chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Muscle cramps in right calf; all over body aches; Headache for 1 1/2days; This is a spontaneous report received from a contactable consumer (patient). This 66-year-old female patient received the second dose of bnt162b2 (PFIZER COVID-19 VACCINE) on 09Feb2021 at single dose (lot/batch number: EL9264/MRN 38072873, expiry date: 31May2021) on Arm left for COVID-19 immunization. Medical history was not reported. Concomitant medications included Salmeterol xinafoate (ADVAIR) from an unspecified date and stop on an unspecified date; Alectinib hydrochloride (ALECENSA), Tiotropium bromide (SPIRIVA), Dupilumab (DUPIXENT), Rivaroxaban (XARELTO), all from an unspecified date and ongoing. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot/batch: EP8982/MRN 38072873; Expiration Date: 31JMay2021) on 21Jan2021 as single dose and experienced Swelling in her ankles on 26Jan2021, her feet are swelling and it has been swelling for about 4 days now on 26Jan2021, she was having liver and kidney issue which could be reason for her ankles are swelling. The patient experienced Muscle cramps in right calf on 24Mar2021, all over body aches, Headache for 1 1/2 days on unspecified date in FEB2021. No Admission to the hospital due to the events. No Surgical treatment needed for the event. The outcomes of the events was unknown.
1997 pt exp diarrhea, n, malaise & icterus;lab eval revealed transaminases in the 300"s, alk phos inc, positive for hep B surface antibodies;hep B core antigen positive, positive hep A imunoglobulin G antibody test;malaise;cancer pancreas
This spontaneous report was received from a doctor of pharmacy concerning a patient of unknown age and gender. On 04-SEP-2013, the patient was vaccinated with 0.65 milliliter (ml) of ZOSTAVAX (lot number and expiry date were reported as J003483 and 29-JUN-2014 respectively), subcutaneously which was placed in the 32 degrees Fahrenheit (F) conditions since 31-AUG-2013 for 14 days which could not be supported. No concomitant therapy was reported. No adverse effects were reported. Additional information has been requested.
Epstein Barr diagnosis; experienced some weird neurological symptoms; Initial information regarding an unsolicited valid non serious case was received from a pharmacist via Medical Information (Reference number- 00728247).  This case involves an unknown age female patient who had Epstein Barr diagnosis and some weird neurological symptoms (Epstein-Barr virus infection), after receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date in last year, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious Epstein Barr diagnosis and some weird neurological symptoms (Epstein-Barr virus infection) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It was reported, "pharmacist stated that a female patient received the Fluzone Quadrivalent flu shot last year and is experiencing some weird neurological symptoms and has had CT scans and other tests and the only thing showing is Epstein Barr diagnosis. Pharmacist stated the flu shot was the only thing different the patient had done".  Relevant laboratory test results included: Computerized tomogram (CT) scans and other tests and the only thing showed was Epstein Barr diagnosis.  It was not reported if the patient received any corrective treatment for the events.  At time of reporting, the outcome was unknown for the events.  There will be no information available on the lot number for this case.
Blotchy redness mostly face. Denies respiratory distress,chest pain. b/p 140/82 pulse62 respirations 18. Denies feeling warm. Denies need for further medical care. 1316 Patient she feels fine and would like to leave. Advised to call MD or 911 is shortness of breath or chest pain.  1259 returned to clinic with reddish blotches on face. None else where.  1316 b/p 122/72 pulse 62 respirations 16 Patient denies any other signs or symptoms of reaction to vaccine.  Lungs sounds are clear.  Denies itching or pain.
Woke up to numbness in the face and "drooping" mouth. Felt like I had been to the dentist. Numbness progressively got better throughout the day, but felt numbness/sensitivity/burning sensation in the face all day. No other side-effects or symptoms.
In May 2021, I had vision, pherifical vision and could see colour for my right eye. 3 strokes since 16 Apr 2021 and 10 Jul 2021 and hospitalized. 7 Jul 2021 I was rushed by ambulance to hospital. Had 3 strokes. I can't drive and live on my own now.
01/25/22 @ 1:00pm:  Tolerated injection well,  30 minutes after administration c/o some 'tingling in her throat, funny sensation on her tongue'.    Employee remained in lounge chair following administration for 45 min for observation due to reported history of allergies.   Employee reported some 'tingling in her throat', tolerated sips of water,  VSS,  in NAD, O2 Saturation 97-98%.  No s/s of distress, benadryl offered via IM administration after 45 minutes - refused by employee because she reported it would make her tired. Following with no c/o after 45 min.   01/26/22 @ 8:58am:  Follow up letter from employee the day after administration reports the following:  'I am happy to report that my arm has little to no discomfort this morning. Unfortunately, I ended up having to take a Benadryl as my throat tingling and tightness sensation persisted. I also woke up today with very puffy eyes-all these are some of my reactions when I am exposed to formaldehyde.
Big, hard knot where vaccine was given. Also red and warm.; Big, hard knot where vaccine was given. Also red and warm.; Big, hard knot where vaccine was given. Also red and warm.; This is a spontaneous report from a contactable nurse via Pfizer sales representative. A 12-month-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, lot number and expiration date not reported), via an unspecified route of administration from an unspecified date at a single dose for immunisation.  The patient medical history and concomitant medications were not reported.  On an unspecified date, the patient had a big, hard knot where vaccine was given, it was also red and warm, the events took place after the use of the product. Outcome of the events was unknown.   No follow-up attempts are possible, information about batch number cannot be obtained.
Extreme pain in upper right shoulder. Having trouble moving arm without feeling pain. Went to hospital following up with a doctor.
severe malaise, fatigue, muscle tenderness (generalised) difficulty with standing and walking without assistance.
PATIENT RECEIVED 3 VACCINES ON APRIL 28, 2018. NEXT DAY HE FELT DIZZY, SLEEPY, LIGHTHEADED, GENERAL MALAISE, LIKE A FLU. HIS ARMS WERE BULGED AND SWOLLEN, HE COULD BARELY MOVE THEM UP. HE DENIES FEVER. HE VISITED HIS PRIMARY PHYSICIAN ON 4/30/2018 AND BROUGHT THE PRESCRIPTION OF LEVAQUIN 750MG 1 TAB EVERY DAY FOR 7 DAYS AND ALLEGRA 180MG FOR 1 TAB DAILY FOR 15 DAYS TO THE PHARMACY. DR. DIAGNOSED A GENERAL REACTION TO THE VACCINES, DERMATITIS AND CELLULITIS HE WAS OPPOSED TO GIVE MULTIPLE SHOTS ON SAME DAY AS YOU COULD NOT STATE WHICH VACCINE WAS THE CAUSATIVE ALTHOUGH BOTH ARMS HAVE THE SAME REACTIONS. I HAVE THE CHANCE TO SEE PATIENT AGAIN ON MAY 2 AND HIS ARMS WERE STILL BULGED AND SWELL. HE HAD A BLACK SPOT ON ONE OF THE INJECTION SITE AT THE LEFT ARM. HE STATES, WHEN HE TOOK THE MEDICINES THE DAY BEFORE, HE FELT DIZZY, LIKE LOW SUGAR, ALTHOUGH HE IS NOT DIABETIC. I TOLD HIM TO TAKE HIS PRESCRIPTIONS AS USUAL AND TAKE THE NEW ONES WITH FOOD.
Patient lost consciousness and fell about 12 hours after receiving Pfizer COVID booster vaccine. She was on the floor of her home about 4 hours before she went to the hospital via ambulance. She was in the hospital for 2 nights. She believes the vaccine caused her to lose consciousness. She states her hospital provider did not give a reason why she lost consciousness. Her provider did tell her she had a UTI. Patient is now home from the hospital.
No Immunity; Initial Report Received 08-Aug-2019  A hepatitis C Program Lead reported that an female patient (age: in the 60s) was administered 2 doses of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and had "no immunity".   Relevant medical history and concomitant medications were not provided.   On unknown dates, the patient was administered with two doses of HEPLISAV-B (lot #, expiration date, and NDC # unknown). It was unknown if the vaccine was administered from a vial or prefilled syringe.   On 08-Aug-2019, the hepatitis C Program Lead reported that she had a patient who received two doses of HEPLSIAV-B.  A titer drawn after a month showed no immunity. No further information was provided.     At the time of the report, no adverse events were reported.   The reporter did not provide a serious assessment for the event.   Company comment: The company assessed the event of therapy non-responder as non-serious. The event of therapy non-responder is listed per HEPLISAV-B USPI.; Sender's Comments: The company assessed the event of therapy non-responder as non-serious. The event of therapy non-responder is listed per HEPLISAV-B USPI.
Patient reported to the ER on 09/16/2021 with left leg swelling. Diagnosed with an acute DVT of the left leg.
It was in August, I started to get shingles and it cleared up with the medication I was given.
Initial information received on 01-Apr-2019 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a patient of an unknown demographics who received vaccine Diphtheria, Tetanus and Acellular Pertussis Vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to Expired vaccine used. It was reported that Expired DtaP given to patient. It was unknown if any adverse event was occurred. 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
positive vaccination history with MMRII and negatiev titers for measles; This spontaneous report was received from a pharmacist refers to a 50-year-old female patient. The patient's medical history, concurrent conditions and concomitant medications were unknown.  The pharmacist reported that, on unspecified dates, the patient received age appropriate measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) vaccination (dose, frequency, route of administration, lot# and expiry unknown) for prophylaxis and had negative titers for measles (measles antibody negative). Concomitant medications included sterile diluent (DILUENT MRK INJ)  The pharmacist reported that on 30-APR-2019, the patient received a booster dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) therapy type: rHA, (dose and frequency unknown) lot# R008685, expiry: 22-MAR-2020.  Outcome of the event was unknown. Causality assessment was not reported. Product quality complaints was not involved.
itches in the skin; vomiting; dose of Shingrix on October 28, 2020 / got her second dose on November 30, 2020; This case was reported by a pharmacist via call center representative and described the occurrence of itchy skin in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 30th November 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 30th November 2020, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On 2nd December 2020, the patient experienced itchy skin and vomiting. On an unknown date, the outcome of the itchy skin, vomiting and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the itchy skin and vomiting to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. On 28th October 2020, the patient received 1st dose of Shingrix. The patient received 2nd dose earlier than the recommended schedule, which led to shortening of the vaccination schedule. The patient experienced itches in the skin and vomiting, 2 days after vaccination. The consent to follow-up was granted.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was provided vaccine after the published expiry date), PRODUCT STORAGE ERROR (Expired vial was stored in refrigerator) and NO ADVERSE EVENT (No adverse event) in a 71-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 prophylaxis. No Medical History information was reported. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jun-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jun-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was provided vaccine after the published expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vial was stored in refrigerator) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was provided vaccine after the published expiry date), PRODUCT STORAGE ERROR (Expired vial was stored in refrigerator) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient was provided vaccine after the published expiry date) and PRODUCT STORAGE ERROR (Expired vial was stored in refrigerator). No concomitant medications were reported. It was reported that, the medical assistant thought that the expiration date was 20-Jun-2022 when looked this up before however there was nothing in writing or printed to confirm the expiration date of 20-Jun-2022. Vial was initially stored in refrigerator on 07-Jun-2022. The vial did not undergo temperature excursion. The patient had not experienced any adverse events. No treatment details were reported. Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2022: Significant live follow up received contains updated reporter details, suspect details and expiry date. On 02-Sep-2022: Follow up received contains nonsignificant information.
Within 3hrs of the vaccine I became lethargic and fell asleep. I was restless and having bone pain but could not wake up to do anything about it. My alarm went off at 4am 12/29/20 for work and I was able to get up but I was confused and unable to comprehend anything I tried to read. I also realized my tongue and throat felt thick and I felt like I was being lightly choked. My vision was blurred, I had tremors and shortness of air. I became lethargic and again fell asleep. When I woke up at 10am I was able to call for an appointment. I was seen on 12/29/20 11:45am and was given Solu-medrol IM and Benadryl orally. I was sent home to take Benadryl every 4hrs.
Received the old flu shot. Showed red swollen reaction. Within 2 hours had blurred vision. Vision problem lasted about 8 days and clear in matter of minutes. Could the flu shot cause this problem.
Breakthrough COVID infection - positive test; Breakthrough COVID infection - positive test; Booster dose; This is a spontaneous report received from a contactable reporter from product quality group.  A 43 year-old male patient received bnt162b2, intramuscular, administration date 03Nov2021 (Lot number: FF2593) at the age of 43 years as dose 3, single, administration date 24Feb2021 (Lot number: EM9810) as dose 2, single and administration date 01Feb2021 (Lot number: EM9810) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: IMMUNISATION with onset 03Nov2021, outcome unknown; COVID-19, VACCINATION FAILURE all with onset 27Dec2021, outcome unknown and all described as Breakthrough COVID infection - positive test. Therapeutic measures were not taken as a result of immunisation, covid-19, vaccination failure. Patient had not received covid prior vaccination and tested positive post vaccination.  No follow-up attempts are needed. No further information is expected.
Rash on chest. Itchy not raised. Started a few  hours after 1st dose.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. The registered nurse reported a temperature excursion dated 02-AUG-2014 of 0 degrees centigrade for 8 hours affecting GARDASIL. The excursion was supported. The nurse reported that GARDASIL INJ was administered post excursion (dose, routes and lot numbers not provided) (approximately in 2014). The nurse did not have access to specific patient or product information. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Narrative:  COVID infection following COVID vaccine series 01/7, Pfizer, dose #1 01/29, Pfizer, dose #2 07/26 pt admitted ED, admit to medicine cc: cough, shob, dx: Acute hypoxic respiratory failure and COPD exacerbation LOS: 2 days 09/01 pt admitted ED, admit medicine cc: dx: covid pneumonia LOS: 16 days 08/03 pt cc: dyspnea, cough, exposure: unknown 08/16 CXR impression: New focal airspace consolidation in the mid to basilar right lung, suggesting bronchopneumonia or aspiration. Recommend follow-up to resolution. Chronic perihilar and bibasilar streaky opacities, suggestive of chronic bronchitis. Background of chronic lung changes and upper lobe predominant emphysema. 08/16 COVID swab, result: detected 08/16 LACTIC ACID result: result 0.95 08/16 SARS-COV-2 LINEAGE B.1.617.2 08/16 SARS-COV-2 CLADE 21A DELTA 08/21 ESR result: 21 08/21 FIBRINOGEN result: 459 08/21 DDIMER result: 0.53 08/21 ABG i-pH 7.45, i-PCO2, i-PO2 54, i-HCO3 32.2 08/26 CXR impression: Slightly improved bilateral airspace opacities with more conspicuous focal opacity projecting over the right upper lung zone. 08/27 ESR result: 6 08/27 Fibrinogen result: 232 08/27 DDIMER result: 1.94 08/28 ESR result: 3 08/28 Fibrinogen result: 210 08/28 DDIMER result: 0.45 08/30 FIBRINOGEN result: 197 08/30 DDIMER result: 0.31 08/30 ESR result: <1
Seen here 12/12/11 with 17x17cm (L) thigh redness and swelling and itching which had worsened over the last 24 hours. Vaccine given 2 days ago. He is started on ZYRTEC 5-7.5mg daily.
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided
Small, red, macular rash on arms, back, and chest. Follow up clinic visit. No treatment; resolved.
Patient's menstrual periods stopped for 4 months then became irregular associated with hot flashes and elevated FSH
Information has been received from a physician concerning a 15 year old female patient with no medical history and no drug allergies who on an unspecified date was vaccinated with the second 0.5mL dose of GARDASIL intramuscularly. There was no concomitant medication. Twenty-four hours after receiving the vaccine. The patient developed a large bump at the site of injection. No lab diagnostic studies performed. At the time of the report, the patient recovered. Follow-up information has been received from a physician reported that he can not provide any information because he did not know who the patient was and a name was not provided. No further information is available.
Slight UTI infection; This is a spontaneous report from a contactable consumer (patient). A 69-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ELT283), via an unspecified route of administration on 20Jan2021 at single dose for COVID-19 immunisation. Medical history included acid reflux and anxiety. Concomitant medications included lisinopril for blood pressure, levothyroxine (SYNTHROID) for thyroid from 10 years. The patient stated that she had her first shot of the Pfizer covid vaccine and she did fine. she is scheduled to get the second dose today and over the weekend she was prescribed Cephalexin for slight UTI infection, have not taken it yet, Famotidine took one dose 2 days ago antacid, sucralfate took one dose a day ago. Patient wanted to know any interactions with covid vaccine. It was reported that saturday night she had really bad acid reflux. she went to the hospital and she was prescribed Keflex. She knew she was going to get the second shot of the covid vaccine today and has not started taking Keflex. She was also given famotidine which she states is like a prescription pepcid. She took one famotidine one or two days ago. She has not taken any medication since she did not want to have any interaction with the vaccine. She was also given sucralfate and she took one sucralfate yesterday or the day before. Reports she has been on levothyroxine for her thyroid and lisinopril for her blood pressure for years. She is asking since she is supposed to be getting the second shot today if she can she start taking keflex after she has the shot or does she have to wait. She would like to start taking it. She took it upon herself and called the pharmacy since she could not get a hold of her doctor. She has not been able to get any answers. On 06Feb2021 she found out she had a slight urinary tract infection (UTI) when she went to the ER Saturday. She did not even know she had a UTI. Confirms she was not admitted to the hospital. She has struggled with acid reflux before, states it is not a reaction to the vaccine. Her acid reflux got really bad and she thinks it was due to some anxiety going on and it exasperated it. She is 69 years old. She just wanted to make sure nothing would interact. She has to leave to go to her appointment and does not have time to complete a report. The outcome of the event was unknown.