chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 28-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose) had resolved.        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 concomitant medications was reported.  Treatment information was not provided.
On Monday, 06/01/2020, we had a patient that received her third HPV vaccine and a Tenivac vaccine. She came in this morning complaining of back spasms and muscle pain that began three hours after receiving the vaccines. When she arrived she was walking briskly with a normal gait with no apparent distress. She stated that she was unable to report to work yesterday or today due to the severity of her pain. Staff and I gave her copies of the VIS for both vaccines and discussed them with her. We also reviewed both vaccine inserts and explained to her that this was not normally a side effect to these vaccines.
fever started 48hr p/vax;febrile sz, witnessed by reporter 72hr p/vax;gen tonic clonic all extreme x 3-4";no obvious postictal pain but weakness apparent 30";fever @ time of sz 104.2 ear;100.9 ax;
Pfizer 4/14/21. Moderna 5/24/21. Positive on 1/10/22
Information has been received from an 18 year old female patient with no pertinent medical history and no drug reactions or allergies, for GARDASIL, a Pregnancy Registry product, reporting on herself who on 17-OCT-2011 was vaccinated intramuscularly with the first dose of GARDASIL (dose and lot # not reported). The patient performed pregnancy test and had discovered that she was 9 weeks pregnant now. There were no adverse events to report. The patient did not seek medical attention. Her LMP was approximately on 23-AUG-2012 and EDD is on 29-MAY-2012. Follow-up information was received from the physician regarding a female patient with attention deficit disorder, seasonal allergies, GERD. Concomitant medications included SINGULAIR, ATROVENT and ZANTAC. On 28-MAY-2012, the patient gave birth to a male (8 lbs., 2 oz.; 20" in length). 40 weeks from LMP. The infant was reported as being normal with no reported congenital anomalies or any other complications. The patient had a shortened cervix during pregnancy and required bed rest during the pregnancy. There were no complications reported during labor or delivery. Additional information has been requested.
Pain in left thigh; This case was reported by a consumer via call center representative and described the occurrence of pain in thigh in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd September 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 29th September 2021, 7 days after receiving Shingrix, the patient experienced pain in thigh. On an unknown date, the outcome of the pain in thigh was not recovered/not resolved.   It was unknown if the reporter considered the pain in thigh to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient for himself. The batch number and expiry date was unknown. The patient reported that he received Shingrix vaccine, at the time of reporting the patient was experiencing pain in his left thigh. The reporter consented to follow up with health care professional.
I had a sore throat with fever and a headache. I also had congestion with a runny nose, nausea and diarrhea. I took the home test for COVID-19 on Saturday and  it was positive. I went to the Urgent Care after contacting my primary care doctor. They ran another test which was also positive. The doctor prescribed Paxlovid. I had to stop taking the Atorvastatin while taking the medication. Paxlovid helped and I was feeling better. However by May 29, the symptoms returned and I had a fever of 1014 degrees. After I took it I had a relapse where the symptoms returned again so I was given a Z-Pack of Azithromycin  by my primary care doctor on May 31, 2022. I started to feel better and by June 2, 2022, my temperature came down to normal. I still had some lingering coughing and post nasal drip for a week after that. I began to feel normal after about a week. I still have a little cough with post nasal drip but I feel for the most part I have recovered.
Heavy period, period spotting throughout the month, period extended from 5 days to 10 days
nausea; dizziness; weakness; not feeling well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 10Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NAUSEA (non-serious), outcome "unknown", described as "nausea"; DIZZINESS (non-serious), outcome "unknown", described as "dizziness"; ASTHENIA (non-serious), outcome "unknown", described as "weakness"; MALAISE (non-serious), outcome "unknown", described as "not feeling well".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
injection site soreness; Achiness at bed time; chills; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19-APR-2023, the patient received the 2nd dose of Shingrix. On 19-APR-2023, immediately after receiving Shingrix, the patient experienced injection site pain (Verbatim: injection site soreness), pain (Verbatim: Achiness at bed time) and chills (Verbatim: chills). The outcome of the injection site pain, pain and chills were not resolved.   It was unknown if the reporter considered the injection site pain, pain and chills to be related to Shingrix.     It was unknown if the company considered the injection site pain, pain and chills to be related to Shingrix.   Additional Information: GSK Receipt Date: 20-APR-2023 The patient self-reported this case. The patient asked about side effects of Shingrix.  The injection site soreness began shortly after the injection and the chills and achiness began at bedtime last night. They continued on the day of reporting. The reporter did not consent to follow-up.
On day 1, Resting Heart Rate went from normal of 60 BPM to 95 to 105 BPM.  Rate stayed at this level 24/7 for next seven days until Cardioversion on day 7.   Note: on day 3, after some yard work, rate went to 195 BPM for about 15 minutes.
3/6/23 I woke up and had a bad headache, sore throat and congested. I had a slightly elevated temperature. I took 2 at home COVID tests that were positive. I spoke with a nurse practitioner who prescribed PAXLOVID and I began taking it on 3/7/23. After I began taking the PAXLOVID, I began feeling better the next day. I could tell a huge improvement. By 3/11/23, I felt better and I have now recovered.
INCORRECT VACCINE ADMINISTERED, PATIENT WAS SUPPOSSED TO RECEIVE PFIZER COVID 19 BIVALENT, BUT RECEIVED PFIZER COVID 19 VACCINE. NO SYMPTOMS OR SIGNS.
Blotchy hives on neck and chest at 15:00. 3 1/2 hours, post vax, mother of child gave Benadryl according to package for child's weight and mom said 1/2 tsp of liquid Benadryl.
Pt received Td booster on 6Jun90 & reported on 27Jun90 had a headache since vacc. Temp of 99.6 F, examed bu MD for possible rxn. 2" swelling at inject. site.
Chills; Diarrhea; Fever; General body pain; Joint pain; Night sweats; Vomiting; This spontaneous case was reported by a nurse and describes the occurrence of NIGHT SWEATS (Night Sweats), DIARRHOEA (Diarrhea), VOMITING (Vomiting), CHILLS (Chills) and PYREXIA (Fever (100.6-104)) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.  The patient's past medical history included No adverse event.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced CHILLS (Chills), PYREXIA (Fever (100.6-104)) and PAIN (Achy Body). On 25-Jan-2021, the patient experienced NIGHT SWEATS (Night Sweats), DIARRHOEA (Diarrhea), VOMITING (Vomiting) and ARTHRALGIA (Joint Pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 27-Jan-2021, CHILLS (Chills), PYREXIA (Fever (100.6-104)) and PAIN (Achy Body) had resolved. At the time of the report, NIGHT SWEATS (Night Sweats), DIARRHOEA (Diarrhea), VOMITING (Vomiting) and ARTHRALGIA (Joint Pain) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jan-2021, Body temperature: 100.6 - 104 (Inconclusive) 100.6 - 104.     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.
MENACTRA vaccine received 6/29/2012. Dr. was paged on call 6/30 by mother. Vaccine site sore, red & swollen, armpit felt swollen, like lymph node swollen. Mother giving MOTRIN 400 every 4 hours. Dr. recommended adding BENADRYL & heating pad & if not improving to urgent care or ER.
Got 1st  Moderna COVID vaccine 415pm 4/22/21 At 5pm started with hives +tingling in lips  + lips swelling Took benadryl and about  30 mins later went away
Moderna COVID-19 vaccine EUA 12/29/20  5pm left arm sore  8pm stomach became upset  9pm muscle aches started,  chills, low grade fever at 99.8 continued all night   12/30/20  9am severe muscle aches and joint pain, skin tingling/ sensitive to touch and temperature.  Continued all day  12/31/20  8am sore left arm and sore back/spine
Information has been received from a physician concerning a 21 year old female with no known medical history, who in December 2007, was vaccinated with a third dose of Gardasil (Lot # 659055/1522U).  On unspecified dates, the patient was also vaccinated with the first and second dose of Gardasil (Lot # 657868/"523U" and 658554/"928U").  Concomitant therapy included rizatriptan benzoate (MSD) as needed (dose and indication not reported).  Other concomitant therapy included birth control (hormonal contraceptives unspecified), TOPAMAX, NASONEX and ZYRTEC.  The physician reported that on an unspecified date, 6 weeks after receiving her third dose, the patient became infected with condyloma.  The patient's condyloma persisted.  The patient sought unspecified medical attention at an office visit.  No product quality complaint was involved.  Additional information has been requested.
Headache, extreme tiredness, vomiting, weakness, dizziness, low fever, poor appetite.
Pediarix instead of 4th dose of dtap; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 16-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number GT39Z, expiry date 3rd December 2024) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 31st January 2023, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 31st January 2023, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was 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: 31-Jan-2023 Reporter's comment: The email was requested to follow-up, but information was declined. The reporter did not consent to follow-up. Additional supportive information: The patient received Pediarix instead of 4th dose of dtap, which led to wrong vaccine administered.
immediately after Dtap injection - had large raised hive on Rt leg around injection site - No wheezing or difficulty breathing. Dr came in to evaluate - patient was given Dexamethasone 0.9ml by mouth. Benadryl 1 tsp given by mouth - also to take pepsid for 3 days - Kept in office for 30 minutes - no other issues.
Sore arm 45 mins after vaccine, redness and swelling to arm. At 2 am, woke up chattering and whole body shaking with a temp of 102F, then woke at 5am with full body swears that soaked my clothes. Fatigue. I slept the entire next day and night. Couldn't stay awake. SEVERE joint pain in every joint that made it difficult to even move or walk. Had sweats and fever for 3 days after the injection. And a sore arm for 2-3 weeks. I have never felt so bad in my life. I will not take it again.
Client states "My right arm began hurting 15 minutes after I received the shot. My right arm began swelling and throbbing within 3 hours after receiving the shot. Swelling occurred from my elbow to my shoulder, mid-shoulder. I had severe itching of my right arm and just under my breast area. I felt sick to my stomach 9 1/2 hours, after the shot. I had a fever of 102F by 03:00 on 11/15/00. I developed fever blisters in my nose, the next day. By Saturday morning, 11/18/00, my glands were swollen in my neck area."
Shingles next to right eye and on face Fatigue, Arm pain, Chills, Skin pain
Patient presents with a potential reaction to the COVID19 vaccine. The patient reported generally feeling unwell a few minutes after her vaccine. She has a history of asthma and adrenal insufficiency for which she takes oral Hydrocortisone without recent need for stress dosing. The patient was monitored in the monitoring area for 45 minutes. EMS was summoned to obtain vitals. BP was 160/90, P 80, SpO2 97%. The patient was given oral hydrated and she rested supine in her car. After further monitoring, all symptoms resolved without issue.  Mild post-vaccination reaction without concerning evolution. Returned home with husband after driver after evaluation.
when the Children tell their parents that they are severely sick" The doctor mentions it is anxiety; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (when the Children tell their parents that they are severely sick" The doctor mentions it is anxiety) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANXIETY (when the Children tell their parents that they are severely sick" The doctor mentions it is anxiety). At the time of the report, ANXIETY (when the Children tell their parents that they are severely sick" The doctor mentions it is anxiety) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   This case was processed as cluster case as there were no identifiable patients.  No concomitant medications were reported.  Treatment information was not provided.
Patient received 3 doses of pfizer. Patient should have only recieved 2 doses. Patient stated on 3/1/2021 that she had not had a previous covid vaccine, however her employer shows she had one on 12/16/2020.  Patient was given a pfizer at the health dept  on 3/1/2021 and 3/23/2021.
Woke up 7:15 am with Headache, chills, fever of101.4, body aches, joint pains, fatigue and on/off chest pain.   Body aches and fever/chills resolved by 1pm and chest pains/joint pains and fatigue and on/off chest pains continued longer Treatment bed rest/Ibuprofen 600 mg x 2 doses
Severe Constipation; Stomach issues; This spontaneous case was reported by a consumer and describes the occurrence of CONSTIPATION (Severe Constipation) and ABDOMINAL DISCOMFORT (Stomach issues) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced CONSTIPATION (Severe Constipation) and ABDOMINAL DISCOMFORT (Stomach issues). At the time of the report, CONSTIPATION (Severe Constipation) and ABDOMINAL DISCOMFORT (Stomach issues) outcome was unknown. Not Provided          No concomitant product use was provided by the reporter.  No treatment medication was provided.  After both doses, she experienced severe constipation and stomach issues that went on for weeks. It didn't linger after the first dose but lasted over two weeks after the second dose. It is now back to Normal.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: New AE Added, Both dose details are updated.
Urticaria on trunk, limbs, face and hand. Low grade fever. FNP treated with Benadryl injection.
Vomiting; Fever; This case was reported by a other health professional via call center representative and described the occurrence of vomiting in a female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number 24PP4, expiry date 30th June 2020) for prophylaxis.   In October 2019, the patient received FluLaval Tetra 2019-2020 season. In October 2019, less than a week after receiving FluLaval Tetra 2019-2020 season, the patient experienced vomiting and fever. On an unknown date, the outcome of the vomiting and fever were unknown.   It was unknown if the reporter considered the vomiting and fever to be related to FluLaval Tetra 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. The medical assiatant stated that, the patient received dose of Flulaval quadrivalent 2019-2020 season either on 18th October 2019, or within the week afterwards. The patient experienced vomiting and fever either the day of vaccination, or the day after vaccination. The reporter consented to follow up. This case has been linked with case US2019207544, reported by same reporter.
Severe fatigue, fever, chills, nausea, vomiting one time, head ache, eyes burning
I developed hives on my right arm that spread to the right side of my body (side, chest, back, shoulders) that lasted on and off for over a week. I experienced shortness of breath and gastro issues (diahhrea). Am currently 7 months pregnant with a due date of 9/25/21.
Erythematous skin, pruritus 10 cm diameter, non tender blanching - warm to touch - apply ice pack, benadryl , Keflex.
First dose Pfizer had no reaction other than sore arm. At that time, injection given in left arm. Second dose in June had injection same arm but severe chills that started around 8:30pm. Simultaneously, I also experienced numbness in my face but subtle and I chaulked it up to chills I had. Two days ago I got Pfizer Booster around 10:30am injected in right arm this time. I got slight chills around 6:30pm. They subsided but I had severe facial numbness on my left side and no signs of stroke. It feels like the numbness wearing off from a dental procedure. Yet, two days later I am still having facial numbness on my left side. No chills or other issues other than standard sore arm.
I had fever, joint and muscle aches. It flared up like my fibromyalgia. They had me stay home and take Tylenol. I had the weekend to recover due to happening on a Friday.
Patient had ? allergic reaction versus cellulitis of left arm. Hospitalized for 1 day on 10/5/15 at hospital. Received IV antibiotic and BENADRYL.
Patient received vaccine at 9:05 am and stated that she was nauseous and felt like her throat was closing up at 9:12 am. Benadryl 25mg PO x 1 dose was given.  Patient stated that she felt better after being observed for 45 minutes. Patient left facility at 10 am.
rash kind of like having hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (rash kind of like having hives) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M2DA) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (rash kind of like having hives). At the time of the report, URTICARIA (rash kind of like having hives) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant product use was not provided by the reporter.  No treatment was received. Patient had rash kind of like having hives all over her body but mostly on her eyes, nose, on her face and neck and shoulders. Patent took second dose on 25-FEB-2021 with lot no. 010A21A.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information about the patient's medical history and concomitant therapies was provided. On 19-OCT-2016, the patient was inadvertently administered an expired dose of M-M-R II, expiration date: 15-OCT-2016 (lot#, dose and route of administration were not reported) which was expired. No adverse effects was reported. Additional information has been requested.
vomiting; dizziness; Initial information regarding this unsolicited valid non-serious case was received from a pharmacist (Reference number- 00322237) and transmitted to Sanofi on 19-Oct-2020.  This case involved 10 patients who experienced vomiting and dizziness, while he/she received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Relevant medical history, past medical treatments, vaccinations details, Concomitant medication and family history were not provided.   On an unknown date, the patients received a dose of 0.7 ml of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ500AB and expiry date: 30-Jun-2021) via intramuscular route, most of them got it in the left arm but a few did not for prophylactic vaccination.  On an unknown date, the patients developed non-serious events vomiting and dizziness (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  No laboratory test was reported.   It was not reported if the patient received a corrective treatment.  The event outcome was reported as unknown for both the events vomiting and dizziness, at the time of reporting.
Pulmonary Embolism suffered on 2/13/2021.  Hospitalized at Medical Center.  Discharged on 2/20/2021.  Still recovering.
PT PRESENTED 7/22 WITH REDNESS, WARMTH, AND SLIGHT SWELLING OF THE LEFT ARM NEAR THE INJECTION SITE. IT BEGAN 7/21, ONE DAY AFTER RECEIVING THE VACCINE. PT STATED IT HAD IMPROVED SLIGHTLY, BUT WAS STILL BOTHERSOME. RECOMMENDED USING AN ICE PACK.
Apple sized, red blotchy (hive-like) rash, itchy, hot.
I noticed that the left side of my mouth was a little droopy around 10:00am on 2/14/2021 but didn?t think anything of it. Then around 4pm my daughter saw me and noticed it as well. We went to the ED immediately and got a stroke rule out work up. There were no other deficits besides the left sided facial palsy.