chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Havrix administered 06/02/2022, expiration date 05/26/2022; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 61-year-old male patient who received HAV (Havrix) (batch number J9587, expiry date 26th May 2022) for prophylaxis.   On 2nd June 2022, the patient received Havrix. On 2nd June 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 2-Jun-2022 Reporter's Comments: The dose of Havrix was administered to the patient on 2nd June 2022 with an expiration date of 26th May 2022. Adverse event report contained all reported information by HCP (health care professional). Health care professional gave consent for safety to follow up. Additional Supportive Information: The patient received Havrix, which was already expired on 26th June 2022, which led to expired vaccine used.
Raised rash-Rose pink, some merging noted-09/18/02, T 99.1 F rectal node/ Thermoscan, Throat-WNL, TM's not well visualized due to cerumen, but not tender. He is alert, interested in surroundings.
pt recvd vax; 4nov94 am devel stomach cramps; 5:30pm emesis cont through 6nov; unable to eat or drink during this period; afebrile; diarrhea for 24 hrs starting 5nov94; Lt arm at inject site red, warm, firm & itching;to  MD 7nov94;
Information has been received from a female patient who was vaccinated with first second and third doses of Recombivax HB (manufacturer unknown) in January 1996 (lot # "1744A2"), on 28-JUN-1996 (lot # "206A?K") and on 07-JUL-1997 (lot # "2118A") respectively.  On an unspecified date in 2001 the patient's serum hepatitis B surface antibody screen was negative.  The patient received a booster dose of Recombivax HB (lot # 650006/0448L) on 22-OCT-2001.  On 24-JAN-2002 the patient's serum hepatitis B surface antibody screen was >150.0 indicating immunity to Hepatitis B.  No further information was provided.  Additional information is not expected.  The patient had a similar experience after vaccination with MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3) (WAES # 0701USA03958).
4 hrs p/DTP/HIB developed paleness, lethargy & quivering of lower lip - lasted 1/2 hr; Still w/dec activity but will smile now;
I became sick with Covid-19 after interacting with unmasked customers at my food/drink service job. I had severe headache, extreme muscle fatigue, body aches, vomiting, stomach aches, and slept for about 16 hours for 4 days straight. My fatigue and body pain continued for the next week. After I had thought I'd recovered, I lost my sense of taste for almost 2 weeks more.
On the day after the vaccination shot, I began to have menstrual bleeding and it was two weeks early. I continued to bleed for about one full and my discharge was thick and almost black. My cramps were a lot more painful than usual and a lot of pain in my back. I started taking birth control pills to control the bleeding and keep cycles regulated. But to this day I still have breakthrough bleeding and my cycles are very heavy. Breakthrough COVID Infection after Booster in January 2022.
ADMINISTERED VACCINE THAT HAD BEEN PUNCTURED FOR 6 HOURS AND 25 MINUTES; VACCINE PUNCTURED FOR 6 HOURS AND 25 MINUTES; This spontaneous report received from a health care professional concerned a 31 year old female. 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: 207A21A, and expiry: 07-AUG-2021) dose was not reported, administered on 24-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-JUL-2021, the subject experienced administered vaccine that had been punctured for 6 hours and 25 minutes. On 24-JUL-2021, the subject experienced vaccine punctured for 6 hours and 25 minutes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administered vaccine that had been punctured for 6 hours and 25 minutes and vaccine punctured for 6 hours and 25 minutes was not reported. This report was non-serious. This case, from the same reporter is linked to 20210752694.
Speech difficulty for 1-2 minutes on 6/26/21 and again on 6/30/21 with left facial numbness prompting ED visit. Testing revealed acute lunar infarct in right temporal lobe and inferior left frontal lobe
This initial spontaneous report was received from a medical assistant referring to an unknown number of patients of unspecified ages and genders. There was no pertinent medical history or drug allergies/drug reactions. The reporter stated that on unspecified dates, the patients were inadvertently administered with improperly stored PROQUAD (Merck) (Lot# L009210, expiration date 17-SEP-2016, dose and route not provided). There was no concomitant medication described. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Arm was painful; Slept all day; chills; Tiredness; Tiredness; headaches; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was painful), SOMNOLENCE (Slept all day), CHILLS (chills), the first episode of FATIGUE (Tiredness) and the second episode of FATIGUE (Tiredness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm was painful), SOMNOLENCE (Slept all day), CHILLS (chills), the first episode of FATIGUE (Tiredness), the second episode of FATIGUE (Tiredness), HEADACHE (headaches) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 19-Mar-2021, PAIN IN EXTREMITY (Arm was painful), SOMNOLENCE (Slept all day), CHILLS (chills), the last episode of FATIGUE (Tiredness), HEADACHE (headaches) and PYREXIA (fever) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, Body temperature: 99.3 (Inconclusive) 99.3.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.
Hives one week after 2nd shot; This is a spontaneous report from a contactable consumer. A 73-year-old non-pregnant female patient received BNT162B2 (solution for injection) dose 2 via an unspecified route of administration, in left arm on 19Feb2021 at 11:30 as single dose for covid-19 immunization. Medical history included penicillin, Sulphur products. Historical vaccine included on 24Jan2021 BNT162B2 (product=COVID19; lot number: unknown; dose number 1; Anatomical location=Left arm). No prior vaccination of covid and no covid tested post vaccination. The patient's concomitant medications was not reported. On 26Feb2021 at 09:00, the patient experienced hives, one week after 2nd shot and there was no event treatment received for the event. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
sciatic nerve pain; This is a spontaneous report from a contactable consumer (patient).  An 83-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on an unspecified date (Batch/Lot Number: EL9261; Expiration Date: May2021) at single dose, second dose via an unspecified route of administration on an unspecified date (Batch/Lot Number: EL9267; Expiration Date: May2021) at single dose for COVID-19 immunization. There was no medical history reported. There were no concomitant medications. Patient is calling about the second vaccination he had for the virus and he developed sciatic nerve pain and he wanted to know if it was safe to take Ibuprofen with having gotten the vaccine or if that would hurt his protection from the virus. He confirmed it is the Pfizer COVID 19 vaccine. He also said with the sciatic nerve pain he actually got the first vaccination and then he was messing around putting in light bulbs and stuff and that is when he got the sciatic nerve pain from an unspecified date so it had been a couple weeks or so. He didn't think it was from the vaccination. He kept hearing it on TV about taking Tylenol and everything with the vaccine. No further information provided. He clarified he was retired from company and he is no longer an employee there. The outcome of the event was unknown.; Sender's Comments: Based on the implied time association, the possible contribution of suspect vaccine BNT162B2 to the event sciatic nerve pain cannot be totally excluded. The concurrent condition reported as  "he was messing around putting in light bulbs and stuff and that is when he got the sciatic nerve pain from an unspecified date " may be major cofounder.
Patient experienced redness, swelling, and itching at injection site immediately following administration. Benadryl oral solution was given. Patient waited 15 minutes without worsening symptoms.
Acute urticaria on chest, back, bilateral arms and legs. No neck/facial involvement.  No airway involvement.
Neck pain, chills, high fever, joint pain for 72hrs nausea, abd. cramping (48 hrs post vaccine) persistent symptoms lasting 5 days after COVID vaccine Cervical & submandibular lymph adenopathy
Rheumatoid arthritis; sore arm; painful; swollen; This case was reported by a other health professional via other manufacturer and described the occurrence of rheumatoid arthritis in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concomitant products included tofacitinib citrate (Xeljanz).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced rheumatoid arthritis (serious criteria GSK medically significant), pain in arm, pain and swelling. On an unknown date, the outcome of the rheumatoid arthritis, pain in arm, pain and swelling were unknown.   It was unknown if the reporter considered the rheumatoid arthritis, pain in arm, pain and swelling to be related to Shingles vaccine.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. The day after receiving the vaccine the patient experienced. arm sore, painful, swollen day after injection the symptoms were improved.
I thought I was having a delayed allergic reaction. At first, I just felt muscle soreness and no other abnormal reactions. However, over the next 12 hours, the rash slowly appeared. The itching was so bad that I couldn't sleep anymore. At first, the most obvious redness and swelling were only at the injection site, but soon became densely in the armpits, chest, back and buttocks. The other parts which are included on the palms, soles of the feet, anus and oral are slowly diffusion. Some rashes have even small blisters. The current trend is still in the process of getting worse. I have started taking Benadryl Allergy Tablets from today (10/11/2023), 1PC/day. Hope these adverse reactions will be more helpful to your research, but please also give me a solution.
expired dose was given to a patient; vial was moved from the freezer to the refrigerator on 13Aug2021; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose was given to a patient) and PRODUCT STORAGE ERROR (vial was moved from the freezer to the refrigerator on 13Aug2021) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose was given to a patient) and PRODUCT STORAGE ERROR (vial was moved from the freezer to the refrigerator on 13Aug2021). On 16-Aug-2021, EXPIRED PRODUCT ADMINISTERED (expired dose was given to a patient) and PRODUCT STORAGE ERROR (vial was moved from the freezer to the refrigerator on 13Aug2021) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information was not provided. Treatment information was not provided.     Most recent FOLLOW-UP information incorporated above includes: On 18-Aug-2021: Non significant Follow up
Irritable, temp 104 during the night p/inject, lasting about 8hrs;
super itchy almost to the touch in all her body; Headache; felt like she had fever; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (super itchy almost to the touch in all her body), HEADACHE (Headache) and PYREXIA (felt like she had fever) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     Concomitant products included ZINC SULFATE MONOHYDRATE (YES 2 ZINC) for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced PRURITUS (super itchy almost to the touch in all her body), HEADACHE (Headache) and PYREXIA (felt like she had fever). At the time of the report, PRURITUS (super itchy almost to the touch in all her body), HEADACHE (Headache) and PYREXIA (felt like she had fever) outcome was unknown.            No treatment information was provided.
The pain starts deep in my arm at the site of the injection, it radiates out in a cone shape about 4 inches in diameter. It's like a burning sensation. It wakes me up at night. I go to bed with the Aspercreme. I went to the doctor about 2 months ago for something else and I mentioned this pain to my doctor and she sent me to get an x-ray of the shoulder and it showed arthritis and suggested physical therapy because I had a hard time moving.
Flu like symptoms started evening of 10/10/2018 and included body aches, joint pain, rib pain, fatigue, shortness of breath, dry cough, headache. Denies fever at that time. Flu like symptoms resolved within about 5 days. Back pain started on 10/20/18 at approximately 2:00 a.m. and became more severe evening of 10/21/2018. 4 clustered lesions detected on back, below shoulder, at that time. 10/22/2018 was seen at Urgent Care and physician diagnosed with shingles. Patient prescribed 1 gram of Valacyclovir three times per day. Along with 500 mg of Naproxen two times aily. Flexoril 3 times per day. Patient unable to take Valacylovir as prescribed, she states she took 3 first 24 hours but found it made her experience occular migraine and felt unable to concentrate and fatigued.  After these events she took only one per day.  She was also unable to take Flexoril due to fatigue/sedation. Switched Naproxen to Ibuprofen because she continued to feel fatigued and attributed this to the medication. 10/29/18 Patient states she is having twinges of pain "under shoulder blade but it is not the noticeable". Lesions are dry.
Three days post vaccine/booster every joint & lymph node were painful and swollen. Around day four most of those symptoms resolved, but swelling and pain continues in both knees and both ankles. Pain is most intense after being stationary for short period of time and resuming movement.  I have tried sitting and sleeping with my knees/legs elevated as well as taking motrin with no effect. I have also tried icing my knees, but the pain resumes as soon as the cold wears off.
nitially on the neck; currently on her lower legs; joint pains; A spontaneous report was received from a healthcare professional concerning a 38-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events joint pains. initially on the neck then in other joints and currently on her lower legs.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 6 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On Feb 2021, the patient experienced the event(s) joint pains. initially on the neck then in other joints and currently on her lower legs  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), joint pains,initially on the neck then in other joints and currently on her lower legs was unknown.
Approx. 1 1/2 hours ago from shot (Hep-B) in left deltoid, cleaned with alcohol. Pt developed diffuse pruritic urticarial rash over trunk and extremities. No cough, shortness of breath or edema. Prescribed Benadryl by mouth every 6 hours. Will submit Hep-B antibodies in the future.
patient developed large volume, non-bloody diarrhea  that started the evening of her first rota virus vaccine and has persisted since.
She received menveo vaccine 1/19/23.  Within 1-2 days of vaccine she developed a large local reaction that then resolved.  Approximately 1 mo later and during a time of possible COVID infection she developed unilateral hand and foot numbness/tingling and inability to bear weight.  She had a hospital admission and was diagnosed with suspected peripheral neuropathy or complex regional pain syndrome.  She had persistent symptoms for approximately 2 months and then completely cleared 1 day and has not returned.
gave second dose 14 days after first dose. patient got first dose 8/23/21 and second dose 9/4/21
It hurt when I got the shot and I knew something was wrong but I identified it as a problem probably after 48 hours. There was a lot of pain at the time of injection then the whole shoulder muscle area got really short, I still have a lump at the injection shot, I went to the doctor and they x-rayed it and sent me to physical therapy and I am still going to physical therapy for the shoulder. The x-ray showed that I did not have a fracture or anything and there was nothing, so they decided it was bursitis from the shot.  They gave me some lidocaine and something to put on my arm but did not work.
Head congestion. Next day after shot noticed arm really red, raised, swollen, hot to touch-2 1/2 inches per needle site; covered almost all upper arm. Child was scratching at this arm- took him to ER July 26th- ER gave Benadryl- amoxicillin. Next day- looked same but softer; Head stuffy next day.
Respiratory syncytial virus infection; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY SYNCYTIAL VIRUS INFECTION (Respiratory syncytial virus infection) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    Concurrent medical conditions included Crohn's disease.   On 08-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2022, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Solution for injection in pre-filled pen, citrate free. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen, citrate free. On an unknown date, the patient experienced RESPIRATORY SYNCYTIAL VIRUS INFECTION (Respiratory syncytial virus infection) (seriousness criterion hospitalization). The patient was hospitalized from sometime in October 2021 to sometime in November 2021 due to RESPIRATORY SYNCYTIAL VIRUS INFECTION. At the time of the report, RESPIRATORY SYNCYTIAL VIRUS INFECTION (Respiratory syncytial virus infection) was resolving.            Company comment: This is a spontaneous case concerning an elderly female patient with Chron´s disease on treatment with Adalimumab, who experienced the serious unexpected event Respiratory virus syncytial infection, approximately 6 months after the second dose of  mRNA-1273. It was reported that patient was hospitalized from October 2021 until November 2021. Adalimumab was reported as a co-suspect product. The benefit-risk relationship of mRNA-1273 is not affected by this report.  The patient took JANSSEN COVID-19 VACCINE(COVID-19 VACCINE NRVV AD26 (JNJ 78436735)) on 17-DEC-2021.  No concomitant medications were reported. No treatment medications were reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The reporter's causality for the event with Humira was reported as no reasonable possibility. The reporter's causality for the event with Janssen COVID-19 vaccine was possible. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2022: Follow-up received included no new information.; Sender's Comments: Company comment: This is a spontaneous case concerning an elderly female patient with Chron´s disease on treatment with Adalimumab, who experienced the serious unexpected event Respiratory virus syncytial infection, approximately 6 months after the second dose of  mRNA-1273.  It was reported that patient was hospitalized from October 2021 until November 2021. Adalimumab was reported as a co-suspect product. The benefit-risk relationship of mRNA-1273 is not affected by this report.
headache, fever 101.9, head congestion, loss of taste & smell, tested for COVID-19 on 1/04/2021 and it was negative
patient given school-required Tdap vaccine prior to 10 years of age (age at time of administration was 9 years 10 months)
Pt recv vax on 3/3/99; approx 2 1/2 hr post vax pt exp fever (102.5); cough, congestion dx=virus; tx=Tylenol, cough &congestion OTC liquid med
Pt recvd 1 dose of Engerix-B 7JUL92 (evening) had back pain, pain in small joints of hands & feet (arthrlagias), low grade temp; fever & peripheral joint c/o largely resolved; symptomatic in back & neck;
Patient reports fever and vomiting 12-14 hours after injections. She also reports extreme swelling and fever around injections site that ER doctor diagnosed as cellulitis. Patient is being treated with antibiotics. She also stated reactions appears to be mostly located around PNEUMOVAX injection site.
Information has been received from an investigator regarding a 2 month old male who received a dose of Prevnar on 12/20/00. On 2/15/01, the child was found dead. The following day, a postmortem was performed and results revealed acute pulmonary edema and congestion and the cause of death was listed as Sudden Infant Death (SIDS), interval-undetermined. Both the medical examiner and the investigator agreed that this event was not related to Prevnar administration. This report of a serious, labeled event is being submitted in a 15-day time frame as requested.
Pt experienced tachycardia and tingling and numbness in legs after receiving vaccines. Started 1-2 hours after vaccines given. Pt reports feeling better the next day. Pt was told to seek medical attention, but decided to wait it out.