chrisvoncsefalvay/vaers-outcomes huggingface dataset:
numbness is in both hands, but the right hand is worse; developed afib; was told he developed COPD/he had mild COPD years ago; diagnosed with pneumonia; shortness of breath; wheezing; dizziness; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6199) via an unspecified route of administration into right arm on 05Mar2021 (at the age of 75-year-old) as single dose for COVID-19 immunisation. Medical history included diabetic, arthritis in hip and back, shingles, ongoing mild chronic obstructive pulmonary disease (COPD) started years ago. There were no concomitant medications. Historical vaccine include first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EM9810) into left arm on 13Feb2021 (at the age of 75-year-old) for COVID-19 immunization and experienced no adverse effect; influenza vaccine (INFLUENZA VACCINE), pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13) and tetanus vaccine (TETANUS VACCINE); all on an unspecified date for immunization and patient experienced no adverse effect. Patient did not receive any other vaccinations within four weeks prior to the first administration date of the vaccine. On 06Mar2021, patient experienced shortness of breath, wheezing and dizziness. On an unspecified date patient also experienced numbness is in both hands, but the right hand is worse. Patient was brought to the emergency room on an unspecified date where he was told that he developed afib (atrial fibrillation) and COPD (chronic obstructive pulmonary disease) to which the patient stated he had mild COPD years ago. On 09Mar2021,patient had a chest X-ray and was told he has pneumonia. The patient was hospitalized for the events reported from 09Mar2021 to 12Mar2021 and was treated with SPIRIVA RESPIMAT inhaled 2 puffs by mouth 1 time each day, PROAIR HFA two puffs by mouth every 4 hours as needed for shortness of breath, APIXABAN one tab by mouth every 12 hours and some medications (unspecified). The patient underwent lab tests and procedures which included computerised tomogram: no blood clots on an unspecified date, electrocardiogram: unknown results on an unspecified date, SARS-CoV-2 test: unknown results on an unspecified date. Outcome of event dizziness was recovered on an unspecified date; event "numbness is in both hands, but the right hand is worse" was not recovered; while for all other events was unknown.
pt began to break out in large red whelps;pt states had only very sl diff breathing;take to ER;c/o rash and abd cramps;also itching;red raised areas on arm back & abd;inc bowels;dx allergic dermatitis;
This solicited report received from the consumer and refers to 2 children of unknown age and gender enrolled in Market Research Program. The consumer reported that the another parent's children were extremely healthy and without any seizures. On an unknown date, the children were vaccinated with a doses of GARDASIL (strength, dose, frequency, route of administration, lot # and expiration date were not reported). On an unknown date (reported as shortly thereafter), the children riddled with seizures. The outcome of the seizures was not reported. The reporter felt that seizures were related to the GARDASIL. Upon internal review the event of seizure was considered to be medically significant. This is one of 2 reports from the same reporter. Additional information is not expected because the reporter did not want his doctor to be contacted.
Pt recvd 3 doses of Engerix-B vax & 22NOV91 it was determined that pt did not respond to vax series;
RECEIVED MODERNA AS FIRST DOSE 1/29/2021 AT  HOSPITAL
Patient had two ED visits (3/13/21 and 4/6/21) within 6 weeks of receiving COVID vaccination.  Patient presented to the ED on 4/10/21 and was subsequently hospitalized for 9 days.
2nd dose produced a large, achy, swollen bruise-like mark on my arm, a few inches below the injection site.  It was a little sore on Monday, after the shot,  achy all night and on Tues morning,  a large, uncomfortable  red buise was present, which hurts and is not fading quickly. (After the 1st shot, there was minor aching,  which lasted a day or so, a month ago, but nothing else. )
Moderna booster administered at the clinic on 11/19/21 was expired (Moderna recommends vials be used within 12 hours of opening).
Patient came in for MCV4 and documented on questionnaire of past vasovagal syncope. She was placed in supine position for vaccine but lost consciousness for about 5 - 10 seconds and slow to respond; denied breathing difficulties. Vitals: BP 102/60 Pulse: 88. She was kept in supine position for 15 minutes. During this time, she complained of dizziness and headache; her mother gave her ADVIL at this point. She then sat up and was in seated position for 15 minutes. While sitting, she stated her head still but dizziness was decreasing. She was then escorted to the waiting area for another 30 minutes. When patient was discharged from clinic, she stated her head continued to bother her. She was instructed to hydrate well and not exercise for the remainder of the day.  Patient verbalized understanding.
pt recvd vax;mom states pt has hives this am;to er; dph prescribed & mom should watch for sxs;
Migraine, spinal pain, blood in urine, TTP, hospitalization starting 4/17/2022, began plasma dialysis 4/18/2022
Pt came in clinic on 6/25/2003 for her one year check and to receive her year old shots. On 7/7/03 the pt's Mom brought her back in clinic and said that the MMR gave her measles.
(4 hours after shot) FACE AND EYE Lid swelling FACE Hot and Red. TROUBLE swallowing Benedryl 5 days
both arms were sore; sore armpit and tenderness in the armpit; slight redness near the injection site; Shingrix injection site is sore; lymph node reaction,; tired; overall achiness.; mild fever; This case was reported by a consumer and described the occurrence of tiredness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included INFLUENZA VIRUS VACCINE INACTIVATED (FLUZONE (FLU SHOT)) for prophylaxis.   In September 2021, the patient received the 1st dose of Shingrix and FLUZONE (FLU SHOT). In September 2021, several hours after receiving Shingrix, the patient experienced tiredness, general body pain, fever, pain in arm, axillary pain, localized erythema, injection site pain and enlargement of lymph nodes. On an unknown date, the outcome of the tiredness, general body pain, fever and pain in arm were recovered/resolved and the outcome of the axillary pain, localized erythema, injection site pain and enlargement of lymph nodes were unknown.   It was unknown if the reporter considered the tiredness, general body pain, fever, pain in arm, axillary pain, localized erythema, injection site pain and enlargement of lymph nodes to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of the Shingrix vaccine four days ago, (Day of reporting) along with the Fluzone high dose in the other arm. The patient usually experience sore arm for a day or two, but this time, several hours later patient got very tired and had overall achiness. The patient also experienced mild fever, both arms were sore and the armpit on the side with the Shingrix shot. There was also slight redness near the injection site. Now there was no soreness on the other side, but the Shingrix injection site was still a little sore, along with tenderness in the armpit, though it was getting better. The patient read that there could be more side effects with this vaccine than with most others, but was concerned that the soreness in the armpit, likely due to lymph node reaction, was not really mentioned as a possible minor side effect.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR202774:same reporter US-GLAXOSMITHKLINE-US2021AMR202783:same reporter
Headache & Myalgia Narrative: January 21st, 4 AM chills that lasted approximately 16 hours, extreme fatigue; dull headache . resolved the next day.
he could not drive; Since 12Apr2021, he had been stuck in vertigo; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Since 12Apr2021, he had been stuck in vertigo) and IMPAIRED DRIVING ABILITY (he could not drive) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     Concurrent medical conditions included Seizure, Headache and Asthma. Concomitant products included SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]) for Asthma, PARACETAMOL (TYLENOL) for Headache, LEVETIRACETAM for Seizure, DOCUSATE SODIUM (STOOL SOFTENER), MACROGOL 3350 (POLYETHYLENE GLYCOL 3350), MULTIVITAMIN [VITAMINS NOS], PANTOPRAZOLE SODIUM SESQUIHYDRATE (PANTOPRAZOLE SODIUM), SIMVASTATIN, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), PHENYTOIN (DILANTIN [PHENYTOIN]) and QUETIAPINE FUMARATE (SEROQUEL XR) for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced VERTIGO (Since 12Apr2021, he had been stuck in vertigo). On an unknown date, the patient experienced IMPAIRED DRIVING ABILITY (he could not drive). The patient was treated with DIMENHYDRINATE (DRAMAMINE) for Adverse event, at a dose of 1 dosage form and MECLIZINE [MECLOZINE] for Adverse event, at a dose of 1 dosage form. At the time of the report, VERTIGO (Since 12Apr2021, he had been stuck in vertigo) and IMPAIRED DRIVING ABILITY (he could not drive) outcome was unknown.            No concomitant medication details was reported. No treatment medication details was reported.   This case was linked to MOD-2021-272286 (Patient Link).
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 13Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 03Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 16Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 14Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "pre-diabetes" (unspecified if ongoing); "obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient received treatment with Paxlovid from 23Oct2022 to 27Oct2022. Other medication in 2weeks was reported as unknown.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Child received Hepatitis A (2nd dose) and MENACTRA 8/21/08. After around 5 minutes, she fainted for few seconds. Mother claims child did not feel good when they went home and vomited 1x after dinner.
Received J&J, then completed Moderna Series; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received J&J, then completed Moderna Series) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939902 and 052E21A) for COVID-19 vaccination.     The patient's past medical history included Chemotherapy (The patient was receiving chemotherapy at that time of the Janssen COVID-19 Vaccine.). Previously administered products included for COVID-19 vaccination: JANSSEN COVID-19 VACCINE (First dose) on 06-Apr-2021. Past adverse reactions to the above products included No adverse event with JANSSEN COVID-19 VACCINE. Concurrent medical conditions included Immunocompromised.   On 20-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received J&J, then completed Moderna Series). On 20-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received J&J, then completed Moderna Series) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment reported. The Oncologist recommended starting the Moderna series after receiving the J&J dose. Patient was trying to receive the next dose of Moderna at the time of this report.
Morning p/receivng booster dose of Td pt exp mild soreness in deltoid started moving toward lt elbow & inside arm; area became red, raised, warm; swelling & tenderness has continued; On 13MAR92 lt inner arm from deltoid to elbow affected;
Broke out in a rash from my head to my feet the first time I took the the vaccine and each time I received the vaccine the rash went further down my body now is that my feet I took my first vaccine shot on 5/20/21 I took my second vaccine shot on 6/10/21 I took my next vaccine shot on 12 /23/22 I took my last back thing shot on 9/10/22
This case was reported by a consumer via call center representative and described the occurrence of fever in a 68-year-old female patient who received Shingrix for prophylaxis. On 10th September 2018, the patient received the 1st dose of Shingrix (intramuscular). On 11th September 2018, 1 days after receiving Shingrix, the patient experienced fever, feeling unwell and pain in arm. On 13th September 2018, the patient experienced localized erythema and itchy skin. In September 2018, the patient experienced muscle soreness. The patient was treated with Tylenol. On an unknown date, the outcome of the fever, feeling unwell and pain in arm were not recovered/not resolved and the outcome of the localized erythema and itchy skin were recovering/resolving and the outcome of the muscle soreness was unknown. It was unknown if the reporter considered the fever, feeling unwell, pain in arm, localized erythema, itchy skin and muscle soreness to be related to Shingrix. Additional details were provided as follows: At 17:35 hours in the evening, the patient received Shingrix on left arm. The patient experienced fever (the patient's body temperature was recorded as 100.2 degree F). The patient stated that her normal body temperature was 97.6 degree F. On 11th Septmber 2018, 1 days after vaccination, the patient woke up in the mroning and said her arm was very sore. On 13th September 2018, in the morning after shower, 3 days after vaccination, the patient noticed a red patch of skin about 2 to 3 inches below the injection site. It was a little itchy as well. It was shrinking and the redness was fading at the time of reporting. In September 2018, less than a week after receiving Shingrix, the patient experienced some muscle soreness which was ongoing at the time of reporting. The patient had been received Tylenol. The patient had denied permission to contact their physician. The patient wanted to know, if the vaccine was the cause of this patch.
No adverse event; Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). No concomitant medication was provided. The vial was initially stored in refrigerator on 07-Jun-2022. The vial did not undergo any temperature excursions. The dates of administration of the vaccines was reported as 01-Apr-2022, 05-Apr-2022, 06-Apr-2022, 08-Apr-2022, 11-Apr-2022, 12-Apr-2022, 13-Apr-2022, 14-Apr-2022, 22-Apr-2022, 09-Jun-2022, 10-Jun-2022, 13-Jun-2022, 18-Jun-2022 and 22-Jun-2022.  The dates of vaccine administration were not reported and it was unknown whether patient took first, second or first and or second booster doses. No treatment medication was provided.
Patient presented to ER on 2/22/21 with dyspnea on exertion x 1 mo with acute worsening over the past 5 days. Prior to sx onset she was able to climb a flight of stairs without difficulty. She was then dyspeneic with minimal exertion. She was diagnosed with acute combination systolic and diastolic heart failure.  TEE showed significant LV dysfunction with EF 15% and Grade 1 diastolic dysfunction. Previously her most recent stress TTE in 2/2019 was negative for ischemia with EF 50%. She was treated with diuretics and started on Entresto. Additionally now on spironolactone and symptomatically improving.
This case was reported by a nurse and described the occurrence of inappropriate age at vaccine administration in a 2-month-old female patient who received KINRIX (batch number 2B463 ?, expiry date unknown). 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 and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown. It was unknown if the reporter considered the inappropriate age at vaccine administration and wrong vaccine administered to be related to KINRIX. Additional information received: Per HCP, patient received KINRIX at 2 months of age on 23 October 2013 while in the care of another health facility.
Administered in left arm.Initial symptoms cooling, itching sensation down arm into tendons in all 5 fingers of left arm. About an hour later pain was sudden and extreme. Could not move arm in any direction or leave it unsupported. Even with Advil + extra strength Tylenol the pain was excruciating and lasted 3 days. After the pain subsided there was noticeable tingling and bussing sensation from forearm to finger tips. Sometimes it?s the entire arm. There has been a steady loss of function since the initial symptoms were reported to my doctor. I can?t drive with my life arm, I can?t use a computer for any length of time or cook etc as holding my arm out in front of me, pinned to my side, or raised forward and up is not sustainable. If I walk and swing my arms like normal I can barely use it the rest of the day. I also get pain in the tendons and a recurrence of the initially shot sensation in my upper arm (sore and itchy at site) as well as pain and burning down my arm to fingers. Dr said he likely hit a nerve but since my symptoms keep worsening I scheduled an appt with ortho.  It?s affecting my ability to work also (massage therapist).
Patient reports Adverse Reactions; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Patient reports Adverse Reactions) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    On an unknown date, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Patient reports Adverse Reactions). At the time of the report, IMMUNISATION REACTION (Patient reports Adverse Reactions) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Patient received first dose of Moderna on 14-Jan-2021, Lot number 012L20A. Second dose of Moderna on 11-Feb-2022, Lot number 031L20A. Fourth dose (second booster) of Moderna on 02-Jun-2022, Lot number 054A22A.  After fifth dose of Moderna bivalent patient experienced adverse reaction. Treatment medication was not reported.   This case was linked to MOD-2022-685772 (Patient Link).
Received my 1st Covid shot yesterday at 11:45. No problem. Went home and went for a 4 mile walk. Still no problem. At about 2:00 AM this morning I woke up shivering. Added another blanked and turned up the heat. No improvement. Finally got up and woke up my wife. Temperature was 101.7° F. Blood pressure was 149/90. Took some ibuprofen and sat on the sofa with a heating pad on my chest for about two hours. Blood Pressure dropped back to its normal 125/75 (may have been high because I took it the moment I got up) but temp was the same. However, shivering had stopped, so I went back to bed.  When I woke up this morning (about 8:00) temperature was 99.1° F, blood pressure was normal (125/71) and no other symptoms. My arm isn't sore either. It appears that the elevated temperature was my only reaction from the shot. It's interesting because during the entire time I did have COVID symptoms, I never had any elevated temperature.
On 8/1/00, the pt was seen in the ER with rash over body. Mother was told this was an allergic reaction to vaccine. Treated with Prednisone and Benadryl IM and given prescription for Prednisone and Zyrtec. Mother states the rash is still present and has increased to face as well as all over body. Told to call PMD and report the same.
No additional adverse events; 8 week old child inadvertently received 2 doses of PEDVAX HIB.; This spontaneous report was received from nurse practitioner concerning an 8-week-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 30-MAY-2023, the patient was inadvertently vaccinated with 2 doses of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, 1 milliliter (2 0.5ml vials were drawn up), lot #W032685, expiration date: 08-MAY-2025, administered intramuscularly as prophylaxis (strength was not provided) (Overdose). No additional adverse events were reported.
patient died at home.  apparently he awoke in the middle of the night and asked for help, then collapsed.  CPR failed.  patient and family did not want an autopsy.  suspect sudden cardiac death
persistent daily headache only slightly relieved by ibuprofen  for more than 10 days