chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was given a vaccine on 7/24/23 that expired on 6/3/23.  No adverse reactions reported by parent. GSK was contacted and said that CDC recommends re-vaccination.  Patient's mom was contacted on 7/25/23 and she said that she and his dad will decide whether to revaccinate.
Debilitating Gout in BOTH Feet and Left Knee.  Went to Kaiser ER after all home remedies did not work. Was placed on IV with Steroids. Worked well for two days... came back.
Information has been received from a physician concerning a pregnant female who was possibly vaccinated with Varivax "in the past" and now has a low antibody titer. It was noted that the patient does not have chickenpox. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Woke up after getting my second vaccine the day before and I was covered head to toe in hives that were extremely itchy and painful. Upon going to the urgent care they gave my fluids, diphenhydramine, methylprednisolone and famotidine.
This spontaneous report was received from an other health professional (nurse) refers to unspecified number of patients of unknown demographics. On an unknown date, unspecified number of patients were vaccinated with VAQTA intramuscular, which was improperly stored. No adverse symptoms were reported. The temperature excursion for VAQTA was supported with in-house stability data. Outcome of the event is unknown. No product quality complaint (PQC) was reported. Causality assessment was reported as not related to therapy with VAQTA. This case is related to MARRS# 1410USA015443, 1410USA015944 and 1410USA015945. Additional information has been requested.
Moderna Covid-19 monovalent booster administered after 9/2/22.  on 9/9/22 monovalent booster administered; no adverse reactions noted.
approx 4 hrs p/inject, eyelids became swollen, eyes were burning, itching, became bloodshot drainage;
This spontaneous report was received from a physician via a company representative refers to a female patient of unknown age. The physician reported that a patient who may or may not received ZOSTAVAX developed a dramatic case of shingles on an unknown date. The patient sought medical attention- visited the office. Unspecified antiviral medication were given to the patient as treatment. The physician mentioned that medical records got mixed up in the office and the physician was not sure if the patient was one of the patients who received ZOSTAVAX. The outcome and causality for herpes zoster was unknown. Additional information is not expected as the reporter does not want to be contacted.
Initial generalized fatigue and arm soreness with axillar node swelling. Over next few days began developing chest pain-pleuritic 8/10 dyspnea. Seen at ER-EXG changes but cardiac enzymes increased-transferred; enzymes increased echo-no-pain resolved with NSAID.
10 hours after receiving vaccination in my right arm I awoke with and experienced severe pain and inability to move arm without severe pain. Upon waking and checking into my arm further, it was noted that Bandaid looked to be placed very high on the arm. Severe pain and decreased range of motion continued for 3 days. Used ice/heat and Aleve.  Right arm continues to ache at 1 week post injection but greatly improved. Presumed injected in error into shoulder joint.
?Covid arm? : itchy, firm, light red circular rash at injection site 7 days post injection and present still 11 days post injection (4 days post symptom occurrence). No treatment, no outcome.
This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. The nurse reported that, on an unknown date, an unspecified amount of doses of VARIVAX (Merck) 0.5 ml, subcutaneous (lot # and expiration date were not reported) that underwent a temperature excursion was administered to an unspecified amount of patients. No adverse effect was reported. Follow up information has been received from a licensed practical nurse on 23-JAN-2015. It was reported that there was no lot numbers, expiration dates and patient data readily available. Nurse reported that no adverse event had been reported following administration of vaccinations. Follow up information has been received from a licensed practical nurse on 23-JAN-2015. The nurse stated that 9 doses of VARIVAX (Merck) with lot number K006137 were administered since fridge incident (since 09-DEC-2014). Follow up information has been received from a licensed practical nurse on 18-MAR-2015. On 15-OCT-2013, the patient of unknown age and gender vaccinated with a dose of VARIVAX (Merck) that underwent a temperature excursion. This is one of several reports received from the same reporter. Additional information is not expected, all available information has been received.
Dizziness, cold sweat, abdominal/chest discomfort and pain, very high blood pressure.
PATIENT WAS QUITE NERVOUS ABOUT THE SHOT, BECAME FAINT AND FELL DOWN, BUT COULD SPEAK SHORTLY AFTERWARDS. PROMPTLY 911 WAS CALLED AND THE PARAMEDICS ARRIVED WITHIN 10 TO 15 MINUTES, EXAMINED HER AND DECLARED THAT HER BLOOD PRESSURE AND VITAL SIGNS WERE NORMAL AND WITH HER PARENTS SHE WAS ABLE TO WALK OUT OF THE STORE TO GO HOME.
Dizziness; Weakness; Sore arm; Joint pain; Headache; Muscle pain; Feeling very tired; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), ASTHENIA (Weakness), PAIN IN EXTREMITY (Sore arm), ARTHRALGIA (Joint pain) and HEADACHE (Headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Anxiety, Sinusitis NOS, Depression, Migraine, Asthma and Incontinence.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness), ASTHENIA (Weakness), PAIN IN EXTREMITY (Sore arm), ARTHRALGIA (Joint pain), HEADACHE (Headache), MYALGIA (Muscle pain) and FATIGUE (Feeling very tired). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizziness), ASTHENIA (Weakness), PAIN IN EXTREMITY (Sore arm), ARTHRALGIA (Joint pain), HEADACHE (Headache), MYALGIA (Muscle pain) and FATIGUE (Feeling very tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient is on some concomitant medications for anxiety, depression, pain, sinus, migraine, asthma, eye  medication, GI medication, calcium , vitamin-d and  other supplements, incontinence  medications, muscle  relaxer.  Patient had  lab work done and  result was good.   This case was linked to MOD-2021-270777 (Patient Link).
Urticarial rash with warmth; erythema at site of injection approximately 2 days after the injection; swelling at site of injection approximately 2 days after the injection; This is a spontaneous report from a non-contactable consumer, the parent. A 14-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182) via an unspecified route of administration in the left arm on 21Jun2021 (at the age of 14-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not receive any medication within two weeks of vaccination. The patient had no known allergies. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0181) via an unspecified route of administration in the left arm on 27May2021 (at the age of 14-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Jun2021, the patient experienced urticarial rash with warmth, erythema and swelling at site of injection, approximately 2 days after the injection. Therapeutic measures were taken as a result of the urticarial rash with warmth and included treatment with oral diphenhydramine (MANUFACTURER UNKNOWN) and topical steroid cream (MANUFACTURER UNKNOWN). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcome of the events urticaria, erythema and swelling at site of injection was recovering at the time of the report.  No follow-up attempts are possible. No further information is expected.
Tingling/pinching of left hand/thumb. No redness/swelling. Pt states feeling sleepy, appeared lethargic, shaking noted. Pt reports feeling weak but able to raise bilateral upper extremity forward. Diphenhydramine 25mg IM given in R arm. Pt alert and oriented. 911 called at 1345, EMS arrived 1350
Pregnant - first child, due 9/30/21.  Adverse event: Muscle and joint aches began approx. 8 hours after shot, overnight progressed to full body aches, particularly joint pain in all joints - relative to the size of the joint, so hips hurt the most. Low grade fever overnight, unsure of duration or temp, but had broken by 7 am ET. Next day joint aches and crummy feeling continued, abating 75% 24 hours after injection. Some pain in arm and overall fatigue continued for the rest of the day, progressing to nausea for the end of the day (approx. 4 hours). However, nausea has been a symptom of my pregnancy for 17 weeks (which is also the progression of my pregnancy) so nausea may not be a cause of the vaccine. 36 hours out from the shot, I feel almost 100% normal, even injection site has stopped hurting.
Approximately 10 min post vax, pt developed cough, gagging sensation, funny feeling in mouth, perioral swelling. Pt was given epi 1:1000 0.2ml SQ and diphenhydramine 12.5mg po. Symptoms improved, but then pt developed urticaria 50 min later. She recvd 2nd epi 0.2ml SQ and was transported to the hospital.
swelling under both eyes; This is a spontaneous report based on the information received by Pfizer from other agency (reference number: GL-012221-1896).   A contactable consumer (patient) reported that a female patient of unspecified age received BNT162B2, via an unspecified route of administration on 18Jan2021 at a single dose for COVID-19 immunization; and hyaluronic acid (RESTYLANE) via an unspecified route of administration from 23May2020 to an unspecified date at an unspecified dose and frequency for tear troughs. Medical history and concomitant medications were not reported. The patient received COVID Vaccine (Pfizer) on 18Jan2021. The patient reported swelling under both eyes on 19Jan2021 treated with prednisone per HCP. The action taken in response to the event for hyaluronic acid was unknown. The outcome of the event was not recovered.    Information about lot/batch number has been requested.
No additional AE information provided.; Caller reported temperature excursion / Caller reported multiple administrations of product; This spontaneous report was received from a nurse, referring to a 12-month-old patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions, or allergies were not reported.  On 10-NOV-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, at a dose of 0.5 milliliter (ml) (strength, vaccination scheme, anatomical site of injection and route of administration were not reported; lot number T017688, expiration date: 21-MAY-2022) as prophylaxis, that experienced a temperature excursion (product storage error). No additional adverse effect (AE) information provided.  On unknown dates, the vaccine underwent a temperature excursion of minus 13.3 degrees Celsius (C) for 4 hours and 15 minutes, as recorded by a data logger. There was no previous temperature excursion.; Sender's Comments:  US-009507513-2012USA013501:
patient came into clinic 10/8 for follow up of hypertension, diabetes.  No symptoms reported.  Agreed to take influenza vaccine.  Medical resident who saw her was call by the medical examiner the next day.  she was found dead in bed by family.  Apparently c/o soreness at injection site; no other symptoms.  Medical examiner signed case out as hypertensive cardiovascular disease, but only did external exam, not full autopsy. The autopsy states hypertensive cardiovascular dx.
ANXIOUS, DIZZINESS, FEELS LIKE HEART IS RACING, VSS HR 68, BP 157/77. PROVIDED WATER, NO TRANSPORT.
On april 5th i had my first dose. From 1-2 days i had few symptoms like headach, tireness & injection site pain. Since it's been 2 weeks i still have few symptoms like mild headach, tiredness(full body pains), but those are not often  (is there anything i need to worried)
Back Pain; Fatigue; Headache; Knee Pain/Shoulder Pain/Joint Pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back Pain), FATIGUE (Fatigue), HEADACHE (Headache) and ARTHRALGIA (Knee Pain/Shoulder Pain/Joint Pain) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Bronchitis (Hospitalized) since an unknown date. Concurrent medical conditions included Thyroid disorder NOS and Blood pressure fluctuation.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced BACK PAIN (Back Pain), FATIGUE (Fatigue), HEADACHE (Headache) and ARTHRALGIA (Knee Pain/Shoulder Pain/Joint Pain). The patient was treated with NAPROXEN SODIUM (ALEVE) for Pain, at an unspecified dose and frequency. At the time of the report, BACK PAIN (Back Pain), FATIGUE (Fatigue), HEADACHE (Headache) and ARTHRALGIA (Knee Pain/Shoulder Pain/Joint Pain) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: negative (Negative) negative.         It was reported that patient was on thyroid and blood pressure medications. Before receiving the vaccination, patient was in a hospital for bronchitis and was on medication for 10 days.  Action taken with mRNA-1273 in response to events was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-108731 (E2B Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Second dose vaccine date was added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-108731:second dose case
Pt developed left upper arm/shoulder pain and slight weakness that has lasted for 3 weeks, unresponsive to OTC meds.
p/vax pt exp reactivation of  Lyme disease, w/h/a, stiff neck, body weakness;sx not as severe as w/dose #1;tx w/doxycycline;pt has not recovered;
Began feeling heart palpitations, noted skipped pulse, sometimes experienced mild dizziness, and developed a dry cough within 2ish weeks of my second shot. Intense bouts would last for approximately 3 days and gradually get better, then repeat again.  As time has gone on, the intensity and duration has lessened, but is still occurring.
This spontaneous report was received from a medical assistant and refers to a 13-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 04-JAN-2016, the patient was vaccinated with a dose of improperly stored GARDASIL 9 (lot # L016429, expiration date: 09-AUG-2017; dose and route of administration were not provided). The vaccine underwent a temperature excursion of either +1 or -1 degree Celsius for 255.5 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, as all required information has been received.
A severe irritation, burning and itching all over legs and arms. It was like a sun poisioning or severe sunburn.   Dermatologist treated me with a steroid shot and betamethasone cream.  Followed up with dermatologist a week later and it had improved but was not fully healed.
A rash on my forehead and that spread around the right eye for next two days; Developed pain on right side of face; This is a spontaneous report from a contactable consumer (patient). A 67-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EK9231), via an unspecified route of administration on Right arm on 21Jan2021 11:45 at single dose for covid-19 immunisation. Medical history included Allergies to Sulfa and Osteopenia/osteoarthritis. The patient's concomitant medications were not reported. The patient reported, On 28Jan2021, one week after receiving the Covid vaccine, I developed pain on right side of face. On 31Jan2021 I developed a rash on my forehead and that spread around the right eye for next two days. The Dr was contacted on 02Feb2021 and I started on Valtrex (Valacyclovir HCL, 1 Gm, 3 times a day on 28Jan2021 13:00 upon Doctor or other healthcare professional office/clinic visit). The patient received treatment for the event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient not been tested for COVID-19. The seriousness was reported as non-serious. The outcome of the events recovering.  Information on the lot/batch number has been requested.
Information has been received from a physician concerning an over 65 year old patient who on approximately 20-DEC-2008, two months ago, was vaccinated with a dose of ZOSTAVAX (Oka/Merck).  On approximately 20-FEB-2009, "2 months later", the patient came down with shingles.  The patient sought unspecified medical attention.  Additional information has been requested.
tested positive for Covid after getting 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for Covid after getting 2nd dose) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, 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 SARS-COV-2 TEST POSITIVE (tested positive for Covid after getting 2nd dose). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for Covid after getting 2nd dose) outcome was unknown.
Headache, Chills,Fever, All over body pain and general weakness and dizziness, cold sores
6 patients received expired moderna vaccine booster doses; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (6 patients received expired moderna vaccine booster doses) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (6 patients received expired moderna vaccine booster doses). On 07-Nov-2021, EXPIRED PRODUCT ADMINISTERED (6 patients received expired moderna vaccine booster doses) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter reported, Date the vial was initially stored in the refrigerator: 07-Nov-2021.  No relevant concomitant medications were reported. No treatment information was provided.
Patient felt light-headed, had a mild seizure (hands and legs contorted), breathing difficulty, and heart discomfort.
Had booster administered at 12:30 pm, started feeling lightheaded and tightness in chest at 12:40 pm. Advised my provider and they immediately made me lie down, took vitals, listened to heart and lungs (3 times). Sent me home when I wasn't feeling better. Once home, I developed extreme body aches, headache, dizziness (dizzy every time I stood or sat up) and felt nauseous. Approximately 3:00 am on 11/3/2021, I was taken to emergency because symptoms became worse. Diagnosed with COVID-19 vaccine reaction and I had a vasovagal episode when heartrate lowered down to 20 bpm. They ran tests, gave pain med and steroid for chest tightness/lungs in IV and sent me home to rest and come back if symptoms get worse. I am off work until 11/08/2021.
Approx. 21 hours after injection, I began feeling cold.  Chills persisted for 5-6 hours, culminating in a fever of 100.5.  Muscle aches concurrent with chills and fever.  When fever subsided (1-2 hours duration), I was better, including good appetite.  This is in addition to very sore upper arm at injection site.
10-15 mins p/vax pt sitting in chair c/o discomfort @ inject site; no longer crying; made a grunting noise, became pale eyes rolled upward lt arm flexed & rigid relaxed on rt side, duration of 10 seconds; c/o h/a & bloaty tongue & nose;
Rash on feet, then arms, then back, bum and trunk, marked increased asthma - heavy rescue inhaler use, Extreme dizziness - couldn?t walk without support for 1.5 days, anxiety sensations (present in other allergic reactions),
Fever of 104, causing febrile seizure.  Symptoms began approx. 12 hours after vaccination.  Patient was hospitalized for observation for 15 hours.
Narrative: Timing error, 2nd dose given too soon 15 days after first dose.  Veteran stayed and received the required 15 min observation, no  complaints voiced or symptoms of distress noted.
Pediarix and Kinrix at the same time; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number PX27D, expiry date 17th January 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) (batch number 5CK5K, expiry date 17th January 2022) for prophylaxis and dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix, Kinrix Pre-Filled Syringe Device, Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix, Kinrix Pre-Filled Syringe Device, Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced overdose. On an unknown date, the outcome of the overdose was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient was administered with Pediarix and Kinrix at the same time, which led to overdose. No adverse event were reported at the time of call and no further details were provided. The reporter consented to follow up via mail.