chrisvoncsefalvay/vaers-outcomes huggingface dataset:
feverish; soreness (arm); This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (feverish) and INJECTION SITE PAIN (soreness (arm)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced PYREXIA (feverish) and INJECTION SITE PAIN (soreness (arm)). At the time of the report, PYREXIA (feverish) and INJECTION SITE PAIN (soreness (arm)) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       NO CONCOMITANT MEDICATION AND TREATMENT PROVIDED; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded
Little sore arm; Little headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Little sore arm) and HEADACHE (Little headache) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy and MS.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced MYALGIA (Little sore arm) and HEADACHE (Little headache). At the time of the report, MYALGIA (Little sore arm) and HEADACHE (Little headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use included infusions for MS.  Treatment information was not provided.   This case was linked to MOD-2021-294520 (Patient Link).
hospitalized 3/5/2022 with Guillian barre  right foot sprain 1/25.  subsequent pain/paresthesia, then 2 weeks prior to presentation weakness. Found to have imaging and CSF findings c/w guillian barre. Being treated with IVIG
Difficulty breathing, Sore Throat, pain throughout the body. Mild fever, loss of appetite, chills, muscle pain, weakness, and unable to walk due to pain in legs. Lasted for 1wk 1/2.
Patient told me that Monday night, of the same day she received the vaccination, she had a very bad headache. By Wednesday, 9/30/21, she had "an incredible rash" which included the top of her head being red and hot. She experienced fatigue and weakness for a few days. She could not lift things as usual or walk without effort. I told the patient to take Tylenol as needed for any pain or fever that is persisting. Benadryl was recommended for the rash. She said she had taken Benadryl when she first noticed it. I told her to continue if needed but if the rash gets worse to see a doctor. Keeping hydrated with water, ex. Smart Water, was recommended, also.
PATIENT CAME INTO OUR OFFICE WITH A KNOT ON HIS RIGHT MID/UPPER THIGH ABOUT TWO INCHES IN DIAMETER. DR. INSTRUCTED PATIENT'S MOTHER TO DO 1TSP BENADRYL, MOTRIN FOR PX, TO ICE THE AFFECTED AREA, AND TO WATCH FOR ANY WORSENING REACTION.  MOTHER INSTRUCTED TO FOLLOW UP WITH ANY OTHER PROBLEMS.
Dental concern; This is a spontaneous report received from a contactable reporter (Consumer) for a Pfizer sponsored program. The reporter is the patient.  A female patient 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: TOOTH DISORDER (non-serious), outcome "unknown", described as "Dental concern". Therapeutic measures were taken as a result of tooth disorder.  Additional Information: The patient was scheduled for her second dose this coming Friday (date unspecified). She was taking amoxicillin until Monday (date unspecified) due to some dental concern. She wanted to know if that was ok.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received Covid-19 vaccine (first dose) at our store today at 9:40 am. Patient was advised to stay in the area for 15 minutes for observation. Patient was sitting in the waiting area. At around 10:00 am, patient knock on the door saying that her son might have an adverse effect. While we were taking care of her son, she felt dizzy, hyperventilated and sat down on a chair. Medics were call to take care of his son. Medics arrived at that time when she was feeling dizzy. They took her blood pressure and gave her IV fluid. She felt a little better and were transported to the hospital.
After 2nd shot, within a week, my left knee cannot bend over 45-deg freely.  It was very painful to bend it.  I must withstand pain to sit down or to stand up.  It lasted about 5 months
patient called stating injection site had a raised, egg-sized, warm-to-the-touch, lump at the injection site. informed patient to call PCP, use Ibuprofen, and ice.  Within 24 hours, symptoms completely subsided
Felt nauseous; vomited once the evening of her second vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 55 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunisation. The following information was reported: NAUSEA (non-serious), outcome "unknown", described as "Felt nauseous"; VOMITING (non-serious), outcome "unknown", described as "vomited once the evening of her second vaccine".  Additional Information: Felt better after vomiting. Event took place after use of product.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient was hospitalized at the Medical Center on 5/29-6/01/2021 following ED visit for worsening dyspnea which reportedly began 2-3 weeks prior following her first Pfizer vaccine.   States that she was told her oral contraceptive was most likely responsible for her DVT and subsequent PE.  She states that she began estrogen-based birth control in November 2020 and switched to a different brand in January 2021.  She reports that at the time of her hospitalization she expressed concerns over the Pfizer vaccine she received on May 1, as following vaccination she began to experience body aches, a "fluttering in her chest" and dyspnea which progressively worsened over the course of 3 weeks and led to her coming to the ED.   Patient was told that her contraceptive use was responsible for her DVT/PE.  Coagulopathy panel was negative.   Patient was started on Eliquis and has been compliant with this medication.  She states that she received the second Pfizer vaccine on August 15, 2021.  Patient reports that she continues to have aching in bilateral shoulder and hip joints, which has not resolved since May 2021.  She experiences some shortness of breath with moderate exertion, which has not fully resolved.  Previously used to go hiking often.
Exp date June 30, 2020. Complaint of R. Jaw pain, moderate to severe.  Aleve and topical heat for treatment. Resolved to mild discomfort after one week
Patient may have inadvertently received 1cc of Moderna COVID vaccine instead of 0.5cc. Patient was notified, advised of potential side effects and treatment if needed.  State of MD was notifed.
Patient was in to be seen by provider and asked if he could get 3rd dose of Pfizer since he was at the right age for it and it had been over 6 months since he completed the 2 dose series.  Then was asked the questions  by staff in the protocol regarding whether he had any monoclonal antibodies in the last 90 days and he answered "no". He met the criteria then based on his answers to the questions and was given the booster of Pfizer vaccine.  The our staff asked his wife the same questions since she was also asking for the booster.  She admitted that she had the monoclonal antibodies and was told then that she would not qualify and needed to wait 90 days before she got a booster at which time this patient said that
Seen 4/30/14 in pediatrician office for red mark on (L) thigh at immun site and rash on torso. Dx with cellulitis on (L) thigh and petechiae rash. Had rec'd 12 mo immuns Hep A, MMR, VARIVAX on 4/22. CBC wnl.
UNCONSOLABLE CRYING 3 HOURS AFTER VACCINES LASTED 6-7 HOURS. TYLENOL .8CC Q 4 HOURS AND COOL COMPRESSES RELIEVED SOME DISCOMFORT. CHILD SLEPT THROUGH NIGHT AND WAS STILL A BIT TENDER THE NEXT MORNING.
PATIENT WAS GIVEN A DOSE OF DTAP VACCINE AND KINRIX AT THE SAME VISIT, ONE IN EACH ARM.  NO IMMEDIATE REACTION WAS SEEN BUT FOLLOW UP WILL BE DONE TO ASSESS THE WELL BEING OF THE CLIENT POST VACCINATION.
Pt recvd MMR/DT/OPV in 1990 & w/in 2 hrs of recving 2nd dose devel periorbital edema that was felt to be life-threatenting; pt responded to tx w/adrenalin and/or DPH; 4 addtl pts exp life-threatening allergic rxn;
Information has been received from a medical assistant via field representative referring to an 18 year old female patient. The patient was vaccinated with her first dose, second dose and third dose of GARDASIL (route, lot#, strength and dose were unknown) on 12-NOV-2014, 24-MAR-2015 and 19-MAY-2015, respectively (inappropriate schedule of vaccine administered). No adverse effects were reported. Additional information is not expected as the medical assistant didn't want to be contacted.
PT RECEIVED HIS COVID-19 VACCINE AND WAS WAITING IN THE OBSERVATION AREA.  AFTER ABOUT 10 MIN MY TECHNICIAN NOTICED HIM SIT ON THE FLOOR FROM HIS CHAIR AND SHE CAME TO GET ME.  AS I APPROACED HIM HE LOOKED DAZED AND SUDDENLY BLACKED OUT.  IN ABOUT 15-20 SECONDS HE AWOKE AND ABOUT 1 MINUTE LATER HE WAS SPEAKING.  ROUGHLY 5 MINUTES LATER, EMS ARRIVED AND CHECKED HIS VITALS, BLOOD SUGAR AND EKG.  ALL WERE WITHIN NORMAL LIMITS.  WHILE TALKING TO PATIENT AND THE TWO LADIES WITH HIM, WE FOUND OUT HE HAD DRIVEN 3 HOURS FROM HIS HOME TO COME TO OUR PHARMACY FOR THEM TO GET VACCINATED.  AND THEY PLANNED TO GET ON THE ROAD AND RETURN.  EMS SUGGESTED HE GO TO THE HOSPITAL, BUT AFTER 20 MINUTES HE WAS WALING AND TALKING AND DRINKING WATER.  HE AND HIS FRIENDS DECIDED THEY WOULD NOT GO TO THE HOSPITAL.  I FOLLOWED UP WITH HIM 2 DAYS LATER ON  4/9 AND HE FELT FINE EXCEPT FOR SORENESS AT THE SITE OF INJECTION.  HE ALSO RECALLED A TIME WHEN HE HAD PASSED OUT FROM AN INJECTION WHEN HE WAS A TEENAGER
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021 at 9:09 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Feb-2021 at 9:09 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 29.11 for dose administered on 28-Feb-2021. No concomitant medications were reported. Batch number 014M20A underwent temperature excursion on 28-Feb-2021 with temperature 26 to 27 degrees Fahrenheit from 09:00 AM to 1:00 PM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 27-Feb-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour. No treatment medications were reported.
Swelling of face, crying screaming that night.  Loss of eye contact.  Will not eat solid foods. no responsiveness,  ear infection,  no progression in any milestones.
arm swelling; broke out in hives all over; arm was tender; arm got red; This spontaneous case was reported by an other health care professional and describes the occurrence of PERIPHERAL SWELLING (arm swelling), URTICARIA (broke out in hives all over), TENDERNESS (arm was tender) and ERYTHEMA (arm got red) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Autoimmune deficiency syndrome, Bipolar disorder, Fatty liver, Barrett's esophagus, Osteoporosis, Allergy, Sinus disorder NOS, Gastrooesophageal reflux disease and Hives (bad). Concomitant products included OMALIZUMAB (XOLAIR), PREDNISONE, LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D), CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF), FAMOTIDINE (PEPCID AC) and HYDROXYZINE for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced PERIPHERAL SWELLING (arm swelling), URTICARIA (broke out in hives all over), TENDERNESS (arm was tender) and ERYTHEMA (arm got red). At the time of the report, PERIPHERAL SWELLING (arm swelling), URTICARIA (broke out in hives all over), TENDERNESS (arm was tender) and ERYTHEMA (arm got red) outcome was unknown.        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 treatment medication included.
3/27/2023  I had a scratchy throat. It progressed into a dry hacking cough and fever. I took an at home COVID test and it was positive on 3/29/23. I had a telehealth appointment and was prescribed Paxlovid which I began taking that day.  I took the Paxlovid for the five days.  My symptoms minimized, the fever went away and cough went down a bit. I later experienced a runny nose that lasted about 48 hours. I took an at home COVID test on 4/7/23 which was positive.  I am still experiencing a cough and upper airway symptoms.
Covid infection in May2022; Covid infection in May2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), in Spring 2021 as dose 1, single (Batch/Lot number: unknown), in Spring 2021 as dose 2, single (Batch/Lot number: unknown) and in Dec2021 as dose 3 (booster), 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: SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset May2022, outcome "unknown" and all described as "Covid infection in May2022". Infection was mild. No medical intervention required.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Rash approx. three inches below injection.  Pink in color and is about three inches wide going from center of right arm below injection site to the left.  Some raised swelling and discomfort or slight pain.  Tylenol does help and make it more comfortable.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Lot number: EP7534), in left arm, on 05Apr2021 as dose 2, single (Lot number: ER8734), in right arm and on 03Dec2021 as dose 3 (booster), single (Lot number: 33030BD) at the age of 49 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LISINOPRIL; OMEPRAZOLE; BUPROPION; TURMERIC [CURCUMA LONGA]. The following information was reported: VACCINATION FAILURE (medically significant) with onset 09May2022, outcome "unknown", COVID-19 (medically significant) with onset 09May2022, outcome "not recovered" and all described as "COVID-19 Treatment". The event "covid-19 treatment" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06May2022) Negative; (09May2022) Positive; (13May2022) Positive; (15May2022) Negative; (20May2022) Positive. Therapeutic measures were taken as a result of vaccination failure. Therapeutic measures were not taken as a result of covid-19. Clinical course included patient started having symptoms Friday 06May2022. Rapid test resulted in a negative test. patient took another test Monday 09May2022 which came back positive. After consult with my Doctor Paxlovid was prescribed for me. Took first dose Monday 09May2022 evening. Last dose was taken Friday 13May2022, however patient still had a positive rapid test although I was feeling better. patient  took another test Sunday 15May2022 and it came back negative. Mon thru most of Friday (16May2022 - 20May2022) patient felt fine. Friday 20May2022, patient started getting similar symptoms from the original onset (Stuffy / Runny nose, Sore throat, Random (infrequent) cough. Patient did another rapid test Friday 20May2022, and it showed a positive test.
Pain and tingling in left arm and back. Sensation of numbness. Patient went to ER, (2 wks after) they did MRI and said could be paresthesia due to FLUVIRIN.
Client  reported warm feeling/ sensation on the left arm immediately after getting the vaccine; followed by left shoulder/ back pain after 5 min. pain scale of 4/10. Client is A/O x 4, no respiratory distress observed; was able to tolerate and drink water. Client was observed through discharge; stated initial symptoms were improved/ resolved. V/S on discharge: BP of 140/80, HR of 62 bpm, O2 saturation of 98% on RA. Client ambulated independently out of the vaccine clinic.
pt recv vax 27JUL95 & 14MAY96 pt exp chickenpox;
big red patch / red blown up arm; fever; feeling uncomfortable; swollen arm; This case was reported by a consumer via call center representative and described the occurrence of skin red in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced skin red, fever, discomfort and swelling arm. On an unknown date, the outcome of the skin red, fever, discomfort and swelling arm were recovered/resolved.   It was unknown if the reporter considered the skin red, fever, discomfort and swelling arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient had dose 1 and 2 of Shingrix. The patient experienced a day or two of feeling uncomfortable, a red blown up arm, fever, and a big red patch. This was 1 of 2 linked cases, reported by same reporter. The reporter did not consent to follow up; Sender's Comments:  US-GLAXOSMITHKLINE-US2020133241:same reporter
hospitalized 9/18/21 with diarrhea, SARS-CoV-2 positive which was found incidentally.  Remains asymptomatic from COVID-19.
Bumps on forehead/bumps that were very itchy; Experiencing a rash and was itchy behind her ear; Experiencing a rash and was itchy behind her ear; This spontaneous case was reported by a patient and describes the occurrence of RASH PRURITIC (Experiencing a rash and was itchy behind her ear), RASH MACULAR (Bumps on forehead/bumps that were very itchy) and RASH (Experiencing a rash and was itchy behind her ear) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007C21A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced RASH PRURITIC (Experiencing a rash and was itchy behind her ear) and RASH (Experiencing a rash and was itchy behind her ear). On an unknown date, the patient experienced RASH MACULAR (Bumps on forehead/bumps that were very itchy). At the time of the report, RASH PRURITIC (Experiencing a rash and was itchy behind her ear), RASH MACULAR (Bumps on forehead/bumps that were very itchy) and RASH (Experiencing a rash and was itchy behind her ear) outcome was unknown.            It was reported that, the patient started experiencing a rash and was itchy behind her ear. A couple of days later it got super itchy. Then it started traveling up to her forehead. There were bumps that were very itchy. She then went to urgent care and was prescribed a cream and an allergy medication. Her rash has now left her forehead and ears, but is traveling down chin, neck, chest and back. She says there are little bumps on those areas of the body.   This case was linked to MOD-2021-149687 (Patient Link).
Patient received shot on 12/17. Reported to pharmacy on 12/20 with large red swollen area of upper arm that was raised and hot to the touch.
It is possible that the patient received 0.3ml instead of 0.5ml in the dose.
Patient lost consciousness immediately after receiving first COVID-19 vaccination, reported to writer by MD on site. MD reports that patient did not hit head. Received patient conscious and in wheelchair at 1625 in nurse response tent. Patient reported dizziness/lightheadedness, shakiness, and "felt weird". Patient received rest, juice, water, reassurance. Patient recovered and was discharged at 1700 per recommendation of Dr., patient denies need for further care.