chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tired; Soreness in her inner arm; Sleepy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Feb2021 (Lot number: EL8982, Expiration Date: 31May2021) at the age of 72 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Sjogren's syndrome" (unspecified if ongoing); "Nodules on lung" (unspecified if ongoing), notes: She has had these nodules for about 3 years and they haven't grown any.; "compromised immune system" (unspecified if ongoing), notes: She clarifies she does have a compromised immune system. Concomitant medication(s) included: REPATHA taken for blood cholesterol increased, start date: 03Oct2021 (ongoing). Vaccination history included: Bnt162b2 (Dose:1, Lot: EK9231, Expiration Date: 30Apr2021, Anatomical location: Right arm), administration date: 12Jan2021, when the patient was 72 years old, for COVID-19 Immunization, reaction(s): "Arm was sore", "Slight fever". The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "recovered" (2021), described as "Tired"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "Soreness in her inner arm"; SOMNOLENCE (non-serious) with onset 2021, outcome "recovered" (2021), described as "Sleepy".  Additional information: NDC number of COVID-19 Vaccine was unknown. It was reported that patient was calling about the booster she had. Patient was clarified that she had the two vaccines before. She explains she had side effects from all three vaccines, but usually the side effects are gone in three days. No side effects were reported and at one time she was having problems with nausea, she doesn't remember what she had going on, but her gastroenterologist gave her some medication that she takes off and on as needed. She hadn't had to take any in about 6 months when she just had a little nausea before. No additional vaccines administered on same date of the Pfizer Suspect. Patient did not visit emergency room and physician office. No prior vaccinations and no other vaccinations were reported within 4 weeks.   No follow-up attempts are possible. No further information is expected.
After the second dose of the vaccine, I broke out in a rash/hives on the checks of my face. The rash was not overly itchy but I did find myself itching more often than I normally do.
Moderna Lot Number 045J21A was inadvertently used one day beyond the expiration date of May 2, 2022.  Per guidance, Moderna was contacted on May 3, 2022 about the vaccine storage error.  Moderna conducted research on the same lot number and simulated the same conditions noted.  Moderna found that the vaccine met the required activity to produce the needed immune response.  This is Moderna Case Number CEA-2351.  Although Moderna noted this vaccine was sufficient to produce the needed immune response, patient was encouraged to speak with their provider to determine the next steps appropriate for them.  Patient has experienced no know adverse events.
Right deltoid swollen. Patient states very, sore. No redness. Mom reports fever of 102.F, relieved with Tylenol. Full range of motion, but guarded.
a patient received the vaccine at 50 years old.; No additional AE reported; This spontaneous report was received from a pharmacist regarding a 50-year-old patient. Information regarding medical history, concurrent conditions and concomitant medications was not provided.   The pharmacist asked if there were any benefits to administering HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) to a 50-year-old patient as they had an incident a few months back (specific date not provided) when the 50-year-old patient received the vaccine (as prophylaxis, no more vaccination details were provided) (product administered to patient of inappropriate age). No additional adverse event (AE) was reported (no adverse event).
This spontaneous report was received from a pharmacist referring to approximately 58 year old female patient. No pertinent medical history and concurrent conditions reported. On 11-SEP-2013 the patient ws vaccinated with ZOSTAVAX. vial 19400 PFU, subcutaneous (dose not reported). No other concomitant therapies reported. On 11-SEP-2013, the patient experienced immediate reaction at the injection site following the administration of ZOSTAVAX. The reporter also stated that the patient developed round circle about the size of a 50 cent piece that was red, swollen and itchy. It was reported that this area decreased in size after about 15 minutes and the patient was recovered within a few days. No treatment was required for the adverse event. The patient sought medical attention. There was no intervention required to prevent serious criteria. There was no significant disability or incapacity. No hospitalization required.The event was not life threatening. The outcome of the events was reported as recovered/resolved. No PQC reported. Additional information has been requested.
Call received both doses of the Pfizer Covid-19 Vaccine.  She tested positive for COVID-19 around 01Aug2021.; Call received both doses of the Pfizer Covid-19 Vaccine.  She tested positive for COVID-19 around 01Aug2021.; This is a spontaneous report from a contactable consumer (patient). This female consumer reported for herself.  A female patient of unspecified age received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), unknown dose via an unspecified route of administration on unspecified date at DOSE NUMBER UKNOWN, SINGLE for COVID-19 immunization. She received both doses of COVID-19 Vaccine. No medical history reported. No concomitant medications reported. On 01Aug2021 patient experienced Covid -19. The patient want to know whether she can take booster dose.  Believes she is eligible to receive it in Oct2021. The patient underwent SARS-CoV-2 test on 01Aug2021 and found positive. The outcome of event was unknown.  Agency: Possible duplicate AE details E-transmitted.  Limited details obtained as caller came from Agency.  The lot number for [bnt162b2], was not provided and will be requested during follow up.
Tinnitus: A sudden onset of significantly distracting tinnitus occurred about a day after my J&J booster shot.  The amplitude of the tinnitus faded over the next couple of days following inoculation, but low-level tinnitus remains.
Indurated, erythematous area 4cm x 6cm over the post. aspect of the right upperarm which is warm and slightly tender. Varicella
Pt with vesicular lesions x 3 beginning 1/1/11 over 1/4/11.
Patient was given vaccines on 2/25/09, developed a red cluster of bumps on right leg where vaccine was given on 3/6/09, and by 3/8/09 a full body rash of red spots had developed. As of 3/13/09, the rash is still all over her body and face, and she's not feeling well. (No fever however) I've spoken with 3 different nurses and nobody knows how long it will take to go away. The clinic has the names of vaccines and where they were given, (right and left legs) lot numbers, etc. in her chart.
The next day after at the injection site it was very red, swollen, hard, hot and it itched like crazy.  I noticed a raised, red rash had developed all over my body and my PCP referred me to use ice for my arm and benedryl to help with the rash.  I was tired and achy all over also.  And the rash lasted about a week and the arm about 2 weeks.
DVT causing Muscle cramps; DVT causing Muscle cramps; fever; chest pain; This is a spontaneous report received from a contactable healthcare professional (patient). A 53-year-old male patient received the second dose of BNT162B2 (lot number: EL9261), intramuscularly in left arm on 03Feb2021 13:00 at single dose for COVID-19 immunisation. Medical history included gout. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number: EL0142), intramuscularly in left arm on 06Jan2021 13:00 for COVID-19 immunisation. The patient experienced deep vein thrombosis (DVT) causing muscle cramps, chest pain, fever, etc 2-3 weeks after the second dose on 24Feb2021 12:00. Patient did not receive any treatment for the adverse events. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was not resolved.; Sender's Comments: Considering a positive temporal association, a causal relationship between the event deep vein thrombosis 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
ON AND OFF JOINT PAIN; MOSTLY ON HER ANKLES, KNEES, HIPS, ELBOWS; ABOUT A WEEK LATER RASH OVER ENTIRE BODY, USUALLY ITCHY BUT NO TROUBLE BREATHING.
Pt had injection site reaction, local macular lesions 8-10 on both legs.
Felt moments of dizziness and sore arm for two days following the first dose that turned into a mild constant ongoing pressure type of pain that has lasted for over five weeks that started at the heart (with moments of pressure at the upper left and bottom right abdomen, upper throat at each side of neck a pressure tightness/ as well as at the left side of my heart/ chest area.  My symptoms are slowly getting better but have been feeling overall week with no issues detected/ found/ diagnosed/ determined.  Currently being evaluated by Medical Doctors, Cardiologist, and will see an Allergy/ Immunologist.
Swollen lymph nodes at neck and collar bone on side vaccine administered. Rash on arm and collarbone/chest  where vaccine administered. Extreme fatigue.
Case number PHEH2014US002267 is an initial spontaneous report received from a pharmacist on 29 Jan 2014. This report refers to a female patient of unknown age. She was vaccinated with FLUVIRIN (batch number: 1309301 and expiry date: Apr 2014) intramuscularly at a dose of 0.5 ml on 19 Jan 2014. Pharmacist reported that FLUVIRIN was stored improperly. Opened and unopened multidose vials of FLUVIRIN had reached 20 degree Fahrenheit for 12 to 18 hours. Pharmacist did not know if the vaccine had frozen during the excursion. No adverse event was reported following this administration error.
Body rash that started under both arms below the elbow  and spread to both legs.; rash spread to genital area; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6208) via unknown route of administration in the left arm on 10Mar2021(at the age of 38-years-old) at 12:30 pm as a single dose for Covid-19 immunisation. Medical history was not reported. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not tested for COVID-19 since having the vaccine. After 3 days from vaccination, on 13Mar2021 patient started to experienced rash under both arms, then it gradually spreads to both arms below the elbow, stomach, genital area. It also sprayed to both legs, back, and up the back of the neck. Therapeutic measures taken were none for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the rash on body was reported as not recovered.   No follow-up attempts are needed. No further information is expected.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site lump in a 74-year-old female patient who received SHINGRIX (batch number 32GR4, expiry date 4th June 2020) for prophylaxis. On 17th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In July 2018, less than a week after receiving SHINGRIX, the patient experienced fever. On 18th July 2018, the patient experienced injection site lump, headache, injection site pain, chills, injection site warmth and injection site erythema. On an unknown date, the outcome of the injection site lump, injection site pain, injection site warmth and injection site erythema were not recovered/not resolved and the outcome of the headache, chills and fever were recovered/resolved. It was unknown if the reporter considered the injection site lump, headache, injection site pain, chills, injection site warmth, injection site erythema and fever to be related to SHINGRIX. Additional information reported as follows: In the evening, 1 day after vaccination the patient had a knot about 4 inches in diameter on her arm at the injection site, which was red, hot to touch and painful. The day of reporting, the fever and chills had resolved, but the knot was still present and was still red, hot to touch and painful.
I received the flumist vaccine on Friday 10/23/2020 and on Saturday 10/31/2020 I woke that morning with general malaise. I then experienced a major loss of appetite all day and began running a 100.4-101.5 fever with chills and body aches by the afternoon around lunchtime. I began vomiting around 9pm that evening. I woke up the next morning on Sunday 11/1/2020 with a 99.5 temperature and progressively improved through the day. Appetite has not fully returned and am experiencing fatigue.
PT states she experienced extreme depression that was immediate after receiving 1st booster shot. No prior history of depression. Lasted 2 months. Also had some symptom after being infected with Covid prior to the booster.
No sings or symptoms reported; Temperature excursion; This spontaneous report was received from an administrator referring to a patient of unknown age and gender. The patient's medical history, concomitant medications, drug allergies, or reactions were not reported.   On 09-APR-2021 and 23-APR-2021, a Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) (lot # T035379 has been verified to be a valid lot number for Pneumococcal Vaccine, Polyvalent (23-valent), expiration date 31-MAY-2022) was exposed to a temperature of 49.0  48.7 Fahrenheit degrees respectively  for a time frame of 1 hours and 15 minutes cumulative.  On an unspecified day between 09-APR-2021 and 12-MAY-2021, the  patient was vaccinated with 1 single dose of  the previous mention Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (strength and administration route were not provided) (product storage error). No digital data logger was involved, non previous excursions were reports and no sing or symptoms were reported (no adverse event).  This case is linked with several same reporter cases. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T035379; expirationdate: 31-MAY-2022; deviceage and unit: 0 ; operatorofdevice: Unknown; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2105USA002935: US-009507513-2105USA002943: US-009507513-2105USA002937: US-009507513-2105USA002938: US-009507513-2105USA002939: US-009507513-2105USA002940: US-009507513-2105USA002941: US-009507513-2105USA002942: US-009507513-2105USA002934: US-009507513-2105USA002933: US-009507513-2105USA002936: US-009507513-2105USA002932:
Day after shot: Redness and bumps around injections site (went away after a few days). Pain on arm (went away after a few days). Persistent strong headache (still present). UTI symptoms (pending lab work).
Patient was given AFLURIA vaccine on 1/18/13 at 11:45 am. Patient's father called back several hours to let us know he has been experiencing headaches.
Right thigh redness covering thigh area. No fever, no other symptoms. Believed to be local reaction to Hep A since no previous reaction to Prevnar.
One week after receiving the shot, I noticed a large rash on my upper arm around the injection site. It was a little warm to the touch and somewhat itchy. Even today, roughly 18 days after the injection and 12 days after it appeared, the site is still itchy. If I don't keep an ointment on it daily, the rash seems to reappear.
This spontaneous report was received from an external source (reported as an executive) via a company representative, and refers to a 54 year old female patient. No information regarding patient's medical history, concurrent conditions and drug reactions/allergies was not reported. On 02-JUN-2016, the patient was vaccinated with a dose of ZOSTAVAX subcutaneously, 19400 PFU, lot # reported as L046893 (expiration date was not reported). No concomitant medications were reported. It was reported that, on an unspecified date in June 2016 (reported as within 24 hours of vaccination), the patient went to an unspecified hospital emergency room for a possible localized cellulitis, where she was "treated with steroids and amoxicillin". However, no intervention to prevent serious criteria was performed. No product quality complaint was involved. At the time of reporting, the outcome of cellulitis was unknown. Additionally, the relatedness between the event and the ZOSTAVAX was not provided by the reporter. Upon internal review, cellulitis was determined to be medically significant event. Additional information has been requested.
Patient developed nosebleed requiring emergency room visit on 4/26/2021, 6 days after vaccination. The nosebleed did not stop until  60 minutes later and after 20 minutes of having clamp on the nose.
Patient received Pfizer vaccine at a local clinic and about 5 hours later developed a facial rash and hives; was given a dose of Benadryl at bedtime and symptoms had resolved when she woke up.
This spontaneous report was received from a nurse practitioner refers to a 16-year-old female patient. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant therapy were unknown. On 09-OCT-2017, the patient was vaccinated with doses of improperly stored GARDASIL 9 (dose, units and frequency were unknown) (lot # N007931 and expiration date 17-NOV-2019). The temperature excursion was at 9 C to 25 C (10 C) [C (degree centigrade)] for 1 hour. No adverse effects were reported. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was reported.
I am now winded easily and get fatigued randomly out of no where. Doctors check my lungs and they are fine, but I have now a pulmonary hypertension of the right side of my heart now with a swollen lymph node there. Not sure if the shot had anything to do with it but I figured I will report it. This could be something I had prior to having the vaccine.
Patient was to receive Hep B vaccine (2nd dose) but received Hep A vaccine, Nurse pulled wrong vaccine by mistake.
This case was reported by a physician and described the occurrence of injection site pain in an unknown number of subjects of unspecified age and gender who were vaccinated with ENGERIX B (GlaxoSmithKline). Historic vaccination included hepatitis B vaccine recombinant; GlaxoSmithKline; unknown; unknown given on an unspecified date. On an unspecified date the subject received 4th dose of ENGERIX B (1 cc, unknown details) and experienced off label use. The physician stated that he had "been vaccinating patients with ENGERIX on a 0, 7, 21 to 30 days, 1 year schedule. He estimated 5 to 10 patients per year for 5 to 10 years." This dosing schedule is not an indicated dosing schedule for ENGERIX B. At an unspecified time after vaccination with ENGERIX B, the subject(s) experienced injection site pain, injection site inflammation. Per the physician, he had "not heard of adverse reactions, other than pain or inflammation in some patients." The physician did not have specific subject information. At the time of reporting the outcome of the events were unspecified.
Flu like symptoms; Bacterial infection; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) and BACTERIAL INFECTION (Bacterial infection) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    There was no reported medical history.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In September 2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) UNK, Citrate free. In 2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) and BACTERIAL INFECTION (Bacterial infection). The patient was treated with AZITHROMYCIN (ZITHROMAX Z-PACK) at an unspecified dose and frequency. In 2021, INFLUENZA LIKE ILLNESS (Flu like symptoms) and BACTERIAL INFECTION (Bacterial infection) had resolved.      Formulation for HUMIRA was given as Solution for injection in pre-filled pen.  The reporter's causality for the events of Influenza like illness and bacterial infection with HUMIRA(ADALIMUMAB) was no reasonable possibility.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  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.
tongue tingled a for a few mins; 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 PARAESTHESIA ORAL (tongue tingled a for a few mins) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced PARAESTHESIA ORAL (tongue tingled a for a few mins). In 2021, PARAESTHESIA ORAL (tongue tingled a for a few mins) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided by the reporter.  No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 29-Aug-2021: Follow up document was received it included no new information