chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shingrix adjuvant only without the lyophilized antigen; Shingrix adjuvant only without the lyophilized antigen; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate dose of vaccine administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered and inappropriate preparation of medication. On an unknown date, the outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.  Additional case details were reported as follows: The age at vaccination was not reported. A pharmacist reported that a patient received a dose of the Shingrix adjuvant only without the lyophilized antigen which led to inappropriate dose of vaccine administered and inappropriate preparation of medication. No symptoms were reported. The reporter consented to follow up. This case was 1 of 12 case reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR179303:Same reporter US-GLAXOSMITHKLINE-US2021AMR179300:Same reporter US-GLAXOSMITHKLINE-US2021AMR179306:Same reporter US-GLAXOSMITHKLINE-US2021AMR179305:Same reporter US-GLAXOSMITHKLINE-US2021AMR179304:Same reporter US-GLAXOSMITHKLINE-US2021AMR179302:Same reporter US-GLAXOSMITHKLINE-US2021AMR179301:Same reporter US-GLAXOSMITHKLINE-US2021AMR179297:Same reporter US-GLAXOSMITHKLINE-US2021AMR179299:Same reporter US-GLAXOSMITHKLINE-US2021AMR179298:Same reporter US-GLAXOSMITHKLINE-US2021178442:Same reporter
18 hrs after shot pt felt chest pain, tense, cold symptoms, and nausea.
Fever is 102.8; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (Fever is 102.8) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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 PYREXIA (Fever is 102.8). At the time of the report, PYREXIA (Fever is 102.8) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102.8 (High) Fever is 102.8.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Patient stated her reaction started the next day 4/15/2021 with a very sore arm along with a burnt tongue, rough and swollen tongue. Patient  thought she had just burnt her tongue on her coffee but as the day went on, she noticed her tongue was still very sensitative.   Saturday 4/17/2021 Tip of her tongue was numb  Sunday 4/18/2021 -- Blueish color tongue   Monday 4/19/2021 Anything the patient ate tasted like burnt peanuts along with her tongue still feeling funny  Tuesday  4/20/2021 Still experiencing the same symptoms as listed above  Wednesday 4/21/2021 Patient has a swollen tongue, lips and face.  Thursday 4/22/2021 Patient went to see PA at medical clinic -- due to her symptoms. The PA said she is having a reaction from the vaccine.
extreme swelling, tenderness, warmth of lt upper arm from shoulder to elbow-very tense w/overlying petechiae @ inj site-recommended DPH & ice;
black and blue very sore. Lump is tender. It is still a little black and blue today 2/19
A few minutes after receiving her vaccine, the patient complained of nausea,  rapid heart rate (pulse was 97), shivering and dizziness.   We continued to observe her for 25 minutes at which time her symptoms did not improve and 911 was called at the request of her husband.  EMS then transported patient to the hospital.
This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 75-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included back surgery (in 2003). Previously administered products included SHINGRIX with an associated reaction of pruritus generalised (For 1st dose, refer case US2019025966). On 4th September 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema and itchy upper limbs. The patient was treated with Anti-Itch Medication. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site erythema was recovered/resolved and the outcome of the itchy upper limbs was not recovered/not resolved. It was unknown if the reporter considered the injection site erythema and itchy upper limbs to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, but it could be 74 or 75 year old. The patient received vaccine on left arm. She experienced itching with the first dose of the SHINGRIX, and it had continued after receiving the second dose of the SHINGRIX vaccine. The patient experienced itching that was associated all throughout the body. The itching occurred on different parts of the body such as arms, legs, shoulders, and face. At the time of reporting, the patient experienced itching from her right arm and down to elbow and the wrist. She felt like spiders crawling on it. She visited her doctor (the previous week before the date of reporting) and she had been prescribed anti-itch medication. The patient also experienced wide pink area measuring 6 inches long and 2 to 3 inches wide at the injection site. She stated it lasted for about 2 weeks with both the doses. The patient received another medication to calm down the itching that she still had months later. The patient believed it was important to put this as some sort of contraindication on the sheets that were given to people when they were administered SHINGRIX so that they would be aware if experienced same kind of reaction. The reporter did not consent to follow-up. And no further details were provided. The patient was referred to health care professional.
I started getting spots on my toes - red spots. I had heard of COVID toes - and I thought it looked similar to that. It started on one foot. I had two spots for about a week and one morning I woke up I had 10 spots on both feet. Started out small and they got bigger and bigger and they turned into scaly sores. I took pictures to document how my feet looked. They were itchy sometimes. I went to on about January 23rd to Medical Center  ER and they prescribed a cream and I'm not remembering the name of it - a steroid cream. The cream did nothing. It took about one month for all of the spots to go away.
moderna arm, lump on vaccination site, redness for 5 days, swelling, cellulitis,
At injection site was no effect, only a scab, however approximately 2 inches below injection site is a 2 inch diameter bruise that did not disappear after 5 days. The area was also red and swollen, with a "hard lump" underneath that is painful to touch. Affected area also felt hot. After a week since injection, the skin around the adverse area became dry, with mild skin flakes forming. The bruise and pain growing as time went on.   At home treatment included an ice pack for 15-20 minutes daily for 2 days. 1,000 mg of over the counter Tylenol Acetaminophen daily for 4 days.  Adverse effect ended after 10 days since injection date. Currently only a very mild pain when lifting right arm up. Area no longer is painful to touch.
She woke up on 01/21/2022 with severe headache and sore throat a couple of hours later she started vomiting. I did the home test that morning and it was negative. Later that afternoon I took her the doctor who did a strep and flu test that came back negative. She was prescribed Zofran and slept the rest of the day and was treated as like it was a stomach bug.  The next day she woke up and felt completely fine except for a little bit nasal congestion. The following morning on Sunday 01/23/2022 she seemed a little more congested and I swabbed her again and that test was positive but she did recover quickly after that. Her max temp was 100.
No adverse effects were reported.; Patient was administered improperly stored PROQUAD; Information has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, previously drug reactions, allergies, concurrent conditions and concomitant medications were not reported.      On 17-JUN-2019, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA(PROQUAD) (lot number was S003170,expiration date was 30-JUL-2020) (strength, anatomical location, dose and route of administration were not provided) for prophylaxis, that was reconstituted with sterile diluent (product storage error).   The measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA(PROQUAD) was stored at a temperature range of -9 degrees Celsius (°C) to 8°C (-3°C), for the time frame of 3 hours and 39 minutes. There was no previous temperature excursion and the call was because of a data logger.   No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA008695: US-009507513-1906USA008644: US-009507513-1906USA008643: US-009507513-1906USA008790: US-009507513-1906USA008791: US-009507513-1906USA008722: US-009507513-1906USA008903:
Chills started at 7pm, low grade fever 99.8 7pm, 99.3 at 8:20, some hip stiffness, same time
A large (4"x 8") welt raised on her left, upper arm. The welt is hot, red, and definitely raised. Painful to touch or arm movement. She states it is very, very itchy. Today is day 4 after injection and she still has the welt with redness, warmth, pain, itching, and raised welt still there. Welt is firm to touch.
came down with covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (non-serious), 4 days after the suspect product(s) administration, outcome "unknown", described as "came down with covid".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Puffed/swollen and itchy left eyelid at 11:06pm and swelling of the throat. Symptoms did not get significantly worse by 2am so I went to sleep and did not seek medical attention. Did not take any medication as didn?t have any Benadryl or anything available
Case number PHEH2014US021983 is an initial spontaneous report received from a pharmacist on 29 OCT 2014. This report refers to a 58 year old female patient. Her past medical history and concomitant medications were not reported. On 29 OCT 2014, she was vaccinated with FLUVIRIN 2014/2015 (batch number: not reported) at a dose of one ml intramuscularly. No adverse events were reported following the administration of overdose.
Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' concurrent condition, medical history and concomitant medication were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (dose and route were unknown, lot # M010485 with expiration date 01-MAR-2018, and lot # L043622 with expiration date 03-NOV-2017). The vaccines were exposed to temperature excursion of 7.8 degrees Fahrenheit (F) for 5 hours and 30 minutes, and 17.4 degrees Fahrenheit (F) for 4 hours and 30 minutes. No previous temperature excursion was reported. Data logger was involved. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
I just had a scratchy throat and then it went away and I started experiencing some achiness but I noticed my eyes got really red and had sinus pressure and congestion.  I took a shower and I felt better and that was it and like 2 days later I got up and didn't feel well and just thought I needed to go get a shot.  I went to the urgent care and tested me for COVID-19 and Flu and I was positive for the COVID-19.  They prescribed me a Z-pack and DM medication and that was for a decongestion cough syrup.   I did receive the infusion on 7/15/22.
The day after the injection I started felling disoriented and suffering from what I call a mind-body disconnect.  Walking was unsteady and organizing thoughts was difficult.  This was my primary symptom with the infection which lasted through 02/16/2021.  The last three days were spent in the Covid-19 unit of a local hospital after which the symptoms disappeared.  The day after the vaccination, the symptoms came back but only lasted for about 24 hours.
Sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Previously administered products included Flu shot with an associated reaction of illness (After received 1st Flu shot patient was sick and coming down, refer case US2020AMR225527).   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced sickness. Rechallenge with Influenza vaccine Quadrivalent unspecified season was positive. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: Age at vaccination was not reported. After the 1st shot of Flu, in next year the patient taken the flu shot again, The patient was so sick it was a reaction. The patient never too the shot again and never got the flu.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR225527:Same patient
This is a spontaneous report from a contactable consumer or other non-health care professional (Patient).  A 43-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0173; Batch no: not reported), via an unspecified route of administration, administered in Arm Right on 04May2021 (at the age of 43-years-old) 12:00 as dose 2, single for covid-19 immunization. Medical history reported as none. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination was yes. Covid prior to vaccination was reported as No. Covid tested post vaccination was Yes. Covid test post vaccination tested with Nasal Swab was Rapid/Molecular. No known allergies reported. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient was tested for COVID-19. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER8737; bath no: not reported), via an unspecified route of administration, administered in Arm Right on 13Apr2021, 12:00 PM (at the age of 43-years-old) as dose 1, single dose for COVID-19 immunization. The patient stated as he was fully vaccinated and got covid pretty bad, muscle aches on 10Aug2021, along with 9 others from his work. Adverse reactions as follows: Day 1 patient woke up with a sore throat on 07Aug2021. Got a text from her boss in the evening saying 2 people were tested positive for covid. Day 2 patient Woke up with chills (around 4am), headache, Stuffy nose on 08Aug2021. Day 3 patient Ran a 101.6 fever, sore throat, loss of taste and smell, chills/shaking at night, weakness on 09Aug2021. Day 4 same symptoms as the other days Fever of 101.7, weakness, muscle aches, Chills, Microbiology test came back positive for Covid 19. Day 5 same symptoms but fever subsiding. 100.2. Day 6 just starting to feel better, no fever, still no taste or smell, headache, stuffy nose. Therapeutic measures were not taken for the events caused. The patient underwent lab tests and procedures which included body temperature: 101.6 on 09Aug2021, body temperature: 101.7 on 10Aug2021, body temperature: 100.2 on 11Aug2021, sars-cov-2 test: positive on 09Aug2021 with Nasal Swab Rapid/Molecular for Covid-19. The outcome of event Got covid pretty bad, muscle aches, sore throat, chills, headache, Stuffy nose, Ran a 101.6 fever, loss of taste and smell, shaking at night and weakness was recovering. Follow-up attempts are completed. No further information is expected.
pt inadvertently recvd 5 ml (instead of 0.5ml) flu vax & exp erythema @ the inject site & resp distress; pt was recovering from pneumonia @ the time of vax;
Pt was given PROQUAD on the outer left thigh. About 12 hrs later area was quite swollen and red. Low grade fever. BENADRYL was given.
Patient started to have secondary nocturnal  enuresis starting the night after he received the first dose of the 5-11 year old Pfizer COVID vaccine. He had previously not had any nocturnal enuresis for over a year. The secondary nocturnal enuresis lasted for a little over a week, then resolved.
per discharge summary  pt given covid vaccine 6/21/21. experienced nausea, vomiting, diarrhea, fever,. These symptoms went away within a day then on 6/25/21 pt was at work and experienced sharp chest pain, shortness of breath, and dizziness. Positive troponin mildy elevated. Discharged at stable condition 25 hours later. Followed up with PCP (MD.)  Pt diagnosed with myocarditis.
continuous pain for 4 months; This case was reported by a consumer via call center representative and described the occurrence of pain in a male patient who received Herpes zoster (Shingrix) (batch number H552G, expiry date 20th September 2022) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was not recovered/not resolved.   The reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported that, he had continual pain for 4 months after receiving the first shingrix vaccine. The reporter would not provide any demographic information. No further adverse event information was provided. The reporter did not consent to follow-up.
Initial unsolicited report received from a nurse on 29 Nov 2016. This case involves a female patient (age not reported) who was vaccinated with a dose of FLUZONE QIV (batch number: UT5673NA, expiry date: 30 Jun 2017, dose, dose in series, were not reported) intramuscularly in left deltoid on 22 Nov 2016. Illness at the time of vaccination was reported as no and pre-existing physician diagnosed allergies, birth defects, medical conditions was no known allergy. Concomitant medications were not reported. On 22 Nov 2016, immediately (since vaccination) following the vaccination, the patient had metallic taste. It was reported that, no other sx reported referred to PCP. The patient's laboratory data and corrective treatment was not reported. The patient was not recovered from the event. List of documents held by sender: none.
Fainted in the shower while shaving; This is a spontaneous report from a contactable consumer (patient). A 22-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 13Apr2021 at 11:00 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient fainted in the shower while shaving on 14Apr2021 at 15:30. There was no treatment received for the event. The outcome of the event was recovering.   Information on the lot/batch number has been requested.
UrticariaPruritus right eye swelling and itching employee presented to ED day after vaccine. was given prednisone and hydroxyzine.
This infant had consistent high pitched crying for 3 1/2 - 4 hours.
No additional adverse events; The nurse is reporting the patient was inadvertently administered a dose of RECOMBIVAX, on 6/10/2020, that had been improperly stored; Information has been received from a registered nurse regarding a male patient of unknown age. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 10-JUN-2020, the patient was vaccinated with an improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) injection, for prophylaxis, lot number R028384 with expiration date in 08-JUN-2021 (route of administration, strength, frequency and anatomical location were not reported).  The hepatitis b vaccine (recombinant) (RECOMBIVAX HB) was stored at a temperature of 10 degrees Celsius (°C) for the time frame of 7 hours and 10 minutes. There was no previous temperature excursion and the call was because of a data logger.   No additional adverse effects reported.
pt recv vax & devel a red circle (5cm) @ the inj site;pt recovered;
Expired vaccine administered to 11 patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 11 patients) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 11 patients). On 16-Mar-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 11 patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.
The morning following routine vaccination, the child became lethargic with cold, clammy skin. He fainted. Child became more alert once a cold damp wash cloth appeared to forehead. he was then given breakfast. No other events occurred since the time of fainting.
Moderna Covid-19 Vaccine  Day after vaccine, woke with low grade fever, sore arm & fatigue.. By the end of the day injection site was swollen, red, and warm. Next day swelling was worse & painful to touch. Swelling of lips started with scratchy/sore throat & perineum swelling - endo of day 2. Took antihistamines, Tylenol, ibuprofen & prednisone. Day 3 symptoms started to abate. Arm with less swelling & lips less puffy.
11/02/2021 I had a stuffy nose 11/03/2021 I noticed I had no taste and no smell.  That lasted till now, I have just now started to regain tasted and smell as of today. 11/06/2021 I had the infusion done.
Pt developed hives at the injection site and trailing several inches down the arm and around the bicep.