chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse effect; the patient received first dose, second dose and third dose of GARDASIL 9 in August 2018, February 2019 and August 2019 respectively; Information has been received from a pharmacist referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.  On unknown date in August 2018, the patient was administered the first dose of hpv rL1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # N003703, expiration date: 29-OCT-2019, strength, dose and route were unknown) for prophylaxis. In February 2019, the patient received the second dose of hpv rL1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # N003703, expiration date: 29-OCT-2019, strength, dose and route were unknown). On an unspecified date in August 2019, the patient received the third dose of hpv rL1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # N003703, expiration date: 29-OCT-2019, strength, dose and route were unknown) (inappropriate schedule of vaccine administered). No adverse effects were reported.
Patient experienced headache, nausea, and light-headedness after receiving the Pfizer BioNTech COVID-19 Vaccine.  She was observed for 30 minutes and her symptoms resolved.
Patient was vaccinated, but tested positive for covid - 20Sep2022.; Patient was vaccinated, but tested positive for covid - 20Sep2022.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 20Sep2022, outcome "recovering" and all described as "Patient was vaccinated, but tested positive for covid - 20Sep2022.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Sep2022) Positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
suspected vaccination failure; shingles; was miserable; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and feeling miserable. On an unknown date, the outcome of the vaccination failure, shingles and feeling miserable were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and feeling miserable to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 25-May-2022 Reporter's Comments: This case was reported by a patient's cousin via interactive digital media. The patient got the shingles after she got the shingles vaccine and never had shingles before and she was miserable. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not be possible as no contact details were available.
POSITIVE COVID TEST ON 1/11 AND NEGATIVE ON 1/13 AND 1/15/ 2021  Narrative:
Information has been received from an unspecified reporter referring to a 10 year old patient of unknown gender. The patient's concomitant medication, concurrent conditions and medical history were not reported. On 23-SEP-2016 the patient was vaccinated with GARDASIL 9 (lot #, expiration date, dose and route were not reported) for prophylaxis. The vaccine was administered at a Heath Center during the temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA003650.
mast cell activation syndrome; Initial information received on 16-Sep-2023 regarding an unsolicited valid  serious case received from a patient.  This case is linked to case 2023SA286262(CLUSTER).  This case involves female patient of an unknown gender who experienced mast cell activation syndrome after receiving diphtheria-2/tetanus/5 Ac Pertussis Vaccine [Adacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Food allergy with allergies are worse--she is more reactive in general than she was 20 years ago..  Concomitant Medications Included Diphenhydramine Hydrochloride (Benadryl [Diphenhydramine Hydrochloride]).  On an unknown date, the patient received a unknown dose of suspect diphtheria-2/tetanus/5 Ac Pertussis Vaccine Suspension for injection (strength, expiry date and lot number not reported) via unknown route in unknown administration site as immunization. Information on the batch number requested.  On an unknown date the patient developed mast cell activation syndrome (unknown latency). This event was assessed as medically significant.  Reported: She recently was able to successfully take the shingles vaccine co-administered with Benadryl. She stated that she has mast cell activation syndrome.   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.; Sender's Comments: Sanofi company comment for information received on 21-Sep-2023: This case involves female patient of an unknown gender who experienced mast cell activation syndrome after receiving diphtheria-2/tetanus/5 Ac Pertussis Vaccine [Adacel]. The patient had current condition included Food allergy which could be confounding factor. Further information regarding tolerance, medical or family history and Concomitant medication excluding alternative etiologies for the reported event are needed to fully assess this case. Based up on the reported information, the role of the individual suspect vaccine cannot be assessed.
Large area of erythema around three injection sites on right anterior thigh, approx. 25 cm x 20 cm. Warm to touch. One small area on right thigh around on of the two injection sites approx 2 cm x 3 cm. BENADRYL given in office and parent told to repeat every 6 hours as needed. ZYRTEC or CLARITIN 10 mg daily.
Fever, staring spells, listless. 9/16/93, adverse reaction began within 1 hour of injection. Pt did not speak for 10 days and was lethargic. Required a visit to his pediatrician and pediatric neurologist. Permanent disability.
Before vaccine, was regularly outside walking, exercising, climbing hills in the snow for sledding with kids, building snowmen.   Immediate head ache, pain in right arm, neck and back. became very tired and body extremely heavy.  Felt sick. Lasted almost a week. Some improvement, but never returned to pre-vaccine state. I have been extremely exhausted/fatigued, unlike anything I have ever experiences, tingling, achy muscles, hard to function and move.  sometimes can barely lift arm to turn on light switch or wash hair without body feeling pained and uncomfortable. Tried for two months to self care, rest, in case it was stress/work related. Tried increasing exercise-I felt worse. Would crash and have to sleep. back and neck and joint pains worse than before. Began improving diet, still no improvement.  Tried some supplements, some improvement. but only about 45%.  Then started having diarrhea in July. Stopped supplements- GI issues continued, but then exhaustion got worse again.  Stopped healthy diet that included raw veggies or cooked veggies. Still had GI issues, but not as bad.  Eating potatoes, applesauce, bananas. Still GI issues. Tried changing other foods in diet to rule out various problems. No success.  Losing a little weight, but should be gaining based on what I was eating and should have been constipated.
Injection + 8 hrs: Began to feel soreness in shoulders and between shoulder blades; tingling/prickly sensation on upper right chest. Injection + 24 hrs: Developed a small, particularly painful (muscular?) knot on left lattisimus dorsi; tingling/prickly sensation moves to abdomen Injection + 48 hrs: Pustular rash develops on upper back; tingling/prickly sensation moves to forearms. Injection + 96 hrs: Pustlar rash spreads to back, right underarm and right chest. Injection + 130 hrs: Medical diagnosis of shingles; dull headaches on right side of head; occasional piercing pain in right ear.
elevated temperature intermittently of 99.5 F but did not exceed; intermittently chills; intermittently body sweatiness; damp skin; day or 2 of fatigue; lower slight body ache / sore; redness where she had shot; tender; This spontaneous case was reported by a patient family member or friend and describes the occurrence of BODY TEMPERATURE INCREASED (elevated temperature intermittently of 99.5 F but did not exceed), CHILLS (intermittently chills), HYPERHIDROSIS (intermittently body sweatiness), SKIN MACERATION (damp skin) and FATIGUE (day or 2 of fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BODY TEMPERATURE INCREASED (elevated temperature intermittently of 99.5 F but did not exceed), CHILLS (intermittently chills), HYPERHIDROSIS (intermittently body sweatiness), SKIN MACERATION (damp skin), FATIGUE (day or 2 of fatigue), MYALGIA (lower slight body ache / sore), ERYTHEMA (redness where she had shot) and TENDERNESS (tender). At the time of the report, BODY TEMPERATURE INCREASED (elevated temperature intermittently of 99.5 F but did not exceed), CHILLS (intermittently chills), HYPERHIDROSIS (intermittently body sweatiness), SKIN MACERATION (damp skin), FATIGUE (day or 2 of fatigue), MYALGIA (lower slight body ache / sore) and TENDERNESS (tender) had resolved and ERYTHEMA (redness where she had shot) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medications were not provided.
No adverse reaction on the date the Moderna COVID-10 Vaccine EUA was given. The following day, Thursday, 12/24/20, I felt pain at the site of injection. When I checked my arm I had a large, painful, red, round, raised bump. It became more erythematous, painful, and larger the next day, Friday, 12/25/20. The pain, swelling, size, and erythema slowly started going away over the next few days.  Wednesday 12/30/20 and Thursday, 12/31/20 the area was nearly back to normal. Today, Friday, 1/1/21, I felt itchy at the site of injection. When I checked it I had large round area of erythema at the site of injection.
tingling in the arm that I had the shot in; This is a spontaneous report received from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (Pfizer BioNTech COVID-19 Vaccine, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm on Aug2021 as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced tingling in the arm that i had the shot in, in Aug2021. Outcome of the event was unknown. PQC Details: Request Name: REQ- Withheld. Product: Pfizer BioNTech COVID-19 Vaccine. Question: Transfer in from DSU Dori: Withheld. Reportum: Withheld. E-transmit, additional information gathered. Did not gather patient's age. Caller is a consumer asking about how long side effects of the Pfizer-Biontech Covid19 vaccine typically last? She did clarify and stated she received her first dose last Tuesday, and that she's been experiencing "tingling in the arm that I had the shot in" and that it "started yesterday, and also today". Response: Answered per 'VR-no info' as there are no reports of "tingling" or "paresthesia" listed in the fact sheet. Explained that frequency data for AEs was gathered in the 7 days after either dose (Tables 1-6). [LAB- Withheld; Revised: 12Aug2021]. Spoke from attached cons doc regarding duration of AEs, "In general, local side effects resolved within 1 to 2 days (systemic side effects) were observed with the first 1 to 2 days after vaccination and resolved shortly thereafter," Referred caller back to HCP for evaluation and treatment if symptoms continue.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Vaccine site left arm. Left hand joints at pointer finger and thumb are swollen and have sever pain. Right arm elbow pain. Can not lift right arm to even shave.  Symptoms started 2 days after vaccination. Three weeks later with no improvement.
Systemic: Headache-Mild, Systemic: Other- Patient stated that she was feeling hot from her feet to her head with sluggishness and headache 4/10 on pain scale.-Medium
Patient reports to having left shoulder pain starting that same evening of 5/8/2022, and reports that he is still having this today 11/7/2022
nausea, chills, headache, back ache, body ache, muscle soreness in left arm, faint/dizzy, muscle soreness in left neck
Drug ineffective; COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 38-year-old male patient received BNT162b2 (BNT162B2), in May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 38 years for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: Other medical history: Asthma. Concomitant medication(s) included: TRAZODONE; BUPROFEN; TYLENOL; TESSALON; DELSYM; CODEINE; MUCINEX. The patient started Azithromycin on 26Aug2022 and stopped on 01Sep2022. The patient had no known allergies. The following information was reported: COVID-19 (medically significant) with onset 2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset 2022, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Treatment of COVID-19; (2022) Positive, notes: Rebound positive test. Therapeutic measures were taken as a result of covid-19. Therapeutic measures included Anti-viral details: Product: COVID 19 Treatment, Brand: Paxlovid, treatment started on 25Aug2022 and treatment stopped on 31Aug2022, Indication: Treatment of Covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information in the case, the causal association between the event Drug ineffective, COVID-19 and the suspect drug BNT162B2 cannot be excluded.
heart palpitations, increased heart rate at rest, heart pounding in chest woke me twice during the night, chest tightness, labored breathing. I received the Moderna booster after initially receiving the Janssen vaccine on 03/19/2021; prescribed a beta blocker for heart palpitations and told to avoid aerobic exercise for two weeks and return to cardiologist for check up
9JUN93 6PM sleepy, pain in arm; recvd APAP; 7PM went to sleep; 10PM woke up, felt warm, vomited;not retaining APAP; 10JUN93 3AM given APAP p/emesis; fever down; 9AM h/a, t104.7, vomited; advised to call MD; 4PM took pt to MD; stomach upset;
about 5 mins p/vax pt vomited moderate amt undigested food; pale; 1245PM p-100, BP 100/70; 105PM P84 BP 80/58-color good;
This is a spontaneous report from a contactable pharmacist. A patient of unspecified age, ethnicity and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, 8 days after administration of pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein), the patient experienced redness and swelling on the injection site. The patient asked if this is an expected adverse event.
Legs heavy, cold chills, joints ache & fever 102 degrees these sxs ended approx 10:30-11:00 pm. Today, 10/19/11 has headache & stiff neck.
Intussusception diagnosed on ultrasound after patient passed bloody stools. Obstruction reduced in emergency room via air barium enema.
Systemic: Rash (other than injection site)-Medium, Systemic: Itchiness on extremities and back-Medium
administered Pentacel with out the ActHib portion/No AE; Initial information received on 04-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 6 months old male patient who received 0.5 mL of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] without the ACTHIB portion, lot U6524BA and Expiry date 02-MAR-2021 via unknown route in the right thigh on 04-NOV-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE), PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Immunisation.  It was a case of actual medication error due to Inappropriate reconstitution technique. Administered Pentacel with out the ActHib portion.   At the time of report no adverse event was reported.  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.
patient said she felt dizzy after getting the vaccine and sour after taste in mouth. patient's blood pressure was normal. patient left after 45 minutes after vaccination at her own will
began to feel ill 8APR99 in evening w/n/v, T101,lt arm sore, fingers numb-fainted following day & cont w/above sx & redness @ inj site;also had asthma attack;began to feel better 12APR99;
Patient began experiencing sob, approx 2-3 hours after vaccination.  Mother drove to the ER (approx 10mins) and px was given steroid injection and benadryl injection.  After 20 mins, px was feeling back to normal
shoulder injury related to vaccine administration; experiencing is shoulder pain it goes down in to my arm some goes down in to my back and lower part of my ribs and some going to my neck; experiencing is shoulder pain it goes down in to my arm some goes down in to my back and lower part of my ribs and some going to my neck; experiencing is shoulder pain it goes down in to my arm some goes down in to my back and lower part of my ribs and some going to my neck; experiencing is shoulder pain it goes down in to my arm some goes down in to my back and lower part of my ribs and some going to my neck; This is a spontaneous report from a contactable consumer via Team. This consumer reported for a patient (reporter's friend) that a patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter stated that his friend and he has been experiencing the same symptoms and they have been going on long term after having the vaccine. The reporter and his friend experiencing shoulder pain it goes down in to arm some goes down in to back and lower part of ribs and some going to neck. Reporter been trying physical therapies. Reporter have been trying Chiropractic to help with it. Reporter have been trying Tylenol and Ibuprofen and it gives very mild relief. The patient was referring SIRVA meaning to shoulder injury related to vaccine administration. He stated that he was really hoping that it was not SIRVA. Therapeutic measures were taken as a result of experiencing was shoulder pain it goes down in to my arm some goes down in to my back and lower part of my ribs and some going to my neck. The outcome of the events was unknown.  Follow-up attempts are completed. Batch/lot number not available.
Information has been received from the registered  nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had been administered dose of GARDASIL on 14-MAY-2013 (lot number: 672232/1495AA; exp date: 22-AUG-2014) (dose, frequency, route and site of administration were not reported). No adverse event was reported. This is one of the reports from the same source. Additional information is not expected.
have gotten sick every time had the stinking shot; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 25-Nov-2020.  This case involves a patient of unknown demographics who had gotten sick every time when had the shot (illness), after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatments, past vaccinations, family history and concomitant medications were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiration date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient had gotten sick every time when had the stinking shot (illness), (non-serious event) (unknown latency) following the administration of INFLUENZA VACCINE. So, the patient would not be taking any shot.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Pt. complaint of chest tightness 10 mins. after administration of vaccines v/s taken WNL BP 143/90, RR-20, P-78, O2Sat 99% RA. Pt. observed For 31 min relieved stated patient to go to ER if symptoms persist.
Pt received Havrix on 8/06/19. States he had some swelling but now has a small lump at injection site but no pain. He says it seems to be bigger than it was a few weeks ago. Showed MD when went for regular visit. MD not concerned
RIGHT UPPER ARM STRTED FORMING A REDDENED AREA SATURDAY 12/19/2020. AREA KEPT GETTING BIGGER SITE MORE PAINFUL. tUESDAY 12/22/2020 RIGHT UPPER ARM HAD GRPE SIZE HARD AREA WARM TO TOUCH, VERY TENDER. DR EVALUATED, PLACED ME ON ANTIBIOTICS FOR 10 DAYS. WAS INSTRUCTED TO CALL AND SEE HIM IF ANY CHANGES/ WORSENING OF THE AREA.
Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Systemic: Weakness-Mild, Additional Details: patient has a history of fainting after vaccine administration