chrisvoncsefalvay/vaers-outcomes huggingface dataset:
cellulitis under his bandaid; This is a spontaneous report from a contactable Nurse (other hcp). A male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 01Feb2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Reporter and her husband both received their first shot on 01Feb2021. Her husband had cellulitis under his bandaid. You could see the injection site puncture for five days (has picture). It looks like a reaction to the adhesive, but it is not he had never bandage reactions. It was an imprint of the bandage and the hole looks large. This has since completely resolved. Neither of them had any reaction to the second shot. The outcome of the event was unknown.The outcome of event was unknown.  Follow-up attempts are needed. Further information is expected.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Cellulitis. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Numbness & tingling noted in (L) arm on 1/11/13, increasing evening. Evening of 1/12/13 - progressed to (L) thigh - no improvement with Ibuprofen tried cold - no improvement - numbness, tingling continued & increased on 1/13/13. 1-13-2013 Saw Dr. Advised to rest & take Ibuprofen. Info per father of client. 1-21-2013 Follow-up conversation with father of client. Patient is improved, however has intermittent discomfort in (L) arm.
This spontaneous report as received from a pharmacist refers to a 62 year old patient of unknown gender. The patient's concomitant therapy, pertinent medical history and drug allergies were reported as none. On 24-MAY-2015 the patient was vaccinated with ZOSTAVAX, lot # reported as L006357, expiry date 11-JUN-2016, 0.65 ml once subcutaneously. Lot number L006357 is an invalid lot number for ZOSTAVAX. On 25-MAY-2015, reported as 2 days post vaccination the patient experienced redness and itchiness at injection site. ON 25-AUG-2015 the patient was in the pharmacy where sought medical attention and reported the events to the pharmacist. The pharmacist stated that the patient doing fine except itchiness which continued, most notably when coming out of the shower. No treatment was given for redness and itchiness at injection site and no laboratory t4ests were performed. The relatedness between the events and suspect therapy was not reported. Additional information has been requested.
a heart attack; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (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 (Dose 1, manufacturer unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, manufacturer unknown), for COVID-19 Immunization. The following information was reported: MYOCARDIAL INFARCTION (medically significant) with onset 14Jun2023, outcome "unknown", described as "a heart attack". 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.
I had pain on my left should for couple of days but it was expected. And I started having joint pain on my feet and hands but It was sporadic and can be ignored. But maybe after 3 weeks from the 1sf shot, I started having  tingling sensation on my left leg and arm.  It started at night, and I was restless and had to do something. The frequency became more often, especially at night. I remember I woke up at 3 am and had to walk to calm it down. I thought it could go away but still have it. I had to climb a ladder several time for house work yesterday and noticed left leg has stronger muscle pain compared to right  leg.
Both feet and ankles swollen and painful so was unable to walk before getting to the ER. Back of right leg painful, place I was injected painful, backache, severe headache, fever
This case was reported by a consumer and described the occurrence of white blood cell count increased in a patient who received SHINGRIX for prophylaxis. On 26th December 2018, the patient received SHINGRIX. On 2nd January 2019, 7 days after receiving SHINGRIX, the patient experienced white blood cell count increased. On an unknown date, the outcome of the white blood cell count increased was recovered/resolved. It was unknown if the reporter considered the white blood cell count increased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On 2nd January 2019, the patient underwent a blood test and wondered if the SHINGRIX vaccine could be the cause for the elevated white blood cell count. The patient's primary care physician referred to a hematologist and wanted to offer a possible explanation because the patient felt perfectly fine.
Woke up during the night and did not feel well, and had a headache. Got up to get Ibuprofen and I fainted and woke up on the kitchen floor with a pounding headache on the back of my head, and learned I had urinated on myself.  Was freezing cold with the chills, and tried to get up and then vomited.  I felt slightly better, cleaned up and took a warm bath, and went back to bed with an ice pack on the back of my head and a hot pack on my lower back (my lower back was sore due to a previous injury, but got worse after fainting in the kitchen).  Fatigue has also been a side effect.
Developed red blotchy spots all over within 1 hour of receiving the varicella vaccine, which resolved with no current itching after 25mg BENADRYL. Patient had rash (L) axilla with 2 eryth. papules 2 mm diameter with positive blanching.
This case was reported by a nurse via call center representative and described the occurrence of local swelling in an unspecified number of patients who received FLUARIX quadrivalent (batch number 5GF43, expiry date unknown). In 2015, the patients received FLUARIX quadrivalent .5 ml. In 2015, the dose was .5 ml. On an unknown date, an unknown time after receiving FLUARIX quadrivalent, the patients experienced local swelling and feeling unwell. On an unknown date, the outcome of the local swelling and feeling unwell were unknown. It was unknown if the reporter considered the local swelling and feeling unwell to be related to FLUARIX quadrivalent. Additional details were received as follows: The reporting nurse was infection control nurse at the hospital. An occupational nurse told to reporting nurse that, in 2015, there were many employees who experienced not feeling well and also having an arm swelling that was described as lump on arm. The reporter provided some batch numbers but was not able to provide the patient information and expiry dates of vaccine.
With the diarrhea, there is no way of proving that it was connected. I went to my gastro recently because I've had this problem for months. They put me on an antibiotic and that was fairly recent. It seems to be helping, possible bacterial infection. Seemed to have improvement. With the fatigue, with the special kind of fatigue that I felt seemed to die down, but I have sleep issues as well. I'm still having tiredness that not normal as far as I'm concerned. I'm not sure where the problem fits with the vaccine. Some improvement but not entirely gone.  Prescribed Antibiotic for the Diarrhea.
This spontaneous report as received from a Doctor of pharmacist concerning a 70 year old female patient with some unspecified pre-existing eye problem and allergic to sulfa drugs who on 11-FEB-2013 was vaccinated with a dose of ZOSTAVAX (dose route and lot # not provided). Concomitant therapies included ALPHAGAN P, prednisolone (manufacturer unspecified) and cyclobenazapine hydrochloride (manufacturer unspecified). The pharmacist stated that after the ZOSTAVAX was given the patient developed an injection site reaction and dry eyes and dry mouth. The injection site reaction developed late yesterday on 12-FEB-2013 or today 13-FEB-2013 and was described as a 2 inch diameter red bump at the injection site. The pharmacist was unsure when the dry eyes and mouth occurred in relation to the administration of the ZOSTAVAX, but stated that the patient reported drink two large glasses of water, just this morning on 13-FEB-2013. TYLENOL was given as a treatment for the events. There were no labs performed. The patient contacted the pharmacist. The outcome of dry mouth, injection site reaction, 2 inch in diameter red bump at the injection site and dry eyes was reported as not recovered. Additional information has been requested.
Information has been received from a Registered Nurse referring to multiple unspecified patients. Patient's concurrent conditions, concomitant medication and medical history were not provided. On unknown dates the patients were vaccinated with improperly stored (Oka-Merck) PROQUAD (injection, lot#, dose, route and dose number were not provided). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Started run low fever Sunday afternoon. Continued to run fever or approx. 102 (rectal temp) Monday, Tuesday, and Wednesday. Wednesday began coughing, fever increased to 104 that evening. Thursday cough continued to get worse. Fever went back up to 104.1 Thursday night. Friday ran fever 102-104 all day. Went to doctor's and diagnosed with small pneumonia in upper part of lung. Currently on 10 days of antibiotics.
pt exp nausea & vomiting & generalized rash, worse on soles of feet & palms of hands, w/severe itching, approximately 36 hrs p/vax; These sx resolved 24-36 hrs later;
pt had a positive COVID test on 1/9/22; was hospitalized for 2 months for COVID pneumonia at a local Medical Center; had a 2nd hospital admission on 3/24/22 at a second Hospital for increase in SOB with fever, on 2L O2 via NC; had a positive  COVID test again on 3/27/22; respiratory status worsened requiring intubation; developed pneumothorax and pneumomediastinum; transitioned to comfort measures and was extubated; she passed away in the hosptial
Patient began to feel hot and sweaty after injection. Pharmacist took patient's temperature, which was 96 F. Patient still felt hot and was lethargic but remained responsive. 911 was called when patient stared to droop head to side as if he was falling asleep. We provided cooling measures and kept patient awake until paramedics arrived.
30 minutes after shot there was pressure in my arm that later turned into pain.  24 hours after shot I had body aches, chills and nausea. Over all I felt like I was going to die.  48 hours have passed now and I?m feeling better except my arm. I can not lift it without pain.  If I had to put a number from 1-10 for my pain and  10 being most severe  At the 30 minutes past injection point I?d give the pain an 8 that lasted 40 hours.  The last 8 hours I?d give the pain a 5 until I try to lay down then it goes up to an 8 again.  I have been moving, icing and taking Tylenol. I can not take any other pain reliever.
Rashes w/ intense itching in patches on torso and arms and legs. One area would begin to subside then another would break out - lasted 3 1/2 weeks.
After about 30 mins felt as though my uvula was swollen and back of throat was dry.  Drank what guilds I had during the hour drive back home.  Did not have trouble breathing and was still able to drink fluids but inflammation did occur. Swelling reduced after a few hours with no other symptoms.
(R) thigh with 0.5 mm x 0.4 cm knot no erythema, no induration, no fluctuation.
swelling on sites of intradermal fillers on face injected in 2018 - ongoing shortness of breath - ongoing joint pains   Above are currently being treated with prednisone and daily Allegra. Both medicines were started on 01/15/2021. Joint pains have resolved. Other symptoms are improving. I am an internist. I self-medicated.
From telephone contact with reporter it was stated that a 10-year-old female patient received third does of  an Imovax Rabies vaccination intramuscularly on May 22, 2001. Within hours of the injection, the patient developed one hour of numbness in her legs, was unable to walk. This was accompanied with a headache. Further information is requested. From telephone call on 6/1/01 it was stated that a 10 year old female patient received her fourth dose of Imovax Rabies IM, lot # R0985, on 5/29/01. The patient experienced headache, nausea and vomiting on 5/30/01. Further information requested. From follow up #1 correspondence received on 9/4/01 it was reported that the patient recovered from this experience. Additional patient, vaccine, vaccine administrator and responsible physician information was also provided. This case is closed.
blister below his belly button; This case was reported by a consumer via call center representative and described the occurrence of blister in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st September 2019, the patient received the 1st dose of Shingrix. On 8th September 2019, 7 days after receiving Shingrix, the patient experienced blister. On an unknown date, the outcome of the blister was unknown.   It was unknown if the reporter considered the blister to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and she developed a blister below his belly button. She reported that he was going to see his physician this week and would inform about the blister. The reporter consented to follow up.
Given vaccine at 6:25 am, started with diarrhea at 11:00 am 10/27/05
No additional AE reported; expired dose of GARDASIL 9 was administered; the patient had previously been vaccinated with the GARDASIL 9 series in 2017 and wanted to receive the vaccine series again; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information regarding their medical history, concurrent conditions nor concomitant therapies provided.  In 2017, the patient received series of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (exact doses, route of administration, anatomical locations, lot numbers and expiration dates were not provided) for prophylaxis. On 28-JUL-2021, the patient was vaccinated with an expired dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 1 time dose, lot # R029900, expiration date 23-JUL-2021 (exact dose, route of administration and anatomical location were not provided), because they wanted to receive the vaccine series again (expired vaccine used, extra dose administered). No adverse event was reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R029900; expirationdate: 23-JUL-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 is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (159558). A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COGNITIVE DISORDER (non-serious), outcome "unknown", described as "Forgot who he was". Additional information: This report is related to a study or program. Reporter's family took the Pfizer Covid 19 vaccine. His uncle took the vaccine as well and forgot who he was. Reporter confirmed above and stated that was for about a 24-hour period. Unable to clarify further. Also stated those are just antidotal family things. On advertisements even while he was on hold it says about the vaccine and it prevented infections and that was a lie, it doesn't prevent infections, people that got the vaccine were the ones getting sick and people like him that are not vaccinated are ok. It's because the vaccine was fighting your own immune system and that was why the vaccinated people have reinfection and that was a fact. Reporter stated vaccine messed with his family's DNA. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Itching rash on tops of hands, bottom of wrists and slightly up forearms. Itching rash on tops of feet and ankles.
Moderate fever 100.2 for approx 36 hours, chills, body aches, malaise, swollen lymph nodes, Flu like symptoms, loss of appetite, chest discomfort.
Fist size rash that now seems to be starting to peel like a burn. It?s day 3 and it doesn?t seem to be getting better yet. Maybe bigger.
Pt developed rash throughout whole body, with fever and chills. Eventually pt seeked medical attention at  ER where pt got prescribed Benadryl and Azithromycin. Wife states pt was diagnosed with pneumonia from vaccine.  Two days later pt got prescriptions for prednisone and glipizide
8 days after shot red rash appears on l arm just below injection site warm to touch.  It lasted 3 days and was itchy.
Nothing after the injection other than a sore arm. The DVT that I had appeared seven months after my second dose and a month before my booster.
Patient was due to receive MMR, Varicella and Hep A vaccines. MMRV was given in error instead of MMR. The boxes are the same color and I got them mixed up and gave the wrong vaccine.
COVID-19 test positive; COVID-19 test positive; received Moderna as dose 4; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 15Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 28Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 22Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 22Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ESTRADIOL, start date: 01Feb2015; PROGESTERONE, start date: 01Feb2015. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 15Apr2022, outcome "unknown", described as "received Moderna as dose 4"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 24Oct2022, outcome "not recovered" and all described as "COVID-19 test positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2022) Positive; (18Oct2022) Negative; (19Oct2022) Negative; (20Oct2022) Negative; (21Oct2022) Negative; (22Oct2022) Negative; (24Oct2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Additional information: The patient tested negative on an antigen rapid test from 18Oct2022 - 22Oct2022. Returned home and tested positive on a rapid antigen test on 24Oct2022. Still testing positive. Symptoms were mild for initial infection. Symptoms were slightly worse on the rebound.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201265273 same patient and reporter, different product and event;
Information has been received from a physician concerning a 21 year old female who on 04, Jan 2007 was vaccinated with a first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). ON approximately 11, Jan 2007 the patient experienced dizziness. The patient described her dizziness as a "head rush" associated with a feeling of 'fuzziness" and a sensation that she was spinning. This feeling may be accompanied by nausea with no vomiting. The dizziness was episodic and lasted for minutes to an hour or so. The dizziness was not positional and did not occur at night. The patient was seen by three physicians and underwent magnetic resonance imaging (MRI). All follow-up examinations and MRI were normal. At the time of this report, the patient had not recovered form the dizziness. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 4/6/2007. Information has been received from a physician concerning a 21 year old female with asthma, migraine headaches, and allergies to penicillin and KEFLEX who on 04-JAN-2007 was vaccinated in the left deltoid with a first dose of GARDASIL (lot 653937/0637F). She had no illness at the time of vaccination. On approximately 14-JAN-2007, 10 days post vaccination, the patient experienced dizziness. The patient described her dizziness as a "head rush" associated with a feeling of "fuzziness" like someone was shaking it, and a sensation that she was spinning in relation to the room. This feeling may be accompanied by nausea with no vomiting. The dizziness was episodic and lasted for minutes to an hour or so. The dizziness was not positional and did not occur at night. The dizziness was followed by generalized nausea and discomfort which lasted for the next 1 to 2 hours. Lying down seemed to help the symptoms. The patient was seen by three physicians and underwent MRI. All follow-up examinations and MRI were normal. The patient subsequently recovered on 21-MAY-2007. No additional information is expected.
Patient did not have a true adverse event, but I was asked by our institute to submit it through VAERS as patient received monoclonal antibodies to treat COVID 7/30/2021, then received Pfizer COVID vaccines 9/9/2021 and 10/11/2021 (within the 90 days of receiving the monoclonal antibodies).