chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Mother called and reported that the child was fine this morning and when the grandmother had lunch with patient at school, the teachers told her about the left arm being red and swollen.  She was asked to take the girl home.  Described the site as the arm with only one injection and has an approximate 2" red, raised, firm, local reaction approximately the size of a lime.  Denies any other signs or symptom other than discomfort at the site.  She appears fine other than not letting the site be touched. To consult physician if not improved with compresses, acetymenophen or ibuprophen and increase fluids, and report back to this office if medical follow-up is necessary. Also referred her back to the "After The Shots" handout for any other potential reaction and action to take.
Redness at injection site; Hard area at injection site; Soreness/tenderness at injection site; Headache; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 55-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th November 2019, the patient received the 1st dose of Shingrix (intramuscular). On 3rd December 2019, 19 days after receiving Shingrix, the patient experienced injection site erythema and injection site induration. On an unknown date, the patient experienced injection site pain and headache. On an unknown date, the outcome of the injection site pain and headache were recovered/resolved and the outcome of the injection site erythema and injection site induration were unknown.   It was unknown if the reporter considered the injection site pain, headache, injection site erythema and injection site induration to be related to Shingrix.  Additional details were received as follows: The patient stated that he received the first dose of Shingrix vaccine and experienced soreness and tenderness at injection site along with a headache. On the day of reporting the patient also woke up with redness and hard area at the injection site which was circular and 1 inch by 1 inch in size. The patient did not consent to follow up.
HAS RED FLAT RASH ALL OVER BODY THAT STARTED 2 NIGHTS AGO.  NO ITCHING, AFEBRILE.
So far very sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (So far very sore arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067P214, 015M2 and 013L2) for COVID-19 vaccination.     The patient's past medical history included Hives and Urticaria. Previously administered products included for Product used for unknown indication: Iodine (Injected and rash appeared immediately) in 1990, Metoprolol (large blister on chest, and tiny thin blister down arm and legs) in 2014, Metoprolol (increased 25 milligram, large blister on chest and and tiny thin blister down arm and legs when dose was increased) in June 2020. Past adverse reactions to the above products included Blister with Metoprolol and Metoprolol; and Rash with Iodine. Concomitant products included AMLODIPINE, UBIDECARENONE (COQ 10), LINUM USITATISSIMUM SEED OIL (FLAX SEED OIL), HYDROCHLOROTHIAZIDE, LEVOTHYROXINE, MULTIVITAMIN [VITAMINS NOS], PRAVASTATIN and VITAMIN C [ASCORBIC ACID] for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (So far very sore arm). At the time of the report, PAIN IN EXTREMITY (So far very sore arm) outcome was unknown.            Concomitant drug included triple flex 50 plus PO 1 tablet by mouth twice a day for unknown indication and Ocuvite adult 50 plus 1 dosage form daily for unknown indication. No treatment medication was reported by reporter.
mom noted 25JAN95 that pt's level of consciousness was not appropriate as well as t104, fussy, drooling from mouth; had croup like breathing, wheezing; seen in ER early 26JAN95; adm to hosp later in day for elevated temp, breathing diff;
2 days after injection of DPAT/IPV on right thigh, was seen here due to swelling, tenderness and warmth covering almost all of right thigh.
No additional AE; tempreature excursion that was intermittent beginning 28-JUL-2020/there have been administered doses; This spontaneous report as received from an nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications, and previous drug allergies or reactions were not reported.   On 28-JUL-2020, varicella virus vaccine live (oka/merck) (VARIVAX) (lot number T002843 verified to be valid with expiration date of 23-JAN-2022, and lot number S032357 verified to be with expiration date 14-OCT-2021) were exposed to a temperature excursion that was intermittent; these doses of vaccine were stored between -14 degrees Celsius (C) to -10 C for a 38 hours and 30 min. There was not a previous temperature excursion. Digital data logger was involved (product storage error).  On an unknown dates, the patient was vaccinated with the improperly storage varicella virus vaccines live (oka/merck) (VARIVAX) reported above at a dose of 0.5 mL (vaccination scheduled, route of administration, and anatomical location was not provided). No adverse event was reported.; Sender's Comments:  US-009507513-2008USA014711: US-009507513-2008USA014701:
Felt hot (temp not measured) one convuls following immun, high pitched abnormal screaming/crying lasting >4 hrs;
C/o itching  and redness and slight swelling in hands.  States this happens when receiving antibiotics.  Assessed by EMS-no treatment.  Discharged home at 1:36pm.
Broke out in chickenpox with "little tiny pox" on back, few on face, legs and was febrile just under 101F on 11/5/00. As of today, they are scabbed over. Used oatmeal baths, lotion and calamine lotion.
feel like I have contract to come down with the COVID since I got the vaccination; lost smell and taste; lost smell and taste; This is a spontaneous report from a contactable consumer or other non hcp (patient).   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 23Sep2021 (Batch/Lot Number: FC3184) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date in 2021, the patient had events reported as "feel like I have contract to come down with the covid since I got the vaccination, lost smell and taste. consumer stated, "No, I haven't had COVID." (Further clarification was unknown). It was reported that after "I got the shot last week, Last Friday or Saturday, I lost taste, smell and taste". The patient was due for the next shot on 14Oct2021. At the time of this report, the outcome of event was unknown.
Thebiopsy resultswere positive for rubella virus by immunohistochemical analysis and reverse transcriptasepolymerasechainreaction(RT-PCR)/were positive for vaccine-derived rubella virus (VDRV); the patient was immunodeficiency and received measles, mumps, and rubella (MMR) vaccine; This literature market report has been received from authors of a published article, titled as below, referring to a currently 11 years old male patient with Nijmegen breakage syndrome, cutaneous granulomatous disease and immunodeficiency. The patient's medical history and concomitant medication were not provided.   On unknown dates, the patient had received measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (strength, dose, route, batch/lot number and expiration date were not provided) for prophylaxis at ages 1 and 5 years (product use issue).   On an unknown date when the patient was 10 years old  (reported as 1 year history), the patient presented with an erythematous plaque on the right cheek. Skin biopsy was performed and demonstrated sarcoidal granulomas. Tissue cultures were negative for bacteria, fungi and mycobacteria. The biopsy results were positive for rubella virus by immunohistochemical analysis and reverse transcriptasepolymerasechainreaction (RT-PCR) (vaccine-derived rubella virus (VDRV)). Infectious virus was recovered from the biopsy by cell culture. Whole-genome sequencing of the isolated virus showed 2% nucleotide divergence from the sequence of the RA27/3 vaccine strain. A nasopharyngeal swab tested negative for rubella virus by RT-PCR. At last follow-up, the lesion remained untreated. The outcome of VDRV was considered as not recovered. The reporter considered rubella was related to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown).   A copy of the published article is attached as further documentation of the patient's experience.  This is one of two reports regarding the same literature(linked case# 1909USA000868).; Sender's Comments:  US-009507513-1909USA000868:
Patient, a 61 year old,  got Fluzone HD for over 65 years old instead of regular Flu  for under 65 yeas old.   I spoke to his wife and she said that patient was fine and did not experience any adverse effect.
The vial was stored in the refrigerator on 04 JUN 2023 after expiration date 11 MAY 2023 and Dose administered to patient on 5 JUN 2023; No adverse event; Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023), PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04 JUN 2023 after expiration date 11 MAY 2023 and Dose administered to patient on 5 JUN 2023) and NO ADVERSE EVENT (No adverse event) in an adult 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. AS7143C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Jun-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 05-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04 JUN 2023 after expiration date 11 MAY 2023 and Dose administered to patient on 5 JUN 2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023), PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04 JUN 2023 after expiration date 11 MAY 2023 and Dose administered to patient on 5 JUN 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023) and PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04 JUN 2023 after expiration date 11 MAY 2023 and Dose administered to patient on 5 JUN 2023).    No concomitant medication was reported.  Suspect product dosage text was reported as unknown. It was reported that no adverse reactions have been reported by any patients. The vial was initially stored in the refrigerator on 4-JUN-2023 and did not underwent any temperature excursions. No treatment medication was reported. This case was reported for patient 32 out of 50 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-735331 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735331:Patient 1 out of 50 (Lot AS7143C was administered on 5Jun2023)
Information has been received from a medical assistant concerning a 20 week old male patient who on 16-MAR-2007 was vaccinated with first dose of Rotateq. On 13-JUN-2007, 12 weeks after first dose, the patient received the second dose of Rotateq. The patient spit up within 15 minutes of administration of his second dose and also the third dose of Rotateq on 23-AUG-2007. The patient may have received an incomplete second and third dose. The patient did not experience any further problems. Additional information has been requested.
Wed 3/5 decreased appetite; Thurs 3/6 fussy, tired, crying vomiting and diarrhea at NOC no fever. 3/9 final diarrhea; decreased appetite.
I woke up with a scratchy throat and throughout the day I started to feel fatigued. By that evening I had a fever about 99 or 100. Next morning I just felt a little icky, as the day went on I became more fatigued and the fever came back, definitely over 100. The day after that I went to an urgent care, thinking it was a sinus infection. They tested me for COVID-19, test came back positive. They weren't able to prescribe anything due to my current medications. I went home to isolate as best I could. Wore a mask whenever I left my room, and was able to mostly stay in my master suite but the rest of my household did end up coming down with it as well. I was still feverish off and on for a few days, definitely had a headache. Never lost my sense of taste and smell, but at some point my sense of taste was lessened. It was probably a good week that I isolated, after the symptoms had cleared up I started having issues breathing and had to use my inhaler more.
Febrile sz 72 hrs post inject; @ 24 hrs had "croup-like" sx @ 48 hrs developed fever;
allergy; hives; Information has been received from a nurse practitioner referring to a 58 year old female patient. This case was split form a case in litigation (captured into 1902USA008631). The patient's medical history, concomitant therapy and concurrent condition has been captured into the case in litigation.   On an unknown date, the patient was vaccinated with hepatitis a vaccine, inactivated (manufacturer unknown) and/or hepatitis b vaccine (recombinant)(manufacturer unknown) (dose, concentration, lot#, expiation date, route and frequency unknown) for prophylaxis. The patient could not recall if it was hepatitis A or B or both vaccines. The patient was allergic to hepatitis a vaccine, inactivated (manufacturer unknown) and/or hepatitis b vaccine (recombinant)(manufacturer unknown) on 09-APR-2015 (side effect: hives). The outcome of events was unknown. The reporter considered events to be related to hepatitis a vaccine, inactivated (manufacturer unknown) and/or hepatitis b vaccine (recombinant)(manufacturer unknown).; Sender's Comments:  US-009507513-1902USA008631:
Information has been received from a physician concerning an adult male, without a reported history of chickenpox and who was VZV negative, who on an unknown date was vaccinated with a first dose of VARIVAX (Merck). On an unspecified date, 3 weeks post vaccination, the patient developed a rash. The rash was found to be positive for the vaccine strain VZV by PCR performed at the CDC. At the time of the report the patient's status was unknown. A product quality complaint was not involved. The reporting physician stated she believes there has been an increase in the frequency of calls to the local health department regarding second dose AEs, particularly rashes in patients who have received a second dose of VARIVAX (Merck). She indicated that other physicians in the region also felt they were seeing an increase in second dose rashes as compared to what they observed following the first dose. With respect to specific types of AEs, the physician stated she saw reports of generalized rashes, injection site reactions and cellulitis. She has spoken with the reporting healthcare providers and all doses of VARIVAX (Merck) were stored and administered appropriately, and all patients involved were normal healthy children. This is one of several reports received from the same source. Additional information has been requested.
pt recv vax 18APR97 & 16MAY97 pt devel a couple of vesicles on wrist & @ the site of inj;dx as possible varicella rash;
Swelling, slight pain in upper arm (between elbow & arm pit) redness of skin and warm to touch.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 03-NOV-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, 0.5 ml, (lot # K009105, expiration date 21-JAN-2016) (route and dose were not reported). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for the first time was 24, 34 and R. The total cumulative excursion time (hour); the highest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for the first time was 72, 47 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Vaccine given twice on 8/22/22 because RN stated that the dose was administered incorrectly. Started experiencing fatigue 3 hours later and was dismissed from work. Tried to sleep off symptom, but had extreme fatigue with headache on morning of 8/23/22 at 4:30AM when trying to get ready for work. Had to call out sick. Slept throughout day of 8/23/22. Started having body-aches in the evening of 8/23/22. Morning of 8/24/22, had improving symptoms though not resolved. At work, could not walk around for rounds much because of fatigue, so was sent home. Slept throughout day of 8/24/22. Fatigue resolved by 8/25/22, so returned to work. Swelling and erythema at site of vaccinations reached a peak on 8/25/22, and now resolved on 8/31/22 with dark marks left on arm.
When injected, shot burned then went away.   Later that night injection started to get itchy, and burned, intermittently.  The next day, site got red and swollen.   That night I had a low temp fever.  The following day, I had flu like symptoms...chills, headaches, very sore arm with itchiness and muscle soreness.  This lasted until Friday or so with these symptoms. I did have a telehealth call with my M.D. office, and was told to watch it.      The injection site was still red, swollen, and itchy though.    I went to the ER, on Sunday for a different issue.  The Er doctor saw the site and prescribed an antibiotic medication as a precaution.
5/20 6-year-old female here with mom, with no past medical history who presents for fall off the slide yesterday
Where i received my injection my arm is still sore whenever I move it it feels like its in my muscle; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 19Feb2021 at 09:00 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Where the patient received her injection, her arm was still sore on 19Feb2021 at 23:00, whenever she moved it, it felt like it's in her muscle. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event where the patient received her injection arm was still sore whenever she moved it, it felt like it's in her muscle was not resolved at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Symptoms of cardiomyopathy; Shortness of breath, tachycardia, irregular heart beat, chest pain, fatigue
Information has been received from a physician concerning a 60 year old female with codeine, ASA and morphine allergy who on 20-NOV-2007 at 10:30 AM was vaccinated with a first 0.6 ml dose of ZOSTAVAX (Lot # 658397/1820U).  On 21-NOV-2007 the patient developed blistering around injection site which did spread along dermatome.  On 27-NOV-2007 the physician diagnosed it as mild to moderate case of shingles.  Additional information has been received from the physician who stated that the patient on 21-NOV-2007 in morning developed zoster like eruption starting at injection site.  It was reported that the eruption occurred within 24 hours of vaccination.  On an unspecified date the patient recovered.  No further information is expected.
pain & induration in <24hr;cellulitis distal upper LE to crust elevation/NSAID/Zelbronzcun
Pt received ZOSTAVAX on 8/4/11 and came in on 8/6/11 presenting with swelling, redness, itching, and localized pain around vaccination site. It appeared to look like shingles and pt stated it had been spreading on arm since vaccination given on 8/4/11. Informed pt to seek care from her PCP.
Aches and pains; Fatigue; Fatigue; Malaise; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of FATIGUE (Fatigue), MALAISE (Malaise), PAIN (Aches and pains) and the second episode of FATIGUE (Fatigue) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced the first episode of FATIGUE (Fatigue) and MALAISE (Malaise). On 11-Mar-2021, the patient experienced PAIN (Aches and pains) and the second episode of FATIGUE (Fatigue). On 13-Feb-2021, MALAISE (Malaise) had resolved. At the time of the report, PAIN (Aches and pains) and the last episode of FATIGUE (Fatigue) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treatment included Tylenol.   This case was linked to US-MODERNATX, INC.-MOD-2021-073869 (Linked Report). This case was linked to MOD-2021-089612 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-073869: