as "15 years ago") the patient was vaccinated with the first dose of VARIVAX (Merck) (dose, lot, and route were not reported) for vaccination. On unspecified date in 2012 (also reported as "2 years ago") the patient was vaccinated with the second dose of VARIVAX (Merck) (dose, duration and indication were not reported). On unknown date, the patient performed lab diagnostics studies included varicella antibody titers with negative titers to varicella. On unknown date, the patient sought medical attention in the office visit. On 16-DEC-2013 (also reported "4 weeks ago"), patient found that had negative antibody titers to varicella. The outcome of negative antibody titers to varicella and administered one dose of VARIVAX 15 years ago and a second dose of VARIVAX 2 years ago was unknown. Additional information has been requested.
No adverse effects; MMR II administered 2 weeks after VARIVAX; Information has been received from a nurse referring to a 13 months old patient of unknown gender. The patient's concomitant medications, pertinent medical history and drug allergies/reactions was not provided.  On 08-APR-2019, the patient was administered varicella virus vaccine live (oka/merck) (VARIVAX) (route of administration, lot number and expiration date were not reported) for prophylaxis. On 26-APR-2019, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (lot number R027999, expiration date 01-OCT-2020 and therapy type: rHA (recombinant Human albumin); route of administration was not reported) for prophylaxis (inappropriate schedule of product administration). No adverse events were reported. No product quality complaint (PQC) was involved.  Lot number R027999 has been verified to be a valid lot number for Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live.
This is a spontaneous report from a contactable pharmacist via Pfizer sales representative. A female patient of an unspecified age and ethnicity received PREVNAR 13, on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced swelling and redness at the injection site. Antibiotics or antihistamines were given for the reaction. Outcome of the events was unknown.
Bottom back of the spine hurting; A spontaneous report was received from a consumer concerning a female patient who received Moderna's Covid-19 vaccine (mRNA-1273) and experienced bottom back of the spine hurting.  The patient's medical history was not provided. Concomitant product use was not provided.  On an unknown date, the patient received an unknown dose of two planned doses of mRNA-1273 (Lot number: not provided) for prophylaxis of COVID-19 infection.   On an unknonwn date, the patient began to experience pain at the bottom back of her spine after receiving the vaccine. Treatment information was not provided  Action taken with mRNA-1273 in response to the events was not provided.   The event, bottom back of the spine hurting, was considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
I immunized the pt Sunday morning and then she called me this afternoon (11/13/19) to inform me that she developed a small rash along the waist line area. She reached out to her physician and her physician instructed her to inform me of this. I discussed w/ the pt and she mentioned she has experienced a similar rash before, many times. She has a vast list of allergies. She described the pain as a burning pain and getting better within 48 hours. She explains the rash doesn't burn anymore and has nearly cleared up.
Immediate (L) deltoid area pain 8/6/15, continued pain then after 2 weeks tingling over (L) thumb up to lateral antecubital area, no swelling or redness or fever.