chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a head nurse in physician assistant office via the field representative refers to a male patient of age approximately 2 years. Concurrent conditions and medical history was not reported. In approximately 2013 (single dose given at 2, 4 and 6 months of age) the patient was vaccinated with ROTATEQ who received all series of doses (lot number, dose, frequency, route of administration not reported). Concomitant medications were not reported. On an unknown date, the patient had rotavirus infection after receiving the full series of ROTATEQ unknown date. The outcome of rotavirus infection was reported as not reported. No further information related to the patient symptoms has been provided. Causality assessment was not reported. This is one of the several reports from the same source. Additional information has been requested.
Patient fainted about 2 minutes after vaccine administration. She was seated - pharmacist was able to keep her in the chair so she was not injured. She was out for about 2 minutes. EMT was called and patient stayed in pharmacy until EMT was able to fully assess her health.
Broken pinky finger; Car accident; experiencing brain fogginess; Slight headache; Arm soreness; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of ROAD TRAFFIC ACCIDENT (Car accident), FEELING ABNORMAL (experiencing brain fogginess) and VACCINATION SITE PAIN (Arm soreness) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M2OA and 01162OA) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020. Concomitant products included AMLODIPINE BESILATE (NORVASC) for Blood pressure, ATORVASTATIN for Cholesterol, LINACLOTIDE (LINZESS) for Irritable bowel syndrome, ERGOCALCIFEROL 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 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE PAIN (Arm soreness). On 07-Jan-2021, the patient experienced ROAD TRAFFIC ACCIDENT (Car accident) and FEELING ABNORMAL (experiencing brain fogginess). On 09-Jan-2021, VACCINATION SITE PAIN (Arm soreness) had resolved. At the time of the report, ROAD TRAFFIC ACCIDENT (Car accident) and FEELING ABNORMAL (experiencing brain fogginess) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable.   Company comment: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Significant follow up received on 16-Apr-2021: Added concomitant drug amlodipine, atorvastine, ergocalcif, linzess, moderna vaccine second dose, outcome and onset date of event brain fog.; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded
Client was given a second dose Moderna on 5/7/2021 and received a first dose Pfizer.
Strong tingling/ pins and needles in left arm & hand multiple times a day since 2nd dose, still happening today 2 months later.  Menstrual cycle completely thrown off, period arrived 10 days early and no subsequent ovulation
I started developing a headache 6 to 7 hours after the injection. Around 5 am the next morning it was the most excruciating headache I have ever experienced. Nothing helped, not medication, cool cloth. I called and had a tele-medicine appointment. The Dr. She thought it was worse and extreme version of the Pfizer headache. I had a CT scan to check for a brain Bleed. I was told to take Valium. The CT scan was negative and given the option to receive ketorolac. I turned it the down because I have pain after injections. I was told to take Naproxen, valium and Benadryl. It was bad but tolerable, but virtually gone by the next day. I had had also light head, joint pain, and nausea.
Client received MCV4 on 8/4/09 in left deltoid.  On 8/5/09 client's left deltoid is sore, swollen and warm to touch.
muscle spasms; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection) via an unspecified route of administration on 19Dec2020 for the first dose (lot number and expiry date unknown), and on 09Jan2021 for the second dose (lot number: E11685, expiry date: May2021) both at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got her first shot on 19Dec2020 and had some muscle spasms on Dec2020, but it was gone after two (2) days. On Saturday (09Jan2021), she got her second shot and she was in a giant muscle spasm from head to toe. It was like a whole-body Charlie horse that won't quit, and it hurts. It started three (3) hours after the shot and is not going away. It hurts and worked her up. The patient called to ask what she can request to treat the muscle spasm; a muscle relaxer? Patient didn't want to take anything that will counteract the vaccine. The event was reported as Non-serious. The patient recovered from muscle spasms on an unspecified date in Dec2020.  information on the lot/batch number has been requested.
Fever 102 for three days; Nausea; Weak; Soreness in shot area; This is a spontaneous report from a contactable other healthcare professional, the patient. An 85-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 09Jun2021 at 00:00 (at the age of 85-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 09Jun2021 at 15:00, the patient experienced fever 102 (units unspecified) for three days, weak, nausea and soreness in shot area. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were not taken as a result of reported events. The clinical outcome of the event fever 102 for three days was recovered on 12Jun2021. The outcome of the events weak, nausea and soreness in shot area were recovered on unspecified date Jun2021.
This spontaneous report was received from a registered nurse referring to an approximately 11 year old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 22-MAR-2016, when the patient was 10 year old, he received the first dose of GARDASIL 9 for prophylaxis (dose, route, frequency, lot/batch # and expiration date were not reported). The reporting nurse referred that the patient would receive the second dose of GARDASIL 9 on 23-MAY-2017 (14 months later). No adverse effect was reported. Additional information has been requested.
Patient's step-daughter came in stating that the patient had experienced an adverse affect from the vaccination he received on 02/14/23. She noted that his arm around the location of the shot "turned black and blue." Did not note any swelling or unusual pain associated with the injection.  She said her father wrapped the area with a bandage. The patient did not come to the pharmacy.
positive for Hepatitis C/wife's sister also had the same thing happen to her; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary immunization series completed), for COVID-19 immunization; Bnt162b2 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: HEPATITIS C VIRUS TEST POSITIVE (non-serious), outcome "unknown", described as "positive for Hepatitis C/wife's sister also had the same thing happen to her". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Reporter had been vaccinated with the Pfizer COVID-19 vaccine and boosters and recently reporter was tested and found to be positive for Hepatitis C (which to the best of his knowledge, he has never had). Reporter wife's sister (the patient) also had the same thing happen to her. The reporter thought this was rather strange.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300009747 same reporter/drug/event, different patient;
In 3/01, (when the pt was a neonate in the hospital), the vaccinee received his 1st injection of Hep-B vaccine (mfr unk). On 4/12/01, the vaccinee received his 2nd injection of Hep-B vaccine (Engerix-B, lot ENG5166A2). On 9/12/01, the vaccinee received his 3rd injection of Hep-B vaccine (Recombivax-HB, lot 0318K). On 3/12/02, the pt was found to be a non-responder. As of 3/19/02, the outcome of the event was unknown.
This case was reported by a pharmacist via call center representative and described the occurrence of muscle pain in a 76-year-old male patient who received SHINGRIX (batch number P539L, expiry date 30th January 2020). Concomitant products Albuterol, amlodipine, Aspirin, Atorvastatin, valsartan, hydrochlorothiazide, Metoprolol, mometasone and SPIRIVA. On 27th March 2018 09:00, the patient received SHINGRIX .5 ml. On 27th March 2018, several hours after receiving SHINGRIX, the patient experienced muscle pain, body temperature increased, flushing and headache. On an unknown date, the outcome of the muscle pain, body temperature increased, flushing and headache were recovering/resolving. The reporter considered the muscle pain, body temperature increased, flushing and headache to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the right deltoid. The patient's wife called the registered pharmacist and reported that her husband experienced the symptoms night before reporting date. The vaccine was administered at the patient's doctor's office.
No Adverse event; A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines) and NO ADVERSE EVENT (No Adverse event) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 025L20A, 030L20A and 014F21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines).    No concomitant medication was provided by reporter. A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines. They want to know what their next step would be for these patients. Lot number 004M21A, expiration date 13Jul2022 Date of administration of vaccine were - 6Jul2022 (40 doses), 04Aug2022 (1 dose),19Aug2022 (1 dose), 30Sep2022 (1 dose).  No treatment medication was provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-704260 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704260:Maste case
Pneumonia due to respiratory syncytial virus (RSV). ED visit and hospital admission. This visit was within 6 weeks of receiving the COVID and influenza vaccines.
Adult Td was given instead of flu vaccine. No reaction noted by mom after 3 days.
INDIVIDUAL ATTENDED A COVID VACCINATION CLINIC ON 9/25/21. THERE WAS NO INTERNET ACCESS SO SIIS COULD NOT BE CHECKED TO SEE IF VACCINE WAS PREVOUSLY NOTED AS BEING GIVEN. THIS INDIVIDUAL ACKOWLEDGED 2 TIMES PER PERMISSION FORM THAT SHE HAD NEVER RECEIVED A COVID VACCINE AND THIS WAS HER FIRST. SHE RECEIVED PFIZER BOINTECH VACCINE ON THIS DATE WITHOUT INCIDENT. SHE WAS MONITORED FOR 15 MINUTES AFTER VACCINATION AND HAD NO SIDE EFFECTS REPORTED. DR.  PUBLIC HEALTH PHYSICIAN WAS NOTIFIED. PHONE CALL TO PATIENT ASKING HER ABOUT RECIEVING J&J VACCINE ON 3/14/21 AS RECORDED. I ASKED IF SHE HAD RECEIVED THAT VACCINE AND SHE DENIED AT THAT TIME, SAID SHE HAD IT.
Information has been received from a physician concerning a 6 month old male with no past medical history or allergies, who on 7/23/02 at 17:30 was vaccinated IM in the left upper leg with a first dose of pneumococcal vaccine 23 polyvalent (lot not reported). It was noted that the pt, "should have had Prevnar." This does not comply with medication administration guidelines. There was no illness at the time of vaccination. Concomitant therapy, that same day and at the same time, included a second dose of hep B vaccine recombinant (lot not reported) given IM in the right deltoid, a third dose of ActHIB (lot not reported) given IM in the right upper leg and a third dose of diphtheria toxoid/pertussis vaccine/teta (lot not reported) given IM in the left deltoid. Approximately 4 to 5 hours after vaccination, on 7/23/02 at 22:00, the pt developed a swollen left thigh, high fever, painful left thigh and was "unconsolable." The pt was seen in ER, then hospitalized for fever of unknown origin, "until wrong vaccine discovered." Relevant diagnostic tests and laboratory data were not available at the time of this report. The pt recovered on 7/27/02. Additional info is not expected.
Noticed my covid arm yesterday, had swelling and itching; Noticed my covid arm yesterday, had swelling and itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Noticed my covid arm yesterday, had swelling and itching) and VACCINATION SITE SWELLING (Noticed my covid arm yesterday, had swelling and itching) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 3002331) for COVID-19 vaccination.     No Medical History information was reported.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, the patient experienced VACCINATION SITE PRURITUS (Noticed my covid arm yesterday, had swelling and itching) and VACCINATION SITE SWELLING (Noticed my covid arm yesterday, had swelling and itching). At the time of the report, VACCINATION SITE PRURITUS (Noticed my covid arm yesterday, had swelling and itching) and VACCINATION SITE SWELLING (Noticed my covid arm yesterday, had swelling and itching) outcome was unknown.        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 concomitant medication were reported. No treatment information was reported.
Nursing home resident vaccinated 2 weeks prior, developed low (80's) saturation, admitted to hospital.
Redness, swelling, heat noted to increase left arm. Mom reports using Tylenol for fever, used cool packs intermittently to child's left arm, past 2 days. Child referred to primary care physician.
Received PPV 23 to left arm 11/13/2002. Pt stated that pm 11/15/2002, he saw white aurafor 3-4 hours. He also had chills, at site of injection, pt c/o increase redness and swelling. At time of my injection 11/22/2002. no redness or swelling.
PT CALLED REPORTING PAIN AND SWELLING AT INJECTION SITE AND NAUSEA A WEEK AFTER RECEIVING VACCINE. HAS HAD SOME RELIEF WITH OTC REMEDIES(TYLENOL, ETC). CALL DISCONNECTED WHILE PLACED ON HOLD TO INVESTIGATE. CALLED NUMBER ON FILE, LEFT VM.
Pt had vaccines (shots) for flu, polio, & yellow fever- She also started oral typhoid vaccine on 5/05/09.  She awoke 5/06/09 @ 6am with nausea by 9am was crying & shaking & felt "tight" in chest.  Returned home- We advised mom to take her to her doctor's office, Dr advised D/C oral typhoid.
Did not use diluent in the box/I am assuming they uses sterile diluent that we keep on the counter; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK Receipt Date: 27-FEB-2023 Reporter's comment: The reporter reported that someone at their clinic had given a Menveo vaccine without using the diluent in the box. The reporter assuming they used sterile diluent that they kept on the counter. The reporter asked for guidance to know how that affects the individual receiving it. Additional supportive information: The patient had Menveo reconstituted with sterile diluent, instead of the supplied diluents, which led to wrong solution used in drug reconstitution. The follow-up could not be possible as no contact details were available. This is 1 of 4 linked cases reported by same reporter for different patients. Conservatively case was processed with event wrong solution used in drug reconstitution considering the sterile diluent was used in vaccine reconstitution.; Sender's Comments:  US-GSK-US2023AMR032666:Same reporter US-GSK-US2023AMR032664:Same reporter US-GSK-US2023AMR032644:Same reporter
Chills, body aches, fever, headache began 12 hours after injection and lasted for about another 12 hours.  Tylenol and fluids were taken to alleviate the symptoms. One week after the injection I developed a rash on my arm at the injection site. The rash was very itchy and spread across my chest and to my legs. My doctor recommended Benadryl and prednisone.
This spontaneous report as received from a other health professional refers to a 19 year old female patient with fatigue and immunisation. On 25-JUL-2018 the patient was vaccinated with GARDASIL 9 lot # N004798, intramuscular for immunisation. On OCT-2018 the patient experienced infectious mononucleosis. The outcome of infectious mononucleosis was reported as recovered/resolved.  {Additional information has been requested. / Additional information is not expected.}
Patient went home Fine, That night she  started experiencing chills, Fever, confusion Husband took her to the ER - where they kept  her overnight for monitoring and released her the next day - feeling much better now
I have pictures of this side effect that I can email to interested parties.  It's a large warm, slightly itchy, round red "circle" or welt at the injection site, approximately 5--6 cm across.    I had no side effects for the first 2 weeks after the injection, and then suddenly this round warm itchy welt showed up 2 days ago.  It's just a tiny bit "tender" or sore.
It's unclear if my items are related to the vaccine, but tinitus definitely became evident and periodic after receiving the first vaccine. (I have had the original two Pfizer shots, 1 Pfizer booster, and 1 Moderna booster.   My wife has noticed it too.   I also developed burning mouth syndrome, but it's unclear if related to the vaccines (likely not).    I wanted to note these in the online/text feedback in case of any commonality with other people.
Injection site was large; Injection site redness; Injection site warmth; Arm was itchy; Hives on arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Arm was itchy), VACCINATION SITE URTICARIA (Hives on arm), VACCINATION SITE SWELLING (Injection site was large), VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE WARMTH (Injection site warmth) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Arm was itchy) and VACCINATION SITE URTICARIA (Hives on arm). On 08-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Injection site was large), VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE WARMTH (Injection site warmth). At the time of the report, VACCINATION SITE PRURITUS (Arm was itchy) and VACCINATION SITE ERYTHEMA (Injection site redness) was resolving and VACCINATION SITE URTICARIA (Hives on arm), VACCINATION SITE SWELLING (Injection site was large) and VACCINATION SITE WARMTH (Injection site warmth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; 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.
Patient received injection on 5/26/09 and was fine until the evening of 5/27 when she had a red spot the size of a quarter at the injection site. The area was raised, hot to the touch, itchy and hard underneath.  Pt used ice packs. On 5/28, the area doubled in size to 2inches in diameter. Also, a second area, 2 finger spaces from the injection site, turned red and was hot and itchy and hard underneath like the injection site. On 5/29, both red areas reduced in size and were no longer hot/itchy. She was afraid the 2nd area may have been the vaccine following a nerve, but Pt felt she was "on the mend."
There has been no treatment. just a little bit ago today I started to have a dizzy feeling in my head. made me very week for about a second. i could  feel my body move like it might fall out. and i got up and moved to another chair and i felt it again. So far i have not felt it again
Child tolerated injections x3 very well. Stood up from the table after sitting for a minute. Became syncopal after standing. Was assisted to the floor by her father.