chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PMH of diet controlled DM, hepatitis C induced cirrhosis, CAD with stent replacement, HTN, osteoarthritis, colonic polyps, history of several liver lesions with an elevated AFP consistent with multifocal HCC (refused biopsy) sent in from PCP office for evaluation of hypotension. Patient has been c/o generalized weakness with decreased appetite for 1 week. Patient also endorses urinary symptoms mainly frequency. Denies any CP, SOB, LH, dizziness, N/V/D, HA, abdominal pain, fever, chills or any other complaints. In the ED blood work showed AKI. UA was positive for UTI and incidentally he was found to be covid +. Patient denies any SOB and is not hypoxic. CXR is unremarkable. In the ED patient was given IVF and was started on ceftriaxone x 5 days for UTI.  CXR without evidence of pneumonia. On 8/16 Breathing comfortably. However, SPO2 was as low as 80s with activity on 8/13, started on Decadron. On 8/17: 8/17 RRT was called this morning for hypotension with BP 70/40s. Per RN patient received 500cc over night which did not respond, remains hypotensive. Patient reports he "doesn't feel well". At bedside, patient is lethargic but responsive to commands, satting 97% on room air. Patient transferred to the MICU and Pt emergently intubated at beginning of ACLS and during intubation was noted to have large amount of coffee ground emesis in esophagus and airway concerning for possible UGIB and aspiration. Despite resuscitative efforts for over 30 minutes, no sustained ROSC was able to be obtained.
A legal complaint was received from an attorney alleging that a male child received series of Tetramune, and Engerix B (GSK) vaccines as well as Hib-Titer, Acel-Imune, Pneumovax 23, and Recombivax-HB (Merck) vaccines from 29-Nov-1995 through 20-Oct-1997 and subsequently "suffered devastating injuries through mercury toxicity and associated complications and sequelae and the aggravation of other conditions directly through exposure, via intramuscular injection of mercury" in the "thimerosal- containing vaccination." According to the legal complaint, the child "was born a perfectly  normal, health boy whose APGAR scores at birth were well within the normal range." It was alleged that at apprx. 18 months of age, the child "was neurologically devastated by the accumalation of Mercury in his body, having been exposed via intramuscular vaccinations, and suddenly regressed developmentally, losing milestones of neurological developement previously achieved, specifically including, but not limited to becoming withdrawn, unresponsive to his environment, engaging in repetitive behavior and the loss of language skills, motor skills and affect." According to the legal complaint, the child "suffered severe and permanent injuries" and sustained and will sustain in the future a mental, intellectual, developmental and neurological incapacity and associated learning disabilities, affect disorders and impairments." Vaccination information contained in the legal complaint indicated that the child received Acel-Imune, Hib-Titer, and Pnu-imune 23 vaccine beyond 18 months of age.  This child's brother experienced the same even's. See related report HQ5401019NOV2002.
After 3 shots on 01/15/2001, depression, crying, nervousness, fatigue, hands burning, right hand thumb pain, also at the same time started having pain in all joints.
Information has been received from a physician concerning a 23 year old female who in December 2006, was vaccinated into the left arm with a 0.5mL first dose of Gardasil. Subsequently, on an unspecified date, the patient developed a swollen arm (reported via company representative). The physician also reported that the patient developed a "nodule on the left arm under the skin, "a pouch, which intermittently becomes itchy." (date not reported). At the time of the report, the patient had not recovered. The patient sough unspecified medical attention. Additional information is not available.
Injection was received on 4/10/00, the mother reports that on 4/11/00, the child woke up with a rash over her entire body. The pt experienced a fever 2-3 days later, shortness of breath. Went to ER.
A mom & siblings of pt recv vax 15APR(7;18APR97 pt devel chicken pox;MD felt may have been possible viral shedding;
Administered the first dose of the Moderna COVID-19 vaccine to a 16 years old patient; A spontaneous report was received from a pharmacist concerning a 16-years-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and administered the first dose of the Moderna COVID-19 vaccine to a 16 years old patient/inappropriate age at vaccine administration.  The patient's medical history was not provided. No relevant concomitant medications were not reported.  On 10 Mar 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot/batch number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On 10 Mar 2021, a 16 years old patient administered the first dose of the Moderna COVID-19 vaccine. No treatment information was reported.  Action taken with mRNA-1273 in response to the event was not reported.   The event administered the first dose of the Moderna COVID-19 vaccine to a 16 years old patient was considered resolved on 10 Mar 2021.; Reporter's Comments: This report refers to a case of Product administered to patient of inappropriate age for mRNA-1273, lot # unknown  with no associated AEs.
SHINGRIX #1 ADMINISTERED 07/09/22.  TYPICAL INJECTION SITE REACTIONS (REDNESS,TENDERNESS,WARMTH JUST BELOW THE INJECTION SITE) SHOWED UP 1 DAY AFTER IMUNIZATION, AND HAVE LASTED 3 DAYS. 1 DAY AFTER VACCINATION, THE PATIENT STARTED DEVELOPING ULCERS/SORES ON ROOF OF MOUTH AND IN BACK OF THROAT. PT IS FOLLOWING UP WITH PRIMARY CARE PROVIDER IN THE MORNING 07/13/22.
Information has been received from a 21 year old female with rituximab allergy who who in 2009 was vaccinated with a series of 3 doses of GARDASIL (lot # not unknown), as encouraged by her physician. Concomitant therapy included CELEXA, LAMICTAL, CONCERTA, lorazepam, rituximab and prednisone. The patient was tired after the first dose of GARDASIL. Six months after the vaccination series she experienced limbic encephalitis, shrinkage of the right hippocampus, short-term memory loss, tiredness and fluid build-up on the temporal lobe and was hospitalized and treated (not further specified). Lab and diagnostics studies were performed (results unknown). The patient stated that her physicians did not know if she could be healed. The patient reported that she was told that if the shrinkage of her brain were to continue, she would be required to have brain surgery. At the time of the report, the patient had not recovered. Additional information has been requested.
I had the usual arm soreness but it was compounded by something much more profound and widespread. From my shoulder down to my elbow I had and still have extreme pain and stiffness accompanied by limited range of motion. This is worse sometimes than others. She it is bad, it interferes with my quality of life (sleep, activity, comfort). I have to be very careful doing things like putting my arm in sleeves and putting weight on it sometimes. I have tried working out, not working out, Tylenol, everything. I?m giving it time, but it has been more than three months.
mom brought pt in for vax & when asked if had fever or sz w/1st shots mom said had brain swelling 1 wk or so p/1st shots given; also said that p/family noticed head looked different they took to MD who said swelling was probably from DTP;
Child received the rotavirus vaccine and the next day was admitted to hospital with intususeption. Intususeption resolved spontaneously. Surgeon felt the obstruction was the result of incarcerated right inguinal hernia in a premature infant. I was concerned about the association of the intususeption and the administration of the rotavirus vaccine
Patient presented to ER with erythema, swelling, warmth, arm pain, and bullous formation at the site of the pneumococcal vaccination in the left arm.  Initially patient was unable to wake up (kept passing out) for 2 days after administration of the shot.   Also complained of 2-3 days of lethargy, diarrhea, vomitting, lightheadedness, and HA.  On exam patient has erythematous, warm, tender left arm with 2cm fluid filled bullae, with tachycardia.  Patient is being treated with Antibiotics and fluids.  Possible hospitalization pending ability to take food and fluids by mouth.
2 days after flu vaccine and nauseous - chest tightness (R) side. 3rd day pea sized bumps under arm (R) between clavical & breast tender & raised - cervical lymph nodes also - scratchy throat & harder to breath - fever > 102.3 on 10/25/10 swelling still.
Case previously recorded as MA2009-4068. Initial case report received from a physician via Novartis Pharma on 09 NOV 2009. A 3-year-old male patient was vaccinated with 0.5 mL of S-OIV FLUVIRIN (batch no. 1008143P) i.m., on 06 NOV 2009. MedCom reference no.: NA09-007849.
HE FAINTED WHILE IN THE ELEVATOR, STRUCK HIS HEAD, AND SEVERLY CHIPPED BOTH FRONT TEETH. RESEMBLED A SEIZURE.
Left arm swollen and moderate entire upper arm with redness and warmth. Treated with Augmentin.
FLUVIRIN shot given 10/16/08 at 9:45 am. Pain in left arm started 10/16/08 at 6:00 pm sharp pain in left arm muscle has continued only with certain movements, e.g. when arm is lifted above his head or put behind. No other problems
bad taste directly after shot, next day left side of face went numb. rushed to er for stoke protocol. was admitted into hospital. Had follow up with rheumatologist and new vascular and neuro doctors scheduled. symptoms come and go  with one sided face numbness headache and extreme tiredness
felt hot and cold; sweating all that night; nausea; fever not rising above 100.6 off and on; chills; felt achy all over; sleeplessness; exhaustion; injection site tenderness; headache; shoulders ached and neck ache; shoulders ached and neck ache/severe joint pain; lymph node swelling under the injection site arm; lymph node swelling under the injection site arm. Painful and swollen; This is a spontaneous report from a contactable consumer (patient). A 40-year-old patient of unspecified gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EN6199) via an unspecified route of administration on 09Mar2021 11:30 as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EN6201) via an unspecified route of administration on 16Feb2021 (age at the time of both vaccination was 40 years) as dose 1, single for covid-19 immunisation. She got the vaccine at 11:30am and later that afternoon (on 09Mar2021), she felt what she did after her first shot, injection site tenderness, headache, shoulders ached and neck ache. By 7:30pm, she had chills and felt achy all over. Through the night she had sleeplessness and severe joint pain (literally every joint she own, it felt like- fingers and toes included. But mostly hip joints), headache, felt hot and cold. The next day (Wednesday/ 10Mar2021) started off with a bit of nausea which thankfully resolved, but then she had a fever not rising above 100.6 off and on, joint aches, exhaustion, headache. She just tried to sleep all day. Some moments were worse than others. She slept better that night but still had joint pain and a headache. Thursday her fever came back in the morning time as her headache and joint pain persisted. She felt almost normal by mid-morning and thought she was past it. But Thursday night, her chills and achy feeling and fever returned. It went away with sweating all that night on 11Mar2021 and Friday she was back at work. By mid-day Friday, her knees were aching again. Advil helped but she felt a bit feverish off and on while working. By last night at about 7pm she felt normal again and had been since. Side note, she had lymph node swelling under the injection site arm. Painful and swollen. Not as bad on the day of reporting though, but still noticeable. The patient underwent lab test and procedure on 10Mar2021 included body temperature and resulted into 100.6 off and on. The outcome of sweating was recovered on 11Mar2021 and nausea in Mar2021, outcome of lymph node swelling under the injection site arm, painful and swollen was not recovered and outcome of other events was unknown.  No follow-up attempts were possible. No further information was expected.  Follow-up attempts completed. No further information expected.
No adverse event; Date of first thaw was 15 Jul 2023 and Date of administration was 16 Aug 2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Date of first thaw was 15 Jul 2023 and Date of administration was 16 Aug 2023) and NO ADVERSE EVENT (No adverse event) in a 75-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7643E) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Aug-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 16-Aug-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Date of first thaw was 15 Jul 2023 and Date of administration was 16 Aug 2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Date of first thaw was 15 Jul 2023 and Date of administration was 16 Aug 2023) 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 EXPIRED PRODUCT ADMINISTERED (Date of first thaw was 15 Jul 2023 and Date of administration was 16 Aug 2023).    Concomitant medication not reported.  Treatment medication not reported.
Low grade fever; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low grade fever) and FATIGUE (fatigue) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high since 01-Jan-2000.    On 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2020, the patient experienced PYREXIA (Low grade fever) and FATIGUE (fatigue). At the time of the report, PYREXIA (Low grade fever) and FATIGUE (fatigue) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
headache; nausea; This case was reported by a consumer via call center representative and described the occurrence of headache in a 69-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced headache and nausea. On an unknown date, the outcome of the headache and nausea were not recovered/not resolved.   It was unknown if the reporter considered the headache and nausea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After received dose of Shingrix the patient experienced headache and nausea. The patient inquired how long do the side effects last from the shingles shot. The patient wanted to know would he/she had the same reactions with the second dose.
chest pain beginning 11:00pm after vaccine given at 9:30am with subsequently confirmed cardiac ischemia. There was associated shortness of breath and fatigue. Patient waited to call on 4/2/2021 and was seen in the office and subsequently sent to the ER after electrocardiogram was abnormal.
severe rash on the face; allergic reaction; face is really itchy and has little tiny bumps; face is really itchy and has little tiny bumps; This is a spontaneous report from a contactable consumer or other non hcp (patient reported for herself). A 30-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on 05Apr2021 at 11 am or 12 pm (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization (at the age of 30-years-old). The patient medical history and concomitant medications were not reported. It was reported by the patient that after receiving the first dose of vaccine on 06Apr2021 she experienced allergic reaction, had a severe rash on the face, her face is really itchy and has little bumps; got a little worse since yesterday, got more bumps since yesterday. She stated that she has not spoken with her Physician. Caller wants to know if there is anything, she can buy for this. The outcome of the events was unknown.   Information about lot/batch number cannot be obtained.   No follow-up attempts are needed. No further information is expected.
On 11/09/2000, the patient developed a vesicular rash around the site of immunization. It was reported that the patient subsequently recovered. No further information is expected.
I got a rash that covered my face, ears, neck and upper back. Now  the rash has moved to my lowered arms.
injection leaked out of the syringe over his arm and on to the floor; my husband's injection leaked out of the syringe over his arm and on to the floor; A spontaneous report was received from patient's wife for a consumer concerning a male patient of an unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced injection leaked out of the syringe over his arm and on to the floor.  The patient's medical history was not provided. No concomitant product use was reported.  On an unknown date patient received their first of two planned doses of mRNA-1273 (Lot number : unknown). On 11-Mar-2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly for prophylaxis of COVID-19 infection.   On 11-Mar-2021, While getting the vaccine the patient's injection leaked out of the syringe over his arm and on the floor. The reporter was unsure if patient had enough to get complete protection.  Treatment information was not provided.  The patient received both scheduled dose of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable.  The outcome of the events, injection leaked out of the syringe over his arm and on to the floor was considered resolved.; Reporter's Comments: This report refers to a case of vaccine Underdose and  Device connection issue for mRNA-1273, lot # unknown with no associated Adverse Events.
GENERALIZED PAPULAR RASH ON TORSO UPPER ARMS NECK AND FACE.
Started experiencing chest pains (near the heart), labored breathing, leg pain (both calves), low-grade fever (99.4), hot flashes, heart palpitations, nausea and sweating approximately 4 days post 1 dose of Pfizer.
Hair falling out after both shots; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Hair falling out after both shots) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced ALOPECIA (Hair falling out after both shots). At the time of the report, ALOPECIA (Hair falling out after both shots) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by reporter.  No treatment details were provided by reporter.  Abundance of red blood cells  and abundance of red blood cells  were reported as events.
Started to notice facial droop left side of face about 2 weeks after receiving the Johnson & Johnson (Janssen) Covid 19 vaccine.  Started behind the ear and worked to the front of his face.  Included eye and nostril.  Couldn't chew food on that side of mouth.   It has been painful, but the pain and the drooping have gotten better. Did not seek out any medical treatment as he felt nothing could be done.
This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and ARTHRALGIA (joint aches and pains) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included TELMISARTAN (MICARDIS), CLONIDINE, DILTIAZEM, METOPROLOL TARTRATE, METFORMIN and EMPAGLIFLOZIN (JARDIANCE) for an unknown indication. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced HEADACHE (headache). In March 2021, the patient experienced ARTHRALGIA (joint aches and pains). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. On 12-Mar-2021, HEADACHE (headache) had resolved. At the time of the report, ARTHRALGIA (joint aches and pains) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient was born on ??-???-1955. Reporter did not allow further contact.
pt brought to hosp with c/o fatigue, SOB, dyspnea with exertion, diarrhea, chills; fever in ED; tested positive for COVID; O2 supplementation; DNR; treated with remdesivir and steroids, Lovenox; on HFNC, and refused intubation; pt's condition worsened and he chose comfort care; he passed away in the hospital
Red rash, itchy.  (still have somewhat of the redness today (2/19/2021.
PRODUCT STORAGE ERROR; THE VACCINE WAS STORE FROZEN UNTIL RECEIVED SINCE 19-NOV-2021; This spontaneous report received from a physician concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A expiry: UNKNOWN) dose was not reported, administered on 04-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On 04-DEC-2021, the patient experienced the vaccine was store frozen until received since 19-nov-2021. On an unspecified date, the patient experienced product storage error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the product storage error and the vaccine was store frozen until received since 19-nov-2021 was not reported. This report was non-serious. This case, from the same reporter is linked to 20220421741. This report was associated with product quality complaint: 90000225540.