chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received doses from the same lot number #015h22a administered after 30-day Use By Date; The vial was initially stored in refrigerator on 01-Nov-2022 and was administered after 30 day use by date; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received doses from the same lot number #015h22a administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 01-Nov-2022 and was administered after 30 day use by date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 015h22a) for COVID-19 prophylaxis.     No Medical History information was reported.    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 EXPIRED PRODUCT ADMINISTERED (received doses from the same lot number #015h22a administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 01-Nov-2022 and was administered after 30 day use by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received doses from the same lot number #015h22a administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 01-Nov-2022 and was administered after 30 day use by 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 EXPIRED PRODUCT ADMINISTERED (received doses from the same lot number #015h22a administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 01-Nov-2022 and was administered after 30 day use by date).    No concomitant medications were reported.  The size of the vial was reported as 2.5ml. The vial was initially stored in the refrigerator on 01-Nov-2022. The vial did not undergo temperature excursion.  No treatment medications were reported.
Headaches/Dizziness Pressure in head started around 2 weeks after shot. Still occasionally occur
This case was reported by a lawyer and described the occurrence of lupus-like syndrome in a 48 year old female patient who received Lyme disease vaccine recombinant injection for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date, the patient received LYMErix. At an unknown time after receiving LYMErix, the patient experienced polymyalgias and polyarthralgias, lupus like disease and inflammatory arthritis with joint swelling consistent with mixed connective tissue disease. Time to onset, treatment, and outcome were not reported. Comment: Lupus-like syndrome was considered medically serious (OMIC). Per follow up recport received 03/21/2005:  Legal case, follow up unavailable.
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadedness-Medium, Systemic: Shakiness-Mild.
itching across shoulders /back of neck; nausea; body aches; chills; She felt like there was a tight band around chest.; sense the she couldn't get a good breath; pulse of 101-129; she had tinnitus, and she noticed that both injections made that worse; This is a spontaneous report from a contactable nurse. A 63-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK4176/expiration date) dose number 2 intramuscularly on 08Jan2021 11:45 at a single dose on the left arm for COVID-19 immunization. The patient received the vaccine in a hospital. Medical history included severe allergic reaction to pecans and tinnitus. Historical vaccine included BNT162B2 on 18Dec2020 (dose number 1, intramuscularly on the left arm) for COVID-19 immunization. The patient experienced tinnitus, sinus infection, and stuffy head after the first dose. No other vaccines were administered within 4 weeks and no other medications were taken within 2 weeks. The patient was not diagnosed with COVID prior vaccination and was not tested for COVID post-vaccination. On 08Jan2021, after the 2nd dose, the patient experienced itching across shoulders/back of neck and sl nausea. She took Benadryl which relieved the itching. She went to bed and had onset of body aches, chills, and sense the she couldn't get a good breath. She felt like there was a tight band around chest. Her O2 Sat was 95% - 98%, with pulse of 101-129, T max was 101.8. The symptoms were lasting about 6 hours. In the morning, the patient took Aleve and Benadryl. Most symptoms were alleviated. She took those meds scheduled for 48 hrs. She noticed that if she tried to push past scheduled time, the itching started to return, so she just kept the meds scheduled for 48 hours. No other symptoms after that. She added that she had tinnitus, and she noticed that both injections made that worse. It was not yet subsiding since last injection. The patient also received Tylenol for the events. The outcome of the events was recovered in Jan2021.
pt recv vax & exp numbness from the neck down,gen fatigue,unsteadiness & joint aches;hypoesthesia assoc w/fatigue r/t viral illness;6JUL94 adm to hosp quadrihypesthesia;also nystagmus;dx MD & acute disseminating encephalomyelitis;
Liver inflammation /5/07-records received-DX Alcohol Abuse. Alcoholic liver damage. Alcohol withdrawal. Sleep disorder. Obesity. HX of sleep apnea. Nightmares cause anxiety. Low back pain, chronic condition. HX of gout. Attends alcohol rehab
This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (arm pain), NIGHT SWEATS (night sweat), PYREXIA (Temperature of 103 for 2 days and then 101F), CHILLS (chills) and MYALGIA (severe muscle aches) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in March 2020.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm pain). On 15-Feb-2021, the patient experienced NIGHT SWEATS (night sweat), PYREXIA (Temperature of 103 for 2 days and then 101F), CHILLS (chills) and MYALGIA (severe muscle aches). The patient was treated with IBUPROFEN for Pain in arm, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. On 14-Feb-2021, PAIN IN EXTREMITY (arm pain) had resolved. On 17-Feb-2021, PYREXIA (Temperature of 103 for 2 days and then 101F) had resolved. On 20-Feb-2021, NIGHT SWEATS (night sweat), CHILLS (chills) and MYALGIA (severe muscle aches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Feb-2021, Body temperature: 103 (High) 103 F for 2 days.. On 17-Feb-2021, Body temperature: 101 (High) got it down to 101..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   concomitant medication includes Tylenol and ibuprofen .
This case was reported by a pharmacist via call center representative and described the occurrence of injection site muscle pain in a 67-year-old female patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020) and (batch number ZX3YA, expiry date unknown). On 16th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, the dose was an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site muscle pain and weight bearing difficulty. On an unknown date, the outcome of the injection site muscle pain was not recovered/not resolved and the outcome of the weight bearing difficulty was unknown. The reporter considered the injection site muscle pain to be related to SHINGRIX. It was unknown if the reporter considered the weight bearing difficulty to be related to SHINGRIX. Additional details were reported as follows: The healthcare professional reported that, the patient still had muscle soreness where the vaccine was administered in the left arm. The patient told the healthcare professional about this 5 weeks after receiving the vaccine but the healthcare professional did not know when the reaction started. The patient said it was not severe but she did work out with weights and she was unable to lift the weights.
This is a spontaneous report received from a contactable consumer, the patient. A 23-year-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via an unspecified route of administration in the left arm on 19Mar2021 at 08:45 (at the age of 23-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not had any allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other medications within 2 weeks of vaccination. On 19Mar2021 at 13:00, the patient experienced fast heartbeat, slight shortness of breath and nausea. The patient did not receive any treatment for the reported events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events fast heartbeat, slight shortness of breath and nausea was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
Patient was inadvertently administered the Pfizer Bivalent as the 2nd dose instead of the Pfizer Monovalent.  No need for redosing per CDC.
Breakthrough case admission after 3 vaccines Pfizer 2/22/22 LOt# FJ6369;  Pfizer 3/17/22 LOt# FK9894; Pfizer 7/25/22 Lot# FN2908;
Same day of vaccine later on that night I started getting a headache. The next morning I felt body aches, tired,  as the day went on I started feeling tightness of chest, had to take deep breath this was around 10 or 11am then my supervisor said to go to the ER, They did an x-ray & covid test it came out negative & in the x-ray came back normal.
Typical shingles of L chest and arm 7 months after vaccine. Zoster/Shingles.
Pt reports after rabies vaccine dose 2, intense fatigue beginning about 8 hours after injection. Reports debilitating migraine with aura the following morning accompanied by nausea/vomiting ("I couldn't keep anything down") and dizziness. States felt like she was going to pass out x 2 but never fainted.  Reported fever and chills as well. Worst of symptoms lasted 24 hours, but states did not feel "back to normal" for 3 or 4 days. Pt reports a hx of migraines. States has not had success in past finding medications to treat/prevent her migraines.
Approximately 6 hours after immunization, got fever, headache, myalgias, laminating pain, red, hot, swollen injection site of Pneumo.
Moderna COVID-19 Vaccine EUA Swellling, redness, hot, pain at injection site on 02-21-2021.
Body aches; Injection arm sore; Headache; Fatigue; Fever 99.1(F)/Fever 100.2(F)/Fever 99.8(F); This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), PYREXIA (Fever 99.1(F)/Fever 100.2(F)/Fever 99.8(F)), VACCINATION SITE PAIN (Injection arm sore), HEADACHE (Headache) and FATIGUE (Fatigue) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced PYREXIA (Fever 99.1(F)/Fever 100.2(F)/Fever 99.8(F)). On 06-Mar-2021, the patient experienced PAIN (Body aches), VACCINATION SITE PAIN (Injection arm sore), HEADACHE (Headache) and FATIGUE (Fatigue). The patient was treated with IBUPROFEN ongoing since an unknown date at an unspecified dose and frequency. On 11-Mar-2021, PAIN (Body aches), PYREXIA (Fever 99.1(F)/Fever 100.2(F)/Fever 99.8(F)), VACCINATION SITE PAIN (Injection arm sore), HEADACHE (Headache) and FATIGUE (Fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Body temperature: 99.1 (High) High. On 06-Mar-2021, Body temperature: 100.2 (High) High. On 07-Mar-2021, Body temperature: 99.8 (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information mentioned Ibuprofen. 05Mar2021 Received 1st Moderna Vaccination. Right arm(dominant) 05Mar2021 Developed fever 99.1F 06Mar2021 Developed a fever(100.2F), achy body, arm sore(injected arm), headache, fatigue. Treatment Ibuprofen 07Mar2021 Started feeling better, fever 99.8F 11Mar2021 Symptoms resolved. 07Feb2021 Patient has been breastfeeding her infant.   This case was linked to MOD21-051199 (Parent-Child Link).   See case MOD21-051199 for details regarding the child case.
Chest pain and burning in the chest and lungs, body aches, diffuse joint pain, and body stiffness
injection site pain; tiredness; insomnia; headache; muscle and joint pain; muscle and joint pain; nausea; feelling unwell; cough for the first30 minutes; accelerated heartbeat; dizziness; weakness; she experienced pain; swollen lymph nodes; This is a spontaneous report from a Pfizer. A contactable consumer or other non-health care professional (patient) reported for a 35-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history included covid-19 from an unknown date. The patient's concomitant medications were not reported.  On an unspecified date in 2021, the patient experienced injection site pain, tiredness, insomnia, headache within the first 4 hours, muscle and joint pain, nausea, feeling unwell, cough for the first30 minutes, accelerated heartbeat for the first 30 minutes but did not last, dizziness and weakness for the first 4hours, pain and swollen lymph nodes. Reporter would like to know if this can indicate that they might have prior COVID19 before getting the 1st dose of the vaccine and if there are currently any antibody test used for detecting the COVID19 virus accurately post vaccination that might not give a false positive result. The patient underwent lab tests and procedures on an unknown date which included sars-cov-2 test: positive.  The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sore arm; Tiredness; Arthralgia; myalgia; fever; headache; strange dreams; Nausea; swollen gland (neck); This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203) via an unspecified route of administration in the right arm on 09Mar2021 at 16:15 (at the age of 53-years-old), as a single dose for COVID-19 immunisation. Medical history included hypertension and gluten allergy (Gluten sensitivity). Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9264) via an unspecified route of administration in the right arm on 16Feb2021 at 16:45 (at the age of 53-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient had not received other vaccines within four weeks prior to the COVID-19 vaccine. On 10Mar2021 at 01:00, the patient experienced sore arm, tiredness, arthralgia, myalgia, fever, headache, strange dreams (bizarre dreams), nausea and swollen gland in neck (gland in neck). The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the adverse events. The clinical outcome for the events sore arm, tiredness, arthralgia, myalgia, fever, headache, vivid dreams, nausea and gland in neck was resolved on unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Difficulty breathing. Chest pain. Abnormally high BPM. Dizziness.
PT REPORTS FEELING LIGHTHEADED AND DIZZY IMMEDIATLY AFTER GETTING VACCINATED. PT STATS SHE HAD SIMILAR SYMPTOMS WITH FIRST DOSE. PT DENIES SHORTNESS OF BREATH, SYSPNEA, HIVES ITCHINNESS PT DID EAT BEFORE GETTING VACCINE WAS ENCARAGE TO STAY HYDRATED AND DRINK WATER. INSTRUCTED TO LAY HEAD BACK TO HELP WITH DIZZINESS. PATENTFELT BETTER AS SYMPTOMS SUBSIDED. INSTRACTED TO FINISH 30 MIN OBSERVATION TIME AND INSTRUCTED TO NOTIFY IF SYMPTOMS WORSEN
Patient recieved the COVID vaccine when the wanted the flu shot. Patient called on Wednesday (10/4) and scheduled the appointment over the phone. Patient states that they requested a flu shot but the person putting in the appointment scheduled them for the COVID19 shot. Patient came for the vaccine appointment and it wasn't until after the vaccination was complete was it noticed the wrong vaccine was schedule.  No reactions to the vaccine as of yet but patient did not wish to receive the vaccine.
couldn't control any of my muscles; All my muscles, my whole body shaked; fever 103.4; This is a spontaneous report from a contactable other healthcare professional (patient). A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 05May2021 14:15 (lot number and expiry date: unknown) as dose 2, single for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. The patient was 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 Facility. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 14Apr2021 at 13:45 in left arm for COVID-19 immunisation. Concomitant medication included IBUPROFEN taken for an unspecified indication from 03May2021 to an unspecified stop date. On 05May2021, 7-8 hours later than second vaccination, all her muscles shook for at least 2 hours, she couldn't stop shaking, she couldn't control any of the muscles. She also had extreme fever of 103.4. She took Ibuprofen, it decreased to 102. It was day 3 at the time of the report, and she still had fever around 101 after Ibuprofen. Without Ibuprofen, it was still around 103. She didn't inform health providers because she was alone, and she was not able to do anything in that situation. The patient did not receive treatment for the other events. The patient has not been tested for COVID-19 since vaccination. Outcome of the events was recovering.  Information on lot/batch number has been requested. Based on the information available  a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events neural atrophy. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the product is evaluated as part of 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, as appropriate.
Very large red welt with large lighter red ring circling.  Approximately 8"L x 6" W.  Hot, sore, itchy.  Felt like coming down with something. Took Benadryl and iced area.
This spontaneous report as received from a registered nurse refers to a 92 years old female patient. Within the last couple of weeks, on approximately November 2012, the patient received subcutaneously a 0.5 mL dose of VARIVAX (Merck) (0.5-VARIVAX dosing instructions) (lot# not provided) instead of ZOSTAVAX (Merck) as she was scheduled for. No treatment at the time of the report was received. Additional information has been requested.
Td given 9:00 AM - seated in waiting area. Attempted to stand - nausea, diaphoresis, fell forward into aisle shelving. Remained conscious. EMS arrived. Bradycardia - heart rate 40's with attempts to stand. Transport ambulance to hospital.
Upper arm muscle where injection administered, extremely sore, stiff and pronounced muscle weakness persists to date.
Arm began itching in area of vaccine admin. right after injection. Later that day swelling began. On 01-30-09- day after injection, outside of arm is red, swollen and hard. with white center.
This spontaneous report as received from a doctor of pharmacy refers to a 88 years old male patient with codeine, morphine, and penicillin allergy. The patient was vaccinated with a 0.5 ml dose PNEUMOVAX23 (lot # not reported) IM into the right arm on 09-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. On 12-OCT-2012, the patient was evaluated at the emergency room, the patient was diagnosed with moderate inflammatory reaction of the soft tissue at the injection site. No treatment information was reported. The outcome of the event was not reported. The relationship between the event and PNEUMOVAX23 was not reported. Additional information has been requested.
Dizzy, diahrrea, fainted, fever, cough later, increase continues in symptoms related to hypertension
This spontaneous report as received from an unknown reporter refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of VARIVAX (Merck) (lot #J003221, expiration date 15-MAR-2015), (dose, location and route unspecified). The outcome of the event was not provided. Follow up information has been received from a registered nurse who called and stated the patient (who received VARIVAX (Merck) exposed to unknown temperatures for 5 hours during interoffice transport) have been revaccinated. No symptoms reported. This is one of several reports received from the same source (Linked MARRS#: 1309USA011086, 1311USA000056, 1310USA014891, 1310USA014881, 1310USA014883, 1310USA014888, 1310USA015417, 1311USA000071, 1311USA000012, 1310USA014858, 1310USA014850, 1310USA014870, 1311USA000289, 1311USA000282, 1310USA014874, 1310USA014861, 1310USA014866, 1310USA014868, 1310USA015422, 1310USA015165, 1311USA000069, 1310USA015424, 1311USA000058, 1311USA000042, 1311USA000013, 1310USA015170, 1311USA000014, 1310USA015153, 1310USA015090, 1311USA000067, 1311USA000064, 1311USA000021, 1311USA000020, 1311USA000022, 1310USA015101, 1310USA014853, 1311USA000075, 1310USA014895, 1310USA015119, 1310USA015113, 1311USA000059, 1311USA004931, 1311USA000065, 1311USA000739, 1311USA000040, 1310USA015096, 1311USA000642, 1310USA014958, 1311USA000072, 1310USA015127, 1311USA000053, 1311USA000085, 1311USA000741, 1311USA000744, 1310USA015134, 1311USA000083, 1310USA015141, 1311USA000006, 1311USA000005, 1310USA014900, 1310USA015268, 1310USA015264, 1310USA014896, 1310USA014909, 1311USA000627, 1310USA015396, 1310USA015270, 1311USA000637, 1310USA014962, 1311USA000039, 1311USA000037, 1311USA000034, 1311USA000032, 1311USA000002, 1310USA014897, 1401USA000205). Additional information is not expected.