chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 07-NOV-2014, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) by a physician, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 06-OCT-2016, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
ANGINA, UNSPECIFIED 3/28/2023 ANGINA, UNSPECIFIED CAD (CORONARY ARTERY DISEASE) WO ANGINA
5 x7 cm area of erythema, pain, swelling, warmth to right deltoid region.
Child was laughing and playing; nothing abnormal. Went down to nap and approximately 1.5 hours later he was found unresponsive in his crib. Was taken to ER and pronounced dead. Autopsy report on 04/28/04 states: SIDS. This report was received from the Centers for Disease Control (CDC) in response to a Freedom-of-Information request by GSK. This case was reported by the Centers for Disease Control and described the occurrence of sudden death infant death syndrome in a 3-month-old female patient who had received PEDIARIX. The Centers for Disease received the report from the Department of Health (Ref. No. CT 2004-03). There was no relevant medical history. On 09 January 2004, the patient received the first dose of PEDIARIX (GlaxoSmithKline lot number 21895A2). Co-administered vaccinations on that dat included ACTHIB (Aventis Pasteur) and PREVNAR (Lederle Laboratories). On 13 January 2004, four days after vaccination, the child was laughing and playing. Nothing abnormal was noticed. The child was put down for a nap. One and one-half hours later, the child was found unresponsive in the crib. The child was taken to the emergency room and upon arrival she was cold, cyanotic, pulseless, and asystolic. She was not breathing. Despite resuscitation attempts (cardiopulmonary resuscitation, advanced cardiac life support, bilateral needle thoracotomy), she was pronounced dead at 1746. Causality was not reported. An autopsy report stated there was no evidence of trauma or significant natural disease processes. Gas chromatography of brain tissue revealed the presence of caffeine. The report identified Sudden Infant Death syndrome as the cause of death.
Swollen Lymph nodes in neck and groin area, diarrhea for 10 consecutive days, weigh loss due to that. Low grade fever for 5 days.  Lymph nodes remain in those places, smaller.
got COVID and it was asymptomatic; This spontaneous case was reported by a nurse and describes the occurrence of ASYMPTOMATIC COVID-19 (got COVID and it was asymptomatic) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ASYMPTOMATIC COVID-19 (got COVID and it was asymptomatic). At the time of the report, ASYMPTOMATIC COVID-19 (got COVID and it was asymptomatic) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  This is a spontaneous case concerning  a  patient of unknown age and gender, with no reported medical history, who experienced the unexpected non-serious event of asymptomatic covid-19. The event occurred on an unknown day after the second dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was not applicable, as the event happened after the first dose. The event outcome was unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.; Sender's Comments: This is a spontaneous case concerning  a  patient of unknown age and gender, with no reported medical history, who experienced the unexpected non-serious event of asymptomatic covid-19. The event occurred on an unknown day after the second dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was not applicable, as the event happened after the first dose. The event outcome was unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.
Information has been received from a health professional concerning a 35-year-old female who was 'having issues with getting pregnant" who on 23-MAY-2005 and 22-JUN-2005 was vaccinated with the first and second doses of Varivax (Lot # 648087/0099P). It was noted that her lab work showed no immunity for chickenpox. No negative effects were noted. Additional information has been requested.
8.2 x 9.0 cm raised warm welt left upper arm - noticed today in the am (10/13/2006) no fever
inability to control diarrhea; arm pain in left arm; severe painful cramps; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of ANAL INCONTINENCE (inability to control diarrhea), PAIN IN EXTREMITY (arm pain in left arm), MUSCLE SPASMS (severe painful cramps) and DIARRHOEA (diarrhea) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported.  Concomitant products included TESTOSTERONE CIPIONATE (TESTOSTERONE CYPIONATE), VENLAFAXINE HYDROCHLORIDE (EFFEXOR), AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) and CLONAZEPAM for an unknown indication.   In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Sep-2021, the patient experienced ANAL INCONTINENCE (inability to control diarrhea), PAIN IN EXTREMITY (arm pain in left arm), MUSCLE SPASMS (severe painful cramps) and DIARRHOEA (diarrhea). The patient was treated with PARACETAMOL (TYLENOL) in September 2021 for Pain in arm, at a dose of 1 UNK. At the time of the report, ANAL INCONTINENCE (inability to control diarrhea), PAIN IN EXTREMITY (arm pain in left arm), MUSCLE SPASMS (severe painful cramps) and DIARRHOEA (diarrhea) outcome was unknown.
Severe left shoulder pain. Unable to move arm - Required surgery. Will send MRI --> operative report. (+) crystals found in specimen. 11/4/09 Medical records received for dates 9/8/09 and 9/15/09. Orthopedic consult. DX: Left shoulder effusion. Inflammatory arthritis. Presenting SX: left shoulder pain, pt. states began after vax given in left arm on 8/20/09. Pt. presented to PCP w/ c/o shoulder pain, pt referred to specialist. Pt had surgery on shoulder that showed there were crystalline arthropathy.  Orthopedic MD theory states opinion as being pt. received vax, which entered her glenohumeral joint and caused this inflammatory arthritis. Pt recovered.
Presented with cough, fever x2 days, CP, mild SOB, fatigue,; Covid-19 + in ED; DX with NSTEMI d/t Covid & Covid PNA; TX with Vitamin C, steroids, Singulair, zinc, and minimal supplemental O2.
This spontaneous report was received from a pharmacist regarding a 64 year old female patient. No concurrent or historical condition was reported. On an unspecified date in October 2011, the patient received an initial dose of PNEUMOVAX 23, lot number, expiration date, dose, route, frequency and anatomical location were not reported. On 10-JAN-2012 the patient received a second dose of PNEUMOVAX 23, lot number, expiration date, dose, route, frequency and anatomical location were not reported. No adverse effect reported. Additional information has been requested.
Patient had vasovagal response approx 4-5 minutes after vaccines were administered while sitting on exam table. She was assisted to floor by NP. Patient was pale but opened eyes within a few seconds. She was briefly nauseated. She recovered quickly after sitting up and drinking water. Mom and patient remained in clinic for an additional 15 minutes and patient was back to baseline without complaints prior to ambulating out of clinic.
Intense dizziness to the point of almost fainting. It started the day before and culminated in almost fainting in the grocery store. I was quiet that night and it seemed to pass by the next morning, so altogether about 36 hours or so, with one substantial episode.
fever 100F; sore arm; headache; rapid heart rate; A spontaneous report was received from a consumer concerning a 47-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events fever 100f, sore arm, headache, rapid heart rate.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) via unknown route for prophylaxis of COVID-19 infection.  On 24 Mar 2021, the patient experienced the event(s) fever 100f, sore arm, headache, rapid heart rate.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), fever 100f, sore arm, headache, rapid heart rate was unknown.
Chills; Mania; Dizziness; Anxiety; Fatigue; Muscle aches; a lot of hot flashes to the point of sweating profusely; a lot of hot flashes to the point of sweating profusely; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 08Aug2021 17:00 (Lot number: FC3181) at the age of 29 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Birth Control" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: Covid prior vaccination: yes. Concomitant medication(s) included: LO LOESTRIN FE taken for contraception. The following information was reported: CHILLS (non-serious) with onset 09Aug2021, outcome "not recovered", described as "Chills"; MANIA (non-serious) with onset 09Aug2021, outcome "not recovered", described as "Mania"; DIZZINESS (non-serious) with onset 09Aug2021, outcome "not recovered", described as "Dizziness"; ANXIETY (non-serious) with onset 09Aug2021, outcome "not recovered", described as "Anxiety"; FATIGUE (non-serious) with onset 09Aug2021, outcome "not recovered", described as "Fatigue"; MYALGIA (non-serious) with onset 09Aug2021, outcome "not recovered", described as "Muscle aches"; HOT FLUSH (non-serious), HYPERHIDROSIS (non-serious) all with onset 09Aug2021, outcome "not recovered" and all described as "a lot of hot flashes to the point of sweating profusely". The events "chills", "mania", "dizziness", "anxiety", "fatigue", "muscle aches", "a lot of hot flashes to the point of sweating profusely" and "a lot of hot flashes to the point of sweating profusely" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were not taken as a result of chills, mania, dizziness, anxiety, fatigue, myalgia, hot flush, hyperhidrosis.  Additional information: Patient did not take any other vaccine in four weeks. Patient received other medications in two weeks: Lo-Loestrin for Birth Control. Patient was tested COVID prior vaccination and patient did not tested COVID post vaccination. Patient did not have known allergies.  No follow-up attempts are possible. No further information is expected.
COVID 19 Treatment; COVID 19 Treatment; Dose #4: Pfizer/ Dose #5: Moderna; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Feb2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 34 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 01Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Non-Hodgkin's lymphoma" (unspecified if ongoing); "Sulfa allergy" (unspecified if ongoing); "Contrast dye allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Clindamycin, reaction(s): "allergy". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 01Oct2022, outcome "unknown", described as "Dose #4: Pfizer/ Dose #5: Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Paxlovid as COVID-19 treatment from 10Apr2023 to 14Apr2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded. Linked Report(s): US-PFIZER INC-202300161451 Same reporter/patient, different product/AE;
Heart almost felt as if it stopped for a second on my way home after shot, not sure if it was slowing or speeding heart rate, and had a severe headache that started after shot.
Patient developed subacute thyroiditis after the first injection. She stopped her thyroid medications and the symptoms resolved. The symptoms recurred after the second vaccination on February 7.
mild symptoms after the first one / side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (mild symptoms after the first one / side effects) 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) (Intramuscular) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced VACCINATION COMPLICATION (mild symptoms after the first one / side effects). At the time of the report, VACCINATION COMPLICATION (mild symptoms after the first one / side effects) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) dosing remained unchanged.       Concomitant drug was not reported. Treatment medication was not reported.   This case was linked to MOD-2021-239046 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Follow up received on 01-JUL-2021 contains No new information (NNI)
Swelling of the superclavicular lymph noid, left side, same side as shot given.
Rredness, itching at injection site after seeing Dentist on 2/9 prescribed Keflex
p/vax pt broke out w/fever 103;to urgent care med clinic given inj rocephin;next day broke out in rash all over body x 3-4 days but fading @ time of report;pt had red ears/throat;
Tiredness, nausea that subsided after eating, feeling woozy rest of day. Had terrible chills in evening, headache during the night. Lasted about 24 hours.
PLATELETS DROPPED 90,000 PICKED UP ON ROUTINE LABS. NO SYMPTOMS AND AT THE TIME DID NOT CONNECT IT TO THE VACCINE UNTIL vaccine was in the news and stopped
Approx 15 min after having vaccine, pt developed rash on feet and lower legs. VSS. Given 25 mg BENADRYL, 10 mg CLARITIN. Rash began receding. Pt sent home when felt to be stable.
Sore Arm; Lousy feeling; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced pain in arm and feeling bad. On an unknown date, the outcome of the pain in arm and feeling bad were recovered/resolved.   It was unknown if the reporter considered the pain in arm and feeling bad to be related to Shingrix.  Additional case details were reported as follows: The case was reported by patient's sister. The reporter stated that the patient experienced sore arm that lasted for 3 days, and lousy feeling that lasted for 24 hours. No further details were provided. This case is 1 out of 2 cases reported by the same reporter.
Presneted with cough, lethargy, weakness, SOB x2 weeks; + Hypoxia on arrival; + Covid 12-14 days prior; No acute disease; most likely post covid syndrome and viral PNA; no remdesivir (out of tx window); Tx: Decadron, pulmicort, heparin, Singulair; supplemental O2 via NC; pt improved and home on O2
Within about 1-2 minutes, the patient started to faint, felt cold and stayed sitting down. In obvious discomfort, a male person who was with her started to get alarmed as he noted "it looked like she had a seizure". Although I noted no signs of a seizure, it seemed to me she was having a reaction similar to fainting  (her face was white, "goose bumps" on skin, elevated legs helped out her symptoms) and with time (10 minutes) the symptoms resolved.
Began getting rash on Sunday last 3-4 then would be gone then reoccur. To ER. Rx of erythromycin, BENADRYL and prednisone. C/O headache and continued rash 0 to 1=2809.
Information has been received from a consumer concerning her 16 month old "perfectly healthy" son with no known allergies who on 10-JAN-2007 was vaccinated in the left arm with a first dose of Varivax (Merck) (Lot #655065/1142F, product circular 7999915) (lot # also reported as "M9108"). Concomitant therapy included influenza virus vaccine (unspecified), Hib conj vaccine (unspecified carrier), hepatitis B virus vaccine (unspecified) and pneumococcal vaccine (unspecified). On 17-JAN-2007, the patient developed chicken pox around his mouth, eyes, chest, arms, and stomach. The patient's mother indicated that her son's condition was getting "worse and worse" since getting the vaccine. The patient sought medical attention and was treated with antibiotics (not further specified). As of 22-JAN-2007, the patient had not recovered. The product quality complaint unit is not involved. Additional information has been requested.  Additional information from a health care professional indicated that the patient had no past medical history and had no illness at the time of vaccination. It was reported that on 20-JAN-2007 the patient developed several vesicles at the injection site and on his face. Medical attention was sought, there were no lab tests performed. The patient recovered on 22-JAN-2007. It was reported that the patient and his sibling had no adverse events following prior vaccination. No further information was provided. Additional information is not expected.
I had started my mental period the day before the first dose. My period stopped abruptly the day after the dose, for a total of 3 days. My period is usually 5 days. After that, I started having my periods every two weeks. Now, in July, I am getting a bit more regular at 3 weeks, but it was 4 weeks prior to the vaccine. The vaccine also made my connective tissue disorder worse, and I have had a lot more pain and dysautonomia symptoms since having the vaccine.
A hot, itchy rash developed on my arm at the injection site two days after getting the vaccine. The rash was approximately 5 inches across and hot to the touch.  I applied cold compresses and took Benadryl. It seems to be nearly gone now, four days after appearing.
About five minutes after receiving the injection, I had tingling at the injection site; then strange taste in my mouth along with tingling; then there was tightness in my throat. The RNs took me another area, gave me ice water and put ice on injection site. After about 45 minutes the tightness in my throat was still there and I was transported to ER for treatment.
the patient is vaccinated and boosted. He's had COVID three times this year; the patient is vaccinated and boosted. He's had COVID three times this year; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "the patient is vaccinated and boosted. He's had COVID three times this year".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Didn't get the second dose before the 37 day mark; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (Didn't get the second dose before the 37 day mark) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (Didn't get the second dose before the 37 day mark). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (Didn't get the second dose before the 37 day mark) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment Medications and concomitant medications were provided.  The patient got an email from the health department stating that they scheduled her for the Pfizer vaccine.
headache, nausea, real tired all the time, leg cramps, all for almost a month
Upper left side chest discomfort.  Pain persisted moderately for 3-4 days, and slowly began fading.  By 10 days the pain had almost completely ended.  About 19 days after shot I had an unusual bruise appear on my right foot, which was not due to any impact, and has just a little pain
After 5 mins. in waiting area PT. STated she felt panic, hot and dizzy. PT. moved to Private screening area and moniTored for 30 mins. Pt. history and vitals obTained. After 30 mins. PT. sTaTed she felt better and was released w/advise to call 911 w/any further Problems.
pt recvd vax & devel upper-resp symptoms with congestion, elevated temp, & cough; pt went on to be treated w/ATB;