chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FG3527) via an unspecified route of administration in the left arm on 24Nov2021 at 14:15 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration on 20Apr2021 (at the age of 56-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left arm on 11May2021 (at the age of 56-years-old); both as single dose for COVID-19 immunisation. On 24Nov2021, the patient experienced severe fever each day since shot, chills, headaches, body aches and fatigue that prevented everyday activities. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe fever each day since shot, chills, headaches, body aches and fatigue that prevented everyday activities were unknown at the time of this report.
a consumer got a dose of PENTACEL and also a injection IPOL/ got a double dose of IPV injections with no reported adverse event; Initial information received on 08-Nov-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 years old female patient and reporter reported a consumer got a dose of pentacel and also a injection Poliomyelitis Vaccine (Inactivated) (Ipol) Ipv (Vero) / got a double dose of ipv injections with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Diphtheria Vaccine Toxoid, Hib Vaccine Conj (Tet Tox), Pertussis Vaccine Acellular 5-Component, Polio Vaccine Inact 3v (Mrc 5), Tetanus Vaccine Toxoid (Pentacel) for Prophylactic vaccination.  On 08-Nov-2023, the patient received 0.5 ml of suspect Poliomyelitis Vaccine (Inactivated) Suspension for injection (lot number: W1A191M) (Expiry date: 16-Feb-2025) (strength: standard) (Frequency: once) via intramuscular route in the left deltoid for prophylactic vaccination (Immunisation).  On 08-Nov-2023,  reporter reported a consumer got a dose of pentacel and also a injection Poliomyelitis Vaccine (Inactivated) / got a double dose of ipv injections with no reported adverse event (extra dose administered) (latency: same day).  It was reported, Medical Assitant called in because a consumer got a dose of PENTACEL and also a injection IPOL. Hence consumer got a double dose of IPV injections. Medical Assistant want to know about what to do or if there is anything to be concern about the 2 shots of IPV  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 the 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.
Developed superficial thrombus and subsequent Masson's tumor on the left arm approximately 3cm below the injection site
This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 77-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 12-Oct-2018, the patient was administered FLUAD (TIV) [route of administration: intramuscular, anatomical location: right deltoid, batch number: 250795, expiry date: 30-Apr-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805493 was crossed linked to original cases 201804863 due to same reporter.
contracted covid from his significant other post vaccination.; contracted covid from his significant other post vaccination.; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "contracted covid from his significant other post vaccination.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: contracted covid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Employee here with a possible shot reaction to the Flu vaccine received at a flu clinic in the bone and joint center on 10/10/18. Site on left arm is red, swollen and warm to the touch with some pain distally. The area is 13cm x 9cm circular, has used conservative measures ice, IBU.  Employee circled the area yesterday but the redness has spread. She has taken the flu vaccine previously without reaction. Employee referred to Occmed for evaluation.
"Hives", which started the evening after the Flu and Pneumonia was given. Worse next day. Itching almost unbearable. Started on Benadryl 2nd day and used Hydrocortisone cream 1%. They are better on 9th day, but still itch.
mild headache; This is a spontaneous report from a non-contactable nurse. A 25-year-old male patient received bnt162b2 (BNT162B2, Lot number: EH9899), via an unspecified route of administration on 18Dec2020 at single dose for immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's medical history and concomitant medications were not reported. The patient previously took amoxicillin and experienced allergies. The patient experienced sudden onset of mild headache approximately 10 minutes after receiving vaccine on 18Dec2020. The most recent COVID-19 vaccine was administered in the hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. There was no treatment for the event. The outcome of the event was unknown.
Arm pain; Arm pain and not able to lift arm after 2 weeks of getting vaccine; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198) via an unspecified route of administration in the left arm on 26Feb2021 at 13:15 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks of vaccination. On 26Feb2021 at 13:30, the patient experienced arm pain and not able to lift arm after 2 weeks of getting vaccine. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event arm pain and not able to lift arm after 2 weeks of getting vaccine was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
EXCESSIVE SWEATING, FEVER (~103 F), LOSS OF FEELING IN LEGS (UNABLE TO WALK)
Tachypnea SOB, facial flushing Narrative:  Benadryl and observation   Other Relevant History:
Rec'd PCV-13 in office 05/27/15; Seen for s/s 5/29/15-> 3.5 cm erythema to (lt) thigh; No streaks; tender to touch; 100.6 temp 5/28/15; Cranky; Tx with PRN TYLENOL/ibuprogen; BENADRYL; Increased fluids r/t fever; Return to office> streaking, increase size; Fever> 5d.
vomiting; Flu-vaccine produces the same results, and attributes that to the preservatives; flu-like symptoms (body aches, being in bed for 3 days); This spontaneous report was received from a 71 year old male patient with hypertension and drug allergy (tramadol hydrochloride), reporting on himself.    No information was provided regarding patient's medical history.  Concomitant therapies included verapamil and unspecified beta blockers.     On approximately 2014 (reported as "in either 2014 or 2015"), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for pneumonia (dose, route and site of administration, lot number and expiration date were not reported).       The patient reported having flu-like symptoms to include vomiting and body aches as well as being in bed for 3 days.  The patient did not seek medical attention, none lab diagnostic test were performed and did not received any treatment for the events.  The outcome of influenza like illness, vomiting and reaction to preservatives was unknown.   The reporter stated that the flu vaccine produced the same results and considered the events attributable to the preservatives.  The reporter considered the events to be disabling.
Body ache; Feeling weak; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number was not reported), via an unspecified route of administration, on an unspecified date, as dose 2, single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the second shot of the COVID-19 vaccine. The patient went to bed okay but woke up with body ache and feeling weak on an unspecified date, no fever. The patient asked what the company recommends for this. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot or batch number cannot be obtained. No further information is expected.
Rash - papules, erythematous. No pustules or vesicles. Clustered on LLE occurred approximately 8 days after MMR given. No fever, rhinorrhea, cough.
arm swollen; Painful, red, swollen lump on injection site; Painful, red, swollen lump on injection site; A spontaneous report was received from a consumer concerning a female patient who received Moderna's Covid-19 vaccine (mRNA-1273) and developed injection site mass, injection site erythema, arm swollen, arm hard to move and injection site pain.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   The patient received their first of two planned doses of mRNA-1273 (Lot # 011J20A) on 22 Dec 2020 in the right arm intramuscularly for prophylaxis of COVID-19 infection.   On 22 Dec 2020, same day post vaccination, the right arm was achy and hard to move and subsided same day. On day 9 the pain came back with swelling and redness about 3 inches at the vaccine site, after treating with Tylenol, Brufen and ice pack they were resolved by day12.   Action taken with mRNA-1273 in response to the events was not provided.   The outcome for the events were considered resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Mother called 11/13/2018 to inform PCP that at 3:30 am, she woke up vomiting and had vomiting episodes for 2 hours. She fell asleep for an hour and when she awoke she no longer had any symptoms. She had had the HPV vaccine on 11/12/2018 at 5:06 pm.
Gave a patient a first dose on 1Jul2021 Patient was 14 years old come in and take a dose of vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Gave a patient a first dose on 1Jul2021 Patient was 14 years old come in and take a dose of vaccine) in a 14-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jul-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Gave a patient a first dose on 1Jul2021 Patient was 14 years old come in and take a dose of vaccine). On 01-Jul-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Gave a patient a first dose on 1Jul2021 Patient was 14 years old come in and take a dose of vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   concomitant medications were not provided.  Treatment medication was not provided.
4 intermittent episodes of blurred vision/unclear speech/unsteady gait/slight confusion lasting 30-45mins in past 9 days.
Pt today reported that wished to refuse further doses on advice of pvt MD;  pt seen by MD day p/recvd Recombivax; was not certain if the flu-like sx were related to vax but considers it possible in view of hx of multiple allergies;
Twelve days (03/31/2021) after receiving the 2nd dose of the vaccine, my face was starting to droop a lot. It was totally distorted. My eyebrows were down and my mouth my going to the left. I called my doctor and she suggested that we go to the ER. My son drove me there and I was diagnosed with Bell's-Palsy. I had an MRI, with dye, to eliminate the thoughts of a stroke. I also had blood drawn for testing. I was given Prednisone and the generic of Valtrex. As of today, it is a little bit better, but it's still here. One of my eyebrows is still drooping, my lip is half swollen, my eye is starting to close a little on it's own. For two months after receiving the vaccine, I had to pull my eyelid down and cover it with gauze and tape it at night so it wouldn't dry out and get infected.
606 doses were given after expiration date; vaccine was kept in refrigrtor on 17/11/2021 and administered/expired 03/10/2021; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (vaccine was kept in refrigrtor on 17/11/2021 and administered/expired 03/10/2021) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Nov-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 EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (vaccine was kept in refrigrtor on 17/11/2021 and administered/expired 03/10/2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (vaccine was kept in refrigrtor on 17/11/2021 and administered/expired 03/10/2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter.  No treatment medications was provided by the reporter.  The vial was placed in the refrigerator on 17-NOV-2021.Vial did not undergo any temperature excursion. No adverse event was reported.
had no symptoms until early March/I have tinnitus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "had no symptoms until early March/I have tinnitus".  Additional information: Patient had tinnitus. One day after patient received COVID booster and tinnitus disappeared. The second day after receiving booster, it came back. Patients previous vaccine was on Oct2022. Patient had no symptoms until patient came back from in early March. In afternoon after patient got booster it disappeared and then it came back the next afternoon, on the second day  The information on the batch/lot number for [BNT162B2 NOS] has been requested and will be submitted if and when received.
Mon 1/25/21: Developed CP and upper back pain on day of vaccine, "heart pressure", neck to collar-bone later the date of admin Tues: Chest pressure Thurs and Fri: felt like "Pen going in temple"-headache;  Sat: about 6 am tried to urinate, back pain came on was so severe was unable to walk back to bed Today 2/2/21: Ovary pain, feels like very painful menstruation, very bad abdominal pain" Ovaries feeling "being squished". She is post-menopausal. PCP met with Pt today via telehealth: wants her to start prednisone, Pt refused due to immunity concerns. Prefers taking Benadryl/zyrterc, motrin but has not because she "does not want to". Chest pressure has not resolved but less severe than day 1.
Pain in left arm upon movement and painful to touch, with reduced range of motion and weakness of the left shoulder and arm.
he developed hives after injection and was seen in the ems - f/u at pcp today
Erythematous hives starting 10/26/2021 which were located on the face covering the entire body to the top of both knees. No changes with diet, household cleaners, or detergents.
Started with tension headache, which has never gone away. Then stomach pain/discomfort, chest pain, groin pain and throat irritation (can't eat normal food, lost 10 pounds). This has been going on since early June. Multiple doctor visits: GI, ENT, cardiologist, eye exam, neurologist etc., taken multiple medications some with adverse reactions, which resulted in ER visits.
immediately felt itching and nausea. 3 days after vaccine, itching, nausea continued and she also developed rash/hives around her nexk, axilla, groin, and back, tongue started to swell
expired booster doses given; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired booster doses given) 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 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired booster doses given). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (expired booster doses given) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the vials remained in frozen storage until day it was thawed then administered.  No concomitant medications were reported.  No treatment information was reported.   Reporter did not allow further contact
Patient started having an allergic reation (localized rash) within 5 minutes of the injection when they came back and noticed some redness and ithcing. Patient stated no other symptoms. Patient was offered Benadryl but prefered to take zyrtec at home when she got home. Patient was told to take immeditely and also given topical benadrl to help alleviate some of the rash and itchiness and told to call back if any other symptoms.
03/07-27 Progressive left and right hip pain        03/13-03/14 and 03/20 Significant hip pain after yard work     03/07-03/27 Progressive left and right groin pain           03/13-03/14 and 03/20 Significant groin pain after yard work 03/07-03/27 Progressive outside lower right calf pain (sporadic)     03/13-03/14 and 03/20  Significant lower right calf pain after yard work 03/28 Unusual reaction at night following second vaccine - flushed 03/28 - 04/01 Progressively acutely severe both hip, groin, and lower outside calf pain 04/02-05 start of indigestion, heartburn, brain fog, fatigue, leg tremors - leg pain less with Tyleniol 04/05 Significant chest pain - went to ER - EKG, blood work, chest x-rays checked OK, given GI cocktail 04/05 - 04/18  Leg/hip/groin pain (joint and muscle) - not as severe as first 5 days after 2nd shot), some heart burn, indigestion , cotton mouth, periodic tremors, periodic fatigue, feeling of thickening throat, slight eye burn, easily chilled o Each episode is preceded with an allergic reaction type feel o     Each episode is near end of 8 hr Tylenol duration although seems worse at night
No adverse effects; A 21 year old patient, name and other demographics unknown to the reporter, received a pediatric dose of VAQTA on an unknown date in 2018 when she was approximately 20 years old; This spontaneous report was received from a registered pharmacist refers to currently 21 year old female patient. The patient's pertinent medical history, concomitant medication and drug reactions or allergies were not reported.  On an unknown date in 2018, the patient was vaccinated with a pediatric dose of hepatitis a vaccine, inactivated (VAQTA) vial 25/0.5 (unknown units), intramuscularly for prophylaxis (lot# and expiry date were not reported) when she was approximately 20 years old (product administered to patient of inappropriate age). The patient did not experience any adverse effects. No product quality complaint (PQC) was involved.
Info has been received from a registered pharmacist concerning an adult female who on 3/27/05 was vaccinated with d dose of varicella virus vaccine live. On 4/12/05, the pt developed a vesicular rash and a mild fever. Unspecified medical attention was sought. At the time of this report, the pt was said to be recovering. No further info was available. No product quality complaint was involved. Additional info has been requested.
Thirty six hours post vax, this child experienced fever and multiple recurrent myoclonic jerks without loss of consciousness. Total of 6 single Myoclonic events.
Information has been received from a physician concerning a 11 or 12 year old female who was vaccinated on an unspecified date with a first dose of Gardasil (lot # unknown). Concomitant therapy included Menactra given on the same date. The patient developed a rash after receiving the first dose of Gardasil and three days later the patient went back to the physician to have the rash taken care of. Medical attention was sought. The physician gave the patient a topical cream for the rash. It was not known if the rash developed at the injection site and it is unknown if the patient will continue the rest of the Gardasil series. At the time of reporting the patient was recovering. No further adverse event information is available. Additional information has been requested.