chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe joint pain; Vertigo; muscle aches; This is a spontaneous report from a non-contactable consumer or other non hcp.   A 37-years-old female patient received BNT162b2 (CONMINTARY, Solution for injection, Lot No: was not reported), via an unspecified route of administration, administered in Arm Left on 10Mar2021 16:00 as unknown, single for covid-19 immunisation (age at vaccination was 37 years). Patient was not pregnant at time of vaccination. Medical history included migraine from an unknown date and unknown if ongoing, motion sickness from an unknown date and unknown if ongoing. Concomitant medication(s) included gabapentin (GABAPENTIN) taken for an unspecified indication, start and stop date were not reported.  The patient previously took reglan [metoclopramide] and experienced drug hypersensitivity, compazine [prochlorperazine maleate] and experienced drug hypersensitivity. The patient experienced severe joint pain, vertigo, muscle aches on an unspecified date. Therapeutic measures were taken as a result of vertigo (vertigo). Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Case number PHEH2014US015700 is an initial spontaneous report received from a medical assistant on 01 Aug 2014. This report refers to a 12 year old patient of an unspecified gender. The past medical history and concomitant medications of the patients were not reported. On 25 Jul 2014, the patient was vaccinated with MENVEO (batch number: M13030, expiry date: 30 Sep 2014) at a dose of 0.5 ml intramuscularly which had multiple temperature excursions while in storage. The temperature of the vaccine reached a maximum of 47.5 F for one hour and 17 minutes on 18 Jul 2014, a maximum of 47.5 F for 42 minutes on 21 Jul 2014, a maximum of 47.5 for one hour and three minutes on 24 Jul 2014 and a maximum of 47.5 for one hour and three minutes on 31 Jul 2014. No adverse events were reported following this maladministration (incorrect storage of drug).
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 18Mar2021 at 16:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 08Apr2021 at 15:30 as dose 2, single (Batch/Lot number: unknown), in left arm, on 20Oct2021 at 14:30 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 13May2022 at 11:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ALBUTEROL SULFATE, start date: 29Jun2022, stop date: 03Jul2022; LATANOPROST, start date: May2014.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Patient received product "Paxlovid (Anti-viral)" as COVID-19 treatment. Treatment start date was 29Jun2022 and treatment stop date was 03Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
High fever started about 10-12 hours after vaccine; ringing in ears; aches; left armpit lymph node is huge, looks like a ping pong ball; This is a spontaneous report from a contactable consumer, the patient. A 45-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in the left arm on 02Apr2021 at 15:00 (Batch/Lot Number: ER8734) as a single dose (at the age of 45-years-old) for COVID-19 immunization.  The patient medical history was not reported. The patient was not pregnant. Prior to the vaccination, the patient was not diagnosed with COVID-19.   Concomitant medications included levothyroxine sodium (SYNTHROID); nebivolol hydrochloride (MAXINEB); and vitamin d5 (VITAMIN D5); all from unknown dates taken for an unspecified indications. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 03Apr2021 at 02:30 the patient experienced high fever, ringing in ears, aches and left armpit lymph node is huge. The patient stated high fever started about 10-12 hours after vaccine, ringing in ears (continued into day 3), aches and left armpit lymph node is huge, looks like a ping pong ball (very painful).  The events were reported as non-serious and did not require hospitalization or prolongation of hospitalization. The patient did not receive any therapeutic intervention for events high fever, ringing in ears, aches and left armpit lymph node is huge. The patient underwent lab tests and procedures which Covid test (nasal swab) on 03Jan2021 with result: negative.  It was also reported that since the vaccination, has the patient been tested for COVID-19 on an unknown date with unknown results. The clinical outcome of the events high fever, ringing in ears, aches and left armpit lymph node is huge was recovered with sequelae (reported as lasting effects) on unknown dates in 2021. The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in the left arm on 23Apr2021 at 14:15 (Batch/Lot Number: EE0152) as a single dose for COVID-19 immunization.  Information on Lot/Batch number was available. Additional information has been requested.
Patient came to pharmacy saying that the very same day he recieved the shot, his arm got swollen and he came down with a high fever.
I exp chills, body aches, lasting 2 days. The neck pain(felt like car accident), pain around the injection site(left arm) and headache lasted 5 days. I had loss of appetite, extreme fatigue and felt nausea on 2/12-2/13 felt better on following Sunday.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Apr2021 as dose 1, single (Lot number: EP6966) and on 26Apr2021 as dose 2, single (Lot number: EW0161) at the age of 51 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 06Nov2021 as dose 3 (booster), single (Lot number: 012F21A) and on 01May2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: Other medical history Asthma; "allergies" (unspecified if ongoing), notes: Other medical history: allergies; "high blood pressure" (unspecified if ongoing), notes: Other medical history: high blood pressure; "Known allergies: Shellfish" (unspecified if ongoing), notes: Known allergies: Shellfish; "sulfa" (unspecified if ongoing), notes: Known allergies: sulfa; "Known allergies: antibiotics" (unspecified if ongoing), notes: Known allergies: antibiotics. Concomitant medication(s) included: Lisinopril; Budesonide; Proair HFA; Azelastine; Flonase [Fluticasone Propionate]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: I was negative after 6 days; Positive, notes: I tested Positive; Positive, notes: Indication=Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical Course: anti-viral product for COVID 19 Treatment, start date was 20Aug2022 and treatment stop date was 24Aug2022. Patient was negative after 6 days and felt fine. Then she started not feeling well 5 days later Aug 30. She tested Positive. she felt sicker than she did during the initial 5 days. It really exacerbated her asthma. No follow-up attempts are possible. No further information is expected.
Painful swollen lymph nodes underarms. I am usually healthy, and I have been sick three times since I?ve received the vaccines. I?ve had a urinary tract infection, and three colds or flus. My lymph nodes are still painful to the touch three months later.
Pt received ANTHRAX 0.5mL in (L) Deltoid on 10 Jan 15. Pt c/o rash, itchiness, and soreness to neck. One hour after shot. Worsening symptoms since. Denies SOB or chest pain.
The morning after the shot I woke up to extreme muscle, whole body pain.  Could hardly move.  Also generally feeling awful.  That lasted for two days.  Then for 3 more days I was on the couch but more mobile experiencing nauseousness, headaches, fatigue, dizziness, pain in armpit in injection arm.  Since then I continue to have nauseousness and fatigue.  It's now been over three weeks. After the 2nd dose, I had extreme reaction also but it only lasted 4 days.
Patient had 2 inch round knot on left upper clavical area-no redness, pain, or itching.  No treatment. Flu shot was given in right arm. To see oncologist in 4 days, who encouraged her to get immunized.
This spontaneous report was received from a Licensed Practical nurse regarding an unknown number of patients of unknown age and gender. No medical history and concurrent conditions were reported. On 19-NOV-2015, 22-NOV-2015, 25-NOV-2015 and 01-DEC-2015, patients were vaccinated with improperly stored GARDASIL (dose number, anatomical location frequency and route unknown) with lot # K006117 (expiry date 14-JAN-2017) and lot number # K007264 (expiry date 02-MAR-2017). Concomitant medications of the patient were unknown. No other adverse events were reported. The outcome of the event incorrectly stored vaccines was unknown. No product quality complaint was reported. This is one of the several reports from the same reporter. Additional information has been requested.
Vaccines administered after more than 1 temperature excursion; Vaccines administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccines administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines administered after more than 1 temperature excursion) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Oct-2021 at 1:05 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Oct-2021 at 1:05 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccines administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccines administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines administered after more than 1 temperature excursion) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient age was reported as 65.60 years.  No concomitant product use was reported.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Vial was stored in cooler 1, on 27-Oct-2021, excursion temperature at 8 am 41, at 9 am 29, at 10 am 32, at 11 am 43, at 12 am 43, at 1 pm 43, at 2 pm 46, at 3 pm 46, at 4 pm 46 and at 5 pm 45.  On 27-Oct-2021, Excursion time 09 AM temp was 29, at 10AM temp was 32, total doses given for the day was 116, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 29-Sep-2021 and 05-Oct-2021, vial was moved to clinic on 27-Oct-2021. 2 and 4 vials was moved to clinic. Vaccine BUD date was 29-Oct-2021 and 04-Nov-2021.  Temperature recordings were taken by using a Fisher brand traceable temperature monitor at every hour. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.
Information has been received from an office manager at the physician's office concerning a 6 month old male patient who was vaccinated PO with a dose of ROTATEQ. Subsequently the patient had stool specimen done and it came back positive for salmonella. At the time of reporting, the outcome was unknown. It is unknown if the patient sought medical attention. It was also reported that the patient's twin experienced adverse event on ROTATEQ (WAES #0906USA00566). Additional information has been requested.
Information has been received from a bachelor of sciences in nursing concerning a patient who on an unspecified date was inadvertently vaccinated with VARIVAX instead of ZOSTAVAX due to nursing error. No adverse effect reported. Additional information has been requested.
reported that doses of GARDASIL9 had been administered following a temperature excursion; This spontaneous report has been received from a health professional, referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, previous drug and/or allergy reactions were not reported.  On 03-AUG-2021, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) at a dose of 0.5 milliliter (vaccination scheme, route and anatomical location of administration were not provided; lot # T026167 has been verified to be a valid lot number, and expiration date reported and established upon internal review as 04-DEC-2022) as prophylaxis.   The administered vaccine underwent a temperature excursion below 2 degrees Celsius (°C) of minus 40.0 °C for a time frame of 15 minutes; and an excursion above 8°C of 9.6 °C for a time frame of 1 hour. No previous temperature excursion was reported. No information about the use of a datalogger was reported.   This is one of several reports, from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T026167; expirationdate: 04-DEC-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Client had a generalized very itchy red rash/not hives that has persisted since shortly after 4/13/18. Clinic visit to date of call 6/15/18. On 7/27/18 client reported that he had been Dx with Graves Disease and is on medication. Rash is improving.
Patient states she started feeling dizzy, weak, and lightheaded on Wednesday.  She also stated she has a headache on and off and sometimes gets the chills/sweats.
pt recvd vax & w/in 12hrs post vax pt exp hives all over body,swelling of hands & feet,stiffness of hands,& a rash on cheeks & buttocks;tx DPH;addl pt exp sinusitis 3JAN95 & began amoxicillin therapy on that day;pt seen by MD 3&4JAN
At 3pm Moderna booster was administered to patient. Patient came back to pharmacy 15minutes after administration of vaccine. She felt tingling and swelling of throat; patient had no hives. no visible swelling, no trouble breathing. Emergency services was called and per instructions, Epinephrine 0.3mg was administered to patient at 3:19pm. EMS arrived immediately after, and took patient to hospital. Spoke to patient at 5:45; she was feeling well and going home. Per patient report, she was treated with corticosteroids and Benadryl.
urticaria; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative. The reporter is the parent.  A 10-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, 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: URTICARIA (non-serious), outcome "unknown".  Additional information:  Dr. s daughter developed urticaria after receiving the vaccine. This adverse event was reported within the 24 hour time frame. Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Woke up on and off all night; Terrible headache; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Woke up on and off all night) and HEADACHE (Terrible headache) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A, 032L20A and 049C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), METOPROLOL, DIAZEPAM (VALIUM), METFORMIN, TERAZOSIN HYDROCHLORIDE (HYTRIN) and LEVOTHYROXINE for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2021, the patient experienced INSOMNIA (Woke up on and off all night) and HEADACHE (Terrible headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache, Insomnia and Body temperature, at an unspecified dose and frequency. At the time of the report, INSOMNIA (Woke up on and off all night) and HEADACHE (Terrible headache) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Aug-2021, Body temperature: inconclusive (High) Inconclusive.         Again started fever on 20-Aug-2021 morning.  Concomitant medication also included Blood thinner.   This case was linked to MOD-2021-005974 (Patient Link).
No additional AE deatils; improperly stored vaccine administered to a patient; This spontaneous report was received from a certified medical assistant and refers to a 8-year-old male patient. The patient's medical history, concomitant therapies and concurrent conditions were not provided.   On 25-APR-2022, the patient was vaccinated with first dose of an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, administered subcutaneously, lot # U025790, expiration date 19-AUG-2023 (dose and anatomical location) for prophylaxis (product storage error). No treatment for the event was required. On 23-MAR-2022, the administered vaccine underwent temperature excursion of -14 Celsius degrees up to - 10 Celsius degrees for 3 hours and -10 Celsius degrees up to 8 Celsius degrees for 1 hour and 30 minutes. There were no previous temperature excursions. No additional adverse event was reported (no adverse event). It was an initial use of vaccine/vaccine-device. The operator of the vaccine/vaccine-device was healthcare professional. The vaccine/vaccine-device was not available for return/evaluation as it was given to the patient.   This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-2204USA009330: US-009507513-2205USA008004: US-009507513-2205USA008051: US-009507513-2205USA003614: US-009507513-2205USA007703: US-009507513-2205USA007704: US-009507513-2205USA007723: US-009507513-2205USA007739: US-009507513-2205USA007809: US-009507513-2205USA007821: US-009507513-2205USA007852: US-009507513-2205USA007860: US-009507513-2205USA007871: US-009507513-2205USA008830: US-009507513-2205USA007957: US-009507513-2205USA008069: US-009507513-2205USA008800: US-009507513-2205USA008100: US-009507513-2205USA008105: US-009507513-2205USA008189: US-009507513-2205USA007978: US-009507513-2205USA008795: US-009507513-2205USA008066: US-009507513-2205USA007982: US-009507513-2205USA008064: US-009507513-2205USA008028: US-009507513-2205USA008000: US-009507513-2205USA008008: US-009507513-2205USA008004: US-009507513-2205USA007852: US-009507513-2205USA008002:
Sore arm; fatigue; 2nd dose received a week early, less than 26 days from first dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), FATIGUE (fatigue) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received a week early, less than 26 days from first dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: COVID-19 VACCINE (First dose Covid-19 vaccination.) on 05-Apr-2021.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received a week early, less than 26 days from first dose). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (fatigue). At the time of the report, PAIN IN EXTREMITY (Sore arm) and FATIGUE (fatigue) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received a week early, less than 26 days from first dose) had resolved. Not Provided      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.   No relevant past medical history provided.  Treatment information was not provided.
This case was reported by a pharmacist via sales rep and described the occurrence of pain in arm in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected adult as per vaccine indication. The patient had a sore arm of 2 months. The pharmacist consented to follow up. This was all the information provided. This case has been linked with the case US2018204750, reported by same reporter.
Rapid heartbeat just lying in bed; fatigue, achy, low grade temp (100 F); chills. Events began in the early morning hours and continued through most of the day. Felt very tired and not able to do much of anything. Spent the day napping and lying around.