chrisvoncsefalvay/vaers-outcomes huggingface dataset:
some nerve issues, hands and feet; tinnitus; This is a spontaneous report from a non-contactable consumer, the patient. A female patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Mar2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient saw her neurologist and reported tinnitus on an unspecified date, it stayed the same as she reported it. Her neurologist that she saw at 7:30 this morning. They were going to do nerve testing. He wanted her to hold off on getting the second dose. He said that it's 80% efficacy. She had already gone past 4 weeks and he said that she could wait longer. She was having some nerve issues, hands and feet, nothing to do with the vaccine as they didn't think so. He didn't think it's related to the vaccine. He told her that she didn't have to get it right away because he said that it was 80% now, from reports that they heard. The patient wanted to know the timing information on the second dose and what was the efficacy of one dose. The patient stated that she would definitely be getting it past 42 days, not even know if I was going to get the second dose. The outcome of events, some nerve issues, hands and feet and tinnitus was unknown. The patient stated that her husband was a superintendent and he talked to health department once week.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of Neuropathy peripheral and tinnitus due to temporal relationship. However, the reported events may possibly represent intercurrent medical conditions in this patient.   There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional 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.
Initial and follow-up information has been received from a registered nurse concerning a female who was vaccinated with a first dose of GARDASIL by a different provider. Subsequently the developed hives over her entire body 2 hours after injection. Unspecified medical attention was sought. At the time of the report the patient's outcome was unknown. Additional information has been requested.
I felt like I was wheezing. There wasn?t an audible sound of breathing difficulty, but it felt like I had mucus in my lungs when taking a deep breath in.
Backache; Fever of 100.4; Headache; Joint pain; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Backache), PYREXIA (Fever of 100.4), HEADACHE (Headache), ARTHRALGIA (Joint pain) and NAUSEA (Nausea) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The medical history was not provided by the reporter.  Concurrent medical conditions included Blood pressure. Concomitant products included LISINOPRIL and METOPROLOL SUCCINATE for an unknown indication.   On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Jun-2021, the patient experienced BACK PAIN (Backache), PYREXIA (Fever of 100.4), HEADACHE (Headache), ARTHRALGIA (Joint pain) and NAUSEA (Nausea). The patient was treated with ACETAMINOPHEN on 17-Jun-2021 at a dose of 1 UNK. At the time of the report, BACK PAIN (Backache), PYREXIA (Fever of 100.4), HEADACHE (Headache) and ARTHRALGIA (Joint pain) outcome was unknown and NAUSEA (Nausea) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Jun-2021, Body temperature: 100.4 (High) High.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not applicable.
9/25/13 heat, redness, hard, pain at injection site. Also headache, sniffling nose. Neck ache began 9/26/13. Has taken TYLENOL.
Raised, itchy rash. Started middle of night on Sunday (11-29). Worse on Mon and Tues (11-30 and 12-1). Inside of mouth burns. Went to see Dr. (Dermatologist) on Wed (12-2-15).
Ok at beginning but then became sore. Increased symptoms 7/17 - swollen oval reddish circle, painful, fever. Taken to ER. CT then MRI. Fluid collection. Transferred to hospital. IV mbx then evacuation of fluid collection/abscess. Diagnosis - pyomyositis.   9/12/2008 MR received for DOS 7/18-24/2008 with DX: Pyomyositis.   Pt presented to local hospital with increased swelling and tenderness of the L deltoid, fever and emesis. Transfered for eval and tx. PE (+) for 8x4 cm markedly indurated, swollen, erythematous area on L deltoid as well as redness to the face/chest. Decreased ROM of shoulder. US guided soft tissue fluid collection and aspiration (+) for purulent material. Tx with vancomycin.
Patient received TDAP and MCV in office at about 10:45 am. At about 1:00 pm, patient's mom called stating patient's eyes were swollen shut. Mom was instructed to return patient back to clinic for evaluation.
10/13 - 10/16 leg pain, double vision, headache, gait disturbance 10/21 progressive LE weakness, gait abnormality disconjugate gase, visual disturbance -  diplopia, tired, falls, numbness/tingling 10/21 transfer hospital MRI - caudal equine peripheral nerve involve 10/28 Rehab.
I had the Shingrix vaccine on 07/22/2020. It interferred with the Levothyroxine I was taking. I had to go to the ER exactly 7 days after getting the vaccine.
2 weeks after vaccination (2/20/2021)  I lost movement of right side of mouth and right eye. Went to ER to check for possible stroke.
GOT AN ENERGY BOOST FROM THE SHOT; This spontaneous report received from a patient concerned an 8 decade old female. The patient's height, and weight were not reported. The patient's concurrent conditions included fatigue.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced got an energy boost from the shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got an energy boost from the shot was not reported. This report was non-serious. This case, from the same reporter is linked to 20210621123.
Verbalize to feel anxious and nervous.  Was evaluated onsite by Fire Rescue and released home at 9:32 am.
got influenza; Initial information was received on 16-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health-care professional.  This case involves an unknown age and unknown gender patient who got influenza after receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.  Concomitant medications included codeine and taking cough medicine with codeine and also have to take steroids.   On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (form, strength, dose, frequency, lot number, expiry date: unknown) via unknown route in unknown administration site for Prophylactic vaccination.  On an unknown date the patient developed a non-serious event of got influenza (unknown latency) following the administration of influenza vaccine.  It is unknown if there were lab data/results available.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (got influenza).  At time of reporting, the outcome was Unknown for the event got influenza.
30JAN98 lesions of various sizes on face, neck, arms & legs;temp 102.4-fever lasted 4 days;lesions lasted 1wk;Ibuprofen for fever;still has scars from lesions;
Kinrix administered to a 4mo; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old male patient who received DTPa-IPV (Kinrix) (batch number G9N2M, expiry date 14-APR-2024) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Kinrix administered to a 4mo). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 05-MAY-2023 The nurse reported that the 4 months old patient had received a doses of kinrix, who was 9 months old at the time of reporting and the nurse mentioned that the vaccine was administered 5 months . The health care professional asked about the effectiveness of the dose. The 4 months old patient received the dose of kinrix which lead inappropriate age of vaccine administered. The permission for follow up was not requested during the call.
Online appointment was requested on pharmacy site.     Indicated first initial shot of COVID vaccination for my daughter.    Appointment was made for 3/17 at 2:15 pm.   We were able to select no previous vaccinations and this was 1st shot for the location.   Arrived at pharmacy and was administered Bivalent vaccination instead of monovalent.    Conversation with vaccinating staff mentioned this was the initial vaccination.    No adverse side effects.    Communicated with health department on 3/20 after realizing that booster vaccine was given instead of original vaccine.  Advised no side effects to be expected and to continue with 2nd initial vaccination not repeating original monovalent dose.   Discussed with pharmacy location Pharmacist on 3/20 that website allowed initial vaccination and staff administered bivalent vaccine in error.
"severe" asthma; shortness of breath; Not feeling well; This is a spontaneous report from a contactable consumer or other non hcp. A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and Expiration Date was not reported) via an unspecified route of administration on 12Mar2021 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced severe asthma, shortness of breath and not feeling well on an unspecified date. It was reported that, patient had severe asthma and her shortness of breath had been more severe. She was scheduled to receive her second dose but she won't be able to make it to her second dose appointment today due to her symptoms. She started a prednisone treatment because of shortness of breath and recurrence severe (not clarified) after the injection, so today as well she was not feeling well, so won't be able to make her second dose appointment. She asked how long can patient wait before getting the second dose without impacting the efficacy of the vaccine and without having to repeat the vaccination series if she didn't make it to her vaccination appointment today and the vaccination series would need to be repeated at a later time, once completed. She asked how to react to the second dose of the vaccine, due to her medical condition and reaction to the first dose and if people with asthma had a stronger reaction to the vaccine. Patient might be receiving the second vaccine. 2 weeks after the injection, patient received treatment with prednisone for severe asthma and shortness of breath. The outcome of the events was unknown.  No follow-up attempts possible. No further information expected.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. It was reported that, the facility was unable to download the data they would need to treat this issue as a temperature excursion. The data was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. No adverse event was reported by patient.  No treatment information was reported.
RASH DEVELOPED ON BOTH ARMS AFTER 15 MINUTES. MOTHER PRESENT, TOOK CHILD HOME.  SHE STATED RASH INCREASED. CALLED MD-PRESCRIBED BENADRYL. CHILD RETURNED TO SCHOOL NEXT DAY WITH NO APPARENT RASH.
Vaccines administered to early.   Patient did not experience any signs/symptoms or reactions per follow up with patient's parents by practitioner within 72hours, and additional follow up within 7 days.
Redness at inject site, inflammation, tenderness, general body aches, golf ball size lump in auxillary area, devel 12 hrs post vax. Difficulty in moving affected arm. Nausea, vomitting, diarrhea. Resolved w/in 48 hrs of vax.
Around the fifth day after the second dose, I became violently ill. nausea, vomiting and diarrhea, with a temp around 100.5. I lost my appetite in about 8 lbs over two weeks. I had a second episode of nausea and vomiting around six days after the first one when I tried to eat normally.
This spontaneous report was received from a healthcare worker regarding unspecified patients of unknown age and gender. Medical history and concurrent conditions of the patients were not reported. On an unknown date the patients were vaccinated with improperly stored ZOSTAVAX lot # L023118 expiry date 24-SEP-2016 (dose, route and site of administration not reported). This was following first temperature excursion of -7.4C for 8 hours. No adverse effects were reported. Temperature: 0.05C Time frame: 9 hours 20 minutes. Based on these supportive parameters the improperly stored vaccines were administered after first excursion. No doses were administered after second excursion. There was previous temperature excursion. This is one of the several reports from the same reporter. Additional information has been requested.
obstructing my breathing at night; upper respiratory/severe nasal problems; upper respiratory/severe nasal problems; has progressively worsened to the point that it is now obstructing my breathing at night; restricting my day to day activities; This is a spontaneous report from a contactable consumer (patient). A 38-year-old male patient received bnt162b2 (BNT162B2, also reported Product=COVID 19 vaccine, lot unknown), via an unspecified route of administration on an unspecified date in Mar2021 as dose 2, single for Covid-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. Two weeks after receiving the 2nd dose (17Mar2021), the patient started having upper respiratory/severe nasal problems. It has progressively worsened to the point that it was obstructing breathing at night and restricting the day to day activities. At this point nothing has helped. The patient still tried to do nasal rinses every hour to gain very minimal relief but this cannot be a long term solution. The event, obstructing breathing at night, was reported serious medically significant. The patient had to do clinic visit to a Doctor or other healthcare professional office. The patient underwent laboratory test which included Sars-cov-2 test: negative on unspecified date.  The outcome of events was not recovered.  Information on the Lot/batch number has been requested.
Red blotches at injection site; arm soreness; exhaustion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 35 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 23Mar2021 09:00 (Lot number: EP6955) at the age of 35 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: OMEPRAZOLE. The following information was reported: VACCINATION SITE RASH (non-serious) with onset 24Mar2021, outcome "recovered" (2021), described as "Red blotches at injection site"; PAIN IN EXTREMITY (non-serious) with onset 24Mar2021, outcome "recovered" (2021), described as "arm soreness"; FATIGUE (non-serious) with onset 24Mar2021, outcome "recovered" (2021), described as "exhaustion". Therapeutic measures were not taken as a result of vaccination site rash, pain in extremity, fatigue.  Additional information: The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Systemic: Dizziness / Lightheadness-Mild, Additional Details: GAVE WATER AFTER PATIENT EXPERIENCED DIZZINESS-PT WAS DEHYDRATED. PATIENT RECOVERED SHORTLY AFTER RECEIVING WATER. WE HAD PATIENT WAIT FOR ANOTHER 15 MINUTES AFTER INITIALLY DRINKING WATER.
First I experienced general body aches and fatigue. Then I experienced intense pain centering on jaw/parotid location.  Felt like anaphylaxis, but no difficulty breathing or swelling in area of breathing. Swelling was in face. This lasted at least 24 hours. Alternated taking Tylenol and ibuprofen for the course of 24 hour period.
Vaccine hit me so hard; Couldnt move any part of my body; Brain fog; This spontaneous report from was received from a 77 year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccine hit me so hard/vaccination complication, couldn't move any part of my body/ hypokinesia and brain fog/feeling abnormal.  The patient's medical history and concomitant medications were not reported.  On 28 Feb 2021 the patient received her second dose of mRNA-1273 (Lot number: 012A21A) solution for injection  intramuscularly prophylaxis of COVID-19 infection.   On 28 Feb 2021, the patient  experienced a strong reaction and couldn't move any parts of body. She said the vaccine hit so hard. She had brain fog. She's never experienced anything like that. She got stuck on the garage floor for so long until her daughter and son in law came to rescue her. She was taken to the emergency room Sunday evening (28 Feb 2021).   On the night of 03 Mar 2021, the patient was released from the hospital.  As of 04 Mar 2021, the patient felt better.  The hospital performed CT scans and she was hydrated with IV fluids.   The outcome of all events were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
She got her vaccine (3), left the center about 1:00 PM, went to her car, and felt something different but did not know what.  She went home, sat down and within an hour or two she was extremely tired.  She went upstairs and laid down, and just continued to be extremely tired.  She laid in bed until 5-5:30, had to use restroom and could not get up.  Finally she did get up, sat on the side of the bed and the next thing she remembers is that she had passed out, daughter heard her fall and was trying to wake her up.  She said she was up for 5-10 minutes.  When she tried to get up she could not, crawled to the bathroom with vomiting and diarrhea.  After that she could not move her arms or legs, and just was so exhausted that all she could lie there for the entire night.   Throughout the night, even when she tried to roll over she could not.  She would get lower back pain and a headache (back pain continues).  About 7-8:00 AM she could move her upper body as she could turn, but she still was not able to get out of bed and walk.  Around 10:00 AM she was able to stand, was very dizzy, needed help to get to bathroom and back.  She still has dizziness, balance issues and back pain.  Feels like she is walking in a fog, could not think straight, cognitively was not together.  She did have a virtual appointment with her doctor the following Monday.  She had a CAT scan as she had fallen trying to get up and hit over her right hand, which showed a mild concussion from the fall.  She is still having the balance issues and back pain with any consistent activity.   She used to run, play tennis, participate in 5K races, walk every day and now she has the severe low back pain and not able to do those things any longer.   The cognitive issues did clear, and she is able to work and do her job now, but the physical back pain is still the issue.   She had COVID in December of 2020 and had severe shoulder pain after that, and still continues with that pain.  With the vaccine and the pains in her back, she feels that she will probably not take another vaccine.
Within 5 min of receiving the injection pt experienced dizziness, fell to the floor, then c/o lump in throat, then occasional hives. Tx With epi pen, PO Benadryl, PO Prednisone. BP always stable.  10/12/06 Received medical records from provider which reveal patient initially had dizziness & had to lie down.  Then started to develop numbness of lips, fullness in back of throat & hives.  EpiPen given which resolved most of s/s but continued to be dizzy.  Taken by ambulance to ER where she received IVF & Benadryl.  She developed headache & treated with ibuprofen.  Admitted for overnight observation.  Seen by PCP next day & patient had HA & cough which was getting worse (pt had hx of cough & asthma w/URIs).
pt recv vax & immed pt left shoulder & lt upper arm began swelling & turning red;no c/o itching from child;no resp distress occurred;DPH given;BP 110/60, P48, R16;