chrisvoncsefalvay/vaers-outcomes huggingface dataset:
17 year old male patient was inadvertently administered an expired dose of Menactra with no reported AE; Initial information received on 14-Jul-2021 regarding an unsolicited valid non-serious case received from a consumer in the United States.   This case involves a 17 year old male patient who was inadvertently administered an expired dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  Patient received no concomitant vaccines. Medical history, medical treatment, concomitant medication, and family history were not provided.   On 16-Jun-2021, the patient received a 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6365AA and expiry date: 24-Sep-2020) via an intramuscular route in the left deltoid (expired product administered) for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency on same day).  It was reported that "Caller stated the vaccine is expired and they administered it to a patient. Caller wants to know how effective the vaccine is, if they needed to give the vaccine to the patient again, or would they need to wait. Reported stated that as of today (14 Jul 2021) the patient has not reported any adverse effects from having received the expired vaccine."  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
15 seconds after injection patient felt tired and like she was going to pass out. Patient was anxious appearing. Patient taken to the Emergency Room for further evaluation.  Upon presentation to the ER, patient diagnosed with vasovagal syncope, treated with fluids and zofran and discharged home.
Dizziness Fatigue Narrative:  The patient is improving daily as of 12.30.2020.
Fri 4-16-21  The night after receiving the second dose had mild insomnia so was a little tired the next day (Sat). Sat 4-17-21  Sat night I had to get up 4 times to urinate. This never happens to me.                               I never have to get up in the middle of the night to urinate. Sun 4-18-21  Back to normal
dizziness/started getting dizzy; vertigo; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration date were not reported), via an unspecified route of administration on 22Apr2021 at first dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient started getting dizzy on 22Apr2021, 2 hours after the first dose. The patient also stated that she had a unique reaction and experienced dizziness and vertigo for 14 days after getting the first dose. it had gotten better, and she did not have the symptoms anymore. The primary care provider suggested she pushed the second dose back, so patient would be getting the second dose on 21May2021 at 5 weeks after the first dose. Additionally, she wanted to know information or guidance regarding dizziness and the second dose. The outcome of the events was recovered in May2021.  Information on the lot/batch number has been requested.
Treatment of COVID-19; Treatment of COVID-19; Dose Number: 1-4: MODERNA; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 5 (booster), single (Lot number: GJ2524) at the age of 71 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 29Dec2020 as dose 1, single (Batch/Lot number: unknown), on 26Jan2021 as dose 2, single (Batch/Lot number: unknown), on 12Nov2021 as dose 3 (booster), single (Lot number: 066F21A) and on 12Apr2022 as dose 4 (booster), single (Lot number: 002M21A) for covid-19 immunisation. The patient's relevant medical history included: "HI CHOLESTEROL" (unspecified if ongoing); "Gerd" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 12Sep2022, outcome "unknown", described as "Dose Number: 1-4: MODERNA"; 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: (unspecified date) Positive, notes: Treatment of COVID-19; (31Mar2023) Negative, notes: Tested negative on 31Mar2023; (01Apr2023) Positive, notes: 0n 01Apr2023 had Headache and Rhinorrhea and tested Positive. Therapeutic measures, Paxlovid was taken from 23Mar2023 to 27Mar2023, were taken as a result of drug ineffective, covid-19.
pt recvd vax 20SEP95 & 21SEP95 exp URI, sinus infect, t104, severe diarrhea;pt hospitalized for IV tx;lab eval revealed WBC count 19 & atypical lymphocytes;mononucleosis test neg & CMV & EBV test pending;macular rash on abdo & feet
My arm started hurting and is now itchy and there is a hard spot about 3 inches in diameter where the injection was.
Started with headache and sore arm, some nausea.  By 12:30 AM, was shaking uncontrollably (like severe chills), especially jaw and legs.  That continued for over an hour.  After putting extra covers on top of me, shaking calmed down and I fell asleep, but frequently woke up feeling very hot, then very cold.  Headache got worse, as did nausea.  Next morning, sore all over from shaking, still had migraine.
outcomes: feeling very weak, fatigue for almost 4 months. menstruation is not normal, it's been spotty before flow and then stopped after two days and then flow again in another two days and last for almost 2 weeks.
still got the awful twitching; ringing in her ears got worse; heart racing lasted for weeks; fever stayed at 100 F after getting the booster shots; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE TWITCHING (still got the awful twitching), TINNITUS (ringing in her ears got worse), PALPITATIONS (heart racing lasted for weeks) and PYREXIA (fever stayed at 100 F after getting the booster shots) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient had no allergies. The patient had never been tested positive or diagnosed with COVID-19.  Previously administered products included for Drug use for unknown indication: Tylenol; for Product used for unknown indication: pneumococcal vaccine, FLU VACCINE VII (flu vaccine) and Shingles vaccine (Shingles vaccine). Past adverse reactions to the above products included No adverse event with FLU VACCINE VII, Shingles vaccine, Tylenol and pneumococcal vaccine. Concurrent medical conditions included Bronchiectasis.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCLE TWITCHING (still got the awful twitching), TINNITUS (ringing in her ears got worse), PALPITATIONS (heart racing lasted for weeks) and PYREXIA (fever stayed at 100 F after getting the booster shots). At the time of the report, MUSCLE TWITCHING (still got the awful twitching) and TINNITUS (ringing in her ears got worse) had not resolved, PALPITATIONS (heart racing lasted for weeks) had resolved and PYREXIA (fever stayed at 100 F after getting the booster shots) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 100 degree Fahrenheit.         No concomitant medications were reported.  On 15-Apr-2022, the patient received second booster dose of Moderna COVID-19 vaccine but the patient could not recall the date of administration of the first booster dose of Moderna COVID-19 vaccine.  The patient was afraid and had to decide whether the patient would get the bivalent booster dose or not, as the patient had experienced symptoms after the first 4 doses.  No treatment medications were reported.   This case was linked to MOD-2022-657512, MOD-2022-657532 (Patient Link).
Edema, erythemia extending down left arm around 4 inches below elbow. No neuro, circulatory, or movement abnormalities.
rash that moved from chest to her face; rash that moved from chest to her face with itching; Skin pain; itchy eyes; muscle ache; Weakness; Fever; Chills; Headache; abdominal pain; Heart palpitations; This case was reported by a other health professional via sales rep and described the occurrence of rash in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 2N9CT, expiry date 18th March 2022) for prophylaxis.   On 27th January 2020, the patient received the 2nd dose of Shingrix (intramuscular). In January 2020, 1 day after receiving Shingrix, the patient experienced rash, pruritus, skin pain, eye pruritus, muscle pain, weakness, fever, chills, headache, abdominal pain and palpitation. On an unknown date, the outcome of the rash, pruritus, skin pain, eye pruritus, muscle pain, weakness, fever, chills, headache, abdominal pain and palpitation were recovered/resolved.   It was unknown if the reporter considered the rash, pruritus, skin pain, eye pruritus, muscle pain, weakness, fever, chills, headache, abdominal pain and palpitation to be related to Shingrix.  Additional details were provided as follows: After receiving the 2nd dose of Shingrix patient experienced a rash that moved from chest to her face associated with itching and skin pain. The patient also experienced itchy eyes, muscle ache, weakness, fever, chills, headache, abdominal pain, and heart palpitations. The patient started experiencing the side effects the day after vaccination. The patient reported the events to the doctor's office on 29th January 2019. The patient had recovered completely. The reporter did not consent to follow up. This case has been linked with case US2020028071, reported by the same reporter.
post neck and upper back rashes Tp: BENADRYL 25mg  2-3 x 1 day Aveeno anti-itch  per rash
short of breath, extreme fatigue, hypoxic, heart palpitations, chest pressure,  light-headedness
This is after the 2nd vaccine - Right eye has been blurry (feels like there is a blurry film over it)  - no treatment at this time yet; I've tried eye drops but my it seems to move around but not go away. Eyesight is off. . My right shoulder (underside of arm) and right side of leg and right hip aches really bad. My wrists and my fingers in both hands in wrists and fingers hurt really bad - x-rays on these and doctor put me on Prednisone for this - it's a month taper. It's getting better with that.  Spongiotic Dermatitis - causes water retention under the skin and outside of skin raised but flat bumps that turn brown - they come and go; the prednisone I'm taking helps with that  - it's up my ankles to calves to thighs to inside left arm and outside of right arm was diagnosed; I have bruises below my knees; I'm still getting something on my scalp - it comes up and goes down - I put cortisone cream on legs and arm.  I have pitting in my fingernails.  Dermatologist - can't get in to him currently because of COVID so I'm going to another Dermatology next week so I can have someone look at my skin. My memory is not good - I can't remember things I was going to do. I forget what I need to do. I can't work because of all of this.  My right leg is really painful and my arm - on the outside - putting my shirt on is really painful. The pain moves to different areas of my body. I don't know where the pain will be next. Everything seems to be inflamed.  I had to see a psychologist. Will also see my psychiatrist to help with the anxiety I'm having. To see if I can get on another anxiety medication.  Note: I had first COVID vaccine 4 months before on 4/29/2021.
Patient states loss of apatite, flatulence, burping, feeling hot and sweating since day after Vaccine
parents describe sz like activity which resolved p/2-3min;eyes rolled back 7 was unresponsive;event resolved & reoccurred later;
patient felt weak and said his vision was blurry and that he could not hear well. I called 911 immediately because of my fear of possible stroke.   I lied him down and took his blood pressure because I was afraid he might faint. We gave him a granola bar and some water while he was sitting. He had not eaten at all before this so I think his blood sugar might have been low.  He was feeling better already before the ambulance came and they released him to home because he seemed to be fine when they arrived.
Redness with inflammation at injection site that became the size of a fist.  Patient used ice packs and Motrin.
This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in an unspecified number of patients who received FLULAVAL QUADRIVALENT (batch number 9K7E4, expiry date 30th April 2017). On 13th October 2016, the patient received FLULAVAL QUADRIVALENT. On 13th October 2016, less than a day after receiving FLULAVAL QUADRIVALENT, the patient experienced injection site erythema, injection site warmth and injection site swelling. On an unknown date, the outcome of the injection site erythema, injection site warmth and injection site swelling were unknown. It was unknown if the reporter considered the injection site erythema, injection site warmth and injection site swelling to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: The age at vaccination of the patients was not reported. Infection Control Specialist reported that out of the 33 Flu vaccines given on 13th October 2016, there were a fair number of local site reactions. She reported that there five to six patients who had redness at the site, warm to touch at the site and swelling at the site of injection. She would gather specific data on each patient and call back.
Swelling, redness, hot to the touch, pain at vaccine sites on bilateral deltoid area; bruising appearance.
Hepatitis A vaccine was ordered. The medical assistant erroneously administered  Tdap. Pt was notified of the error. She returned to the office to receive the Hepatitis A vaccine.  Pt previously had received a Tdap vaccine on 1/5/2021.
Patient's wife noticed red blotches on his arm and suspected hives. Patient brought back to Med OBs at 2:55, he was alert and vital signs were: HR: 63, BP: 134/51, SPO2: 99. denied itchiness, SOB, throat tightening, palpitations. Scattered dry, red blotches on bilateral arms.  Examined legs, back, and chest, no other blotches noted. Had patient wait with us for observation. At 1545 rechecked vitals: HR:65, BP:128/55, SPO2:98, patient had no further redness and continued to deny any symptoms. he felt he was ready to go home. discharged to home with wife. consulted patient and wife he could take Benadryl.
6-2-05 p.m. fever, chills; 6-3-05 3am headache, no Rx taken.  went to work - headache on and off.  Referred to pediatrician &/or E.R.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 06-Feb-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 06-Feb-2022; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 06-Feb-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 06-Feb-2022) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2022 at 3:18 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Feb-2022 at 3:18 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 06-Feb-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 06-Feb-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 06-Feb-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 06-Feb-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.     Concomitant medication of the patient was not reported.  Vaccine administration time was given as 15:18:58. . No treatment information was provided by the reporter.   This case was linked to MOD-2022-542869 (Patient Link).
Mom says injection site was warm and red with 1.5" of induration. Today in the office it measures 2.5". Will treat with BENADRYL and TYLENOL.
Rash-like heat rash appeared around waist and spread to legs, feet and to arms last. Did not get on my face, neck, chest or bottoms of feet or scalp. Under doctor's care since onset. Treated with 2 shots, pills and cream (methylprednisolone and triamcinolone). The 2 doctors who have treated me, don't know the cause of this rash which is almost gone except for a small patch on my leg and fading spots on top of my feet. Since I had called about this and it was in the time frame of the flu shot, I completed the form.
This case was reported by a pharmacist and described the occurrence of drug dose administration interval too short in a neonate male who received ENGERIX B pediatric. Concomitant products included ENGERIX B pediatric. On an unknown date, the patient received the 2nd dose of ENGERIX B pediatric. On an unknown date, an unknown time after receiving ENGERIX B pediatric, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown. Additional information received: Rph states infant received a second birth dose of ENGERIX-B. Rph did not have the lot number or expiration date of the vaccine.
This case was reported by a consumer via call center representative and described the occurrence of shivering in a elderly female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shivering. On an unknown date, the outcome of the shivering was unknown. It was unknown if the reporter considered the shivering to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that a friend of hers received SHINGRIX vaccine and reported to her that she shivered so bad that the bed rocked. For tolerance to next dose, refer case US2018GSK128827. This case has also been linked with US2018122089 reported by the same reporter.
tinnitus, R ear only. last about 3 - 6 months. Did not realize how long when it resolved.  also had fever, chills, myalgia.  asymptomatic after first vaccine 1/12/2021
Patient had intermittent, internal burning near cancer site treatment scar from day of vaccination for 2 days. 3/3 - 3/5.
I had no adverse events related to the flu shot itself. (oct.12, 2017). However, on Nov.27, 2017 I began to have symptoms of flu: sneezing, bad headache, bad head congestion, chills, fever (3degrees-4degrees above my normal), fatigue, coughing, running nose. My normal temp is 97.6 degrees F.
This spontaneous report was received from a medical assistant and refers to 62 year old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 22-APR-2016, the patient received dose of improperly stored ZOSTAVAX lot number L035283, expiry date: 15-DEC-2016; (the dose, dosage number, anatomical location and route of administration were not provided). The vaccine underwent temperature excursion of -13 degrees Celsius for 48 hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Back pain, chills, general body discomfort, headache, redness, swelling, and tenderness at the injection site, mild fever, muscle aches, sore throat, extreme tightness in chest.
The pt experienced a flushed face that was red, tingling scalp, spread to arms and was itching. The pt took Benadryl and felt better. Still had minor symptoms and rash on the day following the vax.
About 9 days after my injection I noticed a red ring around the injection site.  It got slightly bigger within 24 hours, to a diameter of less than 1 inch.  After 48 hours it was gone.  There was no itching or pain with the ring.
Information has been received from a physician concerning a 74 year old male with no medical history who was vaccinated with a dose of Zostavax (Oka/Merck). Concomitant therapy included aspirin. On 05-SEP-2007 it was reported that the patient developed shingles. Unspecified medical attention was sought. At the time of report the patient had not recovered. A product quality complaint was not involved. Additional information has been received from the physician who stated that the patient had an outbreak of herpes zoster after vaccination. At the time of report the patient was not recovered. The patient's experience was considered to be an other important medical event by the reporter. Additional information has been requested.
I have developed IBS symptoms 5 weeks following my shot. Also at the time of the shot my left arm and left side of my face went numb.
red rash; severe headache; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red rash) and HEADACHE (severe headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced RASH ERYTHEMATOUS (red rash) and HEADACHE (severe headache). At the time of the report, RASH ERYTHEMATOUS (red rash) and HEADACHE (severe headache) outcome was unknown.            Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-419257, MOD-2021-419298 (Patient Link).
Client had a vasovagal reaction x 3 seconds within 5 minutes post vaccination. Hx of fainting with blood draws and vaccination during her college years. client stated tingly on left upper chest for just a few seconds. denies chest pain, shortness of breath or dizziness. Client vitals were take at 15:26 with spo2 97, pr 54, BP 147/62, vital #2 at 15:31 spo2 98, pr 67, BP 140/85, vitals #3 15:48 spo2 98, pr 71, bp 150/88. Client was advised to go to an urgent care/ emergency room for further monitoring. Client's son will be transporting.