chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pediatric practice staff member inadvertently administered the  PfizerBioNTech COVID-19 Vaccine  ? 12 years formulation (gray cap) to an 11 year-old patient  for the child's second dose on 03/31/2022. Practice manager contacted the Pfizer COVID hotline for advice on potential side effects. The parents were informed  on 03/31/2022 and advised of potential intensified effects due to the higher dose. As of 04/01/2022, the parents are denying any adverse side effects in the patient. The child's physician will follow up with the patient's parent again on 04/04/2022. Re-education with clinical staff to occur on 04/01/2022.
feeling flushed in my face; my face got puffy; I was nauseated for 2 days; I had extreme fatigue; racing heartbeat; This spontaneous case was reported by a health care professional and describes the occurrence of FLUSHING (feeling flushed in my face), SWELLING FACE (my face got puffy), NAUSEA (I was nauseated for 2 days), FATIGUE (I had extreme fatigue) and HEART RATE INCREASED (racing heartbeat) 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 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FLUSHING (feeling flushed in my face), SWELLING FACE (my face got puffy), NAUSEA (I was nauseated for 2 days), FATIGUE (I had extreme fatigue) and HEART RATE INCREASED (racing heartbeat). At the time of the report, FLUSHING (feeling flushed in my face), SWELLING FACE (my face got puffy), NAUSEA (I was nauseated for 2 days), FATIGUE (I had extreme fatigue) and HEART RATE INCREASED (racing heartbeat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment details were not provided.
separate administration of the PENTACEL components with no reported adverse event; Initial information received from on 10-Oct-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2023SA312759.  This case involves 9 years old male patient who had separate administration of the diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] components with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Heparin [Heparin Sodium]; measles vaccine, mumps vaccine, rubella vaccine (MMR) for immunisation; and varicella zoster vaccine (Varicella Vaccine) for Immunisation.  On 09-Oct-2023, the patient received a standard dose 1 of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection at a dose of 0.5 ml (lot UJ869AA, expiry date- 23-MAR-2024) via intramuscular route in the right deltoid for Immunization.  On 09-OCT-2023 the patient had separate administration of the diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine components with no reported adverse event (single component of a two-component product administered) (latency- same day).  Reportedly, patient was administered with the Hib component. Nurse wanted to know if the dose given would be valid. Nurse mentioned that she was not sure if the Hib part was reconstituted with 0.4mL saline solution. Caller reported that no adverse reactions were experienced by the patient.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  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 the 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.
Hospitalized 12/12/12 through 12/22/12 at medical center.  Complaints of 6 months' increasing edema in hands and feet, current unsteady gait, decreased strength.  Diagnosed with Guillain-Barre Syndrome. Readmit 1/3/13 with worsening weakness, dysphasia. 1/5/13, expired during transport by ambulance.  Stopped at community hospital while en route.  DOA at community hospital.  Medical center reporting seen at another medical center prior to current medical center 1/3/13 admission for chest pain.  Ruled out MI at that time.
Information has been received from a physician concerning a 70 year old female with hypercholesterolemia who on 11-JAN-2008, was vaccinated with a subcutaneous single dose in the left forearm of ZOSTAVAX (Oka/Merck). Concomitant therapy included simvastatin (MSD), aspirin, and calcium. One day after receiving the vaccine, on 12-JAN-2008, the patient developed a 4 by 3 cm. area of redness with a central blister at the injection site of the left forearm. On 15-JAN-2008, the patient was examined by the physician in the office. No diagnostic or laboratory studies were performed. The physician indicated that the symptoms resolved without treatment. As of an unspecified date, the patient is fully recovered. A product quality complaint was not reported. This is one of 2 cases from the same source. Additional information has been requested.
Initial report received from a non healthcare professional on 09-Oct-2013. A female patient was given TENIVAC (Lot # U4503AA) (route, dose, frequency unknown) on an unknown date. ON an unknown date the patient had latex allergy and experienced some form of reaction. Reported stated if the vaccine or the possibility of the tip cap containing latex was the cause of the reaction. List of documents held by sender: none.
Patient diagnosed with a left arm deep vein thrombosis that extends from the forearm to the lateral part of the subclavian vein- nonocclusive in some areas.
nose started bleeding; high blood pressure; pounding headache; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (nose started bleeding), HYPERTENSION (high blood pressure) and HEADACHE (pounding headache) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     The patient's past medical history included Surgery (Had two liver surgeries). Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for an unknown indication.    On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced EPISTAXIS (nose started bleeding), HYPERTENSION (high blood pressure) and HEADACHE (pounding headache). At the time of the report, EPISTAXIS (nose started bleeding), HYPERTENSION (high blood pressure) and HEADACHE (pounding headache) outcome was unknown.
I got my 1st shot October 6, 11 I was really nervous of not receiving period went to my primary Gyn Doctor and she gave me some prescription to help it come which it came on October 24, 11. A month went by and I didnt get my period for November at all, so December came for my second shot December 8th, 11 and I recieve it.  December 14th is when I got my period, but period was very thin not like my normal menstrual, now im still on it and now I'm having systems of a huge blood clot coming out which started Dec 24th, 11.
Weeping rash on the top of the head; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 37-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VAC-CINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration (at the age of 37-years), administered in arm right on 03Mar2021 at 10:00 as dose 1, single for COVID-19 immunization. Medical history included none from an unknown date and unknown if ongoing.  The concomitant medication was not reported. The facility type vaccine was reported as hospital. The patient did not receive any other vaccine in four weeks. Patient does not have covid prior vaccination and has not been tested for covid post vaccination. The patient had no known allergies. On 05Mar2021 at 12:00, the patient experienced weeping rash on the top of the head. The treatment was received for the adverse event with Benadryl. The clinical outcome of the events was reported as not recovered.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Patient had 1st dose Pfizer COVID vaccine 03/18/21 returned to Health Department and received Moderna COVID vaccine for 2nd dose.. The wrong brand was given and the elapsed time between vaccines was out of range.  The patient did not suffer any illness related to this error and are not required  additional COVID vaccines due to the error.
Fever 101 Chills Rash/ painful bump on left side of chest  Body aches
Felt like had the flu; Lethargic; Nauseated/ Nausea; overall unwell feeling, she did not feel well at all; she slept constantly/sleeping; Tiredness; did not eat; felt like throwing up; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: ELI283) via an unspecified route of administration on the left arm on 15Jan2021 10:15 at a single dose for COVID-19 immunization. The patient had no medical history. There were no concomitant medications. She mentioned she felt nauseated on 15Jan2021. She woke on 16Jan2021 and felt like she had the flu. From Friday until Sunday like until 12:45 she slept constantly. She experienced tiredness. She did not eat. She was just sleeping and felt like throwing up (Jan2021). She started the feel the nausea the same day she got the vaccine. She blew it off thinking it was nothing. However, the next morning she felt like she had the flu. She was feeling lethargic. The nausea went away yesterday afternoon. On 19Jan2021 was the first day she felt like herself. She felt like she had the flu soon as she woke up. She had this overall unwell feeling, she did not feel well at all in Jan2021. There were no additional vaccines administered on same date of Pfizer suspect. The events did not require a visit to the emergency room and physician's office. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No relevant tests done. The patient recovered from the events nauseated/ nausea and felt like had the flu on 18Jan2021; lethargic on 19Jan2021. Outcome of the other events was unknown.
INCORRECT PRODUCT STORAGE/ PUT 10 VIALS INTO THE FREEZER INSTEAD  OF THE FRIDGE; 5 DOSES OF VACCINE GIVEN AFTER BEING PUT INTO FREEZER AFTER RECEIVING FROM MANUFACTURER; This spontaneous report received from a pharmacist concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 25-MAY-2021, the subject experienced 5 doses of vaccine given after being put into freezer after receiving from manufacturer. On an unspecified date, the subject experienced incorrect product storage/ put 10 vials into the freezer instead of the fridge. The action taken with covid-19 vaccine  was not applicable. The outcome of the 5 doses of vaccine given after being put into freezer after receiving from manufacturer and incorrect product storage/ put 10 vials into the freezer instead of the fridge was not reported. This report was non-serious.
sore arm and flu like feeling the next day after receiving the 1st Moderna covid19 vaccine  after receiving the 2nd Moderna covid19 vaccine I started feeling ill that night and the next morning I had a fever 102.3, I was extremely nauseated, threw up 14 times even though I only had a little bit of soup that morning, ached all over, chills, fever all day and night. Today, day 2 after receiving the vaccine, my fever is down, I'm able to keep down Tylenol and toast, I have a rash on my left arm around the site of the injection and is still very tender and swollen
Currently breastfeeding. After receiving 1st pfizer vaccine for covid 19, the next day my milk supply was half of the volume it normally is. On the second day after receiving the vaccine,  my milk supply was half of the volume from the day before and I had to substitute with freezer milk half of the day. On the third day I was forced to substitute with breastmilk from the freezer all day. By day 4 , my milk was back on track and seemed to be mostly normal again. My report is that it seems that breastfeeding mothers milk supply may be effected by the vaccine but the effects are temporary.
Constant neuropathy issues feet, hands, arms.  Severe spiking headaches several times a week.  Multiple joints ache , swollen at times. Brain fog, inability to complete thought process, forgetfulness.
reactive arthritis; first dose of Shingrix on 12/17/2019 at the age of 49; This case was reported by a consumer and described the occurrence of reactive arthritis in a 49-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th December 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced reactive arthritis (serious criteria GSK medically significant) and inappropriate age at vaccine administration. The patient was treated with adalimumab (Humira). On an unknown date, the outcome of the reactive arthritis and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the reactive arthritis to be related to Shingrix.  Additional details were provided as follows: The patient reported case for herself/himself. The age at vaccination was not applicable for 2nd dose. The patient received first dose of Shingrix at the age of 49, which led to inappropriate age at vaccine administration. The patient has been taking Humira for reactive arthritis. The patient did not receive the second dose. The patient asked should he/she get 2 doses since it had been over 16 months or should he/she just get second dose.
mother stated that her son got a high fever and cold like symptoms after receiving the influenza vaccine on 9/20/10.She does not want him to get fluenza vaccine anymore.
Woke up abruptly, a terrible headache, fever, nausea, entire body ached and felt dizzy.    Pain in Left arm, sicker than I have ever felt.  The aching got continuously worse.  Could not get comfortable and felt aweful.
Large red area 50mm x 60mm to Lt Deltoid muscle. Area warm to touch and tender. Pain starts at injection site to Lt Deltoid and radiates to axillary region.
This spontaneous report as received from a licensed practical nurse (LPN) refers to a female patient of unknown. The patient was vaccinated with the first dose of GARDASIL (lot # not reported) in 2007 and the second dose of GARDASIL (lot # not reported) in the reporter's office on 30-JUL-2012. Whether the patient sought for medical attention was not reported. No adverse effect was reported. The outcome was unknown. Additional information has been requested.
Patient received 1st vaccine on 4/29/2021 (no side effects), 2nd vaccine on 5/27/2021 (patient states he had sore joints). On 6/5 He awoke at 3:00 a.m.  in the setting of leg cramps.  He got out of bed to walk off the cramps, but then developed substernal chest pain.  He describes the pain as ?squeezing? and cramping with radiation towards the left shoulder.  He began to feel lightheaded and diaphoretic, and thus began driving himself to the ED.  On the way, he felt his symptoms were worsening so he called dispatch he recommended he pull over at a nearby gas station.  EMS met him there and transported him the rest of the way to the ED. In the outside ED, he was initially hypertensive to 175/99.
Dose 1: malaise, brain fog, motion sickness, insomnia. Dose 2: malaise, brain fog, motion sickness, sleep apnea, bradycardia, low blood pressure, brain inflammation, stuttering, fainting episodes, depression.
Pfizer-BioNTech COVID-19 Vaccine  diarrhea, headache, fatigue, general feeling unwell approx. 20  hours post initial vaccination lasting a week and a half.  Still not completely well.  diarrhea x 1 and a half weeks.  headache still ongoing.
Left arm was swollen, red, and painful at the site varicella vaccine was administered. Patient was instructed to take ibuprofen for pain and use an ice pack at the site for swelling and irritation.
Arm at site of injection swelled up - felt painful upon touch - and pt felt shortness of breath - still have pain & swelling in arm 5 days later - MD prescribed a 5 day course of KEFLEX 500mg qid.
pt recv vax 5NOV96  & that evening pt died;pt had a hx of heart disease;pt was not allergic to eggs & had prev recv the flu vax w/o rxn;pt was not taking Coumadin;responsible MD does not think the death was r/t vax;
Patient states she felt pain at the injection site and numbness and tingling up her shoulder right after the immunization. Over the following 72 hours patient complains of pain at the injection site, up her shoulder numbness and pain orally in her gums on the left side of her body.
Employee reported continuous chills off and on for over 12-24 hours, and major-severe headache.
administered vaccine from vial that was past the 12 hour puncture time/vial had been kept cold in the fridge; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered vaccine from vial that was past the 12 hour puncture time/vial had been kept cold in the fridge) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-May-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered vaccine from vial that was past the 12 hour puncture time/vial had been kept cold in the fridge). On 20-May-2021, EXPIRED PRODUCT ADMINISTERED (administered vaccine from vial that was past the 12 hour puncture time/vial had been kept cold in the fridge) had resolved.        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.   Treatment medication was not provided    This case was linked to US-MODERNATX, INC.-MOD-2021-155542, US-MODERNATX, INC.-MOD-2021-155523 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: FUP document included: Updated gender, vaccine route of administration and anatomical location .; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-155542: US-MODERNATX, INC.-MOD-2021-155523:
numbness on left side of face around the eye and cheek, and the left side of the neck. This started about 20 minutes after getting the vaccine. The numbness was constant for about 6-12 hours. It would be a stronger numbness then a weaker numbness, for the next few days the numbness came and went. I would feel the numbness for about an hour, it'd go away, then be back a few hours later.
Tinnitus - starting approximately 1 month after second vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date Mar2021 (Lot number: EM9810) as dose 2, single for covid-19 immunisation. Relevant medical history included: "GERD" (unspecified if ongoing), notes: verbatim: GERD. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1,, Lot Number: EM9810,, Anatomical Location: Left Arm,, Product= Pfizer/BioNTech,), administration date: 11Feb2021, when the patient was 66 years old, for COVID-19 immunization. The following information was reported: TINNITUS (non-serious) with onset 11Apr2021, outcome "not recovered", described as "Tinnitus - starting approximately 1 month after second vaccine". The event "tinnitus - starting approximately 1 month after second vaccine" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of tinnitus.  Additional information: Patient did not have Covid prior vaccination or not test Covid tested post vaccination: Patient had no known allergies. Patient did not receive other vaccine in four weeks or other medications in two weeks.   No follow-up attempts are possible. No further information is expected.
Patient seen at my office 3/18/2021 (ambulatory).  Had dose 2 on 3/19/21.  The next morning around 5am (3/20), he had difficulty get to bathroom.  Was holding onto the sink because his legs would not work.  Family had to help him use bathroom and get him back into bed.  Family got him bedside commode that day and even then had severe weakness like a "bowl of jelly".   Had mild cough and neighbor listened to lungs and was clear.  Cough cleared and had labored breathing intermittently.  His breathing became more labored and he slept a lot and then breathing "kind of erratic" and then breathing slowed down and got slower and slower until he stopped breathing altogether.  Passed on 3/21/2021.
The pt broke out with a rash on 6/8/01. The rash was located under both arms, the groin and private area. The pt was given Hydroxyzine.
Administration of expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported   No treatment information was provided
headache; Muscle ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 as dose 3 (booster), single (Lot number: GJ6742) at the age of 49 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Second dose, lot number=EP6955,), for COVID-19 Immunization; Bnt162b2 (First dose, lot number=EL3247), for COVID-19 Immunization. The following information was reported: MYALGIA (non-serious) with onset 06Oct2022, outcome "unknown", described as "Muscle ache"; HEADACHE (non-serious) with onset 06Oct2022, outcome "unknown". Therapeutic measures were not taken as a result of headache, myalgia.