chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a health professional concerning a 92 year old female with arthritis, glaucoma, macular degeneration and allergies to chocolate and "DAMRON" and hypertension and a history of hysterectomy who on 01-NOV-2007 was vaccinated with ZOSTAVAX (Lot # 658604/1088U) at 10:20 am first dose.  Concomitant medication included aspirin, amlodipine besylate (+) benazepril hydrochloride (LOTREL) esomeprazole magnesium (NEXIUM) and montelukast sodium (MSD).  On 12 NOV-2007 the patient was seen by the physician for a watery draining left eye.  It was reported that the patient had macular degeneration and extremely poor vision at which time she was diagnosed with a bacterial infection and prescribed erythromycin opthalmic ointment.  The patient used this ointment for a few days and then she developed facial pain and a rash.  The patient contacted the office and they presumed it was a reaction to the erythromycin and she was told to stop it.  The patient had pain so she went to the emergency department.  The patient reported that she had macular degeneration and could only see a shadow and movement.  The patient had left sided facial pain forehead.  Vital signs were temperature 96, BP 164/62, pulse 108, respiratory rate 17 and pulse oximetry 98%.  The emergency room summary noted that the patient had a vesicular rash on her forehead and around the eye.  Corneal staining was negative.  The clinical impression was herpes zoster without current evidence of hutchinsons sign.  The patient had a vesicle broken and the fluid sent for smear.  The patient was managed as an outpatient with acyclovir 800mg five times a day and PERCOCET one q 4-5 hours prn pain.  The patient recovered.  Additional information is not expected.
Patient >12 years old and should have received the 12+, purple capped, Pfizer vaccine at 30 mcg, but instead, received the 5-11yo, orange capped, Pfizer 10mcg dose.
Felt itching and notice a small bump on her face and went to sleep. When she woke up, in the morning, she notice her tongue, eyes, and face was swollen, and has a rash like pimples all over her face, and also had 4 episodes of vomiting.
Started 5 hours after shot severe arm swelling and redness and confusion. Arm pain and mental fog for 3 days and then started to improve. Still 10 days out and feels like extra effort to concentrate and started had busted blood vessels on vaccine arm and back. swelling and tenderness almost resolved.
over 42 days. 1st dose 08/13/21, 2nd dose 09/30/21
Information has been received from a healthcare worker concerning a male patient who on 16-OCT-2008 was vaccinated with 1 dose of PNEUMOVAX 23.  On 17-OCT-2008 ("within 24 hours of administration") the patient experienced severe swelling of the arm and extreme pain in that arm.  The patient went to the ER and was admitted to the hospital.  He has been in the hospital since.  Additional information has been requested.
7 Oct 21: 34 year old male patient received his second COVID 19 vaccine. Patient stated before the vaccine was administered that he tends to feel lightheaded. After the vaccine was administered the vaccinator asked the patient how he was feeling and the patient stated he was "fine".  Patient was given discharge instructions and told to sit in the observation area. It was there that the patient stated "he was feeling dizzy, light headed and blurred vision" approx. 10 minutes after receiving the vaccine. Patient stated he had similar reaction to 1st COVID vaccine lasting approx. 3 hours. Pt states he  slept it off and eventually felt better. Vital signs were Within Normal Limits. Patient taken to the Emergency Room based off hospital protocol.
No signs or symptoms. Pt was to receive influenza vaccine and he received Hepatitis B by mistake. The administering nurse immediately notified her supervisor, and the appropriate chain of command was followed along with incident reporting. Pt was notified. Instructed to go to ER if any symptoms occurred once he leaves the clinic. Verbalized understanding.
The left arm from the injection site down to the elbow swelled up, turned red and began itching the next day.  Larger reaction site than the typical "injection site reaction."  Patient treated with benadryl, OTC antihistamine, and topical hydrocortisone.
On 2/6 my shoulder started itching and I noticed a small red patch at the injection site. On 2/7 I woke up to more intense itching and the red area was larger than the night before. The itching continued and on 2/8 the rash was much larger, the outer margins were dark while the inside was lighter. By 2/10 it was completely gone but the itching continued sporadically. I did not treat the rash at all, topically or orally.
fever 3 days p/2nd dose; also local reaction of itching & redness; no reaction p/3rd dose;
Experience side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Experience side effects) in a female patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Experience side effects). At the time of the report, VACCINATION COMPLICATION (Experience side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. No relevant concomitant medications were reported.
SOB, BP 107/68, HR 82, O2 100%,  No progression of Symptoms, SOB resolving, Ate crackers/juice.  Patient provided wheelchair transport to parking lot.  Doing fine per patient.
I had a chronic cough and congestion, I tried over counter for 2 weeks and it it didn't help. I had Frontal lobe headaches from coughing so much, I had a lot of phlegm, I went to express care and they Augmentin and Benzonatate, a steroid prescription Z-pac, cough syrup with codeine. After I finished the first set it helped but didn't go away, I came back 3 weeks later got everything again except for Z-pac,  I still today I have a slight cough and also the 2nd time at express care she gave me an inhaler.
COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test/ Severe Coughing/ a little bit of a headache/ also cannot taste well; This is a spontaneous report from a contactable consumer (patient father).   A 19-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER2613, Expiration date was not reported) via an unspecified route of administration on 09Mar2021 (at the age of 19 years) as dose 1, single and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER2613, Expiration date was not reported), via an unspecified route of administration on 20Apr2021 (at the age of 19 years) as dose 2, single, both for covid-19 immunization. Patient had no medical history and family medical history relevant to events. The patient's concomitant medications were not reported. Patient did not take any other vaccinations within four weeks prior to the first administration date of the suspect vaccine and no other vaccines on same date of the vaccination. On an unknown date, patient experienced severe coughing and a little bit of a headache and patient decided to get tested for covid-19. The symptoms were still persisting. Patient also cannot taste well. On 13Sep2021, patient got covid-19 confirmed by positive covid-19 test, after both doses of vaccine. Product complaint was reported as yes. Patient did not visit to emergency room or physician office. The clinical outcome for the events was unknown.  No follow-up attempts are possible. No further information is expected.
Breakthrough case admission after 2 vaccines Moderna 1/18/21 lot# 027L20A;  Moderna 2/15/21 LOt# 011M20A
This spontaneous case was reported by a nurse and describes the occurrence of INCORRECT PRODUCT FORMULATION ADMINISTERED (Bivalent dose administered instead of the monovalent as 2nd primary dose) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced INCORRECT PRODUCT FORMULATION ADMINISTERED (Bivalent dose administered instead of the monovalent as 2nd primary dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT PRODUCT FORMULATION ADMINISTERED (Bivalent dose administered instead of the monovalent as 2nd primary dose) 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 INCORRECT PRODUCT FORMULATION ADMINISTERED (Bivalent dose administered instead of the monovalent as 2nd primary dose). No concomitant medications were reported. No treatment information was provided.
Patient deceased on 11/27/18. At time of this report, reason of death is unknown, per reporting guidelines from CDC this report is being submitted by administering facility as immunization was given approximately one month prior to death of patient. No known adverse event was reported by patient or other family member directly related to vaccine administration.
11/9 Dizziness and weakness 2 days after vaccination by 4pm on the 9th felt better. Experienced same symptoms plus light headedness & body aches on 11/11/08 x2hrs, then felt better, BP WNL 132/75 at home. HX of receiving flu shot in past w/ no RXNS.
1) Pimple, right upper lip; followed by a pimple on left upper lip. (I do not normally "suffer" pimples. I do not know if the vaccine was responsible for the pimples. Pimples "went away" over a few days. 2) Trigger finger, left hand, middle finger.  It took 6 weeks to get an appointment (on 5/25/22) with a rheumatologist before receiving a steroid injection, which appears to have resolved the pain. Again, I do not know if the vaccine was responsible.
Information has been received from a licensed visiting nurse concerning a 7 year old female who on 05-JUL-2000 was vaccinated with a dose of Varivax. On 02-MAR-2006, the patient was evaluated by a physician and had over 100 lesions. The patient was determined to have varicella. A product quality complaint was not involved. Additional information has been requested.
Diarrhea; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and PAIN IN EXTREMITY (sore arm) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B2114) for COVID-19 vaccination.     Concurrent medical conditions included Lupoid dermatitis and Fibromyalgia. Concomitant products included PREGABALIN (LYRICA), BACLOFEN and AZATHIOPRINE (AZOPINE) for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced DIARRHOEA (Diarrhea) and PAIN IN EXTREMITY (sore arm). At the time of the report, DIARRHOEA (Diarrhea) and PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications Lyrica, baclofen, azopine  topical gel Treatment details included drinking lots of water to keep hydrated her self Action taken with mRNA-1273 in response to the event was unknown   This case was linked to MOD-2021-089573 (Patient Link).
On 7/12/21 started getting sharp pains left side it  felt like it was in my heart then on July 13, 2021 I want to  hospital. The ER they did bloodwork many test  chest x-ray the final diagnosis was pleurisy. I have never had any lung issues in my life except asthma when I was a young child  which I out grew it as a teenager. I am following up with a pulmonologist on Monday, July 19, 2021 as advised.
Headache, Myalgia, Fever, NauseaVomiting, Chills and fatigue Narrative:
Patient received vaccine on 8/7/17 and said her arm from elbow to should was very swollen and red by that evening. She came to pharmacy on 8/9/17 and reported red, swollen, warm upper arm. She was advised to call/see her doctor.
Patient experiences body pain, swelling of arm, fever, and rash on arm of injection. The patient is taking ADVIL for fever and pain relief.
low grade fever; he did not feel well; This is a spontaneous report from a Pfizer-sponsored program. A contactable nurse reported that a male patient of an unspecified age received second dose of bnt162b2, via an unspecified route of administration on an unspecified date at single dose for covid-19 vaccine. The patient's medical history and concomitant medications were not reported. The patient experienced low-grade fever, he did not feel well on an unspecified date. Caller was reporting on herself, her husband, and her doctor. This was the report for the caller's doctor. Her doctor told her that he had a low grade fever after his second dose and he did not feel well. The patient underwent lab tests and procedures which included body temperature: low grade on an unspecified date. The outcome of events unknown.  Information on the lot/batch number has been requested.
This spontaneous report as receivd from the nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medication were not reported. Between November 2014 until 03-DEC-2014 the unspecified number of patients was vaccinated with unspecified number of doses of improperly stored PEDVAXHIB (doses, indications, route of administration were not reported). The nurse did not know whether any patients experienced any adverse effects. This is one of several reports from the same reporter. Additional information has been requested.
Information has been received from a licensed practical nurse, for the Pregnancy Registry for Gardasil concerning a 25 year old female with drug hypersensitivity to ENTEX, erythromycin, codeine, LORTAB, and IMITREX and a history of pregnancy who on 21-NOV-2006 was vaccinated with first dose of Gardasil (lot # 654702/0011U) IM. On 22-JAN-2007, the patient was vaccinated with second dose of Gardasil (lot # 654702/0011U), IM. Concomitant therapy included amitriptylline hydrochloride. The patient sought medical attention. On an unspecified date, urine beta-human chorionic gonadotropin test was positive for pregnancy. The patient's last menstrual period was December 2006 (gestation: first trimester), expected date of delivery is approximately September 2007. No other information was available at the time of reporting. Additional information was received from a health professional from the physician's office via telephone. It was reported that the patient terminated her pregnancy (date not reported), not because of Gardasil but for other reasons. The outcome of the induced abortion was not reported. Upon internal review, abortion induced was determined to be an Other Important Medical Event. No additional information is expected.
Received pneumococcal vaccine 3 days after Moderna COVID 19 vaccine; A spontaneous report was received from a consumer who was also a 49-year-old, female patient who received Moderna's Covid-19 vaccine (mRNA-1273) and received pneumococcal vaccine 3 days after Moderna COVID 19 vaccine  The patient's medical history was not provided. Concomitant product use was not provided.  The patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20-2A) on 11 Jan 2021 in the left arm intramuscularly for prophylaxis of COVID-19 infection.   On 14 Jan 2021, the patient received a pneumococcal vaccine on her right arm. The appropriate schedule would have been to have waited two weeks.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.   The event, received pneumococcal vaccine 3 days after Moderna COVID 19 vaccine, was considered resolved on 14 Jan 2021.  The reporter did not provide an assessment of the event, received pneumococcal vaccine 3 days after Moderna COVID 19 vaccine.; Reporter's Comments: This case concerns a 49-year-old, female patient who received first of two planned doses of mRNA-1273 (Lot number: 039K20-2A) on 11 Jan 2021 in the left arm intramuscularly for prophylaxis of COVID-19 infection and received pneumococcal vaccine 3 days after Moderna COVID 19 vaccine on her right arm. There were no reported adverse events associated with the event of the patient received a pneumococcal vaccine on her right arm
I became infected with Covid about 3 weeks after having had my first Moderna shot.; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I became infected with Covid about 3 weeks after having had my first Moderna shot.) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (I became infected with Covid about 3 weeks after having had my first Moderna shot.). At the time of the report, COVID-19 (I became infected with Covid about 3 weeks after having had my first Moderna shot.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was provided.
Approx 1 hr p/receiving vax, pt spiked temp to almost 104, & was shaking; mom took pt to MD right away & pt was fine but not to receive any more pertussis vax;
Initial report from healthcare professional on 25 August 2014. A female patient in her 30's, whose concomitant medications were not reported, had received injection of first dose of IMOVAX rabies (batch number, route and anatomical site of administration were not reported) on an unspecified date as pre-exposure prophylaxis. Patient has "allergy" to eggs (that is why IMOVAX chosen) with reaction of severe GI distress. The patient didn't have significant other medical history. Rabies was the only vaccine given that day. A prescription for oral typhoid vaccine was provided, but not yet started. It was reported that on an unspecified date, on next day after receiving IMOVAX rabies vaccine, the patient experienced dull headache which was resolved within 24 hours. On day 2 after vaccination, the patient developed fever, diffuse joints and also nausea without improving. The patient could take OTC MOTRIN PRN as a corrective treatment and laboratory investigations were not reported. At the time of this report, the outcome was unknown. Documents held by sender: none. Follow up information received from healthcare professional on 27 March 2015. The patient and responsible physician's details were updated. It was reported that a 31 year old patient had received a dose of IMOVAX RABIES (batch number J-1724-1) intramuscularly in left deltoid on 18 August 2014. Previously patient had also received a dose of TDAP (batch number, route and site of administration not reported) and had also a dose of HEPATITIS A VACCINE (batch number, route and site of administration not reported) approximately 1-2 weeks before IMOVAX RABIES, dates not specified. The patient was vaccinated at a private doctor's office/hospital and the vaccine was purchased through hospital. The patient's medical history included egg allergy, PCOS, kidney stones, migraine headache and PUD. The patient's concomitant medication includes bystolic, DHEA, vitamins and metformin. It was reported that on 21 August 2014 the patient had fever (102 Degree Celsius) and also experienced joint pain and had nausea. The patient was prescribed oral typhoid which she had not started at that time and was also instructed to take MOTRIN as corrective treatment. It was reported that the headache had resolved on 21 August 2014. The final outcome of the event was unknown. Documents held by Sender: None.
Patient felt dizzy and momentarily lost consciousness immediately following vaccination.  Patient felt better after resting and was released to home.
The Adacel was given to a 5 year old instead of diphtheria, tetanus and acellular pertussis vaccine (Dtap), No AE; The Adacel was given to a 5 year old child, No AE; Initial information was received on 17-Aug-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional.  This case involves a five-years-old female patient who was given DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] instead of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DTAP) (Product administered to patient of inappropriate age and wrong product administered).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On 13-Aug-2020, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number: U6043BA, expiry date 22-Aug-2020) via unknown route in the right arm for prophylactic vaccination instead of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DTAP).  It was a case of an actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration.  At the time of report, no adverse event was reported.  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.
Initial report received from the health care professional on 15 Dec 2010: This patient was vaccinated intramuscularly with only MenA lyophilized conjugate component of MENVEO (batch number 024011) that was reconstituted with a sterile diluent on 15 Dec 2010. The patient did not receive the MenCWY-135 liquid conjugate component of MENVEO. No adverse reaction had occurred following this administration.
Cold chills, sinuses clogged & running, heart fluttering, head soreness, ringing in my ears, exhausted feeling shake feeling.
Feeling achy in her back; This is a spontaneous report from a contactable consumer (patient's husband). A female patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medication were not reported. The patient experienced feeling achy in her back on an unspecified date. The outcome was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021414762 same reporter/drug, different patient/AE
Trouble breathing even on oxygen, sleeping 12 to 18 hours straight, brain fog, headaches, coughing that wakes me up, fatigue, legs swelling, sore throat on and off, and fever and chills at different times after 16 months of complete quarantine, having everything delivered to porch, nobody in or out of house!
Vomited once. Goosebumps for about 30 minutes. Uncontrollable shaking (teeth chattering and couldn't hold anything) for about 2 hours. 102104-degree fever for 27 hours.