chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pancreatitis flare-up began as the side effects intensified/ Felt like pancreatic and GI inflammation; Pancreatitis flare-up began as the side effects intensified; Felt like pancreatic and GI inflammation; Could't keep any food or liquid down; vomited green stomach bile; This is a spontaneous report from a contactable consumer (patient). A 40-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 25Apr2021 11:45 AM (Batch/Lot Number: ER8734) as 2ND DOSE, SINGLE for covid-19 immunization, at the age at vaccination of 40 years old. Patient was not pregnant. Medical history included Chronic Pancreatitis (idiopathic) from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included Occassional Benadryl allergy and Tylenol, both taken for an unspecified indication, start and stop date were not reported.  The patient previously took clindamycin and experienced known allergies, bnt162b2 for covid-19 immunisation. Historical vaccine included first dose of BNT162B2 (brand=Pfizer; lot number=EW0172) on Apr2021 03:45 PM at Left arm for covid-19 immunization. The patient experienced pancreatitis flare-up began as the side effects intensified (medically significant), felt like pancreatic inflammation (medically significant), GI inflammation (non-serious), could't keep any food or liquid down (non-serious), vomited green stomach bile (non-serious), all on 25Apr2021 18:00 with outcome of recovering.  Reported as pancreatitis flare-up began as the side effects intensified. Could't keep any food or liquid down and vomited green stomach bile. Felt like pancreatic and GI inflammation as my immune system responded to vax. No treatment received for events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected
no adverse event; Practice manager calling to report that an expired vaccine was administered to a patient; This spontaneous report was received from an office manager, concerning a 46-year-old male patient. No information was provided regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies.  On 11-MAY-2021, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) pre-filled syringe (lot number T014590, which was verified to be a valid lot number, expiration date reported and upon internal validation established as 15-APR-2021), as prophylaxis (dose, frequency, route of administration, anatomical location and vaccination scheme were not reported) (expired product administered). Additionally, it was reported the vaccine was not part of a temperature excursion. No additional adverse events were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T014590; expirationdate: 15-APR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
This spontaneous report was received from nurse refers to a 2 month old patient. On 22-JUL-2013, the patient was vaccinated with a first dose of VARIVAX (Merck) dose 1. No adverse symptoms reported. Additional information has been requested.
Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On unspecified dates the patients were vaccinated with doses of improperly stored PROQUAD (Merck) (lot # L021599 with expiration date of 10-DEC-2016; lot # L008353 with expiration date of 11-SEP-2016; dose and route unknown) (incorrect product storage). The vaccines were exposed at 6 Fahrenheit (F) for 24 hours. There was no previous temperature excursion. No symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with VARIVAX lot # N014366 for prophylaxis. Concomitant therapies included sterile diluent (STERILE DILUENT). On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to VARIVAX.; Sender's Comments: US-009507513-1708USA004800:
All over body rash lasting approx. 30-45mins > treatment: 50mg BENADRYL.
Woke up Saturday 9-7-13 morning after shot's, arm red swollen was taken to ER where they gave her SEPTRA 200mg. The red spot on her arm was 6 inc by 4 inc. She came into our office 9-9-13. Red was gone but in a spot that was 1 inc by 1 1/2 inc. Dr expled it was not cellulitis but a allergic rxn to spot SEPTRA and start Amontolube TID.
Optical nerve damage; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): LRN4715822.  A 77-year-old female patient received BNT162b2 (BNT162B2), on 08Feb2021 as dose 2, single (Batch/Lot number: unknown) at the age of 76 years for covid-19 immunisation. The patient's relevant medical history included: "Other giant cell arteritis" (ongoing), notes: Other giant cell arteritis; "Anxiety" (ongoing); "Depression" (ongoing). Concomitant medication(s) included: XANAX; MIRTAZAPINE; PREDNISONE. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 20Jan2021, when the patient was 76-year-old, for COVID-19 immunization. The following information was reported: OPTIC NERVE INJURY (medically significant), outcome "unknown", described as "Optical nerve damage".  Clinical course: On 20Jan2021 and 08Feb2021, patient started therapy with BioNTech, Pfizer vaccine for Covid. On unknown date, it was reported that patient experienced: optical nerve damage.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On 01/09/2021 & 01/10/2021 I was feeling itchy on both sides of my neck. On 01/11/2021 I was feeling heat in the breast area. I saw OB/GYN and was prescribed an antifungal cream. On 01/15/2021 the rash had spread to the abdomen, lower back, on the sides of my abdomen, upper thigh and a few on my forarms,  so I had a virtual visit and was told to take benedryl and over the counter cream. It took about 2 1/2 weeks to clear up.
Left arm was very sore and stiff following injection. It still burns constantly in the muscle where injection was given. I am unable to lift items with arm in certain positions. Second injection was completed in right arm on 5/10/21 without similar symptoms.
Right after I gave him the shot he said his right hand was tingly. Then the reaction changed to funny feeling like he was going to faint. With in 15 minutes he had 2 waves of this reaction. The 3rd wave started about 20 minutes after shot and he said it was worse, tingly in both hands , funny feeling like he was going to faint , cold and felt like his pulse rate was up . He never fainted. He kept talking to me. Since the 3rd wave  was worse and it lasted the longest, we call 911. They came and checked him out, but he declined to go with them to the hospital. He waited in the store for at least 1 hour. Checked on him at home at 3:05p.m. and he said he felt fine.
global headache; lymphadenopathy; bilateral parotid swelling; mumps; This spontaneous report was received from a consumer and refers to a 23-year-old female. The patient's medical history, concurrent conditions and concomitant medications were not reported.   On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) administered for prophylaxis (strength, formulation, dose description, lot #, expiry date, and route of administration were not provided).  On an unknown date in August 2022, the patient was referred to the reporter for lymphadenopathy since early August. According to the reporter, she had spectacular bilateral parotitis and complained of global headache. Mucosal swab for mumps virus by reverse transcriptase polymerase chain reaction (RT-PCR) result was positive. On an unknown date in August 2022, the patient experienced mumps. At the time of reporting, the outcome of the events was not provided.   The causal relationship between the events and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not provided.  This is one of 2 linked reports.; Sender's Comments:  US-009507513-2208USA008973:
Information has been received from a registered nurse concerning a 10 year old male with NKDA who on 10/19/98 was vaccinated with the 1st dose of varicella virus vaccine live subcutaneously in the right arm. There was no illness at the time of vaccination. On 05/14/2001, he presented to the doctors office with about 100 itchy, fluid filled vesicular lesions on his buttocks, groin and chest. the physician classified the lesions as erythema macules Subsequently, the pt recovered.
Pt received the incorrect vaccine, should have received Moderna 6mo-4years.  Pt received only 0.25ml dose
Right after patient was given vaccine injection he started to feel lightheaded and woozy. He had just worked the night shift and hadn't eaten anything. No prior illness reported. Patient brought to emergency department to be evaluated. Received 500ml of fluids and symptoms resolved and he went home. Diagnosis of near syncope.
4 hrs after pneumonia vaccine, I experienced severe pain in L arm, it lasted all night. It is about 65% better 3 1/2 days later.
The military inoculated me with the smallpox vaccine during basic training, in that I had a reaction to, and become infected with Eczema vaccinatum while serving on active duty on/or about May 18, 1989. The initial reaction occurred three days later - I had  swelling of the throat and passed out or became unconscious.  I had fever and was not conscious for about 3 days after the initial reaction. I broke out with about 75 to 100 sores over my neck, shoulders, face, and scalp area. I was in ICU isolation for over 6 weeks and almost died. They used an "unknown test drug" that was under investigation at the time to expedite the healing. Each time the gauze was changed on my face, I had to put my face in a "downward position" due to the pus dripping everywhere, causing a horrible mess. I have permanent scarring all around my face and will never forget the horrific pain of the huge blisters. This has caused me permanent and ongoing immune problems as well as neurological damage in my brain. From the smallpox, a string of health conditions evolved while on duty.
The individual was so dehydrated, her skin stayed red when pinched. This lasted 4-5 days and she said she felt near death; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  A 65-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 IMMUNIZATION. The following information was reported: NEAR DEATH EXPERIENCE (life threatening), PYREXIA (non-serious), FOOD INTOLERANCE (non-serious), DEHYDRATION (non-serious), SKIN BURNING SENSATION (non-serious), outcome "unknown" and all described as "developed a fever and couldn't keep any food down. The individual was so dehydrated, her skin stayed red when pinched. This lasted 4-5 days and she said she felt near death".  Clinical information: On 20Dec2022, it was reported that a patient started treatment on an unspecified date with Pfizer BioNTech COVID-19 vaccine unspecified dose (reported as booster dose) for COVID-19 immunization. It was reported that about 24 hours after the booster dose, the patient developed a fever and couldn't keep any food down.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Hair loss, and then 6-8 weeks post vaccine considerable hair loss as confirmed by hair stylist
8 days after the Maderna Vaccine I developed Shingles. I had a Shingles vaccine 2015
pt reported @ 3x4 redness an arm given pneumonia w/some tenderness fine days p/vax;no other c/o no fever, no illness;;
swollen itchy toes; facial swelling on right eye; facial swelling on ear, ear canal; facial swelling on cheek; facial swelling on throat; swollen itchy toes; This is a spontaneous report from a contactable consumer (patient). A 34-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN6203, and Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 04Mar2021 15:45 (at the age of 34-year-old) as dose 1, single for COVID-19 immunization, at workplace clinic. The patient medical history included Post traumatic knee arthritis, Ear tubes as a child, surgery for cholesteatoma removal, hospitalization for mononucleosis, seasonal allergies, erythema multiforme, mild psoriasis, anxiety, and tubal ligation. The patient had known allergies of penicillin and soy. The patient previously took ibuprofen and had allergy. Concomitant medications included venlafaxine HCL (VENLAFAXINE HCL) and fexofenadine HCL (FEXOFENADINE HCL). The patient received no other vaccination in four weeks. The patient did not have COVID prior vaccination. The patient was not tested for COVID post vaccination. On 04Mar2021 21:00, the patient experienced swollen itchy toes, facial swelling on right eye, facial swelling on ear, ear canal, facial swelling on cheek, and facial swelling on throat (facial swelling on right eye, ear, ear canal, cheek and throat). The patient received no treatment for the events. The outcome of the events was reported as resolving.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
the rash was on just her arm yesterday and today she woke up and it's on her torso and legs, it's like spreading was reported as worsened.; the rash was on just her arm yesterday and today she woke up and it's on her torso and legs, it's like spreading was reported as worsened.; This is a spontaneous report from a contactable consumer (patient).  A 26-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported) via an unspecified route of administration in left arm around 5pm on 26Jul2021 (at the age of 26-years-old) as dose 1, single for covid-19 immunization. The patient medical history (including any illness at time of vaccination) was none. There were no concomitant medications. History of all previous immunization with the Pfizer vaccine considered as suspect was none. No additional vaccines were administered on same date of the Pfizer Suspect. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 27Jul2021, the patient reported the rash was on just her arm yesterday and today (28Jul2021) she woke up and it was on her torso and legs, it was like spreading and was reported as worsened. Patient stated the rash started on 27Jul2021 mid-day around the afternoon was when she started noticing it and stated that it was getting worse. Patient was asking what she can take, she did not get a rash right where they gave it but, on the side where she got the shot. Patient was asking if she still can get the second dose of the Pfizer Covid-19 vaccine. There were no relevant tests. It was reported that the adverse event did not require any visit to emergency room or physician office. The clinical outcome of the events was not recovered at the time of the report.  Follow-up attempts completed. No further information is expected.
mom reported 7JUL93  pt not holding head up or being active as others;muscle weakness;never crawled, dragged upper part of body, pulled to stand then walked;hypotonia;abn w/muscles- muscle dystrophy;MD casting to strengthen achilles tendon
- April 4, 2022 patient got 3rd COVID vaccine - Vaccine in left arm and left side hurt right away - Within 3-4 hours patient got 103F fever, body aches, chills, puss from eyes, lesions of unknown type on bottom that were painful. - Took "a whole bunch of fever reducers" to go to work - Next day went to ER, wounds swabbed, and was told she was positive and was negative for herpes. Labs unremarkable. - Went to OB/GYN, who stated that she was the 3rd or 4th person that have shown symptoms like this after COVID booster. Blood work WNL except some thyroid dysfunction- retest last week all WNL. - Continues to have fevers and cannot eliminate fever for more than a few hours daily that is 101-102F. Rarely goes below 99.5F. - Started Augmentin sometime last week when she went to another urgent care for continued symptoms. Fever went down for a couple days, but has returned. - Lots of pain on left side and abdomen, at times all over. Visited GYN earlier this week without symptoms other than pain. - Moderna has not been notified to the patients knowledge. Patient has gotten all COVID vaccines at pharmacy.
shaky inside my body; Felt like passing out; ears feel clogged; had a hard time falling asleep; unsettled stomach ( a little queasy).; Felt pressure with slight headache; Felt pressure with slight headache/felt pressure in my head; Loud Ringing in both ears; dizzy/dizzy spell; nauseated/unsettled stomach ( a little queasy)/sick to my stomach; body felt uneasy like it was fighting something inside; pain at injection site and side of left neck; pain at injection site and side of left neck; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 22Mar2021 13:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included vitiligo and known allergies. The patient had no COVID prior to vaccination. There were no concomitant medications. The patient has no other vaccine in four weeks. The patient was not tested for COVID post vaccination. On 22Mar2021, the patient got the shot and later (at 18:00) had pain at injection site and side of left neck. On 23Mar2021 10:30, the patient experienced loud ringing in both ears, felt dizzy and nauseated, and body felt uneasy like it was fighting something inside. On 24Mar2021, the patient was still having ringing in both ears, feel nauseated on and of lasting at least 30 seconds or so. From 25Mar2021 to 29Mar2021, ringing in ears sometimes get louder than other times, he also felt pressure with slight headache. On 30Mar2021, ringing in ears intensified and had a hard time falling asleep. The patient felt pressure in her head. She also had slight headache and an unsettled stomach (a little queasy). On 31Mar2021, ringing seems lower today; ears feel clogged. She still has pressure in head with slight headache and had one episode of dizzy spell for a few seconds only. At night, ringing in ears intensified. On 01Apr2021, lower ringing in ears noted. On 02Apr2021, the patient had pressure in head, clogged ears, sick to her stomach, shaky inside her body, and felt like passing out. Ringing was intensified at night. On 03Apr2021, headache and pressure in head were noted. The events resulted in doctor or other healthcare professional office/clinic visit but were not treated. The outcome of the events was not recovered.  No follow-up attempts are possible, information about lot number cannot be obtained. No further information is expected.
Patient was administered vaccines in patient room. Parent and child opted to wait their 15 minutes in the lobby. Patient with episode of convulsive syncope about 2min after receiving vaccines. Patient  walked out to the waiting room after vaccines given & was standing in a busy waiting room, when he began to feel dizzy while looking at his injection sites and the "blacked out" patient fell to the ground, hitting his left flank and head on the wall. Mother notes 4 seconds of jerking of the extremities while on the floor. Within 20sec, pt was able to open his eyes, sit up and was oriented x3. Was able to get up and sit in a wheelchair. MD evaluated pt immediately after the event. No pallor to the face with good respirations. No jerking of extremities.
Reports feeling dizzy w/associated anxiety; Rest/ laying down, Po hydration, monitoring x 30min  w/minimal improvement; reports increased dizziness when sitting up BP 139/89  P67;  BP 128/ 87 P 87; BP 122/78  P69 declines recommendation for further ER evaluation / treatment post vaccination Patient signs AMA from facility/ released home
Admission note 11/17/2021:  This is a 77yoF with DM, HTN, chronic low back pain d/t L4 disc herniation and stenosis, recent COVID-19 diagnosis who presents with worsening dyspnea, diarrhea, weakness and cough. She was seen in the ED on 11/12 and received a Regeneron infusion then but continued to worsen.  Today she is found to have vitals concerning for hypoxia with ambulation in the high 80s.  Labs were notable for hyperglycemia, mildly elevated CRP and d-dimer>5. CXR without notable infiltrates. She is admitted for management of COVID 19 infection with hypoxia.
patients received the vaccine post excursion with no reported adverse event; The maximum time of all the excursions was 59 minutes and the maximum temperature of the refrigerator reached 10.62 degrees Celsius with no reported adverse event; Initial information received on 07-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 15 years old female patient who received the vaccine post excursion with no reported adverse event and the maximum time of all the excursions was 59 minutes and the maximum temperature of the refrigerator reached 10.62 degrees celsius with no reported adverse event ,while receiving vaccines MMR, VARICELLA VACCINE (LIVE), MENINGOCOCCAL VACCINE, HEPATITIS B VACCINE, HEPATITIS A VACCINE and IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 22-Jun-2022, the patient received a  dose of suspect IPV (VERO)( lot V1A024M and expiration date: 17-Feb-2024) at a dose of 0.5ml via intramuscular route in the left thigh for immunization.   On an unknown date , the reporter states that temperature excursion due to leaving the door ajar. The excursion occurred on numerous dates from 14Jun22-25Jun22. The maximum time of all the excursions was 59 minutes and the maximum temperature of the refrigerator reached 10.62 degrees Celsius  (product storage error) (unknown latency) and on 22-Jun-2022, the patient received the vaccine post excursion(poor quality product administered)(latency: same day).   Action taken :was not applicable.  It was not reported if the patient received a corrective treatment for the events   At time of reporting, the outcome was Unknown for both events    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 guidelines. 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.; Sender's Comments:  01180622: