chrisvoncsefalvay/vaers-outcomes huggingface dataset:
at 11:30 I started feeling pain in my arm. Numbness running down my arm to my thumb. I went to lay down and felt that my heart was racing and that my insides were trying to explode from my skin. I was extremely dizzy and felt that I had taking sleeping medication or another substance. I had a hard time sitting up and felt that I was falling over. When I shut my eyes I kept seeing dark figures coming at me. I had a metallic taste in my mouth. This lasted about 45 minutes-1hour. Nausea and headache occurred after those symptoms subsided.
Injection site began to itch and became red and swollen on April 3,  eight days after first injection.  I did not seek treatment but discussed it with the pharmacist where I received the shot.  He suggested I file this report.  It still remains red and itchy as of today, April 6.
Pt recv vax on 11/10/98; on 11/12/98 pt exp low-pitched cry, hoarse voice x 2 day
The one time I got a flu shot I got to sick; Initial information received on 09-Dec-2020 regarding an unsolicited valid non-serious case received from a consumer (patient) via media.  This case involves an unknown age patient for whom the one time patient got a flu shot patient got to sick to die not happening again had not the flu In over 15 years (illness) was reported, while he/she received vaccine influenza vaccine.  The patient's past medical history, 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 vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site, for Prophylactic vaccination.  On an unknown date, it was reported that the one time patient got a flu shot patient got to sick to die not happening again had not the flu In over 15 years (illness) (Unknown latency) following the administration of influenza vaccine.  Final diagnosis was the one time patient got a flu shot patient got to sick to die not happening again had not the flu In over 15 years.   No laboratory data was reported.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as Unknown.  No further information was reported.
Initial report was received 03 September 2010 from a consumer, who is also the patient. A 26-year-old (also reported as a 27-year-old) female patient had received an intramuscular left deltoid injection of FLUZONE, lot number U3565CA on 26 August 2010 and two days later, she developed a pain on the left side of her neck which moved upward, and a severe headache. Sneezing, bending down, and standing up from a sitting or lying position caused the headache to return. She had no concurrent illness, no pre-existing medical conditions and she had not been taking any concomitant medications. She was evaluated by a physician and her diagnosis was "viral headache". The headache lasted five days and she recovered. Documents held by sender: None.
Patient reports pain at the time of injection. Following the injection the patient states she has a bruise 3" in diameter around the injection site (black and blue) with pain. No treatment sought at time of reporting.
The Patient was given her vaccine on October 27th in the afternoon. The shot itself was not painful.  At first, The Patient arm was sore so I gave her Tylenol. Later that evening she complained of her hand swelling so I gave her Advil. Her hand had gotten so swollen that she could not bend her fingers. The next day we had a virtual visit with the physician who suggested The Patient start taking Benadryl. I gave her Benadryl throughout the day but it was not helping with the swelling. On Friday, we went into the doctor's office and they prescribed a steroid to take. She took it, along with Benadryl, for 7 days and the swelling did not improve. On November 6, we saw an allergist, Dr. who did not believe it was an allergy. She told The Patient to keep her arm as elevated as possible to help bring down the swelling. The swelling came down significantly within 24 hours; however, her hand was still tender and not able to bend her fingers. Over the next week, I could see a drainage under the skin (no visible fluid) and after about another week her  hand looked normal. Now, in early-mid December her hand is much improved - about 95% functional (still a bit tender if she applies pressure)
throat began to feel swollen thirty minutes post-vaccination. The next day, the right lymph node was swollen and tender, which resolved the following day. Repeat episodes of throat swelling sensation 5 days post-vaccination and redness/pain on tip and side of the tongue. Both issues have not resolved.
Information has been received from a pharmacy technician referring to an unknown number of patients of unknown age and gender. Information about patients' concurrent conditions and medical history was not reported. On unspecified dates the patients were inadvertently administered RECOMBIVAX HB (lot#, dose, route not reported, strength 5/0.5 mcg/ml) that had been improperly stored. Concomitant medications were not provided. No adverse effects were reported. Additional information has been requested.
After receiving shots I cannot take allergy, cold or pain medications without having reactions. I have been to doctor twice, allergist and dermatologist. Never had this reaction before.
About 14 hours after receiving the (second in series) Shingrx injection in my upper right arm, I began experiencing - fever, chills, and muscle ache throughout my body. I used blankets to stay warm, I slept, and took acetaminophen.  Symptoms abated after about 15 hours.  I also messaged (online) my physician's office of my side-effects from the vaccination.
About May 15th, I noticed a rash around my armpits, but it didn't really itch. A week later, it started spreading up my back and then up into my neck, and it started itching. I though it may have been a yeast rash so I tried anti yeast cream, but that didn't work. The itching got more intense so I switched to a Benadryl cream. It did help the itch but the rash still didn't go away. The rash got bumpy and worse so I went to the doctor and they gave me triamcinolone acetonide and that helped the rash to go away.
Approximately 4-5 hours after administration of the first shot of the Moderna vaccine on February 15, 2021, patient experienced mild, continuous tinnitus in his left ear.  Tinnitus  continues unabated as of the date of this filing, June 26, 2021.  Patient had no prior tinnitus episodes other than episodes occurring every few years and lasting less than a minute.  Those resolved without issue.
Spontaneous ovulation in post-menopausal woman.  I began ovulating and became estrogen toxic. I had been in menopause for over 4 years at the time of the shot. I was on estrogen. I began feeling very ill. I had a set of labs that confirmed that I was not in "menopause" anymore and had ovulated. I had to immediately come off of estrogen as it was very high. I subsequently ovulated for a few months, developed an ovarian cyst and then stopped spontaneously again and went back on estrogen. I still have the cyst.
Dizziness, nausea and mild confusion  within 5 minutes of administration.   Increased blood pressure and pulse during this time.  Adverse reaction lasted approximately 1 hour.    (Similar adverse reaction to dose 1- but less in severity)
Pt returns to clinic to report redness and slight swelling at site of flu shot. Because of history of shoulder replacements (years ago), pt was prescribed an antibiotic and referred to orthopedic surgeon for follow up.
no adverse event; Dose administered after 30 day beyond use date on 12-Jan-2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30 day beyond use date on 12-Jan-2023) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 042H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30 day beyond use date on 12-Jan-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30 day beyond use date on 12-Jan-2023) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30 day beyond use date on 12-Jan-2023).    No concomitant medication was reported.  No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-697059 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697059:Same reporter
Patient received incorrect vaccine brand for the second dose. First dose of Moderna was administered on 05/26/2021.
This spontaneous case was reported by a consumer and describes the occurrence of PSORIATIC ARTHROPATHY (Psoriatic arthritis flare up) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis. Concurrent medical conditions included Psoriatic arthritis. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled syringe. In 2021, the patient experienced PSORIATIC ARTHROPATHY (Psoriatic arthritis flare up) (seriousness criterion medically significant). At the time of the report, PSORIATIC ARTHROPATHY (Psoriatic arthritis flare up) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication provided. No treatment information mentioned. In 2021, patient experienced a psoriatic arthritis flare up. Reporters causality of events with Humira was no reasonable possibility. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. Company Comment: This is a spontaneous case, reported by a consumer, concerning a 65-year-old male patient with relevant medical condition of Psoriatic arthritis, who experienced the unexpected serious (medically significant) event of Psoriatic arthropathy, reported as psoriatic arthritis flare up, in the context of a dose of mRNA-1273 vaccine. Latency cannot be properly assessed since the vaccination date nor the exact event onset date were provided. No further details about the clinical course, diagnostic procedures and treatments were provided. Outcome of the event was unknown. The medical condition of Psoriatic arthritis remains as a confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This is a spontaneous case, reported by a consumer, concerning a 65-year-old male patient with relevant medical condition of Psoriatic arthritis, who experienced the unexpected serious (medically significant) event of Psoriatic arthropathy, reported as psoriatic arthritis flare up, in the context of a dose of mRNA-1273 vaccine. Latency cannot be properly assessed since the vaccination date nor the exact event onset date were provided. No further details about the clinical course, diagnostic procedures and treatments were provided. Outcome of the event was unknown. The medical condition of Psoriatic arthritis remains as a confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
patient was nervous while asking about vaccines, choose to take J&J covid 19 vaccine. After vaccination, she stated that she felt "woozy" then said she was feeling better so went to sit in designated seat. She then had her daughter come let us know that she was not feeling well. She was feeling clammy and laid in the floor with her feet propped up. BP was checked, she was clammy and sweaty. No issues with breathing, did ask for a Benadryl and it was given to her.
vomiting, loose stool x1  9/23/08 Reviewed hospital medical records of 8/28-8/30/2008. FINAL DX:  vomiting, lethargy, resolved.  Suspect immunization reaction. Records reveal patient experienced vomiting & lethargy later on the day of vaccination then became lethargic.  Tx in ER w/IVF & IV antibiotics.   Improved & d/c to home.
Mother describes 3 episodes each lasting 5-10 seconds of stiffening of arms and legs, jerky movements, grunting, redness in face.  Patient returned to normal after episodes.  Evaluation, including blood work was normal in ER.  Patient afebrile.  Sites post vaccine.
Localized swelling and erythema. Rash that developed along medial thigh. Swelling that extended from vaccine site to knee. Worsened x 48 hours, but today appears to be less red. No change in activity level.
7/7-7-8 high fever, 7/8 midnight woke sweating couldn't sleep stated felt like someone was shaking his head so hard that his brain was bouncing in his skull. Following day 7/9 , brain shaking incidents occurred off and on all day for a minute or so in duration,  7/10 had 3 incidents less duration less severe, 7/11, 1 incident less severe than previous day.  Extremely fatigued as well. Seeing pedetrcian 7/12.
Flu-like symptoms x3 days (severe for throat, generalized aches, severe fatigue). Once that subsided, I lost my voice completely (couldn?t even whisper or squeak) x4 days. Then had severe sinus congestion and croup cough x2 weeks (people asked what was wrong with me)
I had fever over 102.  I had chills and body ache.  I lost my taste and smell for a few days.  I was nausea, diarrhea, and weird vision.  I have pressure headache.  I has had SOB. I had a rapid Covid-19 test, negative.  I went to urgent care and got another rapid covid-19 test which came back positive.
Pt reports that at 2030 hours he experienced itchiness, and then the following day he broke out in hives on both his arms, thighs, back and abdomen. The symptoms lasted for 2 days. Pt was advised by pharmacy that for his second dose to get it at the hospital due to his reaction to the first dose. Pt reported he took some medicine but cannot recall the name, he reported it helped with the symptoms.
One week after receiving 1st dose, patient started getting pain in right leg in joint area,Pain started radiating to the left leg; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (One week after receiving 1st dose, patient started getting pain in right leg in joint area,Pain started radiating to the left leg) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 041C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-May-2021, the patient experienced VACCINATION SITE PAIN (One week after receiving 1st dose, patient started getting pain in right leg in joint area,Pain started radiating to the left leg). At the time of the report, VACCINATION SITE PAIN (One week after receiving 1st dose, patient started getting pain in right leg in joint area,Pain started radiating to the left leg) outcome was unknown.            Concomitant medications include Allergy medication Treatment medications include Advil.   This case was linked to MOD-2021-251334 (Patient Link).
This morning, approximately 48 hours after her COVID vaccination, patient states she woke up with swelling on her cheek and under her left eye, which progressed to her forehead. She sought medical attention from her PCP's office since she was unsure of what was happening. They told her they felt it was related to the vaccination and prescribed an antihistamine.
Covid and flu arms hurting within a hour. Covid arm still hurting (over 24 hours later). Woke in the middle of the night throwing up. Feels achy and sore. Stomach still upset. fever of 100
Local swelling.  Erythema covering entire anterior thigh.  Keflex x 10 days.  2 distinct areas of reaction-overlapping.
patient complaining of numbness on right side of body; has not sought out medical treatment at time of report; patient reports taking ibuprofen and benadryl at bedtime since.  Reaction first occurred 1-2 hours post immunization and is continuing with no improvement.  Immunization done on 4/23, reported to pharmacy on 4/27.
flu-like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a female 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 influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.     Additional Information: GSK Receipt Date: 21-JUN-2022 Reporter's Comments: The case was self reported by the patient. The patient received a dose of Shingrix vaccine and experienced flu-like symptoms. The reporter disconnected the call abruptly and agent was unable to collect any further information including HCP (health care professional) contact information and patients DOB (date of birth), address and consent to contact. AE (adverse event) filed. Spoke from content. Additional supportive Information: This case has been linked with case US2022AMR096275 reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR096275:Same reporter, different patient
Approximately 24 hours after the injection, I developed chills that lasted 10 hours. I had a fever of 101.6 F. I had a headache, tiredness, soreness at the injection site, and tingling in the fingers of the right hand like they were going to sleep. The chills and the headache were the worse. Now, three days after the injection, my only remaining symptom is soreness at the injection site (upper left arm).
pt recvd vax & had 20 min intervals of high pitched screaming intermitt for 48 hrs; low grade fever; not sleeping; reddened eyes; staring; pmd recommends no further full doses;
Client called at 9AM on 6/30/07 reporting that she had received a GARDASIL injection on 6/27/08 and developed a rash within 30 minutes of receiving it.  The rash has spread to other areas on body.
Interchange of vaccine products; had Covid for a week. I had Covid toe, all my toes went blue and it resolved except the blue stayed in 2 of my toes; had Covid for a week. I had Covid toe, all my toes went blue and it resolved except the blue stayed in 2 of my toes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), as dose 3 (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: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "not recovered" and all described as "had Covid for a week. I had Covid toe, all my toes went blue and it resolved except the blue stayed in 2 of my toes".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300111129 same patient/drug, different dose number/event;US-PFIZER INC-202300110146 same patient/drug, different dose number/event;
itching; pinkish skin (6 inch long - 2 inch wide); pain at the injection site; terrible headache-migraine for 24 hs; chills; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching), ERYTHEMA (pinkish skin (6 inch long - 2 inch wide)), MIGRAINE (terrible headache-migraine for 24 hs), CHILLS (chills) and VACCINATION SITE PAIN (pain at the injection site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced MIGRAINE (terrible headache-migraine for 24 hs) and CHILLS (chills). On 01-Mar-2021, the patient experienced PRURITUS (itching), ERYTHEMA (pinkish skin (6 inch long - 2 inch wide)) and VACCINATION SITE PAIN (pain at the injection site). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. On 28-Feb-2021, MIGRAINE (terrible headache-migraine for 24 hs) and CHILLS (chills) outcome was unknown. At the time of the report, PRURITUS (itching), ERYTHEMA (pinkish skin (6 inch long - 2 inch wide)) and VACCINATION SITE PAIN (pain at the injection site) outcome was unknown.            Concomitant medications were not provided.
This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient. A 23-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Sep2021 as dose 3 (booster), single (Lot number: 301558A) at the age of 23 years, in left arm for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", 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; (09May2022) Positive; (10May2022) Positive. Therapeutic measures were taken as a result of Covid-19. Clinical course: Other medication in 2 weeks was reported as no. No known allergies. Sender's Comments: As there is limited information in the case provided, the causal association between the reported events: "Drug ineffective", "COVID-19" and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.