chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a pharmacist concerning a 58 year old male was vaccinated with ZOSTAVAX on 21Sep2012. The pharmacist reported that the patient developed a rash on his chest and generalized itching following the vaccination. The exact time frame of the development of the rash and generalized itching was not specified. The patient had contacted his physician (date, outcome not specified). It was reported the patient was not recovered. No further information was reported. Additional information has been requested.
Sore shoulder; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Sore shoulder) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Sep-2022, the patient received third dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Sore shoulder) and CHILLS (Chills). At the time of the report, ARTHRALGIA (Sore shoulder) and CHILLS (Chills) had not resolved.            No Concomitant medication was reported.  No treatment information was provided. The reporter reported that the reporter knew that these side effects were normal.
Shaking teeth chattering I felt tightened up and felt like I was going to throw up but I was soo tightened up and shaking and fevering that I couldn?t throw up and then stomach sick feeling and shaking and fever and teeth chattering episodes all night and cold and hot and freezing and shaking I felt like I was going to have CCD a siezure if it got any worse it was bad
1 wk p/recvd vax pt had malaise followed by mild dizziness; 2 wks psot vax devel fever w/facial flush followed by generalized pin head sized pink rash;
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 65-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 as dose 5 (booster), single (Lot number: GJ2524) at the age of 64 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes Type II" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19: Treatment with Paxlovid.
fever of 101, rash over entire stomach, no other areas.  very fussy for 2 nocs;
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 12-MAR-2016, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 03-AUG-2016, the patient was treated by a physician for a blistering vesicular outbreak which was diagnosed as shingles. She was prescribed VALTREX and NORCO for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
HPV9 L Deltoid & MCV4 R Deltoid administered. 10 - 20 sec later child fell back onto examination table, eyes rolled back & arms/body stiffened. Recovered within 15 sec. not aware of what had occured & oriented x3. Placed in trendelenburg position. 4:15pm = VS 111/52 HR 48. 4:25 pm = 108/58 HR 58.  4:32 pm = 102/57 HR 54; 4:50 pm = 102/59 HR 59. Ate crackers & drank juice w/o diff.  Stated felt "fine." Walked around clinic before Dr okd him to leave.  EKG ordered.  Sat in room for 45 min after episode.
Minor sore arm at injection site; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration (left arm) on 20Jan2021 11:45 at single dose for Covid-19 immunization. The patient's medical history included "known allergies: phenothiazine drugs". There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received TDAP vaccine and experienced sore arm at injection site. The patient was not diagnosed with COVID-19 prior to vaccination. The patient is not pregnant. On 21Jan2021, the patient experienced minor sore arm at injection site reported as "not nearly as bad as TDAP vaccine".  There was no treatment received for the adverse event. The outcome of event is recovering. The patient has not been tested for COVID-19 since the vaccination.
no adverse event; PNEUMOV AX 23 was inadvertently given to a 12 month old patient.; This spontaneous report was received from a medical assistant and refers to a 12-monts-old patient of unknown gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On 19-APR-2021, the patient was inadvertently vaccinated with a dose of  with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot lumber T035379 with expiration date 31-MAY-2022 (dose, route and anatomical location were not reported) for prophylaxis. No additional adverse events were reported.
Soreness, moderate to severe itching, raised dark pink 2" x 3" arm around injection site starting 24 hrs after injection. Patient applied hydrocortisone lotion to arm 48 hr post injection and again 72 hr post injection w/ improvement.
WITHIN 24 HOURS OF RECEIVING THE VACCINATION SHE GOT BOILS OR BUMPS UNDER HER ARMPIT. HAD TO SEE A MD AND THE MD PRESCRIBED HER ANTIBIOTICS. STILL TAKING ANTIBIOTICS AND HAS A FOLLOW UP WITH HER MD AS THE BOILS/BUMPS ARE STILL THERE/HEALING.
The patient was given Kinrix at age 9 months, indication are to give Kinrix at age 4-7 years,  pt reports no adverse reaction
Not feeling well after first vaccine dose; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Not feeling well after first vaccine dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Not feeling well after first vaccine dose). At the time of the report, ILLNESS (Not feeling well after first vaccine dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant Medications were reported. No Treatment Information Provided.
Mild flu-like symptoms; This case was reported by a physician via call center representative and described the occurrence of influenza-like symptoms in a female 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 influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Physician was self-reporting that she recently finished the Shingrix series.  After receiving Shingrix, the patient experienced mild flu-like symptoms for a day or two. The reporter did not consent to follow up. For the tolerance of 2nd dose, refer linked case US2020154060.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020154060:same patient, 2nd dose
Information has been received from a certified medical assistant (CMA) referring to a patient (2) of unknown age and gender. No information regarding patient's relevant medical history, current condition and concomitant  medications was provided. On 09-DEC-2015, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L013206, expiration date 29-JAN-2017, dose and route were unknown. The vaccines were stored under 34.5 F (Min) and 37.9 F (Max) for 24 hours. There was no previous temperature excursion. It was called because of a "data logger". No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
the morning p/shot given pt awoke w/pain in rt arm, & rt hand was swollen;also ahd severe pain in rt foot & foot was swollen;also generalized aches & pains;pt seen in ER evening, the evening of shot had some SOB.
Tired, muscle pain in my back and neck, shivering, no fever 98.4 F and nausea.
Five days after receiving the second dose of the vaccine, my left hand went completely limp.  I received X-rays of my hand and neck - no visible damage I received an oral steroid.  4 days later, I am slowly gaining use of my left hand
Woke up at 4 am. Very nauseated. Headache. Achy. Sore Arm. Went to bathroom and went back to bed. Awoke again at 7 am with those same symptoms intensified. All day was so tired, weak, nauseated, no vomiting. Headache and neck ache. Arm where shot is is very very sore. Felt like I was in a fog. Tried to nap but could not get comfortable. I am normally achy because of Fibro and arthritis. This seemed to cause a horrible flair. Felt so flu like. . Took my temp twice. 99 both times. Chills a little. Did not last long at all. Sweaty then chilled a bit. Only happened twice. It is now almost 30 hours since shot and I am feeling better. So The worse part was about 14 hours. Still achy. Not as bad. Arm hurts like hell still! Not so foggy feeling. Still no energy and weak legs but that seems to be getting better now.
The booster gave me a lot of chills, sweating and much more discomfort than the second dose and a fever of 101 or 102. It lasted for about 3 days.
Patient describes feeling "like hit by a truck" in the evening follow 2nd Moderna vaccine. She rapid heart rate at home at rest up to 130 beats per minute. Sought care in Emergency departmetn. Tachycardic on cardic monitor 110-130 in Emergency Department. Heart rate responded to IV fluids and dose of Lopressor. 10 mg IVpush, Regalsn 10mg for nausea, Decadron 10 mg IV push.
Big dimple in her left arm; The dimple has a bunch of red dots that looks like a rash but is not a rash; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 79-year-old female patient received BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Batch/Lot number: unknown), on 09Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 15Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SKIN DISORDER (non-serious) with onset Feb2021, outcome "not recovered", described as "Big dimple in her left arm"; ERYTHEMA (non-serious) with onset 2021, outcome "unknown", described as "The dimple has a bunch of red dots that looks like a rash but is not a rash".  Additional Information: Patient had a pretty big dimple in her left arm where she received the vaccines. She stated the dimple has a bunch of red dots that looks like a rash but is not a rash. She stated the dimple started out small and got bigger and has not gone away but has not gotten any bigger and the dimple started in Feb2021.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Temperature developed with temperature max of 105.4 and then febrile seizure x 2 on 11/23/02. Seen in ER and subsequently admitted. Febrile until 11/25. (unknown)LOM; (unknown) Pharyngitis. Medical records state otitis media, and pharyngitis.
This spontaneous case reported by a consumer, describes the occurrence of peripheral swelling  (swollen arm) and rash (rash across arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 044A21A) for COVID-19 immunization. No medical history reported. On Mar 12, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 12, 2021, patient experienced peripheral swelling (swollen arm) and rash (rash across arm). At the time of the report, peripheral swelling (swollen arm) and rash (rash across arm) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. Concomitant products included thyroid medication. Treatment medications included itch cream.
complain of feeling light headed directly after vaccine. Vital signs normal. no other symptoms. resolved after a while.
Urticaria with severe itching, especially at night. Currently being treated with diphenhydramine. Also experienced injection site soreness, mild fever, malaise, muscle aches for 48 hours following vaccination. Urticaria did not appear until day 12, post-vaccination, but continues (5 days and counting). Experienced no urticarial response to dose 1 or 2, only dose 3.
Patient was found on the ground sitting. Reported he was leaving after receiving 1st COVID-19 vaccine and "loss balance". Patient denies hitting head. Laceration to the elbow noted. Patient requested assistance to get up and still felt "dizzy". Patient assisted to wheelchair and recommended to go to ED via ambulance for evaluation. Patient then loss consciousness for 10 seconds. 911 was called. Patient refused all care by EMS. They called by EMS as they deemed patient was not safe to drive due to unsteady gait. It was advised patient to go to ED as instructed by EMS and The provider but refused. They also advised for patient to go to a hotel nearby to rest. Patient refused all recommendations and was escorted by EMS to his car.
This spontaneous report was received from a pharmacy student and refers to a female patient of unknown age. The patient did not have and drug reactions or allergies. Further information about her pertinent medical history, concurrent conditions and information about concomitant medications was not reported. On an unknown date, the patient was vaccinated with RECOMBIVAX HB (lot #, expiration date, dose, route of administration were not reported) for prophylaxis. On an unknown date, the patient experienced severe nausea and vomiting. The outcome of events was unknown. The reporter did not assess the relatedness between events and RECOMBIVAX HB.
on the 3rd day after receiving my 2nd covid vaccine I noticed red bumps starting to form on my chest. They started to itch intently and that following Sunday I had been covered in them on my chest and back.
Fever, Chills, Exhaustion,Body Aches,Congestion,Runny Nose,
This spontaneous report as received from a medical assistant refers to a patient of unknown age. The patient's concurrent condition, medical history and concomitant therapy were not reported. On 10-AUG-2017 the patient was vaccinated with a dose of improperly stored VARIVAX (lot # M044347, expiration date: 04-NOV-2018) for prophylaxis. Temperature and time frame: 6 F to 14 F for 1 hour 36 minutes. There was no previous temperature excursion. The sterile diluent vials used for reconstitution did not undergo a temperature excursion. No adverse effects reported. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1708USA006597:
Flu vaccine was administered in error by MA. Medical director notified. No adverse reaction. Parents notified of error.
On post vaccine day #2, the onset of notable bilateral jaw pain, most intense at TMJ.  Muscle fatigue also noted in the jaw and jaw clenching.    No treatment has been taken at this time, just close monitoring of symptoms and noting progression of pain and constant symptoms.   Currently on day 5 post vaccine and symptoms are still present, worsening since day 2 onset.
she had issues; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 46 year-old female patient received bnt162b2 (BNT162B2), administration date 01Apr2021 (Batch/Lot number: unknown) at the age of 46 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for Covid-19 immunization.  The following information was reported: ADVERSE DRUG REACTION (non-serious), outcome "unknown", described as "she had issues".  Additional information: The patient's side effects following second dose , fine during the first, and the second when she had issues. It was reported that, it was fine now, normal stuff, and was over.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Narrative:  66 y/o male patient w/ PMH significant for HTN, concerns for alcoholic liver cirrhosis, and esophageal squamous cell carcinoma /esophageal stricture s/p recent PEG Tube placement, on TF. Pt presented to ED on 5/23/22 w/ clogged G-tube, headache, sore throat, body aches, and fever. Pt COVID + and admitted to hospital for further evaluation. Pt treated w/ remdesivir (5/24-5/27). Pt also treated for bacterial infection w/ unknown source, likely GI. Pt improved and discharged to home on 05/31/22.
This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (vaccines which underwent a temperature excursion in the freezer were viable) and NO ADVERSE EVENT (No adverse event) in a 67-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.     Reporter reported that a temperature excursion that occurred several days ago in the Freezer. The excursion was found out in an audit and all the vaccines were viable.  No treatment medications were provided.
Cough; Nasal congestion; cold symptoms; Chest congestion; Postnasal drip; Sore throat; Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY CONGESTION (Chest congestion) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Inflammation. Concomitant products included MESALAZINE (LIALDA) for Inflammation NOS.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced UPPER-AIRWAY COUGH SYNDROME (Postnasal drip), OROPHARYNGEAL PAIN (Sore throat) and PAIN IN EXTREMITY (Arm was sore). On 07-Mar-2021, the patient experienced PULMONARY CONGESTION (Chest congestion) (seriousness criterion medically significant), COUGH (Cough), NASAL CONGESTION (Nasal congestion) and NASOPHARYNGITIS (cold symptoms). On 06-Mar-2021, PAIN IN EXTREMITY (Arm was sore) was resolving. At the time of the report, PULMONARY CONGESTION (Chest congestion), UPPER-AIRWAY COUGH SYNDROME (Postnasal drip), OROPHARYNGEAL PAIN (Sore throat), COUGH (Cough), NASAL CONGESTION (Nasal congestion) and NASOPHARYNGITIS (cold symptoms) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, SARS-CoV-2 test: Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No laboratory data was provided. Treatment included pseudoephedrine, guaifenesin daily, nyquil and oxymetazoline at night.; 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.
pt recvd vax; very difficult to arouse, limp & very pale for approx 24 hrs p/ immun;
The patient received a Pfizer COVID vaccine when he was 15 years old, but on the date he received it, the EUA only allowed for administration to ages 16 and older.  The patient subsequently returned for his second vaccine, by which time the EUA had been expanded to include ages 12-15. No concerns reported by patient or parent. Unfortunately, the date of birth supplied to the pharmacy at the time of vaccination was 3/24/2005 instead of 7/24/2005, which caused the pharmacist to believe the patient was 16 years old at the time of his first vaccination.
Mother c/o swelling and redness from injection  area Left thigh to knee also redness, slight fever and "crabby" x2 days. Discuss reaction with mother and recommended she have pt see to document. Mother had pt's grandmother look at site. She states she is an RN and felt it was only soft tissue swelling. TC from mom 05/09/2005,.  pt is doing well.
Fever, diagnosed with UTI, treated in emergency department with antibiotics (Rocephin) sent home on Cefdinir, followed up with Renal ultrasound on 12/02/2014 and VCUG on 01/07/2015. Hydronephrodis revealed.
RECEIVED A HALF DOSE FOR THEIR  BOOSTER; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 35 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient was previously treated with covid-19 vaccine ad26. cov2. s (unspecified manufacturer) for prophylactic vaccination (dose series 1).  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A expiry: Unknown), 0.25 ml, 1 in total, administered on 27-NOV-2021 for prophylactic vaccination (dose series 2). No concomitant medications were reported.   On 27-Nov-2021, the patient received half dose of the Booster dose vaccine (off Label use). The reporter stated that something was printed and was disseminated which said to administer 0.25ml.(dose series 2)  The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The outcome of the received a half dose for their booster and off label use was not reported.  This report was non-serious.  This case, from the same reporter is linked to 20211201450, 20211202515, 20211202379, 20211202371, 20211202250, 20211202246, 20211202207, 20211202199, 20211202193, 20211202161, 20211201963, 20211201443, 20211201392, 20211201362, 20211201304, 20211201286, 20211201228, 20211201179, 20211201168, 20211201082, 20211201046, 20211200994, 20211200752, 20211200769, 20211200723, 20211200675, 20211200717 and 20211165041.
Red, swollen left leg.  Larger than 50 cent piece.  Child brought to office.