chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse concerning a 6 year old female who in approximately 2001 at approximately 15 months of age, was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Subsequently the patient developed chickenpox on her head, neck and underarms. Unspecified medical attention was sought. Subsequently, the patient recovered. No further information was available. There was no product quality complaint involved. Additional information has been requested.
Soreness at injection site; mild headache; mild backache; mild chills; swelling in left armpit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 26Jan2022 15:30 (Lot number: T-K9729) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "high blood pressure", start date: 2005 (ongoing); "Premature Heart contraction (PACs/PUCs)", start date: 2016 (ongoing); "Transient ischeme attack (Diagnosis)", start date: 23Nov2017, stop date: 24Nov2017. Concomitant medication(s) included: ENALAPRIL MALEATE taken for hypertension, start date: 2005 (ongoing). Vaccination history included: Covid-19 vaccine (Dose: 1st, Date: 04Mar2021, Time (24hrs): Afternoon (1310), Site and route of injection:, Anatomical site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot number: EL3247), administration date: 04Mar2021, when the patient was 57 years old, for Covid-19 immunization; Covid-19 vaccine (Dose: 2nd , Date: 24Mar2021, Time (24hrs): Afternoon (1310), Site and route of injection:, Anatomical site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot number: EP6955), administration date: 24Mar2021, when the patient was 57 years old, for Covid-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 26Jan2022 23:00, outcome "recovered" (2022), described as "Soreness at injection site"; HEADACHE (non-serious) with onset 26Jan2022 23:00, outcome "recovered" (2022), described as "mild headache"; BACK PAIN (non-serious) with onset 26Jan2022 23:00, outcome "recovered" (2022), described as "mild backache"; CHILLS (non-serious) with onset 26Jan2022 23:00, outcome "recovered" (2022), described as "mild chills"; SWELLING (non-serious) with onset 26Jan2022 23:00, outcome "recovered" (2022), described as "swelling in left armpit". Therapeutic measures were not taken as a result of vaccination site pain, headache, back pain, chills, swelling. Additional information: Facility type vaccine was Pharmacy or Drug Store. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. No follow-up attempts are possible. No further information is expected.
Started 10 days after she received the vaccine, 2/7/21, found while washing her head, bumps on her head. This progressed to her neck and on Monday 2/8/21, noticed that it was behind her ear. Yesterday and today she has noticed that it has traveled more to her throat area. She has taken Tylenol and this seems to have helped. The symptoms seem to subside while on the Tylenol, but after 6 hours she then notices that the feeling is coming back.
Began 06/04/2003 with 30-40 erythematous papules and macules on trunk, neck and face.  On fluid filled on right flank.  Afebrile.
Patient has whelps and streaking on both legs and on his face following vaccines that were given today. Mom advised to give 2.5 ml Childrens BENADRYL Q6 hrs up to 24 hrs. come to office tomorrow if no improvement ER if resp. distress/excessive drooling.
Malaise, low grade fever, chills, tenderness around injection site, lymph nodes swollen under r arm pit, loss of appetite. Toradol, Naproxen, Tylenol.
Initial and follow up information has been received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. The medical history, drug reactions and allergies of the patients were not reported. On unknown dates, the unspecified patients received improperly stored PEDVAXHIB lot # J014279, expiration date 16-SEP-2016 and lot # K015462, expiration date 10-JUL-2017 (dose, frequency and route were not reported). No concomitant medications were reported. No adverse effect was reported. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
This spontaneous case was reported by another health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered with batch number AR5186C to patients post temperature excursion, temperature excursion was from 09/08/2022 to 09/27/2022), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered with batch number AR5186C to patients post temperature excursion, temperature excursion was from 09/08/2022 to 09/27/2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered with batch number AR5186C to patients post temperature excursion, temperature excursion was from 09/08/2022 to 09/27/2022), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered with batch number AR5186C to patients post temperature excursion, temperature excursion was from 09/08/2022 to 09/27/2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered with batch number AR5186C to patients post temperature excursion, temperature excursion was from 09/08/2022 to 09/27/2022), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered with batch number AR5186C to patients post temperature excursion, temperature excursion was from 09/08/2022 to 09/27/2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.
Extreme pain in injection site for less than 5 days - has not seen health care provider.
some arm soreness; normal fatigue; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (some arm soreness) and FATIGUE (normal fatigue) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     Concurrent medical conditions included Chiari malformation.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form, third dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form and fourth dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (some arm soreness) and FATIGUE (normal fatigue). At the time of the report, PAIN IN EXTREMITY (some arm soreness) and FATIGUE (normal fatigue) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported.  It was reported that patient received all 4 shots with Moderna and did not pass out or had panic attacks with needles or immunizations.  Treatment medications were not provided.
pt recvd vax & w/in 30 mins p/vax pt exp 1 episode of loose stool; following day & over the next day pt exp 8 loose stools/day; etiology is unk @ time of this report;
I got the Jansen vaccine, full body aches, swollen pink eye. Lots of pain
devel itching about 15min p/vax;noticed urticarial rash on face, arms, back, buttock, legs about 3hr later;no diff breathing;rx DPH resolved; evaluated by Allergy Clinic on 5/20/99-dx allerg rxn to Anthrax;
his arm feels like it has a knife in it; when he tries to pick up something, move his arm, or do something he gets a sharp, sharp pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, other case identifier(s) US-PFIZER INC-2021273137.  A 69 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 31Jan2021 (Lot number: EN5318) at the age of 69 years as 2nd dose, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.   Vaccination history included Bnt162b2 (First shot: COVID vaccine, Drug Batch Number: EK4176, Drug dosage text: unknown dose; upper right arm, Drug start date: 03Jan2021), administration date: 03Jan2021, when the patient was 69 years old, for COVID-19 Immunization.  The following information was reported PAIN IN EXTREMITY (non-serious) with onset 04Jan2021, outcome not recovered; PAIN (non-serious) with onset 04Jan2021, outcome not recovered. Therapeutic measures were taken as a result of pain in extremity, pain.  Patient did not receive any other vaccines with in four weeks   No follow-up attempts are possible. No further information is expected. Linked Report(s) US-PFIZER INC-2021267956 similar report from same reporter.
High heart rate high while sleeping; Joint stiffness whole body; Hot; Cold; Armpit pain left side; Swollen left breast; Armpit Swelling (left side); Swollen neck (left side); Night sweats; Loss of appetite; Swollen face left side; Fever; Exhausted; Joint pain whole body; Arm pain (whole left arm); This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 10Apr2021 (at the age of 30-years-old), as a single dose for COVID-19 immunisation. Medical history included polycystic ovarian syndrome, major depression and anxiety, since unknown date. The patient had no known allergies to food, medications or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included VIIBRYD, metformin (MANUFACTURER UNKNOWN), Prenatal vitamins (MANUFACTURER UNKNOWN), fish oil (MANUFACTURER UNKNOWN), VITAMIN B6 and VITAMIN B12 (MANUFACTURER UNKNOWN), all on unknown date, for unknown indications and unknown if ongoing. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the right arm on 19Mar2021 at 17:15 (at the age of 30-years-old), as a single dose for COVID-19 immunisation. On 11Apr2021 at 00:00, the patient experienced high heart rate high while sleeping, fever, night sweats, joint pain stiffness whole body, exhausted, hot/cold, loss of appetite, arm pain (whole left arm), armpit pain and swelling (left side), swollen face/neck (left side) and swollen left breast. No therapeutic measures were taken as a result of reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events high heart rate high while sleeping, fever, night sweats, joint pain stiffness whole body, exhausted, hot/cold, loss of appetite, arm pain (whole left arm), armpit pain and swelling (left side), swollen face/neck (left side) and swollen left breast were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
hardness at injection site; has an area on her arm that is 3 inches in diameter that was red and swollen at the injection site.; has an area on her arm that is 3 inches in diameter that was red and swollen at the injection site; This is a spontaneous report from a contactable nurse reporting for her friend (patient). A 91-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), via an unspecified route of administration, administered in arm Right on 18Feb2021 14:00 at single dose for covid-19 immunisation. Medical history included stage 3 kidney disease, colon cancer, breast cancer and radiation from an unknown date and unknown if ongoing. There were no concomitant medications. The patient experienced hardness at injection site and has an area on her arm that is 3 inches in diameter that was red and swollen at the injection site on 28Feb2021. The nurse reported that her friend got the first injection of the Covid-19 vaccine on 18Feb2021. She was fine and did not have any reactions. Yesterday she showed the nurse an area on her arm that was 3 inches in diameter that was red and swollen at the injection site. The nurse adds that she told her friend to apply ice to the area but she did not do that last night. Her friend said the area did not hurt. The nurse adds that it is strange that it appeared 10 days later. The patient did not recover from the events.  Information about lot/batch number has been requested.; Sender's Comments: Based on a compatible temporal relationship and known product safety profile, causality between reported vaccination site reactions and BNT162B2 vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product 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.
Missed period, ongoing- 5 negative urine pregnancy tests and one negative pregnancy blood test.
2-3 hours after the injection she began having joint achiness that progressed to body aches, fatigue and swelling in her hands and ankles. Symptoms were significant until 1/11/21 but have been improving.
Aggravated ringing in ears; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 55 year-old male patient received bnt162b2 (BNT162B2), administration date 13May2021 10:30 (Lot number: Unknown) at the age of 55 years as dose 2, single and administration date 12Apr2021 (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: TINNITUS (non-serious) with onset 13May2021, outcome "not recovered", described as "Aggravated ringing in ears".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021546995 same reporter/drug/event, different patient;US-PFIZER INC-2021547757 same reporter/drug/event, different patient
Very severe stomach pains, vomiting weakness in legs went on all day went to hospital said maybe virus, went to dr, was sent to have gall bladder check.
Infection at the injection site, fever @107f. and ministroke patient stayed in the hospital for 24 hours.  patient states that he is slow and is still not himself.
pt recv 3 doses of vax between 17OCT96 & 20AUG97 & less than 1yr later on 20AUG97 pt exp alopecia;
At 10:30 p.m. 1/23/03, temp 102.7 deg. Flushed, some difficulty breathing at night. Did not use inhaler. Had weakness & fever. AM hour temperature 1/24 102.1 deg. 1/24/03 MD appt. valley family practice 98.6 temp no infectious cause for fever formed.
SEVERE HEADACHE, SEVERE BODYACHES, FATIGUE, CHILLS, DIZZINESS, DOUBLE VISION, FEELING WEAK, SHORT OF BREATH, CHEST PRESSURE, SWELLING AND AND SEVERE PAIN ON THE INJECTION AREA,  SHARP PAINS THAT TRAVELS ANYWHERE ON AND OFF IN NEW BODY LOCATIONS THAT I NEVER GOT PAIN (MEANING NOT ON NECK, SHOULDERS, BACK, HIPS, KNEES)
Vaccine given to patient after 30 day mark; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given to patient after 30 day mark) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given to patient after 30 day mark). On 08-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given to patient after 30 day mark) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: 800-900 (Inconclusive) All the patient's antibody numbers were in the 800-900 range.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment mediations were reported. Vials delivered in on 24May2021 and immediately placed the vaccine into refrigerated storage. The doctors did not know a 30-day expiration date applied to vaccines kept in the refrigerator and they administered this vaccine to patients after this 30-day mark.  No adverse events or symptoms were reported.   This case was linked to MOD-2021-415889 (Patient Link).
Patient stated that she felt very ill the day after the vaccine with a severe headache and stayed in bed all day. She also noticed itching in her arm. On the morning of Friday, March 30, she noticed a circular, red rash on the front of her upper arm. It was not at the injection site, but about an inch lower and towards the front of her arm. She said it was hot to the touch but not painful and it had stopped itching by the time the rash appeared. It is a flat rash with no visible swelling or bumps. I advised her to take some BENADRYL today and watch the rash. I advised if it got worse or spread, to see her doctor.
I sat down on floor passed out for 5 mins; light headedness, dizzy; Sweaty; arm soreness; legs felt achy; A spontaneous report was received from a consumer who was also a 65-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sat down on floor passed out for 5 mins/ loss of consciousness, legs felt achy/ pain in extremity, light headedness, dizzy/ dizziness, sweaty/hyperhidrosis, and arm soreness/ vaccination site pain.  The patient's medical history was not provided. Concomitant medications included fluticasone propionate and salmeterol xinafoate and salbutamol.  On 27 Feb 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 025A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 28 Feb 2021, the patient had arm soreness and in night her legs felt achy. On 01 Mar 2021, the patient suddenly had light headedness, dizzy, and sweaty. The patient sat down on floor passed out for five minutes. The patient reported feeling better.  Treatment for the events included Ibuprofen and paracetamol.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events, the patient sat down on floor passed out for five minutes was considered as resolved on 1 Mar 2021.  The outcome of the events, the patient suddenly had light headedness, dizzy, and sweaty was considered recovering.; Reporter's Comments: This case concerns a 65-year-old female with serious unexpected events of loss of consciousness along with nonserious unexpected dizziness, hyperhidrosis, pain in extremity and expected vaccination site pain. Event onset occurred 2 days after the first dose of mRNA-1273. Treatment included Motrin and Tylenol. Events resolving. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
He started having hard ticks, rash, fever, stopped using his hands, stop talking, its been a year of detoxing him trying to get him back before the MMR and he has yet to do anything but regress.
I received 3 AVA vaccinations in 2007 and continued to experience cough, fatigue, myalgia, arthralgia, dizziness,and short term memory problems.
Patient initially presented to the ER on 2/18 with epigastric pain, nausea, initial work-up was significant for slightly elevated lipase, elevated D-dimer, positive COVID-19 test on 2/18. 2/20 Pt received A+Ox3 c c/o back/ abdo pain. Prn Iv Fentanyl given as per mar pt tolerated well. Patient seen by infectious disease, patient remained on room air throughout her admission, patient was not qualified for any remdesivir or any antimicrobial treatment, patient initially started on Decadron, this was stopped later as the patient refused. Patient remains A&Ox4 and showing no s/s of distress 2/22. Dishcharged on 2/22.
She has had a sore arm with all 4 doses of the vaccine; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (She has had a sore arm with all 4 doses of the vaccine) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065F21A, 002A21A and 013L20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (She has had a sore arm with all 4 doses of the vaccine). At the time of the report, PAIN IN EXTREMITY (She has had a sore arm with all 4 doses of the vaccine) outcome was unknown.            No concomitant information were reported by the reporter. No treatment information were reported by the reporter.   This case was linked to MOD-2022-649160 (Patient Link).
Patient presented to the ED 3/11/2021 after rolling out of bed and landing on her right knee. Patient reported pain of the right knee but denies any other symptoms.
Patient called 1 hour after receiving the shot reporting pain,bruising and hard knot formed at injection site. Recommend cold compress and analgesic. If symptoms worsen, call the doctor and follow up. Followed up with patient 3 hours later, she was doing better. Informed patient to follow up with the doctor if symptoms don't resolve.
TALKED TO PATIENT ON 10/9/20 AND 10/12/2020. NONE WERE REPORTED BY PATIENT.
Menstrual cycle began in September and has been going on up until today January 7th 2022. Never had menstrual cycle problems until after 2nd dose of vaccine in August. This is causing me to reconsider getting my booster.