chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pfizer booster shot; got infected with Covid; got infected with Covid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A patient (no qualifiers provided) 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: Covid-19 vaccine (MANUFACTURE UNKNOWN, Dose 01), for Covid-19 Immunization; Bnt162b2 (Dose 02), for Covid-19 immunization. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "Pfizer booster shot"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "got infected with Covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive, notes: Infected with Covid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : -PFIZER_INC-202101863868 ;-PFIZER_INC-202101863869
Discoloration of skin at the injection site; This case was reported by a pharmacist and described the occurrence of injection site discoloration in a 79-year-old female patient who received Herpes zoster (Shingrix) (batch number ZR979, expiry date 28th March 2022) for prophylaxis.   On 30th October 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injection site discoloration. On an unknown date, the outcome of the injection site discoloration was not recovered/not resolved.   It was unknown if the reporter considered the injection site discoloration to be related to Shingrix.  Additional information was provided as follows: The patient received 1st dose of Shingrix and experienced discoloration of skin at the injection site. The patient wasn't sure when the discoloration started. The reporter wanted to know if it was ok to give the 2nd dose to the patient. The reporter did not consent to follow up.
Left knee swelled up; Cramping in back of left leg up to buttocks; Left leg tender and achy; Vaccine given in left knee muscle; A spontaneous report was received from a consumer concerning an 83-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) inappropriately in left leg by the knee, left knee swelled up, cramping in back of left leg up to buttocks and left leg was tender and achy.  The patients medical history,as provided by the reporter, included lymphedema in both her arms and can't take vaccines in either arm.  No relevant concomitant medications were reported.   On 28 Jan 2021, prior to the onset of events, the patient received their first of two planned dose of mRNA-1273 (Lot number: 012M20A) vaccine intramuscularly in the left leg by the knee for prophylaxis of COVID-19 infection.  On an unknown date, patient experienced knee swelling and cramping in back of left leg up to the buttocks along with tenderness and achiness in the leg.  No Treatment information for the event was provided.  Action taken mRNA-1273 in response to the event was not reported.  The outcome of the events, left knee swelled up, cramping in back of left leg up to buttocks and left leg tender and achy was unknown.  The outcome of the event vaccine administered at inappropriate site was considered resolved.; Reporter's Comments: This report refers to a case of vaccine administered at inappropriate site for mRNA-1273 (lot # 012M20A) with AE reported of joint swelling, muscle spasms and vaccination site pain.
vaccine brand=Pfizer / BioNTech, vaccine dose number=4/Treatment of COVID-19; Vaccine brand=Pfizer / BioNTech, vaccine dose number=4/Treatment of COVID-19; vaccine brand other=moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 27 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 19Mar2021 as dose 1, single (Batch/Lot number: unknown), on 19Apr2021 as dose 2, single (Batch/Lot number: unknown), on 19Nov2021 as dose 3, single (Batch/Lot number: unknown) and on 19Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) for immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Jul2022, outcome "unknown", described as "vaccine brand other=moderna"; DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "vaccine brand=Pfizer / BioNTech, vaccine dose number=4/Treatment of COVID-19"; COVID-19 (medically significant), outcome "unknown", described as "Vaccine brand=Pfizer / BioNTech, vaccine dose number=4/Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Jan2023) Negative, notes: tested negative on an antigen test yesterday; (11Jan2023) Positive, notes: tested positive on an antigen test today. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Adverse event: tested negative on an antigen test yesterday and then tested positive on an antigen test today. It was unknown if patient recovered. Patient did not take other medication was in 2weeks. Patient received a treatment of Paxlovid for COVID-19 since 02Jan2023 to 07Jan2023.Relevant Med History was reported as none and no other known allergies were reported.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Complain of chest tightness and SOB 15 minutes after receiving injection. Used Proventil inhaler with good relief.   BP 136/82, p-92, O2 sats- 98%
Fever; Headache; Upper respiratory; A spontaneous report was received from a consumer concerning a 64 year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced respiratory symptom/upper respiratory, fever/pyrexia, headache.  The patient's medical history was not reported.  The Concomitant medications were not reported.   On 18 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 025L20A) Intramuscularly in an unknown location for prophylaxis of COVID-19 infection.  On 07 Feb 2021, patient developed upper respiratory symptom.  On 11 Feb 2021 , patient developed headache. On 13 Feb 2021, patient developed fever.  The treatment information was reported as guaifenesin, fluticasone propionate-steroid spray and Sinusitis spray.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of the events upper respiratory symptom, headache and fever were considered as unknown.
This spontaneous report was received from a pharmacist refers to a 67 year old female patient. Information regarding patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On an unknown date, the patient was inadvertently vaccinated with VARIVAX (lot # M023380, expiry date: 11-MAY-2018), instead of ZOSTAVAX. No adverse effects were reported. Additional information has been requested.
I received the Comirnaty vaccine. When I woke up the next morning, I experienced (and continue to experience) pain in my lower front gums, across the base of my lower teeth. There is redness and a few white bumps on the gums and a red spot on the inside of my lower lip. It feels swollen and bruised - very painful to the touch and just pain in general. My mouth is burning a little.  My dentist checked everything out, and there is no reason this should be happening - no tooth infections or nerve infections. Just swollen gums. It hurts!
pain in my left armpit; pain has been worse on Wednesday than it was on Tuesday.; Initial information received on 30-Jun-2022 regarding an unsolicited valid non-serious case received from a consumer/non- health care professional.  This case involves a 20 years old female patient who experienced pain in my left armpit after receiving vaccine Meningococcal A-C-Y-W135 (D Conj) Vaccine [Menactra].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On 27-Jun-2022, the patient received a 0.5 ml dose (total) of suspect meningococcal a-c-y-w135 (d conj) vaccine Solution for injection (strength, frequency, batch lot number and expiry date: unknown) via intramuscular route in the left arm as prophylactic vaccination (immunization).  On 28-JUN-2022 the patient developed a non-serious event pain in my left armpit (axillary pain) with symptom pain has been worse on wednesday than it was on tuesday (pain) latency: 1 day following the administration of meningococcal a-c-y-w135 (d conj) vaccine.  It was reported that the patient has been experiencing pain in her left armpit on Tuesday June 28th, 2022, and Wednesday June29th 2022 after receiving the Menactra vaccination on Monday June27th 2022. The pain can be described as stabbing and aching.  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 events (axillary pain).  At time of reporting, the outcome was Unknown for the event axillary pain.
Premedicated the day before with Solumedrol, prednisone, albuterol, and benadryl. At 2:45 I started getting a tight chest, tight throat, itchy mouth, itchy throat, hives, throat clearing, and throat hoarseness/ fading. I then took benadryl and a breathing treatment every 4 hours. It got worse later in the day and even worse the next day. The next day I had body aches, chills, headache, brain fog, dizziness, fever, itchy mouth, itchy throat  , hives, tight / thick throat, very tight chest, and difficulty breathing.
Patient complained of chills to the severity of feeling as if she was paralyzed. Reported that it went away after about 24 hours. Initiation was hours after the vaccination.
Ringing in my ears. Began after getting my first dose. Has persisted. It lasts all day, every day without any breaks. Is most noticeable when atmospheric sounds are low. Increased in volume upon getting my second dose. Is now more noticeable throughout the day even with atmospheric sounds because the ringing is louder.
C/O headache & numbness of legs for 3 days after vaccination. No other symptoms but he was unable to walk.
Mom called on 4/25/16 and stated that patient got his 2nd Hep A dose on 4/15/16 and had hives on his back of legs, chest, tummy and bottom. The hives started 24 hours after the Hep A shot and resolved by 4/20/16. No breathing difficulty no fever.
8/5/04 Pt came into clinic left arm swollen and warm (.8cmx6cm). Advised parent to give Tylenol, Benadryl topical cream and cool compress. Also advised to return to clinic if pt worsens.
This spontaneous report was received from a physician and refers to a currently age 34, not pregnant,  female patient. The patient had an antecedent of allergies to penicillin and unspecified sulfa drugs. Concomitant therapies and concurrent conditions were not reported. On an unspecified date, at age of 12 year old, the patient was vaccinated with a dose of VARIVAX for prevention of varicella, reconstituted with sterile diluent (MERCK STERILE DILUENT). The number of doses and dates of vaccination were unknown (Strength, dose, route, frequency, lot # and expiration date were not reported). On an unspecified date in 2016, reported as "within the past year",  the patient had negative titers for varicella (antibody test negative). The patient did not receive treatment. The outcome of antibody test negative was unknown and the assessment causality between VARIVAX with the event mentioned before was not provided. There was no product quality complaint involved.
20 year old with cerebral palsy, chronic bronchitis, G-tube dependent received COVID 19 vaccine approximately 1030 on 2/18. Within 5 minutes c/o headache and had audible wheezing.  He was treated with Benadryl in the vaccine clinic.  He was taken to ER noted to be in resp distress. He received IM epinephrine and symptoms quickly improved. Less than an hour later was again noted to be wheezing and in respiratory distress. He was treated with second IM epinephrine, albuterol, steroids, and antihistamines. Admitted into PICU overnight and remained asymptomatic. Patient received the pneumococcal and influenza vaccines 3 days prior. Has never had any similar reactions in the past.  Patient was discharged on 2/19.21.
Presented to ER with ascending weakness that started in foot, shakes/tremors, slurred speech.  Lab workup done, Head CT done, IV started.  Patient transferred to another facility for evaluation by neurologist, suspected Guillain-Barre syndrome.
1 week and 1 day following administration pt noticed arm itching near injection site, and a developed rash.  Pt took Benadryl with no relief, and has been using hydrocortisone with some short lasting relief (about 1 hour of relief).  Denies other symptoms.
Information has been received from a health professional concerning a 17 year old female who in November 2006, was vaccinated with a first dose of HPV vaccine (yeast).  In December 2006, the patient tested positive for human immunodeficiency virus (HIV). The HIV test was performed in December 2006 when the patient donated blood.  Unspecified medical attention was sought.  The patient had 2 subsequent HIV tests.  The first test was "equivocal" and the second test was negative.  It was reported that the patient was not sexually active and did not use intravenous (IV) drugs.  At the time of the report, the patient's outcome was unknown.  Additional information has been requested.
Initial information received on 17-Oct-2018 regarding an unsolicited valid serious case received from a Nurse. This case involves a 47 years old female patient who experienced itching at the injection site that developed into a rash, throat was closing and redness at the site, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapy was reported. On 16-Oct-2018, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UJ035AA and Exp. Date 30-JUN-2019) via intramuscular route in the right deltoid. On 16-Oct-2018, the patient developed a serious itching at the injection site that developed into a rash, throat was closing and redness at the site immediately after the administration of INFLUENZA QUADRIVAL A-B VACCINE. These events were considered medically significant. Details of lab data not provided. Final diagnosis was redness at the site, throat was closing and itching at the injection site that developed into a rash. On an unknown date, the patient was treated with DEPO-MEDROL and SALBUTAMOL, BENADRYL 15 ml was administered and ice was applied to injection site as corrective treatment. The patient was transported via ambulance to the nearest hospital where she was kept for observation in ER. On an unknown date, the patient recovered from events. List of documents held by sender: none. Sender's Comments: This case concerns an adult patient who presented with itchy rash, throat tightness and vaccination site redness after use of FLUZONE QUADRIVALENT vaccine. The time to onset is compatible. There is, however, no information regarding patient's condition at time of vaccination and lab tests do not rule out alternate etiologies, particularly infectious. Based upon the reported information, the role of the vaccine cannot be assessed.
Warm patch; Soreness; swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm patch), VACCINATION SITE PAIN (Soreness) and VACCINATION SITE SWELLING (swelling) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Warm patch), VACCINATION SITE PAIN (Soreness) and VACCINATION SITE SWELLING (swelling). At the time of the report, VACCINATION SITE WARMTH (Warm patch), VACCINATION SITE PAIN (Soreness) and VACCINATION SITE SWELLING (swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
This health authority case was initially received on 03-Nov-2015. The case report was received from a Health Professional and concerns a 23 year old female patient. Weight: 240 pounds, Height: 74 inches. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on 09-Oct-2015 - 09-Oct-2015, Batch no: T51608, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 09-Oct-2015, the patient received an IM dose of expired AFLURIA. For relevant test results see appropriate report section. Reporter's assessment:  Case correction (08-Dec-2015): AE #1 and #2 combined and coded to PT 'Expired product administered'.
some reactions to it and had chills; This is a spontaneous report received from a contactable reporter (Other HCP) from medical information team. The reporter is the patient.  A 90 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "some reactions to it and had chills".  Additional information: It was reported that the patient was a retired Dentist in a good health. He was reporting that after receiving the first and second dose of Pfizer BioNtech Covid vaccine, after 24hours he had some reactions to it and had chills. He understood that this reactions were not that common but they did happen. He was told that he shouldn't get the booster because of this reaction but he wanted to know what were the risks of getting chills after booster shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Extreme nausea for extended period of time that started on 3/12 and didnt go away until 4/5. Urgent care blood (Hemogram/PLTS) and urine test (UA w/ microscope) that came back normal on 3/21. ER visit with blood test (Hemogram/ PLTS/DIFF, liver panel- hepatic function panel, Lipase panel, basic metabolic panel), urine culture, UA conditional UC, Pregnancy test urine, CT w/ contrast all came back normal on 3/24. Surgical pathology via microscopic examination w/ biopsy results were A.  Duodenum, second part, biopsy: No diagnostic abnormality, B.  Stomach, antrum, biopsy: Changes consistent with reactive gastropathy, Negative for Helicobacter pylori all came back normal on 3/25. Fecial CALPROTECTIN CONCENTRATION and ENTERIC PARASITE MOLECULAR DETECTION (GIARDIA, CRYPTOSPORIDIUM, E.HISTOLYTICA) all came back normal on 4/6. And finally Gastric Emptying Scan/ study came back normal on 4/5. 40 yo female for evaluation of early satiety, nausea and vomiting.  Gastric emptying study: Normal at 1 hour (70% in stomach with < 90 being normal) Normal at 2 hours (25% with goal being less than 60%) Normal at 4 hours (3.1% with less than 10 %)
All joints hurt when I wake in the morning. The doctor suspects Rheumatoid Arthritis, but tests have not been completed and final diagnosis has not been made.
Swollen glands above thyroid, difficulty swallowing, fever and chills at night, headaches
Child had 15-20 second episode of tonic seizure activity with 40 minute post-ictal episode. Child had fever to 105.5 AX, did have brief vomiting and chest congestion.  No diarrhea. Family members had similar illness symptoms, also older sibling had history of febrile seizures.
Breakthrough case: My symptoms were sore throat, tight chest (I felt the urge to cough), shortness of breath, tiredness, night sweats, shakes & tremors, and achiness.   I received the Regen-cov monoclonal antibodies infusion. I received 4 injections in the abdomen.  I am still dealing with shortness of breath and I run a low-grade fever almost everyday.
The patients mother called and stated that her daughter is experience rapid heart rate of 120 bpm or greater, fatigue, nausea, and vomiting. She was instructed to seek medical attention. The patients provider is seeing her on 6/14/21. Outcome is still pending.
a lot of pain; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult male patient received BNT162b2 (BNT162B2 NOS), 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: PAIN (non-serious), outcome "unknown", described as "a lot of pain".  Additional information: The patient experienced a lot of pain during the initial shots so that was preventing him.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Everything was fine, but on 04/15/2021, I started having a headache. It continued on until 05/06/2021. I am currently waiting to see a neurologist. I only had 2 days without headaches. I am not working right now because the headaches get really bad. I went on 05/25/2021 to review the finding of an MRI that was done on 05/20/2021.  I also had a CAT scan performed and both tests came back negative for any problems.
Tenderness at injection site. Warm w/itching 7/25/17 pm w/itching and erythema w/hives 7/26/17 PM.
Received J+J booster in November 2021. In June 2022 I became infected with COVID. At the same time a sizable breast abscess formed in one of my breast. Although I have undergone breast imaging to determine there is a low risk this growth is cancerous, the cause of this infection or inflammation response has not been identified. I am not sure if there may be an association with my previous Janssen vaccinations.
This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender with no pertinent medical history/drug allergies or drug reactions reported. On an unknown date, the patients were vaccinated with an improperly stored VARIVAX and quadrivalent (route, anatomical location, dose, lot# and expiration date were not reported). There was not concomitant therapy reported. No adverse effects reported. The reporter did not have the lot numbers for VARIVAX (Merck) at the time of this report. This is one of several cases from the same reporter. Additional information has been requested.