chrisvoncsefalvay/vaers-outcomes huggingface dataset:
NERVE TINGLING; BLISTER UNDER THE TONGUE; TIRED; FATIGUE; HEADACHE; MUSCLE ACHE; INJECTION SITE SORE; INJECTION SITE BRUISED; CRAWLING UNDER THE SKIN; BUZZING; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's past medical history included menopausal, and concurrent conditions included penicilline allergy, sulfa allergy, wheat allergy, alcohol abstain, and non smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. Concomitant medications included paracetamol for spinal stenosis. The batch number was not reported. The Company is unable to perform  follow-up to request batch/lot numbers. On APR-2021, the subject experienced injection site bruised. On APR-2021, the subject experienced crawling under the skin. On APR-2021, the subject experienced buzzing. On APR-2021, the subject experienced injection site sore. On 07-APR-2021, the subject experienced nerve tingling. On 07-APR-2021, the subject experienced blister under the tongue. On 07-APR-2021, the subject experienced tired. On 07-APR-2021, the subject experienced fatigue. On 07-APR-2021, the subject experienced headache. On 07-APR-2021, the subject experienced muscle ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nerve tingling, blister under the tongue, and headache on 09-APR-2021, and injection site bruised, and injection site sore on APR-2021, and the outcome of tired, fatigue, muscle ache, crawling under the skin and buzzing was not reported. This report was non-serious.
COULD NOT GET OUT OF BED THE NEXT MORNING/COULD NOT MOVE ANY JOINTS IN MY BODY WITHOUT PAIN/ NEEDED HELP TO USE THE RESTROOM/SLEPT ALL DAY/ LOST ABOUT 36 HOURS OF MY LIFE/VERY SCARY
On 1/4 I started having nausea.  I vomited once on 1/4.  I was also weak, tired and dizzy, and I had a headache off and on.  This lasted until 1/6.  On 1/7 the dizziness subsided, but  I still had the weakness, tiredness and headache.  These lasted until 1/9 and resolved on 1/10.  I had to call out sick on 1/7 and 1/8.  I was unable to enjoy my vacation time 1/4-1/6.
Pt here in clinic today with chicken pox - 3/23/09 1st vaccine 7/3/8 2nd vaccine 2/24/9.
Information has been received from an 81 year old female with a sulfonamide allergy and no pertinent medical history who on 30-Jul-2007 was vaccinated with a dose of Zostavax.  Concomitant therapy included "HBP" and ascorbic acid (+) beta carotene (+) cupric oxide (+) vitamin E acetate (+) zinc oxide (Ocuvite Preservision).  About one week after vaccination, in "early August 2007" the patient developed coughing and flu symptoms.  Unspecified medical attention was sought.  No lab studies were performed.  Follow-up information received from the patient indicated that she experienced an upper respiratory infection after vaccination.  At the time of this report the patient was recovering.  No further information was provided.  There was no product quality complaint involved.  Additional information is not expected.
This is a spontaneous report from a contactable registered nurse via Pfizer sales representative. The nurse reported similar events for 2 patients. This is the first of two reports. A patient of unspecified age (16-17 unit not provided), ethnicity and gender received a single dose of TRUMENBA and MENVEO, both via an unspecified route of administration on an unspecified date. Relevant medical history and concomitant medications were not reported. The patient experienced dizziness on an unspecified date and he/she was put in observation for 2 or 3 minutes and the situation was resolved. The patient recovered from the event. Follow-up (19AUG2016): Follow-up attempts are completed. No further information is expected.
Initial unsolicited report received from a non-healthcare professional on 20-Jan-2016. This case involves a 40-year-old male patient, who was vaccinated with Fluzone (batch number: unknown, dose, dose in series, route and site of administration were not reported) on an unspecified date. Medical history and concomitant medications were not reported. On 16-Jan-2016 at 5:00 P.M, unspecified time after vaccination, patient found positive for influenza A virus test. It was reported that the patient required emergency room/doctor visit. Laboratory investigations and corrective treatments were not reported. At the time of this report patient was not recovered from the event. Documents held by sender: none. Follow up information received from the non-healthcare professional on 19 February 2016. The patient received a dose of FLUZONE (batch number U5321FA, expiration date 30 Jun 2016) on 22 October 2016. It was reported that the patient did not receive any previous vaccine. The patient did not have any known drug allergy and patient had tonsillectomy in 2001. Upon internal review this case considered as serious due to important medical events: Influenza A virus infection and vaccination failure. On 16 January 2016, two month after vaccination, the patient found positive for influenza A virus and it was a vaccination failure case. Sender's Comments: As with any vaccine, vaccination with INFLUENZA QUADRIVAL A-B VACCINE may not protect 100% of susceptible individuals. In the current case, the patient was tested positive for influenza group A 86 days post vaccination. Additional information regarding infectious work-up results, patient's immune status at the time of vaccination (medical history, concomitant medication), exact chronology with symptoms as well as confirmatory investigation results (details of test method used to confirm specific influenza A strain, e.g. PCR) are needed for complete assessment. Based on the available information, a possible vaccination failure cannot be ruled out.
Experienced Mild flu symptoms on 11./11/19 AM. Mild fever that night with rhonorrhea and back ache. Fainted Tuesday AM (11/12/19), tachycardia, went to ER and tested positive for Flu
Fever, Passing Out, Loss of Apatite,  elevated calcium levels, shakes, nausea, tired, chills, memory loss. Near death.  Has been in the hospital for 7 days.  Was released yesterday without notice to the family to a rehabilitation facility. Doctors have not released the results of test or diagnosis and resolution or time frame for recovery. Very little communication to my mom and zero communication to the family members who were visiting the hospital daily. I was present when nurse was giving a shot in the stomach as a blood thinner.  Only other relevant communication was told to my mom that 4 other patients at the hospital had similar effects from the vaccine and were in the hospital.  It is important to point out that after getting the first dose of the vaccine and falling deathly ill,   Doctor told him to NOT get the second dose or he could die
Day after shot: aches, very tired, low grade fever (not verified) weak, hot then cold ended 8-23-21. Area of injection is swollen light red and warm still on 8-24-21.
Information has been received from a health professional concerning a female who was vaccinated with a dose of Gardasil. Subsequently the patient experienced rash at injection site and itching at injection site. The patient's rash at injection site and itching at injection site persisted. The patient sought unspecified medical attention. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 6/14/2007. Initial and follow up information has been received from a health professional concerning an approximately 23 year old female with a sulfa allergy and no other medical history who was vaccinated with a dose of GARDASIL (lot # 655324/0089U). Concomitant therapy included unspecified birth control pills and acidophilus. Subsequently the patient experienced rash at injection site and itching at injection site. The patient's rash at injection site and itching at injection site subsided with no treatment required. The patient told the nurse she will not complete the series at the office. No additional information was available. Additional information is not expected.
On 01-27-2020, I had right arm pain with headaches. I felt my mind foggy. I developed right axillary pain with tenderness. On  12-28-2020 my symptoms got bit better. On 12-29-2020 my right arm pain resolved. On 01-31-2021, I had a bad migraine and I could not go to work. i had nausea and had left eye pain to the back of my eye. On 1-29-21, 01-30,21 and 01-31 I took Emerge medication for my migraines.
positive covid test Narrative: ED visit for respiratory issues, found to be covid positive but not likely due to covid sx- other likely explanations.
Patient experienced major swelling, bruising and pain described as a 5 on a 1-10 scale.
Hives and swollen lips appeared three days after I took the second dose of the vaccine. But as I mentioned earlier, I have been experiencing these allergic reactions ever since I took the first dose of Shingrix in June 2021. It is only now with the allergic reaction to the second dose that I believe I am reacting long term to the Shingrix vaccine. I have been taking antihistamine pills throughout but am not sure if the dose is correct as the allergic reaction occurred after the second dose despite my being on Allegra 180 mg per day.
headache, swelling to hands, , epigastric pain, bilateral shoulder pain, go the second dose of the COV shot 4 days ago  49 Years old Female with headache for the past month. She states that she has had generalized body aches and epigastric pain since she got her second Moderna vaccine 4 days ago. She complains of fatigue. She was given a prescription for her migraine but states that it only helps a little bit. The patient rates her symptoms as moderate. She denies that this is the worst headache of her life or that it was maximal onset.
2 pts completed series of 3 Engerix-B vax (0,1.6 mo schedule)& TEST IN JAN90 & did not seroconvert.
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 17-DEC-2018, the patient was vaccinated with LIQUID PEDVAXHIB (lot # N003698 with expiry date 31-OCT-2019, dose, strength, route, vaccination site unspecified) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion of 47 degrees Fahrenheit (53.37 F) for 3 hours and 46 minutes, as recorded by a data logger. There was no previous temperature excursion. There was no adverse effect reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Sender's Comments: 1903USA010362:Original Case : 1903USA004795; 1903USA010363:Original Case : 1903USA004795; 1903USA004795:Original Case : 1903USA004795; 1903USA010361:Original Case : 1903USA004795; 1903USA010360:Original Case : 1903USA004795; 1903USA010365:Original Case : 1903USA004795; 1903USA010358:Original Case : 1903USA004795; 1903USA010359:Original Case : 1903USA004795.
3/21/2021   Mr. Silverman was observed post Covid-19 immunization for 15 minutes .  During the observation period, he experienced an adverse reaction with the following symptoms:  Tingling around moutn.   Assessment : Time of assessment 1748 Alert and oriented. No rash , swelling around mouth, or redness.   Actions taken:      There were no vitals filed for this visit.patient refused, voiced that he had an EPI pen.   Medications administered: No medication administered.   Disposition:The Patient was provided with Vaccine Information Sheet and instruction to access the V-Safe system.      Immunizations Administered    Name Date Dose VIS Date Route   Pfizer COVID-19 Vaccine 3/21/2021  5:28 PM 0.3 mL 12/11/2020 Intramuscular   Manufacturer: Pfizer, Inc   Lot: ER2613
The shot was administered very high on left arm. Have had low grade pain since. Have contacted my primary care physician twice via his email portal. No treatment prescribed.
This case was reported by a consumer and described the occurrence of allergic reaction in an elderly subject of unspecified gender who was vaccinated with Flulaval for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Flulaval (unknown). At an unknown time after vaccination with Flulaval, the subject experienced allergic reaction. At the time of reporting the outcome of the event was unspecified.
Within two days after receiving vaccine patient developed a rash which was rough & scaly in appearance. Patient said it was itchy & burning. It was located on her arm, face, & back, but not around the injection site. The doctor diagnosed it as shingles & treated it as such with antivirals & pain medicine. On follow up with patient rash is not on entire face, both legs, & across chest. Patient going back to doctor.
Arm pain at injection site, Severe Nausea with vomiting and diaherrea, mild shortness of breath, extreme fatigue
The patient had flu injection, returned to her work area and within 10 minutes reported that she felt "dizzy and clammy" Checked B/P results 150/98. Patient appeared flushed on her face and neck, pupils dilated. After about 10 minutes she stated she felt better B/P now 138/84. Walked with patient back to flu clinic area where she again became flushed and pupils dilated, felt "dizzy and faint". BP now 160/110, pulse - 100 with regular rhythm. Her symptoms continued and B/P now 180/110. Placed 911 call to paramedics. On their arrival the patient was feeling better but when paramedic performed a finger stick to check her blood glucose she again became symptomatic. They advised client that she needed to see her MD or go to the ER today. She refused to go by ambulance. They left the scene. Her B/P was 140/80. Her husband was called to get her and transport her to the ER. On 10/27/2014 the client returned to work. She stated she went to the ER, was given 'something for dizziness and nausea and observed. They discharged her home the same day. Stated she had not exhibited any further symptoms.
On 1JAN92 stomach flu w/t102 x 24 hrs vomiting x 8-9 hrs; pt very weak for couple of days;
ARM PAIN AND SORENESS; This spontaneous report received from a patient concerned a 69 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 06-MAR-2021 on left arm for prophylactic vaccination. The batch number was not reported and has been requested No concomitant medications were reported. On FEB-2021, Laboratory data included: Antibody test (NR: not provided) No Igm or Igg detected. On 06-MAR-2021, the subject experienced arm pain and soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm pain and soreness. This report was non-serious.
I received my second Moderna booster on 4/7/22. On the afternoon of 6/11/2022, I developed a mild to moderate headache, sore throat with hoarseness, and body aches. I went to bed early that day, because I felt ill. On the morning of 6/12/2022, I took a home test for COVID-19, and the result was positive. I went to an urgent care clinic that morning and was tested for both the flu and COVID-19. I tested negative for the flu and positive for COVID-19. I was prescribed a 5-day course of Paxlovid. I started the regimen immediately that day and continued taking it for the prescribed 5 days. While I was on Paxlovid, I was advised that I should probably discontinue my amlodipine and my statins in order to prevent possible negative drug interactions. The sore throat didn't resolve until about 5 or 6 days after the onset. The headache I developed at the onset lasted for about 6 days; since it was mild to moderate, I didn't feel the need to take medicine specifically for it. The body aches also lasted for about 6 days. On 6/16/2022, I tested myself again, and I still got a positive result indicated by a faint line. By 6/17/2022, I felt markedly better; by this time, the aforementioned symptoms were gone. On 6/18/2022, 6/19/2022, and 6/21/2022, I tested myself again and got a negative result. I felt well for several days afterwards. However, sometime during the last week of June, I developed a severe headache, sore throat,  body aches, a dry cough, what felt like congestion, but no fever. I did another home test, and I got a positive result! I then went to the urgent care clinic and underwent another test, which yielded a positive result. On the upside, though, I was told that my lungs were clear. A second round of Paxlovid was not recommended. My rebound lasted for about 5 days. During this time, I took Extra Strength Tylenol for the headache and body aches, so I could sleep at night. Thankfully, it was very effective.  On 7/2/2022, I retested myself at home, and the result was positive. When I retested on 7/3/2022, 7/4/2022, and 7/7/2022, the result was negative. By this point, I finally considered myself fully recovered and felt much better.
Left side neck pain, from jawline to collarbone, with some swelling where most pain located, on lower left area of neck, from side to left front (muscle or lymph node behind muscle) Treated with cold compress, prescription Ibuprofen and Baclofen. after seen by Urgent Care doctor today.
This spontaneous case reported by a consumer, describes the occurrence of tinnitus in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot#  unknown) for COVID-19  immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jul 13, 2021, patient experienced tinnitus. At the time of the report, tinnitus outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information reported.
No additional AEs or PQC reported; expired dose of MMR II was administered; This spontaneous report as received from a physician refers to a patient of unknown age and gender. There was no information about the patient's medical history, concurrent conditions or concomitant medication.  On 24-AUG-2021,  the patient was vaccinated with an expired dose of   measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II),  subcutaneously, dose: 0.5 milliliter,  lot # S025158, expiration date : 13-AUG-2021;  for prophylaxis. No other information provided. No additional AEs or PQC reported.
1st day 1.23.2021 slight soreness then gone. Day 8 1.31.2021 redness, swollen (150mm long) x 150mm wide)itchy,
No known adverse effects; A 35 year old patient received a dose ofGARDASIL 9 on 09/27/2019 and on 03/17/2020; A 35 year old patient received a dose ofGARDASIL 9 on 09/27/2019 and on 03/17/2020; This spontaneous report as received from a pharmacist concerning a 35-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies, concurrent conditions, and concomitant medications were not reported.  On 27-SEP-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (strength, dose, vaccination schedule, and anatomical location was not provided) with lot # 1602284 which was confirmed to be valid for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) and with expiration date reported and upon internal review established as 26-SEP-2021 for prophylaxis (product administered to patient of inappropriate age).  On 17-MAR-2020, the patient was vaccinated with a second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (strength, dose, vaccination schedule, and anatomical location was not provided) with lot # 1602284 which was confirmed to be valid for for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) and with expiration date reported and upon internal review established as 26-SEP-2021 (same lot # and expiration date for both doses) for prophylaxis (inappropriate schedule of product administration). No known adverse effects were reported. No further information provided. 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: 1602284; expirationdate: 26-SEP-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Mild, Systemic: Nausea-Mild, Systemic: Tachycardia-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium
Rash and hives on both arms, but mostly on the injection arm. Hands and feet have a burning sensation and are itchy. Tongue is also swollen and has a loss of taste.
Sneezing; Runny nose; Soreness in arm; Headache; Tingling in sinuses; This is a spontaneous case reported by other non-health professional on 18-Dec-2018, concerning a female patient of an unspecified age.  On 10-Dec-2018, the patient was administered Fluad (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 250800 and expiry date: 31-May-2019) for influenza prophylaxis.  On an unspecified date after vaccination, the patient experienced tingling in her sinuses and sudden sneezing, runny nose and headache. The patient also experienced a little soreness in her arm.  The outcome of the events was not reported.  The reporter assessed the case as non-serious.  This case was linked to case: 201806213 due to same reporter.; Reporter's Comments: A female patient of an unspecified age experienced tingling in sinuses, sneezing, headache, runny nose and pain in arm, on an unspecified date after the administration of Fluad (TIV). The causality of the events was unassessable due to lack of information regarding onset latency. The case will be further assessed upon receipt of follow up information.