chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. On an unknown date, the patients were vaccinated with PEDVAXHIB (dose, lot number and route not provided). No co-suspect or concomitant therapies were reported. The medical assistant reported that multiple unspecified patients were administered PEDVAXHIB that was improperly stored (dates not specified). No adverse effects were reported. This case is linked to cases 1406USA008435, 1406USA008521, 1406USA008523, 1406USA008524 and 1406USA008525 (same reporter link). Additional information has been requested.
A few hours after my 2nd Shingrix shot I began to feel lethargic and achey. I went to bed early but slept fitfully with shivers. I felt feverish but did not take my temp. My whole body ached. I had a sore left arm where the vaccination shot was so I could not sleep on my left side, nausea but did not vomit, joint pain in my elbows and lower back and dizziness. Thankfully no diarrhea or stomach ache. The following day, Sunday 7/28/2019 I felt very weak and dizzy with shivers began to feel better in the evening. Today I feel much better...phew!
pt recv vax & inj site rxn characterized by redness, swelling & warmth p/vax;
Fever; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3286), via an unspecified route of administration on 08Jan2021 at a single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included clonidine, losartan and propranolol. It was reported that the patient called after the first shot also which was on the 8th. She called on 9th because she got a fever and I asked if she can take a medication because she is trying to figure out if it is same thing interacting with anything. The outcome of the event was unknown.
This spontaneous report from two contactable nurses via a sales representative, who reported similar events for two patients. This is the first case out of two reports. A 19 years old female patient of unspecified ethnicity received TRUMENBA; lot J29203, expiry date 30Jun2016, via intramuscular route of administration in the left arm on 27Apr2016 at 11:13, at 0.5 ml, single. Illness at time of vaccination was none. The patient medical history and concomitant medications were not reported. On 28Apr2016 the patient had a localized reaction in left arm of a sizeable lump with redness and swelling of the injection site on an unspecified date with outcome of unknown. The events did not require an emergency room or physician visit. The second reporting nurse considered the vaccine had a causal effect to the adverse events. Follow up (30Jun2016): New information from a contactable nurse includes: patient age, vaccine lot number, expiry date, route of administration, vaccination date, events onset date, details, causality assessment.
Patient reported tingling feeling in her throat and slight swelling of tongue with similar effect from seafood allergic reaction she had ten years ago. Patient alert and oriented, vital signs 135/83, pulse 64, O2 98%, 1525 administered benadryl 50mg IM to right deltoid. Patient tolerated it well. Patient resting in gurney monitored for 30 minutes she then stated she felt better  bp 129/87, pulse 54, o2 100%. No respiratory distress noted. Patient denies swelling of tongue, throat closing and any other symptoms. Advised patient if symptoms worsened contact ER or 911.
improperly stored vaccine administration ofMMR II.; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not reported.   On 13-OCT-2020, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, route of administration and anatomical site of vaccination were not reported, lot# S007813, expiration date was 14-MAR-2021) for prophylaxis.  Other suspect therapies included sterile diluent (STERILE DILUENT). The administered dose of vaccine experienced improperly stored vaccine administration and the temperature excursion of 62 Fahrenheit (F) for 2 hours (product storage error), as recorded by data logger. No previous temperature excursion was reported. The outcome of product storage error was unknown.; Sender's Comments:  US-009507513-2010USA009775: US-009507513-2010USA010221: US-009507513-2010USA010255:
Extreme fatigue, low grade fever, joint pain, pain lower back.  2 hours of numbness in left arm 07:00-09:00; Headache.
Pt received wrong vaccine for his Covid 19 booster; Pfizer -BioNTech  instead of Pfizer Bivalent. No adverse effects at this time.
missed the second dose; no additional adverse events; This spontaneous report was received from a pharmacist referring to a 32-year-old patient of unknown gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, at around age 30 or 31, the patient was vaccinated with the dose 1 of Hepatitis A Vaccine, Inactivated (VAQTA) intramuscular injection, one dose, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). Th patient only received one dose and did not get the second dose within the 6-18 month recommended period. The patient missed the second dose. No additional adverse event was reported.
Client broke out in hives, began coughing, decreased breath sounds with wheeze. Sent to ED.
last night she couldn't sleep; Itchy Hives/Welts/welts are annoying; on her inner thighs, groin, waist and arms pits; developed welts and itching; Rash, Hives and welts, and states they are itchy; start with a small regular size and get bigger and elevated on the skin; start with a small regular size and get bigger and elevated on the skin; This is a spontaneous report from a contactable Nurse (patient).  A 69-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration as single dose 1st dose in left arm on 22Jan2021 (Lot # EL9741), 2nd dose in right arm on 12Feb2021 (Lot # EM9809) for COVID-19 immunisation.  Medical history was none. There were no concomitant medications.  On 06Feb2021, 2 weeks after receiving her first dose, the patient experienced itchy hives, welts/welts are annoying; on her inner thighs, groin, waist and arms pits, developed welts and itching, rash, hives and welts, and states they are itchy. Patient also reported she received her 1st Covid dose on 22Jan2021 which is clarified that this is when the hives and welts started (under clarification). On unspecified date the patient experienced start with a small regular size and get bigger and elevated on the skin. On 03Mar2021 she couldn't sleep. The event itchy hives was considered medically significant by reporter.  Course of events: Two weeks after receiving her first dose she developed welts and itching that has persisted through today. She has not changed medicines, foods, soaps or detergents. She has been taking Benadryl for about a month now for the itching. She reported rash, hives and welts, and stated they are itchy.  They started with a small regular size and get bigger and elevated on the skin. The welts are annoying; on her inner thighs, groin, waist and arms pits. She ruled out foods or any products she had, and she wasn't taking anything new. She was using Benadryl Extra Strength Cream on her hives and after a few minutes it resolved, but last night (03Mar23021) she couldn't sleep, it usually resolved after a few minutes, but this time it lasted over an hour, states she had to just keep slathering it on because it wasn't helping.  The outcome of itchy hives, welts/welts are annoying; on her inner thighs, groin, waist and arms pits, welts and itching, rash, hives and welts, and states they are itchy was not recovered, of start with a small regular size and get bigger and elevated on the skin, last night she couldn't sleep was unknown. A Product Complaint was filed. The reporter assessed the events hives and welts as related to the vaccine.
Resident administered expired moderna vaccine, expired on 10/13/2021. No ASE noted.
Erythema, cellulitis at injection site right upper arm. Treated with KEFLEX & sx resolved.
Approx 2-5 min. after receiving vaccinations, pt developed macular erythematous rash of various size lesions, 1-2.5 cm around all 3 vaccine sites, also on face and left side of neck, no wheezing, possible swelling on right upper arm as well (seen by nurse). Pt given X 1 start dose of Benadryl, 12.5 mg. Rash disappeared within 5 to 10 minutes. Pt observed for 30 minutes in office. Rash did not reappear and no other symptoms. Called mom on 8/30 to follow up no answer. Mom called back-no further sequela.
Shingles/symptoms were shingles like; This case was reported by a pharmacist and described the occurrence of shingles in a 65-year-old male patient who received Herpes zoster (Shingrix) (batch number 377MK, expiry date unknown) for prophylaxis.   On 1st July 2019, the patient received the 1st dose of Shingrix. On 6th July 2019, 5 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient experienced shingles 5 to 6 days after receiving their 1st dose of Shingrix.  It was unknown if symptoms remained, at the time of reporting. The reporter declined to provide initials, and stated that symptoms were shingles-like and that the physician thought the patient developed shingles. The reporter consented to follow up.
I had chills and body aches and fatigue and short breaths. Then I developed Tinittus in left ear that has continued for 4 weeks and still continues.
pt recv vax 26MAR97 & 14APR97 pt devel rashes;pt recovered;
Pt recvd 2 doses of vax 30JAN91 & 28FEB91 & following 2nd dose exp a confusional episode & fever which lasted x 24 hrs; pt driving was restricted for 1 wk, performed several wks later, was nl;
L arm soreness swelling 1 day post vax. No fever, itching, swelled from inject site to elbow.
PARKING LOT ATTENDANT CAME RUNNING INTO CLINIC STATING CLIENT WAS COMPLAINING OF DIZZINESS, HEART PALPATIONS, AND APPEARED PALE. CLIENT STATED HISTORY OF LOW BLOOD PRESSURE. BLOOD PRESSURE TAKEN ABOUT  1420. 120/90.  EMT NOTIFIED THAT THEY MAYBE NEEDED. EPINEPHRINE BROUGHT TO CAR. ENCOURAGED CLIENT TO TAKE SLOW, DEEP BREATHS. AFTER 10 MINUTES, STATED FELT MUCH BETTER.  PARKING ATTENDANT STATED CLIENT'S COLOR HAD RETURNED. ENCOURAGED TO WAIT FOR ANOTHER 10 MINUTES BEFORE DRIVING AWAY.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021 at 2:27 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 2:27 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 33.72 for dose administered on 20-MAR-2021 No concomitant medications were reported.  Batch number 031A21A underwent temperature excursion on 20-Mar-2021 with temperature 34, 37 degrees Fahrenheit from 09:00AM to 10:00 AM. This vial was moved to fridge on 09-Mar-2021 and beyond use date for the vial was reported as 08Apr-2021. Product moved to clinic on 20-Mar-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Chest pains developed the night after my second dose. It felt like really bad heart burn, it lasted for about 3-4 hours.
SM c/o redness, swelling, pain and pruritus at smallpox vaccination site x 1 day. He c/o chills, headache, body ache x2 day - rec'd smallpox on 7/16/07 on lt arm. Was seen by medical provider.
Headache; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Lot Number: ER8736) as dose number unknown, single for COVID-19 immunization; ibuprofen, route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced headache. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Patient admitted to MCH-BG on 7/12/21 with complaint of chest pain starting 2 days prior and worsening.  No radiation quality of chest pain.  Also complaint of diarrhea x2 days and sweating.  Diagnosed with community acquired pneumonia on admission.  Possible exposure to COVID at residential facility, so COVID testing was ordered which resulted as positive.
4 hours after receiving immunizations started high pitch, loud screaming that lasted 3 hours. Inconsolable. Refused to nurse. Mom gave tylenol
Pt experienced vesicular rash with burning/tingling on right lower back and right thigh consistent with shingles 1 week after he received his first COVID vaccine. Symptoms are improving 1 week following the onset of the rash, but symptoms have not resolved yet.
Quite Anxious;     Patient received Pfizer vaccine #2 today.    After the vaccine, the employee reported the following symptoms:  shaky feeling inside   Lot: EL3247  Time of Administration:1053  Time Symptoms Began: ~1104   _____  Patient alerted observer who took the them to the medical observation area.  I was alerted and responded.   Initial Assessment @ _~1115_:  Patient is patient is AAO.  The employee is sitting up in a chair with the observer.  The employee is pink and does not appear to be in distress but is anxious.  They are talking and making conversation.    Vitals @:1115  HR: 103  BP: 151/85  O2:99   Vitals @: 1121  HR: 92  BP: 136/85  O2: 99   Discharged at 1121 without treatment.  Pt feels much better.  She thinks that she was anxious due to seeing her mother die from an anaphylactic reaction to an antibiotic in an ER in 2019.  She was with her mom when the reaction occurred and when she died.  She was being treated for a UTI.  She thinks the abx was rocephin.    She notes that her only allergy is sulfa-- it causes her skin to itch.
Information has been received from a physician and a practice manager via company representative referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 17-OCT-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 2,5 ml/five dose vial, lot # K007773 and expiration date 01-MAY-2015 (administration route was not provided). No adverse effects were reported. The vaccine had one temperature excursion of 48 hours with a lowest recorded temperature of 1 Fahrenheit (F) (1 Celsius (C)). The storage criteria and the type of excursion for this vaccine was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
2 days p/vax pt devel a pruritic, light red rash on abd;tx w/cortisone ointment;As of 28OCT (12 days p/onset), the rash was resolving;
Sore arm; Sore neck; Sore shoulder; Headaches; Dizziness; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8733) via an unspecified route of administration in the left arm on 01Mar2021 (at the age of 60-year-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0161) via an unspecified route of administration in the right arm on an unknown date in 2021 (at the age of 60-year-old) as a single dose for COVID-19 immunization. Medical history included inflammatory bowel disease (IBD) and penicillin allergy. 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. Concomitant medications included estrogens conjugated (PREMARIN), cetrizine hydrochloride (ZYRTEC) and paracetamol (TYLENOL), all for unknown indications on unknown dates and unknown if ongoing. The patient was allergic to dairy products and wheat. On 22Apr2021 at 08:00, the patient experienced sore arm, sore neck, sore shoulder, headaches and  dizziness. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of  the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sore arm, sore neck, sore shoulder, headaches and  dizziness was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Had injections at 11:20 am on 7-27-09. Fever of 103.5, rapid heart rate, body aches, hallucinations, rapid speech in a high pitched voice, vomiting, and rash running the length of upper thigh at site of DTaP injection at 3:30 am 7-28-09.  Called on-call Dr. at 3:48 am and he told us to manage fever from home and call our Dr. in the morning.  Fever came down with Motrin and wrapping him in wet towels.  Saw Dr. at 11:00 am.  He assessed my son and told me to continue fever control for possibly the next 3 days. He told me what to watch for. And to bring my son back in, if the fever doesn't respond to Tylenol/Motrin.  My son had Varicella, DTaP, MMR and Polio vaccines administered at once on 7-27-09. We are still controlling his fever and watching for increased symptoms.  I don't know the manufacturer of the vaccine. You'll have to contact Dr's office for that.
Patient believed to have a vasovagal reaction/syncopal episode. He was monitored by EMT before leaving clinic.
doses were administered on 31st day after moving the vaccine from freezer to fridge; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses were administered on 31st day after moving the vaccine from freezer to fridge) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses were administered on 31st day after moving the vaccine from freezer to fridge). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses were administered on 31st day after moving the vaccine from freezer to fridge) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   Reporter did not allow further contact
Sharp pains in right temple area/ right side and shooting pain radiating from jaw area to ear to right temple; Over several days I have developed a sore throat on right side and shooting pain radiating from jaw area to ear to right temple; I have swollen lymph nodes; Severe fatigue; Brain fog; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: CW0167) via an unspecified route of administration in the Left arm on 24Apr2021 at 11:30 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had known allergies to penicillin. Concomitant medications were not reported. 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. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8737) via an unspecified route of administration in the right arm on 27Mar2021 (at the age of 55 -years-old) as a single dose for COVID-19 immunisation.  On 13May2021 the patient experienced sharp pains in right temple area. Over several days she had developed a sore throat on right side and shooting pain radiating from jaw area to ear to right temple. She had swollen lymph nodes, severe fatigue, and brain fog. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of reported events. The clinical outcome of the events sharp pains in right temple area. Over several days she had developed a sore throat on right side and shooting pain radiating from jaw area to ear to right temple. She had swollen lymph nodes, severe fatigue, and brain fog were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
body aches; fever of 102; This is a spontaneous report from a non-contactable consumer (patient), from An 83-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on 13Feb2021 as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported.  It was reported that, patient got vaccine Yesterday and today started with body aches and fever of 102. Advised that they contact her HCP since she is 83 yr old. The patient underwent lab tests and procedures which included fever (body temperature): 102 on an unspecified date. The outcome of the events was unknown.  No follow up attempts are possible. No further information is expected.