chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Started with mild headache the evening of vaccine administration. 12/27/20 woke up with severe body aches, severe chills, sorethroat, sinus congestion and sinus discomfort, and extreme fatigue. Took temp once and it was 99.5 oral. Symptoms were gone within 28 hours of onset. Minor discomfort at vaccine site as expected.
Rash where the vaccine was administered, pain, swollen and warm to touch. Client also complained that she started having pain in right arm that was consistent and is still bothering her. Allergy medicine and tylenol/ibuprofen.
Initial information received on 17-Dec-2018 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a five months old female patient who was vaccinated with a 0.25 ml first dose of vaccine FLUZONE QUADRIVALENT (lot UT626KA and Exp. Date 30 Jun 2019) via unknown route in the left thigh on 03-Oct-2018 when she was 5 months old. The patient's medical history not reported and concomitant medications included PENTACEL; POLIO VACCINE INACT (IPV); and ROTAVIRUS VACCINE via oral route for Immunization on 03-Oct-2018. It was an actual medication error case due to inappropriate age at vaccine administration. No any adverse event experienced by patient. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
0755 Pt notified other Nurse that he is feeling nausea; slight dizziness. He reported to Nurse that he did eat light breakfast this AM prior to COVID #1 Injection.  Pt resting with eyes closed. Nurse  spoke with pt, DOB, pt works in, Nurse offered pt Water, Crackers, snack.  Pt offered to be taken to ER or to call Rapid Response so vitals can be taken and closer monitored.  Pt refused ED and Rapid Response.  Pt stated he will just sit longer and complete his Observation time.  Nurse provided Continuous Monitoring; checked on Pt symptoms every 5-8 minutes.  Pt stated he is fine and symptoms are subsiding.  After 15-20 minutes of Observation; Pt was ready to leave.  Pt stated he is well, symptoms have resolved, he is fine; per pt. Pt left Observation at 0808; steady gait, denies chest pain, SOB, any further Dizziness, or any further Nausea.
Day one after vaccine, extreme joint pain, head and neck pain. Day 2 extreme neck and low back pain/widespread muscle pain/aches. Day 3 Vertigo, headache, neck pain, nauseous. Day 4 sore throat, nasal congestion, ringing in Right ear, with fullness on R side of head, continued Vertigo for 10 days. Currently dizzy, uneasy on feet, ear fullness, post nasal drip, slight sore throat, cough.
11pm nausea and cold shivers started. I couldn't sleep and by 1am I had a fever of 100.9. I took 1000mg Tylenol at 4:30 am, and at 5:30am have a fever of 102.5. I still cannot sleep, and the fever keeps rising.
Pt. stated, "I felt lightheaded and I started to sweat a lot 5 minutes after getting vaccinated."  "I suffer from anxiety sometimes."  Vital signs done  BP 124/84, HR 73, R 19.  At 1:16pm pt. stated, "I feel better, I will call my family to pick me up."  At 1:27pm pt. went home with family members.
This spontaneous report was received from a 51 year old female nurse practitioner student, with diabetes, hypertension and penicillin allergy, regarding herself. On 21-JAN-2015, the patient was vaccinated with a singles dose of ZOSTAVAX, subcutaneous in the left arm (lot number and expiration date were not reported). Concomitant therapies included VICTOZA, metformin and TRIBENZOR. On 22-JAN-2015, the patient experienced redness, swelling, itching, warmth and pain at the injection site. Subcutaneously the area of the reaction extended from the back of the left arm to her left elbow. The patient contacted an unspecified physician who advised the patient to take ZYRTEC and hydrocortisone cream. The consumer also applied ice packs to the area. The reaction resolved after 1 week, in 29-JAN-2015. This is one of two reports from the same reporter. Additional information has been requested.
reports that sometime in between this shot and when her second dose is scheduled (19APR2021), her doctor gave her a Depo Medrol allergy shot; had "a little sore" arm; "little bit of a headache"; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) The reporter is the patient.  A 76 year-old female patient received bnt162b2 (BNT162B2), administration date 17Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: DEPO MEDROL taken for asthma, hypersensitivity. The following information was reported: CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (non-serious), outcome "unknown", described as "reports that sometime in between this shot and when her second dose is scheduled (19APR2021), her doctor gave her a Depo Medrol allergy shot"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "had "a little sore" arm"; HEADACHE (non-serious), outcome "unknown", described as ""little bit of a headache"".  Additional Information: She states that she read online that she should have waited to get this shot 2-4 weeks after getting her second dose of the vaccine, and now would like to know if she is still safe to get the second dose on 19Apr2021.  Response: Spoke from the attached documents regarding contraindications to getting a dose of the vaccine and the caution of administering the vaccine to people with weakened immune systems, including those on medications that could weaken the immune system.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
chills; nausea; This case was reported by a pharmacist and described the occurrence of nausea in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th January 2021, the patient received the 2nd dose of Shingrix. On 4th January 2021, 5 hrs after receiving Shingrix, the patient experienced nausea. On 5th January 2021, the patient experienced chills. On an unknown date, the outcome of the nausea and chills were unknown.   It was unknown if the reporter considered the nausea and chills to be related to Shingrix.  Additional details were provided as follows: The patient was vaccinated with 2nd dose of Shingrix. 5 hours after vaccination patient had nausea. On next day after vaccination patient experienced Chills. The reporter consented to follow up.
Paresthesias, muscle weakness: Guillian Barre syndrome. Onset 12 days following first COVID vaccination. No other acute illness typically associated with GB.
The left arm was sore following the injection, same day. Woke me up during night when I would turn in bed. But not bad (level 3 of a 1-10 chart). Following morning, I had a slight foggy headache, but not bad.  Approximately 9:30, my joints (knees, elbows, hands, shoulders, ankles - started becoming uncomfortable and hurting. I took 800 mg of Ibprofen about 10:00 am and around 12 - 1:00  realized I did not have any more discomfort.  That was it.  It did not come back. No more headache either.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On 03-MAR-2017, the patient was vaccinated with an expired dose of GARDASIL injection, lot # K006191 with expiry date 02-FEB-2017, 0.5 ml intramuscularly. It was unknown which dose in the series that dose had been. No adverse effects were reported. Product quality complaint was not involved. Additional information has been requested.
Initial information received on 21-Feb-2019 regarding an unsolicited valid non-serious case received from other healthcare professional. This case involves female patient who was exposed to vaccine ADACEL during pregnancy. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The vaccination occurred at unknown gestation period. The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error case due to inappropriate schedule of vaccine administered. It was also a case of off label use and vaccine exposure during pregnancy. It was reported that they have been vaccinating pregnant women each pregnancy even if it has been less time between vaccinations than what is recommended by the PI. Sometimes if they are pregnant back to back it could be 14 months from the last vaccination. It was unknown whether the patient had any adverse reactions. Additionally, at time of reporting, the outcome of the pregnancy was unknown. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
difficulty in breathing properly; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (difficulty in breathing properly) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Cancer (cancer survivor) and Lung lobectomy (removal of part of a lung.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (difficulty in breathing properly). At the time of the report, DYSPNOEA (difficulty in breathing properly) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication were reported. Treatment medication was not provided.
This spontaneous report was received from a physician, via company representatives, and refers to a patient of unknown age and gender. Information about the patient's pertinent medical history, drug reactions or allergies and concomitant medications was not reported. On 12-JUL-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ 2 ML, 10 unit dose tube, which had the lot # K022995, with expiration date 22-JUL-2016, orally (dose and dosage number were not reported). No adverse effects were reported and no product quality complaint was involved. On unspecified dates, the vaccine experienced temperature excursion of 24 hours. The highest recorded temperature was 47 F (8.333333333 Celsius degrees), the lowest temperature was not reported. The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type were reported as "Refrigerator(R)". This is one of the several reports received from the same reporter. Additional information has been requested.
That same evening of the vaccine administration date, the patient experienced a red, 2in x 1&1/2 in circle at the injection site. The color has lightened to a pink color but the diameter has stayed the same. Patient brought this to Pharmacist attention on 6th day after administration. Patient has not taken any medication or applied any medication to site.
Fever 101.5, injection site swelling, , Lymph node swelling (table tennis ball size,  tachycardia 117-150, feeling tired, feeling of being flushed, insomnia, chills. Joint pain. Used extra strength Tylenol.
Patient attended mass vaccination clinic and received Moderna as second dose. Patient should have received Pfizer for second dose.
guillain barre syndrome; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP) from medical information team. A 18 year-old female patient received bnt162b2 (COMIRNATY) (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: GUILLAIN-BARRE SYNDROME (hospitalization, medically significant), outcome "unknown", described as "guillain barre syndrome". The patient was hospitalized for guillain-barre syndrome (hospitalization duration: 14 day(s)). Clinical course: the consumer's granddaughter developed guillain barre syndrome from the Pfizer COVID-19 vaccine. Her nerves has been affected and cannot walk and is in a wheelchair. It has also went to her face and has affected her eyesight. Her doctor has said that the Pfizer COVID-19 vaccine has contributed to it.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Cough, chest congestion, hoarse-ness, rapid heart rate, shortness of breath, tired.
Breakthrough COVID infection on 07/14/2022. Cough noted. Unsure onset of symptoms.
Red rash, itchy, raised on lower forearm and on side of back and torso reported to MD; told her to take BENADRYL, Erythromycin, MUCINEX, Hydrocort oint 1%.
Information has been received from a pharmacist concerning a female patient who on an unspecified date was vaccinated with zoster vaccine live (Oka/Merck) (lot # 658861/1822U). Subsequently, the patient developed an erythematous injection site rash. It was unspecified if medical attention was sought. The patient recovered on an unspecified date. There was no product quality complaint involved. Follow-up information from the pharmacist indicated she did not have the names of the patients involved in the event. Follow-up information has been received from the pharmacist concerning this 65 year old female consumer who on 13-FEB-2008 was vaccinated SQ with a first dose of zoster vaccine live (Oka/Merck) (lot # 658861/1822U). Subsequently on 14-FEB-2008 the patient developed a rash about 2 inches in diameter around the injection site. There was no medical attention sought. The patient recovered on 15-FEB-2008. This is one of several reports from the same source. Additional information is not expected.
she experience ringing in her ears, worse then ever before, states she has had ringing in the ears prior to ever receiving the Moderna vaccine but says it was worse then ever; Had a temperature which lasted for 48 hours; Felt off; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt off), TINNITUS (she experience ringing in her ears, worse then ever before, states she has had ringing in the ears prior to ever receiving the Moderna vaccine but says it was worse then ever) and PYREXIA (Had a temperature which lasted for 48 hours) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Drug allergy (Aspirin,), Drug allergy (cough syrup) and Drug allergy (codeine). Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced FEELING ABNORMAL (Felt off) and PYREXIA (Had a temperature which lasted for 48 hours). On 14-Apr-2021, the patient experienced TINNITUS (she experience ringing in her ears, worse then ever before, states she has had ringing in the ears prior to ever receiving the Moderna vaccine but says it was worse then ever). On 15-Apr-2021, PYREXIA (Had a temperature which lasted for 48 hours) had resolved. At the time of the report, FEELING ABNORMAL (Felt off) had resolved and TINNITUS (she experience ringing in her ears, worse then ever before, states she has had ringing in the ears prior to ever receiving the Moderna vaccine but says it was worse then ever) had not resolved.        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.   Treatment  was "white noise machine to help" for the symptom to recede, as reported by the patient.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Follow up received on 10-jun-2021 includes patient demographic details and medical history was added out come of the event was updated
Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. On unknown dates in 2015 ("since 16-APR-2015") the patients were vaccinated with doses of RECOMBIVAX HB (lot # K021581, expiration date 24-OCT-2016) (dose and route were not reported), which were exposed to temperatures outside of the recommended range. No adverse experience had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Half inch diameter redness; non healing sore at the inoculation site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 83-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Lot number: FJ4991), in right arm for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing), notes: Other medical history: COPD, High Blood Pressure, Gout, Anemia; "High Blood Pressure" (unspecified if ongoing), notes: Other medical history: COPD, High Blood Pressure, Gout, Anemia; "Gout" (unspecified if ongoing), notes: Other medical history: COPD, High Blood Pressure, Gout, Anemia; "Anemia" (unspecified if ongoing), notes: Other medical history: COPD, High Blood Pressure, Gout, Anemia. Concomitant medication(s) included: IRON; CALCIUM; LOSARTAN; B-12; SIMVASTATIN; ALLOPUR. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer.), for COVID-19 immunization; Bnt162b2 (product: Pfizer-BioNTech,, lot number: 30/4s8a,, dose number: DOSE 3 (BOOSTER), SINGLE, vaccine location: left arm), for COVID-19 immunization. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), outcome "not recovered", described as "Half inch diameter redness"; VACCINATION SITE ULCER (non-serious), outcome "not recovered", described as "non healing sore at the inoculation site". Therapeutic measures were not taken as a result of vaccination site erythema, vaccination site ulcer.  Additional information: Half inch diameter redness and non healing sore at the inoculation site since the day of the third booster on Jul2022.
DEATH; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown cause of death. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient received the Janssen COVID-19 vaccine and then died 15 days later. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).  .; Sender's Comments: V0-20210456256- COVID-19 VACCINE AD26.COV2.s.adverse effect . This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Redness and swelling at injection site 9 cm x 13 cm swollen area. TYLENOL PRN, BENADRYL and ice packs to site.
Stay there 20 minutes after vaccine. Right after I left started to feel strange stopped at the store down the street went inside for 40 minutes until it passed.  Was like doing 4  shots of tequila in 2 minutes.  Leaned up against shelf and my shopping cart for about 5 minutes at one point.  Walked around the store for a while and then drove home, now 2 hours later and I am fine.
Information has been received from a consumer concerning her 17 year old daughter without medical history or drug allergies who around 25-SEP-2008 was vaccinated with the first 0.5 ml dose of GARDASIL (lot number not provided).  There was no concomitant medication.  Around 11-NOV-2008 the patient had PAP and urine analysis done and it was discovered that she had HPV (the patient developed HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68).  No further information was provided.  The outcome was unknown.  The patient sought unspecified medical attention.  Additional information has been requested.
I am the patient. I had a gallbladder attack among the other usual symptoms shortly after my first Moderna shot. An ultrasound confirm the existence of a gallstone and sludge, which had never been symptomatic. Nausea started the second morning after the shot along with other typical post vaccinations symptoms. Progressed to pain, in what they said is a typical gallbladder attack sequence. Added in were typical side effects of covid-19 vaccination: feverishness (under 101°), pain at the injection site, fatigue, very bad headache. Headache responded to 800 mg acetaminophen. Other symptoms subsided in 3 days. Gall bladder attack symptoms continued for weeks. Modified diet to mostly vegetarian with rare portions of low-fat meats like turkey and egg whites. Symptoms resolved by 04/12/2021.
pt recv vax 21NOV98 & exp photophobia, ocular burning, sensation of orbital swelling & itching;
Right upper arm red, swollen, and warm to touch. Recommended cold pack times 20 minutes as tolerated. Also BENADRYL and ibuprofen as directed.
The shot was given in my left arm below my shoulder on 11/15/19. The shot was a little painful. I went home and within a few hours my arm and shoulder area was extremely sore and painful. At one point, I was crying because of the sharp pain and almost had frozen shoulder because I was not able to move it for a bit. This sharp pain last for two weeks, receding slightly. I called the same doctor after these two weeks of pain, and they did nothing. They asked me to give it more time. I called a month later, and they prescribed me Gabapention, which did not help. The sharp pain got a little better, but then it started to turn into deep shoulder pains in my shoulder joint. Four months later on 2/20/2020, I went back to the doctor because the pain was not getting any better. Then, they referred me to the orthopedic doctor.
Patient began having seizures again after 3rd hepatitis B vaccine according to mother. has had seizure activity previously but apparently were under control.
Developed hives with itching 04/04/2005. Increased hives and itching on 04/05/05. Increased SS 04/06/05-Pt called travel nurse and was told to call regular MD and MD did not see pt but ordered Benadryl 25mg TID and for him to continue Allegra he already was taking.