chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of buttock pain in a 62-year-old female patient who received SHINGRIX (batch number 3AF9E, expiry date 2nd February 2021) for prophylaxis. On 13th July 2018, the patient received SHINGRIX (intramuscular) .5 ml. On 15th July 2018, 2 days after receiving SHINGRIX, the patient experienced buttock pain. On an unknown date, the outcome of the buttock pain was not recovered/not resolved. It was unknown if the reporter considered the buttock pain to be related to SHINGRIX. Additional details were provided as follows: On 13th July 2018 (Friday), the patient was given the vaccine in her left deltoid. On 15th July 2018 (Sunday) beginning, the patient started to experience pain in her right gluteal which was worsened on next day (Monday) and again on the reporting date.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 37 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LEVOTHYROXINE, start date: 01Jan2012. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 01Apr2023 to 05Apr2023.  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.
Apart from expected side effects I'd read about (fever, chills, insomnia, fatigue-absolutely all of which I experienced after the second shot), what I'm actually reaching out to report is that both my first and second vaccines were followed by a few days of experiencing mild Lymphocytic Colitis symptoms. Typically I'm only triggered by taking NSAIDs or consuming the grains that are associated with Celaic Disease. The symptoms I experienced were diarrhea accompanied by some gastric discomfort and bathroom urgency. The symptoms were not worst I've ever had them, but they did last a few days.
4cm x 7cm shaped rash began 1 day after injection at site of injection. Tender, warm, itchy.
Information has been received from a licensed practical nurse referring to an unspecified patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were not reported. On 22-SEP-2016, the patient was vaccinated with one improperly stored dose of GARDASIL 9 (lot # M011117, expiration date 07-DEC-2017, dose and route were not reported). No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information is not expected as there is no contact consent to follow up.
Initial information received on 22-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer or non healthcare professional. This case involves a 44 months old male patient who was vaccinated with 0.5 ml second dose of PENTACEL (lot number: C5316AA and expiry date: 13-Feb-2018) via intramuscular route in the left thigh at 05-May-2017 (16 months) and 0.5 ml first dose of ACT-HIB (Batch number: UI366AA and expiry date: 14-Apr-2017) via intramuscular route in the right thigh on 05-Mar-2016 (9 weeks). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation. It was a case of actual medication error due to inappropriate schedule of vaccine administered. It was unknown if any adverse event occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Likely date of exposure was 9/9/21 after review of my calendar.  Evening of the 12th had flu-like symptoms, sinus congestion, followed by dry coughs.  These subsided after 2 days but sinus irritation/congestion, fatigue and loss of smell gradually came down over 2 weeks.  Isolated for 10 days after test results(below)
Expired Havrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 54-year-old female patient who received HAV (Havrix) (batch number 2BA99, expiry date 16th December 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 21st December 2022, the patient received the 1st dose of Havrix (intramuscular) and Havrix Pre-Filled Syringe Device. On 21st December 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 22-Dec-2022 Reporter's comment: The call transferred to medical information department for further information on expired vaccines. The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Havrix in right deltoid, which led to expired vaccine used.
This case was reported by a pharmacist via call center representative and described the occurrence of generalized rash in a 74-year-old male patient who received SHINGRIX (batch number E3Z7E, expiry date 18th May 2021) for prophylaxis. Previously administered products included SHINGRIX (1st dose received on 14th August 2018, for tolerance, refer case: US2019032539). On 18th January 2019, the patient received the 2nd dose of SHINGRIX. On 19th January 2019, 1 days after receiving SHINGRIX, the patient experienced generalized rash. On an unknown date, the outcome of the generalized rash was not recovered/not resolved. It was unknown if the reporter considered the generalized rash to be related to SHINGRIX. Additional details were provided as follows: A day or two after receiving SHINGRIX, the patient had rash all over his body. The reporter gave consent to follow up.
tingling above lip on Sunday, went into left cheek, tightness in eye muscle, lymph node pain, lt-headache in occipital bone -2/26 went to hospital, paralyzed  in left side of face, bells palsy
A report has been received from a Health Professional concerning a 44 years old female patient. The patient has no significant medical history and no concurrent diseases were reported. Concomitant medications were not reported. On 24-Sep-2012, the patient started receiving a treatment with nasal FLUMIST. Indication, dosing and frequency were not provided. One hour after receiving FLUMIST, she had a headache and 12 hours later she felt the symptoms like dizzy, nauseous, no appetite, malaise, fatigue. Therefore, on 25-Sep-2012, the patient experienced flu like symptoms. Her blood pressure was 119/92, and had a low heart rate of 48. The patient had chills but no fever. Her body temperature was 96.5F. The patient was not tested for influenza. The patient went to her primary physician, who felt that she probably had an anaphylactic reaction because of her change in blood pressure and heart rate. She was treated with TYLENOL for headache, BENADRYL for anaphylaxis and increased her fluid intake. The action taken with the vaccine of FLUMIST was unknown. On 27-Sep-2012, she returned to work and her blood pressure and heart rate were back at normal, the events of anaphylactic reaction and flu like symptoms were considered to be resolved. The event of anaphylactic reaction was considered to be serious by the company physician with the serious criteria of important medical event. The event of flu like symptoms was considered to be non-serious by the reporter. Follow up information received by AstraZeneca/MedImmune on 03-Oct-2012 from a consumer upgraded this case serious with the new event of anaphylactic reaction which was assessed as serious by the company physician with the seriousness criteria of important medical event, the action taken with the events of anaphylactic shock and flu like symptoms was changed to recovered, laboratory values added, narrative updated.
Fever 100 8JUL91, swollen glands, achy all over, knees swollen & painful; 5AUG91 joints no longer swollen, some soreness remains;
Information has been received regarding a case in litigation, from a lawyer, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date in 2016, the patient was vaccinated with ZOSTAVAX, due to health care professional recommendation, for permanent prevention and protection against shingles and zoster-related injuries (prophylaxis) (strength, anatomical location, dose, route of administration, lot # and expiration date were not provided). On an unknown date in 2016, the patient experienced shingles (herpes zoster) and other zoster-related injuries despite being inoculated with the ZOSTAVAX vaccine (vaccination failure). On 12-DEC-2016, the patient was treated by a health care provider for shingles. It was also reported that, on unknown dates, the patient suffered serious physical, emotional and economic damages as a result. In addition, the patient would continue to suffer ongoing injuries, included but not limited to: mental and physical pain and suffering (Emotional distress and pain), extensive medical care and treatment for these injuries, significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of pre-existing conditions and activations of latent conditions, lost wages, loss of earning capacity and other losses and damages. At the time of report, the patient was not recovered from emotional distress and pain, and the outcome of the patient regarding the vaccination failure, herpes zoster, quality of life decreased and  the pre-existing unspecified conditions aggravated was unknown. The reporter considered the adverse events to be related to ZOSTAVAX. The reporter considered the events to be disabling, life-threatening and medically significant.
contracted COVID a week or two after the vaccination; no second dose past 42 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (contracted COVID a week or two after the vaccination) and INTENTIONAL PRODUCT USE ISSUE (no second dose past 42 days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (contracted COVID a week or two after the vaccination) and INTENTIONAL PRODUCT USE ISSUE (no second dose past 42 days). At the time of the report, COVID-19 (contracted COVID a week or two after the vaccination) and INTENTIONAL PRODUCT USE ISSUE (no second dose past 42 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications provided  Treatment medications includes Antibody plasma    Reporter did not allow further contact
Information was received on 14-OCT-2016 via a company representative calling on the behalf of a pharmacist who is the patient, a female of unknown age. Concomitant medication included SINGULAIR for an unspecified indication. Medical history was not reported. On an unknown date, the patient received a dose of ZOSTAVAX subcutaneously (lot number, expiration, dose and injection site were unknown). After the patient received the vaccine, on an unknown date, the patient experienced "a rash on her legs". The patient saw a physician on an unknown date and received an unspecified treatment. The patient has not yet recovered from rash on legs. The causality was not reported. No other information was provided. Additional information has been requested.
Information has been received from a physician assistant concerning a 13 year old male patient with no drug reactions/allergies who was vaccinated with VARIVAX (Merck). On 15-FEB-2009 the patient had shingles, extensive vesicles on T1 on the right side of chest, back and axilla and slight pain on the right side. The patient was being treated with acyclovir. The patient had visited office for medical attention. At the time of reporting the patient's adverse events persisted. Follow-up information has been received from the physician assistant that the 13 year old female (not male) patient with acne, seasonal allergy and Seasonal allergic rhinitis who was vaccinated with VARIVAX (Merck) (lot # 612228/1503B) SQ into the deltoid of her left arm on 29-APR-2006 for her first dose. On 04-APR-2007 the patient was vaccinated with VARIVAX (Merck) (lot # reported as "9311507") SQ into the deltoid of her right arm for her second dose. Concomitant medication included over the counter unspecified antihistamine, and topical acne cream. On 15-FEB-2009 the patient experienced shingles and herpes zoster that was located in T1 dermatome. There were numerous scattered lesions on upper of her right chest and upper of her right back. It was also reported the patient had an extensive vesicular rash along T1 dermatome and experienced itching. Subsequently, the patient recovered from the adverse events. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine VZV strain. The sample of the lesion was collected on 20-FEB-2009. The sample was taken from the upper right chest, back and right axilla. Follow-up information has been received that the final VZVIP PCR results for the specimen were Wild Type Strain. Follow-up information has been received that the adequate specimen, which was from a lesion (scab), was sent to laboratory on 21-FEB-2009 and arrived in laboratory on 24-FEB-2009. The VZV DNA was amplified and the VZV strain identification showed Wild-Type. Other identification number was associated with this case VZVIP 13297012695. Additional information has been requested.
FROZEN (-1.7F TO 2F) AND THAWED VACCINE WAS GIVEN TO PATIENT; This spontaneous report received from a pharmacist concerned a 45 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1820095, and batch number: 1820095 expiry: 04-JUL-2021) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAY-2021, the subject experienced frozen (-1.7f to 2f) and thawed vaccine was given to subject. The action taken with covid-19 vaccine  was not applicable. The outcome of frozen (-1.7f to 2f) and thawed vaccine was given to patient was not reported. This report was non-serious. This case, from the same reporter is linked to 20210535717, 20210534639, 20210536001 and 20210536595.
Left arm experienced a numbness-like feeling from shoulder to elbow, as well as a heavy feeling. After about 20 minutes the numb like feeling had begun to regress back toward the injection site. It had not fully faded away after 30 minutes but did seem to be improving.
Pt started with a fever of 103F-104F on 12/3/01 and continues with a fever, fussiness and decreased activity. He saw doctor on 12/5/01 and was dx'd with "viral illness". He still is with increased temperature.
Woke up with swollen tongue, area under tongue, and throat.  Took Claritin and inhaler and monitored.
Arm where shot was given started swelling, turning red, and warm to touch. Mom stated PCP is out of town and she didn't want to go there, advised going to local urgent care as ther was no doctor at The Health Dept. today.
pt was seen in ER 4MAY97w/abscess of rt upper arm which was lanced & drained;given IM ATB & pain med;
1 of 3 pts (immunized from same lot; 2 pts from same vial) upon nursing home admission who recvd tetanus toxoid & reimmunized 4 wks later (nursing home policy) exp inj site rxn; pt devel cellulitis; tx ATB; no culture done; pt recovered;
Significant chills - uncontrollable teeth chattering - and a headache. These both occurred 13 hours after injection. The chills occurred suddenly and lasted for an hour or more. The headache went away with ADVIL and TYLENOL about 8 hours later. These symptoms did not occur with the 1st shot two months ago. Also, there is a red spot at injection site and muscle soreness - this happened with the 1st shot as well.
Extreme sharp pain when Shot was administered Upper Arm and shoulder ache for 5 months- Shoulder subsided after 2 months - Arm continues
pt states p/vax-got home-vomit, shaky, dizzy, nurse states sx-existed prior to vax;
Patient successfully vaccinated a patient in the left deltoid. When the needle retracted into the syringe, a small amount of liquid was ejected, landing near patient eye. Patient was wearing glasses and states no liquid made it directly into his eye. Patient then rinsed his eyes with water for 10 minutes.
Red swollen anterior thigh lateral thigh low grade fever ----> Tylenol every 6. Red rash over upper leg after 48 post injection ---> office visit 8/9/07.
given 0.3ml of pizer with out being mixed wit 0.9 sodium chloride
Lower right lumbar radicolopathy* ("pinched nerve") affecting the right leg, with pain inability to walk, without intense pain. Spent one      night in the hospital 2 days later, at a Medical Center due to  pain meds, drugs required to lay flat for MRI study. Discharged the       next AM, much improved could walk, stand ever since, but with residual right leg discomfort, with numbness (with pain to tottouch), mild muscle weakness). (*Note:  I have become aware of at least three other individuals with same, similar new onset occurrence after vaccine. For this reason, and combined with other reports of vaccine related nerve inflammation, I am not 100% certain it is a "side effect", but is     "suggested."
On Tuesday I started feeling under the weather. I was coughing more than usual. On Wednesday I tested positive or COVID 19. I scheduled a telehealth visit and was prescribed PAXLOVID. I did have some trouble breathing an used my albuterol along with a Symbicort inhaler. I had a low grade fever and a runny nose. I also had lower back soreness a few days later. When I had the doctors appointment, they told me not to use the Symbicort inhaler with PAXLOVID. I was exposed on May 12 and May 13. I tested negative on the 17th and I started feeling a little bad. I felt very bad on the 18th. I still have some phlegm, I am a little tired because I am not sleeping well and my taste buds have been affected.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  CHRONIC RESPIRATORY FAILURE RESPIRATORY FAILURE, UNSPECIFIED ACUITY
Had a bad reaction; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Had a bad reaction) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History Information was reported.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (Had a bad reaction). At the time of the report, ADVERSE REACTION (Had a bad reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment was reported.
pt recv vax 11DEC98 & pt exp pain @ the inj site;12DEC98 pt exp a gen rash;pt was eval by NP who felt that sx might be d/t a medication reaction;
Day 1: day of shot. Stiffness & soreness begin in evening Day 2 & 3: intense arm pain (unable to sleep with maximum dose of painkillers & difficulty with daily activities) Day 4: moderate arm pain (some difficulty with daily activities & sleeping) Day 5-8: typical after-shot arm soreness Day 9-10: moderate arm pain (some difficulty with daily activities; sleeping was difficult) Day 11: typical after-shot arm soreness (today)
Pt recvd MMR vax; 12 days following vax pt devel a fever & a rash;
noticed spot about the size of a quarter that was tender and warm on friday 2/13/09
Started experiencing chest pain/tightening a few days after first dose. I have off and on chest pain that comes and goes.
No Sid effects until about 21 days after first dose. Severe head pain from base of neck wrapping around head, Facial dropping on one side, rash spider web like, swelling of face of eyes, nose, and lips, neck swelling, inability to turn head, SEVERE confusion, photophobia,  impaired motor skills, blurred vision, ringing in ear. Neurologist dx with meningitis---had CT scan at ED clear, no lumbar puncture to confirm meg dx. On 2/25/2021 admitted to hospital.  Full work up of lots of testing.  All was fine except MRI showed edema on c1-c7 and noted new in appearance from a MRI completed 2/5/2021, slightly elevated WBC, and platelets however improved over 24 hrs. My symptoms continued to improve each day. On 3/26 approx 25 days after second dose same symptoms occurred----sudden acute head pain, facial sores, swelling of face, confusion etc. Today, 4/29/2021 I am much better however my memory recall in not 100%, motor skills not 100% and still have some fatigue compared normal functioning  to prior to first onset. I have two neurologist, eye doc, PCP, and had doctors from the clinic involved in my case.
Sore arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Sore arm at the injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced INJECTION SITE PAIN (Sore arm at the injection site). At the time of the report, INJECTION SITE PAIN (Sore arm at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information provided.