chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She feels like she has COVID all over again; She feels like she has COVID all over again; Her lips got super numb and she was light headed; Lightheaded and dizzy; She had chills, a severe headache and the next day she had a fever and for the next 2 days she had a fever of 101; Unrelenting headache and her limbs are so fatigued she can't even get around.; Severe lower back pain; Unrelenting headache and her limbs are so fatigued she can't even get around./She had chills, a severe headache and the next day she had a fever and for the next 2 days she had a fever of 101; She had chills, a severe headache and the next day she had a fever and for the next 2 days she had a fever of 101; This is a spontaneous report received from a contactable consumer. This 70-year-old female consumer, the patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number, Expiration date: not reported) via an unspecified route of administration on 25Mar2021 at single dose for COVID-19 Immunization. Patient medical history and concomitant medication were unknown. On 25Mar2021 (15 minutes later after vaccination), Patient experienced her lips got super numb and was very lightheaded. The patient received some apple juice and a gram cracker and after extra 30 minutes the numbness went away, and she felt lightheaded and dizzy. That night patient started getting chills and severe headache getting so bad she is thinking of going to the ER. On 26Mar2021 (next day of vaccination) patient had a fever and for next 2 days patient had fever of 101. After a week of vaccination her headache was unrelated since she had the vaccination, her limbs are so fatigued she could not even get around. The patient thought about going to the ER. She had severe lower back pain on an unspecified date. She had COVID in December she felt like she had COVID all over again and was worse than she did when she had COVID the first time. She thought about cancelling the second dose as it because she feels so horrible, people say the 2nd is worse than the first. The side effects are worse. The patient had an appointment with her doctor. The patient wanted to mention something that sounds weird. It tracks your pattern of sleep REM, the patient sleep since January she was getting 8 hours and getting 2 hours of REM sleep, the deep sleep which is needed for cell repair and such. Ever since she had the shot, she is getting enough sleep but, not enough REM sleep. Probably a very unusual reaction that she thought was kind odd but, thought we should know. Patient reported as a Product Complaint.  Information on the lot/batch number has been requested.
Patient received first dose of Moderna COVID-19 vaccine on 3/31/2021. Vaccine given at 0857. Patient complained of dizziness, confusion, fatigue, and mild SOB. He was evaluated by PCP and PA-C. BP 150/100 and glucose 156. EMS evaluated the patient and did not send to ED. Patient was observed for 30 min.
chickenpox started apparently around eyes & eyebrows rubbing eyes, around neck;giving DPH w/o relief;
none noted or reported by pt- pt received flu vaccine 11-19-07 stated he had received one 3 wk prior
choking sensation in the back of the throat 15 minutes after receiving the vaccine. No other symptoms. Symptom reported 24 hours later and was decreasing.
Arthritis in her hands and knees; Soreness in both arms; Palpable swelling; Tenderness in the joints; Hands swollen / couldn't grip anything; Ached over; could not grip anything; Immune complex; Serum-sickness like reaction / thinking it's an immune complex; This case was reported by a physician via call center representative and described the occurrence of immune complex reaction in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included general body pain, polymyalgia (a year ago had potential polymyalgia) and colitis microscopic (had microscopic collits from duloxetine). Previously administered products included Duloxetine (received Duloxetine on an unknown date).   On 9th December 2020, the patient received the 1st dose of Shingrix. In December 2020, less than a month after receiving Shingrix, the patient experienced immune complex reaction (serious criteria GSK medically significant), serum-sickness like disorder, pain in arm, swelling, joint tenderness, hand swelling, pain and grip strength decreased. On 21st December 2020, the patient experienced arthritis. The patient was treated with prednisone. On an unknown date, the outcome of the immune complex reaction, serum-sickness like disorder, arthritis, pain in arm, swelling, joint tenderness, hand swelling, pain and grip strength decreased were recovering/resolving.   It was unknown if the reporter considered the immune complex reaction, serum-sickness like disorder, arthritis, pain in arm, swelling, joint tenderness, hand swelling, pain and grip strength decreased to be related to Shingrix.  Additional details were provided as follows: The patient had history of general aches, a year ago worked up for potential polymyalgia and received Duloxetine as a historical drug with microscopic colitis. The age at vaccination was not reported. The reporter stated that, by 21st December 2020 after vaccination, the patient had some soreness in both arms, developed arthritis in right hand, then left hand, then knee; palpable swelling and tenderness in the joints, hands swollen, could not grip anything and ached over a fewdays time. On 28th December 2020, the patient visited physician and diagnosed with serum-sickness like disorder, arthritis and thought it was an immune complex reaction. The patient had sedimentaion rte, nuclear antibody and rheum factor negative. When the patient went to office the sedimentation rate was 21. The patient treated with prednisone and the symptoms were improving. No further details provided at this time. The reporter did not consent to follow up.
Information has been received from a consumer concerning her son who on an unspecified date was vaccinated with a dose of MMR II. It was reported that the patient developed delayed speech and ASPERGER's syndrome. The consumer stated her child was now recovered. It was also reported that her son still had negative titers to MMR II. It was unspecified if the patient sought medical attention or not. Upon internal review, ASPERGER's syndrome was considered to be other important medical events. No further information is available.
approx 5 hrs following vax pt awoke from nap screaming & crying w/soreness in legs; cried for aobut an hr; mom knows had fever, but doesn't remember exact reading; knows did not reach 104; MD recommended no more pertussis;
normal congestion; diarrhea; body aches; extreme emotional distress; lost sense of smell and taste; still little bit of fatigue; lost sense of smell and taste; serious outbreak of psoriasis; tested positive for Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (lost sense of smell and taste), PSORIASIS (serious outbreak of psoriasis), SARS-COV-2 TEST POSITIVE (tested positive for Covid-19), NASAL CONGESTION (normal congestion) and DIARRHOEA (diarrhea) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced PSORIASIS (serious outbreak of psoriasis) and SARS-COV-2 TEST POSITIVE (tested positive for Covid-19). On an unknown date, the patient experienced AGEUSIA (lost sense of smell and taste), NASAL CONGESTION (normal congestion), DIARRHOEA (diarrhea), PAIN (body aches), EMOTIONAL DISTRESS (extreme emotional distress), ANOSMIA (lost sense of smell and taste) and FATIGUE (still little bit of fatigue). The patient was treated with VITAMIN D NOS at an unspecified dose and frequency. At the time of the report, AGEUSIA (lost sense of smell and taste), PSORIASIS (serious outbreak of psoriasis), SARS-COV-2 TEST POSITIVE (tested positive for Covid-19), NASAL CONGESTION (normal congestion), DIARRHOEA (diarrhea), PAIN (body aches), EMOTIONAL DISTRESS (extreme emotional distress), ANOSMIA (lost sense of smell and taste) and FATIGUE (still little bit of fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications also included antihistamine and steroids cream. No concomitant medications were reported.
Information has been received from a physician concerning a 9 week old female with gastrooesophageal reflux disease who on 17-APR-2008 was vaccinated PO with a 2.0 ml dose ROTATEQ (lot# 659855/1692U) . On 23-APR-2008 the patient experienced severe diarrhea. A stool sample was preformed which was positive for rotavirus. The patient sought medical attention through a physician office visit. The patient was not recovered at the time of this report. No other information is available at this time. There was no product quality complaint. Additional information has been requested. This is one of several reports from the same source. Follow-up information has been received from an administering health professinal and medical records concerning a 9 week old female with GERD and apnea who on 17-APR-2008 was vaccinated PO with her first dose of ROTATEQ (lot#059855/16920U). There was no illness at the time of vacciantion. Concomitant vaccinations administered on that same day included the firse IM doseof PREVENAR (lot# 057543) in the right thigh, th first IM dose of PEDIARIX (lot#AC218145AA) in the left thigh and the first dose of ACTIB (lot#UF256AB) in the left thigh. On 23-APR-2008 the patient experienced explosive diarrhea that was green and foul-smelling with 12 stools on 11-APR-2008. 8 stools on 14-APR-2008 and 7 stools on 15-APR-2008 which lasted approximately 7 days. The patient was seen for a doctor visit and was treated with push fluids and monitored for dehydration. On 26-APR-2008 a stool rotavirus antigen test was positive for rotavirus. On 01-MAY-2008 the patient recovered. Additional information has been requested. This is one of several reports from the same source. All available medical records will be provided upon request.
I experienced severe pain at the injection site. Mild soreness began immediately after injection but became progressively worse over the next 5-7 hours. The pain felt like a constant ache and sharp pain when I moved my arm at all. I eventually took Ibuprofen at around 9 or 10 pm, which helped somewhat. My arm was still sore the next day but the pain was more moderate.
Double vision started about 10 hours after vaccine.  Resolved but continued on and off over next 2 days.
Due date 7/21. 17 weeks pregnant.  Covid arm rash, raised and red started today. Very sore and warm to touch. Since aches, fatigue, nausea and vomiting. Low grade fever.
1. Redness, itchiness, warm, swelling, like hives on my left arm - on April 17, 2021 gone exactly after a week(happened a week after the first dose/shot).  First dose shot was April 10, 2021 - took tylenol and allegra 2. Redness, itchiness, warm, swelling, like hives on my left arm from May 15-19, 2021 BUT also had fever all day on May 15, 2021 - second dose shot was May 14, 2021 around 4pm - took benadryl and tylenol
difficulty moving; Mild insomnia the evening after the shot (difficulty both falling asleep and staying asleep).; Adverse event is pain at the site of injection from ~5 hr post injection (right arm, same location as previous doses); This spontaneous case was reported by an other health care professional and describes the occurrence of MOBILITY DECREASED (difficulty moving), INSOMNIA (Mild insomnia the evening after the shot (difficulty both falling asleep and staying asleep).) and VACCINATION SITE PAIN (Adverse event is pain at the site of injection from ~5 hr post injection (right arm, same location as previous doses)) in a 36-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022J221A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer (EL 9262) on 24-Jan-2021, pfizer (EL 9261) on 14-Feb-2021 and pfizer (FD 8448) on 05-Sep-2021. Past adverse reactions to the above products included No adverse reaction with Pfizer, pfizer and pfizer.    On 13-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2022, the patient experienced MOBILITY DECREASED (difficulty moving), INSOMNIA (Mild insomnia the evening after the shot (difficulty both falling asleep and staying asleep).) and VACCINATION SITE PAIN (Adverse event is pain at the site of injection from ~5 hr post injection (right arm, same location as previous doses)). At the time of the report, MOBILITY DECREASED (difficulty moving), INSOMNIA (Mild insomnia the evening after the shot (difficulty both falling asleep and staying asleep).) and VACCINATION SITE PAIN (Adverse event is pain at the site of injection from ~5 hr post injection (right arm, same location as previous doses)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment and concomitant medications were provided.
Asymptomatic SARS-CoV-2 infection Screening swab on admission was positive.  This could also explain her fever on presentation. three day course of remdesivir IV
Fully vaccinated . COVID breakthrough infection with inpatient hospital stay.   Lot number of vaccine EW0176  and  EW0187
Full Body Aches and Chills. Headache. Dizziness. Fever. Nausea. Hot Flashes. Rash on arches of both feet.
Experienced pain in my left arm around the site of injection; Not sleeping well; Pain in the left clavicle and shoulder; My arm still hurts a little bit; This is a spontaneous report received from a non-contactable consumer. A 50-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EN5318), via an unspecified route of administration in left arm on 27Jan2021 as single dose for COVID-19 immunization. Medical history included high blood pressure. Concomitant medications included metoprolol, vitamin D3, multivitamins. Patient had no known allergies. On 27Jan2021, the patient experienced pain in my left arm around the site of injection. First night I was not sleeping well because of the pain. Next day there was also pain in the left clavicle and shoulder. My arm still hurts a little bit but now I was able to sleep on the left side again. No treatment was received for the events. Prior to vaccination, was the patient did not diagnosed with COVID-19. Since the vaccination, did not patient been tested for COVID-19. The outcome of the events was reported as recovered on unspecified date.   No follow-up attempts are possible. No further information is expected.
Following her booster, the patient states she developed smoldering chills, fatigue, and malaise until she ultimately noticed petechiae on her breasts and bruising on her arms. She also noticed a bleeding lesion on the roof of her mouth. She came to the ED where a CBC showed a platelet count of 0k.
After 2 days from injection I woke with moderate to severe pain began in arms, shoulders, and thighs, as well as a tightness in hands, feet, and chest.   The highest point of pain was specifically in the areas of the median cubital vein, having a consistent range of 5/10 to 7/10 pain, and this seems to radiate to shoulders and down to finger tips. Thigh area of pain was in the area of obturator nerve.
This is a spontaneous report from a contactable nurse reporting on her son. An 8-month-old male patient received PREVNAR13, via an unspecified route of administration on 09AUG2012 (Lot Number: F72493) and 12NOV2012 at single doses. The patient medical history was not reported. There were no concomitant medications. On 20NOV2012, the patient had a 5 panel hair drug test revealed t hat his amphetamine and methamphetamine levels were high at 3068pg/mg. The nurse also reported that 5 panel hair drug test also revealed that there were high levels of aluminum phosphate in the patient's body. Therapeutic measures taken in response to the events, amphetamine and methamphetamine levels were high and high levels of aluminum phosphate, were unknown; however the nurse reported that the patient was under physician care. The clinical outcome of the events, amphetamine and methamphetamine levels were high and high levels of aluminum phosphate, was unknown at the time of report. The nurse mentioned that the high levels of amphetamine and methamphetamine were due to aluminum phosphate base present in PREVNAR13. Follow-up (21-FEB-2013): Follow-up attempts completed. No further information expected.
Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) and NO ADVERSE EVENT (No adverse event) in a child 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. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 10 microgram. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) 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 WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box).    Concomitant drugs were not reported.  It was reported that there was a dark blue cap vial with a dose of 25 mcg for age group 6 months to 5 years instead patient was administered with 10 mcg dosage from the dark pink cap and a label with a yellow box.  Treatment medications were not provided.  This case was reported for patient 18 Out of 18(12 Patients-Initial Dose).   This case was linked to US-MODERNATX, INC.-MOD-2023-723704 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723704:Patient 1(Master Case)
pt admitted to hospital on 8/13/21 with COVID pneumonia, started on Azithromycin & Rocephin, O2 need increased due to low O2 saturations, placed on non-rebreather; transferred Medical Center on 8/19/21 where Rocephin was changed to Cefepime, started on Dexamethasone & remdesivir, on 100% non-rebreather; went into renal failure; condition deteriorated and pt died in the hospital
7 cm x 7 cm cellulitis at injection site. No fever/systemic illness.
Arm began to break out from injection site all the way to my wrist. Then hives all over my neck.
strange welts; itchy; This is a spontaneous report from a Pfizer-sponsored program Support. A contactable consumer (patient) reported for herself. A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 25Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included 1st dose of BNT162B2 on 04Feb2021 for COVID-19 immunization. 4-5 days after the second dose, she started to develop welts that were all over her body. She described them as itchy, they "come and go"/were intermittent (longest lasted for 10 minutes) and can be 6-8 inches in length. She stated they look like she's been scratched by a dog or they look like red worms. She had been taking antihistamines, which help, but she didn't want to rely on them. They go away with diphenhydramine hydrochloride (BENADRYL), but she stated she can't keep taking diphenhydramine hydrochloride. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Flu-like symptoms; muscle aches; joint pain; lack of appetite; This is a spontaneous report from a non-contactable Nurse(reported for himself). A 62-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 11Mar2021 as Dose Number Unknown, Single (at the age of 62-years-old) for COVID-19 immunization. The patient's medical history included gastroesophageal reflux disease (GERD), high cholesterol. The patient had allergy to bell peppers and mushrooms. Concomitant medications included esomeprazole magnesium (NEXIUM [ESOMEPRAZOLE MAGNESIUM]); and colesevelam hydrochloride (WELCHOL). The patient did not receive no other vaccine in four weeks. On 12Mar2021, the patient experienced flu-like symptoms, muscle aches, joint pain, and lack of appetite. The patient did not receive treatment for the events. The patient has got no COVID prior vaccination. The patient has not been COVID tested post vaccination. The patient recovered from the events on an unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Received Flu shot 10/13/08. States felt  lousy a few days later for 4-5 days then felt better. About 3 weeks after vaccination developed significant polyarthralgias and fatigue. Getting worse. visit here 11/3/08