chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Aching all over; Running a fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injecion), as dose 4 (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, Dose 1 and 2), for covid 19 immunization; Covid-19 vaccine (Dose 3 (booster), MANUFACTURER UNKNOWN), for covid 19 immunization.  The following information was reported: PAIN (non-serious), outcome "unknown", described as "Aching all over"; PYREXIA (non-serious), outcome "unknown", described as "Running a fever". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient and his wife had their second booster shot and the patient was aching all over and running a fever. The reporter asked on how long she should worry about it.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient developed vesicles around vaccine site and later burning and itching pain similar to what would be expected from shingles itself. As of today (9/27/2012), all symptoms had resolved.
expired dose of IPOL was inadvertently administered today with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via physician via Global Medical Information (Reference number- 00530069) and transmitted to Sanofi on 22-Mar-2021.  This case involves a 1 years old male patient who inadvertently received 0.5 mL dose of suspect IPV (VERO) lot R1B252M, expiry date- 13-Mar-2021 via intramuscular route in right thigh for prophylactic vaccination on 22-Mar-2021.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation.  It was a case of an actual medication error due to expired vaccine used (latency same day).  Caller with question on whether dose needs repeating and in what time frame. Additional Description of event Adverse events: Clinic administrator reporting an expired dose of IPOL was inadvertently administered today.  At the time of report there was no adverse event was reported.  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 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.
pt recv vax & devel cellulitis & erythema;tx w/ATB;
He came back to the pharmacy around 10 minutes after the vaccine saying he had pain in his neck and lower back and down his sides (both). He said it came on slowly and got sharper. I offered to have him take a seat and called. I offered him an ambulance and/or to call his primary care doctor. As I was talking to him and others he said it was starting to subside. After about 30 minutes he said he felt pretty good and basically no pain any longer.
My arm became extremely red, blistered, hot, and very sore. It continued to spread and covered an area the size of my palm and fingers. This continued for 2 weeks when I returned to pharmacy where I received the PREVNAR 13 and was told to contact the doctor. The following morning, I emailed pictures and dr called me in antibiotic with follow up in 4 days, where I was told to finish the 10-day course and contact her if no better. To date, it is still visible, but not hot or painful and lighter in color. The doctor is aware.
After my vaccine was administered, around 11:30, I started getting achy. the aches started getting intense. I got off work and I went home around 2pm and layed down. I had an intense headache. I woke with a fever of 101. A few hours later I had a fever of 102. I took ibuprofen to help. 24 hours from the shot I had a fever of 103. I could barely walk and I just couldn't even go downstairs. 103.8  by the afternoon. my PCP said if it goes over 104 to go to the hospital ER and advised me to take more Ibuprofen. I woke up early thursday morning and it was down to 103 and then it got down to 99 by thursday night and is still 99 today on Friday. Meanwhile, the sight of the injection, (nurse delivered it at an angle) I could not lift my arm for 2 days. I had a swollen sight and it was bruised to almost black. I managed to eat a little soup on thursday. I almost felt paralyzed, my body ached so badly I couldn't move up until thursday morning.
Moderna COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Received Moderna Vaccine on 01/15/2021, 02/25/21 and 10/10/2021. Per pt. Covid + 1/14/22. Presented to ED on 1/21/22 with COVID PNA. Hospital course c/b worsening respiratory distress requiring intubation 1/25, persistent bacteremia with fevers, AKI, pneumothorax requiring bil chest tubes and respiratory acidosis refractory to vent optimization and bicarb drip. Transitioned to DNAR, life support withdrawn per family request on 2/8/22. Treated with remdesivir, vancomycin, daptomycin, ceftaroline, and solumedrol. Expired 02/08/22.
This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (drowsy), MYALGIA (sore left arm) and HEADACHE (headache) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A and 088D21A) for COVID-19 vaccination. No Medical History information was reported. On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (drowsy), MYALGIA (sore left arm) and HEADACHE (headache). At the time of the report, SOMNOLENCE (drowsy), MYALGIA (sore left arm) and HEADACHE (headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. Treatment medications were not reported. This case was linked to MOD-2021-301574..
4 months after receiving a Pfizer vaccine, developed without signifiant PMHx developed shingles.; This is a spontaneous report from a contactable healthcare professional, the patient. A 26-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK5730) via an unspecified route of administration in the left arm on 04Jan2021 at 16:00 (at the age of 26-year-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient had no known allergies to medications, food 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 vaccination. On 14May2021 at 12:00, 4 months after receiving a Pfizer vaccine, the patient without significant past medical history (PMHx) developed shingles. The event resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of shingles and included treatment with Valacyclovir 1g PO TID x 10days. The clinical outcome of the event shingles was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Severe, Systemic: Abdominal Pain-Mild, Systemic: Chills-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Headache-Mild, Systemic: Nausea-Severe
NO ADVERSE EVENTS OCCURRED. DOSE WAS GIVEN AFTER BIVALENT BOOSTER WAS AUTHORIZED AND MANDATED ON 8/31/22.
episodes of light headiness; This is a spontaneous report from non-contactable Other-HCP via Pfizer Sales Representative.  A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, Lot Number: Unknown), via unspecified route of administration, on an unspecified date as a dose 2, single for COVID-19 immunization. The patient medical history and concomitant medication were not reported. On an unspecified date the patient experienced episodes of light headiness. It was reported that, patient experienced episodes of light headiness after second dose lasted less than 24 hours. The outcome for the reported event was resolved on an unspecified date.  No follow-up attempts are possible. Information on Batch number, Lot number cannot be obtained.
My arm became quite sore about 8 hours after my initial vaccination.  It was sensitive to the touch to the point that I couldn't sleep on that side of my body.  It also hurt to raise my arm any higher than shoulder height.  It went away on its own after about 36 hours.  One week later, on January 7th, my husband noticed that I had a large red patch on my arm where I had gotten the vaccination.  It was about 1.5-2" across, raised, red and warm to the touch.  It was slightly itchy, but didn't hurt.  My husband noticed this in the evening, but I am not sure how long it had been that way since I had had long sleeves on all day.  By the morning, it had gone away.  I didn't treat it in any way.
This non-serious initial spontaneous case, was received on 11-Oct-2017, from other health professional (pharmacist), concerning a 71-year-old, elderly, female patient. On 09-Oct-2017, the patient was administered with FLUAD (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 179102, expiry date: May-2018). The reporter stated that, the patient was administered with suspect vaccine and during administration, part of the dose leaked out of the injection site. The reporter was unsure whether complete dose was administered (explicitly coded as under-dose and drug administration error). The patient had not experienced any adverse reactions after the vaccination. The outcome of the event was not reported. Significant case correction received 11-OCT-2017: The 'route of administration' was taken as not reported, reporter says site of administration was left deltoid. Left deltoid was updated in the route of administration field and in narrative was amended. The description of the event 'drug administration error was taken incorrect'. The event was removed from the event field.
TRUMENBA was administered as an alternative to MENVEO or MENACTRA. No adverse reactions reported to this facility.
Severe episodes of shock-like sensations on right side of lower face just above jaw-line causing extreme pain. Diagnosed with Trigeminal Neuralgia and eventually was prescribed Oxcarbazepine (have been taking Oxcarbazepine since April 2021). Symptoms generally well-controlled (with very occasional break-through "shocks") with exception of brief period of time in August 2021 when medication was stopped which resulted in return of frequent symptoms and necessitated increase in medication dosage.
Late mentsruation (1.5 weeks past due); Heavy flow; Heavy cramps and long lasting cramps; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6202) via an unspecified route of administration in the arm left on 11Mar2021 at 11:45 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. Medical history included fibromyalgia, spinal cord injury, joint and nerve damage/illness. The patient had latex and iodine allergy. Concomitant medications included lamotrigine (MANUFACTURER UNKNOWN) and hydrocodone bitartrate, paracetamol (NORCO) from unknown dates and for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 22Mar2021, the patient experienced late menstruation (1.5 weeks past due), heavy flow, heavy cramps and long-lasting cramps. It was 2 weeks after her flow and still cramping at the time of this report. The patient did not receive any treatment for the reported events. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. On 25Mar2021, the patient underwent rapid test (SASRs-CoV-2 test) and the result was negative. The clinical outcome of the event late menstruation (1.5 weeks past due) and heavy flow was unknown, while that of heavy cramps were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Patient woke up with a red swollen arm about 2 inches around.  1/23/22 it started to itch and spread.  1/24/22 it has spread to 6 inches around and still itching.
Patient had swelling of the upper lip. No other symptoms - no difficulty breathing, patient talking fine. Vital signs were stable. Patient shared she was burping. Patient decline Epi-Pen. Patient then stated that she "felt something in her throat." Epi-Pen administered and 911 called. Patient transported by Ambulance to hospital. No reactions to vaccines in the past. Allergic to Sulfa, zithromax, Avlox, peanuts, seafood, all nuts, aspirin, ibuprofen. VS: 14:06 BP 152/98, P 95, Resp 10, breath sounds clear, alert.        14:22 BP 124/85, P 85, Resp 10, breath sounds clear, alert.        14:34 BP 130/90, P 85, Resp 13, breath sounds clear, alert. Temp 99.1 F
Healthy and asymptomatic prior to vaccination.  Vaccinated with Flu-Mist On 12/19/03.  On 12/20/03 developed couph,  & chest "tightness' On 12/21/03 Cough worsened (croupy) and Fever to 103F reported. Temp. reported to have reached 105.5 on 12/22/03 ( report by mother). Seen by Dr. and put on Antibiotic 12/22/03. Temp. coming down today and child somewhat better today per mother. Medical records state rhinitis, epistaxis and ear pain. msv
CHILLS, 100.4 FEVER, NAUSEA, FATIGUE, LOSS OF APPETITE 5 DAYS
I developed a rash on the upper left arm around the area of injection.  I have had it since February 26, 2021.  Today is February 27, 2021.  Yesterday the rash was more itchy.  Today the rash is less itchy.
Covid Arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERSENSITIVITY (Covid Arm) 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 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (Covid Arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, HYPERSENSITIVITY (Covid Arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-042732 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-042732:
Severe muscle and joint pain.; Severe muscle and joint pain.; Stiffening is joints; This is a spontaneous report from a contactable other healthcare professional. A 47-year-old female patient received second dose of dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) intramuscular in the right arm, on 13Jan2021 at 14:15 at a single dose, for COVID-19 immunization. Medical history included depression. Concomitant medications included escitalopram oxalate (LEXAPRO). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: expiry date: unknown) on 22Dec2020, at 09:30 AM in the right arm for COVID-19 immunization. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 14Jan2021 at 05:15 A.M., the patient experienced severe muscle and joint pain, and stiffening of joints. The patient did not receive treatment for the events. Outcome of the events was not recovered. The patient has not been tested for COVID-19 since vaccination.  Information of lot/batch number has been requested.
Pt. got SHINGRIX on 12/27/18 and on 1/2/19 pt. developed difficulty swallowing and was diagnosed with Herpes Simplex.
hypotension 71/48;T101;chills;body pain;lt arm warm & swollen 4hr p/vax;to ER-ICU adm 10/13;10/16 disch;10/28 readmit w/hypotens, n/v diarrhea;MD assessment local & anaphylactic rxn;pt had I&D of lt arm;area is healing;
Temp Excursion was Yes/ Received vaccine after beyond use date; No adverse event; Erroneously vaccinated  clients with expired vaccine/ Received vaccine that underwent temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Erroneously vaccinated  clients with expired vaccine/ Received vaccine that underwent temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Temp Excursion was Yes/ Received vaccine after beyond use date) and NO ADVERSE EVENT (No adverse event) in a 56-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 057F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Nov-2022, 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 11-Nov-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Erroneously vaccinated  clients with expired vaccine/ Received vaccine that underwent temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temp Excursion was Yes/ Received vaccine after beyond use date) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Erroneously vaccinated  clients with expired vaccine/ Received vaccine that underwent temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Temp Excursion was Yes/ Received vaccine after beyond use date) 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 assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Erroneously vaccinated  clients with expired vaccine/ Received vaccine that underwent temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temp Excursion was Yes/ Received vaccine after beyond use date).    No concomitant medications were reported.  It was reported that the patient was administered a vaccine dose after 30 day use by which was 9 days past expiry date. The size of the vial was 2.5 ml. The vial was initially stored in the refrigerator on 03-Oct-2022 and was administered on 11-Nov-2022. Beyond use date was reported as 02-Nov-2022. The vial had also undergone a temperature excursion.    No treatment information was reported.
her lip and tip of her tongue were tingling; Soreness in arm; This is a spontaneous report received from a non-contactable reporter (Consumer or other non-HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 17Mar2021 (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: PARAESTHESIA ORAL (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "her lip and tip of her tongue were tingling"; PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "Soreness in arm".  Additional information: on 17Mar2021, was first dose of covid vaccine. Four hours later her lip and tip of her tongue were tingling and lasted for about an hour. Soreness in arm. She wanted to know if she can take the Johnson & Johnson vaccine as her second dose.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient started having "difficulty swallowing" and "lips going numb" approximately 10-15 minutes after injection. Denied SOB or any other symptoms. Assessed via EMS who took over care of patient. EMS administered epinephrine (pt. allergic to benadryl)  and transported patient to  Hospital ER. Pt. was observed/monitored  x 1 hour then discharged per pt. Pt. states no other medications administered.
Left upper arm - large local reaction at site of injection - 13 cm. Progressively increase in size of reaction over 48 hours w/ constitutional symptoms: lassitude, chills;  arm pain due to same. No respiratory symptoms.
Exactly 12 hours after booster shot, I either vomited or dry-heaved for approximately 12-hours straight and unable to get out of bed.  In addition, I had periods of chills, stiff neck and low grade further.  During this entire time, and approximately for 48-hours after the booster shot, I also had a constant and unrelenting piercing migraine, mostly frontally located.  I rotated Tylenol and Ibuprophen every 4 hours which had zero effect on pain.  48-hours after booster shot all my symptoms seem to have disappeared.  Of note, I had the same symptoms after the 2nd shot, although a little less in severity.  I did not report that adverse event though.  I got the 3rd shot thinking i wouldn't get as sick due to my body having that reaction the 2nd time but i was wrong--it was worse.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 04Oct2021 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 70 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Afib" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) positive. Therapeutic measures were taken as a result of covid-19. Clinical course: Patient did not take other medication in 2 weeks. He had no known allergies. He took Paxlovid for COVID-19 treatment (treatment start date: 21Jul2022 and stop date: 26Jul2022). He was feeling normal after completing Paxlovid and 6 days later woke up feeling ill, took at home COVID test resulting in positive test.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.