chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had pain in left deltoid at site of injection. Pain has persisted in left deltoid x 3-4 weeks. Hurts to lift arm up over head. Pain radiates down arm and into left 3 fingers (3, 4, 5th digits). FROM. No redness, swelling, induration. Pt referred to PCP/orthopedics.
Debilitating dizziness/I cannot look at the ground (while standing) without falling over/I have a general "hum" of dizziness in my head at all times; Debilitating dizziness/I cannot look at the ground (while standing) without falling over/I have a general "hum" of dizziness in my head at all times; I cannot get into or out of bed without nauseating vertigo; I cannot get into or out of bed without nauseating vertigo; I cannot use stairs without leaning on the wall; This is a spontaneous report from a contactable consumer or other non hcp (patient, self-reporting). A 53-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: ew0185), dose 2 via an unspecified route of administration in arm left on 20May2021 at 10:45 (Age at vaccination 53 Years old) as single dose for COVID-19 immunisation. Medical history included diabetes mellitus from an unknown date and unknown if ongoing. Concomitant medication included insulin lispro (HUMALOG), insulin detemir (LEVEMIR) taken for an unspecified indication, start and stop date were not reported. On 29-APR-2021 patient Historical vaccine first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: ew0170 and expiration dates were not reported), dose 1 via an unspecified route of administration in left arm on 29Apr2021 at 10:45 am as single dose for COVID-19 immunisation. If treatment ae Meclizine, plus "exercises" for vertigo. No COVID prior vaccination and no COVID tested post vaccination, Known allergies. On 21May2021 the patient experienced debilitating dizziness. Patient cannot look at the ground (while standing) without falling over. Patient cannot get into or out of bed leaning on the wall and cannot get into or out of bed without nauseating vertigo. Patient have a general "hum" of dizziness in his head at all times. It was awful. No other vaccine in four weeks. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment for the adverse event. Outcome of events was not recovered.   No follow-up attempts are possible; information about lot/batch without nauseating vertigo. Patient cannot use stairs without number cannot be obtained
Received vac. 4/11/02. Began running fever-feeling ill 4/19/02. Fever spiked 105 degrees 4/21/02 resulting in ER visit. Headache, swollen glands and joints-all over body.
Developed generalized erythema, swelling of fingers and itching. Epinephrine, BENADRYL and DECADRON. Admitted for overnight observation.
Pt. presented to ER at 2200 on 10/13/14 for pain/swelling to left shoulder radiating to left elbow. Pt. treated with IV BENADRYL, DEMEROL 50mg and PHENERGAN 25mg. Pt. was discharged with oral pain medication received teaching and handouts on hypersensitivity reaction. Patient advised to follow up in clinic in A.M. Pt. was seen in clinic on 10/14/14 at 9:12 A.M. and advised to continue current medication regimen along with Prednisone 20mg TID #15. Patient returned to clinic at 4PM and was admitted to county hospital for allergic reaction.
Information has been received from a licensed practical nurse concerning a male (approximately 4 years of age to 15 years of age) who on 01-AUG-2007 was vaccinated with Zostavax (Oka/Merck, lot # 657558/0461U) instead of Varivax (MSD).  Subsequently, no adverse experiences have been reported.  Unspecified medical attention was sought.  This is one of several reports received from the same source.  Additional information has been requested.
Patient experienced rash underneath both breasts. Stated her mother and aunt had exact same reaction after Covid vaccine and skin eventually dried out and flaked off. Patient stated rash was itchy and dry. She put baby oil on it and nothing else. Said she ruled out using any new products or soaps during the time the rash arrived.
Shoulder pain; Fever; hurt so bad, she's never had so much pain in her back, it felt like a truck ran her over; body had a shaky attack; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (hurt so bad, she's never had so much pain in her back, it felt like a truck ran her over), TREMOR (body had a shaky attack), PYREXIA (Fever) and ARTHRALGIA (Shoulder pain) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     Concurrent medical conditions included Heart murmur. Concomitant products included GABAPENTIN and TRAMADOL for an unknown indication.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced TREMOR (body had a shaky attack). On 06-Jan-2021, the patient experienced BACK PAIN (hurt so bad, she's never had so much pain in her back, it felt like a truck ran her over). On 07-Jan-2021, the patient experienced PYREXIA (Fever). On 08-Jan-2021, the patient experienced ARTHRALGIA (Shoulder pain). On 05-Jan-2021, TREMOR (body had a shaky attack) had resolved. On 08-Jan-2021, BACK PAIN (hurt so bad, she's never had so much pain in her back, it felt like a truck ran her over) and PYREXIA (Fever) had resolved. At the time of the report, ARTHRALGIA (Shoulder pain) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; 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.
The 25 year old was very apprehensive- stated that her daughter was goig to receive the vaccine for the first time.  The 25 yr old received the nasal spray vaccine first- then held her daughter for the vaccine (nasal)- the child got down from the mother's lap and that's when the mother (25 year old) appeared to be having a reaction and the nurse sat her back in the chair.  This was approx 10 minutes after receiving the H1N1 live viral nasal spray vaccine, she became pale, cyanotic around the lips and face, having weakness, dizzinesss. Her BP was 80/50.  She was held at the clinic until 7:30 pm and her BP was up to 90/50.  She was recommended to go to the hospital ED but she refused and wanted to go home.
rheumatoid arthritis; Information had been received on 09-MAR-2021 from a lawyer regarding a case in litigation. This case is regarding a currently 72-year-old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 11-SEP-2012, the patient was vaccinated with a dose of Zoster Vaccine Live (ZOSTAVAX) (dosage information was not provided) for the prevention of shingles at the physician's office. On unspecified date after vaccination, the patient suffered rheumatoid arthritis. At the time of the report, the patient's outcome was unknown, and the reporter considered the adverse event to be related to suspect therapy.  Upon internal review, the event of rheumatoid arthritis was considered medically significant.
Nausea, diarrhea, slight headache, lightheadedness and discomfort at injection site. no muscle or joint pain but slight fatigue.
A report has been received from a Health Professional concerning a 14 year old, male subject, who had been receiving FLUMIST (Intranasal). FLUMIST (Intranasal) started on 24-Jan-2014. The patient experienced EXPIRED FLUMIST whish started on 24-Jan-2014. The outcome of the event of EXPIRED FLUMIST is unknown. The report was considered to be non-serious as per reporter.
From initial information received on Apr 15 2005 from the patients parent regarding an adverse event, it was reported that an 18 year old female patient received his first dose of Menactra administered in the left deltoid on Apr 14 2005 at 3:30pm. The lot number was unknown as per the reporter. The route of administration was not reported. One day later, on Apr 15 2005 at 7:00pm, the patient complained of chills and had a temperature of 101-102 degrees F. She also had a headache and a neck ache. The patient did not have a rash, nausea or vomiting. She was treated at home with Motrin and was scheduled to see her physician on Apr 15 2005. At the time of this report, the patient had not recovered from these events.
Vaccine received from off site facility.  Unknown site or lot number.  Patient started to experience joint pain the evening of vaccine.  Joint pain leading to joint swelling in both knees, wrist and elbow.  No fever.  Lower leg swelling.  Complaint of extreme pain.
Broke-out in hives/Hives started on abdomen and under arms, spread to random places on the body /One area heals and hives pop-up on another body part/Inflamed Hive Lesions/Hives come and go; A little sore arm after 3rd shot; Chills arm after 3rd shot; Nausea arm after 3rd shot; Headache arm after 3rd shot; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Broke-out in hives/Hives started on abdomen and under arms, spread to random places on the body /One area heals and hives pop-up on another body part/Inflamed Hive Lesions/Hives come and go), MYALGIA (A little sore arm after 3rd shot), CHILLS (Chills arm after 3rd shot), NAUSEA (Nausea arm after 3rd shot) and HEADACHE (Headache arm after 3rd shot) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Nov-2021, the patient experienced MYALGIA (A little sore arm after 3rd shot), CHILLS (Chills arm after 3rd shot), NAUSEA (Nausea arm after 3rd shot) and HEADACHE (Headache arm after 3rd shot). On 17-Nov-2021, the patient experienced URTICARIA (Broke-out in hives/Hives started on abdomen and under arms, spread to random places on the body /One area heals and hives pop-up on another body part/Inflamed Hive Lesions/Hives come and go). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at a dose of 1 dosage form; PREDNISONE for Hives, at a dose of Prednisone for 7 days and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Hives, at a dose of 1 dosage form. On 09-Nov-2021, MYALGIA (A little sore arm after 3rd shot) had resolved. On 10-Nov-2021, CHILLS (Chills arm after 3rd shot), NAUSEA (Nausea arm after 3rd shot) and HEADACHE (Headache arm after 3rd shot) had resolved. At the time of the report, URTICARIA (Broke-out in hives/Hives started on abdomen and under arms, spread to random places on the body /One area heals and hives pop-up on another body part/Inflamed Hive Lesions/Hives come and go) had not resolved.            It was reported within 12 hours after booster had chills, nausea, and headache.  After the booster shot she had a little sore arm for a few days. The patient  took Tylenol and missed work had those symptoms for 3 days. On 17-Nov-2021, broke in hives. Hives started on abdomen and under arms then spread to random places on the body. On 19-Nov-2021, the doctor gave a steroid shot. It did not help. On 22-Nov-2021 started Prednisone for 7 days and Benadryl oral. The lesions were inflamed also. 09-Dec-2021 (Today ) the inflammation had improved but still had hives coming and going.   This case was linked to MOD-2021-407363, MOD-2021-407436, MOD-2021-407436 (Patient Link).
Vesicular eruption, 3-4 lesions consistent with Varicella lesions. Fever of 103 and febrile convulsions lasting approx. one minute.
PT BECAME VERY PALE, SAID HER HEAD AND MOUTH WERE HURTING, SHE LOOKED AS IF SHE WAS GOING TO PASS OUT. ALSO SAID SHE FELT LIKE SHE MIGHT VOMIT. I TOOK PT'S BLOOD PRESSURE AND IT HAD DROPPED TO APPROX 80/40. OVER THE NEXT 5 MINUTES SHE DID NOT IMPROVE AT ALL AND I HAD TROUBLE GETTING HER TO TALK TO ME AND DESCRIBE HER SYMPTOMS, SO I CALLED FOR AMBULANCE TO COME EVALUATE HER AND TREAT IF NECESSARY. THEY ARRIVED AND TRANSPORTED HER TO THE LOCAL HOSPITAL FACILITY.
Headache; fever; chills; nausea; dizziness; injection site pain; This is a spontaneous report from a contactable Consumer or other non-health care professional (Patient). A 42-years-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, batch no/Lot number: Not reported) via an unspecified route of administration on an unspecified date as dose 2, single. The patient medical history and concomitant medications were not reported. No history of reactions, no underlying medical conditions. Historical vaccine included patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, batch no/Lot number: Not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. On an unspecified date, patient experienced headache, fever, chills, nausea, dizziness, injection site pain post dose 2 of BNT162b2. Patient reported that events took place after use of product. Outcome of the events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information expected.
A nurse reported that a 20 year old female with a history of asthma received an injection of Flu Shield '00-'01 on 12/12/00. On the morning of 12/13/00, she experienced numbness and tingling in her left arm and left leg. The reporter indicated the physician treated the reaction as an allergic reaction. She recovered.
After 1 week, the lymph node in my armpit swelled to the size of tangerine. It was misdiagnosed by the doctor as cellulitis.
pt recv vax 28AUG96 & 30AUG96 pt exp cellulitis which consisted of redness, swelling & tenderness around the inj site;tx w/ATB;
Pt ended up with fever 100 for five days also combined with flu-like symptoms and ear infection. That was 1 wk later. 2 days after shot his arm swelled up and was very hot to touch from shoulder to elbow. Went to doc, took Benadryl.
Information has been received from a registered nurse concerning of her 22 year old daughter with no known allergies and a history of contact dermatitis who on 15-DEC-2008 was vaccinated with the first dose of GARDASIL (Lot not reported). Concomitant therapy included hormonal contraceptives (unspecified). On 19-DEC-2009 the patient developed what appears to be an allergic reaction. The patient developed swelling of her injection arm that had progressed up her arm to her neck and face. The patient took Benadryl and Hidroxyzine (Unspecified) (left over from a recent bout of contact dermatitis that "got out of hand"). As of 19-DEC-2008 the patient had not recovered. Additional information has been requested.
Fever - onset 10 hours after vaccination (April 6, 2021 2:00am) for roughly 20 hours Headache - onset 18 hours after vaccination, lasted for several days Chest pain - onset 20 hours after vaccination. Lasted for six hours (was not constant)  Pain in the injection site - onset 3 hours after vaccination, lasted for several days
Started 9/10/21 and still there but manageable on 9/11  All symptoms on right side only: Very sore under arm, felt like hand was swollen but wasn't, painful to touch hand, throbbing from shoulder to hand. But to use right hand/ side to pick anything up.   Also fatigue, nausea, and headache
fever 104.4 ax;3FEB98 T101 when left clinician 28FEB98 less than 5min later started having sz, stopped breathing;pt hosp;
Started as an itchy spot where injection site was. Within about 6 hrs of itchiness, tightness began, then swelling and redness. Area was hot and inflamed.
This report is regarding the Pfizer COVID-19 vaccination the patient received on the above date, which was lot number FD0809. The Department of Health, Centers for Disease Control and Prevention (CDC), and Pfizer have determined that the dose of vaccine the patient  received is valid.
patient given an expired quadracel / after giving the expired product, they repeated the dose with no reported adverse events; patient given an expired quadracel with no reported adverse events; Initial information received on 02-May-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 years old female patient and Is reported patient given an expired diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] and patient given an expired quadracel / after giving the expired product, they repeated the dose with no reported adverse events    The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included measles vaccine, mumps vaccine, rubella vaccine (MMR VACCIN) for Immunisation.  On 26-Apr-2023, the patient received a DOSE 1 dose 0.5 ml of suspect Diphtheria-15/Tetanus/5 Hybrid AC Pertussis/IPV (MRC5) Vaccine Suspension for injection expiry date: 01-Apr-2023 lot C5862BA via intramuscular route in the right deltoid for prophylactic vaccination (immunization).  On 26-APR-2023 at 9:55 the patient developed a non-serious patient given an expired quadracel with no reported adverse events (expired product administered) and at 11:24 patient given an expired quadracel / after giving the expired product, they repeated the dose with no reported adverse events (extra dose administered) latency on the same day.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
BODY ACHES; JAW PAIN; CHILL; HEAVY WAVES OF HEADACHES; NAUSEA; This spontaneous report received from a patient concerned a 53 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies, non smoker, and non alcohol user, and other pre-existing medical conditions included no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: 13-JUN-2021) dose was not reported, administered on 01-APR-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced body aches. On 01-APR-2021, the subject experienced jaw pain. On 01-APR-2021, the subject experienced chill. On 01-APR-2021, the subject experienced heavy waves of headaches. On 01-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from heavy waves of headaches, nausea, chill, body aches, and jaw pain. This report was non-serious.
Symptoms began with lethargy the night of the 10th followed by body aches, chills and a fever as well as diarrhea by noon on the 11th. Came home early and am resting now.
I was fine all day on the 24. I woke up at 1:30 in the morning on 3/25, Took my pulse and it was 120-130. I could not keep my arms and legs from shaking. Not just the chills. They wouldn't stop shaking and I could hardly walk. So between that and the pulse, I called the paramedic and they wanted to give me an EKG at home. They asked me to keep my legs still and I couldn't stop shaking and they took me to the ER. I was there for a few hours and the doctor gave me an antibiotic. My temperature was also 102. He asked me for a urine sample and thought I had a UTI. I haven't had one in ages and he thought that might be it. so he gave me intravenous injection and sent me home. He told me to see my primary as a follow up. My PCP looked at my levels and said he didn't see a urinary tract infection. He said I thought I had a bad reaction to the vaccine. I was okay but it took me about 2 days to be okay. I took Tylenol and in 2 days, I was fine.
Patient presented for evaluation for erythema and edema that started at site of injection, then seemed to travel down the arm away from vaccination site.  Not painful.
Patient received PNEUMOVAX 23 on 1/27/2016. Right deltoid; reported pain, swelling, joint pain, warm to touch, streak formation at injection site.
Pale skin color, sweating. Patient passed out and fell on floor. He said he felt dizzy ("didn't feel good"). He was conscious within seconds and slowly felt better (within 10 min).
This spontaneous report as received from healthcare workers refers to multiple unspecified patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was reported. On unknown dates, the patients were vaccinated with improperly stored PEDVAXHIB, lot # L004740, expiration date: 16-NOV-2017, (dose, route of administration and injection site were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information had been received on 17-MAY-2017 from a field representative who reported that a female patient (age unknown) of a nurse practitioner mentioned she received ZOSTAVAX subcutaneous injection (date of vaccination, lot#/expiration and dose not reported). Patient also informed nurse practitioner that she "never had chicken pox". On an unspecified date after receiving the shot, the patient has "come down with a case of shingles". No additional adverse events have been reported. No further information provided. Additional information has been requested.
Pfizer 4/12/21, 5/3/21. Positive on 2/14/22
Intially started as lip numbness, then tongue, lasting for about 10-15 minutes.  It went away, then about 10 minutes later her Right arm became numb, then it returned to her lips on the Right side of her mouth, and then feeling wobbly, weakness on the Right leg.  Elevated blood pressure, 182/112.  Got medication prescribed and is lowerin blood pressure now, within an hour of taking medication, but numbness remains.
1/6 developed fevers, chills, body aches, and a sore throat, following the vaccine.  Her fevers subsided over the weekend, but she still has body aches/sore throat/chills. Red swollen eyes at night Sent to medical center 1/12, medical center f/u allergic reaction to covid 19 vaccine
Head aches, problems breathing, fatigue, increased asthma issues and cold like symptoms. Cognitive decline.
Heart racing and increased blood pressure 2-3months after second shot. Had to be put on medication for both. Otherwise was healthy and in good physical condition.
Migrane; throwing up; This is a spontaneous report received from non-contactable reporter (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 55-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MIGRAINE (non-serious), outcome "unknown", described as "Migrane"; VOMITING (non-serious), outcome "unknown", described as "throwing up".  No follow-up attempts are possible. Information on lot/batch number cannot be obtained. No further information is expected.
Symptoms of mild COVID. Loss of taste, smell starting 4/10. Fatigue and muscle soreness starting 4/9, at approx 3 PM. Nasal congestion starting 4/9 early AM.  Chills, fever 4/10.