chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Skin rash broke out on abdomen about 9 days after injection.  Red, hot, and itchy.  I treated with apple cider vinegar and then Calamine lotion for the itch.  As of this date 3 weeks later, I still have the rash.  I am treating with a herbal treatment for Skin Rash from a Doctor. My primary physician told me to take Benadryl prior to the 2nd COVID shot, but I still got the rash.
pt says area is inflammed. pt has flu like symptoms. tested negative. the injection site is still swollen. injection site and flu like symptoms have not improved. they started  the day after the immunization
broke out with rash on mine chest and back with cream it when away then it went down to mine arms both of them and cannot get rid of this rash; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP), Program ID: The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Jan2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunization. The following information was reported: RASH (non-serious), outcome "not recovered", described as "broke out with rash on mine chest and back with cream it when away then it went down to mine arms both of then and can not get rid of this rash". Therapeutic measures were taken as a result of rash.  Additional information: Patient took Pfizer booster shot in Jan2022 and broke out with rash on chest and back with cream it when away then it went down to mine arms both of then and can not get rid of this rash.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
night sweat; Fatigue; Sore arm; Nausea; Chills; This is a spontaneous report from a contactable consumer (reporting for herself). A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE,Batch/Lot Number: EL3247), dose 2 via an unspecified route of administration, administered in Arm Left on 23Feb2021 11:15 (at the age of 30-year-old) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL3247), dose 1, via an unspecified route of administration single dose arm left on 02Feb2021 23:15 for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient not been tested for COVID-19. On 23Feb2021 at 23:00, the patient experienced night sweat, fatigue, sore arm, nausea and chills. No treatment received. The outcome of the events was recovering.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Patient required hospitalization due to breakthrough infection. He received Pfizer vaccine final dose in series on 04/17/21. Hospitalized from 07/27/21 - 07/29/21. Below is copied from discharge summary:   Hospital Course:  Pt. is a 55 y.o. male with no known PMH presenting after a fall, he was found conscious lying down on the ground by his wife. On arrival, patient was febrile to 103.2F and found to be Covid-19 positive despite being fully vaccinated with Pfizer. He is having no respiratory symptoms and remained on room air. He endorsed decreased PO intake,  but continued to drink Alcohol daily (6 beers/day for the past 20 years), which was likely the reason for his falls. RUQ ultrasound findings suggestive of cirrhosis and showed Cholelithiasis without Cholecystitis. AST was elevated, ALT normal. Acute Hepatitis Panel and HIV negative. Labs also significant for Hyponatremia with Sodium of 121 on arrival, improved to 128 after NaCl fluid bolus. Hyponatremia attributed to Beer Potomania and SIADH. No offending medications. No sodium tablets were prescribed on discharge due to untreated Hypertension. He was started on Norvasc 10mg and will follow up with primary care for further blood pressure management. He was offered to establish primary care here, but denied stating that he has another doctor although he has not seen by any Physician since 2015. He was counseled on Alcohol cessation. He worked with Physical Therapy inpatient and no post- discharge rehab was recommended. A script for outpatient Physical Therapy was provided.
sore arm; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 47 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Apr2021 17:30 (Lot number: EN6202) at the age of 47 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: If covid prior vaccination: Yes. Concomitant medication(s) included: NASACORT; CLARITIN ALLERGIC; LISINOPRIL. Vaccination history included: Bnt162b2 (Product=COVID 19, Lot unknown= ER2613, Administration time=01:15 PM, Dose number=1, Vaccine location=Left arm), administration date: 24Mar2021, when the patient was 47 years old, for covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 14Apr2021 20:00, outcome "recovered" (17Apr2021), described as "sore arm"; HEADACHE (non-serious) with onset 14Apr2021 20:00, outcome "recovered" (17Apr2021), described as "headache". Therapeutic measures were taken as a result of pain in extremity, headache.  Additional information: Evening of day of vaccination had a slightly sore arm, was moderately sore the next morning and continued throughout the day. The soreness had resolved the next day (Day 3 after injection). Also had a headache most of the day after vaccination. The headache was resolved by Day 3 after vaccination. Patient took Tylenol as a treatment of adverse events. The patient did not receive other vaccine in four weeks. No covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
1st dose pfizer vaccine was given to patient on 07/06/2021. We found out on 07/09/2021 vaccine was stored outside the recommended 31 day expiration window.
Pt. had vaccination 8 day before redness. Less likely vaccination produce redness and swelling, most likely insect bite.
Ipsilateral facial neuritis (Facial dysesthesias in the temporal, buccal, and mandibular branches with orbicularis oculi and orbicularis oris fasciculations).   Never developed true Bell's Palsy.  Symptoms persisted for less than 48 hours and then dissipated.  Only occurred on right side (ipsilateral to injection site)  Submandibular and anterior cervical adenopathy that developed within 24 hours of injection.  One week later adenopathy PERSISTS and has not yet abated.  No other illness to explain adenopathy.
This spontaneous report as received from nurse practitioner refers to a patient of unknown age and gender. No information provided regarding concurrent conditions and medical history. On an unknown date the patient was vaccinated with LIQUID PEDVAXHIB (dose, route, lot# not reported). No concomitant medications were reported. It was reported that the LIQUID PEDVAXHIB was exposed to 20.5 degree Celsius for 2.5 hours and may have been administered to patients and no adverse effects reported. PQC was not involved. This is one of the 3 report reported by the same reporter (1405USA009701, 1405USA008829). Additional information has been requested.
Pain at base of skull right side extending up side of head and around ear and eye socket .  Not headache.  Started like strained muscle.  Over a week became  very intense like ? Charlie horse in side of head?.   Constant severe pain  with no relief .  No help from otc meds. No relief from  Muscle relaxant Robaxin.  Some relief with Tizanidine plus oxycodone.  Better after three weeks
7/2/07 10-15 min. after Tdap administered onset of anxiousness, lightheadedness, body shakes and increased heart rate, lasting about 5 minutes. 7/3/07 - Body aches all day - low grade fever 99.9, swelling at site. Fever increased 101 in evening. 7/4/07 2 AM fever increased 103.9 - remained 101-103 all day. Increased swelling in arm and redness. 7-5-07 Fever down 100.4-100.5. Called in sick to work. Returned to work on 7/6/07.
Within a  few hr of vax, pt devel redness & tenderness @inj site of Typhoid vax. Pt also devel swelling & soreness left axilla.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. In 2012, the patient was inoculated with ZOSTAVAX at a doctor's office as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2016, the patient was treated at a doctor's office for the onset of a severe vesicular rash which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.
After I received PREVNAR 13 and flu shot start having fatigue, headaches, muscle pain, rash, pain around eyes.
red bumps on his skin and it is itching; red bumps on his skin and it is itching; he does not feel comfort; This is a spontaneous report from a contactable consumer (patient). A 23-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 24Aug2021 as dose 1, single for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. Caller reported that he got his first shot yesterday (24Aug2021) and explained he did not feel comfort. He experienced red bumps on his skin, and it was itching. Caller wanted to know if this was an allergy to the product. The outcome of events was unknown.    Information about lot/batch number cannot be obtained. No further information expected.
Pain in arm, shoulders, knees-within 3 hours after vaccination, difficulty sleeping-resolved in 24 hours;  Temporary blackout and fainting with fall from a standing position-13 hours after vaccination, ambulance called,vitals normal (temperature 97.9, bp & heart rate normal.
Fatigue; Sore arm; This spontaneous case was reported by a nurse and describes the occurrence of FATIGUE (Fatigue) and PAIN IN EXTREMITY (Sore arm) in an 18-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 0377A22B) for COVID-19 vaccination.     The patient had not received other vaccines given within 1 month prior to Moderna COVID-19 vaccine. The patient had not COVID + test or diagnosis.  Concurrent medical conditions included Obesity, Nerve pain (Neuro pain), Allergy to antibiotic (Amoxicillin) and Penicillin allergy.    On 27-Jun-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced FATIGUE (Fatigue) and PAIN IN EXTREMITY (Sore arm). At the time of the report, FATIGUE (Fatigue) and PAIN IN EXTREMITY (Sore arm) had resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.   For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  There were no other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  The patient did not seek medical care for the event.   It was unknown if the patient experienced a similar event in the past.  The events lasted for 24 hours.  No treatment medications were reported.   This case was linked to MOD-2022-615220 (Patient Link).
Information has been received from a register nurse, for GARDASIL a Pregnancy Registry product, concerning a 14 year old smoker female with depression, who on 12-AUG-2009 was vaccinated with the first dose of GARDASIL (Lot # unknown) and on 11-MAY-2010 with the second dose of GARDASIL (lot # 661531/1311Y). Suspect vaccine therapy included a dose of HEPATITIS A (manufacturer unknown). Other concomitant therapy included "depression medication". The nurse reported that the patient, requested an in-office pregnancy test afterwards which determined she was pregnant. The patient was reported to be 10 weeks pregnant. LMP approximately 28-FEB-2010, EDD approximately 06-DEC-2010). The patient sought unspecified medical attention. Follow-up information has been received from a completed questionnaire, concerning the 14 years old patient with anxiety. Patient's LMP was reported as 20-MAR-2010 and the EDD on 26-DEC-2010 (previously reported as 28-FEB-2010 and 06-DEC-2010 respectively). It was reported that that patient was taken LEXAPRO as concomitant therapy during the pregnancy. On 27-MAY-2010 the patient experienced a spontaneous abortion (<20 weeks). It was unknown if the product of conception was examined or if the fetus was normal. At the time of this report, the patient's outcome was unknown. Upon internal review, spontaneous abortion was considered to be an other important medical event. Additional information has been requested.
NECK PAIN; SICK (AFTER ABOUT 8 HOURS); CHILLS; HIGH FEVER; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a 40 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On 11-MAR-2021, the subject experienced neck pain. On 11-MAR-2021, the subject experienced sick (after about 8 hours). On 11-MAR-2021, the subject experienced chills. On 11-MAR-2021, the subject experienced high fever. On 11-MAR-2021, the subject experienced nausea. On 11-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from neck pain, chills, high fever, nausea, and headache on 13-MAR-2021, and the outcome of sick (after about 8 hours) was not reported. This report was non-serious.
Varicella given 7/15/98 at clinic. Came to clinic 11/18/02 with skin rash-few vesicular erythematous lesion on upper chest, scalp, face. Tx-Atarax, Keflex, Bactracin.
Allergic reaction; This is a spontaneous report from a contactable consumer (patient). A patient of unknown gender and age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown date at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. The patient had an allergic reaction to the COVID vaccine and she/ he was sent to the ER for treatment. The outcome of the event was unknown. Information on Lot/Batch number has been requested.
11/26/18 Pt was seen for post office testing. At time of visit C/O on 11/14/18 at 0200 C/O no energy, weak, fever 102 degrees achiness, stated symptoms lasted x4 days. C/O fever 1 1/2 days. At present visit 11/26/18 offered no further C/O above symptoms. 11/26/18 Lt delt site of vaccine area checked no redness, swelling or warmth upon touch.
patient Recieved pfizer covid-19 booster dose today. After several minutes she began experiencing tingling and numbness in the mouth and tongue. additional tingling in the throat. She was stating that she could breath but can not take deep breaths.  She was visibly upset and her hand was shaking. I sat her down and took her BP and it was 178/90. I waited a few minutes and she still was having the same issues and I decided to administer 10 ml of liquid benadyrl to the patient. she had a history of allergic reactions to various antibiotics including amox, macrobid, and sulfa antibiotics.  After 10-15 min patient started to feel better. She started to be able to take deep breaths and her bp had come down significatnly to 130-80.   After she was stable and she felt better she called her husband and decided she was okay to go home.
Information has been received from a 33 year old female patient, for GARDASIL, a Pregnancy Registry product, reporting on herself who on 10-AUG-2011 was vaccinated with the first dose of GARDASIL (dose, route and lot # not reported). The patient was pregnant and her LMP was on 27-JUN-2011 and EDD is on 02-APR-2012. The patient reported that she was given the "HPV vaccine" instead of the "HBV vaccine". The patient was not certain if the product she was given was GARDASIL and that would have been her first dose of "HPV vaccine". She was also not sure why the error took place at the physician's office. No adverse events reported. The patient spoke to the physician. Follow up information has been received from the patient who reported that she experienced some bleeding and a miscarriage. At the time of reporting, the patient's status was unknown. Follow up information has been received from a registered nurse and the patient. The vaccine was confirmed to be GARDASIL (lot # 666987/1016Z). The patient had no pertinent medical history and no known drug allergies. There were no concomitant therapies. This was the patient's second pregnancy; the first was 12 years ago and it was "perfect". The patient reported that she was 6 and 1/2 weeks pregnant at the 08-SEP-2011 visit when she saw a midwife for the vaginal bleeding. An ultrasound "showed an empty sac". According to what the midwife told the patient, the complete miscarriage had not yet occurred. Another ultrasound was scheduled for 15-SEP-2011. At the time of reporting, the patient's status was unknown. Upon internal review, miscarriage was considered to be an other important medical event. Additional information has been requested.
pt recv vax 26JAN99 & first 24hr felt fine, then severe arthralgias & myalgias for 3 days; tx w/rest, muscle relaxant (flexeril) & ASA w/gradual improvement;
Received immunizations on 7/23/03. Within 12  hours he developed redness and swelling from left deltoid down to elbow. Was seen in office by CFNP 7/25/03. Treated with ice application and Tylenol or Ibuprofen PRN. Mom states redness/swelling resolved within several hours. No redness or swelling the next day.
-intermittent low grade fevers (highest recorded temp 100.4), treated with tylenol, lasted 48 hours -intermittent headaches, treated with tylenol or ibuprofen, lasted 96 hours -nausea, lasted 72 hours -fatigue & generalized weakness, lasted 96 hours -generalized muscle soreness, treated with tylenol or ibuprofen, lasted 48 hours -pain at injection site, lasted 48 hours -joint soreness (elbows), treated with ibuprofen, started 72 hours after vaccine and lasted for 48 hours after that.
09/03/21- Ct came into COVID-19 vaccine clinic to receive a 3rd dose of Moderna vaccine. PHN inadvertently gave client a Pfizer COVID-19 dose, not realizing it till after client had left the clinic/smg PHN attempted to call client later in day, no answer, voice mail message left to call PHN back. As of 18:35pm ct had not called back. PHN will attempt to contact client next week when back in the office.
Caller is going in for a lung transplant later on this year; This spontaneous case was reported by a patient and describes the occurrence of LUNG DISORDER (Caller is going in for a lung transplant later on this year) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 013h22a) for COVID-19 prophylaxis.     Patient never had COVID.     On an unknown date, 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 an unknown date, the patient experienced LUNG DISORDER (Caller is going in for a lung transplant later on this year). At the time of the report, LUNG DISORDER (Caller is going in for a lung transplant later on this year) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. The patient was going in for a lung transplant later on this year. Not related to vaccine. No treatment medication was provided.
Two weeks post vax, pt experienced severe pain in all joints from the ankles up. Pt reported they were red, hot and painful. Pt was treated with prednisone and the symptoms improved.  The symptoms have since returned and have worsened. Pt noted swelling and Raynaud's type symptoms. Pts experience was considered an other medical event.
developed a rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (developed a rash at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (developed a rash at the injection site). At the time of the report, VACCINATION SITE RASH (developed a rash at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Headache, Myalgia, extreme tiredness Narrative:  Other Relevant History:
24hr post vax pt exp swelling of rt side of face, rt shoulder, rt elbow & swollen foreskin of penis;no compromise of cardio-resp system was present;NOS were noted in other pt recv same lot#;pt did not have any prev rxn to vax;
10 minutes after shot I felt, chest congestion and a strange taste in my mouth. I stayed at injection facility for over an hour to make sure I would feel better.  Later that evening, I was fine without any marks on injection site. Nine days later I got an itchy, sore arm with a bulls eye, raised red rash larger than a quarter, about 1.75" and a bit warmer than other areas of the arm.