chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Left arm became slightly sore evening after flu and pneumo vaccine. After a week arm pain became more severe and has continued to get worse. Patient now can't raise arm, arm has had swelling and heat. Saw MD on 11/12/14 regarding pain. Patient reported symptoms to MD (made appointment because arm pain was so severe) on Wednesday, 11/12/14. Patient notified pharmacy on 11/16/14 consulted patient to take ibuprofen 200mg - 2 tabs 3x daily for next 3 days and I will contact MD and vaccine manufacturers for addition treatment recommendations. Patient will follow up on Wednesday 11/19/14 if we do not contact before then with additional info. At MD visit, Dr. advised patient to apply heat. Symptoms have not gotten any better (still having severe pain and cannot raise arm). 11/20/14: Patient is on day 3 of MEDROL dose pack and has not had any improvement in her arm. Will continue dose pack. 12/10/14: Patient is still experiencing pain in her (L) arm that is preventing her from lifting, bearing weight and performing daily tasks; she cannot lay on her (L) side due to pain.
Left arm tinging sensation. monitored for 30 mins vitals taken.  reports improvement in symptom
Itchiness in the injection arm; Had itchy in her vaginal area; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (Itchiness in the injection arm) and VULVOVAGINAL PRURITUS (Had itchy in her vaginal area) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 006M20A) for COVID-19 vaccination.     Concurrent medical conditions included Lymphoma.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itchiness in the injection arm) and VULVOVAGINAL PRURITUS (Had itchy in her vaginal area). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) for Itching, at an unspecified dose and frequency and ALCOHOL for Itching, at an unspecified dose and frequency. At the time of the report, PRURITUS (Itchiness in the injection arm) and VULVOVAGINAL PRURITUS (Had itchy in her vaginal area) outcome was unknown. Not Provided          HCP recommended that she need a surgery because its look like a cancer and surgery was scheduled on 29 April 2021.  No concomitant medication was reported.  Action taken with mRNA-1273 in response to the event was not applicable.
redness and itchiness intense for 14-12 hrs. Patient took Claritin 10mg  to decrease itching
Extreme swelling, Redness at injection site, Chills, Fever at injection site, Loss of use of left arm, Nauseated, Extreme soreness at injection site.
There was no adverse event. The vaccine had gone through one freeze thaw excursion. After speaking with Pfizer and reading the information they provided, the safety and efficacy of the vaccine was not affected.
Injection site hot/red/swollen/hard 3-days after injection Patient experienced low grade fever.
Painful arm (L) aches for a month plus; fast heartbeats; weakness; fatigue etc.
Severe body aches fever w/ chills headache dizziness weakness diarrhea. Motrin for aches and pain water to keep hydrated
Information has been received from a RN concerning a pt who on 13Feb1996 was vaccinated with a dose of varicella virus vaccine live (lot 612214/1124B). Subsequently, on 28Oct1999, the pt developed chickenpox. The pt was seen in the office.  The reporter also indicated that 30 other pts were vaccinated with varicella virus vaccine live and developed chickenpox (WAES0409USA00600, WAES0409USA01045, WAES0409USA01046, WAES0409USA01047, WAES0409USA01048, WAES0409USA01049, WAES0409USA01050, WAES0409USA01051, WAES0409USA01052, WAES0409USA01053, WAES0409USA01054, WAES0409USA01055, WAES0409USA01056, WAES0409USA01057, WAES0409USA01059, WAES0409USA01060, WAES0409USA01061, WAES0409USA01062, WAES0409USA01063, WAES0409USA01064, WAES0409USA01065, WAES0409USA01066, WAES0409USA01067, WAES0409USA01068, WAES0409USA01069, WAES0409USA01070, WAES0409USA01071, WAES0409USA01072, WAES0409USA01073, WAES0409USA01074). No further information is expected.
The patient reports that at 2 am on 5/18/2021 (approximately 36 hours after his second dose) he woke up with chest pain and fever to 101.3.  The chest pain was described as a constant throbbing around the sternum.  He was treated with ibuprofen and he did not participate in online school that day.  Mom called in to his primary care provider's office in the morning.  At the time, the potential for post-vaccine myocarditis was not well recognized.  They advised Rolaids or Tums, recommended ED evaluation if worsened.  He felt better after resting, and the chest pain seemed to resolve by the morning of 5/19/2021.  He felt enough better that day that he tried to do his assignment for his online gym class, which was to go out and run a mile.  He developed a significant recurrence of the chest pain that lasted for another 2 to 3 days.  He just took it easy, and by about 5 to 7 days after the second vaccine dose, he was feeling back to himself.  He continued to participate in his gym class for the rest of the academic year without difficulty.  He was evaluated in Cardiology ono 3/28/2022 (approximately 10 months later) and had a normal exam, EKG and echocardiogram.
This case was reported by a nurse via sales rep and described the occurrence of muscle pain in a adult 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 muscle pain. On an unknown date, the outcome of the muscle pain was recovered/resolved. It was unknown if the reporter considered the muscle pain to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported. The patient presented with severe muscle pain for 5 to 6 months followed by a dose of SHINGRIX. The patient felt like muscle was tearing with arm movement. The patient received 2nd dose of SHINGRIX vaccine with no issues. The reporter did not agree to follow up from GlaxoSmithKline.
PT has severe arm pain, joint pain, unable to move her left arm. Pain 9/10
Headache, Myalgia, NauseaVomiting, chills, stomach cramps Narrative:  Used OTC tylenol
Information has been received from a medical assistant referring to unspecified patients of unknown age and gender. There was no concurrent condition or medical history reported. The reporter was reporting 2 doses of MMR II (lot # L026551, expiration date 16-JUL-2017) (dosage, strength and route unknown), that had been improperly stored (temperature and time frame: 34 degree F for 3 hours 24 minutes and 47 degree F for 6 minutes), were inadvertently administered to the unspecified patients on unspecified dates. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
she said about 15 minutes after the vaccine she had a rash on her arm, the next morning her face was swollen  - no breathing issues
Redness, swelling, pain, headache started the night of 2/19/13. Pt. came in 2/21/13 to be seen, felt symptom's were getting worse. Tx: Antibiotics, TYLENOL, warm compress to site.
Had chills and fever and could not stand up without throwing up ( I rarely throw up). Nausea continued when I was lying down this started at 5am and continued straight through, getting a little worse in the middle of the day and started to subside at about 5p. By 7p I was able to go to couch and take tiny sips of pedialite and water. The next day I was completely fine, just fatigued and weak from throwing up all day. I ate normally, did normal exercise, etc.
Hidradenitis suppurativa Flare up; Boils on inner thigh; chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), HEADACHE (Headache), HIDRADENITIS (Hidradenitis suppurativa Flare up) and FURUNCLE (Boils on inner thigh) in a 28-year-old 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 Hidradenitis suppurativa.    Concurrent medical conditions included Hidradenitis suppurativa.   On 20-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Oct-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 2021, the patient experienced CHILLS (chills) and HEADACHE (Headache). On an unknown date, the patient experienced HIDRADENITIS (Hidradenitis suppurativa Flare up) and FURUNCLE (Boils on inner thigh). In December 2021, CHILLS (chills) and HEADACHE (Headache) had resolved. At the time of the report, HIDRADENITIS (Hidradenitis suppurativa Flare up) had not resolved and FURUNCLE (Boils on inner thigh) outcome was unknown.            Concomitant information was not provided.  In dec 2021, Patient had Moderna covid booster vaccine which caused headache and chills for 48 hrs. In May 2022, the patient had surgery on boils under arms. It was healing and draining slowely. Patient had flare up of Hidradenitis suppurativa. Patient had bolis on inner thigh. The reporters causality for event Hidradenitis suppurativa with Humira was reasonable possibility and with chills and headache no reasonable possibility.
Extreme insomnia (both inability to fall asleep and inability to stay asleep) beginning after vaccine and worsening to a peak at 10 days. Treatment resistant severe insomnia continuing for 2+ months.  Ability to sleep with pharmaceutical sleep aids after 2nd month.  Now, at nearly 4 months, sleeping normally but ONLY with prescription sleep aids. (No sleep aids needed before vaccine).  Patient had 4 previous Covid vaccine doses without incident, but had first bout of Covid between dose 4 and dose 5 (the bivalent booster, the one starting the severe insomnia)
10 minutes, after vaccination, patient came up to the pharmacy counter and mentioned that she is experiencing tingling in her hands and feet, and has some discomfort in her throat. She described it as bubble stuck in her throat, with difficult swallowing. Pharmacist administered Benadryl to patient immediately and asked her to sit down for further observation.   Patient was offered Epi-Pen several times but refused each time, however the situation didn't seem to warrant an Epi-Pen, as the symptoms were not consistant with anaphylactic shock.  We did check her BP and her temperature several times.  As symptoms did not improve completely, 911 was called.
Patient is having trouble sleeping; Patient having panic attacks; Anxiety; Felt very weak and then nearly fell down; Patient felt extremely weak/ patient continued to feel weak on 10Apr2021; Nausea; Headache; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Patient felt extremely weak/ patient continued to feel weak on 10Apr2021) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced NAUSEA (Nausea), HEADACHE (Headache) and VOMITING (Vomiting). On 08-Apr-2021, the patient experienced ASTHENIA (Patient felt extremely weak/ patient continued to feel weak on 10Apr2021) (seriousness criterion medically significant). On 15-Apr-2021, the patient experienced FALL (Felt very weak and then nearly fell down). On an unknown date, the patient experienced INSOMNIA (Patient is having trouble sleeping), PANIC ATTACK (Patient having panic attacks) and ANXIETY (Anxiety). On 05-Apr-2021, HEADACHE (Headache) had resolved. At the time of the report, ASTHENIA (Patient felt extremely weak/ patient continued to feel weak on 10Apr2021), INSOMNIA (Patient is having trouble sleeping), PANIC ATTACK (Patient having panic attacks), ANXIETY (Anxiety), FALL (Felt very weak and then nearly fell down), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient visited emergency room where Electrocardiogram, Blood work was done and results was not reported .  Patient was given IV fluids. Everything came back normal. Patient was discharged from Emergency room and was asked to follow up with the Physician. Patient went to see his Primary Care Physician on 16APR2021. The patient' Doctor advised that he take one week off from work which he did. The patient went to go see his Physician again  Treatment medications include medications for anxiety.  company comment: 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.   This case was linked to MOD-2021-286531 (Patient Link).; 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.
Constant headache; This is a spontaneous report from a contactable nurse (patient). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EH9899) on 24Dec2020 at 09:00 at single dose for COVID-19 immunization.  Medical history was none. Concomitant medication included multivitamin (unspecified) . The patient experienced constant headache on 24Dec2020 at 15:00. The patient, who was a health care worker front line (nurse), received the vaccine on 24Dec2020. She started having a headache, bad like afternoon around 6 hours after she was given the vaccine. The headache has not gone away. It was not like a terrible headache. It was a constant headache like if she took some paracetamol (TYLENOL) it went away but it came back. Patient stated she did not suffer from headaches and she had been having a constant headache since 24Dec2020, when she received the vaccine. The final outcome of the event was reported as not recovered.
felt tachycardic; This case was reported by a nurse and described the occurrence of tachycardia in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced tachycardia. On an unknown date, the outcome of the tachycardia was recovered/resolved.   It was unknown if the reporter considered the tachycardia to be related to Shingrix.  Additional details provided were as follows: The case was reported by the wife of the patient. Age at vaccination was not reported. The patient received the 2nd dose of Shingrix vaccine and felt tachycardic afterwards. The reporter consented to follow-up. The case was linked with case US2021AMR196413, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR196413:same reporter
Out of the window for the second shot; Tested positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive) and OFF LABEL USE (Out of the window for the second shot) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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. On 28-Jan-2021, the patient experienced COVID-19 (Tested positive). On an unknown date, the patient experienced OFF LABEL USE (Out of the window for the second shot). At the time of the report, COVID-19 (Tested positive) and OFF LABEL USE (Out of the window for the second shot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. The event outcome was not reported.   Sender's Comments: WIFE CASE
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 17-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Doctor reported 5-6 cm erythema, slightly raised, non tender. Temperature 97.0. Tx: cool compresses, OTC hydrocortisone cream and/ or Benadryl cream to area.
Lips numb, tongue tingling, check neck back. Heart racing, palms sweating, very tired, explosive diarrhea in the night.
Allergic reaction; Initial information regarding an unsolicited valid non-serious case was received from a other healthcare professional via Information (Reference number- 00550239).  This case involves a female patient (age not reported) who had allergic reaction (hypersensitivity) while receiving INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE].  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot number not reported via unknown route in unknown administration site.  In 2017 (date not reported), the patient developed a non-serious allergic reaction (hypersensitivity) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.  The reporter were trying to find the components to what was in this vaccine so they could do further allergy testing, but they were struggling to do so online.  The details of laboratory data were not reported.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
About a month after receiving the vaccine I began getting migraine headaches during sex, specifically at the time of ejaculation.
Hives (painful, elevated). Elevated blood pressure. Prescribed : (1) BENADRYL 25-50mg @ night. (2) ZYRTEC 10mg a day. (4) Prednisone 20mg po. (5) Call 911 if Sx increase.
light bloody discharge from the vagina; not feeling well; felt miserable, did not feel as myself,felt awful; disengaging from her body; temperature recorded as 99.9F, 102F, 99F, and 98.6F; This spontaneous case was reported by an other health care professional and describes the occurrence of MALAISE (not feeling well), FEELING ABNORMAL (felt miserable, did not feel as myself,felt awful), DISCOMFORT (disengaging from her body), VAGINAL HAEMORRHAGE (light bloody discharge from the vagina) and PYREXIA (temperature recorded as 99.9F, 102F, 99F, and 98.6F) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L21B, 001A21A and 031L20A) for COVID-19 vaccination.     Patient did not had any COVID positive test or diagnosis.  The patient's past medical history included Menopause (Had Menopause at 62 year old). Previously administered products included for Product used for unknown indication: Flu vaccine in October 2021. Past adverse reactions to the above products included No adverse event with Flu vaccine. Concurrent medical conditions included Lactose intolerant, Drug allergy (Meclizine), Sarcoidosis (Sarcoidosis which is remission) and Hot flushes. Concomitant products included ESTROGENS CONJUGATED (PREMARIN) for Hot flushes, PROGESTERONE for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (temperature recorded as 99.9F, 102F, 99F, and 98.6F). On 29-Jan-2022 at 4:00 AM, the patient experienced MALAISE (not feeling well), FEELING ABNORMAL (felt miserable, did not feel as myself,felt awful) and DISCOMFORT (disengaging from her body). In February 2022, the patient experienced VAGINAL HAEMORRHAGE (light bloody discharge from the vagina). At the time of the report, MALAISE (not feeling well), FEELING ABNORMAL (felt miserable, did not feel as myself,felt awful), DISCOMFORT (disengaging from her body), VAGINAL HAEMORRHAGE (light bloody discharge from the vagina) and PYREXIA (temperature recorded as 99.9F, 102F, 99F, and 98.6F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jan-2022, Body temperature: 99.9 f (High) 99.9 F, 102 f at 6:00 am (High) 102 F at 6:00 am, 99 f (High) 99 F and 98.6 f at 9:00 pm (Low) 98.6 F at 9:00 pm. On 05-Mar-2022, Ultrasound scan vagina: lining of her uterus was thin (abnormal) Lining of her uterus was thin. On an unknown date, Gynaecological examination: normal (normal) Was okay.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment details were reported.   This case was linked to MOD-2022-566495 (Patient Link).
Sore arm; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in an unspecified number of patient who received Herpes zoster (Shingrix) 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 in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient received Shingrix and experienced a sore arm and it has lasted for months. The reporter consented to follow up.  For tolerances of 2nd dose, refer case US2020078683, reported by same reporter for the same patient. This case linked with US2020078681, reported by same reporter.
This spontaneous report was received from a registered nurse regarding an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions, and concomitant therapies were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ oral liquid (lot number M041768; expiration date: 25-JUN-2018) for prophylaxis. According to the reporter, ROTATEQ doses were exposed to the following temperature excursions: between 32 degrees Fahrenheit (F) to 35 F for 1 minute, and 47 F to 77 F for 5 minutes. No previous temperature excursions were reported. No adverse effects were reported. A digital data logger was involved.