chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Customer reported PNEUMOVAX 23 (pfs) was administered past expiration date of administration April 7, 2022.  NO PQC.  NO other issues or concerns noted.  Caller refuse AE letter. LOT: T009743 EXP: Jan 27, 2022 Admin: April 7, 2022; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.         On 07-APR-2022, the patient was vaccinated with expired pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # T009743 with expiration date 27-JAN-2022, for prophylaxis (strength, dose,  route of administration and anatomical location were not reported). No other issues or concerns noted.
Lengthening of menstrual cycle. Prior to the vaccine, my periods were always 30-33 days apart. After vaccination, my cycle has lengthened to about 6 weeks. Since the shot in April, I have had 2 periods (It is now August). I have also had nausea during the luteal phase of my cycle since getting the vaccine.
1 wk after vax, c/o'd weakness and malaise. 4/3/03 Dizziness in the a.m. Approx 2 p.m. had episode of irregular heartbeat for approx. 10 mins then tachycardia 130-140 BPM. Chest pain & burning sensation.
headache, muscle pain throughout entire body, tiredness, chills, nausea - all began this morning
Left arm was red, tender, warm to touch with 1.5inch by 2.5 inch reddened and swollen area.
The first symptom was the swollen lymph nodes in neck - that lasted a day and a half. About a week ago, same thing - swollen lymph nodes in my neck (or throat area)  - that lasted about a day and a half also. Two and 1/2 weeks later, when I developed the swelling and pain in my paratoid gland in my left jaw. Severe swelling - could barely open my mouth. So I saw DR,  on the 19th of March. She prescribed a Z-pak antibiotic and the swelling took about a good week to two weeks and maybe a little longer for the swelling and everything to go away. I was on antibiotic for seven days. Since then I have had no other problems.
Information has been received from a physician concerning a 22 year old female who was vaccinated with three dose of GARDASIL between February 2007 and August 2007 (lot number not provided, 1st dose 0.5ml). In 2009 the patient had PAP test on unspecified sate and results came in as HPV positive. The patient sought unspecified medical attention and did not recover at time of reporting. Additional information has been requested.
Case number PHEH2014US006796 is an initial spontaneous report received from a health care professional on 04 Apr 2014 and a follow up report from the health care professional on 20 May 2014: This report refers to a 14-year-old adolescent female patient. She was vaccinated with MENVEO (batch number: A13047) intramuscularly on 03 Apr 2014 (at 04:40 pm). During the vaccination, she moved and as a consequence she received a dose less than 0.5 ml. No adverse event was reported following this medication error. Follow up report from the health care professional on 20 May 2014: Updated patient details and vaccination time of MENVEO.
I had a swollen armpit and it moved up to the top of my shoulder to my neck and back around the base of my skull. I woke up the next day with a very swollen uvula. I called office and asked if there's anything I can do regarding the side effects I was experiencing but she said there's really nothing and just to wait for it to subside and if it persists and I had difficulty breathing I should go to the hospital. It took about 4 days for me to recover back to normal.
- Chills accompanied by uncontrollable shaking, lasting approximately an hour.  - Muscle soreness, ongoing  - Fatigue, ongoing  - Fever, ongoing
Never experience bleeding during the period because of  IUD but did after receiving both vaccine shots; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0198) via an unspecified route of administration in the left arm on 16Jul2021 at 19:00 (at the age of 27-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3181) via an unspecified route of administration in the left arm on an unknown date in 2021 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included ulcerative colitis and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medication included levonorgestrel (MIRENA) intra uterine device (IUD) for an unknown indication from an unknown date and unknown if ongoing. On 17Jul2021 at 12:00, the patient experienced bleeding during her period. It was reported that the patient had never experienced bleeding during her period because of  the IUD but did after receiving both vaccine shots. The event did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event never experienced bleeding during the period because of IUD but did after receiving both vaccine shots was not resolved at the time of the report.
Severemuscle soreness radiating frominjection site; General malaise; Mild chills; Night sweats; Arm of limited use; This is a spontaneous report from a non-contactable consumer, the patient. A 56-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 19Mar2021 at 18:15 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Relevant medical history included high blood pressure. No concomitant medication was reported. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 25Mar2021 at 11:00, after 5.5 days of the injection, the patient had severe muscle soreness radiating from injection site, to the point where arm was of limited use, mild chills, generalised malaise and night sweats and no known fever. Temperature was taken in the evening and again in the morning. The patient did not have any other COVID or flu symptoms. Therapeutic measures were taken as a result of the events that included treatment with over the counter (OTC) cold and flu medications. The adverse events did not result in a doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcomes of the events muscle soreness, arm of limited use, mild chills, generalised malaise and night sweats was resolving.   No follow-up attempts are possible; Information about lot number cannot be obtained.
Patient vomited after breakfast.  She was given ginger tea and bed rest. The vomiting stopped about 30 minutes and she stayed in bed for about 4 hours.
Narrative:  COVID infection following COVID vaccine series 03/25, Pfizer, dose #1 04/16, Pfizer, dose #2 11/05, Pfizer, dose #3 12/26 COVID swab, result: detected 12/23 pt cc: cough, fatigue, headache, loss of taste or smell, myalgias, rhinorrhea, sore throat exposure: unknown 12/26 pt medicine cc: cough sob dx: Covid Pneumonia LOS: 4 days APTT 35.2 12/26 SARS-COV-2 Variant Sequencing: pending 12/26 CXR impression: No acute cardiopulmonary disease. 12/26 INR; 1.11 12/26 DDIMER: 0.41 12/26 PT: 12.4 12/26 12/26 BNP: 104.8 12/27 FIBRINOGEN: 596 12/27 DDIMER: 0.26 12/27 PROCALCITONIN: <0.05 12/27 ESR: 20 12/28 FIBRINOGEN: 506 12/28 DDIMER: 0.30 12/28 ESR: 27 12/29 FIBRINOGEN: 430 12/29 DDIMER: 0.27 12/29 ESR: 24 12/29 CXR impression: No acute cardiopulmonary disease.
Patient got vaccinated but got the flu only time he/she ever passed out in his/her life; with asthma patient's symptoms were fairly tough; was out of work for a week; Patient got vaccinated but got the flu; Initial information received on 06-Oct-2021 regarding an unsolicited valid Social Media serious case received from a consume (under reference US-SA-SAC20211011000354).  This case involves an adult patient with unknown gender who experienced serious event patient got vaccinated but got the flu only time he/she ever passed out in his/her life (loss of consciousness), with asthma patient's symptoms were fairly tough (asthma), patient got vaccinated but got the flu (influenza)  and was out of work for a week(impaired work ability) while receiving INFLUENZA VACCINE.  The patient's past medical treatments, concomitant medications, vaccinations and family history were not provided.  At the time of the event, the patient had ongoing Asthma.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number and expiry date not reported via unknown route in unknown administration site for prophylactic vaccination.   On an unknown date, the patient developed a serious event patient got vaccinated but got the flu only time he/she ever passed out in his/her life (loss of consciousness) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  On an unknown date the patient developed non-serious events with asthma patient's symptoms were fairly tough (asthma), patient got vaccinated but got the flu (influenza) and was out of work for a week(impaired work ability) (unknown latency) following the administration of INFLUENZA VACCINE. The patient reported that four years ago, he/she got vaccinated but got the flu the only time he/she ever passed out in his/her life and with asthma his/her symptoms got tougher and was not able to work for a week. The patient also mentioned that with vaccine protection he/she would not be alive till date.  It was unknown if the patient experienced any additional symptoms/events.  It is unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome of events was reported as unknown.; Sender's Comments: This case involves an adult patient with unknown gender who experienced a serious event loss of consciousness and non serious events asthma, influenza and impaired work ability after receiving INFLUENZA VACCINE (unknown manufacturer). The patient had ongoing Asthma. The time to onset is unknown for the events. However, patient's medical condition at the time of vaccination and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed
On 1/1/21 noticed swelling and electric pain (R) temple and scalp.  Persisted and  on 1/2/21 went to an Urgent Care and was diagnosed with Shingles.  I was prescribed Acycylovir. Symptoms began to resolve 24 hours later.
MOTHER CALLED 1 DAY AFTER PT RECEIVED FLU VACCINE AND STATED THE PATIENT'S LEFT UPPER ARM STARTED TO GET "WARM, RED., AND HARD"  MOTHER DENIES FEVER, HA, CHANGE IN APPETITE.   PARENT STATES IT WAS THE WHOLE UPPER ARM.  PARENTS STATES CHILD MAY HAVE HAD PREVIOUS REACTION TO FLU VACCINE BUT SHE WASN'T SURE IF IT WAS THE FLU VACCINE. PARENT STATE SHE DID NOT GIVE PATIENT AND MEDS.  INSTRUCTED PARENT TO GIVE IBUPROFEN AND BENADRYL AND TO CONTACT CLINIC IF NOT BETTER THE NEXT DAY AND GO TO URGENT CARE IF SX GET WORSE OVERNIGHT.
After receiving my vaccine on 7th of May I wasn't getting better, I had a headache and started to cough. I do not remember having a fever, joint pains aching all over, also was experiencing chills as well. I did a telehealth appointment on May 7th and the doctor wanted me to go for a COVID-19 test but I was very sick and just could not go. I was very lightheaded and dizzy was hard for me to even walk. She suggested me to take over the counter medicine to help. On August 5th I saw the doctor she ordered a lot of blood work, and she started me on Albuterol, Anaflexerale, and Benzonatate. All my blood work came back normal, and then I saw doctor on September 22nd I was still experiencing muscle pain, fatigue and a slight cough, chills. Just wasn't feeling well at all. She ordered a chest x-ray and to repeat all blood work. Everything came back normal again. She also prescribed Alvesco and for me to continue to take the previous medication. I was sent to doctor for the muscle pain I was still experiencing on October 7th, she did more blood work, and ordered an MRI for the muscles in my thighs, and X-ray's because at the time my arms started to hurt as well. All my results came back normal. Doctor noticed a rash during the appointment and sent me to a dermatologist on October 27th, he didn't believe the rash came from the vaccine and he started me on an antibiotic and a cream to apply twice a day.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 75 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 26Oct2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 29Jan2022 as dose 2, single (Batch/Lot number: unknown), in left arm and on 13Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Positive test occurred 5 days after negative test; Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300102870 same patient, different drug and different event;
Received a 2nd dose of Menveo on 16th June 2021/1st dose in 2016; Received a 2nd shot of Menveo but they only administered the liquid portion; Received a 2nd shot of Menveo but they only administered the liquid portion; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA568A, expiry date May 2022) for prophylaxis.   Previously administered products included Menveo (1st vaccination occurred on 2016).   On 16th June 2021, the patient received the 2nd dose of Menveo. On 16th June 2021, unknown after receiving Menveo, the patient experienced extra dose administered, inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the extra dose administered, inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: All patients identifiers were reported as well as batch Number and expiration Date, expiry date was reported as May of 2022. The patient had received 2nd shot of Menveo but they had only administered the liquid portion, which led to extra dose administered, inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow-up.
On day 8 after February 7, 2021 at 6 p.m., itching and pain started at the injection site which was red and inflamed. Reaction came out of the blue. It is being referred to in "non-medical terms" as Covid arm.
I injected a needle into a patient that was connected to the Fluzone HD flu vaccine. I realized that was the incorrect vaccine and I did not administer the vaccine and I removed the needle. The patient did not actually receive the incorrect vaccine but I did put the needle into his arm. I then administer the age appropriate flu vaccine.
itching; chicken pox type lesions; This case was reported by a consumer via call center representative and described the occurrence of itching in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th February 2020, the patient received Shingrix. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced itching and varicella-like rash. On an unknown date, the outcome of the itching and varicella-like rash were recovered/resolved.   It was unknown if the reporter considered the itching and varicella-like rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated even though they never had chicken pox as a child and I told the doctor. They started having terrible itching and chicken pox type lesions after vaccination. Events lasted for about three days and subsided.
Intense pain at the injection site over two and a half weeks after the second dose. It feels the same as the day after receiving the shot; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 06Apr2021 (at the age of 22-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6208) via an unspecified route of administration in the left arm on 16Mar2021 (at the age of 21-years-old) as a single dose for COVID-19 immunisation.  On 06Apr2021, the patient experienced intense pain at the injection site over two and a half weeks after the second dose and it felt the same as the day after receiving the shot. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event intense pain at the injection site was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
Neuropathy in feet; Feeling tired; ended up in emergency room with Pfizer booster vaccine; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4426123-00 (Agency).  A 68-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1160837), subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEUROPATHY PERIPHERAL (medically significant), outcome "not recovered", described as "Neuropathy in feet"; FATIGUE (non-serious), outcome "not recovered", described as "Feeling tired"; IMMUNISATION REACTION (non-serious), outcome "unknown", described as "ended up in emergency room with Pfizer booster vaccine". The event "ended up in emergency room with pfizer booster vaccine" required emergency room visit. The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "neuropathy in feet" and "feeling tired" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The reporter considered "ended up in emergency room with pfizer booster vaccine" related to BNT162b2. The reporters causality for the event (s) of feeling tired, ended up in emergency room with Pfizer booster vaccine and neuropathy in feet with the suspect product Humira was not reported.  Clinical course: Solicited report from a consumer of an elderly female with events of non-serious feeling tired, ended up in emergency room with Pfizer booster vaccine and neuropathy in feet with Humira (Adalimumab). There was no reported medical history. On unknown dates, the patient experienced feeling tired, ended up in emergency room with Pfizer booster vaccine and neuropathy in feet. Pfizer BioNTech COVID-19 Vaccine (Tozinameran) was also considered suspect.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available, the causal relationship between the reported events and suspect drug BNT162B2 cannot be excluded. 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
Typical cold symptoms.  Sinus drainage, sore throat.  Tested positive for COVID with home test kit.
I had chronic headaches for about a month following my second shot.  I sought treatment, and was told to take OTC painkillers at first, but then not to because there could be a "bounceback" headache, and it wasn't clear that it was related to the vaccine. After a month or so, they went away. After my booster, however, I once again experienced chronic headaches, this time a little less frequently, but for a longer overall time period, about 2 months or so.
Headache, nausea, body aches, chills, sore arm at vaccination site
Patient's husband called on 12/1/10 for reporting possible vaccine reactions. Spoke with patient, has intermittent dizziness, vertigo episodes one week after flu shot, seen by her doctor, unknown causes, and she is scheduled CT scan today. Her daughter had flu shot in other doctor's office, has some complaints of dizziness also.
fever; chills; body aches; This case was reported by a nurse via sales rep and described the occurrence of fever in a 18-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) for prophylaxis.   On 22nd July 2020, the patient received Menveo and Bexsero. On 22nd July 2020, 3 hrs 15 min after receiving Menveo and Bexsero, the patient experienced fever, chills and general body pain. On an unknown date, the outcome of the fever, chills and general body pain were unknown.   It was unknown if the reporter considered the fever, chills and general body pain to be related to Menveo and Bexsero.  Additional case details were reported as follows: The age at vaccination was not reported. At9:45 p.m, the patient received Menveo and Bexsero. At 1:00 p.m, the patient experienced the symptoms were fever, chills, body aches.
Patient fully vaccinated (Moderna), but not boosted, and was admitted to the hospital on 01/02/2022 with COVID-19 and associated hypoxia. Patient was discharged on 01/08/2022.