chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within few days of having 2nd dose, he started with muscle cramping all over the body./Cramping gets worst when he does physical activity./The muscles are extremely fatigued, cramping and locking; The muscles are extremely fatigued; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Sep-2021 and was forwarded to Moderna on 29-Sep-2021.    This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Sep-2021 and was forwarded to Moderna on 29-Sep-2021.    This spontaneous case was reported by a nurse and describes the occurrence of MUSCLE SPASMS (Within few days of having 2nd dose, he started with muscle cramping all over the body./Cramping gets worst when he does physical activity./The muscles are extremely fatigued, cramping and locking) and MUSCLE FATIGUE (The muscles are extremely fatigued) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939893 and 017E21A) for COVID-19 vaccination.     Concomitant products included CREATINE for an unknown indication.   On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced MUSCLE SPASMS (Within few days of having 2nd dose, he started with muscle cramping all over the body./Cramping gets worst when he does physical activity./The muscles are extremely fatigued, cramping and locking) and MUSCLE FATIGUE (The muscles are extremely fatigued). At the time of the report, MUSCLE SPASMS (Within few days of having 2nd dose, he started with muscle cramping all over the body./Cramping gets worst when he does physical activity./The muscles are extremely fatigued, cramping and locking) and MUSCLE FATIGUE (The muscles are extremely fatigued) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, White blood cell count: elevated (High) Elevated.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product included supplements. Treatment medications were given as none.   Most recent FOLLOW-UP information incorporated above includes: On 05-Oct-2021: Follow-up received on 05Oct 2021 contain no new information
68y.o. female known to me from previous hospitalization with recent diagnosis of Spindle cell sarcoma with initial evidence of SVC syndrome.  Patient receiving chemotherapy with initial doses (AIM) causing neutropenic fever and diarrheal stools. She was admitted on 10/10/22 for cycle 2 of chemotherapy.  Initial COVID test on admission Positive but determined to be persistence of viral particles in nasopharynx from prior infection in late June 2022 (rx with paxlovid). No isolation recommended.
ACUTE HYPOXEMIC RESPIRATORY FAILURE ACUTE PULMONARY EMBOLISM HYPOXIA
This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine experienced excursion in the refrigerator), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine experienced excursion in the refrigerator on 21-Aug-2022 and dose was adminitered on 22-Aug-2022) and NO ADVERSE EVENT (No adverse event) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053B22A) for COVID-19 vaccination. No Medical History information was reported. On 22-Aug-2022 at 9:30 AM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Aug-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine experienced excursion in the refrigerator on 21-Aug-2022 and dose was administered on 22-Aug-2022). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine experienced excursion in the refrigerator) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine experienced excursion in the refrigerator), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine experienced excursion in the refrigerator on 21-Aug-2022 and dose was administered on 22-Aug-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine experienced excursion in the refrigerator) and POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine experienced excursion in the refrigerator on 21-Aug-2022 and dose was administered on 22-Aug-2022). Patient received 2nd booster dose. No concomitant medications were reported. Vaccine experienced excursion in the refrigerator on 21-AUG-2022. Vaccine was refrigerated at the time of excursion. Maximum or minimum  temperatures reached was reported as Maximum 54 Fahrenheit. Excursion duration was 12 hours. Vial was moved from  freezer to refrigerator on 21-AUG-2022. Visual inspection noting any vaccine state change was reported as normal. Total 12 Unpunctured vials experienced excursion. No treatment information was provided.
Pediarix #3, Hib #3, PCV7 #3-given as directed on 8/03/04 child RTC on 8/06/04 c/o of  104-102 temp, fussy and crying, not sleeping x 3 days after receiving immunizations. 02 Sat 91% - has some nasal congestion
Pt received 0.1 mL of the Jynneos smallpox/monkeypox vaccine intradermally in the right forearm. Pt did have a confirmed case of moneypox in July 2022 so he should not have received it.  Pt was monitored post injection - no adverse reaction noted.
One week post injection, on February 18, I developed  chills and a fever starting around 9 PM. I experienced diarrhea starting around 10 PM. Fever was approx 100.4 F and was accompanied by a splitting headache and significant body aches, to the point where I was unable to get any sleep that night. I noticed Covid arm the next morning. Fever, headache and body aches continued until Monday morning. I took only Extra Strength Tylenol. Most of the time Tylenol was effective only for the first 2-3 hrs before the discomfort overcame it. I was tested twice for COVID, both Friday AM and Monday AM. Both came back negative. Starting Monday the body aches and fever began to subside but I was left with a feeling of exhaustion and required continuous sleep.  Today is the first day I feel back to normal. I still have a large Covid arm rash, two weeks post injection. It causes no discomfort whatsoever.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A 50-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (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) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "obesity" (unspecified if ongoing); "known allergies Shellfish" (unspecified if ongoing), notes: known allergies Shellfish. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. Anti-viral product Paxlovid started on 16Jun2022 and ended on 20Jun2022, for COVID 19 Treatment. Reported Event included return of positive test. Cold symptoms. Asthma symptoms and start date was 22Jun2022.It was reported that the patient was recovering without treatment. Device Date: 04Jul2022.  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 available information and the known product safety profile a causal relationship between the reported events, COVID 19, Drug Ineffective and BNT162B2 is considered possible.
Severe rash and itching; Severe rash and itching; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 81 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 07Oct2021 (Lot number: FF8841) at the age of 82 years as dose 3 (booster), single, administered in arm right, administration date 15Feb2021 (Lot number: EN6201) as dose 2, single and administered in arm right, administration date 28Jan2021 (Lot number: EL9262) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Flu shot (Vaccine Name: Flu shot, Manufacturer: , Lot Number: Unknown, Route: Unknown, Anatomical Location: Right arm). The following information was reported: PRURITUS (non-serious), RASH (non-serious) all with onset 28Jan2021, outcome "not recovered" and all described as "Severe rash and itching". The event "severe rash and itching" and "severe rash and itching" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pruritus, rash.  Follow-up (09Feb2022): This is a spontaneous follow-up report received from a contactable consumer. This 81-year-old male consumer reported that: Updated information included: Patient Details. Lab data. Start Date/Time, Stop Date/Time, Lot #, Anatomical Location of all doses, Vaccine Facility Information. Onset Date/Time, Outcome of Event of all AEs.  Follow-up (09Feb2022): This is a spontaneous follow-up report received from the same contactable consumer. Additional information included all 3 shots, the last one on 08Jul2021. After each one, within 2 days started to break out in a terrible rash and itching. Also after each shot, the rash was worst. The first and second  had was on his back, front from the waste on up plus on both arms. Lasted about 6-8weeks. The 3rd one was the same plus on his legs to the top of his feet.  Follow-Up (14Feb2022): Follow-up attempts are completed. No further information is expected.
At 4:03 p.m. Fainted in hallway and causing an abrasion beside his left eye. Wet paper towels applied to face. Patient's legs elevated. Cold pack to abrasion beside left eye. BP was 114/70.
Narrative:  Patient double vaccinated in March, Admitted with COVID in July, transferred to ICU and ventilated. Patient passed away 8/3/2021
On 8/29/01, on awakening at 07:00, the child would not stand on left leg and cried with pain upon trying to stand. Her left leg is swollen, 2" in diameter, warm to touch, with a "knot", but no redness noted. Mom used Advil for low-grade temperature and pain. She used a cool wash rag to area and mom massaged leg. On 8/30/01, the pt is back walking without complaint of pain, swelling is gone, "knot remains palpable per mom in left leg.
mother received BNT162B2/while the mother was breast feeding this 5-month-old patient; vomiting (throwing up); not eating. Not nursing, Not breastfeeding and not taking her bottle; her 5month old baby is lethargic; all of a sudden took ill; This is a spontaneous report from a contactable consumer (parent). This consumer reported information for both mother and baby. This is baby report.   This is a case for a 5-month-old patient of an unspecified gender whose mother of unspecified age received first dose of BNT162B2 (PFIZER/BNT162 Covid-19 Vaccine), via an unspecified route of administration on 18Dec2020 13:15 at a single dose for COVID-19 immunization, while the mother was breast feeding this 5-month-old patient. The patient's medical history and concomitant medications were not reported. On 19Dec2020, all of a sudden took ill. The patient was lethargic, vomiting (throwing up) and not eating. Not nursing, Not breastfeeding and not taking her bottle. The outcome of events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020503099 mother/baby case
Mom called 11/15/02 stating child's L arm was swollen; offered to see child in clinic. Seen by private MD & Dx with cellulitis L arm and Tx with Lortab 250mg BID. 11/19/02 Mom states child is better now.
Hepatitis B 3/16/07 Received copy of Death Certificate from reporter which states COD as cirrhosis & fatty metamorphosis of liver with pulmonary emphysema as contributing factor.  Also noted corrected DOB & DOD. Immediate cause disease or condition resulting in death. Cirrhosis and fatty metomorphsis of liver. Cancer to liver. Pulmonary emphysemo. He die of pulmonary emphysome and the vaccine cause to get worse.
on June 20, 2021 I became unresponsive spouse took her to ER. No Stroke, stay in hospital for 2 days, Diagnosis was Migraine with Brain stem  aura. CT done mass of head and neck showed mass in front neck.
Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 03-MAR-2012 at 11:30am, ZOSTAVAX lot # 672477/1604AA was exposed to -12 C for an estimated total time out of range of 4 hours. On 17-APR-2012 at 07:30am, ZOSTAVAX lot # 672477/1604AA was exposed to -12 C for am estimated total time out of range of 14 hours. On 03-MAY-2012, the patient was administered an out of range dose of ZOSTAVAX lot # 672477/1604AA expiration date: 13-JAN-2013 (dose and route were not reported). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
pt recvd vax 23OCT95 & same day devel sore throat, aches, & low gever;24OCT95 t100, severe body aches, labored breathing, lightheaded, anorexic;25OCT95 2" red area @ site of inj, joint aches, was prescribed Biaxin by MD;
received expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 19-year-old female patient who received HBV (Engerix B pediatric) (batch number 77B59, expiry date 30th September 2021) for prophylaxis.   On 29th December 2021, the patient received Engerix B pediatric (intramuscular). On 29th December 2021, unknown after receiving Engerix B pediatric, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Engerix B pediatric in left arm. The patient inadvertently received expired dose of 10mcg Engerix-B, which led to expired vaccine used.
This case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a 85-year-old female patient who received SHINGRIX (batch number T4952, expiry date 18th June 2021) for prophylaxis. Previously administered products included SHINGRIX (on an unknown date received 1st dose). On 3rd February 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In February 2019, less than a week after receiving SHINGRIX, the patient experienced erythema of extremities, skin warm and pruritus. On an unknown date, the outcome of the erythema of extremities and skin warm were unknown and the outcome of the pruritus was not recovered/not resolved. It was unknown if the reporter considered the erythema of extremities, skin warm and pruritus to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on right arm. The patient experienced redness and warmth to touch which was spreading down to her elbow. The patient was also experiencing itching. No further details were provided. This case has been linked to the case US2019021292, reported by the same reporter.
she was hurting all over; chills; injection site sore; injection site sore; Tired; Sore arm; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Sore arm), MYALGIA (she was hurting all over), CHILLS (chills), VACCINATION SITE PAIN (injection site sore) and VACCINATION SITE ERYTHEMA (injection site sore) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 013L208) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 16-Feb-2021, the patient experienced MYALGIA (she was hurting all over), CHILLS (chills), VACCINATION SITE PAIN (injection site sore), VACCINATION SITE ERYTHEMA (injection site sore) and FATIGUE (Tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 17-Feb-2021, MYALGIA (she was hurting all over) and CHILLS (chills) outcome was unknown. At the time of the report, PAIN IN EXTREMITY (Sore arm), VACCINATION SITE PAIN (injection site sore), VACCINATION SITE ERYTHEMA (injection site sore) and FATIGUE (Tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   CONCOMITANT MEDICATIONS - BLOOD PRESSURE PILLS, CHOLESTEROL PILLS, VITAMINS. Treatment included Tylenol   This case was linked to MOD-2021-050778 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Feb-2021: No specific follow-up information recorded.
receiving ACT-HIB that was reconstituted with sterile diluent (with no reported adverse event); Initial information received on 25-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 year old female patient who was receiving act-hib (HIB (PRP/T) VACCINE) that was reconstituted with sterile diluent (with no reported adverse event).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP); ELASOMERAN (MODERNA COVID-19 VACCINE); and PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE) all for Prophylactic vaccination.  On 21-Jul-2022, the patient received a  dose of 0.25 ml (0.25 mL to 2 mL ) of suspect HIB (PRP/T) VACCINE lot UJ646AAA, expiration date: 05-Mar-2023, via intramuscular route in the left deltoid as Immunization.  On 21-JUL-2022 the patient was receiving act-hib that was reconstituted with sterile diluent (with no reported adverse event) (product preparation error) same day following the administration of HIB (PRP/T) VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (receiving ACT-HIB that was reconstituted with sterile diluent (with no reported adverse event)).  At time of reporting, the outcome was Unknown for the event.  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 the guidelines. 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.
This spontaneous report was received from a registered nurse refers to unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unspecified date, in September 2015, reported as "sometime during the month of September 2015", the patients were vaccinated with unspecified improperly stored doses of ROTATEQ, oral, lot # K013861 and expiration date 18-MAY-2016 and lot # K022990 expiration date 26-JUN-2016, (dose and anatomical location were not provided). There were not concomitant medications reported. There was not product quality issue involved. This is one of case of several cases from the same reporter. Additional information has been requested.
Pt got the shot on 6/11/2020, said he was fine. On 6/13/2020, he said he started experiencing joint pain and shoulder pain (Rheumatoid Arthritis). He felt pressure on back and chest, like passing out. Lasted for about 20-30 minutes. the next morning he was up and well playing golf.
ACUTE PULMONARY EMBOLISM 2/22/2023 -- RECURRENCE OF SAME SYMPTOMS
Had her covid shot at 3 PM after her physical with me on 6/9/22. She was driving around 5 PM and passed out when driving and ended up into a house.
Patient received Moderna vaccine and was in her usual state of health. Developed shortness of breath and dyspnea of exertion for 2 weeks. Presented to her Physician's office who ordered a CT Angio which revealed multiple acute pulmonary emboli throughout both left and right main pulmonary arteries and lobar branches with ventricular strain. Patient underwent EKOS procedure to remove clot burden and was initiated on Xarelto. Patient is requiring 4L of oxygen at this time.
Faint erythema to lateral right neck and upper right arm. Given pepcid, prednisone and zyrtec. She was observed for 2 hours. Rash, itching improved. Patient sent home.
hives and rash throughout body and face, labored breathing, fatigued, pressure in head and upper jawline on right side of head/behind ear.
macular skin rash on trunk, arms and legs. No drainage, No cardio pulmonary symptoms
Called HD and reported c/o nurse child broke out with few rash dots on face. 3 days after shots then  11/23/2002 broke out all over with red dot like rash and fever 102.3 degrees. Mother took to ER and told had a virus and given Tylenol supp. Reports child has not been sleeping well and crying in sleep x 4 days and crying getting worse. Mother is giving Tylenol drops. At time of shots was antibiotic, Robitussin, and Albutrol for URI, Bronchitis and ear infection since 11/07/2002.
Outsized soreness at injection site 12 hours post injection, followed by in 1 hour by fever, chills, malaise, headache, sore muscles and joints, tender skin all over, stiffness lasting from its onset 12 hours post injection to 28 hours post injection. Forced to miss work the following day.
Information has been received from an office nurse concerning a 9 month old male who on 12-DEC-2007 was vaccinated with COMVAX, (lot # not reported). In December 2007, the nurse reported that the mother called in to complain that the baby was experiencing fussiness and crying. The nurse reported that this was "one of the doses that was recalled". The outcome of the events was not reported. Additional information has been requested.
b/l weakness in numbness starting in arm receiving vaccine shot at 0846 developed numbness in arm receiving injection which gradually spread to both arms grew to include weakness. After 30 minutes symptoms began to ease and she was released without intervention. VSS throughout. BP in 130s/80s, HR 70s, sats upper 90s. Employee kept at vaccination site until symptoms began to ease.