chrisvoncsefalvay/vaers-outcomes huggingface dataset:
feeling very shaky and dizzy when I stand up.; feeling very shaky and dizzy when I stand up.; This is a spontaneous report from a contactable other health professional (patient). A 51-year-old female patient received the first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19, lot number and expiry date not reported), intramuscular on 03Jan2021 13:15 at a single dose on right arm for COVID-19 immunisation. Medical history included none. The patient had no known allergies to medications, food, or other products. There were no concomitant medications. The patient reported, "I'm feeling very shaky and dizzy when I stand up on 03Jan2021 14:30. No treatment was given for the events. The outcome of the events was unknown. The events were considered as non-serious. Facility where the most recent COVID-19 vaccine was administered was in Nursing Home/Senior Living Facility. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications received within 2 weeks of vaccination. Prior to vaccination and since the vaccination, the patient was not diagnosed with COVID-19.  Information about lot/batch number has been requested.
hot lump on arm at the injection site; red lump on arm at the injection site; lump on arm at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th August 2019, the patient received the 1st dose of Shingrix. In August 2019, less than a week after receiving Shingrix, the patient experienced injection site warmth, injection site erythema and injection site lump. On an unknown date, the outcome of the injection site warmth, injection site erythema and injection site lump were not recovered/not resolved.   It was unknown if the reporter considered the injection site warmth, injection site erythema and injection site lump to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the dose of Shingrix in an unknown arm, one day before reporting date and had a hot, red lump at the injection site. The patient did not want to share any information for the event and would not answer further questions.
Patient had varicella vaccine 01/23/2003 but today has obvious clinical varicella.
I have a history of heart palpitations(PSVT), well controlled with atenolol and cardizem. I began having irregular heart beats the day after my injection,( not PSVT). This lasted approximately 45 minutes. It happened twice more that evening, but did not last but about 5-10 minutes.  On the following day I had another episode lasting approximately 30 minutes. Have had no further episodes as of this date.
The first shot was given 02/17/21. Moderna. Patient went to bed that night everything was fine.  The next morning he woke with the worst headache. He stayed in bed all day. That evening he was so cold he was shaking. The following day he was so tired and had to really push himself out of bed.
I keep getting COVID, when I have the vaccine; I keep getting COVID, when I have the vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I keep getting COVID, when I have the vaccine". The patient was just wondering why no one was liable for any of the side effects for the COVID-19 Vaccine when patient keep getting COVID, when have the vaccine. Patient was informed about the Role of Pfizer Drug Safety and Pfizer Medical Information Department. As consumer was unwilling to complete the report, further probing could not be done. Hence, limited information available over the call and appropriate response could not be provided over the call.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Due to the bee sting the previous day I took 50mg of Benadryl 9/14 in the afternoon. Began feeling nauseous,  at dinner time, could not eat, vomited, passed out and hit my head (laceration that did not need stitches).  Experienced the chills and went to bed and felt better the next morning.
No additional AE reported; her first dose of GARDASIL 9 on 24JUN2021 and was given second dose pf GARDASIL 9 today, 08JUL2021; This spontaneous report as received from a registered nurse refers to a 35-year-old female patient. There was no information about the patient's medical history, concurrent conditions or concomitant medication. On 24-JUN-2021, the patient was vaccinated with a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)  for prophylaxis (dose, dose number, route, Lot #, anatomical location and expiration date were not reported).On 08-JUL-2021, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) prefilled syringe, lot #: T038529, (expiration date :11-MAR-2023). No additional adverse event reported. No product quality complaint was reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T038529; expirationdate: 11-MAR-2023; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Diabetes; This spontaneous case was reported by a consumer and describes the occurrence of DIABETES MELLITUS (Diabetes) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIABETES MELLITUS (Diabetes) (seriousness criterion medically significant). At the time of the report, DIABETES MELLITUS (Diabetes) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Reporter did not allow further contact
Information has been received on 04-OCT-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age and her spouse. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 2016, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving the ZOSTAVAX, the patient presented to a medical center and was diagnosed as suffering from shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
After receiving injection c/o feeling dizzy "going to pass out, unconscious, extremities became rigid, blue, nonresponsive, respiration shallow, unconscious approx 15-20 sec, regained conscious speech slow, color improved to pink, lost conscious x 2, lethargic, sleepy used ammonia inhalant 1st response-O2 per mask.
This non-serious initial spontaneous case, was received from nurse on 27-Nov-2017, concerning a 22-year-old, adult, male patient. The patient had no known allergies. The patient's medical history and concomitant medications were not reported. On 01-Nov-2017, patient was administrated with AFLURIA QUADRIVALENT (dose: 05. ml, route of administration: intramuscular, batch number: 00144621A, anatomical location: right deltoid and expiry date: not reported). On the same day, after about 1.5 hours of vaccination, the patient experienced hives all over the body and went to ER (emergency room), where he received the BENADRYL and discharged to home. The same day (01-Nov-2017), the patient recovered from the event. The reporter considered the causality of the event as related to the suspect vaccine.
Stabbing pain left 5th toe pain pm of 11/13/09 that went throughout night. Woke patient up out of sleep. 11/14/09 cooling sensation left half of body with overall feeling of "fatigue" and sick. 11/15/09. Cool sensation on R/L upper body with joint pain mostly left ankle/knee up through 11/15.
Patient reported dizziness approximately 10min following vaccination. During assessment, patient complained of swelling in throat (was able to swallow and drink water). Patient received liquid diphenhydramine 63.6mg PO 15min after vaccination and stayed for observation. Patient notes 15min after receiving diphenhydramine throat swelling had resolved and requested to go home from work. Patient was released from work to boyfriend, vitals WNL at discharge.
A report was received from a health care professional on 12/4/03 concerning a female vaccinee, aged between 22-24 years who developed swelling of the injection site following administration of Fluvirin on an unknown date in either late October 2003 or early November 2003. On an unknown date in either late October 2003 or early November 2003 the vaccinee developed swelling at the injection site following administration of Fluvirin. The swelling became enlarged from the elbow to the shoulder. The reporter also suspected that the adverse event had resolved at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown ages and gender. On an unknown dates the patients were administered unspecified number of doses of PNEUMOVAX23 that were improperly stored. No adverse events were reported. This is one of several reports from the same source. Additional information has been requested.
Sudden lymph node swelling in under-arm/armpit, same arm as injection within 24 hours of vaccination.
No adverse event; HCP stated they administered a 1st dose of Moderna COVID-19 Vaccine to a 16 months old patient on 28-FEB-2023 but they just realized the vaccine expired on 02-FEB-2023; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP stated they administered a 1st dose of Moderna COVID-19 Vaccine to a 16 months old patient on 28-FEB-2023 but they just realized the vaccine expired on 02-FEB-2023) and NO ADVERSE EVENT (No adverse event) in a 1-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Feb-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP stated they administered a 1st dose of Moderna COVID-19 Vaccine to a 16 months old patient on 28-FEB-2023 but they just realized the vaccine expired on 02-FEB-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP stated they administered a 1st dose of Moderna COVID-19 Vaccine to a 16 months old patient on 28-FEB-2023 but they just realized the vaccine expired on 02-FEB-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP stated they administered a 1st dose of Moderna COVID-19 Vaccine to a 16 months old patient on 28-FEB-2023 but they just realized the vaccine expired on 02-FEB-2023).    No concomitant medication was reported.    HCP stated they administered a 1st dose of Moderna COVID-19 Vaccine to a 16 months old patient on 28-FEB-2023 but they just realized the vaccine expired on 02-FEB-2023. No treatment information was reported.
Muscle aches and twitching 9pm 7-13-16. Crying in pain and chest discomfort by 11:15p. Shortness of breath. Given IVF and NSAIDS in the ED.
Hot and cold flashes, fever of 100.1, dizziness, pain in arm at injection site
Patient felt light-headed, then became unresponsive. He moved both arms halfway up, and they both quivered simultaneously. I called for help. One nurse raised his legs & another put a pulse oximeter on patient & took his BP. Patient started responding to verbal cues. A nurse gave him Gatorade to start drinking. He was drenched in sweat from head to feet. The nurse continued to take his BP, which did hit 120/~70, but then dipped again. Once his BP & pulse stabilized, he was able to go home. Patient ate a full meal & a non-diet soda. He reported being exhausted ~4 pm. He fell asleep & rose once to urinate.  Dr. at a Family Medicine practice checked his heart and lungs, and confirmed this did not appear to be an allergic reaction, but more likely was a vagovasal reaction. Patient started reacting ~10 minutes after the injection.
This spontaneous report was received from a nurse prescriber referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 12-NOV-2018, the patient was vaccinated with VAQTA 25/0.5 (Units not reported) (dose, frequency, route and anatomical location unknown) lot # N026997, Expiration date: 10-NOV-2018 for prophylaxis (expired product administered). No adverse effects reported.
This spontaneous report as received from a registered nurse refers to a 6 month old patient of an unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 19-OCT-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M006112 with expiry date: 16-NOV-2017 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1610USA014706:
Initial onset w 1st dosage- fever headache body ache and dizziness. Second dosage on 4/15 past standard side effects led to massive hair loss, bleeding and clotting issues,  lasting and persistent headache, extreme fatigue still two months out, bouts of dizziness, menstrual pain and excessive bleeding.
Started in her back and goes across her back, shoots down the middle of her back and both sides. Front in the ribs and around the breast - chest pains.  Exhausted - energy is gone. Can't do normal activities that she was able to do prior to vaccine.  Sharp pains. When I breath or cough/sneeze or laugh it hurts. Had some relief from heat and cold packs.  Left knee has hurt a lot since this happened, too.
Information has been received from an advanced nurse practitioner concerning a male patient who, on an unspecified date, was vaccinated with a dose of VARIVAX (Merck) (Lot # and expire date not reported), subcutaneously. The patient received the injection of VARIVAX (Merck) and came down with varicella 10 days later. Patient was not hospitalized, but went on Workman's Compensation. The patient sought unspecified medical attention. At the time of the report, the outcome of the patient was unknown. Varicella was considered to be disabling by the advanced nurse practitioner. Additional information has been requested.
Severe pain near injection site  and very limited movement in left arm/shoulder near injection site.  Unable to raise arm above shoulder level.
Took the vaccine on Friday, 01/15/2021, no side effect on the first day, but on about 2-3 days later, was breaking out with rashes on my back from neck to waist, and both sides,  very itchy and painful, been taking benadryle  and  applying Clobetasol cream and moisturelizer , feeling  a little bid better
This spontaneous report was received from an office manager and refers to an unknown number of adult patients of unknown gender and age. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the adult patients had received two doses of pediatric VAQTA (doses, route of administration, anatomical location, lot# and expiration date were not provided) to equal adult doses. No adverse effects reported. Product quality complaint was not reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA010453.
patients post vaccination who presented with light respiratory difficulty, tongue edema and lip (light). Placed on cardiac monitor, administered oxygen, solumedrol 125IV push, canalized with 0.45cc KVO. Patient was left under observation for 1 and half hour.
Allergic reaction; Throat swelling; tightness; difficulty swallowing; This is a spontaneous report from a contactable Other Health Professional (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was unknown), via an unspecified route of administration on 15Jan2021 at single dose for covid-19 immunization. The patient medical history reported no current heath issue like no "acute" (not clarified) current she got but she had got "bulging" (not clarified) disc and "effects" in the past, no "aplasia" (not clarified) nothing, no and she was "marina" (not clarified)." There were no concomitant medications. The reporter reported a patient that had an allergic reaction to the Pfizer Covid vaccine. Nurse stated that when she was "admitted" (not clarified) she was in the ER being monitored she got "admitted" (not clarified) first day today 7:45 not clarified (15Jan2021). The patient experienced allergic reaction, included "Throat swelling, tightness, difficulty swallowing." The reporter gave the patient "Api" (not clarified) 0.3 milligram and then also she had "Dimedrol" (not clarified) 125 and then she had CAPCID 20mg IV "piggy back" (not clarified). She had Benadryl 50 milligrams." The outcome of the events was unknown.  Information on the batch number and lot number has been requested.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of allergic reaction cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product.  Severe allergic reaction is the known risk for the product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
On the evening of the first vaccination, my sister experienced chills and fever. The next morning she experienced a kind of paralysis, could not sit up or stand up, was falling out of bed and out of her chair, had to be carried to the bathroom, although she usually can walk by herself. This lasted about a day. I took her to the ER where they excluded other possible causes of her condition and simiply attributed it to the vaccine. No treatment was prescribed.
Swelling and pain at injection site a week after. Along with fatigue and nausea.
Two weeks after first shot was dizzy,. One night after second vaccine dizzyness and emesis  lasted for one day
It was reported that a 54-year-old female patient received a TD Adult vaccination on 26 Jan 2001 at 10:00am. Reportedly on 27 Jan 2001 at 1:00 pm the patient developed on her left forearm volar--1.5 cm x 1 cm, red with induration entire. No margin of red outside of induration. Treatment of Benadryl per oral was prescribed. Temperature 98.9. The patient reportedly recovered from this experience. From follow-up received on 4/3/01, no further information was provided.
Intermittent extreme fatigue, so much so that I could not work or eat. Beyond any fatigue I have experienced before despite having ME/CFS since 2008 and Fibromyalgia since 2012.
COUGH, EARACHE, FEVER, HEADACHE, JOINT PAINS, RUNNY NOSE AND DIARRHEA.
Dose was given at 13 hours post puncture expiration (vial had been punctured at 10:30 AM on 25/Aug/2021); This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose was given at 13 hours post puncture expiration (vial had been punctured at 10:30 AM on 25/Aug/2021)) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A, 031B21A and 003F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Aug-2021 at 11:30 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose was given at 13 hours post puncture expiration (vial had been punctured at 10:30 AM on 25/Aug/2021)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose was given at 13 hours post puncture expiration (vial had been punctured at 10:30 AM on 25/Aug/2021)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were provided by the reporter. No treatment medication were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 26-Aug-2021: Follow-up received and included suspect dose details updated and updated narrative.
I got a pneumonia vaccine yesterday. Approximately five minutes after receiving the shot I experienced severe pain in my lower back. I was driving at the time and managed to get to a parking lot. The pain subsided as quickly as it came on after about five minutes. It is now 24 hours later and I have had no other side effects.
I started running a fever and had flu like symptoms yesterday starting at 3pm. Overnight I lost control of my bowels during sleep! Today at 11am,  I have a bright red blotchy and spotty rash on my chest, shoulders and fronts of legs. It does not itch, but is spreading to my back.
AFTER ABOUT 10 MINUTES OF RECEIVING INJ, PT FELT LIGHT HEADED AND HAD A SYNCOPE EVENT.
Rash & swollen in area of vaccination, was given allergy medication at ER by mother, doesn't know name,  P return to clinic to f/u and rash was gone