chrisvoncsefalvay/vaers-outcomes huggingface dataset:
smell of blood on and off; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm) and PAROSMIA (smell of blood on and off) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergy to Aspirin).    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced VACCINATION SITE PAIN (sore arm). On 23-Apr-2021, the patient experienced PAROSMIA (smell of blood on and off). At the time of the report, VACCINATION SITE PAIN (sore arm) and PAROSMIA (smell of blood on and off) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment drugs were reported. She has an allergy to aspirin where she vomits blood.
Fever, lethargy, swelling to arm, shoulder and neck, arm pain, shoulder joint pain and unable to move shoulder for 1 week.
Patient noticed enlarged lymph node in left side of neck the night of Oct. 16th and forehead swelling on left side the morning of Oct. 17th. The skin over the left eyebrow broke open into blister like pustule.  The patient went to see Dr. the afternoon of Oct. 17th and was prescribed generic BACTRIM DS. After taking multiple doses of the antibiotic with no relief and continued breakout of pustules, the patient called the MD and discussed changing the medication to Acyclovir 400mg 1 TID for 10 days. The patient is continuing to have excessive itching as well as blister-like pustules on the forehead.
Information has been received from a registered pharmacist concerning a 12 month old female child with a possible allergy to penicillin who on 21-FEB-2007 was vaccinated with a dose of MMR. "Recently" in approximately March 2007, the patient developed a diffuse body rash that resembled "full blown" measles, fever and swollen eyes. The patient was treated with amoxicillin considering the possible allergy to penicillin. The patient's outcome was not reported. No further information is available.
Patients experience local injection site hot to touch, pain, red, itchy, and swelling, possible cellulitis and was prescribed doxycylcine 100mg qd.
This spontaneous case reported by a consumer, describes the occurrence of myalgia (arm soreness) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 025C21A) for COVID-19 immunization. Concurrent medical conditions included Vitamin D deficiency. Concomitant products included Vitamin D 2000 (calcium carbonate/cholecalciferol) for Vitamin D deficiency. On May 6, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced myalgia (arm soreness). At the time of the report, myalgia (arm soreness) resolved. No concomitant medication or treatment information reported. This case linked to MOD-2021-400021, MOD-2021-404753 (patient link).
ON 10/18 PT UNRESPONSIVE IN AM, INAPPROPRIATE AND CONFUSED WHEN AWOKEN, FEVER/CHILLS; CAME TO ER, CT OF HEAD NEGATIVE; DIAGNOSIS MENINGOENCEPHALITIS; SEIZURE, DEVELOPED RESP FAILURE, INTUBATED ON 10/19; SEROLOGY NEGATIVE, AUTOIMMUNE EVAL NEG (TO DATE) NO SIGN CHANGE (COMA UNTIL 12/25) THEN SOME IMPROVEMENT; BUT WITH FLACCID PARALYSIS FROM NECK DOWN; EMG DIAGNOSTIC FOR GUILLAIN BARRE; IVIG STARTED WITH IMPROVEMENT DAILY TO DATE; STILL INTUBATED AS OF 10/27 STILL IN INTENSIVE CARE
Got sick to her stomach, very weak with dizziness and disoriented like in a fog.  No headache, fatigue.  Not as sick to her stomach, but the weakness is still there and not getting better.  Shaking hands.  Not able to talk right now due to weakness.
Patient started having cervical and thoracic sharp neck pain; Patient started having cervical and thoracic sharp neck pain; This is a spontaneous report from a contactable Physician. A 28-year-old non-pregnant female patient received unknown dose number of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via intramuscular route on an unspecified date in Apr2021 (at the age of 28-year-old) as single dose for COVID-19 immunization. Medical history of the patient included depression. Patient had no known allergies. Concomitant/other medications in two weeks included bupropion hydrochloride (WELLBUTRIN) taken for an unspecified indication. It was unknown if patient received any other vaccine in four weeks. It was unknown if patient had COVID prior vaccination and was not tested for COVID post vaccination. On an unspecified date in Apr2021, patient started having cervical and thoracic sharp neck pain. AE resulted in Doctor or other healthcare professional office/clinic visit. Treatment included NSAIDS and muscle relaxer. Outcome of the events were not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
severe swelling of their whole arm and chest; severe swelling of their whole arm and chest; Initial information received on 20-Aug-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a patient of unknown demography who received vaccine DIPHTHERIA AND TETANUS TOXOIDS and experienced severe swelling of their whole arm and chest.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA AND TETANUS TOXOIDS produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date, following the vaccination the patient experienced swelling arm (peripheral swelling) and swelling.  (Other relevant tests included no lab data.)  Final diagnosis was swelling arm and swelling.  It was not reported if the patient received a corrective treatment.  The outcome of the events was unknown at the time of reporting.  Information on the batch number was requested.  List of documents held by sender: none.
Body pains; Muscles and bone aches; Muscles and bone aches; Headache; Fatigue; This is a spontaneous report received from a contactable consumer (patient). This non-pregnant 75-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EP7534) via an unspecified route of administration in the left arm on 29Mar2021 at 9:30 (at the age of 75-years-old) as a single dose for COVID-19 immunisation. Medical history included seasonal allergies from an unknown date and unknown if ongoing. Prior to vaccination the patient had not been diagnosed with COVID-19 and had not received any other vaccines in the 4 weeks prior to the COVID vaccine. Concomitant medications included citalopram hydrobromide (CELEXA), carvedilol, allergy pill, and fish oil, all from unknown dates for unknown indications. The patient previously received prochlorperazine edisylate (COMPAZINE), azithromycin, and fluoxetine hydrochloride (PROZAC), all from unknown dates for unknown indications and experienced allergies; the patient previously received the first dose of BNT162B2 (lot number not reported) on 08Mar2021 at 09:45 (at the age of 75-years-old) for COVID-19 immunisation. On 30Mar2021 at 02:30 the patient experienced body pains consisting of muscle and bone aches, headache and fatigue. The events were reported as non-serious and did not require hospitalization. No treatment was provided for the events. The clinical outcomes of body pains consisting of muscle and bone aches, headache and fatigue were recovering. It was also reported that since vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are needed. No further information is expected.
Information has been received from an infectious disease specialist as part of a marketing research program, referring to a patient of unknown age and gender. There was no concurrent condition or medical history reported. On an unknown date, the patient was vaccinated with PNEUMOVAX23 (dosage, strength, route and lot # not reported). There was no concomitant medication reported. On an unknown date, the patient had pneumonia. The outcome of the event was recovered. This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not want to be contacted.
When driving home my throat started to feel like it was closing. I drank cold water the entire way home. I kept debating on turning around but was able to drink water. This started 15 minutes into my drive home, 30 minutes after shot. Once home I ate dinner and drank more water. This feeling last a couple hours.   Am concerned about booster.
Narrative:  Pt was a 85y.o. male who died on 05/06/2021 has h/o CKD3, HLD, HTN, and pancreatic cancer. He received Modern Covid-19 vaccination on 03/13/2021. Pt admitted to Hospital with acute right-sided stroke and left hemiparesis and eventually transition to comfort measures admitted to the hospital for inpatient hospice care (5/4/2021).
Vaccine Administration Error Only: Patient is immunocompromised and should have received full 3rd dose of Moderna, but instead received a half dose booster only. Per current CDC recommendations, will repeat with a full dose of Moderna immediately and then have patient return 6 months after for booster dose.
Fever; Redness in the arm; Malaise; This case was reported by a nurse via call center representative and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On 15th April 2020, less than a day after receiving Shingrix, the patient experienced fever, erythema of extremities and malaise. On an unknown date, the outcome of the fever, erythema of extremities and malaise were unknown.   It was unknown if the reporter considered the fever, erythema of extremities and malaise to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient received the first dose of Shingrix and experienced fever, redness in the arm and malaise. Nurse practitioner did not provide any detail for the adverse event report, she said she was in a hurry. She talked in regards to the patient as a female.
L sore red swollen arm very tender T101.4 nauseated muscle weakness and muscle ache. Dr stated was due to antigens battling. Pt has history of strep from which she developed pneumonia. Dr advised Tylenol fluids and heat to arm. Denies celluliis as had sweats feels better 11/8/02. Has a little muscle weakness 11/8/02.
Within 15" of shot became hot/flush. Head became dizzy. Laid down & was better.  Each time I got up my head was very bad - dizzy, I guess. I threw up in the afternoon (rec'd flu shot at 10 am 11-17-08).  Went to doctor, everything ok, including an EKG. Lasted all day.  Couldn't eat. To bed at 10:30 pm & slept ok. Next morning, pretty much ok. Some residual headache.
This spontaneous report was received from a healthcare professional referring to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions and drug reactions/allergies was not reported. On 28-OCT-2015, the patient was vaccinated with PNEUMOVAX 23, (dose, lot # and expiration date were not provided).  Concomitant medication was not reported. On 29-OCT-2015, reported as "within 24 hours", the patient experienced terrible pain in the arm after being vaccinated with PNEUMOVAX 23. The outcome of pain in extremity was reported as recovered on an unspecified date in November 2015, reported as "approximately one week after vaccination". The reporter did not assess the relatedness between pain in extremity and PNEUMOVAX 23. This is one of the several reports received from the same source. Additional information has been requested.
Positive rapid Covid test on January 1. Subsequent high antibodies found in bloodwork. Long Covid symptoms including loss of taste 3 weeks after positive result, brain fog, fatigue and hair loss.
Covid "arm'.  I am 13 days out from 1st injection.  Arm is redish about 4x6 inches.  Still tender to touch  and warm to touch.
Lightheaded, fever 100°, severe muscle aches,  headache, exhaustion.
just slept the day after; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (115193). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 18Nov2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer, dose number unknown), for covid-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 18Nov2021, outcome "unknown", described as "booster"; FATIGUE (non-serious) with onset 19Nov2021, outcome "unknown", described as "just slept the day after".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 45 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 182070, and expiry: UNKNOWN) dose was not reported, administered 1 total on 14-MAR-2021 around 12:00 PM at right arm for prophylactic vaccination. No concomitant medications were reported.  On 19-APR-2021 the patient had a antibody test for Immunoglobulin M (IGM) and Immunoglobulin G (IGG) antibodies, and the antibody test showed no antibodies. She did the antibody test at home as she was part of a home clinical trial. Test results suggested that the patient experienced confirmed immunological vaccine failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 : 20210445661- covid-19 vaccine ad26.cov2.s-CONFIRMED IMMUNOLOGICAL VACCINE FAILURE. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS.
Nausea; Throwing up; Sick; This is a spontaneous report received from a contactable consumer or other non hcp.   A 33-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EW0185), via an unspecified route of administration, in Arm Left on 09Jun2021 16:30 (age at vaccination 33years old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced nausea, throwing up, sick on an unspecified date. The clinical outcome of the event was unknown.  Information on Lot/Batch information has been requested.
Migraine headache and ordinary headachy on next three days. Fatigue. Chills. Mild fleeting dizzy.
1445 - Injection given. 1510 - Pt returned to clinic c/o dizziness, spacey feeling and tremulousness of hands and "a nervous feeling" BP 116/62. P- 61, hands cold, clammy. Declined TYLENOL, rest
Fever, chills, sweats, huge red and swollen arm at injection site, headaches, can?t hardly move that arm! For,  3 days +
Immediatley after vaccination my glands in my right armpit, throat started to swell.  This moved into my groan a few hours later.  All my glands continued to swell on and off.  They were tender and irritated and i could feel them externally and internally.  I became extremely fatigued but could not sleep.  I continued to have gland swelling and irritation and extreme fatigue.  The fatigue never cleared up and neither did the swollen glands specifically in my neck and armpits.  I started having some dizzy spells, brain fog, memory lapses and continued extreme fatigue.  I called my PCP to let her know what was going on on at week 3 before my scheduled second as i was worried and did not want to get a second dose.  She ordered blood work CBC and a EBV panel and COVID testing
Initial report received on 07 October 2009 from a consumer, who is the patient. A 51 year old female patient, with allergies to dust and chocolate, received a dose of FLUZONE (lot number and route/site not reported) on 07 October 2009. Within a few hours of vaccination, the patient developed a headache, lip tingling, lip swelling, and hoarseness when speaking. The patient was advised to seek medical treatment. At the time of the report, the patient had not recovered. No other information was provided. Follow up information received on 09 November 2009 from a health care professional. Treatment included DECADRON 1 cc intramuscularly which was administered in the office. A script was provided for MEDROL dose pack which was to be taken as directed. The patient recovered from the events. No further information was provided. Based upon new information received this case has been upgraded to serious.
Mother of child describes rash starting on left leg 2-3 days after immunizations, child scratching at area. First reported to Clinic on 7-12-17 by mother of child. No other s/sx. Rash improving as of 7-12-17. Provider aware and consultation provided to family according to the child's EHR.
Admission to critical care hospital with COVID-19 diagnosis on admission. Passed on 9/22/21
irritating generalized itchiness which comes and goes; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (irritating generalized itchiness which comes and goes) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced PRURITUS (irritating generalized itchiness which comes and goes). In January 2021, PRURITUS (irritating generalized itchiness which comes and goes) had 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.   Concomitant medication was not reported.
Pt received Japanese Encephalitis on 4/25/13 approx 3 minutes after receiving vaccine pt told nurse she felt funny - head hurting - and c/o rapid heart rate - pulse rate 90/ B/P 100/60 - pt denies itching or breathing issue - monitor pt for 30 minutes pulse rate down - left with father stable and alert. Spoke with pt on 4/26/13 no additional problems.
This spontaneous report was received from a physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 17-NOV-2015, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 single dose: 0.5 ml (lot # L013428, expiration date: 03-FEB-2017; dose and route were not provided). The vaccine was exposed to following separate temperature excursions: first lasting for 72 hours, with the lowest recorded temperature of 33 degrees Fahrenheit (0.56 degrees Celsius), second lasting for 24 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (1.11 degrees Celsius), third lasting for 88 hours, with the lowest recorded temperature of 30 degrees Fahrenheit (-1.11 degrees Celsius) and fourth lasting for 136 hours, with the lowest recorded temperature of 31 degrees Fahrenheit (-0.56 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
6NOV97 c/o soreness, sl erythematous;afternoon 7NOV97 c/o severe itching @ inj site-1 pimple noted;w/in 24hr area completely covered w/pimple like bumps;circular area 3" out from inj site covered w/numerous bumps w/itching;
3 hours after vaccine patient started feeling muscle fasciculations in the legs, with occasional pins and needles and weakness
After receiving vaccines, patient turned pale and felt lightheaded. Returned to baseline after drinking water and lying down for a few minutes.
Nobody was listening to her.She couldn't take it anymore and she took her life; Woman that had the shot the moderna shot had the same symptoms that I had.; This spontaneous case was reported by a consumer and describes the occurrence of COMPLETED SUICIDE (Nobody was listening to her.She couldn't take it anymore and she took her life) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COMPLETED SUICIDE (Nobody was listening to her.She couldn't take it anymore and she took her life) (seriousness criteria death and medically significant) and ADVERSE EVENT (Woman that had the shot the moderna shot had the same symptoms that I had.). The patient died on an unknown date. The reported cause of death was nobody was listening to her.she couldn't take it anymore and she took her life. It is unknown if an autopsy was performed. At the time of death, ADVERSE EVENT (Woman that had the shot the moderna shot had the same symptoms that I had.) outcome was unknown.            The caller stated that he was talking to his cousin and they had family friends that the woman that had the shot the Moderna shot had the same symptoms he had and nobody was listening to her. She couldn't take it anymore and she took her life.  No concomitant product use was provided by the reporter.    No treatment medications were reported.  Company Comment: This case concerns a female patient of an unknown age who with no reported medical history, who experienced unexpected event of completed suicide as a result of unknown adverse event stated as  nobody was listening to her, she couldn't take it anymore and she took her life. The event occurred following an unspecified period after an unspecified dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was unknown as dosing order details was not disclosed.  Causality for the event with product use was not provided by the reporter. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This case concerns a female patient of an unknown age who with no reported medical history, who experienced unexpected event of completed suicide as a result of unknown adverse event stated as  nobody was listening to her, she couldn't take it anymore and she took her life.  The event occurred following an unspecified period after an unspecified dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was unknown as dosing order details was not disclosed.  Causality for the event with product use was not provided by the reporter. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Reported Cause(s) of Death: Nobody was listening to her.She couldn't take it anymore and she took her life