chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received the administration of only the diluent; Received the administration of only the diluent; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a infant female patient who received Rota (Rotarix lyophilized formulation) (batch number H395H, expiry date 9th July 2022) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On an unknown date, the patient received Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On an unknown date, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 29-APR-2022 Reporter's Comment: The reporter was medical assistant. The patient received the administration of only the diluent of Rotarix vaccine. The reporter consented to follow up. Additional Supportive Information: The patient received only the diluent of Rotarix vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The case had been linked to US2022071939,reported by the same reporter, for a twin patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022071939:Same Reporter
Breakthrough case admission after 4 vaccines Pfizer 2/28/21 Lot# EN6201;  Pfizer 3/21/21 Lot# EN6207;  Moderna 12/1/21 Lot# 012h;  THIS IS THE INFORMATION IN THE LOCAL DATABASE Moderna 5/5/22 Lot# 065k-21A
Sore arm at vaccination site Narrative:  Per supervisor report: "when ask about her symptoms [3/18] she stated" My arm is sore"."
Information has been received from RN concerning a 6 y/o male with no known allergies who on 20Jul1998 was vaccinated SC with a 0.5mL dose of varicella virus vaccine live. There was no concomitant medication.  On 31May2003 the pt started breaking out in a chicken pox rash and now has full blown chicken pox. The mother counted over 100 lesions. He also had a fever as well. Medical attention was sought and no treatment was required. No diagnostics studies were performed. No product quality complaint was noted. Additional information has been requested.
This spontaneous report as received from a licensed practical nurse refers to an unknown number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB injection lot # M007762 with expiration date 07-DEC-2018 and lot # M014927 with expiration date 18-FEB-2019 (dose and route of administration were not reported). No adverse effects were reported. There was no product quality complaint involved. Administered doses of vaccines were exposed to the temperature excursion of 11.8 degrees Celsius for a time frame of 1 hour 3 minutes on an unspecified date.  A digital data logger was involved. There was a previous excursion of 10.2 Celsius for a time frame of 1 hour 3 minutes involved (date unknown). This is one of several reports received from the same reporter. Follow up information has been received on 21-NOV-2016. All telephone attempts to obtain follow-up information had been unsuccessful. Additional information has been requested. Sender's Comments: US-009507513-1610USA000210: US-009507513-1610USA004153: MERCK 1610USA004154:Mfr number.
After vaccination in  24 hours it started itching into pubic area, then further below chest and anove stomach, under boobs, in the middle portion and pubic area  triangle was filled with red bumps, itchy all the time and very painful.pfizer vaccine.
fever: Feb 12 sweating:Friday Feb 12 vomiting: Thursday evening Feb 11,
About 15 minutes after the vaccination, I noticed a fast heartbeat and some dizziness. The dizziness was very brief but the fast heartbeat continued off and one for about 1-2 hours.
patient fainted immediately after receiving the vaccine. she was only unconscious for less than a minute. she came around and is doing fine. no medical treatment was sought
Rash, hives all over from head to toe, very itchy, went to ER told to take Benadryl, did not help, went back to ER next night I was given pepcid and Atarax wich did help relieve somewhat. Symptoms lasted for 4days. Now I  getting severe muscle cramps in hands, legs, feet and between shoulder blades about 10 times at night and consistently during the day.
Pt. states that after receiving the 1st the dose of Pfizer 04/06/2021, started experiencing symptoms of Tachycardia. Urgent Care 04/08/2021 visit with recommendations of "Rest". Emergency Room visit 06/2021 with recommendations of Cardiologist. Cardiologist visit 08/2021 with recommendations Follow-Up (Metaphorim). Emergency Room visit 09/2021 with "episodes" with follow-up prescription for Diltiacem. Pt. still experiencing symptoms.
Severe joint pain in knees. Difficult to walk, move; no over the counter pain medication provides any relief. Same reaction occurred with the second dose of the same vaccine.
Extreme Anxiety Extreme Anxiety Attacks shaking jerking movements in my arms and legs a grandma seizure that closed my windpipe and felt like a rubber band squeezing my brain full body jerking anger outbursts deep depression suicidal thoughts wanting to die praying for death pain intense pain
Info has been received from a physician concerning a 7 year old white female who on 9/10/98 was vaccinated with the 1st dose of varicella virus vaccine live. Concomitant vaccinations on the same day, included the 1st dose of MMRII and the 4th dose of Hib-Titer. On 2/19/05, the pt developed 6 lesions after exposure to a child with active chickenpox, 2 weeks earlier. It was reported that the pt recovered. No product quality complaint was involved. Additional info has been requested.
Pfizer dose administered based on beyond used date 9/26/2022, but the expiration on vial 8/31/2022. Mother was notified. communicated Pfizer of incident. Pfizer stated vial is viable to use until 9/28/22. Parent was updated.
Patient reports itchy rash without difficulty or pain in moving arm on injected side. Rash appears roughly 4 to 5 inches in diameter.
temp on 24JUL PM 102;temp on 26JUL @ 12MN 105.7;emesis 25JUL AM;
took Second shot of Moderna vaccine after 2 shots of Pfizer; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (took Second shot of Moderna vaccine after 2 shots of Pfizer) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Lot# 030B21A and 024C21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history reported ).   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 06-May-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (took Second shot of Moderna vaccine after 2 shots of Pfizer). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (took Second shot of Moderna vaccine after 2 shots of Pfizer) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-114880 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-114880:dose 1
Patient received a dose of Pfizer vaccine. It was noted that the vaccine 5-day expiration date/time was 5/12/2021 at 9:30 am. Vaccine was administered to patient at 10:20 am on 5/12/2021. No adverse reactions noted during observation period.  MD and management team aware.
Sibling reported that friend caught Covid-19 even though they were vaccinated; Sibling reported that friend caught Covid-19 even though they were vaccinated; This is a spontaneous report from a contactable consumer and a non-contactable consumer (Sibling), these consumers reported for an adult patient. An adult patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 2 and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, Sibling reported that friend caught Covid-19 even though they were vaccinated. Patient tested positive for covid post vaccination. The patient underwent lab tests and procedures, which included Covid test: positive on an unspecified date. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Little lip swollen that looks like a classic symptom of little angioedema on her left side; Little lip swollen that looks like a classic symptom of little angioedema on her left side; This is a spontaneous report from contactable consumer. This consumer reported for a female patient (mother in law) of an unspecified age that received first dose of bnt162b2 (BNT162B2, lot number: EN6201) , via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient experienced little lip swollen that looks like a classic symptom of little angioedema on her left side on an unspecified date with outcome of unknown. Reporter stated, "It is for my mother in law. Looks like she has a little angioedema on her lip. She did have the second shot today, Pfizer, 2nd shot (Unspecified Medication). It is not severe but she does have a little lip swollen that looks like a classic symptom of little angioedema on her left side. She had the shot on her right side. I just was not sure, I mean should she take Benadryl."  Information on Lot/Batch number has been requested.
2 days after first shot, his foot, thigh, back, and spine started hurting and has been feeling the pain ever since. Patient stated that he told nurses how he was feeling after first dose but he got 2nd dose anyway.  Patient was not prescribed medication for pain.
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown demographics. The patients' concurrent conditions, medical history and concomitant medications were not reported. Since 19-JUN-2016, the patients' were vaccinated with improperly stored doses of PNEUMOVAX 23 from lot # L019836 with expiry date of 24-MAR-2017 and from lot # L013428 with expiry date of 03-FEB-2017 (dose and route not reported). No adverse effects were reported. No product quality complaint was involved. This is one of the two reports received from the same reporter. Additional information has been requested.
Sore arm starting night of shot and lasting for ~48 hours. Headache and fatigue starting the day after the shot and lasting about 24 hours.
pt returned to imz. table reporting trouble swallowing felt "something in throat". Pt had personal Epi Pen, this was administered at 350. BP were taken and documented, 911 was called and transported her
Moderna COVID-19 Vaccine EUA. Injection site pain, headaches, fatigue, chills, low-grade temperature (99.4)
lethargy; Fever; Chills; headache; muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (lethargy), PYREXIA (Fever), CHILLS (Chills), HEADACHE (headache) and MYALGIA (muscle ache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. CC1BZIA) for COVID-19 vaccination.     The patient's past medical history included Ovarian cancer (20-years ago) and Clot blood. Concurrent medical conditions included Diabetes and Glaucoma. Concomitant products included METFORMIN, PRASUGREL HYDROCHLORIDE (EFFIENT), GLIPIZIDE, FENOFIBRATE, LOSARTAN, TRAZODONE, ATORVASTATIN, LINAGLIPTIN (TRADJENTA), EICOSAPENTAENOIC ACID ETHYL ESTER (VASCEPA), MECLIZINE [MECLOZINE], ACETYLSALICYLIC ACID (BABY ASPIRIN), VITAMIN C [ASCORBIC ACID], FOLIC ACID, ZINC, CALCIUM and MAGNESIUM for an unknown indication.    On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LETHARGY (lethargy), PYREXIA (Fever), CHILLS (Chills), HEADACHE (headache) and MYALGIA (muscle ache). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, LETHARGY (lethargy), PYREXIA (Fever), CHILLS (Chills), HEADACHE (headache) and MYALGIA (muscle ache) outcome was unknown.            The patient was taking eyedrops for glaucoma and sulfate for unknown indication.  The patient mentioned that she took Tylenol and symptoms lasted 2 days.
No additional AE reported; Received PROQUAD instead of PRIORIX; Overdose; This spontaneous report was received from Other and refers to a 23-years-old female.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 23-JUN-2023, the patient started therapy with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided); and  varicella virus vaccine live (oka/merck) (VARIVAX) injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On an unknown date (before the appointment), patient had titers done for MMR and Varicella. Varicella titer was low less than 135 (needed a booster), Rubella and Measles were normal, Mumps were low, needed a booster. On 23-JUN-2023, the patient received PROQUAD instead of PRIORIX, the patient experienced Overdose. No additional AE reported. No PQC reported.
On May 27, 2022, my throat became sore and I had nasal discharge. I phoned my doctor's office and was given tele health appointment for May 31. I proceeded to take an at home covid test and it was positive. I spoke to the doctor on Tuesday and he prescribed some cough medication and throat soothing medication. On Thursday, June 2, I continue to have symptoms of covid, including fever, sore throat, cough and dizziness.  When my symptoms resolve, I will take another covid test.
Initial report received from a health care professional on 05 October 2010. A male patient, with no medical history provided, received on an unknown date an injection (route and site not provided) of FLUZONE SV 2010-2011, lot number U3655AA. The patient developed Guillain Barre' Syndrome (GBS) 2-3 days after the administration of FLUZONE. The patient started with back pain and then he lost feeling on the left side of his body and it then moved to the right side of the body. The patient was hospitalized on 28 September (year not provided) and spent over a week in the hospital. The outcome was not reported. Documents held by sender: None.
had COVID arm with red spots; Nausea; inflammation in body, physician said normal; dizziness; area was swollen; had red spots 3 inches in diameter below injection site; rash on chest or torso area; area was warm; The area was also warm and swollen.; chills for a few days; very tired,  tiredness ,fatigue; wanted to lay down all the time; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (area was warm), VACCINATION SITE REACTION (had COVID arm with red spots), SWELLING (area was swollen), INFLAMMATION (inflammation in body, physician said normal) and DIZZINESS (dizziness) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included CENTRUM FORTE and VITAMIN D3 for an unknown indication.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced MALAISE (wanted to lay down all the time) and FATIGUE (very tired,  tiredness ,fatigue). 23-Apr-2021, the patient experienced CHILLS (chills for a few days). On 26-Apr-2021, the patient experienced VACCINATION SITE WARMTH (area was warm), SWELLING (area was swollen), RASH (rash on chest or torso area), VACCINATION SITE ERYTHEMA (had red spots 3 inches in diameter below injection site) and VACCINATION SITE SWELLING (The area was also warm and swollen.). On 28-Apr-2021, the patient experienced DIZZINESS (dizziness). On 30-Apr-2021, the patient experienced INFLAMMATION (inflammation in body, physician said normal). On 03-May-2021, the patient experienced NAUSEA (Nausea). On an unknown date, the patient experienced VACCINATION SITE REACTION (had COVID arm with red spots). The patient was treated with LORATADINE at a dose of 1 dosage form and IBUPROFEN at a dose of 1 dosage form. On 28-Apr-2021, VACCINATION SITE WARMTH (area was warm), SWELLING (area was swollen), RASH (rash on chest or torso area) and VACCINATION SITE ERYTHEMA (had red spots 3 inches in diameter below injection site) had resolved, VACCINATION SITE SWELLING (The area was also warm and swollen.) outcome was unknown. On 01-May-2021, DIZZINESS (dizziness) had resolved. At the time of the report, VACCINATION SITE REACTION (had COVID arm with red spots) had resolved and INFLAMMATION (inflammation in body, physician said normal), MALAISE (wanted to lay down all the time), CHILLS (chills for a few days), NAUSEA (Nausea) and FATIGUE (very tired,  tiredness ,fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Apr-2021, Full blood count: nothing significant (Inconclusive) Nothing significant was discovered. On 30-Apr-2021, SARS-CoV-2 test: negative (Negative) Nothing significant was discovered.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    .
Client, a 27yo female,who reported that following her first dose Pfizer COVID vaccine (LOT EW0182, Expiration 08/31/2021) received 05/06/2021 she felt her tongue swelling, her face tingling and a headache in her left temporal area. Client denied any other symptoms such as nausea, chest pain or shortness of breath. She stated the onset of symptoms was approximately 5 minutes post vaccine and lasted less than 20 minutes. She did not notify the EMTs at the time and did not notify her primary care provider because the symptoms resolved on their own. Client denied any other medical conditions or regular medication use. She stated positive for allergy to pollen and dust with a non-anaphylactic reaction,  denied any other allergies to environment/medication/foods. Lead RN consulted with medical team.
Patient stating that started feeling dizzy approximately 3 days after the first dose of Pfizer vaccine. He is still experiencing dizzy spells that tend to last a couple hours. They will come out of no where and happen regardless of what he is doing.
Information has been received from a registered nurse concerning a female, pediatric patient, who was vaccinated with Gardasil, (lot not reported). Subsequently the patient experienced severe injection site pain. It was reported that the pain was in the muscle and started at the time of injection. The pain lasted for 2 days and then resolved. The patient was treated with warm compresses. The patient sought unspecified medical attention. Additional information has been requested.
Patient reported having allergy to Amoxicillin and has Asthma.  About 10 minutes after vaccinated, patient  c/o not able to feel bilateral face and arms, severe fatigue, nausea, unable to swallow and feeling hot.  Patient was warm to touch and had small rashes on face. Pulse Ox ranging from 97 to 99 on RA. HR 118 then dropped to 103 . Patient monitored closely then  at 12:23pm 911 called . Pt sent to ER via ambulance and family in attendance with her.
Fatigue; A spontaneous report was received from a consumer who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced fatigue.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On an unknown date, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the patient experienced fatigue. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the event, fatigue, was unknown.; Reporter's Comments: This case concerns a female patient, who experienced a non-serious expected event of fatigue. The event occurred on an unspecified date after first dose of mRNA-1273, lot # unknown. Treatment details were not provided.  Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded.
Became flushed and described a scratchy swallowing sensation.  Blood pressure was elevated.  SPO2 remained steady at 98%. Sat with healthcare staff for additional 40 minutes.  Benadryl 25mg given.
8-7-08 fever started at 6:30p 101F. Slept all day 8-8-08 and most of 8-9 and 8-10. On 8-11-08 chest pain and SOB with NIV during late afternoon. Mom to take child to Pediatrician this A.M. Brother started having fever 8-11-08 with coughing and gaggling.
I received the Moderna vaccine on 2/8/21. On 2/16)21 Shingles symptoms occured pain to left scalp on 2/19/21 first rash noted to left scalp , left temple and left eyebrow. I went to urgent care and was Treated with acyclovir and neurontin and on 2/22/21 I went to the ER due to pain and eye swelling and more shingle rashes occuring to left eye lid. I was started  on Steroids and stronger pain meds were added.
Pt had PCV vaccine placed 4/27/15 and developed cellulitis at site of vaccine placement.
Pt. received Tdap immunization on 1/10/14. Pt RTC on 1/13/14 c/o tremors that were affecting ability to cut hair.
No adverse effect reported; The patient received fone improperly stored of VARIVAX; This spontaneous report was received from a nurse prescriber concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concurrent conditions and drug reactions or allergies.     On 26-FEB-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX), lot # S028920, expiration date 16-SEP-2021 as prophylaxis (dosage schedule, anatomical location and route of administration, were not reported) (product storage error). The sterile diluent  used to reconstitute was stored properly.   The administered dose of the vaccine experienced a temperature excursion 6 degrees Fahrenheit to 14 degrees Fahrenheit (5.69 degrees Fahrenheit) for 1 second and a previous temperature excursion 6 degrees Fahrenheit to 14 degrees Fahrenheit (5.81 degrees Fahrenheit) for 28 minutes, as recorded by a data logger. There was no adverse effect reported.
Postural Orthostatic Tachycardia first presented to urgent care with palpitations and elevated heart rate in August 2021