chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received Expired Dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose). On 03-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was provided. No treatment medication details was provided.
Myalgia FATIGUE,MUSCLE ACHES, JOINT PAIN Narrative:
Patient was administered a dose from an expired vial; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered a dose from an expired vial) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered a dose from an expired vial). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient was administered a dose from an expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were provided. No treatment information was provided. Expiration date was  11 Oct 2021.   This case was linked to MOD-2021-366918, MOD-2021-365543, MOD-2021-365600, MOD-2021-365692, MOD-2021-365742, MOD-2021-365891, MOD-2021-366043, MOD-2021-366226, MOD-2021-366595 (Patient Link).
hives; horrendous full body rashes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer Unknown), for Covid-19 Immunization. The following information was reported: URTICARIA (non-serious), outcome "unknown", described as "hives"; RASH (non-serious), outcome "unknown", described as "horrendous full body rashes".  Additional information: My wife and dozens of other people in the area are suffering horrendous full body rashes and hives following the Covid booster dose of your vaccine. Her dermatologist is advising her patients with this adverse reaction that they must suffer with debilitating rash for 6-8 weeks. Why is Pfizer not warning people about this major side effect from the booster dose? My wife Ts condition had been reported to VAERS and we are seeking legal help for action against Pfizer.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200133100 same reporter/drug/event, different patients
Two days after receiving the first dose of the Pfizer COVID vaccine, my 11 month old breastfed son began having a 102-degree fever.
Patient presented a form completed by himself with his 1st dose administration date 04/11/2021. 2nd dose was administered based off this information, today 05/05/2021. We were alerted when a clerk went to update his information in impactsiis.  Attempted to contact patient at 1203 on 05/05/2021. Left a message to call back. will continue to attempt to reach out to inform of too early administration
Patient received MMRII on 10/15/2018 and patient's titer showed low titer on unspecified date; Nurse reports the patient received another dose of MMRII on 8/6/2019 due to low titer; If yes, Treatment Provided: Received 2nd dose of MMRII; Information has been received from a pharmacist, concerning a 42 years-old male patient. The patient's medical history, concurrent conditions, previously drug reactions, allergies and concomitant medications were not provided.  On 15-OCT-2018, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneously injection for prophylaxis (reported as required by his job site) (strength, lot number and expiration date were unknown by the reporter).   On an unknown date, the patient's titer showed low titer (viral titre decreased). On 06-AUG-2019, the patient was vaccinated with another dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneously injection for prophylaxis (reported as required by his job site) (strength, lot number and expiration date were unknown by the reporter) due to low titer (product use in unapproved indication and extra dose administered). The outcome of the viral titre decreased was unknown  The causal relationship between the viral titre decreased and the therapy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not provided.
This spontaneous report as received from a physician refers to one or two patients of unknown age. No concurrent conditions or medical history were provided. On an unknown date, the patient (s) was (were) vaccinated with a dose of PNEUMOVAX 23 (dose, route of administration, indication, lot#, expiry date unspecified). No concomitant medications were reported. On an unknown date, the patient (s) experienced itching red oval at injection site. This progressed to involve entire back of left arm and fluid was spending to elbow point. Area was red and tender. The outcome of events was unknown. The relatedness between event and PNEUMOVAX 23 was not reported. This is one of several reports from the same source. Additional information is not expected. Permission for follow up was not obtained as the physician abruptly disconnected.
pt recv vax 19JUL95 & 18JUN97 pt exp chickenpox w/a lot of lesions but no fever;
Golf ball redness, swelling, warmth, and itching at injection site (right deltoid) reported by Mother to clinic 08/11/2010.
Patient described red inflamed shot with 1st vaccine but Dr told her to get 2nd vaccine and she did as this was her 2nd vaccine of shingrix.  She had same Inflamed red arm, however this time she said it hurt more and she had a fever that evening which did not have with first - took fever reducer that evening and is did fine -- she just thought we should turn in to database so aware of reaction she had
symptomatic for COVID-19 after being exposed during a wedding; patient was scheduled to come in to the office this week to take the second dose but is not able to because of COVID; Initial information received on 01-Jun-2022 regarding an unsolicited valid non-serious case received from a other health professional via call center.  This case involves an unknown age male patient who experienced patient was scheduled to come in to the office this week to take the second dose but is not able to because of covid and symptomatic for covid-19 after being exposed during a wedding while receiving vaccine ipv (vero) [Imovax].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 26-May-2022, the patient received a dose of suspect ipv (vero) [Imovax] (unknown batch lot number ,dosage.formulation and expiry date)via unknown route in unknown administration site for immunization.  On 02-Jun-2022 (latency :unknown) the patient developed a non-serious event of patient was scheduled to come in to the office this week to take the second dose but is not able to because of covid (product dose omission issue) and symptomatic for covid-19 after being exposed during a wedding (exposure to sars-cov-2)   Relevant laboratory test results included: SARS-CoV-2 test - On an unknown date:  [negative]  Action taken : not applicable.  At time of reporting, the outcome was Unknown for the events  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 the 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.
01/08/21: Sudden onset of extreme body/muscular pain, such that moving was difficult. Extreme chills, headache.  Needed pain medicine to alleviate pain. Fatigue.  01/09:21:  AM: Less body pain , but feeling of heaviness in head; weak.                           PM: Had onset of lower GI symptoms: painful abdominal/cramps, stomach pain, nausea. No vomiting, but had several                           episodes of diarrhea. Feeling like passing out but never did. Loss of appetite.  Slowly resolving.
Information has been received from the Merck pregnancy registry for Gardasil vaccine from a nurse practitioner concerning an 18 year old female, with no drug reactions/allergies and asthma, who on 16-APR-2007 was vaccinated with a 0.5 mL dose of Gardasil intramuscularly at another facility. Concomitant therapy included albuterol inhaler and possibly other unspecified medications. On 16-APR-2007 a urine pregnancy test was negative. The nurse practitioner reported that subsequently the patient was determined to be pregnant. A urine pregnancy test on 25-MAY-2007 was positive. Last menstrual period was 09-MAR-2007 and the estimated date of delivery was 15-DEC-2007. The nurse practitioner noted that the conception may have occurred on 14-APR-2007. On approximately 20-JUL-2007, the patient developed anemia. On 20-JUL-2007, the patient was placed on therapy ferrous sulfate for the treatment of anemia. On approximately 07-SEP-2007, the patient developed heartburn. On 07-SEP-2007, the patient was placed on Tums for the treatment of heartburn. Additional information has been requested. On 07-JAN-2008, 40 weeks and 1 day from LMP, the patient gave birth to a normal female baby. The baby's weight was 1065 gm, length was 49.5 cm. APGAR score 9/9. Pediatric medical records were received and reviewed and the following experience was identified: the nurse practioner reported that the baby had mongolian spots on her back. Mongolina spots are considered to be an congenital anomaly. Addiitonal information is not expected.
Serious headache, fatigue 24 hours after vaccine.  4 weeks after the first dose, I experienced a massive bleeding period. My blood pressure dropped to 40/60. I was chilling on the bed under 28C room temperature.
The vaccination was the most painful I have ever received. Within one hour the muscle started becoming sore and overnight it disturbed my sleep. By the next morning the area was extremely sore and I couldn't raise my arm above shoulder height. I canceled an event I was to attend and I would estimate loss of 80% use of that arm due to pain. That decreased very slowly over the next week and was down to 20% in three weeks. This morning 6 weeks after the event I still felt slight twinges in that area.
pt recv vax 15NOV96 & on 1JAN97 MD lab results revealed a lack of seroconversion;
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown demographics. No concurrent medications or medical history were provided. The medical assistant reported that those patients were administered with a doses of ROTATEQ that had been improperly stored (doses, indications, lot#, expiry dates unspecified) between 13-OCT-2013 and 13-NOV-2013. No concomitant medications were reported. No adverse effects were reported. This is one of several reports from the same source.  Additional information has been requested.
5/11/21 About 6 hours after injection patient's right leg was sore and swollen. She did experience a sore arm as expected. Both legs were red but not itching.   5/12/21 Early the next morning she went to healthcare facility and blood pressure was elevated and they advised her to go to ER.  She was not treated for anything. The swelling slowly went down throughout the day. Later that night she experienced extreme back pain. She will follow-up with PCP.
Sore Arm; Chills; Red Mark on Injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm), CHILLS (Chills) and VACCINATION SITE ERYTHEMA (Red Mark on Injection site) in a 28-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm), CHILLS (Chills) and VACCINATION SITE ERYTHEMA (Red Mark on Injection site). At the time of the report, PAIN IN EXTREMITY (Sore Arm), CHILLS (Chills) and VACCINATION SITE ERYTHEMA (Red Mark on Injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.  Treatment information was not provided.   Reporter did not allow further contact
This spontaneous report was received from a healthcare worker referring to a 6 month old patient of unknown gender. The patients' concurrent conditions and medical histories were not provided. On 27-OCT-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ orally (dose was unknown, lot # K023532, expiration date 21-JUN-2016). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
This spontaneous report as received from a physician refers to unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with doses of improperly stored VAQTA lot # L036300, expiration date 04-NOV-2016 (dose and route of administration not reported). The vaccines were exposed to the following conditions: temperature 1.5 degrees Centigrade for 1 hour. No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
OFF LABEL USE IN UNAPPROVED AGE GROUP (VACCINE ADMINISTERED TO 15 YEAR OLD); This spontaneous report received from a pharmacist concerned a 15 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202F21A expiry: UNKNOWN) dose was not reported, administered on 19-DEC-2022 for covid-19 prophylaxis. The drug was associated with Off label use. Age at time of vaccination 15 years old. No concomitant medications were reported.  On 19-DEC-2022, the patient experienced off label use in unapproved age group (vaccine administered to 15 year old). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of off label use in unapproved age group (vaccine administered to 15 year old) was not reported. This report was non-serious. This case, involving the same patient is linked to 20220355536.
pt recvd vax & had loss of color & was pale white 3-5 sec; pt was crying;
Dizziness, vertigo, lightheadedness Comes and goes frequently appears to decrease some if over the counter medication such as tylenol or advil is taken
a 88y.o. year old female with PMH dementia,depression/anxiety, paroxysmal afib who presents for COVID concern. Patient recently had a L total knee arthroplasty done at hospital on 8/16. Patient was transferred to SAR and began having flu like symptoms. Patient's son at bedside helps with most of history as patient is very somnolent.  Son states the patient was having a cough, body aches, fatigue. Patient took a COVID test and was positive 8/26/2021. Patient's son states the facility wanted to transfer the patient to a "COVID friendly facility", but the son did not feel comfortable with that and wanted to bring her home. Patient then came home and symptoms began to worsen. Yesterday, patient became much more short of breath and this made the son bring her into the hospital. Since arrival, patient has been started on antibiotics, heparin d/t a PE found on CTA. However, patient began having hemoptysis. Patient will answer yes/no to questions and sometimes will describe she has "trouble breathing". Patient denies fevers/chills, but does endorse cough, shortness of breath.    She did receive both doses of Moderna vaccine early this year Patient was previously a school teacher. No history of TB, frequently tested as teacher and all negative.
Pt is 15 years old and was given ProQuad.  This was her second dose of MMR and first dose of Varicella.  Pt had no adverse reaction to this vaccine.  Informed parents of the error immediately and explained that the patient did not need to be revaccinated according to  CDC guidance.
woke at1 am with pain, that made sleep impossible, diarrheas', nausea, chills , fever;  still experiencing at 2"15 pm
Started to get a scratchy throat, 5 days later tested positive for COVID-19; Spoke with Dr and was prescribed Paxlovid.
States had a syncope event shortly after 2nd COVID vaccine.  Vaccine administered approximately 10am then about 40-45 minutes later had a syncope episode and fell from a standing position.
Site: Itching at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Chills-Medium, Systemic: Headache-Medium
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patients/ Dose administered after 30-day use by date or after manufacturer date of expiry) in a 79-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 vaccination. No Medical History information was reported. On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patients/ Dose administered after 30-day use by date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patients/ Dose administered after 30-day use by date or after manufacturer date of expiry) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was provided. The vial did not undergo any temperature excursions. Total of 173 doses were given from LOT 070H21A. It was reported that the date vial initially stored in refrigerator was unknown. Treatment medication was not provided by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Non Significant  follow up was received.
Numbness in left leg for a few days; Within three weeks have been experiencing headaches or pressure in my head.; Within three weeks have been experiencing headaches or pressure in my head.; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0185) via an unspecified route of administration in the left arm on 01Jul2021 at 18:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Other medical history not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Jul2021, the patient experienced numbness in left leg for a few days. On an unknown date in Jul2021, within three weeks, the patient experienced headaches and pressure in head. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headaches, pressure in head and numbness in left leg for a few days was not recovered at the time of this report.
Initial report received on 03 December 2007 from a health care professional. An adult patient, with no concurrent illness, who was traveling on a cruise ship as an entertainer, had received subcutaneous dose of YF VAX vaccine (lot number UF197AA) on 26 November 2007. The site of administration was not reported. At an unspecified amount of time later, the patient developed big red spots and burning at the injection site, along with sweating, fever, and nausea. The patient did not seek medical attention. Treatment received was not reported. At the time of this report, the adverse events were resolving. The reporter for this case is the same as for cases 2007-04170, 2007-04171, 2007-04172, 2007-04173.
much pain in her elbow down to her fingers since the injection; much pain in her elbow down to her fingers since the injection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious), outcome "unknown" and all described as "much pain in her elbow down to her fingers since the injection".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
TD given left upper extremity 10/27/2003.  1 day later with erythema and pain at site.  2 days later with escalating pain and redness, better ? 3 week normal range of motion.  7.5x7.5 edema with 5.5x5.5 erythematous.  10/30/2003 recovering.  No other symptoms.
Initially there were no side effects therefore I left the facility.  Approximately 20 minutes later there was a decrease in my BPM.  Usually my resting BPM is 58-62.  It dropped to 46.  I pulled over and waited a few minutes.  Shortly 10-15 minutes, I was fine.  I felt alright until 11:30 that night.  I woke up with terrible cramping in my feet, calves and fingers.  The following day I experienced fatigue and muscle aches.  On Sunday morning I began to experience vertigo and nausea.  This did not subside.  I work as a dean and educator and the commute was difficult.  Especially on the train.  On Wednesday, I began menstruating.  For the record, I was menopausal and have not experienced a menstrual cycle in months.  Mostly spotting on Wednesday and  heavier on Thursday. I attempted to go to a Urgent Care but I was unable to return that day.  On Friday, I visited Primary care.  I was prescribed Meclizine and Ondansetron.   At this time this is quite debilitating.  I continue to go work.  The only day I missed was Friday 9/17.