chrisvoncsefalvay/vaers-outcomes huggingface dataset:
intermittent dizzy spells; tingling in his head; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 71 year-old male patient received bnt162b2 (BNT162B2), administration date 25Mar2021 (Lot number: ER8732) at the age of 71 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number: 1, lot/Batch : ER8732, vaccine site : Right arm), administration date: 25Feb2021, for COVID-19 Immunization. The following information was reported: DIZZINESS (non-serious) with onset 25Apr2021, outcome "not recovered", described as "intermittent dizzy spells"; PARAESTHESIA (non-serious) with onset 25Apr2021, outcome "not recovered", described as "tingling in his head".  Additional information: Caller received his second Pfizer Covid vaccine dose on 25Mar2021 (Lot#ER8732). On 25Apr2021 he started to experience intermittent dizzy spells and tingling in his head. Reports it happens "when I lay down, when I get up from laying down, I got dizzy and tried to steady myself and my right side gave away." Response: Referred caller to HCP for treatment recommendations. Spoke from attached document VR-Consumer Inquiry Management (Off-Label or No Info) (v15.0) and FACT SHEET FOR HCPs ADMINISTERING VACCINE; FULL EUA PI (v1.0) (LAB-1457-7.0 Revised: 06 April 2021) section 6.1. Caller says that he has read the flyer that they gave to them after the inoculation and he is having symptoms of something and he didn't know if they are related to the COVID vaccine or not. The flyer didn't touch on what he is having happen to him so it made him wonder if there are other side effects that could occur with the COVID vaccine. He has dizzy spells and from time to time if he lays on his back and puts his head on the pillow he notices tingling. They started about 5 days ago, confirmed to 25Apr2021. Caller is 71 y/o male. Unsuccessful attempt to warm transfer caller to due to long hold time. Will e-transmit to RA as AE. Caller consents to follow-up contact. The caller was provided with phone number of, option 3, and hours of operation of Monday through Friday 8AM to 8PM, EST and Saturday to Sunday 9AM to 3PM EST prior to a cold transfer due to a high call volume.  No follow-up attempts are possible. No further information is expected.
Horrible and sharp pain in joints . Some days aren?t bad but others can barely hold a pen or a utensil.  Alleve and ibuprofen helps some .
Bad headache; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE (INFLUENZA SHOT) for prophylaxis.   On 29-SEP-2023, the patient received RSV vaccine and INFLUENZA SHOT. On 30-SEP-2023, 1 days after receiving RSV vaccine, the patient experienced headache (Verbatim: Bad headache).The outcome of the headache was not reported.   It was unknown if the reporter considered the headache to be related to RSV vaccine.  It was unknown if the company considered the headache to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 30-SEP-2023 This case was reported by a patient via  interactive digital media. The patient got RSV and flu shot the day before reporting and bad headache at the time of reporting. It was unknown if the reporter considered the headache to be related to flu shot. The follow up would not possible as no contact details were available.
soreness in arm of injection; lymph node under her am is extremely swollen and extremely painful; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness in arm of injection) and LYMPHADENOPATHY (lymph node under her am is extremely swollen and extremely painful) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (soreness in arm of injection) and LYMPHADENOPATHY (lymph node under her am is extremely swollen and extremely painful). At the time of the report, VACCINATION SITE PAIN (soreness in arm of injection) and LYMPHADENOPATHY (lymph node under her am is extremely swollen and extremely painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication include birth control.  No treatment medications were provided.
Broke out in a rash, burning hot in both legs and head about 102 fever, jolting out of her sleep at night screaming in pain as of 11/09/2017 starting approx. 10pm lasting until about 6am. Brought her to office to tell them what has been going on and was told the rash and fever would probably worsen. Treated with MOTRIN around 2pm after she seemed a little lethargic and exhausted. On 11/10/2017 at around 1am, was awoken with another high fever of 103. Was treated with MOTRIN at around 1:30am and cold cloth on her head fever finally went down around 2:30 am but legs were still hot. Still has rash on her body.
Woke crying from nap; began vomiting at 12:15pm, then again at 12:52pm and 1:52. Loss of appetite, Irritability to follow remainder of 7/19. 7/20; increased tiredness, loss of appetite, irritability.
This spontaneous report was received from a licensed practical nurse (L.P.N.) concerning to a patient of unknown age and gender. On 13-NOV-2007 the patient was vaccinated with the first GARDASIL (lot number and expiration date not reported) (dose, frequency and route not reported). No other co-suspects or concomitant medications were reported. It was reported that the patient was in the office now to receive her second dose. No adverse symptoms reported. Additional information has been requested.
Given expired vaccine; Patient was seen in the office that day for cough; Patient was seen in the office that day for wheezing; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team.  An 8-year-old male patient received BNT162b2 (BNT162B2), on 04Apr2023 as dose 1 (orange cap), 0.2 ml single (Lot number: FL2757, Expiration Date: 31Mar2023) at the age of 8 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: EXPIRED PRODUCT ADMINISTERED (non-serious) with onset 04Apr2023, outcome "unknown", described as "Given expired vaccine"; COUGH (non-serious) with onset 2023, outcome "unknown", described as "Patient was seen in the office that day for cough"; WHEEZING (non-serious) with onset 2023, outcome "unknown", described as "Patient was seen in the office that day for wheezing". The events "patient was seen in the office that day for cough" and "patient was seen in the office that day for wheezing" required physician office visit.  Additional information: Caller Confirmed date of manufacturing as Oct2021 for Lot # FL2757. 18 month manufacturer expiration date was 31Mar2023 on this particular lot. Clarified that 2 patients received these vaccines; 1 patient received their vaccine 05Apr2023 and the other received theirs on 04Apr2023. Vaccination Facility Type was Doctor's Office. No prior vaccinations were given within 4 weeks. There was no family medical history relevant to adverse events. There was no investigation. Upon follow-up on 06Apr2023, it was stated that physician was out today, will contact parent tomorrow. Patient was seen in the office that day for cough and wheezing.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300147411 same drug, different patient/ event;
Immediately after I took the shot I got all of the symptoms of COVID. Extreme Fatigue, Loss of appetite, Loss of Taste, Loss of Smell, Cough, Stuffy Nose, Headache, Body Aches
0935- child got pale and eyes rolled back in head and passed out for 25 seconds. Mom at side. Wakes up and put cold cloth on head. Put child on left side lying position. After 10 minutes I sat child up in chair. Then 5 minutes later I walked child to waiting room. Sat in waiting room for 5 minutes and then vomited.  I got cold cloth and a bottle of water for child. Child sat another 15 minutes and then helped child and mom to car. At the doorway of office building the child felt faint and I carried child to the floor with help from mom. Child then started vomiting again (about 3 times). Child awake but very "out of it" for about 2 minutes. Resp 18 per minutes and Pulse was 62. Child breathing well and starts to awaken. Myself and another nurse moved child with blanket back into the health office room. Cold cloth to head and back of neck. Vitals taken. Blood pressure 88/58. P: 64 and resp 20 per minute. 10:10 am child on floor in supine position with head elevated and mom at side. I called family Dr. at this time to report incident (Dr. at Medical Center). Dr said this was something that could happen after vaccines and to monitor and have mom monitor today and if symptoms worsen she can bring child to clinic if not better in 1-2 hours. 1030 am - child sips at water and rests on floor. Talking and alert. 1045 am - staff sits child up slowly and then sits in a chair for another 5 minutes. Child starts to have pink skin color and denies any dizziness or nausea. 1055 am mom takes child to car and heads home.
Information has been received from a nurse practitioner concerning a 13 year old female not pregnant and with no known medical history who on 22-SEP-2007 was vaccinated with the second 0.5 mL dose of Gardasil (lot # 659439/1267U).  There was no concomitant medication.  On 27-DEC-2007 the patient experienced hives and redness on her skin.  Subsequently, the patient recovered from hives and redness on her skin.  No laboratory diagnostic tests were performed.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 2/14/2008. Information has been received from a nurse practitioner concerning a 13 year old female not pregnant and with no known medical history who on 22-SEP-2007 was vaccinated with the second 0.5 mL dose of GARDASIL (lot # 658439/1267U). There was no concomitant medication. On 27-DEC-2007 the patient experienced hives and redness on her skin. subsequently, the patient recovered from hives and redness on her skin. No laboratory diagnostic testes were performed. Follow up information was received. The health care professional reported that the now 14 year old female patient with no medical conditions reported and no known drug allergies was vaccinated IM in the right arm with the first dose of GARDASIL (lot # 659419/1267U). On 27-DEC-2007 the patient was vaccinated IM in the right arm with the second dose of GARDASIL (lot # 659039/1237U). Concomitant therapy included YAZ and BACTRIM. On 27-DEC-2007 the patient experinced hives and redness on her skin. On 28-DEC-2007 the patient experienced whelps all over her body that itched. The patient was treated with BENADRYL oral for a few days and rash subsided. No hospialization was required. It was reported that currently there are no problems. The patient recovered on an unspecified date. It was also reported that the patient had no reaction with the first injection of GARDASIL (lot # 659419/1267U). No further information is available.
ITCHY HEAD AND FACE; LIPS SLIGHTLY SWOLLEN; BLOTCHY LOOKING RASH ABOVE AND BELOW THE INJECTION SITE SPREAD TO NECK AND CHEST; HIVES; INJECTION ARM TINGLING; TONGUE TINGLING; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and it has been requested. No concomitant medications were reported. On 09-APR-2021, the subject experienced injection arm tingling. On 09-APR-2021, the subject experienced tongue tingling. Treatment medications included: diphenhydramine hydrochloride. On 10-APR-2021, the subject experienced blotchy looking rash above and below the injection site spread to neck and chest. On 10-APR-2021, the subject experienced hives. Treatment medications included: calamine/glycerol/zinc oxide, and cetirizine hydrochloride/pseudoephedrine hydrochloride. On 12-APR-2021, the subject experienced itchy head and face. On 12-APR-2021, the subject experienced lips slightly swollen. On 13-APR-2021, treatment medications included: cetirizine hydrochloride, and famotidine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection arm tingling, tongue tingling, itchy head and face, lips slightly swollen, blotchy looking rash above and below the injection site spread to neck and chest, and hives on APR-2021. This report was non-serious.
His arm was a little sore, which was expected. He ended up being extremely tired, he slept straight for 14 hours that night, which is highly unusual. Then on Saturday, we got together with my daughter- a family gathering, and he was not feeling great. We went out to eat, he did not have an appetite. He did not eat, and slept another 14hours, he went to bed early. He wasnt running a fever, but his arm was extremely sore. He was just like completely out of it. He could not play tennis or could do anything. He just did nothing, and he is not a couch potato. That Monday, he was feeling better. After his Adverse event started, he did not seek treatment any place, at time of reporting.
19OCT 3PM pt recvd vax 10mins later sneezing, runny nose, congestion develops; 20OCT low grade temp, flu like s/s, gen malaise lt work early;21-22OCT gen malaise cont;23OCT axilla lt pain, swelling, hard area;lt arm spasm 24OCT95
This spontaneous report as received from a 41 years old female patient referring herself. The patient was not pregnant. The patient had no medical history, concurrent conditions and concomitant medications. On an unknown date in January 2018 (reported as about two months ago), the patient was vaccinated with first dose of GARDASIL 9 intramuscularly for prophylaxis. On an unknown date in January 2018, the patient experienced severe arm pain at the site lasting 3 to 4 days and had very limited range of motion. Unspecified treatment was given for the adverse events. There was no lab tests performed. The outcome of vaccination site pain and joint range of motion decreased was reported as recovered/resolved. The reporter did not provide the causality assessment for the events. There was no product quality complaint involved.
7 days after vaccine the site began to itch and 3 little bumps appeared, like mosquito bites. Today (day 8)it's 1 round, hard itchy 2 inch circle that is slightly red.  I'm also feeling tired even though I slept well.  Not sure if that is related.
eyelid twitching; This spontaneous case was reported by a consumer and describes the occurrence of BLEPHAROSPASM (eyelid twitching) in a 73-year-old female patient 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 BLEPHAROSPASM (eyelid twitching). At the time of the report, BLEPHAROSPASM (eyelid twitching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and  treatment medication was reported by patient.
Headache; body aches; neck and shoulder pain; neck and shoulder pain; This is a spontaneous report from a non-contactable consumer or other non hcp.   A 55-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL9264), via an unspecified route of administration left arm single dose on 10Feb2021 15:00 for covid-19 immunisation. The patient received the first dose on 20Jan2021 lot#lEL9263. The patient medical history was not reported. No other vaccine was received in four weeks. The patient's concomitant medications were not reported. The patient experienced headache on 11Feb2021 12:00, body aches on 11Feb2021 12:00, neck and shoulder pain on 11Feb2021 12:00. No treatment received. The events recovered in Feb2021  No follow-up attempts are possible. No further information is expected.
I had submitted my initial side effects after my first shot but just to put all of it this in one place I am going to include them again along with the latter. One hour after getting my 1st vaccine shot (03/12/21) I began to experience hot flashes, which I had never before experienced. They lasted for 10 days. They began hourly and started tapering off as the days went on. I keep track of my cycle and received the vaccine the day before I was supposed to ovulate. I am 39 years old, healthy, and have always had a regular period. I should have gotten my period 2 weeks after (around 3/26/21). It did not come until 04/14/21. It was much heavier, more painful and lasted a little longer than what I am typically used to. I figured it was just a month and it would get back on schedule. It is now  May 22nd and once again my period is not here. I had a 26-27 day cycle prior to the vaccine so this is highly abnormal for me and concerning since there is no information as to how long this could go on for. I am not under any kind of unusual stress or going through any life changes. It has to be associated with my first shot. It's the only thing that is a variable in this time frame.
Sudden onset of vestibulopathy 7-8 hours post second Covid vaccine. 2-3 severe episodes per day. Treatment by ENT with diuretics, intratympanic steroid injections. Severity of symptoms have lessesned but still persist today. Decreased ability to perform daily functions, work duty modifications necessary.
The next morning (12/29/20) - I had typical symptoms -- > minimal body aches/fatigue and a sore Left arm  At 6pm (12/29/20) -- > I just finished dinner and all of sudden I felt like I zoned out/passed out for a minute.  When I came to -- > my sight was blurry, I felt very nauseous, dizzy, light-headed and felt like I was going to pass out.  I ran to the kitchen and drank some water to try and calm it down, the sensation of passing out was still there with palpitations.  I called out to my roommate who called an ambulance.  My bp/hr were a  bit on the lower side initially when the EMTs got to my apt.  I was still feeling like I was going to pass out.  My labs, vs, and tests all came back WNL when I got to the ED and by that time, I had a severe migraine and nothing else.  From that night (Tuesday night 12/29) until the following Tuesday (1/5/21), I had a migraine, severe lethargy, body aches, and a swollen left armpit lymph node.
By about 6 PM, started having chills and shaking which lasted until around midnight. Awoke the next morning with virtually confluent maculopapular rash over both feet and lower legs and some sparse areas of rash on torso. The rash resolved over the next 24 hours. Left arm at site of injection had a hard, red, swollen, tender area about 3 by 4 cm for 1 week that then resolved over a few days during the next week.    About June 10, a thickened area in the left breast was discovered.     Another unexplained, virtually confluent maculopapular rash of the feet and lower legs occurred 6/21/2019 (32 days after the Shingrix vaccine) and continued through the next several days resulting in a visit to the internist on 6/25/2019. The internist said that he did not know what the rash was but opted to treat with prednisone 30 mg for 3 days followed by 20 mg for 3 days followed by 10 mg for 3 days. The rash resolved during the first 3 days of this treatment. The breast mass was seen by the gynecologist who referred for an ultrasound. The ultrasound noted a suspicious mass the left breast. This was biopsied 7/3/2019 and found to be ductal carcinoma. Ultrasound examinations on 7/16/2019 found multiple enlarged lymph nodes in the left axilla and supraclavicular area. It was impossible to know whether these were secondary to the carcinoma or were a reaction to the Shingrix vaccine. Fine needle aspiration was required and was inconclusive. It would have been nice if the manufacturer has some published information about lymph node reaction to the vaccine.
When I received the first shot I had body and joint aches but did not connect the two and not on the second shot. There was a point where I wondered if maybe it was the shot but after the third shot, there was no doubt in my mind my hip was affected and I felt very sick that night and next day  am still having trouble.
Patient was waiting the 15 minutes after receiving vaccine and during wait stated she had a dry mouth and felt like it was going a "little numb"....patient was given a 25 mg dose of benadryl and given a bottle of water and waited another 45 minutes. after waiting about half an hour patient stated she was "feeling normal" and she waited 15 more minutes and felt good to go.  Called and followed up with patient a couple hours after leaving and she stated she was doing well with no issues.
STUDENT RETURNED APPROX. 15 MIN. AFTER VACCINE ADMIN. & REPORTED NAUSEA, DIZZINESS & FEELING CLAMMY.  COLOR MODERATERLY PALE, SKIN MILDLY DIAPHORETIC.  STUDENT FELT BETTER AFTER RESTING AND RETURN TO CLASS AND FELT HUNGRY FOR LUNCH.
Patient seemed weak and had a fever that first night. After that stuffy nose daily, irritable, constant crying, not sleeping well, constipated.
Rash pustular at left deltoid with swelling rising, began 5 days after immunization (with Dtap or Pedvax HIB) or Varicella). Similar reaction in twin sister.
Adverse events: 2:05 p.m. Erythema, flushing, tightness in throat and chest, flushing  Treatment: 2:10 p.m. EpiPen administered and call to emergency line
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31-Jan-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31-Jan-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31-Jan-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31-Jan-2022) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jan-2022 at 11:45 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 31-Jan-2022 at 11:45 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31-Jan-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31-Jan-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31-Jan-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31-Jan-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient ethnicity reported. No concomitant medications were reported.  Date and time of vaccine administered provided as 31-JAN-2022 11:45:14. The patient received Moderna vaccine past its 30 day of expiry date.   No treatment medications were reported