chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient reported numbness sensation in her lower jaw and tongue, as well as warmness near her eyes. She was given 2 benadryl 25 mg tablets and 2 famotidine 10 mg tablets. Patient reported some relief, but after about 10 minutes reported she was starting to have tightness in her throat. The first epipen was administered. Patient reported some relief after the first injection, but still had numbness in her jaw, tongue and did not have full relief of throat tightness. 2nd epipen was administered. Patient reported full relief of symptoms. EMS arrived, took patients vitals. Patient's vitals were within normal limits, but was taken to the emergency room for further observation.
Temp 97.7 BP 118/68 complained of rash 2nd day after TdaP on arms, legs.
SED rate and C Reactive Protiine as well as other bloodwork started being abnormal about ten days after shot two.  It did not go down until I was hospitalized May 7 and diagnosed with atypical pneumonia.  Felt bad whole time and ran temps.
pain at site, continues, had chills, felt tired and body pain for 48 hours after shot
Respiratory distress, breath shortness, had to think to breathe, Flemm, cannot clear throat
Patient received flu shot at approximately 12:30pm, around, 3:30pm began feeling increased heart rate, shortness of breath followed by dizziness. Pt went to Er where vitals were monitored, no treatment was given, just observation.
After the 2nd dose vaccine,  I had fatigue and sore arm.  I also  had swelling of lymph node in my left arm pit for 1 week.  About 5/10/2021 I did not get my menstrual cycle when expected.  I am relatively very regular.   On 6/16/2021, I had light spotting that day. On 6/27/2021 I did get my period.  It was heavier than normal and lasted 3 days.   My last normal period was in March 2021. So I basically did not get a period for 3.5 months.  I am going to follow up with OBGYN and my appointment is on 7/28/2021 in 2 weeks.
Received first dose 1/8/21. woke up 1/18/21 with severe vertigo. Still has it. Was started on Meclizine, with no effects. Started on prednisone yesterday 2/1/21
Experienced vaccinator Dr, MD was vaccinating the VR and during the attempt to deploy the syringe, the needle separated from the syringe.  Dr, MD was certain that the needle separated prior to the actual deployment of the syringe.  The Vaccinator wasted the dose and removed the needle from the VRs arm and administered a new dose.  The Vaccinator discussed the situation with staff who then discussed the incident with the VR and the VRs mother.  Both the VR and mother demonstrated understanding of the situation.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Jul2023 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hayfever" (unspecified if ongoing); "lactose intolerance" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (Aug2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 as Paxlovid from 10Aug2023 to 14Aug2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Within 48 hrs of receiving flu vaccine, pt develped sharp chest pain,non-productive cough. No fever/chills/SOB. CXR-neg. Dx. ?
6 patient received vaccine from the syringes after 6 hours of recommended time frame; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (6 patient received vaccine from the syringes after 6 hours of recommended time frame) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. unknown, unknown and unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (6 patient received vaccine from the syringes after 6 hours of recommended time frame). On 13-Mar-2021, EXPIRED PRODUCT ADMINISTERED (6 patient received vaccine from the syringes after 6 hours of recommended time frame) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information not provided.  Treatment information not provided.  Action taken with mRNA-1273 in response to the event/s was not applicable
Left forearm swollen the night of the shot. Next day, Sunday, right hand swollen.  Monday  morning, left eye swollen shut. Wednesday morning, right eye swollen
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant information was reported. The date of placed in refrigerator was on 22-Sep-2021 and vaccine did not undergone any temperature excursion. No other adverse events were reported for patient. No Treatment information was reported.
Information has been received from a registered nurse concerning a female patient who was vaccinated with a dose of GARDASIL concomitantly with a dose of MENACTRA and a dose of DTaP.  Subsequently the patient developed knot at the injection site where she received DTaP. It was reported that the patient with a knot or "raised area" that was 1 and 1/2 inches long. At the time of the report, the patient's outcome was unknown. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 2/14/2007. Initial and follow-up information has been received from a registered nurse concerning a 13 year old female who on 15-JAN-2006 was vaccinated, into the left deltoid, with a first dose of GARDASIL vaccine (lot #654389/0961F) concomitantly with a first dose of MENACTRA vaccine (lot #U1893AA) in the left deltoid and first dose of BOOSTRIX (lot #AC52B009AA) into the right deltoid. There were no concomitant medications. On 17-JAN-2007, the patient developed knot at the injection site where she received BOOSTRIX. It was reported that the patient presented with redness and a knot of "raised area" that was 1 and 1/2 inches long. Follow-up reported that the patient had mild erythema (no swelling) at the injection site of GARDASIL vaccine and MENACTRA. The patient was seen in the physician's office on 17-JAN-2007. At the time of the follow-up report, the patient's outcome was unknown. Additional information is not expected.
Red arm, swollen, hot, hard, painful. Site of injection look fine, but had bug bite on spot below from early summer.
Pt has had extreme shoulder pain, limited range of motion, can not do normal every day activities such as clasping bra strap, lifitng weights. has had to make modifications for daily activities. has seen a dr and taken ibuprofen 800mg, which did not alleviate pain and caused gi side effects. still in pain 1 month post immunization
Extreme fatigue, headache, body aches, rash at injection site, pain/soreness in arm
Information has been received from a health professional concerning a patient who on an unspecified date, was vaccinated with the first dose of MMR II, 0.5 mL. The reporter stated, that on an unknown date, "after receiving MMR II the patient experienced hives at the site the injection was given. Additional information has been requested.
After my first vaccine I started to have cellulite at the injection site. With my second vaccine I continued to have severe inflammation and cellulitis at the injection site, lower back pain, nausea, and headaches which I did not have before. These headaches started four days after my second dose. I also had dehydration and I am still having low back pain with weakness.
Sore Arm immediately. Body aches, chills, sweats, high blood pressure 156/105, sore joints, severe headache, nausea, swollen glands in neck and under arm pits and in breasts,  could not lift arms without pain, walking hurt, swallowing hurt, chest and ribs hurt to breathe, insomnia, jitters, entire body was in pain, every ounce of my body and it hurt to even roll over in bed or get up and walk. This lasted for 5 days in a row and started the evening that I got the shot. I was perfectly well before the shot.
Large (approximately 3 inch by 4 inch) bright red patch on upper left arm where injection was given, but not centered around injection site (lower). Hot, red, swollen. Intermittently itchy. Onset 7 days post vaccination and being hot/bright red lasted 8 days, but visible ring on skin lasted another week.
This spontaneous report was received from a Certified Medical Assistant (C.M.A.), regarding to multiple unspecified patients of unknown ages and gender. The patients' medical history or concurrent conditions were not provided. On an unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (therapy type: Digital Data Logger) (lot # L044475, expiration date 12-MAY-2017) (dose, route of administration and anatomical location were not provided). The vaccines were subjected to temperature excursions of 23.3 degrees C for a time frame of 45 minutes. Back in range was reported as yes and there was no previous temperature excursion. Concomitant medications were not provided. No adverse effects were reported. Product quality complaint was not filed. This is one of several reports from the same source (MARRS #1605USA012734, 1606USA005737, 1606USA005738, 1606USA005740, and 1606USA005741). Additional information has been requested.
Patient was administered original Pfizer Covid-19 vaccine instead of requested /indicated bivalent Covid-19 vaccine
The symptoms gradually came on over a six-day period from the time I received the vaccination. Had a fever and a red rash. Weakness in lower part of my body. Foot, legs, thighs and knees, had extreme pain in my joints, the crippling effects slowly moved up my body and rash followed, blisters in mouth, horrible skin infection testicle, grown.
chills; myalgia; fatigue; nausea; diarrhea; This is a spontaneous report received from a non-contactable reporter(s) (Pharmacist).  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 immunization, reaction(s): "Chills", "Fatigue", "Myalgia".  The following information was reported: CHILLS (non-serious) with onset 04Oct2021, outcome "recovered" (06Oct2021), described as "chills"; MYALGIA (non-serious) with onset 04Oct2021, outcome "recovered" (06Oct2021), described as "myalgia"; FATIGUE (non-serious) with onset 04Oct2021, outcome "recovered" (06Oct2021), described as "fatigue"; NAUSEA (non-serious) with onset 04Oct2021, outcome "recovered" (06Oct2021), described as "nausea"; DIARRHOEA (non-serious) with onset 04Oct2021, outcome "recovered" (06Oct2021), described as "diarrhea". Therapeutic measures were not taken as a result of chills, myalgia, fatigue, nausea, diarrhoea.  Additional information: The patient, who is a pediatrician, received a booster dose of the Pfizer COVID vaccine and experienced chills, myalgia, fatigue, nausea and diarrhea. The symptoms lasted for two days. The patient stated that she had experienced similar symptoms after the second dose of the vaccine except for nausea and diarrhea. The patient did not have covid prior vaccination, not tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician referring to an unknown number of patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unknown dates, on or after 01-APR-2016, the patients were vaccinated with improperly stored doses of PROQUAD (lot # L031603 with expiration date 18-FEB-2017, therapy type rHA; lot # M007965 with expiration date 15-AUG-2017, therapy type rHA; dose and route were not reported). It was reported that the vaccine was improperly stored at 35.47 Fahrenheit for 314 hours and 15 minutes. There was no previous excursion. Data logger was involved. No adverse effect was reported. Follow up information has been received from the physician on 24-OCT-2016. On 24-OCT-2016, a call was placed to the physician. The call was received by another physician. The physician reported that she would have to research the request made for patient identifiers, lot number and expiration date and dates of vaccination. Follow-up information was received on 09-NOV-2016 from an unspecified reporter, who provided the patient's demographics, and stated that the patient was vaccinated with an improperly stored dose of PROQUAD 0.5 ml (dose unspecified) with lot number K011188 (unspecified expiration date). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information is not expected, as follow ups requested to complete the case were received.
pt recv vax 19DEC96 & w/in 12hr of vax pt exp chills, fever to 102, & nasal congestion;
This case reference number 2000004144-1, is a spontaneous report from a nurse practitioner referring to a 35 year old male. The patient is Allergic to Penicillin, peanuts, ragweed, pollen, bee stings, and mold. He has had Asthma since birth and eczema for which he uses Cortisone cream when necessary. On 6/3/99 and 7/7/99, the patient received the first and second doses of Engerix-B for Prophylaxis of Hepatitis B (job requirement). Following his second dose of Engerix-B, the patient broke out all over in hives, and was nauseous. The most recent information, received on 2/10/00, reports the condition of the patient as resolved.
one of their pediatricians had given a Daptacel and Pentacel vaccinations to a 15 month old on the same day. 0.5 ml Daptacel was given in the left thigh, today and 0.5 ml of Pentacel was given in the right thigh with no reported adverse event; Initial information was received on 12-May-2021 regarding an unsolicited valid non-serious case from a other health professional (Inquiry number: 00598178).  It was reported that a 15 month old female patient received 0.5 ml of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number: C5765BA, expiry date: 28-Aug-2022)in the left thigh, today and 0.5 ml of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and also received PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVENAR 13) (not produced by Sanofi Pasteur) via an unknown route for prophylactic vaccination (extra dose administered).  It was a case of actual medication error due to extra dose administered.  At the time of report, no adverse event reported.  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.
rash to the tops of her hands, the inside of her wrists, tops of her feet, and a big splotch on her ankle; This is a spontaneous report from a contactable consumer or other non hcp.    A 49-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection Batch/Lot Number: EN5318), dose 1 via an unspecified route of administration, administered in Arm Right on 01Feb2021 11:00 as 1ST dose, single for covid-19 immunisation. Medical history included osteoarthritis from 2019 to an unknown date, major depression from 2000 to an unknown date, arthritis. Concomitant medication(s) included prednisone (PREDNISONE) taken for arthritis. Consumer stated she had her first dose of the Pfizer COVID-19 vaccine on Monday morning, and this morning she had a rash to the tops of her hands, the inside of her wrists, tops of her feet, and a big splotch on her ankle and also having any difficulty in breathing, but she is wondering if she can take an antihistamine and monitor the rash. but sometimes she took Prednisone 10mg for inflammation of arthritis, and she was taking it before she got the vaccine then discontinued for two days after the vaccine, then resumed. The outcome of the event was unknown.   Follow-up attempts are completed. No further information Is expected.
vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) 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 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 18-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy). On 18-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant products were provided by reporter.  No treatment information was provided. She was 20 weeks pregnant.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Minor itching on face, lower back, arms, legs, and belly. Elevated heart rate ranging from 80-95bpm. I took a Zyrtec to help with symptoms at 2:00pm. It did help reduce some of the symptoms. It is presently 3:23pm and some of the itching has subsided but my heart rate is still in the 80s.
My arm got sorer and stiffer. Followed by I could barely lift it and can hardly steer my car. Hard to put on and take off t-shirts. Hard to lift with my arm and it is weaker now.
patient chest broke out in hives. gave 10ml benadryl and hives went down
Headache-2 days Fever-8 hours Muscle ache-2 days (hip joint still feels achey almost a week later Fatigue-1 day Swollen lymph nodes in armpit and collar bone 3 days Tylenol taken as needed
NO ADVERSE EVENT OCCURRED, BUT THE DRUG INTERACTION WITH REMICADE WAS IDENTIFIED
Pain started to radiate up my arm, from the injection site, up to my neck and collar bone; Pain in neck/ The lump was painful to the touch.; Firm lump the size of a marble on neck; Area is also red and swollen; Area is also red and swollen; Sweat profusely; Pain has begun to radiate up the left side of head; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0161) via an unspecified route of administration in the arm left on 19Apr2021 at 11:45 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. It was unknown if the patient had any medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) for unknown indication, from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on an unknown date as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 19Apr2021, the patient experienced pain started to radiate up her arm, from the injection site, up to her neck and collar bone, pain in neck, and upon inspection found a firm lump the size of a marble on neck. The area was also red and swollen. The lump was painful to the touch. She began to sweat profusely the at the time the pain started and the pain had begun to radiate up the left side of her head. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken for the reported events. The clinical outcome of the events pain started to radiate up her arm, from the injection site, up to her neck and collar bone, pain in neck, firm lump the size of a marble on neck, area was red and swollen, sweat profusely and pain begun to radiate up the left side of her head was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.