chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After the 2nd shot, my right knee has continual pain and weakness, which makes it difficult to stand up after sitting, especially after using the toilet.; After the 2nd shot, my right knee has continual pain and weakness, which makes it difficult to stand up after sitting, especially after using the toilet.; After the 2nd shot, my right knee has continual pain and weakness, which makes it difficult to stand up after sitting, especially after using the toilet.; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 56-year-old non pregnant female patient received (not pregnant at the time of vaccination) second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection, Batch/Lot Number: EN6208), dose 2 via an unspecified route of administration, administered in arm left on 26Mar2021 16:00 (at the age of 56-year-old) as dose 2, single for COVID-19 immunization. Medical history included osteoarthritis from an unknown date and unknown if ongoing, atrial fibrillation from an unknown date and unknown if ongoing, enlarged thyroid with goitre from an unknown date and unknown if ongoing and goitre from an unknown date and unknown if ongoing. Concomitant medication(s) (taken within two weeks of vaccination) included bisoprolol fumarate, hydrochlorothiazide (BISPROLOL COMP) taken for an unspecified indication, start and stop date were not reported; vitamin d nos (VITAMIN D NOS) taken for an unspecified indication, start and stop date were not reported; cyanocobalamin (B-12) taken for an unspecified indication, start and stop date were not reported; aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) taken for an unspecified indication, start and stop date were not reported. The patient had a known allergy to sulfa, cephzil and Macrobid. The patient did not receive any other vaccines within 4 weeks prior to the covid 19 vaccine. The patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The patient had previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection, Batch/Lot Number: EL6198), dose 1 via an unspecified route of administration, administered in left arm on 09Mar2021 4:00 PM as dose 1, single for COVID-19 immunization and experienced leg cramps. On an unspecified date in 2021, after the 2nd shot, her right knee has continual pain and weakness, which makes it difficult to stand up after sitting, especially after using the toilet. The patient went to her primary care provider for the pain, they ordered an x-ray, which came back normal, but she continued to have the pain and weakness. The patient received treatment for the events and her doctor suggested for X-ray, ice and exercise. The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included x-ray: normal on an unspecified date. The outcome of the event was not recovered at the time of the report.  Follow-up attempts are completed. No further information is expected.
Patient states headache, flu like symptoms and temp >100.  Symptoms resolved as of 10/15/2023, Pt  was told these are common side effects after immunizations
Bright red Arm swollen at injection site traveling towards elbow  Dose 2 anaphylactic. Stinging lips, chest pain, both injection site pain
Difficulty catching breath, fever of 102 degree.  She received Flu Mist instead of shot.
Moderna vaccine given to a 9 years old child; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna vaccine given to a 9 years old child) in a 9-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 084J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna vaccine given to a 9 years old child). On 30-Dec-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna vaccine given to a 9 years old child) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitants were provided. No treatment was provided.
Gave flu shot and patient had symptoms immediately shooting pain across middle of back, lower back spasms, felt like fainting, flushing head, head, back spasms-lower, couldn't stand-very weak.
Redness about the size of an orange near injection site & very slight itching occurred morning after vaccine received. Redness & itching completely resolved by 09/27/14. Nausea & mild headache occurred on morning of 09/27/14.
Pt recvd vax 17FEB93 devel rash (torso);
severe blotchiness & hives over 1st 24 hrs; rash stung and was painful; bronchial spasms-severe breathing problems & hands were swollen @ 24 hrs mark; 21MAY rash still present;
Dozens of mouth ulcers for 8 out of 10 weeks afterward; ear infection; clogged eustachian tube; continued single mouth ulcers 8 months later; second clogged eustachian tube 7 months later; extreme tiredness
Swelling and pain from shoulder to elbow ... fluid-like build-up, hot to the touch.  Felt feverish and nearly blacked out.  Took Ibuprofen, benadryl and iced it.  Went back the next day to report it to the manaager.  She indicated, not common, but does happen; should take a week to clear; if not, see a doctor..  Odd because I don't get adverse reactions from injections.  Is it because of COVID shot, 2nd one in March 2021?  Nervous about getting any COVID booster shots for the remainder of the year.
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 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021 at 11:55 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Mar-2021 at 11:55 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, 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.   The age of patient was provided as 68.68 years.  Concomitant products were not provided.  Number of vials sent to clinic were 10. Vial moved to fridge on 24-Feb-2021 and beyond use date for these vials was reported as 26-Mar-2021. Vial was moved to clinic on 03-Mar-2021. Batch number 014M20A administered on 03-Mar-201 underwent temperature excursion with temperature of 51 degrees Fahrenheit at 09:00 am, 34 degrees Fahrenheit at 10:00 am and 35 degrees Fahrenheit at 01:00 pm.  On 03-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 51, 10 AM: 34, 11 AM: 44, 12 AM: 46, 1PM: 35, 2 PM: 36, 3 PM: 36 and 4 PM: 36.  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 Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.
Patient ended up in hospital 2 days after first shot, recovered, received second dose, ended up back in the hospital 4 days later, is now on end of life comfort, patient has dnr per conversation with son.
0.3 ml dose was drawn up from Pediatric Pfizer vial and administered to patient. Patient received 0.3 ml of the Pediatric Pfizer vaccine instead of 0.3 ml of the adult Pfizer. The patient was notified as soon as it was discovered and advised to return to get 0.3ml of the 12+ adult pfizer vaccine. Patient returned on 12/06/2021 and was given the replacement dose of 0.3ml of the adult pfizer vaccine.on 12/03/2021. No adverse events were reported.
Chills starting at about 11:00 the night of receiving the vaccine, followed by intense fever and nausea. These lasted throughout the night until about 7:00 the next morning. Had an on and off fever throughout the course of the next day and extreme fatigue. By the second day after the vaccination, only fatigue and headaches persisted until about 6:00 in the evening. Then all symptoms ceased.
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 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Nov2022 as dose 5 (booster), single (Lot number: Gj6796) at the age of 62 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered with sequelae" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (27Dec2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Covid-19 treatment with Paxlovid from 21Dec2022 to 26Dec2022. It was reported that the patient recovered with lasting effects.
2 days p/vax broke out into rash around inject site; rt deltoid will see MD this afternoon;
his driving was affected too; some memory loss; mild fevers; This spontaneous case was reported by a consumer and describes the occurrence of IMPAIRED DRIVING ABILITY (his driving was affected too), AMNESIA (some memory loss) and PYREXIA (mild fevers) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced IMPAIRED DRIVING ABILITY (his driving was affected too), AMNESIA (some memory loss) and PYREXIA (mild fevers). At the time of the report, IMPAIRED DRIVING ABILITY (his driving was affected too) and PYREXIA (mild fevers) outcome was unknown and AMNESIA (some memory loss) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Patient reported that his driving was affected too, after vaccination, due to which he ran into a ditch as an accident. He did not get second dose out of fear. No treatment details were provided.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2021: Non Sig Follow-Up received- reporter phone number added.
Headache, Myalgia, Arthralgia, Fever,  Fatigue
7-16-07 Rec'd 4th Rabies shot (Imovax). 7-17-07 woke up with arthralgia, arthritis, dizziness, fever, headache. 7-24-07 arthralgia, arthritis, dizziness is gone. Only signs of headache now.
This spontaneous report was received from a Medical Assistant concerning an unspecified number of patients of unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with an improperly stored doses of ROTATEQ orally (lot number M004508, expiration date 29-JUN-2017, dose was not reported) for prophylaxis. The temperature exposure was between 46° F and 77° F for 2 hours and 54 minutes and between 32° F and 36° F for 17 hours and 42 minutes. It was reported that there was additional excursions but the reporter did not have details. There was no previous excursions involved and a data logger was related. A product quality complaint was not involved. Additional information has been requested. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1702USA004114:Original Case : 1702USA002297.
Breakthrough case admission after 3 vaccines ;Moderna 1/29/21 NO LOT #;  Moderna 2/26/21 Lot# 015M20A ; Moderna 10/23/21 Lot# 041C21A
This spontaneous report as received from a pharmacist refers to a 58 years old female patient. The patient's pertinent medical history included hypertension and diabetes. The patient's current conditions included allergy to sulfonamides, fluoroquinolones and tetracycline. On 19-NOV-2012, the patient was vaccinated with a single dose of ZOSTAVAX (dose was not reported)subcutaneously to the left arm. Lot number was reported as H013943 and expiry date was 25-OCT-2013. Concomitant medications included lisinopril and metformin. Approximately on an unknown date in November 2012, the patient experienced redness, swelling and warmth at injection site. The patient had called the pharmacy on 21-NOV-2012 and described the area of reaction as measuring 3 inches by 4 inches. The patient sought medical attention (called the pharmacy) and no treatment was given. No laboratory diagnostics studies were performed. The outcome of redness, swelling and warmth at injection site was not recovered. Additional information is not expected.
Patient stated he blacked out or passed out within a couple minutes after receiving the vaccine, then proceeded to lay on the floor once he came to and elevated his feet.  When we left the patient he was sitting upright in the chair.  Upon checking on the patient we found him lying on the floor with his feet elevated.  The patient's mother arrived and helped him back to an upright sitting position, he then proceeded to vomit.  We continually offered to call EMS for the patient, but they both refused.  We gave the patient some water and they were able to walk out of the store and he was driven home.  This happened over the course of about 30 to 45 minutes.  I followed up with the patient and his mother the following evening.  She stated he was doing better and just had a low grade fever
ALL JOINTS ACHING VERY BAD. SWELLING OF HANDS AND MOST OF ENTIRE BODY.
Severe join pain on shoulders, neck, back, hips, elbows, wrists, hands, hips, knees and ankles. The pain started 12 hours after the second dosage of Moderna. The pain on the injection area subsided and the joint pain did not. I have trouble performing daily tasks like dressing my self, carrying, groceries, sleeping, grabbing things. The pain wakes me up at night, some days is a little better but it never disappears completely.
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. Information regarding medical history and drug reactions or allergies was not reported. The nurse reported that on unspecified date in approximately 2014, unspecified patients were vaccinated with (oka/merck) VARIVAX (subcutaneous injection, 0.5 ml once, subcutaneous, strength, lot #, expiration date and anatomical location not reported), that was improperly stored at a maximum of 7.5 degrees Fahrenheit for up to 11 hours in July 2014 and August 2014. Concomitant medications were not reported. No adverse effects reported. Follow up information has been received from medical assistant on 27-AUG-2014. The medical assistant was able to provide patient identifier, lot number and expiration dates of (oka/merck) VARIVAX that was administered to a 4 years old patient on 21-AUG-2014: lot# J014228 and expiration date: 08-NOV-2015. This is one several reports received from the same source. Additional information has been requested.
DEATH; This spontaneous report received from a consumer concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced death. On an unspecified date, the patient died from unknown cause of death. It was unknown if the autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20211053420-Covid-19 vaccine ad26.cov2.s - Death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Tongue felt tingly and felt drunk; Tongue felt tingly and felt drunk; Blood sugar was 40 points below normal; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 24Apr2021 at 12:15 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes. The patient previously had penicillin for unknown indication on unknown date and experienced penicillin allergy. Concomitant medications taken within two weeks of vaccination were not reported. The patient previously took valproate semisodium (DEPAKOTE) for unknown indication on unknown date and experienced drug allergy. The patient previously also took morphine (MANUFACTURER UNKNOWN) for unknown indication on unknown date and experienced drug allergy. 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 24Apr2021 at 13:00, the patients tongue felt tingly and felt drunk. Also, blood sugar was 40 points below normal. Therapeutic measures were taken as a result of tongue felt tingly and felt drunk, blood sugar was 40 points below normal and included Ambulance check. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events tongue felt tingly and felt drunk, blood sugar was 40 points below normal was resolved on 24Apr2021.   No follow-up attempts are needed. No further information is expected.
couldn't get up; kept on falling; rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash at the injection site), ILLNESS (couldn't get up) and ASTHENIA (kept on falling) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hypertension, Cholesterol, Parkinson's disease, Kidney stones, Breast cancer, Fibromyalgia, Arthritis, Osteoarthritis, Neuropathy and Acid reflux (esophageal). Concurrent medical conditions included Type II diabetes mellitus and Liver disorder (stage 4 liver disease). Concomitant products included GABAPENTIN, INSULIN GLARGINE (BASAGLAR), LISINOPRIL, CARBIDOPA, Levadopa, Omega fish oil, TRAMADOL, EZETIMIBE, SITAGLIPTIN PHOSPHATE (JANUVIA [SITAGLIPTIN PHOSPHATE]), Carbidopa ER and ALUMINIUM HYDROXIDE, DICYCLOVERINE HYDROCHLORIDE, MAGNESIUM OXIDUM LEVE (DICYCLOMINE CO) for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE RASH (rash at the injection site). On an unknown date, the patient experienced ILLNESS (couldn't get up) and ASTHENIA (kept on falling). At the time of the report, VACCINATION SITE RASH (rash at the injection site), ILLNESS (couldn't get up) and ASTHENIA (kept on falling) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication details was reported.
numbness to her tongue; numbness under her lip; This is a spontaneous report from a contactable pharmacist. A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at the age of 65-year-old) as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced numbness to her tongue, numbness under her lip on an unspecified date. Reporter is a pharmacist who is calling to report a patient who received the Pfizer Covid vaccine today and is 15 minutes after the dose is experiencing numbness to her tongue. Reporter wants to know if this has been reported and is a side effect of the vaccine. After hanging up with caller document found that was specific to Paresthesia. Called provider back and informed her of updated information. As of 31Dec2020, a search of our safety surveillance database for Pfizer-BioNTech COVID-19 vaccine revealed that we have received spontaneous reports of dental paresthesia, paresthesia, paresthesia oral, paresthesia mucosal, intranasal paresthesia, pharyngeal paresthesia, paresthesia ear and vaccination site paresthesia since the market introduction (including emergency use authorization) of Pfizer-BioNTech COVID-19 vaccine. Calling about Pfizer COVID vaccine. She just gave the vaccine to a patient and within 15 minutes started having numbness under her lip, is that normal. Outcome of the events was unknown.  Information regarding the Lot/Batch number has been requested.  Follow-Up (PRD/SRD 20Aug2021): No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
8 days later after received vaccine developed localized reaction on her arm- swelling, redness, warmth, no streaking noted
One day after getting the shot, I developed left hip pain. Walking upstairs is now painful in the left hip. To avoid pain, I lead with the right foot and then place the left foot on the same stair before continuing up.  Today is Day 2. Same symptom. Walking downstairs is easier, ie, not as painful.
APPROXIMATELY 8 DAYS AFTER RECEIVING VACCINE RASH DEVELOPED ON CHEST