chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I GAVE THE PNEUMOVAX FIRST AND THE FLUZONE HD SECOND. AFTER THE FLUZONE HD WAS GIVEN THE PATIENT HAD A RED FACE AND NECK AND FELT DIZZY. SHE COMPLAINED OF A FUNNY TASTE IN HER MOUTH AND FELT A LITTLE "SICK". AFTER 3 MINUTES THE REDNESS WENT AWAY COMPLETELY AND THE PATIENT COMPLAINED THAT HER LOWER BACK HURT AND FELT WALKING WOULD BE DIFFICULT. THE PATIENT THEN STOOD UP AND COULD WALK JUST FINE. HER BLOOD PRESSURE WAS NORMAL AND SHE WAITED 15 MORE MINUTES BEFORE LEAVING. THE PATIENT SAID ON HER WAY TO THE CAR WITH HER HUSBAND SHE FELT A LITTLE DIZZY BUT AFTER EATING LUNCH SHE FELT JUST FINE. I CALLED HER PRIMARY CARE PHYSICIAN AND MADE HIM AWARE. I FOLLOWED UP WITH THE PATIENT 4 HOURS LATER AND SHE STATED SHE WAS FEELING FINE.
Information has been received from a male patient of unknown age via Pfizer (manufacturer report number 2015355195), concerning himself. No relevant medical history or concurrent conditions were reported. The patient recently requested a PREVNAR 13 vaccine from his pharmacy, but was vaccinated with Pneumococcal vaccine (manufacturer unknown) (dose, route, lot# and expiration date not reported) instead (Product name confusion) on an unknown date. Concomitant therapy included influenza virus vaccine (unspecified). This is one of two reports received from the same reporter. Additional information has been requested.
pt recv vax 6JAN97 & on 13JAN97 pt exp numbness in fingers & h/a;
Initial case received on 17 March 2014 from a nurse. Upon receipt of follow-up information from the health care professional on 21 April 2014, it was confirmed that this case is a duplicate of 2014SA036023. All information will be combined in this case (2014SA034541) which will remain the case of reference; 2014SA036023 will be deleted. A baby (date of birth, age and gender not reported), with no reported medical history and no reported concomitant medication, had a seizure less than 24 hours after receiving a second dose of FLUZONE on an unspecified date. The batch number, site and route of administration were not reported. The outcome of the event was not reported. Further information will be requested from the reporter. Follow-up information was received from the healthcare professional on 21 April 2014 which confirmed that this case is a duplicate of 2014SA036023. The following combines information received on 18 March 2014 and 21 April 2014: A 7 month old female infant, received a second left thigh ("quad") injection of FLUZONE (lot number U4712AA) on 12 March 2014 at 15:30. Approximately 10 hours post-vaccination, at 01:45 on 13 March 2014, the patient experienced an afebrile seizure lasting approximately two minutes. She was admitted to the hospital, where an MRI of the brain, EEG, and unspecified laboratory testing were normal. She was discharged after one day, and the event was considered recovered. The patient had a history of amoxicillin allergy, and birth weight was reported as 3.629 kg. No illness was reported at the time of vaccination. She had one sibling. One month prior to vaccination, on 12 February 2014, the patient had received the following vaccines: a first dose of FLUZONE (lot number U4697CA); PENTACEL (lot not reported); HepB vaccine (manufacturer and lot not reported); Pneumococcal vaccine (manufacturer and lot not reported); and oral Rotavirus vaccine (manufacturer and lot not reported). She did not experience any adverse events after receiving these vaccines. Follow-up information received from the healthcare professional on 12 May 2014: The reporter's relation to patient was updated from other to vaccine provider. The dose of FLUZONE received was 0.25 ml. The patient had no pre-existing physician-diagnosed birth defects, nor medical conditions. It was reported that the patient had been hospitalized overnight to obtain MRI of brain and EEG. Patient did not have any further seizures. She never developed fever. She had no symptoms of illness. She recovered fully within a few hours after the seizure. No medications were prescribed. Documents held by sender: none.
Approximately 3 minutes after the immunizations were given, the child's mother reported that the child had had a convulsion while lying on the exam table. The convulsion lasted less than 10 seconds per the mother. The mother reported that her eyes rolled back into her head. The child did not urinate on herself. Her Pulse ox was 97%, BP 80/44, and pulse 68. After the reported convulsion the child was acting extremely sleepy and was lying on the exam table. She was in this "post-ictal" state for approximately 30 minutes. Afterwards she was talkative and laughing as normal. We observed her for 30 minutes more and FNP spoke with a neurology office that said it was okay to send her home and she can take a nap and an appointment was made for their office at 4 o'clock that afternoon.
became unresponsive; lethargic; This spontaneous report was received from a physician and refers to a 2-month-old male patient. No information regarding the patient's concomitant therapies was provided. The patient had no pertinent medical history and drug reactions or allergies. On an unknown date in approximately February 2011 (reported as "when the patient was 2 or 4 months old"), the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally (formulation, strength, dose, frequency, lot # and expiration date were not reported) for vaccination and with pneumococcal vaccine conj 7v (crm197) (PREVNAR) and diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (PENTACEL) (formulation, strength, dose, frequency, route of administration, indication, lot # and expiration date were not reported for both). After receiving rotavirus vaccine, live, oral, pentavalent (ROTATEQ),pneumococcal vaccine conj 7v (crm197) (PREVNAR) and diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (PENTACEL), the patient became unresponsive and lethargic. On an unknown date, he sought medical attention, and was taken to an unspecified hospital and released on an unknown date, after an unspecified days later. The outcome of the events was reported as recovered on an unknown date. Relatedness between the events and suspect vaccines was not provided.  Upon internal review, the event of unresponsive was considered to be medically significant.
Purple splotches on sols of feet, behind ears, and on armpits. They are extremely painful with and without touch. They do not turn white when touched. I soaked my feet and epsom salt and that didn?t help. I took ibuprofen and that leased the pain but not a lot.
pt recv vax 10FEB98 & FEB98 pt exp neck pain, vertigo, dizziness;
Date and time the vial was initially stored in the refrigerator on 25-Feb-2022 and date administered on 01-Apr- 2022; Patient received a vaccine past the 30 day storage on the refrigerator; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine past the 30 day storage on the refrigerator) and PRODUCT STORAGE ERROR (Date and time the vial was initially stored in the refrigerator on 25-Feb-2022 and date administered on 01-Apr- 2022) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     Concomitant products included OMEPRAZOLE, IRON and CLINDAMYCIN for an unknown indication.    On 01-Apr-2022 at 11:22 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2022 at 11:22 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine past the 30 day storage on the refrigerator). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date and time the vial was initially stored in the refrigerator on 25-Feb-2022 and date administered on 01-Apr- 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine past the 30 day storage on the refrigerator) and PRODUCT STORAGE ERROR (Date and time the vial was initially stored in the refrigerator on 25-Feb-2022 and date administered on 01-Apr- 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 25-Feb-2022 the vial was initially stored in the refrigerator, its 30 day used by date was 25-Mar-2022. The vial did not undergo any temperature excursions. Patient was administered with booster dose. No treatment information was reported. Patient did not had COVID-19 preceding month of vaccination. Patient had no known allergies of medicines and food.
high fever 10DEC92 t105 until Friday noc, APAP brought fever down no hosp required; not examined by MD but Md states it may be from vax; MD saw pt 14DEC92 fever still 100-101 then found no infect; states not to have HBV until p/1yr of age;
Soreness started at 3:20pm. By 8-9 pm difficulty moving arm. 36 hours later; swelling at injection site hen's egg. Thus called doctor who said that sounded like capillaries were broken inside muscle during administration. Told to apply head for 3-4 days to go back to normal . Today only tenderness at site. Problem at Pneumovax site.
Approximately 3 hours after vaccine given patient reported feeling lightheaded nauseated, faint feelings. Subsided with rest. Next morning felt better but pain from (L) deltoid down to wrist and nausea. 9/6/18-spoke to mother-still with pain at site and nausea. On the date of vaccination-she was not well hydrated with minimal lunch 3 hr prior.
Left arm swelled to 2 x size (per mother). Area not hot to touch. Red - not itchy. BENADRYL/ice to area.
COVID-19 Vaccine Pfizer 5-11 was diluted on 02/22/2022 at 1036 and not discarded at expiration time. Patient was immunized with the  vaccine on  02/23/2022 at 1328.
No local site rxn. No fever. Marble size (L) cervical lymph node tender. No redness.
inconsolable cry for 4 days (if awake was crying);had fever 101-102 w/APAP for 3 days & by 4th day T105;unable to take formula well;rash 2 days p/vax;
Pt claims to have woken up and was burning up.  Sweating and had to remove clothes. She then passed out for what she says was about 15 seconds. Says she has no prior experience of getting any sort of side effects from any other vaccination. Says she was okay after 15 minutes.
This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug allergies/reactions were not provided. On an unspecified date, the patient was vaccinated with an improperly stored PEDVAXHIB (lot #: M047666, expiration date: 24-OCT-2019) for prophylaxis (dose, frequency and route of administration were not reported). The administered dose of the vaccine experienced a temperature excursion of 32 degree Fahrenheit to 35 degree Fahrenheit for 6 hours. There were no adverse effects reported. There was no previous temperature excursion. Digital Data logger was involved. No product quality complaint was involved. This is one of several reports received from the same reporter.
Red raised inflammation at site of vaccine injection. Sore to the touch and slightly itchy. I noticed it a week after injection.
I am having some long term achiness in my left arm it is gone into my shoulder and joint; I am having some long term achiness in my left arm it is gone into my shoulder and joint; the right side is hurting too; This is a spontaneous report from a contactable consumer (patient herself). A 76-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0150/Batch number was not reported), dose 2 via an unspecified route of administration, administered in arm left on 01Apr2021 at 14:00 (at the age of 76-years-old) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation at Hospital. Medical history included diabetes mellitus from an unknown date and unknown if ongoing (Verbatim: Diabetes), hypertension from an unknown date and unknown if ongoing (Verbatim: high blood pressure), blood cholesterol increased from an unknown date and unknown if ongoing (Verbatim: High cholesterol). Concomitant medication(s) included metformin (METFORMIN) taken for diabetes mellitus, lisinopril (LISINOPRIL) taken for an unspecified indication, atorvastatin (ATORVASTATIN) taken for blood cholesterol, acetylsalicylic acid (ASPIRIN (E.C.)) taken for an unspecified indication, pravastatin (PRAVASTATIN) taken for an unspecified indication and insulin (INSULIN) taken for an unspecified indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EN6206/Batch number was not reported), dose 1 via an unspecified route of administration, administered in arm right on 10Mar2021 at 15:00 for covid-19 immunisation. Consumer stated that, patient having some long term achiness in his left arm it is gone into his shoulder and joint and he had Rotator pesto (Not alpha spelled, further clarification unknown) long time ago but he know its not torn he haven't done any thing, and the right side is hurting too, both arm kind of hot, he don't know if its the vaccine but its both arm, right one not too bad, left one so bad, applied cream with lidocaine on it. Consumer stated that, for the treatment of the events he taken Tylenol, and he put Aspercreme with lidocaine. The patient underwent lab tests and procedures which included blood test was unknown on an unspecified date. Therapeutic measures were taken for the events. The outcome of the events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
I was given the Vaccine. I called the CDC after my vaccine and they told me to report it. I was told by numerous people that the vaccine was administered too far up in my left arm it was given in my shoulder. I couldn't move my whole left side 2 hours later after and for several days and had hematoma. I went to a HCF and they told me the vaccine was administered to far up or too deep I have pictures, given me hematoma and sent me home on pain meds. I made a follow-up with Orthopedic who did x-ray and was told I have Bursitis, tendinitis in the rotary cuff due to vaccine on the left shoulder.
Pfzizer vaccine 8/20.  ONset of back pain. onset of dizziness, migraine Saturday. Pounding migraine. photophobia and body aches.   She has "never felt this sick before"   pfizer ew0185
Rt leg swelling, red, warm to touch. Treatment with Cephalexin 250mg.
Narrative: 92yo male died at nursing home with family at bedside. Cause of death not in system. Pt received covid vaccines on 1/15/21 and 2/12/21. Likely death is not related to vaccinations given pt's advanced age and time btwn date of vaccinations & date of death.
2hr post shot - left arm pain, severe headache- lay flat was moderate- sit up felt like my head would explode- severe left eye pain like my eyeball was going to Pop out 4 hrs post shot- chills no fever temp 97.1 fatigue- took a nap.  12 hrs post shot - severe headache,  moderate arm pain and mild swelling at site. SEVERE joint pained tiny joints in ties feet, finger, wrists, neck jaw. Knees were the worst.  16 hours later the joint pain is unbearable . Muscle aching and headache continues at the same time as joint pain.  24 hours post Injection. Chills,moderate painful stomach aching from the inside. Nausea. No vomiting, no energy.  Could not work, had to leave.  29 hours post shot- now all symptoms at the same time chills, headache, severe joint pain, stomach pain, nausea, felt like I couldn?t drive home or walk to my car.  Got home. Called dr. Went to bed. Slept 14 hours.  48 hours post shot- symptoms decreasing. Headache mild joint pain is the worst. Tired and very cold feeling 72 hours- feeling much better.
Employee was given the vaccine in her right arm. Site of vaccine was up to high on her arm resulting in pain and limited range of motion.
Myalgia chills Narrative: Per nursing: "reports took 2nd Covid vaccine on 8- 17-21. C/o body aches and chills and was not able to come to work on 8-18 and 8-20".
started aching 4 days p/vax site of inj lt deltoid progressed to redness & tenderness w/movement;warmth & edema @ inj site progressing through day;local redness erythema swelling=65x65mm;
Information has been received from a pharmacist via a company representative concerning a patient of unknown age and gender. On unknown dates, the patient might was vaccinated with two doses of ZOSTAVAX (lot numbers, expiration dates and route unspecified), respectively. It was reported that each dose was administered on a separate unspecified date but within 5 years of each other (extra dose administered). No adverse effect was reported. Additional information has been requested.
pregnant; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnant) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 05-Aug-2021. On 13-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnant). On 13-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (pregnant) 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 considered MATERNAL EXPOSURE DURING PREGNANCY (pregnant) to be not related.    Concomitant medications were not reported.; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 31-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jun-2021 at 9:14 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 22-Jun-2021 at 9:14 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 18.32.  Concomitant medication of the patient was not reported.  Batch number 008C21A underwent temperature excursion on 22-Jun-2021 with temperature of 35 degrees Fahrenheit at 08:00 AM. These vials were moved to fridge on 27-May-2021 and beyond use date for the vials was reported as 26-Jun-2021. The vaccines moved to clinic on 22-Jun-2021. Storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination. Vials were only punctured right before administration. Vaccines were not frozen at time of administration and prior to administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. The reporter reported that, no data logger reports were available and temperature monitor was used to record hourly temperatures.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-566976 (Patient Link).
head pain - still have this pain - more than 12 hours  mouth and lip trembling - 6 hours  face swollen- still have a swollen face  chest pain - he still has chest pain  high fever - still has fever
Information has been received from a 17 year old female for the Pregnancy Registry for GARDASIL, who in approximately February 2008, was vaccinated with the third dose of GARDASIL when she was 3-4 months pregnant. The patient delivered a healthy baby on 25-SEP-2008. After the third vaccination, the patient had vaginal irritation and sensitivity. She was exposed to HPV after her 2nd dose of GARDASIL. The patient sought unspecified medical attention in the office. Follow up information was received from a Medical Assistant (M.A.) who reported that the patient received the vaccines from her primary physician but baby was delivered by the physician in this office. It was reported that the baby was healthy. No further information is available.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 39-year-old male patient received BNT162b2 (BNT162B2), on 22May2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 38 years, in left arm for Covid-19 immunisation. The patient had no relevant medical history and no known allergies. There were no concomitant medications or other medication in 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Pfizer / BioNTech 22May2021 / Treatment of COVID-19 23May2022". Therapeutic measures were taken as a result of drug ineffective, suspected Covid-19 which included Paxlovid from 23May2022 to 27May2022. The patient had diarrhea and metallic taste in mouth during treatment. Symptoms reduced on second day, gone by day three of 5 day treatment. Three days after completion, fever, congestion, cough all returned. Unsure if adverse reaction to medications or COVID bounce back. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient complained of painful arm since receiving shot. Came in with very red and itchy arm. Gave pt Benadryl, but did not seem to help. Pt went to urgent care who said it was infected. They prescribed Keflex 500mg and Prednisone 20mg. Pt feeling better as of 10/24.
Patient is not 12 years old yet, the minimum age of Pfizer Covid 19 Vaccine.