chrisvoncsefalvay/vaers-outcomes huggingface dataset:
At about 15:45 on 04/09/21, a 15 years and 9 months old patient - who had received a first dose of the Pfizer Covid-19 vaccine on 03/19/21 at the clinic - returns to the same location for a second  dose of the vaccine as scheduled.  Per the parents accompanying the minor, they had pre -registered, received messages, and had scheduled an appointment (as a family of 3) at the clinic by visiting the website. The family of 3 (parents and the minor) had received the first dose without a problem on 03/19/21. Patient is 15 yo & will be 16 yo in July 2021, thus not cleared to receive a Covid-19 vaccine. Second dose not administered.
Rash over body started 1/8/09, worsened 1/9/09. Fever.
Cough, sore throat, severe headache, diarrhea.   Covid--19 Antigen Test positive.
Developed rash, hives on face, neck, chest and scalp since 3 1/2 hours after receiving 2nd dose of Moderna vaccine. I still am experiencing same for 7 days now with no sign of ending.
she has had more diarrhea; felt terrible; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt terrible) and DIARRHOEA (she has had more diarrhea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Irritable bowel syndrome.   On 13-Mar-2021 at 5:00 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced FEELING ABNORMAL (felt terrible). On 15-Mar-2021, the patient experienced DIARRHOEA (she has had more diarrhea). At the time of the report, FEELING ABNORMAL (felt terrible) and DIARRHOEA (she has had more diarrhea) outcome was unknown.            No concomitant medications were provided by the reporter.  Treatment information was not provided.
it was really very hot and burning; redness is travelling down in my arm; have been icing it up; When she injected it into my arm it burned really bad like fire; Arm  was sore; had a little circle at first like quarter that was turning red; it is itching; This is a spontaneous report from  a contactable consumer (patient). A 68-year-old female patient received  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6205) via an unspecified route of administration on 27Feb2021 (at age of 68 year old) as dose 2, single for COVID-19 immunisation.  Medical history included High Blood Pressure. Concomitant medications included Lisinopril, Triamterene, Fenofibrate and Pantoprazole, all taken for an unspecified indication. Historical vaccine included first dose of BNT162B2, lot number unknown, via an unspecified route of administration on an unspecified date, as single dose for COVID-19 immunization and the patient was fine. On 27Feb2021, when vaccine was injected into patient's  arm, it got burned really bad like fire, and her arm was sore, also found a little circle at first, like quarter and that was turning red, then formed to a half dollar and it was itching. So on 01Mar2021 (Monday), patient spoke with her regular doctor. It was reported that, on an unspecified date in Mar2021, redness was travelling down in her arm, where redness is not just in the injection site. She don't know whether it was from her shot. On 03Mar2021, patient felt really hot and burning, was icing it up to cool down. On the same day, patient spoked to her doctor's office. Lab tests included, on 23Feb2021, patient did normal blood work, where results were not provided. Therapeutic measures in response to the events included, Tylenol use. At the time of the report, the outcome of the sore arm was unknown and of all other events was not recovered.  No follow-up attempts are possible. No further information is expected.
The patient did not received IMOVAX vaccine after exposed to bat bite with no reported AE; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional via  Medical Information (Reference number- 00737754) and transmitted to Sanofi on 23-Aug-2021.  This case involves a female patient (age unknown) who did not receive RABIES (HDC) VACCINE [IMOVAX RABIES] after being exposed to bat bite [product dose omission issue].  Medical history included Animal bite on 20-Aug-2021.  The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  It was a case of an actual medication error due to Missed dose (latency same day).  It was reported "A possible delay in dose of IMOVAX due to the caller not being able to afford the cost of (dollar) 10000 after being exposed to a bat on 20Aug2021. The caller is asking about an application to be able to get the rabies vaccine after having a rabies exposure. The caller reported that the insurance is not covering the vaccine; that she was exposed to a bat in the house on 20Aug2021; that her primary care provider feels she does not need a rabies vaccine; and that the caller placed an online application for the IMOVAX vaccine in hopes to get coverage"   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on lot number for this case.
RECEIVED A VACCINE OUTSIDE OF 6 HOUR WINDOW; This spontaneous report received from a health care professional concerned a 47 year old of unspecified sex. 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, route of admin not reported, batch number: 202A21A, expiry: 07-AUG-2021) dose was not reported, administered on 15-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-JUN-2021, the subject experienced received a vaccine outside of 6 hour window. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of received a vaccine outside of 6 hour window was not reported. This report was non-serious.
Mom states crying all night long, extremely fussy, not eating, not drinking, fever for about 12-18 hours.
I had a very bad sore throat and cough. My clinic sent me home out of concern for COVID to isolate. After getting tested at Urgent Care for COVID-19 and for strep throat and for the flu, it was determined that I just had a very bad cold. I was home sick for about a week and I am pretty much over my cough now.
pt recv vax 28APR97 & 2wk post vax exp loss of clumps of hair;pt had used hair straightener @ the time of the hair loss;some hair was growing back @ the time of this report 9JUN, but some is still being lost;no tx of the event is reported;
Red circle (4-5? In diameter) around injection site, swollen and firm to touch; minor discomfort.
A report has been received from a literature source concerning an adult, subject of unknown gender, who had been receiving nasal FLUMIST on an unknown date. The patient experienced vomiting. The outcome of the event of vomiting is unknown. The report was considered to be non-serious.
Vaccine expired on 13 Oct 2021 and placed in refrigerator on 27 Nov 2021; Doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13 Oct 2021 and placed in refrigerator on 27 Nov 2021) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 13 Oct 2021 and placed in refrigerator on 27 Nov 2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13 Oct 2021 and placed in refrigerator on 27 Nov 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. HCP stated that there was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned.Patient did not reported any adverse events. The vials did not undergo any temperature excursion. The vaccine was kept in the refrigerator on 27 Nov 2021. No treatment medications were reported.
p/vax pt arm blew up & was red;pt also exp terrible pain;pt was seen by MD who rx cephalexin;
No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 11-AUG-2020, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 injection, lot # 1660991, expiration date 27-APR-2021 (exact dose, dose number, vaccination site and route of administration were not provided) for prophylaxis.  Administered dose of vaccine was exposed to the temperature excursions of 1.1 degrees Celsius for 27 hours and 45 minutes and 9 degrees Celsius for 1 hour and 15 minutes on 04-AUG-2020. There were no previous temperature excursions. Digital Data Logger was involved. No further adverse events were reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Began with sore arm ,extreme fatigue fever 100.1 . Next day on  12/29/2020  fever 101.2,  chills, extreme fatigue , nausea  vomiting and diarrhea.  Diarrhea continued as many as 20 times a days through 01/03/2021 when she went to the ER where was treated for dehydration and diagnosed with Enterocolitis, was given antibiotic x 7 days
Patient developed L sided weakness and numbness on 4/15/21, and was found to have a transient ischemic attack.
Went to work the following at 6 AM and had to leave by 9:30 as he felt tired, weak, and miserable.  He was feeling hot and feverish. Never had diarrhea or vomiting. Then next morning he still had to call someone to come and feed his horses as he did not have the strength, by about 4 PM that day (53 hours after the dose) he felt better again. His arm is till store 8 days after the dose.
Swelling, redness, pain and itchy at the injection site 6 days after injection. Much like a bug bite or sting. "COVID arm"
Information has been received from a registered nurse concerning a 48 year old female patient with no pertinent medical history and no drug reactions/allergies, who on 30-NOV-2010 was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 (Lot # 667915/1111Z)) IM. Concomitant therapy included CLONOPIN, AMBIEN, cyclobenzaprine HCl, DEPAKOTE ER, SYNTHROID, TRUVADA, VIREAD, SUSTIVA (also reported as STUSTIVA), NEURONTIN, MOTRIN and prazosin. The nurse reported that on 02-DEC-2010, 48 hours after the vaccination, the patient developed a severe injection site reaction. The injection site became painfully red and swollen and spread to axilla and chest wall area. There were no lab diagnosis/studies performed. The patient sought unspecified medical attention. At the time of the report, the outcome of the patient was unknown. The nurse requested a lot check for this lot# due to adverse experiences. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 667915/1111Z were satisfactory. The lot met the requirements of the Center of Biologics Evaluation and Research and was released. This is one of two reports from the same source. Follow-up information has been received from the registered nurse who reported that the immunecompromised patient with no medical history no pre-existing allergies and no birth defects was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 (Lot # 667915/1111Z) IM, on 30-NOV-2010 at 14:38. The nurse stated that on 02-DEC-2010, 48 hours after immunization the patient was seen and present with an erythema pain at the injection site and an exam was performed for the Doctor's patient that noted cellulitis axilla and spread to chest wall. The patient was prescribed with dicloxacillin 500mg for 5 days to the treatment of cellulitis. On 09-DEC-2010 the patient had recovered. The patient did not seek medical attention. No further information is available.
Cold hands and feet, fever began around 3:00 pm, at 6:00 pm it was 96.6, 8:00 pm, it was 100.6, 2:00 am, it was 101.9, 6:00 am, it was back to 99.9, 9:00 am, back to normal.  Felt normal except for exhaustion possibly due to lack of sleep.  Took aspirin or aleve.  Kept cold compresses on from 6:00 pm to 9:00 am.
Contracted COVID in April before they could receive the 2nd dose and were hospitalized for 2 weeks; Contracted COVID in April before they could receive the 2nd dose and were hospitalized for 2 weeks; Husband passed away; This is a spontaneous report from a contactable pharmacist. This pharmacist (Patient's wife) reported for a male patient (Reporter's husband).  A 70-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot number: unknown), dose 1 via an unspecified route of administration on 26Mar2021 as dose 1, single for COVID-19 immunization. No medical and concomitant medication history were reported. She and her husband (who also received the vaccine) contracted COVID in April 2021 before they could receive the second dose and were hospitalized for 2 weeks. The husband passed away on an unspecified date, while the patient recovered from a severe (not mild) COVID infection. She was asking if she can get the second dose and when should she receive the second dose.The patient underwent lab tests and procedures which included SARS-CoV-2 test contracted COVID-19 in Apr2021.It was not reported if an autopsy was performed. The outcome of the event death was fatal and rest on events was unknown.   information about lot/batch number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the event and the suspect drug cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug 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.; Reported Cause(s) of Death: husband passed away
A FEW DAYS AFTER  RECIEVING THE FLU SHOT ON NOV 6TH, I HAVE BEEN EXPERIENCING SHARP PAIN AND BURNING SENSATIONS WHEN I MOVE MY ARM.  HOWEVER, WHEN I DO NOT MOVE MY ARM THE SIDE EFFECTS GO AWAY.  I WENT TO URGERT CARE ON NOV 10TH AND WAS PRESCRIBED CLINDAMYCIN AND PREDNISONE. THE NEXT DAY, NOV 11TH, I SAW MY PCM AND SHE SUSPECTS THAT WHEN I RECEIVED THE SHOT, THE ADMINISTRATOR STRUCT AN NERVE IN MY ARM.  I AM SCHEDULING AN APPOINTMENT TO RECIEVE AN MRI.  THE DAY AND TIME OF THE MRI IS TBD.
The nurse used the Merck diluent to reconstitute the MENVEO, and the patient was immunized with this product.
In July of 2021, two months after receiving the second vaccination, my hands began hurting at night. the pain was originally in my elbow area and moved to my hands and became severe in my right thumb overnight. I awoke one morning in July and my right thumb stuck and clicked when I tried to straighten it. Since this time, the pain in my thumb became very severe and swollen. By September I could barely move/use my thumb. My primary care provider sent me to a reumatologist who diagnosed the thumb with osteoarthritis. To this day, October 19, 2021, the use of my thumb is limited and I am not able to fully straighten my thumb. I also have experienced severe tingling in my hands and fingers at night or when I use my fingers steadily. The pain, swelling, and tingling keeps me awake at nights.
This spontaneous report as received from a nurse manager refers to unspecified number of patients of unknown age and gender. On an unknown dates, since October 2014, the patients were vaccinated with a doses of GARDASIL, VAQTA, RECOMBIVAX HB and ROTATEQ (doses, routes, lot numbers and expiration date were not provided) which were exposed to multiple excursions. No adverse effect had been reported. Additional information has been requested.
On Monday, August 21, the same day my daughter was vaccinated, she awoke in the night with a fever and chills. I didn't think much of it because she always gets a fever after vaccinations. She has also had swelling at injection site on some occasions. I gave her some children's ibuprofen, her fever subsided, and she went back to sleep. I noticed that she had a swelling around an injection on her right leg. Her fever did not return, but on Wednesday, August 23, we were eating lunch at 1:30 when she began complaining of seeing "flashes" of light. She was still seeing them that night when she laid down to go to bed. The next day she was still seeing them, so I called both her pediatrician and her allergist. The pediatrician said to call an opthamologist, and her allergist said it didn't sound like an allergic reaction and to call an opthamologist. We got an appointment with an opthamologist the next day. He dialated her eyes and found nothing wrong. Several days later on Sunday, August 27, she was laying in her bed to go to sleep when she told me that she felt like her legs were shaking. Her legs were not actually moving, but the felt like they were. The next night, Monday, August 28, she felt like her head was shaking, although it wasn't shaking. She also began to hear sounds like a buzzing sound. We got an appointment with her pediatrician the next morning, Tuesday August 29 at 8:45 a.m. On this morning she also stated that her "flashes" of light instead of just being white were now colored and grey, too. Her pediatrician said that her reaction was not a reaction to the shot, but a result of a fear of needles and referred her to a neuropsychologist. I disagree with the pediatrician because she has had many times that she has been stuck with needles (i.e. allergy testing, other vaccinations, blood drawn, even an i.v. once), and she has never reacted. In fact after this vaccination, she was playing and having fun at the park directly after the visit, and had forgotten all about the vaccinations. She and her sister play "giving shots" sometimes. I don't believe that it is logical to say that her reaction was due to a "fear of needles". It is logical that her reaction was due to either a bad vaccine or a reaction to the vaccine. She contines to see "flashes" of light, mainly colored, feel like she is shaking, and hear sounds. I believe the shots have caused central nervous system damage.
Information has been received from a registered nurse concerning a 12 week, 4 day old patient who on approximately 30-JAN-2008 was vaccinated PO with the first dose of ROTATEQ. No adverse experience was related to this event. There was no product quality complaint. No further information is available.
Pt called on 4/6/12. Patient complains of neck & jaw pain, left upper arm pain. Denies any swelling to mouth or jaw. Referred to medical care - pt did not seek medical care. Symptoms resolved by 4/9/12. Follow-up telephone call - denies any symptoms at present.
I got the vaccine yesterday and I have only had arm soreness as a negative side effect.; Cough; breathing is very clear today even though I have asthma/My nose would frequently swell shut and now my nose is very clear/now after the vaccine the rash is gone/My eyes would water a lot and now my eyes feel almost normal today; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 02Feb2021 (Batch/Lot number was not reported) as UNKNOWN, SINGLE for covid-19 immunisation. Medical history included A\allergies, respiratory infection, asthma and rash. The patient's concomitant medications were not reported.  The patient experienced "i got the vaccine yesterday and i have only had arm soreness as a negative side effect" cough and "breathing is very clear today even though i have asthma/my nose would frequently swell shut and now my nose is very clear/now after the vaccine the rash is gone/my eyes would water a lot and now my eyes feel almost normal today". It was reported that when the patient heard vaccines were being developed, she heard they were not including pregnant women or people with severe seasonal allergies. She informs that she might be an interest specifically for a study. Her allergies are in the 39,000 range. She got the vaccine yesterday and she has only had arm soreness as a negative side effect. However, she had had some very good side effects as well. Last night she coughed up a lot of old nodules from a respiratory infection she had a year ago. Her breathing is very clear today even though she has asthma. Her nose would frequently swell shut and now her nose is very clear. Her skin was broken out before the vaccine, so much so that she used a different arm because of the rash and now after the vaccine the rash is gone and is only a little pink where it was before. Her eyes would water a lot and now her eyes feel almost normal today. When she told her friend about this, she said her mom actually coughed up a lot of old infection nodules as well. Outcome of the events were unknown.   Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
Became overly tired. Had cluster of brief stiffening, shaking, breath holding lasting 2-3 seconds, pause x 3-5 minutes, recur. Lasted approximately 20 minutes. Seen in ER. Temp 101. Resolved. No other signs of illness. May have been seizure, may have been fussy baby.
Within minutes of sitting down for observation period after second dose of Pfizer vaccine, patient began c/ feeling cold and was observed to be shaking most localized in R UE and without resolution.  Sent to ED by Clinic staff.  In ED waiting room given ativan after R arm noted to be shaking.  Labs normal.  Tox screen negative.  Patient seen by neurology who recommended MRI, EEG, admission.  After pateitn was at baseline mental status after ativan, she left ER AMA.    Vaccine clinic staff spoke to her on 4/22/21 and she reported being back at work and back to her baseline.  PCP/outpatient neurology f/u recommended.