chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt was a non-responder to complete series of Engerix-B given on 26FEB90,29MAR90 & 29AUG90.Outcome of 2 addt'l doses unk.
Events leading up to positive COVID: Patient fell from ladder, 2/19/2022, while still in hospital, on 3/5/2022, lost taste, staff administered PCR test, positive result. Patient denied all other symptoms, treatments related to COVID, was treated for fall injuries, discharged 3/16/2022.
This spontaneous report was received from a social media user, as part of a marketing research program and refers to a male patient of unknown age. There was no information about the patient's concomitant therapies or medical histories provided. The patient's concurrent condition included puberty. On an unknown date, the patient was vaccinated with GARDASIL injection (exact dose, dose number, route of administration, anatomical location, lot # and expiration date were not reported). On an unknown date, the patient experienced adverse event (reported as "He might have had no reference for the things that were happening to his body as he came into puberty, or why things just did not work anymore"). The outcome of the event was unknown. The reporter considered the event to be related to GARDASIL. This is one of several reports received from the same reporter. Additional information has been requested.
ACUTE HYPERCAPNIC RESPIRATORY FAILURE ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE
Case number PHEH2014US003879 is an initial spontaneous report received form a nurse on 21 Feb 2014: This report refers to a male patient under 18-years of age who was inadvertently vaccinated with FLUCELVAX (batch number: 009021A and expiry date: Jun 2014) intramuscularly at a dose of 0.5 ml on an undetermined date. The vaccine was reported to be from he 2013/2014 season. No adverse event was reported following this administration error (inappropriate age at vaccine administration). Following an internal review on 18 Aug 2014, significant correction was done for the information received on 21 Feb 2014: The BPI labeling of the event "Inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population.
12/10/03 Child received vaccines at approximately 15:30 12/10/03. Mom states at approximately 19:30 crawled up on couch and went to sleep. At approximately 21:00 child sleeping but restless/fussy noted to have increased temperature no thermometer available. At that time 21:45 given Tylenol (160 ml) and placed in tepid bath dressed in T-shirt and under pants. 22:15 temperature 100.7 F. (auxillary) Approximately 8:30 Reading to infant and he jerked all over body response like a "startle" to Personal Care Physician. At this AM felt "due to shots". 12/12/03 Follow up telephone call mom states fever "broke" at approximately 04:30 this AM and child "slept well" the remainder of the night. States last "jerking" was at approximately midnight. 01/06/04 Follow up telephone call today. Mom states no further fever noted had 1 additional time that infant had 1 "light jerk like a startle". No change in orientation or other symptoms at that time. No further problem. Notes need to return for booster influenza.
About 20 minutes after vaccine given, patient reported symptoms of anxiety.  Vital signs within normal limits.  Symptoms resolved on own.
Pt was nauseous, sweaty and skin became pale. Pt also experienced lightheadedness and felt weak. P:54, BP: 140/80, 96% room air. When EMS arrived the vitals were BP: 110/72.
Information has been received from a healthcare student referring to a patient of unknown age and gender. On 26-AUG-2015 the patient was inadvertently vaccinated with an expired dose of VARIVAX (Merck) injection (lot # J008652, expiration date 10-JUL-2015) (dose and route were not reported). No adverse effects reported. Additional information has been requested.
No AEs; RN called to report temperature excursion that occurred on 7/12/2022. Caller states that 100 doses of PROQUAD and 94 doses of VARIVAX were administered since 7/12/2022 from mobile unit. No further information provided. No add; This spontaneous report was received from a nurse and refers a child of unknown gender. The patients' concurrent conditions, medical history, allergies and concomitant therapies were not reported.  On 12-JUL-2022, 40 doses of the vaccine varicella virus vaccine live (oka/merck) (VARIVAX) (lot # U029621with expiration date 20-SEP-2023) underwent a temperature excursion during storage.   On an unknown date, the patient was one of 40 patients vaccinated with vaccine varicella virus vaccine live (oka/merck) (VARIVAX) (lot # U029621, expiration date 20-SEP-2023) administered as prophylaxis (dose regimen details were not provided).   No adverse event was reported. No further information was reported.  This is one of several reports received from the same reporter.
itching and hives on face and arms starting the next day after vaccine and lasted for 3 days. She did seek out urgent care and received a steroid injection. This helped with the hives and itching
red, warm, indurated area left arm.  BENADRYL, IBUPROFEN, ice
pt had sl temp 1JUN mostly forehead was warm rest of body regular temp;2JUN broke out in small red rashes mostly neck & a little on face;3JUN has more rashes-some blotching behind ears & on neck, little rashes on back of legs & arms;
Pt experienced cold symptoms within 24 hours of vax. Pt had a severe cold and cough. Prescribed Levaquin.
After receiving vaccine she got light headed and broke out in a rash. Her body got hot and itchy. The rash spread throughout her entire body. The pharmacist on duty gave her Allegra 180mg for the rash. Early Monday morning around 2:00am she went to the emergency room due to having a fever of 102.1. She was given Tylenol and was released from the hospital at 7:00am.
Headache fatigue, arm soreness, chills Narrative: state: woke up during the night with chills and severe headache both relived by ibuprofen. following day fatigue and injection site soreness
Patient came in clinic stating that she could no longer move her left arm. Patient had had some swelling in left arm after a Td vaccine on 12/04/07. It later progressed to left shoulder pain and now has advanced to atrophy in the left arm/shoulder.  6/8/09 Medical records received 3/27/08 to 5/7/09. Assessment: Rotator cuff tendonitis.  Cervical radiculopathy. Post vaccination patient states that there was swelling and pain at injection site in 2007. Now complains of shoulder pain, neck pain. Tenderness on palpation in cervical region, shoulder, trapezius spasm, shoulder rotation / abduction decreased, tenderness on palpation of biceps/triceps, weakness. Patient unable to afford diagnostic testing to confirm rotator cuff disorder, cervical radiculopathy.
Site: Bruising at Injection Site-Medium, Additional Details: Patient's left arm was black & blue with a bruised appearance running the length of the entire arm. Patient states this started the day of the injection and presented to the pharmacy to show his arm on 11/3/22. I advised the patient to reach out to his doctor or visit an urgent care for assessment.
Miller Fisher syndrome(Gullian Barre variant); Tongue deviation; This spontaneous case was reported by a physician and describes the occurrence of MILLER FISHER SYNDROME (Miller Fisher syndrome(Gullian Barre variant)) and TONGUE PARALYSIS (Tongue deviation) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Cipro allergy), Allergy to antibiotic (Cefapime allergy), Hypertension, Hypercholesterolemia and Acid reflux (esophageal). Concomitant products included FAMOTIDINE for Acid reflux (esophageal), UBIDECARENONE (COQ) and ATORVASTATIN for Cholesterol, LISINOPRIL for Hypertension.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MILLER FISHER SYNDROME (Miller Fisher syndrome(Gullian Barre variant)) (seriousness criterion medically significant) and TONGUE PARALYSIS (Tongue deviation) (seriousness criterion medically significant). At the time of the report, MILLER FISHER SYNDROME (Miller Fisher syndrome(Gullian Barre variant)) and TONGUE PARALYSIS (Tongue deviation) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Magnetic resonance imaging head: negative (Negative) Negative. In 2021, Magnetic resonance imaging spinal: negative (Negative) negative. In 2021, Ultrasound scan: negative (Negative) negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MILLER FISHER SYNDROME (Miller Fisher syndrome(Gullian Barre variant)) and TONGUE PARALYSIS (Tongue deviation) to be probably related.    No treatment information was provided.  The symptoms remain appear after 2nd dose of vaccine, slightly milder but not resolved.  This case concerns a 70 year old male patient, with no relevant medical history, who experienced the serious unexpected AESI of MILLER-FISHERMAN SYNDROME. The event occurred on an unknown date after the second dose of Spikevax. Rechallenge is not applicable since no additional dose will be given. The benefit-risk relation of Spikevax is not affected by this report.   This case was linked to MOD-2021-071178 (Patient Link).; Sender's Comments: This case concerns a 70 year old male patient, with no relevant medical history, who experienced the serious unexpected AESI of MILLER-FISHERMAN SYNDROME. The event occurred on an unknown date after the second dose of Spikevax. Rechallenge is not applicable since no additional dose will be given. The benefit-risk relation of Spikevax is not affected by this report.
This spontaneous report as received from a nurse to a female patient of unknown age. Medical history and concurrent conditions were not reported. On 06-JUN-2013 the patient was vaccinated with GARDASIL, intramuscular. Lot number and expiration date were not reported. Other suspect therapies included CERVARIX. Lot number and expiration date were not reported. The patient received CERVARIX on 13-JAN-2013. She received GARDASIL on 06-JUN-2013 and on 10-SEP-2014. No known adverse effects. This is one of two reports from the same source (other case # 1409USA013045). Additional information has been requested.
Pt. states that after receiving the 3rd Booster of Phizer 11/22/2021, started experiencing symptoms 11/23/2021 of swelling of a lump located on the (right-side) neck, under the (right) armpit, and around the (right) elbow. Body aches, chills, slight fever, and joint pain (self-treated with Tylenol). Pt. still experiencing the swelling of the neck, armpit, and elbow area. No noted Primary visit/communications.
t103 ax, vomits fluid, will not hold anything in hand; shaking; t102 since 11PM 21APR92;  MD felt virus;
Skin rashes (Hives or Hived? ) Whole body, starting around 36 hours after vaccination.   Took Benadryl, and saw my family doctor who has consulted with an immunologist for my case before saw me . Until now 1/15/2021, still have skin rashes if stop taking Benadryl.  It becomes an on-going problem.  Still plan to get the 2nd dose of vaccine, according my doctor's suggestion.   She has prescribed Epinephrine and famotidine (and ask me to also take fexofenadine or certrizine, plus Benadryl at night) after my 2nd dose in the near future.
Inconsolable, nonstop very pitched crying for four hours. Onset 2 days past vaccines. She did calm during the drive to the pediatricians office.
Narrative: Covid infection after Covid vaccine series. 02/12 COVID vaccine dose #1 03/12 COVID vaccine dose #2 09/15: Sinus congestion, cough, loss of smell 09/17: Regeneron
Patient stated at the time of her second Moderna vaccine that she has been on her period ever since receiving the first dose 4 weeks ago. She states that she is usually very regular but is not on any type of birth control. She mentions that she did have 2 or 3 days out of the 4 weeks that she did not bleed. She does not have a primary care physician at the time. She decided not to get the second dose at this time, instead wanting to wait on it.
Day 1: high heart rate for about 12 hours after injection - would not go below 100 even lying down; warm flushing feeling randomly through body. Chills and fatigue 2 hours after shot. Day 2: arm sore; as day went on got achy all the way down to rest. heart rate back to normal but still high when walking. Very fatigued - head pressure Day 3: Still fatigued; heart rate normalized - no appetite, some stomach discomfort and head pressure Day 4: Fatigue, stomach discomfort and achy joints down left side of body - still have head pressure Day 5: Low fever of 99, ear canals swollen and waves of nausea; head pressure; ear ringing Day 6: Fatigue is gone, aches are gone and ear canals/pressure/ringing seem to be getting better. Day 11: Off and on stomach distress
Information was received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. ON an unknown date the patient was administered a recently expired dose of PNEUMOVAX23 injection (dose and route unknown). No adverse effect was reported. Additional information is not expected as there is no report's contact details provided.
States 30-40 minutes after vaccine was administered started felt tightening in the chest and progressively got worse and had to use her asthma Albuterol inhaler.  One week post of getting Flu vaccine developed a cough and went to the doctor.  she was given another inhaler(ProAir) Steroids, Z-pack, Tessalon Pill and Cherratussin cough syrup.  States over the weekend progressively got worse and had to go back to see her PCP on Monday  and was given an X-Ray of the chest and was diagnosed with early Pneumonia. More medications was prescribed. Levaquin, Was given a Solumedrol IM injection and increased the Z-Pack medication.  States referral was given to see and Allergist.
Both immunizations were given on left deltoid. The MENVEO was given superiorly and TRUMENBA was given inferiorly. A day after immunization, 2 indurations appeared which were raised and red. Patient did not come to office for evaluation of lesions but she took a picture of her arm which I saw at office. Patient also complaining of both pain and pruritus. I saw the patient on 4th day after immunization was administered. The swelling  was resolved but erythema was still there. 2 areas appreciated with measurement as follows: superior area measured 2x1 in and inferior area measured 1x1 inch. Patient still had mild itching.
patient presented to pharmacy for covid vaccine - she filled out form and indicated that she has had reactions following vaccinations in the past - I inquired to see what kind of reactions - patient said she sometimes has felt light headed or fainted before but it hasn't happened in a long time - she also said she has given blood recently and was fine without issues - Following vaccine administration, patient said she wasn't feeling well several minutes later and was feeling faint - I offered water or for her to lie down - pt then fainted sitting in the chair and remained sitting in chair - I stayed with patient while tech called 911 - patient was out for about 30 seconds then came back and said she felt nauseous - patient was able to answer questions about who she was and her date of birth right away - patient remained in chair and drank water - EMS arrived and assessed patient - after talking to EMS and resting for about 20 minutes, patient was fine and left pharmacy in normal state
Patient presented to the ED and was subsequently hospitalized for small bowel obstruction within 6 weeks of receiving covid vaccination.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Nov2021 10:00 (Batch/Lot number: unknown) at the age of 49 years as dose 3 (booster), single for Covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing), notes: Note: Arthritis. Concomitant medication(s) included: TYLENOL; ENBREL. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left, Vaccine Administration Time: 02:00, PM), administration date: 30Apr2021, when the patient was 49 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 07Apr2021, when the patient was 49 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 22Nov2021 10:00, outcome "unknown", described as "Booster"; BACK PAIN (non-serious) with onset 23Nov2021 01:00, outcome "not recovered", described as "Lower and Middle back pain". The event "lower and middle back pain" was evaluated at the physician office visit. Therapeutic measures were taken as a result of back pain. The lot number for bnt162b2 was not provided and will be requested during follow up.
3/25 Nickel size red spot at vacc site, arm very sore, over next 7 days area of redness more diffuse, warm to touch and very sore. And 3/29, red spots on back, top of head with itching. On 4/1 rash over all of scalp, forehead, back & trunk, severe itching. ER visit 4/1 - Dx Chicken Pox.
24MAR pt recvd vax 120PM; on 25MAR pt devel fever of 102; approx 6PM pt devel hives all over body; red & puffy in appearance; MD visit 27MAR92; MD prescribed DPH; pt is almost fully recovered today;
Patient complains of rash-like symptoms all over her body but specifically in the mid-section. She has contacted her primary care physician who has since prescribed for her steroid cream to be used on the area of redness/itching.
Patient was given a peds dose of Hep B instead of an adult dose.    Pt did not have a adverse event reaction.
no adverse event; inadvertently received first dose of rotateq; inadvertently received first dose of rotateq; This spontaneous report was received from a nurse practitioner referring to a 3 months old patient of unknown gender. Information about patient's concurrent condition, concomitant medication, medical history and drug allergy/reaction was not reported.   On 30-APR-2020, the patient was inadvertently vaccinated with first dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) for prophylaxis, lot# S013890, expiry date: 14-FEB-2021 (strength, route, anatomical location was not reported) (wrong product administered and product administered to patient of inappropriate age). No adverse events were reported. No product quality complaint was involved.
Chills; Fever; Myalgia; weakness; This case was reported by a physician via call center representative and described the occurrence of chills in a 87-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included varicella (in childhood), breast cancer (received chemo therapy and radiation therapy), ovarian cancer (received chemo therapy and radiation therapy) and varicella zoster (in 2019). Previously administered products included Shingrix (1st dose received on 27th September 2019, refer linked case US2019231590), Varicella zoster vaccine (received many years before the date of reporting and experienced varicella) and valcyclovir.   On 10th January 2020, the patient received the 2nd dose of Shingrix. In January 2020, less than a week after receiving Shingrix, the patient experienced chills, fever, myalgia and weakness. Rechallenge with Shingrix was positive. On 15th January 2020, the outcome of the chills, fever, myalgia and weakness were recovered/resolved.   It was unknown if the reporter considered the chills, fever, myalgia and weakness to be related to Shingrix.  Additional details were provided as follows: The patient received 2nd dose of Shingrix and recurrent events did not involve a rash but did expereince fever, chills, weakness and myalgia. The reporter consented to follow up.
pt recvd vax & had high pitched cry for 7 hrs; t 101.5;
Pain in arm at injection site started about 3 hours after injection. Full muscle pain and painful to lift or move arm for next 3 days. Dizziness/lightheaded starting around 7PM after moderate walk, then persisted for next 3 days. Fever of 99.5, strong chills and shaking, and mild nausea started at 10PM as I prepared for bed, persisted through the night, but chills and nausea gone in morning, and fever mildly subsided. Took NyQuil before going to bed to treat fever.  Chills returned next night, but much milder than before and for shorter.  Took ibuprofen, 2 tablets twice a day for next two days. Dizziness and mental fog persisted until 3 days after injection.
Patient received booster Pfizer dose, aware it was kept at wrong storage temperature and needs to be repeated.
2/26/23  I was playing sports and fell into the boards hitting my head. I had neck pain afterwards. I went to the emergency room and was diagnosed with a neck strain and likely concussion.  I have had headaches and neck pain since then, but am recovering. I am not back to full time work yet.
who received "expired" vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (who received "expired" vaccine) in a 33-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (who received "expired" vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (who received "expired" vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not provided.   Reporter did not allow further contact
First headache & wobbly legs - "hot to the touch & cold to the bone" on day 5.  Day 6 temperature of 101.5 degrees F.  Day 7 temp of 103.4 degrees F.  Gave MOTRIN.  Delayed 4th dose.
Pt received Pfizer COVID vaccine in left arm at 0828 at our high-risk anaphylaxis clinic. After receiving the shot she then proceeded to our monitoring area for 30 minutes. At 0836 pt c/o of mild pain in her left deltoid. RN observed the injection area to be slightly red. Pt no c/o of itchiness or SOB. RN provided the pt with an ice pack. VS 162/110 and pulse ox of 97-99%. At 0855 left arm redness notably decreased. At 0905 pt c/o of feeling SOB. O2 sat of 99% with HR of 114. Pt taken into exam area in back of clinic and put on a stretcher. Now c/o of left shoulder and neck pain. Area tender to touch.  Pt placed in 2 liters nasal O2. Rapid response was called at 0915. Team arrived, evaluated pt, and then transported pt to ER for further eval and tx.
This initial spontaneous report was received from a nurse referring to an unspecified number of patients of unknown age and genders. Concurrent conditions and medical history were not provided. The nurse stated that on an unspecified dates, "about 250" patients received doses of improperly stored vaccines, within them GARDASIL 9 injection (dose, route, lot number and expiration date not provided). There was no concomitant medication described. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.