chrisvoncsefalvay/vaers-outcomes huggingface dataset:
feeling like I was breaking out; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of skin breakout in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 27-APR-2023, the patient received Shingles vaccine. On 29-APR-2023, 2 days after receiving Shingles vaccine, the patient experienced skin breakout (Verbatim: feeling like I was breaking out). The outcome of the skin breakout was resolved (duration 2 hrs).   It was unknown if the reporter considered the skin breakout to be related to Shingles vaccine.     It was unknown if the company considered the skin breakout to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 30-APR-2023 This case was reported by a patient via interactive digital media. The patient had her/his shot Thursday and Saturday start feeling like he/she was breaking out however two hours later it went away patient not normal. The follow-up could not be possible as no contact details were available.
rash on face & chest pressure are reported in a pt receiving 1 dose of fluogen vax given on 4NOV93; the folowing day pt exp chest pressure & a rash on the skin around the eyes which abated a day later;
rash to 6 to 7hr p/vax to arms, legs, face & small rash to abd area;pt had itching all over body;tx;cellulitis on lt arm swelling & erythema;
pt recv vax 3OCT97 & 10OCT97 pt exp cerebellar ataxia;pt presented w/unsteady gait, sl h/a, fever & drowsiness;MD considered the event to be life threatening;pt sx have resolved;
Exhaustion, lightheaded, increased heart lasting 4 weeks after vaccination. Resting heart rate frequently over 100 BPM.  Severe abdominal cramps after 7 days. Was diagnosed with constipation although having regular bowel movements (2-3 per day) or possible pregnancy (not sexually active).  Possibility of vaccine reaction seemed to be disregarded.
Information regarding PREVNAR was received from a physician regarding a female patient who received the fourth dose on 05-May-2008 at 12 months of age and experienced neurogenic septic shock, neurogenic respiratory failure, brain dead, pneumococcal bacteria in blood, vaccine failure and pneumococcal meningitis at 13 months of age. On 11-May-2008, the patient was admitted to the intensive care unit brain dead and in neurogenic respiratory failure. Laboratory results revealed pneumococcal bacteria in blood and a large amount of pneumococcal bacteria that grew in less than eight hours in CSF culture, which led to the additional diagnosis of pneumococcal meningitis. Serotype testing was not performed. An antimicrobial susceptibility test was unremarkable. The physician felt "like this is a vaccine failure". The patient also developed neurogenic septic shock. Treatment included ROCEPHIN and VANCOMYCIN. On 12-May-2008, the patient died. The cause of death were reported as meningitis pneumococcal, respiratory failure, septic shock, vaccination failure, brain death and pneumococcal sepsis. No additional information was available at the time of this report.  6/3/08-records received for DOS 5/11-5/13/08-Date of Death 5/13/08. Final DX: Meningitis secondary to Streptococcus pneumoniae. Gram-positive coccal bacteremia. Admission neurologic examination consistent with brain death, subsequently confirmed. Brain death confirmed by repeat examination and confirmatory tests through course of hospitalization. Admitted via emergency room previously well child until 3/10/08, warm to touch temperature 101, listless and febrile with temperature as high as 104.4. Vomited. Became limp, feet cold, apneic. CPR initiated at home. Cyanotic. Pupils dilated and nonreactive. GCS 3. Heart rate 170 but not palpable pulses. No spontaneous respirations. Intubation, mechanical ventilation.
Patient states she returned to worksite after vaccine received and felt fine. States around 12:00 pm she was having a conversation with a coworker about her history of fainting spells when she speaks about medical procedures. While she was talking to coworker she fainted and hit the back of her head on the floor. States she recovered within 5 minutes. School nurse was notified and reported a faint pulse and blood pressure was low (around80/40). Was transported home by parents. States she felt groggy after fainting and a slight headache, tunnel vision, and muffled hearing that resolved the next day, 2/25/2021 around 7:00 pm. States she has a bump on the back right side of her head but denies other injuries. States she did return to work the next day.
Classic pericardial pain.  Admitted to Hosp. Cardiac enzymes up a little followed by negative heart cath.  Etiology of symptoms thought (by me) to be due to MCTD.  Settled down with colchicine/ibuprofen.  I assume 41 days between vaccine and onset means not due to vaccine.  But then she had another vaccine (#5) on 9/15/2022.  The following day she developed ischemic colits and admitted to same hospital for 6 days.  Still not able to eat real food.  Assume this was due to MCTD since surgeon says was not due to radiation.  It did not occur to me to mention vaccines to hospitalist and they were not considered to my knowledge on either hospitalization.  I could send pdf hospital summary if desired.
Rash on leg, body, arm; Body itchy; This case was reported by a consumer via call center representative and described the occurrence of generalized rash in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2022, the patient received the 1st dose of Shingrix. On an unknown date, 3 weeks after receiving Shingrix, the patient experienced generalized rash and pruritus. On an unknown date, the outcome of the generalized rash and pruritus were unknown.   It was unknown if the reporter considered the generalized rash and pruritus to be related to Shingrix.     Additional Information: GSK Receipt Date: 5-DEC-2022. Reporter's Comment: The reporter stated that the patient got his first Shingrix shot in his right arm.  The patient was due for his second Shingrix dose in a few weeks.  The patient said about 3 weeks to a month after getting the first Shingrix shot, he had a rash break out on his leg, body and arm.  The patient also said some parts of his body were itchy. The reporter declined consent for healthcare professional follow-up. The reporter did not give consent to follow up.
This spontaneous report was received from a licensed nurse practitioner refers to 11 unspecified patients of unknown age. On an unknown date, the patients were vaccinated with an improperly stored dose of GARDASIL (lot number, expiry date was unknown). Concomitant medications were not reported, no adverse effects reported. The outcome of the events was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Narrative:  COVID infection following COVID vaccine series 06/07, Pfizer, dose #1 08/06, Pfizer, dose #2 12/22 COVID swab, result: detected 12/20 pt cc: cough, fever, sore throat, diarrhea, fatigue, rhinorrhea exposure: unknown 12/22 SARS-COV-2 Variant Sequencing: pending 12/28 clinically resolved
Patient administered vaccine that was past it's BUD of 7/22/2022 - No known adverse effects
PATIENT REPORTED PAIN IN LEFT ARM, SHOULDER TO ELBOW WAS SWOLLEN AND RED.
Slight headache; slight soreness at IJ; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Slight headache) and VACCINATION SITE PAIN (slight soreness at IJ) in a 56-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19.    On 21-Sep-2022, 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 an unknown date, the patient experienced HEADACHE (Slight headache) and VACCINATION SITE PAIN (slight soreness at IJ). At the time of the report, HEADACHE (Slight headache) and VACCINATION SITE PAIN (slight soreness at IJ) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Patient took Johnson and Johnson vaccine.  Treatment information was not provided.
Reporter indicated that over the last 1 & 1/2 yrs 6 pts recvd a series of 3 doses of Engerix-B for Hep B did not convert; booster doses will be given;
This spontaneous report was received from a Certified Medical Assistant (C.M.A.) concerning a patient of unknown age and gender. No concurrent conditions or medical history were reported. On 10-JUN-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck), 0.5 ml, subcutaneous (Lot No., expiration date and anatomical administered location were not reported). The patient did not experience any adverse effects. It was unknown if the patient sought medical attention. Additional information has been requested.
Pt recd immun 3MAY91; During night broke out in "whelps" w/red spots in center all over trunk, arms, neck, face; No dyspnea or other sx other than itching; Seen @ hosp by nurse (not ER); Given DPH;
Information has been received from a medical assistant(also reported as office manager) referring to a 2 year old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not provided. On 12-MAY-2017, the patient was vaccinated with the second improperly stored dose of VAQTA (lot # M039202, expiration date: 11-MAR-2018; dose and route of administration were not provided) for prophylaxis(Incorrect product storage). No adverse effects were reported. The vaccine was involved in Vaccines For Children Program(VFC) stock and the VFC status appointment was reported as 1. The patient received the vaccine with the temperature excursion of 17.6 degrees Celsius for 74 hours and 8 minutes (also reported as 1 hour and 38 minutes). The vaccine was previously exposed to a temperature excursion in 13 degrees Celsius for 72 hours 30 minutes. Data logger was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.; Sender's Comments: US-009507513-1704USA014784:
PATIENT (1/10/10) RECEIVED PEDIATRIC (ORANGE CAP) PFIZER VACCINE AS A SECOND DOSE.  PATIENT IS 12 YEARS OLD.  PATIENT HAD RECEIVED PFIZER (PURPLE TOP) ON 1/20/22 10 DAYS AFTER TURNING 12.  THE CDC RECOMMENDATION IS NOT TO REDOSE AND UPON CLINICAL JUDGEMENT WITH PEDIATRICIAN A CORRECTED DOSE CAN BE GIVEN 21 DAYS AFTER THE INCORRECT (ORANGE TOP) DOSE.   WE WILL BE CONTACTING PEDIATRICIAN ON MONDAY 2/14/22.  SPOKE WITH MOM ON SATURDAY 2/12/22 TO ALERT HER OF THE ERROR AND EXPLAIN THE CDC GUIDELINES FOR CORRECTIONS.   MOM STATED THAT PATIENT IS DOING FINE.
11/15 8:00 Started coughing - burning in lungs and esophagus with each deep breath - pain in lungs. Tightness in chest, ears feeling full and painful, eyes painful. hard to swallow, gums feeling puffy. Face swollen. 11/16 Today face still swollen, eyes with discharge (yellow). feeling very tired.
Patient admitted to hospital for shortness of breath. She was found to be in a-fib RVR with a heart rate of 150-170. Medication unable to get heart rate under control in usual time frame.
Itching and raised, serpigiuar  rash left deltoid at site of MMR and Hep B #1. Sxs began 1-2 days after injection and persist 1 month later.
Malaise; Fatigue; Swollen lymph node left arm; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (Malaise), FATIGUE (Fatigue) and LYMPHADENOPATHY (Swollen lymph node left arm) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced MALAISE (Malaise), FATIGUE (Fatigue) and LYMPHADENOPATHY (Swollen lymph node left arm). On 10-May-2021, MALAISE (Malaise), FATIGUE (Fatigue) and LYMPHADENOPATHY (Swollen lymph node left arm) 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 medications were not reported . Treatment information was not provided.    This case was linked to MOD-2021-231719 (Patient Link).
This spontaneous report as received from licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 18-FEB-2014, the patient was vaccinated with PROQUAD (Merck) (dose strength and route was not reported) (lot # J004319 and expiry date: 17-OCT-2014) which was improperly stored. Primary reporter was reported excursion of 6 F since 01-JUN-2013 (confirmed date) affecting PROQUAD (Merck), nurse also reported that products were not stored in an overall average support range of -58 degree D and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for PROQUAD (Merck). This is one of the several reports from the same reporter. Additional information has been requested.
Systemic: Body Aches Generalized-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Headache-Severe, Systemic: Unable to Sleep-Severe
Severe soreness in my arm in and around the site of the vaccine within a few hours of the injections to the point of not being able to move my arm without pain.  Itching at the site of the injection started two days after and continued for 10 days.
Pt complained of arm soreness after injection saw Dr about a month after and received a cortisone shot. Had physical therapy for 2 weeks. Has full ROM, but still has soreness.
Quite a few pt's were found to be non-immune p/completing a 3 dose series of Engerix-B; some of the pts completed their series a yr ago & are just being tested;
Beginning 1 day after the vaccine, the patient states that the injection site became very itchy. 2 days after, she stated she could not breathe very well. She was never tested for covid. Currently, 6 days later (today), the injection site is very hard, irritated, sore, and there is an open sore where the needle was injected.
Patient developed lactose intolerance; This spontaneous case was reported by a consumer and describes the occurrence of LACTOSE INTOLERANCE (Patient developed lactose intolerance) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 012LM0A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LACTOSE INTOLERANCE (Patient developed lactose intolerance). At the time of the report, LACTOSE INTOLERANCE (Patient developed lactose intolerance) outcome was unknown.            No concomitant medication details was reported. No treatment medication details was reported.
I was in the city from 07/13/2022 to 07/16/2022. Around 09:00PM on 07/16 I had a headache. When I returned home, I also noticed a sore throat and I felt very fatigued and when I went to bed I had the chills. The next morning I felt off, I was still fatigued and the headache continued. I also began to feel a stuffy nose and congestion. I took an at home COVID-19 test the afternoon of 07/17 and it was positive. I immediately began to isolate from my husband. I called my doctor that Monday 07/18 who advised that I just treat my symptoms with over the counter medication. I've been taking Advil for my headache and throat lozenges for my sore throat. My symptoms have been improving and I would say that I am currently on 07/21/2022 at 90%. I still have some congestion and an occasional cough, but I feel pretty much better at this point.
Patient was admitted to hospital on 01/17/2022 with high fever, cough, and shortness of breath. Patient had an abnormal chest CT scan and had developed pneumonia. Patient tested positive for Covid-19. Patient has multiple medical conditions, listed in this report. This information was obtained by medical records posted in "PRIVATE".
This spontaneous report received from a medical assistant referred to multiple patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. Medical assistant reported that on an unknown dates, multiple unspecified patients received improperly stored doses of PROQUAD (dose, frequency not reported) (Lot: M043306, expiry date: 24-APR-2018) reconstituted with sterile water diluent (unknown lot number and expiration date). No adverse effects reported. Temperature and Time frame: -14°C to -10°C for 9 hours 43 minutes, -14°C to -10°C for 15 hours 46 minutes, -14°C to -10°C for 12 hours 31 minutes. Previous temperature excursion was -14°C to -10°C for 6 hours 26 minutes. The call was because of data logger. This is one of the two reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) human serum albumin (HSA), lot # L014401, expiration date 23-OCT-2016 (dose and route of administration were not reported) or PROQUAD (Merck) recombinant human albumin (rHA), lot # L026728, expiration date 15-JAN-2017 (dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Starting 12 hrs after 2nd vaccination I started having aches, fever, chills, sweats, headaches. Side effects lasted about 4-5 days. Fever reached 102/103. Started feeling better, but about 10 days later had the same reoccurring symptoms, although milder. 3 weeks after vaccine still hadn?t  returned to normal energy level.  Just recently started feeling better.
Prelim reported that pt's vomited and gone to respiratory arrest.  8/21/07 Spoke w/MD who states patient was in good health on day of vax.  Looked tired but exam was WNL.  Family concerned only about umbilical hernia.  8/21/07 Received pcp medical records & vax records which confirm RO dose & lot # as reported.  Records indicate patient was in good health on day of vax w/only medical concern umbilical hernia.  3/11/08 Autopsy report states COD as undetermined.
pt recvd vax 22SEP94 & 23SEP94 pt presented in sick call w/either a fever &/or a local or systemic rxn;sxs resolved p/several days;
The location of the injection still looks like an insect bite, with a raised area about .5" in diameter. Two days after the injection there is now a 2" red circle on the skin below the injection site. The area is sore to the touch and also with muscle soreness.
Joint pain moving between and among knees, hips, shoulders, elbows and right wrist/hand. Treatment was Tylenol. Symptoms almost gone 26MAR2021.
Reaction: Vasovagal response; flushing; loss of consciousness; Tachycardia; nausea; vomiting.
VACCINE NOT STORED IN REFRIGERATOR GIVEN  TO 80 PATIENTS; PRODUCT STORAGE ERROR; This spontaneous report received from a health care professional 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: 201A21A, expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced vaccine not stored in refrigerator given to 80 subjects, and product storage error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine not stored in refrigerator given to 80 patients and product storage error was not reported. This report was non-serious.
Myalgia, Arthralgia, Fever, NauseaVomiting, Localized swelling, pain; chills, fatigue Narrative:
Had mild Tinnitus for many years. Now have severe tinnitus, especially after sleeping.
No adverse event; lower than authorized dose of Moderna bivalent vaccine administered to patients; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (lower than authorized dose of Moderna bivalent vaccine administered to patients) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 061F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 27-Oct-2022, the patient experienced UNDERDOSE (lower than authorized dose of Moderna bivalent vaccine administered to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (lower than authorized dose of Moderna bivalent vaccine administered to patients) 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 UNDERDOSE (lower than authorized dose of Moderna bivalent vaccine administered to patients).    No concomitant medication details was reported. The patient had not reported any adverse reactions at that time. This case is reported for 15th patient out of 18 patients. No treatment medication details was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-666277, US-MODERNATX, INC.-MOD-2022-666284, US-MODERNATX, INC.-MOD-2022-666280 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-666277:Patient 15 US-MODERNATX, INC.-MOD-2022-666284: US-MODERNATX, INC.-MOD-2022-666280: