chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient requested Shingrix vaccine, but due to miscommunication was administered a COVID vaccine. She had previously completed her 2 dose series of the Pfizer vaccine on March 29, so this constituted a third dose. She began experiencing general body aches on the day following administration (May 1), then also experienced fatigue and swelling at the injection site on May 2. These symptoms mostly resolved by May 3.
A few hours after improper administration technique, had severe pain and loss of range of motion.  Had taken pain medication and NSAIDS as well as cold compress.  After one week of continued pain and decreased ROM, notified my nurse manager.  After two weeks, had been seen at corporate health office.
Hive like rash in a dermatomal distribution on the contralateral side of the body (L lower abdomen).
Initial and follow up information has been received from a physician and a pharmacist concerning the pharmacist's daughter, a 15 month old female, with no reported medical history or allergies, who on 21-NOV-2007 at 09:45 was vaccinated intramuscularly into the right anterior thigh with a third 0.5 ml dose of COMVAX (Lot# 657380/0377U). Concomitant medication given intramuscularly into the lateral anterior thigh included a fourth dose of PREVNAR (Lot # B540071H). "Within 24-48 hours," her leg became hard at the injection site on the right anterior thigh. She had a "marble like" feeling at the injection site." On 22-NOV-2007 the patient experienced redness and swelling of the thigh at the injection site on the right anterior thigh. No diagnostic laboratory studies were performed. On 28-NOV-2007 the patient recovered. No product quality complaint was involved. No further information is available.
flu like symptoms for 1 day (no date given) day after covid booster; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP), Program ID. The reporter is the patient.  A 59-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number unknown, MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered", described as "flu like symptoms for 1 day (no date given) day after covid booster". Additional information: Patient took Xeljanz 5mg once daily, Oral from May2021 to current for rheumatoid arthritis per MD instructions, differs from manufacturer recommended 5mg twice daily. MD aware. Patient reported flu like symptoms for 1 day (no date given) day after covid booster. Patient agreed that it was hard to cope with rheumatoid arthritis and sometimes felt discouraged/depressed (no dates given). Unsure if md aware. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
slightly sore arm/had the same problems with different symptom; they were so chilled, and under the covers; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "slightly sore arm/had the same problems with different symptom"; CHILLS (non-serious), outcome "unknown", described as "they were so chilled, and under the covers".  Additional Information: Reporter seriousness for slightly sore arm, felt so depleted she couldn't get out of bed and they were so chilled, and under the covers was unspecified. She got the first shot of the Pfizer-BioNTech COVID-19 vaccine she didn't have a problem except for a slightly sore arm. Agent reports caller said after the booster dose she felt so depleted she couldn't get out of bed, and mentioned that she was immunocompromised so she will need to get a fourth vaccine, but she hasn't gotten that. After the first dose, she would turn over in bed and think she shouldn't have, it was mild, and when she woke up the next day it was gone, it was not a big deal. She says this happened both times, with her first and second dose, and no treatment was needed, it was a mild inconvenience. she was depleted after her booster dose and had to drag herself out of bed the next day. She says she knows someone who also had no problems with the first two doses, and then the booster put her away.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Initially kind of soreness in right arm, (left handed). Sunday, head started hurting, started having body aches, stomach ache.  Then it moved to both arms, and entire body, nauseous.  By Monday, really getting worse and at night extremely uncomfortable and not wanting to get up in the morning.  Tuesday, off work and still having symptoms throughout the day.  Went to the chiropractor and stated she was tight.  Also got PT and said the same thing, she was very tight in her muscles.  Today, Wednesday she's feeling better.   Called employee health and notified them.
Irregular heartbeat.  Diagnosed as PAC from Pericarditis (VERY rapid onset) after 75 minute treadmill walk less than 48 hours after 2nd dose.
Blurred vision started a week after, then 3.5 weeks later noticed tremor in both hands Narrative:
Reaction to right thigh 15x11 red, hot, swollen: DTaP
Waxing and waning bilateral pulmonary infiltrates COVID infection December 2021.   concerned that he could have still some smoldering COVID infection.
Redness and swelling at injection site that appeared 6 days after 1st dose of Pfizer vaccine.  No pain or itching.
I did not have any adverse reactions to the moderna vaccine except localized pain at injection site. I wanted to let you know because I had such a horrible reaction to the Pfizer second shot. I chose this because that have the original dose for the booster.
Employee reported reaction to Covid Moderna booster today, 12/22/21.  Her Moderna booster was given on 12/10/21.  With her first two doses, she only had a headache following the administrations.  With booster dose on 12/10/21, the following happened:  Horrible pain right shoulder blade and side and right breast area for a week.  Pain was intense?like shingles pain.  No rash or redness.  At injection site on right arm, employee reports that it was hard as a rock and red?the size of half dollar.  Still having some pain on 12/22/21 when reported, but able to wear bra and clothes now.
pt came in 5/4/21 to talk about her moderna vaccine. she received 1st dose on 4/6/21 and reported that she developed a itchy rash all over on 4/10. she tried chinese herbs to help with itching and rash was resolved within 24 hours. we checked guidance together regarding second dose which she has scheduled and the possiblity of trying benadryl to help with an itching or allergy response after second dose
KEY SYMPTOMS AND ASSESSMENT: 1 week now hasn't been able to eat, or drink, last vomited yesterday, dry coughing, bodyaches, sore throat, headache, feels dizzy, shakey, feels hard for her to breath,       PERTINENT HISTORY: Vaccinated Pfizer 2/28/2021 and 3/21/2021  -  11/11/2021  TAV - cough    -  11/11/2021 Covid test still in process  - 11/11/2021 went to ER, left without being seen     OTHER: Taking sips of water so far tol well         Per MD ok for VAV/TAV if breathing worsens needs to go back to ER, member informed and verbalized understanding
Appendicitus; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 8-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Dec2021 (Batch/Lot number: unknown) at the age of 8 years as dose 2 (tris), single for covid-19 immunisation. Relevant medical history included: "Allergy-Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (prev dose product: COVID 19, prev dose Brand unknown: True, Prev dose Brand name unknown: COVID 19 Vaccine,, prev dose brand unknown: True, prev dose lot unknown reason: Not available/ provided to reporter at the time of report completion,, prev dose administration date: 23Nov2021, prev dose number: 1, prev dose vaccine location: Right arm), administration date: 23Nov2021, when the patient was 8 years old, for Covid-19 immunization. The following information was reported: APPENDICITIS (hospitalization, medically significant) with onset 03Feb2022 18:30, outcome "recovering", described as "Appendicitus". The patient was hospitalized for appendicitis (hospitalization duration: 2 day(s)). The event "appendicitus" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: magnetic resonance imaging: unknown results; sars-cov-2 test: negative; ultrasound scan: unknown results. Therapeutic measures were taken as a result of appendicitis. Patient did not receive any other vaccine in four weeks. Patient did not receive any other medications in two weeks. The facility type vaccine was doctor's office/urgent care. Patient was treated with IV, MRI, Ultrasound and Antibiotics. Patient did not had covid prior vaccination. Patient was tested negative for covid via nasal swab test post vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fever/Her temperature was 100.4; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 31Aug2021 16:40 (Lot number: FC3183) at the age of 39 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Severe migraine" (ongoing), notes: Verbatim: Severe migraine and vertigo; "vertigo" (ongoing). There were no concomitant medications. The following information was reported: PYREXIA (non-serious) with onset 01Sep2021, outcome "unknown", described as "Fever/Her temperature was 100.4". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia.  Additional information: Reporter is other HCP. Patient stated she was calling because the information she has indicated to call to report a side effect if it is not listed on the paperwork. The paperwork she has does not list anything about getting a fever. She did not specify what paperwork she had. She was calling to report getting a fever, a temperature. Event Details: She mentioned the fever started about ten minutes ago. Her temperature was 100.4. Treatment/Intervention: None. Product Details: This was her first dose. She got it yesterday. Time the vaccination was given: 4:40 PM. Anatomical Location: Upper left arm. Patient did not receive any other vaccine within 4 weeks prior vaccinations.  No follow-up attempts are possible. No further information is expected.
First dose: 3/18/21 Second dose: 4/15/21 A little over a month ago I started experiencing frequent heart palpitations/fluttering and the feeling of a fast heart beat, even when I check and my heart rate is normal. I went to my Doctor last week and my Lisinopril dosage was increased. I will continue to monitor and follow-up with my Doctor. As of today the symptoms have been continuing.
For some strange reason unknown to me, I get horrible headaches. I drink water, have always been healthy, I am aware that this might be something with age but it did not start until after the vaccine. It got so bad after the vaccine that I had to call my doctor, but they never went away and it's been over a year.
Cough- X5days Using Trelegy. Wheeze x5 days, mild congestion x6days
12hrs after shot-fever of 101 degrees night sweats throughout night chills, shaking, fever over next 3 days - dull constant headache across forehead, extreme fatigue over next 3 days. 4th day went to Doctor as I had never had anything this long. No appetite. Drank lot of fluids. If I did not take 1 ADVIL and 1 xstrength TYLENOL every 5 hours the headache, chills and fever would return. Its now 1 week later.
Vial was initially stored in the refrigerator on 11-Jan-2022 and administered on 13-Apr-2022; Vial was initially stored in the refrigerator on 11-Jan-2022 and administered on 13-Apr-2022/Dose administered after 30-day Use By Date; 1st dose given on 09-Feb-2021 and 2nd dose given on 10-Nov-2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vial was initially stored in the refrigerator on 11-Jan-2022 and administered on 13-Apr-2022/Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 11-Jan-2022 and administered on 13-Apr-2022) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose given on 09-Feb-2021 and 2nd dose given on 10-Nov-2021) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 035C21A and 011M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose given on 09-Feb-2021 and 2nd dose given on 10-Nov-2021). On 13-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vial was initially stored in the refrigerator on 11-Jan-2022 and administered on 13-Apr-2022/Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 11-Jan-2022 and administered on 13-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vial was initially stored in the refrigerator on 11-Jan-2022 and administered on 13-Apr-2022/Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 11-Jan-2022 and administered on 13-Apr-2022) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose given on 09-Feb-2021 and 2nd dose given on 10-Nov-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  The patient received 1st booster on 13-Apr-2022. The vial was stored initial in the refrigerator on 11-Jan-2022. The vial undergo did not any temperature excursions.  It was reported that patient did not reported adverse reaction.  Treatment information was not provided by the reporter.
Redness/erythema of upper arm - (R) upper arm with slight induration surrounding the injection site. No tenderness. Started the night following the vaccine administration. Mild itching. NO fever or systemic signs. Benadryl PO PRN given.
feeling sick.; feeling dizzy frequently; c-reactive protein high; second shot on February 13, 2020 / second shot a second time on September 21, 2020; This case was reported by a consumer and described the occurrence of feeling unwell in a 84-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 3rd october 2019) and Shingrix (2nd dose received on 13th february 2020).   On 21st September 2020, the patient received Shingrix. On 21st September 2020, unknown after receiving Shingrix, the patient experienced extra dose administered. On 22nd September 2020, the patient experienced feeling unwell, dizziness and c-reactive protein increased. On an unknown date, the outcome of the feeling unwell, dizziness, c-reactive protein increased and extra dose administered were unknown.   It was unknown if the reporter considered the feeling unwell, dizziness and c-reactive protein increased to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix on 21st september 2020 and experienced feeling sick ,feeling dizzy,c-reactive protein and extra dose administered. The patient received the first Shingrix shot on 3rd October 2019 and second shot on 13th february  2020 according to his diary but hs doctor did not kept a record. The doctor assured him there would be no problems if he got it for second time. The day afterwards patient  went for the Lab for test for creactive protein has been 1 for last 10 years and after the second dose it was 13.8. The reporter did not consented to follow up. No further information was available.
Experienced chest and joint  pain that gradually became worse several days after the vaccine. Went to local ER at 03:30 on 4/9 due to severe chest pain, left arm pain, and shortness of breath. Vital signs were normal and stable, but had severe shortness of breath. Was given a breathing treatment. Chest CT was done due to an elevated D-Dimer level. Sent home without resolution. Continued with severe pain, shortness of breath, and inability to complete simple daily tasks. Went back to ER 2 days later for rapid heartbeat and continued severe chest pain. EKG. Vital signs were again normal. Followed up with my doctor and a cardiologist two weeks later. Blood   pressure was very high during both visits (previously controlled) and changes were made to medication. Severe joint pain continued until 6/3/21
Large localized reaction at injection site. Pain, swelling, redness, lumps under the skin and intense itching lasting for just over 1 week and unresolved but slowly improving. Initial reaction was approximately 10 cm in diameter and lasted for 5 days. Current reaction is approximately 5 cm but itching is worsening.
inflammed lymph node under arm of injection site; general malaise; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 37 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 Immunization.  The following information was reported: LYMPHADENITIS (non-serious) with onset 31Oct2021, outcome "recovered", described as "inflammed lymph node under arm of injection site"; MALAISE (non-serious) with onset 31Oct2021, outcome "recovered", described as "general malaise". Therapeutic measures were not taken as a result of lymphadenitis, malaise.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not tested positive for covid 19 prior to vaccination and had not been tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recv vax; broke out in rash on both arms eventually, inject site of TD pinkish; 2" size w/ definite edge;wheals; rash on knees; disappeared on 16may95;
01/10/02 rash on legs, arms, trunk, back, face, temperature 98.5, eating well, not fussy, normal behavior, happy, cooing, sleeping well, not irritabl
pulsatile tinnitus, migraines, diarrhea x 4 days
Redness & swelling at Inj site back of Lt arm began about 8pm. Size of 50mm in diameter. C/o itching.
CHILLS, FEVER, SPIKING TO 101, FATIGUE, JOINT STIFFNESS, LOSS OF APPETITE, NIGHT SWEATS CONTINUING  3 DAYS
Patient received Covid Vaccine approved for 12+ SDV instead of  the recommended Covid Vaccine  6month-11 yr. No side effects reported to clinic after the vaccine was administered. no further treatment required per Health care provider
Pregnant patient received the first dose of moderna covid-19 vaccine; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant patient received the first dose of moderna covid-19 vaccine) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 21-May-2020 and the estimated date of delivery was 26-Feb-2021. On 22-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant patient received the first dose of moderna covid-19 vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-fifth week of the pregnancy.  On 22-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnant patient received the first dose of moderna covid-19 vaccine) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jun-2020, Pregnancy test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant treatment medications and concomitant medications were reported.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 32-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Patient have rash all over; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Patient have rash all over) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced RASH (Patient have rash all over). At the time of the report, RASH (Patient have rash all over) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Rash is consistent with the known safety profile of mRNA-1273.
pt recvd vax & devel rash; presented to clinic 9 days p/vax w/rash over most of body; tx DPH & Pred;
2/21 patient presented for leg weakness. Patient had UTI on work up treated with antibiotics. Patient discharged 2/22. Per EAU, hospitalizations are to be reported irrespective of attribution to the vaccine
Approximately 2 months after my 2nd booster shot (Dose 4) I tested positive for COVID-19 and had the following symptoms: Fatigue, Cold like symptoms (stuffy nose, etc.), Low grade fever and Diarrhea. I took TYLENOL for treatment and called my primary care for consultation and she advised me to take PAXLOVID and it did help me to feel better. As of today 05/6/2022 my symptoms are pretty much gone except for my fatigue.