chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm; Feel a little punky in my head and light headed; Dizzy sort of like my brain is pause; brain feels fuzzy; dizziness; light headedness; This is a spontaneous report from a contactable consumer or other non hcp. A 70-years-old female patient received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN5318; Expiration Date: May2021), via intramuscular route, administered in Arm Left on 20Feb2021 09:00 as DOSE 1, SINGLE for COVID-19 immunisation.  Medical history included hypertension, blood cholesterol, gastro oesophageal reflux disease, anxiety, depression, and sleep disorder. Concomitant medication(s) included indapamide (INDAPAMIDE) taken for hypertension, atorvastatin (ATORVASTATIN) taken for blood cholesterol, omeprazole (PROTONIX [OMEPRAZOLE]) taken for gastro oesophageal reflux disease, alprazolam (XANAX) taken for anxiety, escitalopram oxalate (LEXAPRO) taken for depression and amitriptyline (AMITRIPTYLINE) taken for sleep disorder. The patient previously took erythromycin for drug hypersensitivity. On 20Feb2021 09:00 the patient experienced dizziness, light headedness, and dizzy sort of like her brain was paused. On an unspecified date patient developed sore arm and felt a little punky in her head and lightheaded. The patient underwent lab tests and procedures which included blood test: unknown.  The event outcome for dizziness, light headedness, and dizzy sort of like her brain was paused was reported as not recovered. The events outcome for sore arm and felt a little punky in her head and lightheaded was reported as unknown.   No follow-up attempts are needed. No further information is expected.
INJECTION SITE IS PAINFUL AND HARD TO THE TOUCH AND ARM IS INFLAMED. PAIN WORSENS  WHEN I MOVE MY ARM. I HAVE AN APPOINTMENT TOMORROW TO SEE MY PHYSICIAN.
received his COVID vaccine yesterday but got COVID today; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team and product quality group. The reporter is the patient.  A male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Oct2023 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (non-serious) with onset 03Oct2023, outcome "unknown", described as "received his COVID vaccine yesterday but got COVID today". Therapeutic measures were taken as a result of covid-19.  Additional information: Reporter was a Doctor but he was also a patient. He took the vaccine yesterday and he got sick. He thought he had a COVID but he sure he did. Now he is taking Paxlovid, but he also has a COVID virus and he starts taking Paxlovid, he would like to know if the vaccine he took yesterday will negate the Paxlovid, he would like to know some recommendations about it. Suspect Product(s): Pfizer vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient developed a significant local reaction at the injection site requiring antibiotics, steroids and analgesics.
PATIENT WAS GIVEN 0.2ML OF THE 30MCG FORMULA INSTEAD OF O.2ML OF THE 10MCG FORMULA,
Started sneezing that afternoon.  His nose became runny that evening.  That night he would repeatedly wake up coughing due to congestion.  Conditions persist through present time.
uncomfortable; feeling sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 66 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DISCOMFORT (non-serious), outcome "recovered", described as "uncomfortable"; MALAISE (non-serious), outcome "recovered", described as "feeling sick".  Additional Information: It was reported that events were over in 2 days.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Tingling all over my body like mini shiversinside my body; Dizzy spells; I experience my own little wacko earthquake senation, like everything around me is heaving or rolling; Nausea; swollen neck lymph nodes; Wrong drug administered; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of WRONG PRODUCT ADMINISTERED (Wrong drug administered), PARAESTHESIA (Tingling all over my body like mini shiversinside my body), DIZZINESS (Dizzy spells), VERTIGO (I experience my own little wacko earthquake senation, like everything around me is heaving or rolling) and NAUSEA (Nausea) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced WRONG PRODUCT ADMINISTERED (Wrong drug administered). On an unknown date, the patient experienced PARAESTHESIA (Tingling all over my body like mini shiversinside my body), DIZZINESS (Dizzy spells), VERTIGO (I experience my own little wacko earthquake senation, like everything around me is heaving or rolling), NAUSEA (Nausea) and LYMPHADENOPATHY (swollen neck lymph nodes). On 28-Mar-2021, WRONG PRODUCT ADMINISTERED (Wrong drug administered) had resolved. At the time of the report, PARAESTHESIA (Tingling all over my body like mini shiversinside my body), DIZZINESS (Dizzy spells), VERTIGO (I experience my own little wacko earthquake senation, like everything around me is heaving or rolling), NAUSEA (Nausea) and LYMPHADENOPATHY (swollen neck lymph nodes) outcome was unknown.            The concomitant medication was not provided.  The treatment information was not provided.  The action taken with mRNA 1273 with the events was considered as not applicable.   This case was linked to MOD-2021-232182, MOD-2021-232186 (Patient Link).
Severe local reaction (Right arm). Red, indented, tender at site. Give 7-10 days to resolve. Darvocet N-100 - pain. Allegra 180 mg qd per MD, ice. Redness is out, still a little tender but recovered.
Enlargement of lymph nodes; This spontaneous case was reported by a pharmacist and describes the occurrence of LYMPHADENOPATHY (Enlargement of lymph nodes) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 078C21A and 039C21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included CITALOPRAM, CLONAZEPAM, LORATADINE, FISH OIL and IBUPROFEN for an unknown indication.   On 21-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (Enlargement of lymph nodes). At the time of the report, LYMPHADENOPATHY (Enlargement of lymph nodes) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment details were added.
Bruise and bump on inner elbow of left arm (shot was upper right arm) and slight rash near bruising.
Pt had redness, warmth, stiffness in arm, swelling, extreme pain in her entire arm for 4 days.
This spontaneous report was received from a nurse refers to multiple unspecified patients of an unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored ROTATEQ (lot # L013190, expiry date 16-NOV-2016 and lot #L013192, expiry date 19-NOV-2017), oral. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
27MAY92 fever; 28MAY92 fever up to 105 a; 1030PM pt had sz in bed; taken to ER; 2AM spinal tap-?mengitis; Spinal tap-OK; red throat; ears OK; hemoglobin 8gm;
During administration into left deltoid the hub of the syringe separated from the needle, causing some of the solution to spray out rather than inject into arm.
day p/vax devel rash on legs, back & chest;T101;fussy;took pt to MD who said it was rxn to shots;
Information has been received from a nurse in a doctor's office concerning a female (age not specified) patient who on approximately 17-MAR-2008 was vaccinated with Gardasil (dose number unknown) (lot number, route and site of administration not specified) and then fainted.  The patient's outcome is unknown.  No additional information was available.  Additional information has been requested.
VACCINE GIVEN IN AM ON 11/25.  DEVELOPED A 5 MINUTE TONIC CLONIC SEIZURE AT 6 am ON 11/26--SHE WAS ASLEEP WHEN IT OCCURRED.  SEIZURE HAD STOPPED BY THE TIME AN AMBULANCE ARRIVED.  SHE WAS EVALUATED AND DISCHARGED AT A LOCAL EMERGENCY DEPT.  THERE WAS NO FEVER, BUT SHE FELT CHILLED.
This spontaneous report as received from a pharmacist refers to a 62 year old non-pregnant female patient. The patient's chart listed allergy to horse serum in an unspecified tetanus vaccine, allergy to penicillin and acetaminophen, VICODIN. No other pertinent medical history was reported. On 23-OCT-2014, the patient was vaccinated with ZOSTAVAX ( lot # K008883, exp. date: 20-SEP-2015)0.65 ml, subcutaneously (anatomical location was not reported). There were not concomitant medications. On an unspecified date, approximately in October 2014, the patient experienced a warm pink area, a little bit larger than a 50 cent piece, surrounding the injection site. The pharmacist stated that the patient reported that it seemed to have gotten larger in circumference from the date she first noticed it, which date was unspecified(approximately in October 2014). There was not treatment given for the adverse events, the patient did not seek for medical attention, no laboratory tests were performed. The outcome of the events was unknown. The relatedness between vaccination with ZOSTAVAX and the events was not reported. There was not product quality complaint reported for this case. Additional information has been requested.
Trouble breathing, tightening of chest, usual asthma attack symptoms. Had 2 attacks within 4 days of symptoms starting. Took three weeks to get over. Worst asthma I've had in many years. Took Advair; Combivent every 4 hrs for three weeks, then went back to Proair every 4 hours for another week.
Pt reported back to pharmacy about adverse event. Has since gone to clinic to have monitored and checked. Per patient had "big red hot bump".  Clinic will be monitoring in case of infection.  Per patient, clinic reason for possible reaction is that immunization was given too low and missed the muscle arm.
Approximately 3 hours after the injection, I felt dizzy and lightheaded.  I went to bed but soon felt my heart pounding.  I got really cold and began to shake uncontrollably.  My heart rate continued to accelerate and I thought it best to seek emergency medical help.  I dialed 911, an ambulance was sent.  EMTs determined that I should go to the hospital for monitoring.  EMTs reported that my vital statistics were elevated.  While at hospital, I was administered a saline IV and was kept there until my vital signs reached normal levels.
This spontaneous report as received from a doctor of pharmacy refers to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 30-AUG-2013, the patient was vaccinated with ZOSTAVAX (lot # J002777 and expiry date 07-JUN-2014) (dose and route were not reported). No concomitant medication was reported. The call was reported originally on 04-NOV-2013 in which the reporter requested the stability for an improperly stored ZOSTAVAX. At the time of the call it was reported that the ZOSTAVAX was exposed to 15F for an unspecified amount of hours but reported that no doses of ZOSTAVAX were administered. The reporter called back again on 05-NOV-2013, and stated that he thought that the ZOSTAVAX might had been stored improperly since May 2013 and that the temperature of the ZOSTAVAX had ranged between 15F and 20F for an unspecified amount of hours. At that time the reporter was unsure if the ZOSTAVAX was administered but stated that he thought the ZOSTAVAX would have been administered. On further investigation, the pharmacist reported that ZOSTAVAX had been improperly stored since about 10-OCT-2013 reaching a highest of 20F for a total time of 600 hours. It was reported that the patient had no adverse effect. Further investigation stated that the pharmacist had determined that this case might involve approximately 5 different Lots of ZOSTAVAX (details unspecified) stored improperly at temperatures up to 21F. He stated the time frame for the excursions would be as of the day each of the ZOSTAVAX Lots was received at his facility through the date of patient administration, which he believed might had been months, dating back to on an unknown date in May 2013. These involved approximately 40 patients. He had no specific breakdown of time frame as his record didn't indicate when he received each Lot but he was calling further for the data. He also could not identify, at this time, which Lot # was administered on which date. Pharmacist would call back after he had compiled all of the necessary information and would like revaccination recommendations for any excursion that could not be supported. Pharmacist stated there had been no adverse effects noted by any of the patients. The pharmacist faxed a spreadsheet which included the 38 patients names, the date of administration as well as the lot and expiration dates of the ZOSTAVAX which was unsupported an administrated. This is one of several reports from the same source. Additional information has been requested.
accidently stuck with the needle, syringe contained SHINGRIX adjuvant; accidently stuck with the needle, syringe contained SHINGRIX adjuvant; This case was reported by a pharmacist via call center representative and described the occurrence of accidental occupational exposure to product in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number 35l52, expiry date 6th July 2023) for prophylaxis.   On 16th June 2022, the patient received Shingrix. On 16th June 2022, unknown after receiving Shingrix, the patient experienced accidental occupational exposure to product and exposure via skin contact. On an unknown date, the outcome of the accidental occupational exposure to product and exposure via skin contact were unknown.   Additional Information: GSK Receipt Date: 22-JUN-2022 Reporter's Comment: Health Care Professional was the reporter who stated that after drawing up the Shingrix adjuvant from the vial, she accidently stuck herself with the needle. The syringe only contained the Shingrix adjuvant. The adjuvant was disposed of and was not used. The reporter did not consent to follow-up. Additional supportive information:  The HCP (Health Care Professional) stated that after drawing up the Shingrix adjuvant from the vial, she accidently stuck herself with the needle, which led to accidental occupational exposure to product and exposure via skin contact.
Client received his Pfizer COVID vaccine first dose (lot # FK5127, exp. 01.24.22) in his left arm at Health Center site on 12.02.21. At 1640, client felt nauseous, dizzy, and vomited 50 mL at the EMT station. RN assisted PHN with client and translated for client?s mother who speaks only Spanish throughout the assessment. PHN assessed client and client was alert and oriented x 4. Client's mother reported he ate only cookies, milk, and apple juice today. She told they were in line for seven hours in the walk-in line. At 1641, RN took client?s vital signs: BP 82/68, 02 Sat. 99 %, P 79 with pale and moist skin and drinking water provided without any issues. Client's mother reported child had no chronic health illnesses and not on any medications. But client?s mother told PHN that child had similar experience of nausea, vomiting, and chills when he was under anesthesia at the dentist. Child denied any signs and symptoms of anaphylaxis. At 1650, EMT transferred client to the anti-gravity chair in semi-fowler position and client denied any new symptoms. At 1650, RN took client?s vital signs: BP 88/62, 02 98 %, P 69, R 24 and denied any nausea, vomiting or dizziness. At 1657, RN took client?s vital signs: BP 94/60, 02 Sat. 99 %, P 73 and client denied any new symptoms nor nauseas, vomiting, and dizziness. At 1657, client ate crackers, and juice provided without any issues. Client?s father came to site at 1700. At 1706, EMT took client?s last vital signs: BP 104/56, 02 Sat. 99 %, P72 and client denied any new symptoms nor nauseas, vomiting, and dizziness. PHN educated client?s mother on S/S of anaphylaxis and when to seek EMS. Client's mother verbalized understanding. At 1710, client left the hospital site with a steady gait accompanied by his parents.
Gastrointestinal infection with diarrhea at 7-10 times a day to start. Abdominal cramping and nausea. Diarrhea is up to 25 times a day currently with abdominal cramping, nausea and vomiting.
Several hours after the injection, I started to feel slightly feverish and achy, but those symptoms were not unexpected. However, about 15 hours later and about an hour after getting up the next morning, I started to feel really, really sick. I felt as though I was going to pass out, was trembling, and experienced a wave of severe nausea and an intense urge to defecate. I fought to stay conscious, but my husband was so alarmed he called for an ambulance. The episode passed in around 10-15 minutes, so we canceled the ambulance. But I did see my doctor a couple of hours later, and he said that what I had experienced was a result of the vaccine. The rest of the day I remained slightly feverish (about 100 F) and achy. By the next morning (today), I was perfectly fine. Just so you know, I am a healthy 73-year-old woman who has never had such a reaction to a vaccine before. I did have a COVID vaccine and a flu shot (simultaneously) 2.5 weeks before, on October 12, ie, 18 days before getting the RSV vaccine. My husband, by the way, was vaccinated with the same RSV vaccine and the COVID and flu shots at the same time and did not experience the episode I experienced, although he did feel achy and feverish.
This spontaneous report received from a consumer which she heard on the news (social media) concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the consumer reported that "she heard on the news that there were break through infections in 2 officials who received the Janssen covid-19 vaccine and one was hospitalized". The date of hospitalization was unspecified. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of breakthrough infections was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20210860115. This report was associated with product quality complaint: 90000191561.; Sender's Comments: V0: 20210860259-: Covid-19 Vaccine Ad26.Cov2.S -Breakthrough infection. 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).
Around 2am on 1/19/20, developed really bad chills. No fever. Had to use 5 blankets to keep warm and quit from having chills. Tylenol helped too. 1/19/20 during the day, tired and sore all over. Sore under same arm as inject- feels like swollen lymph node. Injection site is red, sore and hot on 1/19 and 1/20.
administered with vaccine that experienced more than 1 temperature excursion; administered with vaccine that experienced more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (administered with vaccine that experienced more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (administered with vaccine that experienced more than 1 temperature excursion) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021 at 4:07 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Nov-2021 at 4:07 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (administered with vaccine that experienced more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (administered with vaccine that experienced more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (administered with vaccine that experienced more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (administered with vaccine that experienced more than 1 temperature excursion) 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 62.30.  Concomitant medication of the patient was not reported.  Batch number 035C21A underwent temperature excursion on 03-Nov-2021 with temperature of 35 degree Fahrenheit at 10:00 AM. These vials were moved to fridge on 05-Oct-2021 and beyond use date for the vials was reported as 05-Nov-2021. The vaccines moved to clinic on 03-Nov-2021. Storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination. Vials were only punctured right before administration. Vaccines were not frozen at time of administration and prior to 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. The reporter reported that, no data logger reports were available and fisher brand traceable temperature monitor was used to record hourly temperatures.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-566976 (Patient Link).
Pt experienced a fever of 103, rash from head to toe, that was pink and macular.
Dizziness, blurry vision within 10 mins of administration of vaccine. Monitored VS. No treatment; was given ice, cold water.