chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician via a company representative concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history or concomitant medications were not reported. On 22-JUN-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 10 single DS, 0.5 mLVls 10SDV, (lot number L035885, with an expiration date of 19-APR-2017) (route and anatomical location were not reported) that was improperly stored. On an unspecified date, the PNEUMOVAX 23 had a temperature excursion. The lowest temperature excursion was of 34 Fahrenheit (F), (1.111111111 Celsius degrees) for a total of 176 hours. No adverse effects were reported. The vaccine storage criteria and the type of the excursion were reported as refrigerator (R), and the vaccine status was reported as "in excursion". Furthermore, no product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
a lump in between my shoulder blade and my collar bone. The lump it is like size of a small grape like a very small grape; little sore right there; This is a spontaneous report from a contactable consumer (patient). A 39-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in left arm on 15Apr2021 (Lot Number: EW0162; Expiration Date: 31Jul2021) as single dose for covid-19 immunisation. There were no medical history and concomitant medications. Patient previously received first dose of vaccine on 25Mar2021 (lot number: EN6207) administered in left arm for COVID-19 immunization. Patient had COVID vaccine second shot on last Thursday on 15Apr2021 and on Sunday this past Sunday on 18Apr2021, patient noticed had a lump in between shoulder blade and collar bone and patient noticed it was little sore right there and started rubbing it and a little lump there. Patient stated that the lump it is like size of a small grape like a very small grape. Patient stated the lump is there and still a little sore, the soreness has improved but the lump is still there. Patient stated no treatment. No investigation assessment. The event outcome for a lump in between my shoulder blade and my collar bone. The lump it is like size of a small grape like a very small grape was not recovered, for little sore right there was recovering.  No follow-up attempts are needed. No further information is expected.
Slight dizziness followed by Allergic reaction to include swelling of feet, hands, chest, face, mouth, tongue and throat and slight headache. Dizziness occurring at 10:40 am and swelling starting at 10:40 am with ER visit at 12:45 pm. Given steroids, antihistamines and anti itch medication, sent home with instruction to take Benadryl. Allergy broke through by next morning, patient took pepcide and claritin, allergy got worse, went to ER. Given steroids, two epinephrine shots and albuterol and released with prescription for Epinephrine and Steroids. Sunday, allergy broke through medications again at 8:30pm patient returned to ER after taking steroids, all allergy medications, and one shot of ephinephrine. Hospital gave second shot of epinephrine and albuterol treatment. Patient's allergy calmed down and patient was sent home with albuterol to be used as necessary.
Had reaction starting 10 to 11 days after the shot. Saw dr. on Monday Feb. 1, 2021 Would have liked to have gone on Sunday but it was Sunday.  I was given steroids - A large shot and then subsequent pills lowering the dosage each day.    The rash first appeared on my arms and was very uncomfortable. It moved to include my chest, neck, back, underarms and thighs. Very uncomfortable. Barely a fever.   Went to my dematologist who prescribed Triamcinolone 1% cream, Allegra (or Zyrtec).  Also Hydroxyzine at night and by the middle of each night it was too uncomfortable to sleep.  After 8 days I am finally considerably better but not clear.
On an unspecified date, the pt received a dose of Lymerix; it is not known whether the pt had received prior injections of Lymerix. Reportedly, after a "few" months, the vaccinee developed "severe joint and muscle pain and stiffness". The physician "did not give me any further shots." Reportedly, the physician treated the pt with ibuprofen 400mg three times daily. As of 5/15/01, the adverse events were unresolved.
Cheeks were red; Cheeks were itchy; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Cheeks were red) and PRURITUS (Cheeks were itchy) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 05-Mar-2021, the patient experienced ERYTHEMA (Cheeks were red) and PRURITUS (Cheeks were itchy). At the time of the report, ERYTHEMA (Cheeks were red) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not Applicable. No concomitant medications reported by investigator  No treatment medications provided by the reporter.
Initial and follow-up information has been received from a physician and a nurse through a Merck Pregnancy Registry concerning a 19 year old female patient, who was vaccinated by injection with the first, 0.5 ml dose of GARDASIL.  After a couple of weeks the patient developed vomiting pains and was rushed to the Emergency Room.  The patient was tested and diagnosed as being pregnant.  The patient sought medical attention.  Follow-up information indicated that the patient vaginally delivered a healthy, normal female at 39 weeks on an unspecified date.  The infant weighed 6 pounds 14 ounces.  The baby experienced some jaundice as a newborn.  It was reported that the mother and baby were doing well.  Additional information is not expected.
Administered Flu Mist Intranasally and client had heavy nose bleed immediately following.
Injection site became red, swollen and hot to touch, tender to touch, approx 5 cm x 5 cm in diameter.  Some lymph node swelling under the arm.
This spontaneous report as received from a physician refers to a 12 months old male patient who on 29-AUG-2012 was vaccinated in the right thigh with a one vial dose of M-M-R II (lot number 1570AA, expiration date: October 2013) and VARIVAX (Merck) (lot number 1145AA, expiration date: July 2013) on the left thigh. No concomitant medications were reported.. The patient was very cranky after the shot. Then when the patient was taken to home. The patietn expeirienced several very severe adverse experiences on 29-AUG-2012. These adverse experienced were vomiting, hiving seizures, having an alered mental state and respiration failure. The patient's mother called 911 and the patient was taken in an ambulance to the hospital for an unspecified about of time until the patient was transferred to other hospital. The patient sought medical attention and was treated for adverse events, he was incubated while he was at this hospital. At the time of the repot, the patient had not recovered from adverse events. He was currently stable and he was removed from incubation. The patient was still at the hospital. The relatedness for the adverse events was unknown for M-M-R II and VARIVAX (Merck). The adverse events were considered as life-threatening and disabling. Follow up information received with aware date of 11-SEP-2012. The patient's current conditions included torticollis for which he was scheduled for physical therapy and a very mild growth motor delay. The patient was vaccinated with M-M-R II and VARIVAX (Merck) subcutaneously. The patient was treated with DIASTAT rectal gel for the event of seizures. The patient was discharged form the hospital on 31-AUG-2012 (also reported as 2 or 3 days after admission) but she has not yet seen him in the office. It was unknown if the patient has started on any anti-seizure medications but the patient wsa noted to follow up with the neurologist. Additional information has been requested.
Tremors, elevated BUP and Heart Rate, Elevated temperature of 100.6 that continued to rise to 101.6 despite tylenol being administered. Altered Level of consciousness.
Within 30 minutes, patient complained of a metallic taste in her mouth, dizziness, throat hoarseness and a general feeling of being unwell.
12 hours later almost exactly, I started to feel hypothermic, my brain became foggy, I started shaking uncontrollably, could not think straight, stuttered, repeated saying how cold I was, temp 97 deg.  Ended up falling asleep from exhaustion. Later was told it was likely seizures and should have sought treatment but couldn?t think straight to make that decision. Next day my body was extremely sour and tight from the convulsions.
PATIENT PRESENTED TO THE PHARMACY 9/11/18 (3 DAYS AFTER RECEIVING VACCINE) WITH A RED, INDURATED AREA AROUND THE INJECTION SITE MEASURING APPROXIMATELY 2.5" ACROSS. PATIENT SAID THEY ALSO HAD NAUSEA, FEVER, CHILLS, AND FATIGUE THE DAY AFTER RECEIVING THE VACCINE (9/9/18). PATIENT COMPLAINED THAT THE INDURATED AREA WAS SORE AND ITCHED AS WELL. ACCORDING TO THE PATIENT, THE REDNESS AND INDURATED AREA SHE PRESENTED ON 9/11/18 WAS APPROXIMATELY 1/2 THE SIZE OF WHAT IT WHAT ON 9/9/18.
Sore throat, cough, fatigue. Cough and Lasted 3 weeks
products reached 8.5 degrees Celsius for 30 minutes and the excursion cause was unknown with no reported adverse event; Human error involved, stability data of vaccine was not reported, and vaccine was not administered hence it is a non case.
Case number PHEH2013US015772, is an initial spontaneous report received from a nurse on 18 Jul 2013. This report refers to an 11-year-old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with MENVEO, (batch number: A12011, expiry date: Feb 2014) at dose of 0.5 ml intramuscularly on 12 Jul 2013. On 15 Jul 2013, her parent called and reported that, she experienced injection site of MENVEO was red and hot (exact date of onset of reaction was not known). The outcome, seriousness and causality of the events were not reported.
Janssen COVID vaccine given to person under the age of 18. No treatment, no adverse reactions, patients mother was called and notified, pts mother states no issues, pt is doing fine, no reaction.
Day 1 - 1x bout of acid reflux while eating dinner (I don't have acid reflux). Day 3 - Extreme fatigue.  Diarrhea all day. In p.m., burning sensation in fingertips, toes, and all nails; along with tingling in fingertips.                  Felt like I got a rash along entire lower back and both upper arms. Day 4 - Both  index fingernails, very white underneath entire nails, most of the day.   Fatigue, all day. Day 5 - Fingernails burn and tips tingle.  Off and on white color under both index fingernails. Day 6 and today - I still don't feel right.
Soreness in the arm and redness gone by 01/05/2021. It became red and swollen with numbness and tingling. There was a rash and coldness in the arm. Sharp chest pain onset with coldness feeling. On 1/09/2021 one onset of chest pain and coldness in the arm  all the way down the arm and into the fingers. Observed in the ER with EKG. Followed up with care clinic. Stress test scheduled but cancelled, rescheduled on Mar 29th.
This spontaneous report as received from a healthcare worker refers to two unspecified patients of unknown age and gender. On an unknown date the patients were vaccinated with a dose of 0.5 ml improperly GARDASIL that exposed to 32F for 39 hours, intramuscular. No adverse effects were reported. Follow up information received on 17-DEC-2014 regarding 2 patients who received improperly stored GARDASIL, via a phone call that was placed to the CMA. The CMA did not have any additional information available at this time. The CMA stated she would look for the patient's information and if available the CMA would call back at a later date. The CMA called back and reported on the names of the two patients (refer to MARRS # 1411USA01208) who received the improperly stored GARDASIL. Also the CMA reported on the GARDASIL information for both was Lot # J006236 and Exp. date: 25-FEB-2016. This is one of two reports from the same reporter. Additional information has been requested.
I get my period twice a month now. It's painful and heavy. This has never happened to me and started on the day I got the vaccine. I also got diarrhea for over a month. A rash on my arm near my armpit. My arm inflammation and pain were so great that I couldn't move it for days and it took 2+ weeks for me to be able to start using my arm again.
Flushed face; Clogged ears; hot flash that got worse" and "her face felt weird."; Face felt flushed and red; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Flushed face), EAR CONGESTION (Clogged ears), HOT FLUSH (hot flash that got worse" and "her face felt weird."), ERYTHEMA (Face felt flushed and red) and HEADACHE (Headache) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced FLUSHING (Flushed face), EAR CONGESTION (Clogged ears), HOT FLUSH (hot flash that got worse" and "her face felt weird."), ERYTHEMA (Face felt flushed and red) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. On 02-Mar-2021, FLUSHING (Flushed face), EAR CONGESTION (Clogged ears), HOT FLUSH (hot flash that got worse" and "her face felt weird."), ERYTHEMA (Face felt flushed and red) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Plaque psoriasis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free pre-filled pen. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) was resolving.            No concomitant medication was reported.   Treatment information was not provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Immediately after injection -c/o feeling sick/nauseous. Eyes rolled back - C/o feeling faint. Blacked out x few seconds. Extremities stiffened - body spasms x 2. Buccal area - white. Forehead clammy - cheeks warm. Placed on floor with legs up. Tol. Powerade without diff. Color returned after 10' - Oriented to T. & P. Pulse 88 radially - Resp. unlabored. Instructed parent to notify pediatrician of event.
States at 4:30 PM had chills, fever 104, cough with production of brownish sputum, headache, weakness, vomiting, chest tightness, muscle soreness, sores in mouth
Patient received IM injection. 30 minutes later developed "tickle in her throat." Pt sent to clinic; had onset of shortness of breathe, swollen tongue, erythema. Given 5 x IM EPI shots, SOLUMEDROL, albuterol. Transferred to ER and placed on EPI drip at hospital with observation over night.
Gave Hep B immunization at 12 months well child visit. Mother authorized PENTACEL instead of routine Hep B vaccine. Pt asymptomatic at clinic. Pt on delayed immunization schedule. Mother aware of error. MD notified and spoke with mother.
Patient c/o numbness of arm and feeling like she is floating - resolved after 2-3 seconds
Both shoulders injection sights very hot, tight and swollen, started feeling very lethargic, looked very pale. Kept getting sicker and sicker over the next few days developed high fever, hoarseness, fast heart beat pale and fatigued.
Patient developed hives around 2-3 hours post-vaccination and proceeded to have lip swelling, throat tightness, shortness of breath, nausea and abdominal pain. She was given 50mg of Benadryl po by her mother on the evening of vaccination, but mother noted that it didn't seem to help, so did not give any additional medication. She presented to clinic the following morning at 0900 with continued symptoms and was directed to go directly to the ED for management of anaphylaxis.
CAME IN 06/20/2018 8:30PM WITH A LITTLE SWELLING OF THE FACE AND SWELLING OF THE FEET. NOT SURE WHY HE WAITED SO LONG TO COME IN? I TOLD HIM TO GO HOME AND ELEVATE THE FEET AND I WOULD REEVALUATE HIM ON 06/21/2018.  HE HAS NOT SEEN THE DR FOR THIS YET.
Patient reported numbness around teeth, diaphoresis, sensation of tongue swelling and difficulty swallowing. Treated with Benadryl 25 mg.
Information has been received from a registered nurse concerning an adult female she accompanied her daughter, to a health department, where the child was vaccinated with the first dose of varicella virus vaccine live (site unknown). While the child was being vaccinated, there was an inadvertent splash onto the mother's hand. Subsequently, she developed a localized blistery rash on one hand and sought medical attention. The nurse called to inquire if topical exposure to varicella virus vaccine live can cause this reaction. It was not known if the pt has had "natural chicken pox" or if she could have been pregnant at the time of the exposure. It was also reported that the woman's daughter received the second dose of varicella virus vaccine live and developed a generalized rash (WAES0101514)
Flu shot given on 9-5-18. On 10-3-18 patient complained of arm soreness, but no other symptoms. Patient will call MD.
Came down with shingles, sick not feeling well. Slept, loss of appetite, large rash on left side under armpit.
arm soreness; low blood pressure; ataxic; clammy; tremors; high lactic acid level; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included sepsis (sepsis infection requiring 23 days of hospitalization 6 months ago). Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose in early November 2019, refer case US2020002561). Concomitant products included hydrochlorothiazide.   On 2nd January 2020, the patient received the 2nd dose of Shingrix. On 2nd January 2020, 5 hrs after receiving Shingrix, the patient experienced low blood pressure, ataxia, clamminess, tremor and blood lactic acid increased. On an unknown date, the patient experienced pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the low blood pressure, ataxia, clamminess, tremor and blood lactic acid increased were recovered/resolved.   It was unknown if the reporter considered the pain in arm, low blood pressure, ataxia, clamminess, tremor and blood lactic acid increased to be related to Shingrix.  Additional case details were reported as follows: The patient experienced arm soreness which has yet to resolve.   After dose 2, about 5 hours after, the husband went to the gym.   He reports a drop in blood pressure,feeling clammy, and ataxic.  The patient also had low systolic blood pressure of 90 and tremors. The patient was taken to the emergency department and was assessed. He was given 2 liters of fluids, which stabilized him. During the emergency room visit, his pressure went back up to systolic.  The patient also had a lactic acid level at 2.6, which went back to normal after hydration to 1.2.   The patient was not admitted and discharged. All events have resolved except the arm soreness.The reporter consented to follow up. Emergency room visit required.
Drug ineffective; 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 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 09Sep2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown", described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: positive test 3 days after negative test; Positive. 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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300148050 same patient/product, different dose/event;
About seven (7) days post vaccine injection I began to experience pain and numbness in both arms, numbness and swelling in my lips and face area and a feeling of indigestion/heartburn.  I presented to urgent care and subsequently the emergency room on 03.27.2021 with those symptoms and was treated and released.  The following day, the symptoms continued, specifically the pain and numbness in the bi-lateral arms and additionally began to experience pain in the chest area and increased resting heart rate (125+ bpm).  Again presented to emergency room on 03.28.2021, treated and released.
This spontaneous report was received from a medical assistant and refers to a 15 month old patient of unknown gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 20-OCT-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # L042267, expiration date 27-OCT-2017; site, dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as no further information is available.
intermittent itchy hives, most prominent on the arms, legs and lower back, started a week after the vaccine and have persisted (about a month since onset now).   antihistamines seem to control it but returned once stopped antihistamines.   trying a longer course of antihistamines to see if it resolves.
pt had fever 102 & bodyaches;in bed x 2 days;had flu vax 10/5/99;