chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a registered nurse and refers to a 13 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 11-JUL-2017, the patient was vaccinated with an improperly stored VARIVAX at a dose of 0.5 (units not specified) from lot # N012132 with expiry date: 17-APR-2019 (dose number, route, anatomical location and site of administration were not reported) for prophylaxis. Concomitant medications included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA004945.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (received a 2nd dose of Moderna Covid-19 vaccine, Bivalent) and NO ADVERSE EVENT (No Adverse Event) in a 76-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.   On 26-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 18-Jan-2023, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 18-Jan-2023, the patient experienced EXTRA DOSE ADMINISTERED (received a 2nd dose of Moderna Covid-19 vaccine, Bivalent). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXTRA DOSE ADMINISTERED (received a 2nd dose of Moderna Covid-19 vaccine, Bivalent) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.           No concomitant and treatment medications were reported.
Vomiting projectile with diarrhea started 3-26-17 at midnight. Went to ED 3-26-17 at noon.
Headache; Flu-like symptoms; A spontaneous report was received from a consumer concerning a 75-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced headache and flu-like symptoms.  The patient's medical history was not provided. Concomitant medications included warfarin as blood thinner.  On 22 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced real bad headache and flu-like symptoms, treated with Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events real bad headache and flu-like symptoms was not recovered (ongoing).; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
APPROXIMATELY 20 MINUTES AFTER VACCINATION, SHE BECAME ILL, VOMITING THEN COMPLAINING OF CLOSING THROAT, FELT WEAK.  EMT AND FACILITY DOCTOR ON SITE WAS CALLED, THEY DETERMINED SHE DID NOT NEED TO BE TRANSPORTED TO THE ER.  CONTINUED TO MONITOR PATIENT .
Patient received the influenza vaccine at work around 09:30 on 4 October 2017. Patient felt dizzy and had a headache/lightheadedness following the vaccine. That evening around 6PM, the Patient took a bath and following began to feel weak, lightheaded, dizzy, and vision blurred. Patient's heart rate elevated and breathing was rapid and shallow. Patient's hands/arms began to tingle and feel numb. Patient legs and cheeks also began to tingle and hands cramped. The Patient laid on the couch and elevated their feet. The Patient's spouse was able to assist. The Patient began alternate nostril breathing to control breathing and decrease heart rate. Symptoms persisted for about 20 minutes before slowly subsiding. The Patient was able to drink water. Following the event, the Patient was exhausted and developed a migraine. Sleep was also disrupted the night following.
INFLAMMED SWOLLEN RED ITCHY ARM  Narrative:  At 2nd dose of covid vaccine appointment pt reported adverse reaction from 1st dose of the following taken from nurses note: "6 to 7 days sp Moderna dose 1, pt reports and showed image of red swollen upper arm left injection side, pt describes as "inflamed arm that was huge", she reports it lasted approx 10 days, now reports mild itching, arm is of normal size when compared to left, pt informed to seek medical care if it occurs again, pt verbalized understanding, pt desires 2nd dose" 2nd dose was given on 2/23/21 without any issues reported at this time 2/24/21.
Information has been received from a nurse practitioner concerning a 6 month old male patient who on an unspecified date was vaccinated orally with a third dose of ROTATEQ "on a Friday."  Concomitant vaccinations on the same day included PEDVAX HIB (OMPC) (manufacturer unknown), DTaP (manufacturer unknown), IPV (unspecified) (manufacturer unknown) and PREVNAR.  Subsequently, "by the next Monday" the patient had a bloody stool.  Medical attention was sought in the office.  It was unspecified if lab studies were performed.  At the time of the report, the patient's status was unknown.  There was no product quality complaint involved.  Upon internal review "a bloody stool" was considered to be an other important medical event.  Additional information has been requested.
Pain, tingling, numbness, weakness in arm stemming from vaccine location. Arm aches on and off, feels bruised like I just got the shot. Becomes very weak and painful and am unable to lift arm. Eventually it subsides.  But returns- comes and goes. Feels bruised afterwards.
Lightheadedness  Headache Body aches Chills (without fever) Exhaustion
This spontaneous report as received from a pharmacist refers to a 61 year old male patient. The patient had no pertinent medical history or drug reaction/allergies. On 19-MAY-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot # J014809, expiration date 20-FEB-2015, dose 0.65 ml, subcutaneous in the left arm). No concomitant medications were provided. The pharmacist stated the patient called the pharmacy stating that he developed issues approximately one week post vaccination with ZOSTAVAX (on 26-MAY-2014). Pharmacist stated the patient had joint pain, felt nauseated and rash developed on his left arm, and a little bit of rash on his right arm. Pharmacist stated the patient still had on his left arm but rash on his right arm was gone "now" (at the reporting time). No treatment was given for the events. No lab diagnostics studies were performed. The patient had sought medical attention by calling pharmacy. At time of the reporting, outcome of the events was reported as not recovered. Additional information is not expected because the reporter did not want to be contacted.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included shoulder operation (right shoulder surgery). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain and fever. On an unknown date, the outcome of the injection site pain and fever were unknown. It was unknown if the reporter considered the injection site pain and fever to be related to SHINGRIX. Additional details were provided as follows: This case was received via chat. The age at vaccination was not reported. The patient received the 2nd dose of SHINGRIX a few months before the reporting date. The patient had severe pain in the area that she was given the SHINGRIX vaccine and also experienced a low grade fever. No additional information was provided. The patient gave contact details of the healthcare provider.
Extreme headache when laying down to go to sleep. Large knot popped up on right side of face in front of right ear just below right temple.
Severe spasm in left arm lasted until 4:30 am 7/22/18. Do not have full use of arm.
This spontaneous report as received from the patient's mother refers to her daughter of unknown age. The patient had no pertinent medical history, drug allergies/reactions  or concomitant medications. On 13-FEB-2010, the patient was vaccinated with  a dose of MUMPSVAX (expiration date: 13-MAR-2010) (lot #, dose, frequency and route were not provided). On an unknown date (reported as recently), the patient had a titer test done and the results showed she was not protected from the mumps virus. The reporter also believed the MUMPSVAX may not have been potent enough to prevent the mumps virus as it was due to expire on 13-MAR-2010. The patient did not seek medical attention and did not receive treatment for the events. A product quality complaint was not involved. At the time of reporting, the outcome of the event was unknown. The reporter did not provide the causality assessment between the event and the suspect therapy. Additional information has been requested.
chose the Pfizer vax for family as the best fit/we caught Covid this summer; chose the Pfizer vax for family as the best fit/we caught Covid this summer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "chose the Pfizer vax for family as the best fit/we caught Covid this summer".  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Participant felt like she had to urinate frequently, thought she had UTI. She would urinate very little. She saw a urologist and physical therapist through July with symptoms subsided in August.
Patient was noncompliant during administration of MMRV vaccine and I was only able to administer half of the dose before he moved and I had to remove the needle. The provider was informed of this immediately and spoke with parents, who decided to come back in one month for a repeat dose. Patient left clinic about 5-10 minutes later and had no other issues.
Sore shoulder; This is a spontaneous report from a non-contactable consumer (patient). A 69-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 18Feb2021 (at the age of 69-year-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had not been tested for COVID-19. On 18Feb2021 21:00, patient experienced sore shoulder. There was no treatment for the event. The clinical outcome of event was recovering.  No follow-up attempts are possible. Information about lot/batch number cannot be requested.
patient with h/o polycythemia rubra vera, followed by heme and has monitoring CBC  almost weekly to q2weeks. day prior to pfizer #2,  platelets increased to 757. previous value 10/12/21 at 95.  ranges low with high of 1176. h/o thrombocytosis when she is ill with COPD/pneumonia in past. started on hydroxyurea 9/21 and had complaints of diarrhea, but improved. then 10/27, platelets were 1558. minimal symptoms. urine culture negative. seen in my office 10/29/21 and just started with worsening SOB and cough. RLL lung findings and started on augmentin. covid test negative.  Seen 11/4/21 for f/u and plt now down to 511. Thrombocytosis could be due to infection, resolving with antibiotics, but just wanted to report for possible link with pfizer vaccine. thanks
pulmonary edema; congestive heart failure; Undifferentiated spondyloarthritis.; herpes zoster; post herpetic neuralgia; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a currently 54-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medication were not provided.   On or about 25-JAN-2013, the patient was vaccinated with a dose zoster vaccine live (ZOSTAVAX) (dosage regimen was not reported) for the long-term prevention of shingles and zoster-related conditions.  On an unspecified date, subsequent to the patient vaccination, the patient presented multiple outbreaks of herpes zoster, post herpetic neuralgia, congestive heart failure, pulmonary edema and undifferentiated spondylarthritis. As a direct and proximate result, the patient had been treated by provider. At the reporting time, the outcome for all the events was unknown.  The reporter considered all the events to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review the events of pulmonary edema and congestive heart failure were considered as medically significant.
Extreme Nausea-Headache-Dizziness-Soreness of Arm
began w/fussiness & some crying then persistent crying for 1 1/2hr;then a very high pitched shrieking or screaming for 1 1/2hr;vomited & afeb;pt cranky & weak crying until fell asleep;cont every 6hr  w/motrin overnoc;
Vaccine was administered to patient past the BUD of 17-Feb-2023; No adverse event; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to patient past the BUD of 17-Feb-2023) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 065H22A) for COVID-19 prophylaxis.     Patient did not report any medical history, conditions, allergy, concomitant diseases, or risk factor (including any previous COVID-19 diagnosis). It was reported that patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to patient past the BUD of 17-Feb-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to patient past the BUD of 17-Feb-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to patient past the BUD of 17-Feb-2023).    Concomitant drugs were not reported. It was reported that vaccines were administered to 20 patients between 13-Mar-2023 to 05-Jun-2023 past the BUD of 17-Feb-2023. Patients received the vaccine either as the 3rd, 4th or 5th dose. Treatment medications were not provided.  This case was reported for patient 16 of 20.   This case was linked to US-MODERNATX, INC.-MOD-2023-727707 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727707:Master Case(Patient 1)
adverse effect to the booster shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (adverse effect to the booster shot) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (adverse effect to the booster shot). At the time of the report, VACCINATION COMPLICATION (adverse effect to the booster shot) outcome was unknown.            Concomitant medications were not reported. Treatment medications were not reported.
Redness in circular form in left arm where injection was administered on day 7  "Moderna COVID-19 Vaccine
presented to his office 4 days later with pain in her right leg/pain in her right leg from the knee down; This is a spontaneous report received from contactable reporter(s) (Physician) from the medical information team.  A 11-year-old female patient received bnt162b2 (BNT162B2), administration date 04Dec2021 (Batch/Lot number: unknown) at the age of 11 years as dose 1, single for covid-19 immunization. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered" (Dec2021), described as "presented to his office 4 days later with pain in her right leg/pain in her right leg from the knee down". Therapeutic measures were taken as a result of pain in the extremity.  Additional Information: The reported was stated that a patient, female11 y/o, who received the 1st dose of the Pfizer BTC vaccine (orange cap formula, 5-11y/o) on 04Dec2021 and presented to his office 4 days later with pain in her right leg. The pain was from the knee down, no swelling, no fever or warmth, good ROM in all joints, and no weakness in the leg. The patient took ibuprofen and 24hours later was doing better.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt. appeared somewhat apprehensive. History filled out by father/reviewed with father and son. He received flu shot and within seconds passed out as he tried to get up (out about 7 seconds) - woke up when I spoke to him and passed out (3 seconds) and he awakened very groggy - BP taken 121/85. Paramedics called - no feverish. BP was low when they took it. ? possible vasovagal response.
Patient observed a rash on cheek over the nose and on other cheek and wanted to know if it was related to vaccinations given on 8-28-17.
tender to site of injection, redness, swelling (3 red rings, one being larger than the other two-larger one on lower deltoid) and warm to touch
Pain in my legs and lower back from my hips down to the bottom of my feet which includes muscles, joints of knees and ankles.; Pain in my legs and lower back from my hips down to the bottom of my feet which includes muscles, joints of knees and ankles; Pain in my legs and lower back from my hips down to the bottom of my feet which includes muscles, joints of knees and ankles; Pain in my legs and lower back from my hips down to the bottom of my feet which includes muscles, joints of knees and ankles; This is a spontaneous report from a contactable reporter (consumer or other non-hcp). The reporter is the patient.  A 62-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Apr2021 at 04:45 (Lot number: EP6955) at the age of 62 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Meniere's disease" (unspecified if ongoing), notes: Meniere's Disease with Vestibular Migraines and "Vestibular migraine" (unspecified if ongoing), notes: Meniere's Disease with Vestibular Migraines. Concomitant medications included: MONTELUKAST 10MG and TRIAMTERENE 37.5 MG/HYDROCHLOROTHIAZIDE 25 MG. Past drug history included: Codeine, reactions: "Drug allergy", notes: known allergies: Codine. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: EN6204; Administration Time: 05:45; Vaccine Location: Left Arm, Route of administration: Unspecified), administration date: 25Mar2021, when the patient was 62 years old, for COVID-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 20Apr2021, outcome "not recovered", described as "Pain in my legs and lower back from my hips down to the bottom of my feet which includes muscles, joints of knees and ankles"; BACK PAIN (non-serious), MYALGIA (non-serious), ARTHRALGIA (non-serious) all with onset 20Apr2021, outcome "not recovered", and all described as "Pain in my legs and lower back from my hips down to the bottom of my feet which includes muscles, joints of knees and ankles". Therapeutic measures were taken as a result of pain in extremity, back pain, myalgia and arthralgia.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The patient received treatment with steroids for the reported events. The patient received COVID-19 vaccine mRNA (mRNA 123)(MODERNA VACCINE COVID19) administered in arm left, administration date 20Dec2021 at 14:15 (Lot Number: 012H21B), as dose 3, single for COVID-19 immunisation.
Pt complained (L) arm pain within 48 hours of receiving vaccination. Currently pain still exists. More pronounced in the evening.
Patient has the shingles on his arm and back / The rash started on holiday/ the rash starts at his arm and goes up his shoulder blade/ patient was diagnosed with shingles; Initial and follow-up information was received from a consumer referring her son, a 13-month-old male patient. The patient's pertinent medical history, concurrent conditions, drug allergies or previous reactions, and concomitant medications, were not reported.  Approximately on 12-APR-2019, also reported as "around 12-APR-2019, on or after this date", the patient was vaccinated with a dose of an unspecified "chickenpox vaccine", it was later confirmed by the reporter that the vaccine was varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (strength, route of administration, anatomical location of injection site, lot # and expiration date were not reported).         On 27-MAY-2019, the patient developed a rash that started on his arm and went up to his shoulder blade, the mother first reported it as shingles. On 03-JUN-2019, the patient was medically diagnosed with shingles (herpes zoster). The patient sought medical attention and visited the doctor's office, and received treatment due to the event. It was reported that no laboratory diagnostics or studies were performed.  By the time of this report, the patient was not recovered from the event.   The causality assessment between varicella virus vaccine live (oka/merck) (VARIVAX) administration and shingles (herpes zoster) occurrence was reported as related.
Alarming tightness in chest for 3 days, difficulty breathing.  Other symptoms, extreme fatigue, soreness at injection site for 5 days, headache for 10 days, body ache 7 days.