chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received 1st dose of Pfizer COVID-19 Vaccine around 3:30 pm on February 13th and was asked to wait 30 minutes for observation due to previous history of anaphylaxis to peanuts and latex.    Around 3:43pm patient stated she felt dizzy and light headed and appeared flushed.    Her blood pressure taken at the onset of symptoms was 146/72 and patient stated she had chest pain (7/10 on pain scale).   She stated she felt the same way when she had previous anaphylaxis so an epipen was administered and 911 was called.   About 10 minutes later there was no improvement so a 2nd epipen was administered and she left with EMT.    We have been unable to reach for follow up.
Pt received HPV #3. Once she walked to the front felt dizzy & faint. Had pt lie down with feet elevated & gave juice & crackers.
Developed fever < 12 alter shot swollen tonsil or lymph nodes & L facial swelling injection given SQ on left arm.  No pain or swelling around injection site.  Sx resolving after 48h.
Information has been received from a physician concerning a 12 month old male with a history of asthma and no known allergies who on 28-JUN-2007 at 09:00 was vaccinated subcutaneously in the left upper arm with a 0.5 mL first dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot# 656526/0284U). Concomitant therapy included albuterol. On 28-JUN-2007, the patient developed a red, raised welt at the injection site of the left upper arm within 5 minutes of administration of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). The patient was observed in the office for 20 minutes but no medical treatment was required. The patient was released to home after the symptoms improved. The patient recovered on 28-JUN-2007. There were no laboratory diagnostic tests performed. There was no product quality complaint. Additional information is not expected. This is one of several reports from the same source.
Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 09-SEP-2020, the patient was vaccinated with an improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally as prophylaxis (lot # 1660991 with expiration date 27-APR-2021) (strength and frequency were not reported) and with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0.5 ml as prophylaxis (lot # S036821 with expiration date 21-APR-2022) (strength, frequency, route of administration and anatomical location were not reported).  The improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter. ; Sender's Comments:  US-009507513-2009USA006106:
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021 at 11:54 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 14-Feb-2021 at 11:54 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) 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 31.49 years.  Concomitant medication information was not provided by the reporter.  On 13-Jan-2021, 30 vials were moved to the clinic. On 09-Feb-2021, the vaccine with batch number 031L20A was moved to fridge. Batch number 031L20A underwent temperature excursion on 14-Feb-2021 with temperature 32 to 35 degrees Fahrenheit from 09:00 AM to 03:00 PM. The condition of vaccine prior to vaccination was not frozen. The vaccine beyond use date was reported as 10-Mar-2021.  It was reported that, the storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. It was reported that, the patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021. The health care professional explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree Fahrenheit.  Treatment information was not provided by the reporter.   This case was linked to MOD-2022-566976 (Patient Link).
Narrative: Pt called spoke to Triage who also DX pt to have had an allergic reaction to Covid 19- Pfizer. Pt is treated as an output. Pt has taken Benadryl- 4/19- 75mg total, 4/20-25mg at time of phone with this RN. This RN per PCP advise- pt was advised to take with Loratadine or Cetirizine 1-2X per  day and Benadryl 50mg Q6hrs for breakthrough itching.
Red spot and swelling noted about 2-3 inches below injection site. It was noted upon waking up on Thursday 2/11. Spot is 4-6 inches in diameter. It is warm to the touch. Treating with ice/heat and Benadryl.
Call received after 15 to 20 minutes after father left with the child. He is very upset and states that child is vomiting since getting her flu shot. I can hear child talking and crying in the background. Tried to calm father and assess to see if child got really upset after leaving or had any other symptoms and father hung up or lost connection. Shortly after child's mother called and advised that her husband was taking the child to the ER to be assessed.  Called and spoke with child father after noon. Additional information for Item 18: He reports that he took the child to the ER. He was told at the ER that the vomiting after an injection is a common reaction with a child. He reports that he was told that the child probably got upset and then vomited. No type of treatment was administered at the ER per child's father. He reports that he and his daughter are home now and that she is fine and playing. Patient father very apologetic for "overreacting". Father reports that he plans to get child's next flu vaccine at her PCP's offi
Patient was to received a TDaP vaccine at an Urgent Care Center after repair of a laceration. Due to similar packaging of the TDaP and DTaP vaccines located in the medication refrigerator, the patient inadvertently received the DTaP which is intended for those <7 y/o. After the event it was noted the two prefilled syringes both have the same color green on the syringe label which may have contributed to the error.
patient experienced TMI approx 2 hours post vacc presneted with loss of balance and listed to right. diagnosed by MRI the next day.
Local erythema, swelling, headache, Ibuprofen, DECADRON.
Patient observed circular red area approx 7 cm in diameter around injection site 7 days after vaccination. No tenderness, pain or itching at site.
No signs or symptoms of adverse event.  Inappropriate dosage of vaccination given for patient's age.
I  awoke on May 9th to an extreme itchy feeling on my arm over the area where I received the injection. It is raised and has a  diameter the size of a golf ball . I contacted convienient md and they recommended antihistamine, watch it should become more bothersome or worse, and that I fill out this form.
uncontrollable watery diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (uncontrollable watery diarrhea) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced DIARRHOEA (uncontrollable watery diarrhea). At the time of the report, DIARRHOEA (uncontrollable watery diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
hypersensitivity in his skin; rash all over his body; a rash near injection site; A spontaneous report was received from a consumer concerning a 27-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccination site rash, hypersensitivity in his skin, and  rash all over his body.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 22-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 041L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 30-JAN-2021, the patient experienced the event(s) hypersensitivity in his skin, rash all over his body. The seriousness criteria for both the event was mention as other as per source document.  Treatment details included Benadryl.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), hypersensitivity in his skin, rash all over his body was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient presents with    cough, sputum production, rhinorrhea, congestion, fatigue and sinus pressure     Days since symptom onset: 6   Patient reports that he had COVID 19 in January He is moving in the next few days He has been vaccinated for it.  Feels a numbness and pressure in his teeth.  Felt "really bad" Friday and then felt better Believes this is a sinus infection.
Pt. received HPV #2 on 8/31/15. Injection site became hot and swollen. Pt. returned 1/9/16 for HPV #3 and showed the MD a 6mm non tender pink macule with central thickening, 2mm yellow central discoloration as if a flat pustule. Plan: trial of warm compresses to attempt to get it to drain.
On and off dizziness continuing on and off till present. Dizziness bad enough that can't stand
18 hrs after injection he experienced left chest pain, sore shoulder and bilateral chest pain and shortness of breath. We went to ER where they administered heparin IV, kept home, did an angiogram and then quadruple bypass. We are not doing the vaccination caused his blockages.. just want to make sure it doesn't cause blood clotting which led to his angina.
pt recv vax 23SEP97 & w/in 4hr of vax pt exp a local rxn, 3 inches in size that was red, hard, warm & painful;pt arm was reported as sore & APAP gave some relief;
This spontaneous report as received from a medical assistant referring to unspecified number of patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patients were vaccinated with improperly stored dose of ROTATEQ lot # M007298, expiry date: 19-NOV-2017 (dosing details were not reported). It was reported that the vaccines were exposed to a temperature of 0.7C during a time frame of 2 hours. No previous temperature excursion was reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Pt is a 55 yr old male 2nd Moderna covid19 vaccine on 2/11/2021 presented to the ER on 4/24 with c/o rlq abd pain x 1 day. CT scan with acute appendicitis. Taken to the OR for appendectomy.
Intense metallic, burning sensation in mouth and on tongue within 1 minute after vaccine and lasting 3.5 hours. Mouth irritation is milder but still present the day following the vaccination (22 hours).
This is a spontaneous report from a contactable consumer (medical assistant) on behalf of the practice. A 69-year-old female patient received PREVNAR 13, (Lot # R28322, Expiry Date 30Mar2018, NDC #0005-1971-01) intramuscular at 0.5ml, single at left deltoid on 25May2017 approximately 11:30am for immunization, for prophylactic vaccination against pneumonia, at physician office. Medical history included vitamin D deficiency from Nov2016 and ongoing, nicotine dependence from Nov2016 and ongoing, anxiety from Mar2016 and ongoing, dyslipidaemia from Mar2016 and ongoing, hypertension from 20Mar2016 and ongoing, ongoing atrial tachycardia, constipation treated with Glycoax. Concomitant medication included ongoing ALPRAZOLAM 0.5 mg, as needed (0.5mg BID PRN tablet) for anxiety, ongoing AMLODIPINE 5 mg, 1x/day (5mg 1 tablet QD) for hypertension, ongoing ASPIRIN 81 mg, daily (81mg daily tablet) for atrial tachycardia, ongoing GLYCOLAX 17g per dose oral powder daily for constipation. No history of all previous immunizations with PREVNAR 13. No additional vaccines administered on same date of PREVNAR 13. No prior vaccinations within 4 weeks. The patient's last vaccine was the influenza in Nov2016 for immunisation. On 25May2017 the patient experienced lump at injection site and soreness at injection site. On 30May2017 she experienced rash at the injection site, a couple inches from the injection site that started 5 days after the vaccination. The patient thought she had shingles because the rash was away from the injection site. She had been applying AVEENO cream to the area. No event required a visit to Emergency Room, but Rash and lump required a visit to physician office. The outcome of rash and soreness was unknown, of lump at injection site was not recovered.
No additional AE reported; Patient was administered both improperly stored ROTATEQ and improperly stored VAXELIS; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapies were not reported.       On 05-FEB-2022, both rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot #1741817, expiration date 30-JUL-2022) and diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) (lot #U7124AA, expiration date 13-JUL-2024) had occurred a temperature excursion in 0.8 degree Celsius for 35 minutes. And on 25-FEB-2022, the patient was vaccinated with both improperly stored vaccines (strength, dose and route of administration were not provided) for prophylaxis (product storage error). There was no previous temperature excursion. No additional adverse event (AE) reported.   This is one of multiple cases received from the same reporter.
Patient became pale and felt faint while sitting in the observation area after receiving the vaccination. He was alert and talking but quickly reported the need to lay on the floor with dizziness and faintness. The patient began feeling better after laying down and wanted to then sit in the chair again. After sitting up a second time the patient fainted in the chair and was guided to the ground where he became alert again and waited until the medics arrived. After some time with the medics the patient began feeling better and declined to be taken for further medical treatment.
Patient received an adult dose of HEP A and not the pediatric dose, no adverse signs or symptoms that I am aware of.
Muscle aches, headache, earache, Sever chills, loss of appetite, diarrhea
A physician reported that an 11 month old male, post vax, "presented with symptoms of diabetes". The pt was dx'd with insulin-dependent diabetes mellitus. The pt's family has no history of diabetes. Hospitalization was presumed but not documented.
Altered mental state/semi-conscious.  Awake but  unable to respond to questions., unable to rise from seated position.   Lasted approximately 5 hours.  Has no memory of this time  period.   Headache, weakness, fatigue persisted beyond 5 hours.  Was fatigued for approximately 48 hours.  Typically, he has excellent cognition,  and is alert and oriented.  His wife spoke to Dr., but didn?t have office visit.
soreness and pain at injection site that worsened in left arm upper back and left axilla lymphadenopathy
Dizziness started  2 hours after vaccination. Next day, dizziness.  Dizziness persisted on 4th day and had an associated headache. Seen by MD. No meds given; blood work drawn. She feels her speech is slurred. She feels slow.
Patient's parent reported to manager that his daughter had nerve damage from receiving the shot. Her arm is in pain and getting progressively worse since receiving the vaccine. She has to wear a sling.
Pt. stated we gave her a "lethal injection" and that she is now paralyzed. When asked to clarify and give more symptoms she refused to give any more information and just kept repeating that we gave her a "lethal injection".
The vial was stored in refrigerator post puncture; No adverse event; Received expired Bivalent booster beyond 12 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired Bivalent booster beyond 12 hours post puncture), PRODUCT STORAGE ERROR (The vial was stored in refrigerator post puncture) and NO ADVERSE EVENT (No adverse event) in a 35-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 020H22A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Nov-2022 at 2:10 PM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 22-Nov-2022 at 2:10 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired Bivalent booster beyond 12 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was stored in refrigerator post puncture) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired Bivalent booster beyond 12 hours post puncture), PRODUCT STORAGE ERROR (The vial was stored in refrigerator post puncture) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Received expired Bivalent booster beyond 12 hours post puncture) and PRODUCT STORAGE ERROR (The vial was stored in refrigerator post puncture).    No concomitant medications were reported.  It was reported that individual vials was first punctured on 21-Nov-2022 at 8:15AM. The vial did not undergo any temperature excursions. Vial was not stored at room Temperature. It was exposed to refrigerator temperature after first puncture for less than 24 hours. The vial was initially stored in the refrigerator was on 16-Nov-2022.   No treatment medications were reported.
The night of the vaccine i developped chills and a fever which lasted through the next day.... after that i started having a sensation of a blood pressure cuff going on and then wierd sensations down to my finger tips.. like a tens unit would feel like... my arm gets weak as this happens... it is in the left arm where i had the vaccine done.  it happens  on and off day and night since day 2 of getting the vaccine...
SECOND SHOT MADE ME EXTREMELY DIZZY; I ABOUT INJURIED MYSELF FALLING SEVERAL TIMES; I ABOUT INJURIED MYSELF FALLING SEVERAL TIMES; doses administered 14 days apart; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (SECOND SHOT MADE ME EXTREMELY DIZZY), INJURY (I ABOUT INJURIED MYSELF FALLING SEVERAL TIMES), FALL (I ABOUT INJURIED MYSELF FALLING SEVERAL TIMES) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (doses administered 14 days apart) in a 64-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 025J20-2A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol and Blood pressure high. Concomitant products included INSULIN for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (SECOND SHOT MADE ME EXTREMELY DIZZY), INJURY (I ABOUT INJURIED MYSELF FALLING SEVERAL TIMES), FALL (I ABOUT INJURIED MYSELF FALLING SEVERAL TIMES) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (doses administered 14 days apart). At the time of the report, DIZZINESS (SECOND SHOT MADE ME EXTREMELY DIZZY), INJURY (I ABOUT INJURIED MYSELF FALLING SEVERAL TIMES) and FALL (I ABOUT INJURIED MYSELF FALLING SEVERAL TIMES) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (doses administered 14 days apart) had resolved.            Patient was on cholesterol medication and high blood pressure medication before he received the vaccine. No Treatment medications was provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Sep-2021: Followup received on 10-sep-2021, contains about concomitant medication and about dosage details.
Heavy menstrual period started day after vaccination. Currently breastfeeding and have not had menstrual cycle since October 2020. Menstrual cycle not expected.
She got her vaccine, had no reaction, basically felt fine.  Then about on 10/10/21, her body started vibrating and woke up with whole body vibration.  She went to the hospital and said that they could not help her.  She went to the doctor to ask him what he can do, and ordered an MRI of the brain, and advised to go to a neurologist.  She has had a frozen shoulder and has a neck issue.   She has neuralgia of her face but takes no medication for that.  They gave her Neurontin and the neuralgia comes and goes.  She has not had any symptoms for a year and a half.    She is trying to see about the vibration.