chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 52-year-old male patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2020). Concomitant products included LYRICA, VICTOZA, cyclobenzaprine, FIORICET, meloxicam and topiramate. On 19th February 2018, the patient received SHINGRIX. On 20th February 2018, 1 days after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site erythema, injection site warmth and nausea. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site warmth and nausea to be almost certainly related to SHINGRIX. Additional details were reported as follows: This case was not reported previously to anyone. This case was reported by a registered pharmacist. The patient had redness at the injection site which spread from the upper arm to the elbow and also experienced nausea the next day after the injection. The portion of the arm from upper arm to elbow appeared swollen and warm to the touch. The pharmacist reported that the patient did not have fever.
headache; fever; nausea; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), PYREXIA (fever) and NAUSEA (nausea) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History was provided by the reporter.  Concomitant products included IBUPROFEN and PARACETAMOL (TYLENOL) for Adverse event.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.  On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced HEADACHE (headache), PYREXIA (fever) and NAUSEA (nausea).   On 30-Jan-2021, HEADACHE (headache), PYREXIA (fever) and NAUSEA (nausea) was resolving.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Patient had Tea with honey and cinnamon as treatment medicine.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 19-APR-2018, the patient was vaccinated with GARDASIL 9 lot number N021572 with expiration date on 01-MAY-2020 (strength, dose, route of administration and anatomical location were not reported) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion in the range between 32°F up to 35°F for 270 minutes and 47°F to 77°F for 75 minutes, as recorded by a data logger. The vaccine had not had any previous temperature excursions.  There was no adverse effect reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1805USA003078.
Information has been received from a lawyer concerning a 13 month old female wit no prior medical history and no known allergies who on 7/23/99 was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. On 8/4/99 the pt was diagnosed with diabetes. Unspecified medical attention was sought. Upon internal review, diabetes was considered to be an other important medial event (OMIC). Additional info is not expected.
Post vax, the pt developed 5 or 6 vesicles, never itched, cleared within one week. No fever, treated with symptomatics.
6 hours after shot in ER with 102+ degrees fever body aches vomiting.
The Covid19 vaccine accelerated my menstrual cycle. My periods were 19 days apart for roughly 3-4 months after the 2nd dose of the covid19-Pfizer vaccine.
I had all the symptoms of the Flu for 3 days, fever, muscle pains, cough, fatigue, and on the 4th day I started having horrible cramps, felt like labor/contractions, followed by my period, which wasn't due for another 3 weeks. I'm still having a very heavy flow and horrible cramping a week later.
Left knee swelling, cellulitis, septic joint. Admitted to hospital 12/3/99-12/4/99. Received IV antibiotics x 24 hrs. then discharged.
Patient with past medical history of renal transplant on immunosuppressants received Moderna vaccine on 3/12/21 and 4/9/21. Presented to the hospital on 4/10/21 with worsening shortness of breath, cough, weakness, diarrhea for 5 to 6 days. Admitted for COVID pneumonia. Patient is currently intubated on ventilator.
Flu & GARDASIL vaccine given about 16:10, on the way home (20 min) pt developed oral swelling and breathing difficulty, urticarial rash - went to Urgent Care, then to Emergency Dept.
Left shoulder pain. Started 1 hr after flu shot, has continued since, approximately 3 wks. Dr prescribed MOBIC and physical therapy.
Fever; Chills; Body aches; Headache; Fatigue; A spontaneous report was received from a reporter(consumer) concerning unknown age, male patient , who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever,chills, body aches, headache, fatigue and temperature was about 103 degree fahrenheit. The patient medical history was not provided.  The relevant concomitant medications were also not provided. On unknown date , prior to the consent of the events, the patients received their second of two planned doses of mRNA-1273(batch number: not provided) through the unknown route of administration for prophylaxis of COVID-19 injection. On unknown date the patient experienced pyrexia, chills, myalgia, headache, fatigue and temperature was about 103 degree Fahrenheit. Patient was feeling better Laboratory details not provided.  No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events were unknown.
developed hives localized to anterior chest 48 hours after vaccination which resolved within another 12-24 hours after taking Zyrtec.  No associated other systemic symptoms.
after administering the johnson and johnson covid vaccine patient fainted a few minutes later. He fell to the floor . he also cut his jaw in the process once we saw what was happening we rushed to help patient but he got back up almost immediately and refused calling 911 or going to convenient care of emergency room from for further care. he reported that he had fainted in the past with a different vaccine and believes he will be fine. we had patient sit in the pharmacy for an additional 30 minutes and confirmed that he wasn't experiencing any more symptoms before letting him go.
After each dose I had a very heavy menstrual period that I was not due for within 24 hours
This case was reported by a nurse via licensee and described the occurrence of headache in a 16-year-old female patient who received Influenza vaccine Quadrivalent. Co-suspect products included Meningococcal polysaccharide groups A, C, W-135, Y conjugate vaccine and Meningitis B vaccine. On 29th October 2015, the patient received Influenza vaccine Quadrivalent, the 2nd dose of Meningococcal polysaccharide groups A, C, W-135, Y conjugate vaccine and the 1st dose of Meningitis B vaccine. In 2015, less than a month after receiving Influenza vaccine Quadrivalent and Meningococcal polysaccharide groups A, C, W-135, Y conjugate vaccine, the patient experienced headache. In 2015, the outcome of the headache was recovered/resolved. The reporter considered the headache to be related to Influenza vaccine Quadrivalent and Meningococcal polysaccharide groups A, C, W-135, Y conjugate vaccine. Additional details were provided as follows: On Thursday, 29th October 2015, the patient received 1st dose of TRUMENBA and 2nd dose of Meningococcal polysaccharide groups A, C, W-135, Y conjugate vaccine in her left arm. On the same day, the patient received Influenza vaccine Quadrivalent in her right arm. The patient then complained of experiencing a bad headache for two and half days and this was reported by patient's mother at the office. The patient's mother began some sort of medication at home for the patient's headache but she did not say what the medication was. The sales representative of other manufacturer reported that he did not have any patient details including name, medical history and other details and added that the doctor's office will be happy to share other information. The reporter mentioned that the doctor did not know but he suspect that the adverse event was related to the vaccines. The doctor also did not know if it was combination of the vaccines or a single vaccine and they were actually calling to find out that and the reporter told them to call Medical Affairs to find the information. The sales representative called back to confirm the reporter of the adverse event and nurse as confirmed as reporter who had same address and contact as of doctor and added that he did not have the email address of the doctor. Limited information was available to the sales representative. It was unknown if the reporter considered the headache to be related to TRUMENBA. This case has been linked to case US2015GSK172261, reported by the same reporter.
viral meningitis; Initial information was received on 08-Dec-2020 regarding an unsolicited valid serious case from a non-healthcare professional.  This case involved a 48-year-old female patient who had viral meningitis (meningitis viral), after she received INFLUENZA VACCINE (MONOVALENT) (H1N1: Hemagglutinin Type 1 and Neuraminidase Type 1) and died.  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medication were not reported.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (MONOVALENT) produced by unknown manufacturer (batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, the patient developed serious viral meningitis (meningitis viral), 2 days following the administration of INFLUENZA VACCINE (MONOVALENT). This event was assessed as medically significant and was leading to death.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  On an unknown date, 2 days after vaccination, the patient had died due to viral meningitis.  It was unknown if an autopsy was done and the cause of death was reported as viral meningitis.  Information on the batch number was requested.; Sender's Comments: This poorly documented case concerns a 48-year-old patient who had meningitis viral, after vaccination with INFLUENZA VACCINE (MONOVALENT) (produced by unknown manufacturer) and died 2 days after meningitis. The time to onset is unknown. Also, patient's medical condition at the time of vaccination, autopsy result, previous vaccination and tolerance, lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: Viral meningitis
Flushing, sweating, throat itching, facial swelling. Observation with stable vital signs, pt took own Benadryl 25 mg PO with good effect. Patient discharged home with no issues.
Fever 100.4, chills, mild headache, fatigue, sore arm Took acetaminophen  Headache was longest lasting symptom Flu-like symptoms were gone within 9 hours. Sore arm lasted about 4 days
This spontaneous report as received from a pharmacist refers to a 53 year old male patient. The patient's medical history and current conditions were not provided. The patient had no known drug reactions or allergies. On 23-APR-2015 at 8:00, the patient was vaccinated with a dose of ZOTAVAX lot # K014835, expiration date 14-DEC-2015, subcutaneous in the right deltoid. Secondary suspects and concomitant therapies were not reported. On 23-APR-2015 at 13:00, the patient experienced redness extending down the length of his arm. It was unknown if the patient developed a rash. There was no treatment given for adverse event. The outcome of redness was reported as not recovered. The patient did not seek medical attention. The relatedness between redness and ZOSTAVAX was not reported. Additional information has been requested.
Received dose from a vial punctured more than 20 times; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Received dose from a vial punctured more than 20 times) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced ACCIDENTAL UNDERDOSE (Received dose from a vial punctured more than 20 times). On 19-Nov-2021, ACCIDENTAL UNDERDOSE (Received dose from a vial punctured more than 20 times) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   No treatment details were reported.   This case was linked to MOD-2021-393407 (Patient Link).
The headache, chills, nausea were initial symptoms. Within a week I became disoriented, forgetful, and had terrible headaches that led me to the Emergency Department. I was diagnosed with a Glioblastoma, clogged rear brain ventricles, and encephaly within 3 weeks of receiving the vaccine.
About 5 minutes after getting the second Pfizer vaccine she collapsed in produce section in front of the Pharmacy. When I saw the patient she lying on the floor and was responsive but filling dizzy. I got her some water and we had her lying for few minutes before we slowly started getting her up on the chair. When she set down she started feeling syncope again and almost collapsed again. we got her again lying down on the floor until paramedics came in about 5 to 10 minutes
Headache, Arthralgia, "right shoulder, hip, knee, foot, headache 9/10"  Narrative:
pt recv vax;irritable & had flu like sx; fever;cried himself to sleep;acted like was drunk,kept falling & could not support himself on rt leg;
Systemic: Body Aches Generalized-Mild, Systemic: Chest Tightness/Heaviness/Pain-Medium, Additional Details: Patient reported chest tightness and generalized body aches beginning 2 days after receiving booster dose of Pfizer/BioNTech vaccine. Patient stated chest tightness made it difficult to take a deep breath or even yawn. She described the tightness as "crushing," but said it resolved quickly. She has continued to improve back to baseline. All adverse effects reported resolved at the time of patient report.
Information has been received from a health professional concerning a 10 year old patient who was vaccinated with a first dose of Varivax. "In the past few years", beginning in approximately 2004, the patient experienced "shingles many times". Additional information has been requested.
Error by vaccine administration nurse, 0.2 mL given by nurse on 3/2/21. Client was called at 4:29 pm on 3/2/21 and incident was explained. PT understood situation and will be returning on 3/3/21 to receive correct dosage.
No additional AE; Nurse reporting VAQTA was administered after expiration. No additional AE. No PQC.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. Information regarding the patient medical history, concomitant medications, drug allergies or reactions was not provided.       On 23-NOV-2022, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA), 0.5 milligram, lot # U031911 expiry date 11-NOV-2022, for prophylaxis (expired product administered) (dose number frequency and administration route was not provided) .
Swelling, redness, tightness at the site of injection within few hours of the shot. Pt was seen in ER and received prednisone taper, clindamycin and NORCO for pain. Pt was seen today, improving swelling and redness.
Information has been received from a registered nurse concerning a 5 year old female who was vaccinated on 09/13/1999 with a dose of varicella virus vaccine live (Oka/In August 2003, the patient was seen with a few lesions after a known exposure.  The child was noted to have chickenpox breakthrough.  Unspecified medical attention was sought.  There was no product quality complaint.  The reporter indicated that 19 other patients were vaccinated with a dose of varicella virus vaccine live.  No further information is expected.
Parent reported 2 days after vaccination :   On the afternoon after vaccination, patient exhibited shortness of breath, dizziness and nausea.  No action was taken at the time of the symptoms.  Nausea, fever and fatigue continued for the following 2 days.  Appointment  was recommended but declined by parent (father).
Headache; Body aches; Swelling at site; This is a spontaneous report from a contactable nurse. A 59-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration, on 20Jan2021, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 30Dec2020 for COVID-19 immunization. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the Nursing Home/Senior Living Facility. On 20Jan2021, the patient experienced headache, body aches and swelling at site. The patient did not receive treatment for the events. Outcome of the events was recovering. The patient underwent nasal swab on 21Jan2021 and showed a negative COVID test result.  Information about lot/batch number has been requested.
Fever of 102 degrees fahrenheit approximately 12 hours after injection. The fever lasted approximately 3 days, decreasing incrementally until it ended on day 4 Extremely run down, headache, fatigue, general fogginess. This fade away with the fever. Painless, swelling in both armpits, approximately the size of a lemon and felt fluid filled. The swelling slowly went away on its own after about a week.
Within 5 minutes after injections the patient fainted and had mild seizure-like activity.  Pt was diaphoretic and incontinent of urine.  The patient regained consciousness and walked to exam table to lie down with RN assistance.  Blood pressures taken twice 15 minutes apart, patient monitored for 30 minutes then released to mother's care.  Patient walked out of clinic.  Patient referred to PCP for follow up care.  Mom states pt had anxiety related to medical treatment and the use of needles.
Narrative:  COVID infection following COVID vaccine series 01/04,  MODERNA, dose #1 02/02, MODERNA, dose #2 08/27 COVID swab, result: detected 08/27 pt cc: exposure: unknown
Headache, Myalgia, Arthralgia, Fever, injection site reaction, chills, fatigue Narrative: Employee reported experiencing leg pain (received vaccine in right gluteus maximus), body aches, chills, fever, headaches, joint pain, body aches, and fatigue. Reports pain was 7/10. Reports took Tylenol (no dose or frequency provided).
1:37PM PT IN PASSENGER SEAT OF HER VAN.  VERY SOB. SQUAD CALLED.  STATES SHE GOT COVID VACCINE, WAITED 15MIN WITHOUT ANY PROBLEMS. WALKED OUT TO VAN AND BECAME VERY SOB AND HAS NOT BEEN ABLE TO RECOVER. ON PERSONAL 02/NC. A/O, PALE, W/D WITH MOD RESP DISTRESS. 1:45PM TRANSPORT TO ER PER SQUAD. STATES SHE WAS TO HAVEA LUNG SCAN TODAY AT 2PM. 3-5-21 4:30PM TC - STATES SHE WASTX AND RELEASED 3-4-21 AT 11PM WAS GIVEN LASIX 120MG AND HAD LUNG SCAN. STATES SHE DOES FEEL BETTER TODAY. ALL S/S RESOLVED.
The onset started on Friday, 23 Mar 07 at approx. 1730 with a slight rash on both arms. The symptoms progressed to a sore throat, headache, congestion, fever, night sweats, hot and cold flashes and an unproductive cough on Saturday, 24 Mar 07 at approx. 2230. I was seen by a provider 26 Mar 07 and was given Sudafed and Robitussin and placed on quarters for 48 hours. The symptoms continued without relief and I was again seen by a  provider on 28 Mar 07. At that time I was given another cough medicine and Zithromax and placed on another 48 hours of quarters. On 30 Mar 07, I was back at work and felt slightly better but still had a cough, congestion, and a headache. The symptoms finally resolved on 5 April 07 even though I still have a dry hacking cough.
Mother ill with GE symp for approx 1 week following first vaccination.  Mother and father ill with GE symp for approx 1 week after second vaccination.
Migraine with aura weekly for 6 weeks straight after 2nd dose. Duration was 5-6 days compared to previously lasting only 24 hrs. After the 6 week period, migraine is easily triggered by skipped meal or vigorous exercise and is occurring monthly as compared to 1-2 x per year.
This is a spontaneous report from a contactable physician via a Pfizer colleague. A female patient of unspecified age received first dose of TRUMENBA on unknown date, at single dose. Medical history and concomitant medications were not reported. The patient became very short of breath with wheezing about 12-15 hours after vaccination. The patient visited an allergist who felt that while this was a side effect to the vaccine and could reoccur (however did not call it an allergic hypersensitivity reaction). Prior to receiving second dose of TRUMENBA, she was pre-medicated with BENADRYL and provided EPIPEN. The same reaction re-occurred. This time the allergist has recommended to not proceed with further immunizations. He did not feel that skin testing or progressive dilution injections would be beneficial because of the delay in the time of the development of symptoms. Events outcome was unknown. Follow-up (24DEC2015): Follow-up attempts are completed. No further information is expected.
Patient comes to the ED with complaint of being covid positive and increased shortness of breath and coughing.  Patient admitted with covid pneumonia with hypoxia.  Patient treated with remdesivir.
HX: Prior to event pt reported weakness for 5 days post vaccine.  On 06/17 c/o chest pain throughout the day.  Pt experienced syncopal episode on EMS arrival at home.  Afib- Asystole- Cardiac Arrest.  Shocked and cowated, transport - ed.  Tarry black stool on arrival to ED.  Cardiac arrest in ED, CPR initiated- ACLS algorithm followed.   Lab h/h 2.8/10.4, APTT 5635, PT 17.5, INR 1.4, BNP POCT 308, LACTIC ACID 20.00 /Patient died at 8:00 pm 06/21/21. ME accepted the case.
Intense itching, redness (rash), and hardness at the injection site one week after the vaccination
nauseous; a little vomiting; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nauseous) and VOMITING (a little vomiting) in an 18-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021, the patient experienced NAUSEA (nauseous) and VOMITING (a little vomiting). At the time of the report, NAUSEA (nauseous) and VOMITING (a little vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information was provided.  Treatment information was not provided.   Reporter did not allow further contact
The day after I received the shot, I had the following symptoms:  1. Redness and large swelling at the injection site  2. A runny nose and sore throat 3. Fatigue and muscle pain