chrisvoncsefalvay/vaers-outcomes huggingface dataset:
has pain in the arm of the injection; lower back pain; little nausea; ¨stomach fell like odd, kind of full with no appetite; The headache was worse; lost of appetite; headache; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (lost of appetite), HEADACHE (headache), HEADACHE (The headache was worse), VACCINATION SITE PAIN (has pain in the arm of the injection) and BACK PAIN (lower back pain) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure and Inflammation.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced DECREASED APPETITE (lost of appetite) and HEADACHE (headache). On 18-Mar-2021, the patient experienced HEADACHE (The headache was worse). On 19-Mar-2021, the patient experienced VACCINATION SITE PAIN (has pain in the arm of the injection), BACK PAIN (lower back pain), NAUSEA (little nausea) and ABDOMINAL DISCOMFORT (¨stomach fell like odd, kind of full with no appetite). At the time of the report, DECREASED APPETITE (lost of appetite), HEADACHE (headache), HEADACHE (The headache was worse), VACCINATION SITE PAIN (has pain in the arm of the injection), BACK PAIN (lower back pain), NAUSEA (little nausea) and ABDOMINAL DISCOMFORT (¨stomach fell like odd, kind of full with no appetite) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided Concomitant medication includes blood pressure and anti-inflammatory medicines   This case was linked to US-MODERNATX, INC.-MOD-2021-052694 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-052694:Crosslinked case
Headache, Arthralgia, Fever, chills. Narrative:  Other Relevant History:
Narrative:  94 yo patient s/p covid vaccine on 6/16/22 felt weak got up off his recliner and walked to the bathroom and fell on the floor patient crawled over to phone and called neighbor to pick him up and put him inrecliner. he rested in recliner all day and then next day felt fine no injuriesno hitting head
Painful breasts; Large painful swelling in underarm of the injected arm; Large painful swelling in underarm of the injected arm; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 23Jul2021 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On an unknown date in Jul2021, the patient experienced large painful swelling in underarm of the injected arm and painful breasts. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of events large painful swelling in underarm of the injected arm and painful breasts were not resolved at the time of this report.   The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
I had a local injection site reaction with swelling and redness for 2 weeks. I started having pain with physical limitations when pushing/pulling movements with arm. The pain is not in shoulder but deep in arm at injection site. If I use my arm to push or pull in up, down, forward, backward motions I have pain that restricts further action.
patient went to the pharmacy with a prescription to get the first dose / at 37 years of age; This case was reported by a pharmacist via call center representative and described the occurrence of intercepted product prescribing error in a 37-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced intercepted product prescribing error. On an unknown date, the outcome of the intercepted product prescribing error was unknown.  Additional details were provided as follows: The age at the vaccination was not applicable.  Not all patient's identifiers were provided.  The pharmacist reported that, the patient went to the pharmacy with a prescription to get the first dose of Shingrix at 37 years of age, which led to  intercepted product prescribing error. The health care professional informed that they might not administer the injection. The reporter did not consent to follow-up
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 16-SEP-2014 the patient was vaccinated with expired dose of PNEUMOVAX 23 (0.5 ml, intramuscular, lot# J002646, expiry date: 11-MAR-2014). Pertinent medical history and concomitant medications were unspecified by reporter. No adverse effects were reported. The outcome of the events was unknown. No further information was provided. Additional information has been requested.
not yet received their second dose/ missed his second dose because he missed his appointment; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (not yet received their second dose/ missed his second dose because he missed his appointment) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METFORMIN for Diabetes.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (not yet received their second dose/ missed his second dose because he missed his appointment). At the time of the report, PRODUCT DOSE OMISSION ISSUE (not yet received their second dose/ missed his second dose because he missed his appointment) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication also included blood pressure medication No treatment information was provided
No adverse reaction. Patient is an 11 year old boy, given FLULAVAL flu vaccine which is for 18 years and older.
Child is doing fine, no adverse reaction. Child got immunizations on. DTaP - 4-10-10. IPV - 4-10-10. DTaP - 4-16-10. IPV - 4-16-10.
pediatric patient was given 0.3 ml of adult vaccine in place of 0.2 ml of pediatric vaccine
UPON MY TECHNICIAN GIVING THE VACCINE, PATIENT FELT WEAK AND MY TECHNICIAN DESCRIBED HER AS HAVING A SEIZURE TYPE REACTION FOR A FEW SECONDS. THE PATIENT THEN FELT NAUSEOUS AND NEEDED TO LIE ON THE GROUND. UPON ARRIVAL OF THE PARAMEDICS, THEY EVALUATED PATIENT AND STATED THAT SHE WAS FINE AND DID NOT THINK THAT IT WAS A TRUE SEIZURE. PATIENT AND HER MOTHER LEFT THE PHARMACY AFTER FURTHER OBSERVATION WITH NO OTHER ISSUES THUS FAR.
Intense joint pain lasted over 2 months. Had to have a steroid prescribed to combat the pain and symptoms. Blood pressure went from normal to being high, I had to have medication prescribed. 3 months after the second dose, I still don't feel back to normal.
the patient went "unconscious/unresponsive for about 30 seconds."; the patient went "unconscious/unresponsive for about 30 seconds."; The patient's eyes were open but they were not able to speak; the patient had no recollection of the event; This spontaneous report has been received from a healthcare professional (who was a nurse or medical assistant), referring to an 11-year-old female patient. Her pertinent medical history included anxiety. The patient's concomitant medications, previous drug reactions or allergies, and historical conditions were not reported.   On 07-SEP-2021, the patient was vaccinated with one dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), one dose of diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP), and one dose of meningococcal vaccine a/c/y/w conj (crm197) (MENVEO) (doses, vaccine scheme, anatomical sites of vaccination, lot numbers and expiration dates were not provided), intramuscularly as prophylaxis.   On 07-SEP-2021, after the vaccination, the patient went unconscious (loss of consciousness) and unresponsive (unresponsive to stimuli) for about 30 seconds. Additionally, the reporter stated that the patient's eyes were open, but she was not able to speak (speech disorder) and when she regained consciousness, the patient had no recollection of the event (amnesia). The patient did not seek medical attention, and no treatment was given for the events. The patient recovered from loss of consciousness, unresponsive to stimuli, speech disorder and amnesia.   The reporter's causality assessment between the suspect vaccines and the events was not provided.   Upon internal review, the loss of consciousness and the unresponsive to stimuli were determined to be medically significant events.
This spontaneous report was received from a healthcare worker (office manager), refers to an unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with doses of GARDASIL 9, lot # L016428, expiry date 30-JUL-2017, (dose and frequency not reported), which were exposed to temperatures outside of the recommended range. No adverse effect has been reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. No additional information was provided.
Patient presented with Mother and sister. Mom and sibling needed a Flu and COVID vaccination, while patient requested a COVID vaccine. After reviewing documentation, the nurse actually gave the patient a flu vaccine and not the requested COVID vaccine. Patient had already received the flu vaccine on 9/20/2023.
This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever - Temperature of 100.0F) and PAIN IN EXTREMITY (Arm Pain) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced PYREXIA (Fever - Temperature of 100.0F) and PAIN IN EXTREMITY (Arm Pain). At the time of the report, PYREXIA (Fever - Temperature of 100.0F) and PAIN IN EXTREMITY (Arm Pain) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
sleepiness; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SOMNOLENCE (non-serious), outcome "recovered", described as "sleepiness".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101333902 same reporter/drug/AE, different patient;US-PFIZER INC-202101333935 same reporter/drug/AE, different patient
01/202006 I spoke to mom on phone 2D of intermittent fever, cranky and staring episodes. Urination during staring episode. Sent patient to ER to R/O seizure and pt appeared healthy. No further ? seizure activity. Mom declined neuro consult.
Initial case received from a health care professional on 10 December 2009. An 11-year-old male patient developed chickenpox and died after receiving ADACEL (lot not reported) and VARIVAX (Merck, lot number 0630X410). The patient, who was HIV positive, received VARIVAX on 20 August 2008 and developed chickenpox (start date reported as August 2008). On 16 September 2008 he received ADACEL, and developed chickenpox again. He was seen in his physician's office on 28 November 2008 and was admitted to the hospital at that time. He later died (date of death not reported). No additional information was reported. Documents held by sender: None.
Patient received expired ActHIB vaccine with no adverse event; Initial information regarding an unsolicited valid non-serious was received from a Physician (Reference number- 00527706) and transmitted to Sanofi on 19-Mar-2021.  This case involves a 16 months old female patient who received a fourth 0.5 mL expired dose HIB (PRP/T) VACCINE [ACT-HIB] (lot UJ182AA and expiration date: 08-Mar-2021) via intramuscular route in the right thigh (right leg) (expired product administered) for prophylactic vaccination on 19-Mar-2021.  Medical history, past medical treatments, past vaccinations and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE) and INFLUENZA VACCINE (INFLUENZA VACCINE) for Immunisation.  It was actual medication error due to expired vaccine used (on same day).  It was reported that after administration it was later discovered that the vaccine was expired by 11 days. The reporter would like to know if the patient must be revaccinated.  At the time of report, the patients experienced no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
I didn't know that I had COVID. I had a family member to call and told me that they had COVID-19 and I was exposed. I tested and was positive for COVID-19. I took a test 2 days later and was positive and also went to a drive thru and had a PCR COVID-19 test that was positive. I tested positive for 2 weeks. Then I called my doctor. I had mild symptoms of an occasional cough, sore throat for 1 day, and a headache that was mild.
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about patients' concomitant medications, pertinent medical histories, drug reactions and allergies provided. On an unknown dates, the patients were vaccinated with improperly stored VAQTA 50/1.0 U/ml (lot# J003719, expiration date 27-SEP-2015, doses, frequency, site and route of administration were not reported). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Redness of face and neck, states he thinks his throat is closing, shortness of breath.
headache ringing in ears and light sensitivity and one week later redness swelling and itching at injection site.
seizure like event; Dizzy; Her head, neck, back and legs stiffened up/her entire body stiffened; This is a spontaneous report from a contactable pharmacist. A 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 27May2021 (at 17-year-old) (Batch/Lot number was not reported) at 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On Thursday 27May2021, a few minutes after the shot she started having a very small episode of seizure that lasted for maybe 1 or 2 seconds then after that she felt a little dizzy after that and then she was fine. It's described as a very brief seizure like event. Her head, neck, back and legs stiffened up and if she would have been sitting on a stool she probably would have fallen out of her seat. She was sitting in a chair that had a back to it, though, so she did not fall out of the chair. She did not every lose consciousness and he stated that this was not a syncopal event. He reported that it happened very quickly and multiple people did not even notice that it happened. Her entire body stiffened, however, "she stayed with us throughout the entire event and it only lasted a couple of seconds before her body went back to normal position, The reporter offered to call an ambulance the day of the event but the mother of the patient declined. The mother was advised to have her daughter seen by a medical provider for follow up care given the event. The mother also told the pharmacist that the patient would not be receiving the second dose and the pharmacist encouraged her to have this conversation and make that decision with the pediatrician or medical provider. Caller stated that he personally gave about 100 doses of the Pfizer BioNTech COVID-19 vaccine on that day and this was the only serious reaction that he witness. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based from timing of occurrence, the event that occurred with the patient post vaccination which Is seizure like phenomenon cannot be totally ruled out to be not related suspected drug BNT162B2.   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
Headache the evening after , migraine overnight, soreness at the injection site, fatigue the next day, mild myalgia
This spontaneous report was received from licensed practical nurse concerning an unspecified number of patients of unknown ages. The patients' concurrent conditions and medical histories were not reported. On an unknown dates, the patients were vaccinated with an unspecified dose of improperly stored of GARDASIL (lot #s: K011325 and K007264, expiration dates: 08-APR-2017 and 02-MAR-2017, respectively), (doses, route and anatomical were not reported). Co-suspect therapies or concomitant medications were not provided. No adverse effects were reported. It was unknown if the patients sought medical attention. No product quality complaint was involved. Additional information has been requested.
830 pm felt all over very strange and started to get chills  930-10pm all over body chills and fever of 103 -ear thermometer  Terrible shaking, body aches all over and chills throughout the night and fever stayed at 103-103.4 until 10 am and couldn?t sleep.   then after 10 am Friday went down to 102 and fluctuating to 100 with medication (ibuprofen and Tylenol alternating) still having body aches and chills.  Had fever/chills/body aches until Saturday afternoon 6pm
115PM pt was returned to station mom stating pt c/o of SOB & that felt something in throat; pt in resp distress w/labored, shallow breathing; auscultated lungs & prominent wheezing present bilat; cough & unable to swallow saliva; BP 120/84;
No adverse effects; Improperly stored (-8.89 Celsius degree for 1 hour) PROQUAD was administered to the patient; Information has been received from a medical assistant referring to a patient of unknown age and gender. Information about medical history and concurrent conditions were not provided.   On 06-APR-2019, the patient was administered improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot number R020815, expiration date 16-JAN-2020; strength, dose and frequency were not reported) was subcutaneously for prophylaxis with properly stored sterile diluent (no lot information was provided). The administered dose experienced a temperature excursion of -8.89 degree Celsius for 1 hour which were detected by a data logger. No previous excursions were reported. No adverse effects was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA004258: US-009507513-1904USA005131: US-009507513-1904USA005130: US-009507513-1904USA005133: US-009507513-1904USA005129: US-009507513-1904USA005627: US-009507513-1904USA005628: US-009507513-1904USA005629: US-009507513-1904USA005630: US-009507513-1904USA005631:
3:30  Rash w/ 25mg of Benadryl.  Director of nurses observed rash; Observed til 4:30 - reviewed with director of nurses - was fine to go home
developed vertigo; inner ear infection; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (developed vertigo) and LABYRINTHITIS (inner ear infection) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced VERTIGO (developed vertigo) and LABYRINTHITIS (inner ear infection). The patient was treated with AMOXICILLIN at an unspecified dose and frequency. At the time of the report, VERTIGO (developed vertigo) and LABYRINTHITIS (inner ear infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided.
52 yo female vaccinated 1-8-21 with Pfizer. No reaction. Then had massage yesterday and then today developed chills and fever. 101.5 now. Also has rash on breast and stomach. Flushed. Headache, nausea and myalgias.
NOT APPLICABLE TO REPORT AS THERE WAS NO ADVERSE REACTION , PATIENT RECEIVED A BIT, EXPIRED LOT
Aching all over, mild fever. Stayed home all day long. Flu like symptoms. Pt never had flu. Felt awful.
lymphoedema  in both arms; This case was reported by a pharmacist via call center representative and described the occurrence of lymphedema in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced lymphedema. On an unknown date, the outcome of the lymphedema was unknown.   It was unknown if the reporter considered the lymphedema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter asked would the patient be able to receive Shingrix on the gluteus muscle, due to a lymphoedema in both arms not clarified if this was previous to dose one.  When asked heath care professional reported this would be 2nd dose of Shingrix, but not completely sure as reported.  The reporter consent to follow up.
02/15/2006 Mother called, child's right arm red and swollen, painful.  Good circulation in hand, feverish, didn't take temperature as didn't have thermometer.  Advised to give Tylenol or Advil as needed.  02/16/2006 mother states child went to school, arm still little swollen and reddish, but didn't complain about it hurting.