chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information has been received from a physician and follow up information from a health professional concerning a 66 year old female patient who with no known allergies who on 21-Oct-2008 was vaccinated intramuscularly in her right deltoid with 0.65ml dose of ZOSTER vaccine (lot# 659406/0298X). Concomitant therapy included vitamins (unspecified). On 25-Oct-2008 the patient developed an eruption on the left side of her neck with approximately 5 lesions, along a dermatome consistent with shingles (also reported as mild shingles) and no pain (0 on a scale of 0 to 10 with 10 being the highest). A direst fluorescent antibody was not performed. A photo was not taken. At the time of this report the patient had recovered. The patient was enrolled in the VARICELLA  ZOSTER virus identification program to identify if VZV is present and if it is present to identify if it is associated with the wild- type VZV strain. No further information is available.
Case number PHEH2014US003632 is an initial spontaneous report received from a pharmacist on 21 Feb 2014: This report refers to a 68-year-old male patient who was inadvertently vaccinated with MENVEO (batch number: unknown) intramuscularly at a dose 0.5ml on 25 Jan 2014. No adverse event was reported following this administration error (inappropriate age at vaccine administration).
Allergic reaction to TDAP rash, shortness of breath, wheezing chest tightness.
About 30 minutes, post vax, pt felt anxious, nauseous, faint and had a funny sensation in throat. He was given .3 of Epi and Benadryl and felt better. No SOB, no tongue swelling, DTR's ok, nml exam following visit to our facility. He subsequently, visited the ER 4 times over the next 5 days with dizziness, near syncope and nausea. Received fluids and labs nml, CT Scan of head-nml. Referred to a neurologist to see on 4/21/01. Also saw PMD on 4/5/01. Symptoms wax and wan. Still having symptoms.
This initial spontaneous case, was received on 17-Oct-2017, from other non-health professional, concerning an female patient (reported as of mid-50's). The patient had no medical history or concomitant medications. On 17-Oct-2017, the patient was administered with FLUVIRIN (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number, expiry date: not reported). It was reported that, when the needle was removed from the patient's arm a drop of vaccine splashed into the patient's eye (explicitly coded as exposure via eye contact). No treatment was provided and no adverse events were reported. The reporter assessed the events as non-serious.
Night Sweating; Chills; Constant Headache; Nausea; Body ache; Covid 19; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (Night Sweating), COVID-19 (Covid 19), CHILLS (Chills), HEADACHE (Constant Headache) and NAUSEA (Nausea) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced COVID-19 (Covid 19). On an unknown date, the patient experienced NIGHT SWEATS (Night Sweating), CHILLS (Chills), HEADACHE (Constant Headache), NAUSEA (Nausea) and MYALGIA (Body ache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, NIGHT SWEATS (Night Sweating), CHILLS (Chills), HEADACHE (Constant Headache), NAUSEA (Nausea) and MYALGIA (Body ache) had not resolved and COVID-19 (Covid 19) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Feb-2021, COVID-19: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
fever x 2 days;had febrile sz 48hr post vax event lasted 3min;generalized tonic sz;
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with ROTATEQ. Dose, route, lot number and expiration date were not reported. The nurse reported that doses of ROTATEQ were stored improperly and administered to an unspecified number of patients on unspecified dates. No adverse effects were reported. This is one of several reports from the same source. Additional information is not expected since we can not contact physician.
This spontaneous report as received from a Licensed Vocational Nurse refers to a female patient of unknown age. Medical history, concomitant medication and current conditions were not reported. On 26-OCT-2013, the patient was vaccinated with VARIVAX (dose, indication, Lot # and expiration date were not provided) in error, because the patient was indicated to receive ZOSTAVAX. The nurse states that the person who administered the dose of VARIVAX to the patient may have confused VARIVAX with ZOSTAVAX. The nurse reports "They refer to ZOSTAVAX as chickenpox because if a person has had chickenpox, he or she has chance of developing shingles." The medication error was identified on a routine office visit on an unknown date, on which the patient claimed she had received the shingles vaccine. The patient did not experience any adverse events. Additional information has been requested.
This spontaneous report has been received from a physician referring to a 14 years old female patient. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not provided. On an unknown date, the patient was vaccinated with GARDASIL 9 (dose 1; batch/lot#, expiration date and route were unknown) for prophylaxis. On an unknown date, the patient started getting dizzy a lot. The physician mentioned the patient never came in to the office to receive a second dose. The outcome of the event was unknown.  The causality between GARDASIL 9 and the event was unknown.
Child c/o face hurting and stomach ache following nasal mist (H1N1). Stated she did not have breakfast, no Resp. distress or rash observed. B/P 110/68. Child allowed to eat lunch since vaccine given on empty stomach. After lunch states she feels no better. Parent called by school.
i have been throwing up; heavy coughing; congestion; always exhausted; can't sleep; This is a spontaneous report from a contactable consumer (patient). A 20-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0217, Expiry date: not reported) via an unspecified route of administration, administered in Arm Right on 09Jun2021 11:45 (at the age of 20 years old) as dose 1, single for COVID-19 immunization at Pharmacy or Drug Store. The patient was non pregnant at the time of vaccination. The patient medical history and concomitant medications were not reported. The patient had no known allergies. The patient had not received any other vaccine within 4 weeks. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID post vaccination. On 10Jun2021 10:30, the patient had been throwing up, heavy coughing, congestion, always exhausted but can't sleep. It was unknown if patient received treatment for the events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.  Follow-up (12Jul2021): Follow-up attempts are completed. No further information is expected.
exhaustion; I came down with fever; chills; clogged sinuses; body aches; I was sick for 6 days and then got a bad sinus infection because of it; I was sick for 6 days and then got a bad sinus infection because of it; I still dont feel well.; This is a spontaneous report from a contactable consumer (patient). A 70-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date were not reported), via an unspecified route of administration, administered in left arm on 15Feb2021 12:00 (at the age of 69 years) as dose 1, single for covid-19 immunization. Patient also received an unspecified Pfizer vaccine (Lot number: SA1849568) via unspecified route on 22Feb2021, for unspecified indication. Patient's medical history included haemochromatosis from an unknown date and unknown if ongoing and had allergies to codeine and morphine. Patient did not have covid prior vaccination. Concomitant medications included amlodipine; fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]); and hydrochlorothiazide, all taken for an unspecified indication, start and stop date were not reported. No other vaccine were given in four weeks (as reported). On 25Feb2021 12:00, 9 days after the first dose, the patient came down with fever, chills, clogged sinuses, body aches and exhaustion. Patient was sick for 6 days and then got a bad sinus infection because of it. Patient also got retested for covid during that time because it was very similar to covid and underwent lab tests and procedures which included sars-cov-2 test by nasal swab: negative, home test on 28Feb2021. It was reported that, it had been 10 days and patient still was not feel well. Patient went to doctor who said that it was pretty common. Therapeutic measures were taken as a result of events and patient received treatment with Tylenol, used rescue inhaler if needed, and rest. The clinical outcome of all the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
could not sleep; full long lasting numbness of the right foot/numbness below the knee; could not move; sharp and extreme pain in calf; swollen leg/knee; little soreness at the injection site; pain and soreness in whole arm (injected arm); This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (could not sleep), HYPOAESTHESIA (full long lasting numbness of the right foot/numbness below the knee), HYPOKINESIA (could not move), PAIN IN EXTREMITY (sharp and extreme pain in calf) and PERIPHERAL SWELLING (swollen leg/knee) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced INSOMNIA (could not sleep), HYPOAESTHESIA (full long lasting numbness of the right foot/numbness below the knee), HYPOKINESIA (could not move), PAIN IN EXTREMITY (sharp and extreme pain in calf), PERIPHERAL SWELLING (swollen leg/knee), VACCINATION SITE PAIN (little soreness at the injection site) and MYALGIA (pain and soreness in whole arm (injected arm)). At the time of the report, INSOMNIA (could not sleep), HYPOAESTHESIA (full long lasting numbness of the right foot/numbness below the knee), HYPOKINESIA (could not move), PAIN IN EXTREMITY (sharp and extreme pain in calf), PERIPHERAL SWELLING (swollen leg/knee), VACCINATION SITE PAIN (little soreness at the injection site) and MYALGIA (pain and soreness in whole arm (injected arm)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided. Treatment details included Heat application.
Developed shingles two weeks after 2nd dose; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 20Mar2021 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. The patient had medical history of known allergies to anticholinergic drugs. Concomitant medications included antibiotics, loratadine (CLARITIN), vitamin d nos (VIT D), ascorbic acid (VITAMIN C), cyanocobalamin (vitamin B12), bifidobacterium Infantis, lactobacillus acidophilus (PROBIOTIC) and fish oil (MANUFACTURER UNKNOWN); all from an unknown date for an unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left arm on 27Feb2021 at 13:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 01Apr2021, two weeks after second dose, the patient experienced shingles. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of shingles which included treatment with valacyclovir (VALTREX). On 04Apr2021, the patient underwent lab tests and procedures, which included PCR test (nasal swab) and the result was pending. The clinical outcome of shingles was recovering at the time of this report.   No follow-up attempts are possible; No further information is expected.
it hurts down the ribcage; side hurts; couldn't lift her arm up; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received pneumococcal 13-valent conjugate vaccine (Diphtheria CRM 197 Protein) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as for immunization.  The patient's medical history and concomitant medications were not reported.  The patient reported when she got the pneumonia shot, she got the thing where she couldn't lift her arm up and it hurts down the ribcage. She was not sure if it effects the lungs more. Her side hurts when she gets the pneumonia vaccine. Outcome of the events was unknown.  Pfizer is a marketing authorization holder of pneumococcal vaccine in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of pneumococcal vaccine has submitted the same report to the regulatory authorities.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recvd vax; pt devel diarrhea, nausea & vomiting; pt taken to MD;
Became very itchy almost a week after, is swollen with red ring around where I got injection and has a huge hard lump and hurts
On 1/16/08, patient phoned office to report some redness and tenderness of left arm.  On 1/17/08, client reported to myself that left upper arm where she received pneumonia and flu was the size of a "baseball" in redness, very warm, painful to touch.
I started on 11-16-12 with a severe scratchy throat then followed by body aches and pains all over, headache, lightheadedness, dizziness, no appetite, not able to hold anything down but water, extreme fatigue, extreme weakness, chest tightness, congestion, severe coughing spells with sputum, vomiting, diarrhea, wheezing, thick phlegm, rib pain and fever.
Temp of 103.5 the night of vaccine, 101.5 the second night. Severe headache, body aches, fatigue
diagnosed a bacterial infection; rash at injection site/The rash is just below the injection site and measures about 2 inches by 3 inches; muscle aches; injection site pain; This case was reported by a consumer via call center representative and described the occurrence of bacterial infection in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (received 1st dose on unknown date, refer case US2019210389).   On 15th May 2020, the patient received the 2nd dose of Shingrix. On 15th May 2020, less than a day after receiving Shingrix, the patient experienced injection site pain. On 16th May 2020, the patient experienced bacterial infection, rash and muscle pain. The patient was treated with doxycycline. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the bacterial infection was unknown and the outcome of the injection site pain and muscle pain were recovered/resolved and the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the bacterial infection, injection site pain, rash and muscle pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced injection site pain that had resolved.   The patient experienced muscle aches the next day, which had resolved.   The patient reported that a rash at the injection site began the next day, and had progressed further and larger.   The rash was just below the injection site and measured about 2 inches by 3 inches and was rectangular.  This event has not resolved. The patient called again and reported that the rash was below the injection site.  The patient took photos and sent them to her dermatologist who diagnosed a bacterial infection and prescribed doxycycline.  The rash was still present. The reporter did not consent to follow up.
Tachycardia on day 6 and day 7 after the second Moderna shot, lasting approximately 5 to 10 minutes each day.
This spontaneous report as received from a nurse refers to a 19 year old female patient. The patient was not pregnant and had no drug reaction/allergies. On 22-APR-1994, the patient received her first dose of an unspecified Hepatitis B vaccine (route, dose, frequency, lot # and expired date were not reported). Since the first dose of the Hepatitis B vaccine was unknown, this was being reported as Merck's RECOMBIVAX HB. The patient received a second and third dose of a Hepatitis B vaccine which the nurse confirmed was ENGERIX-B lot#1259A9, on 16-JUN-1994 and a third dose of ENGERIX-B, lot# 1468B2, on 20-OCT-1994. The patient had titers drawn on 22-JUL-2013 and the titers showed that the patient did not "seroconvert". Since the patient's titer showed that the patient did not "seroconvert" on 22-JUL-2013, the patient was administered RECOMBIVAX HB, (batch # H018635, lot # 1722Z, expired date: 16-DEC-2013), on 05-AUG-2013 and a second dose of RECOMBIVAX HB, (batch # H010849, lot# 0334AE, expired date: 28-FEB-2015) on 25-NOV-2013. The nurse reported that the patient would be receiving a third dose of RECOMBIVAX HB "today" (approximately on 21-APR-2014). She stated that the lot# of the RECOMBIVAX HB the patient would be receiving "today" was "0334A3", batch # "H010671" and the expiration date was 28-FEB-2015. The patient was given treatment. The outcome of adverse event was not reported. Additional information has been requested.
Patient chronic conditions (JIA, UC) previously controlled on adalimumab.  Within several days of receiving COVID-19 vaccine dose #2, patient began experiencing worsening/flare of ulcerative colitis symptoms including stomach pain, diarrhea, fatigue, arthritis pain that lasted beyond the reasonable and known duration of vaccine related side-effects. Symptoms treated with dicyclomine and acetaminophen with no relief.  Symptoms continued x 2 weeks.  Patient ultimately required addition of budesonide to treatment regimen for ulcerative colitis and is currently having relief of symptoms.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. The nurse reported that on 22-JUN-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # K009953, expiry date 03-APR-2016 (dose and route of administration unspecified). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 28-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 14-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided. No concomitant medication was provided. The vaccine was administered after 19 days from  time from first puncture.   This case was linked to MOD-2021-332638 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow-up received with no new information, but action reassessed and updated to not applicable because only event in case is medication error.
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. On an unknown dates, the patients received improperly stored GARDASIL dose, route, lot numbers and expiration dates were not reported. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
2 days after receiving vaccines pt developed increased redness, warmth and pain of left thigh. Continued to worsen over next 2 days until seen at apt on 7/22/08. At that time an area of cellulitis was noted on leg measures 9 x 6.4 cm. She was started on KEFLEX and BACTRIM (to cover MRSA) at the appt.
Patient was administered Pfizer vaccine as a second dose; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Patient was administered Pfizer vaccine as a second dose) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Aug-2021, the patient received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. On 09-Aug-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Patient was administered Pfizer vaccine as a second dose). On 09-Aug-2021, INTERCHANGE OF VACCINE PRODUCTS (Patient was administered Pfizer vaccine as a second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  Treatment information not reported.
None-this was a medication error. Patient was inadvertently administered the Pfizer vaccine prior to her 16th birthday. HOWEVER, parent falsified the VAR in order for child to receive the vaccine (age was recorded as 16, year of birth as 2005). Correct DOB was determined from 2 independent medical records when vaccine entered into system.
Per email: I just wanted to mention that I woke up at 2am sick with chills, fever and abdominal cramps. My right arm is sore, not the left. I am slow to day for sure.  I didn't want to miss what I needed to do here.  I just didn't know if you needed to know or not.  I'm praying that it will just go away and I won't get sick. I do not think it is the skin test, it is flat and fading. Thank you for being there. Hope you have a good day! Patient denied offer to see Workman's comp provider.