chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in an unspecified number of the adult patients who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine at an unknown dose. On an unknown date, less than a year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The reporter stated that to them the wolf represents the big government. The reporter also stated that there were too many kids with too many problems that took all the vaccines. The reporter stated, do not forget the vaccine given to new borns for Hepatitis C. The reporter stated that many people received shingles vaccine and experienced shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for SHINGRIX and time to onset for event were not provided.
Subsequent to receiving the third dose of Lymerix, the pt noticed soreness in the deltoid muscle (NOS). On follow-up the reporter stated that the pt did not experience a side effect from the Lymerix, but rather had a muscle condition that was not caused by the vax. As of 12/14/2000 the outcome of the event is unknown.
Initially my left gland in my neck was swollen for about three days. About 10 to 14 days later I discovered 2 pea-sized lumps in my neck, left side.   I have a doctors appointment two get ultrasound on Thursday, April 8.
upper left arm redness the size of a dollar bill; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (upper left arm redness the size of a dollar bill) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METOPROLOL, ATORVASTATIN, GABAPENTIN, CALCITRIOL and ACETYLSALICYLIC ACID (ASPIRIN LOW) for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced ERYTHEMA (upper left arm redness the size of a dollar bill). At the time of the report, ERYTHEMA (upper left arm redness the size of a dollar bill) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no treatment medication reported.   This case was linked to MOD-2021-092343 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: no new information updated.
12 hours after vaccination, really sore arm, massive headache, nausea, chills for 150 minutes then very warm rest of night; restless.  Next morning, still experiencing nausea and very dry sinus passages.  All symptoms with rest, 10+ hours of sleep, and otc meds gone within 48 hours.
Without your boosters (Pfizer COVID-19 Vaccine) I would have died, I have had two of the Boosters and my first COVID shot was Johnson & Johnson so, I have had three shots; Without your boosters (Pfizer COVID-19 Vaccine) I would have died, I have had two of the Boosters and my first COVID shot was Johnson & Johnson so, I have had three shots; Without your boosters (Pfizer COVID-19 Vaccine) I would have died, I have had two of the Boosters and my first COVID shot was Johnson & Johnson so, I have had three shots; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient received BNT162b2 (BNT162B2), as dose 2 (booster), single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 71 years for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (COVID-19 VACCINE JANSSEN), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Interstitial cystitis" (unspecified if ongoing), notes: I have interstitial cystitis (captured in history). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown" and all described as "Without your boosters (Pfizer COVID-19 Vaccine) I would have died, I have had two of the Boosters and my first COVID shot was Johnson & Johnson so, I have had three shots". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: 166, notes: My blood pressure shot up to 166 over a 100; Better, notes: Now it is better and not 166. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course:Consumer stated side effect for Paxlovid, I have interstitial cystitis (captured in history). I don't know if that caused it or what but after I took the Paxlovid, I took one and I started on the second little card and my blood pressure Shot up to 166 over a 100 and I took it three times to make sure, it was right and then I passed out. They called a doctor he said, immediately stop it and I needed to come in to their urgent care. Well I guess, now it is better and not 166 but it hasn't come all the way back down to normal."  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Legs shaking extreme; first dose on 18Mar2021, second dose on 13May2021; This is a spontaneous report from a contactable consumer (patient). A 20-years-old female patient received bnt162b2 (PFIZER/BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 13May2021 17:00 (Batch/Lot Number: EW0177) at the age of 20-yers-old, as DOSE 2, SINGLE for covid-19 immunisation. No prior vaccinations. The patient medical history was not reported. Concomitant medication included fluvoxamine (FLUVOXAMINE) taken for an unspecified indication from 2006 and ongoing; lamotrigine (LAMICTAL) taken for an unspecified indication from 2009 and ongoing. Historical Vaccine included bnt162b2 (1st shot of covid vaccine, Anatomical location: Left arm, Lot number: EN6208, EN6206, Time: 12:00 PM) for covid-19 immunisation on 18Mar2021 at the age of 20 year old and experienced (Sinus) tachycardia, Heart inflammation, chest pain, left atrial enlargement, enlarged heart size. The patient previously used Rexulti from 2010 to 06Jan2021. The patient experienced legs shaking extreme on 16May2021. Seriousness criteria was provided as: Persistent/Significant disability/Incapacity, Important medical event, and Hospitalized for 2 days in 2021. AE required visit to: Physician office, Emergency room. The event outcome of legs shaking extreme was recovering.   Follow-up attempts are completed. No further information is expected.
itchy eye watering eye all around eyes were watering and itchy they are swollen and puffy
From telephone correspondence received on 10/14/02, it was reported that a 30 year old female received Fluzone (lot number U0904CA) on 10/10/02. The vaccination was administered IM in the right deltoid. Three hours post-vaccination, the patient complained of joint pain in the right shoulder extending to the clavicle. She was prescribed Tylenol and the event resolved by 10/11/02. On 10/12/02, the patient experienced soreness under her right arm. By 10/14/02, she was also complaining of sore lymph node in the cervical area. At the time of the report, the patient was being evaluated by a neurologist for numbness that extended from her elbow to the finger of the right upper extremity. An MRI was done and results are pending. It was not reported whether the patient recovered from these adverse events.
Severe headache, nasal congestion, temp 100 F., sore scratchy throat, sneezing, itchy, red eyes, coughing, nausea, unsteady balance.
He was administered Vaccination at 2:47pm.  He stood up at about 3pm and collapsed to the floor and started to get unresponsive.  I administered 1 dose of epipen 0.3mg and he started to get better.  911 arrived and patient was feeling better so he refused to go to hospital.   He is in good spirits and said he was OK that day.  He said he will follow up with his doctor .  Tried to follow up but have not been able to reach patient but have left a couple of voice messages.
(L) arm red, swollen and red to elbow, warm to touch hard area approx 2" diameter total area 13cm x 13 cm.
Patient report adverse reaction to vaccination FLUZONE-HD and PREVNAR 13. Pt said she had severe diarrhea following the vaccine administration.
This spontaneous report was received from a pharmacist via company representative regarding a female patient of unknown age. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX 0.65 ml (route, anatomical location, lot number and expiration date were not reported). There was no concomitant medication reported. On an unknown date, the patient visited the pharmacist for the second time after received the ZOSTAVAX due to a "large swelling at the injection site". At the time of the report, the outcome of the injection site swelling was unknown. The relatedness between the event and therapy with ZOSTAVAX was not reported. Additional information has been requested.
Fatigue/Muscle Aches/Lethargy/Nausea/Body Aches March 30th through April 2nd
7 patients devel large welt (approx 1 1/2inches), redness, swelling & pain @ inj site;all pt had negative allergy history to eggs;
30 minutes after injection, pt noticed redness and swelling at injection site. this progressed to swollen eyes, pruritus on face and upper trunk and periorbital edema. Lips were tingling and mild nausea. treated with Diphenhyromide and Prednisone x 2 days. Pt returned several hours later with palpitations and tachycardia and anxiety. pt calmed down over 2 hours and discharged home.
pt recv vax 6NOV96 & 11NOV96 w/a rash on abd;1 1/2wk the rash is reported to have covered most of body;
The pt developed pneumococcal meningitis resulting in death 36 days post vax.
severe diarrhea; severe chills then a sudden feeling of hotness; still felt weak; lightheaded; severe body and muscle aches; severe throwing up; severe chills; severe headache; tried to work a little but she couldn't; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (severe diarrhea), FEELING HOT (severe chills then a sudden feeling of hotness), ASTHENIA (still felt weak), DIZZINESS (lightheaded) and MYALGIA (severe body and muscle aches) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Arm operation (surgery on her right arm). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced DIARRHOEA (severe diarrhea), FEELING HOT (severe chills then a sudden feeling of hotness), ASTHENIA (still felt weak), DIZZINESS (lightheaded), MYALGIA (severe body and muscle aches), VOMITING (severe throwing up), CHILLS (severe chills), HEADACHE (severe headache) and FATIGUE (tried to work a little but she couldn't). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (severe diarrhea), FEELING HOT (severe chills then a sudden feeling of hotness), MYALGIA (severe body and muscle aches), VOMITING (severe throwing up), CHILLS (severe chills) and HEADACHE (severe headache) had resolved and ASTHENIA (still felt weak), DIZZINESS (lightheaded) and FATIGUE (tried to work a little but she couldn't) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication include Excedrin for Headache.  Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD21-057451, MOD-2021-049504 (Patient Link).
This initial spontaneous case, received from pharmacist on 19-Oct-2017, concerning an adult, female patient of unspecified age. This refers to fourth of 04 reports. The patient had no relevant medical history. The patient's concomitant medication included unspecified birth control medication. On 04-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, batch number: 195126, expiry date: Apr-2018 and anatomical location: not reported). On an unspecified date, after the administration of the vaccine. It was reported that the patient's period was late by 13 days. She underwent pregnancy test and the result was negative. No treatment was taken for the event. The reporter assessed the event as non-serious. Follow-up received on 30-Oct-2017: It was reported that the patient's period was late by 13 days. She underwent pregnancy test and the result was negative. The narrative was amended accordingly.
Received Covid Moderna vaccine on 02/03/2021 & no adverse events until I noticed a rash near injection site on Friday, . The rash spread & I sought medical attention on Saturday. I was prescribed a steroid to be filled if adverse event worsened.
spot under my armpit; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SKIN DEPIGMENTATION (spot under my armpit) in a 54-year-old male patient who received mRNA-1273 for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced SKIN DEPIGMENTATION (spot under my armpit). The patient was treated with DOXYCYCLINE at a dose of UNK, q2wk. At the time of the report, SKIN DEPIGMENTATION (spot under my armpit) had not resolved.        The action taken with mRNA-1273 (Intramuscular) was unknown.       no concomitant medications reported.
PATIENT STATES HE HAD SHOULDER PAIN PRIOR TO RECEIVING THE MODERNA VACCINE ON 7/29/22 BUT THE VACCINE MADE HIS PAIN WORSE. HE NOW STATES HE HAS PAIN THAT RADIATES FROM THE RIGHT SHOULDER DOWN THROUGH HIS ELBOW TO THE BACK OF HIS FOREARM. PATIENT DOES HAVE ARTHRITIS AND WAS RECEIVING INFLECTRA INFUSIONS PRIOR TO VACCINE DOSE (HE BELIEVES THE LAST DOSE OF THAT WAS IN MAY OR JUNE OF 2022)
received first Shingrix dose on 09/03/2020 / 2nd dose is scheduled for today 04/16/2021; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (Received 1st dose of Shingrix on 03rd September 2020 with batch number 59EA2 and expiry date of 13th September 2021.).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist reported that 2nd dose was scheduled on the day of reporting and till the time of reporting, the patient did not receive 2nd dose, which led to incomplete course of vaccination. The reporter did not consent to follow-up.
Information has been received from a medical assistant concerning a 15 year old white female student with no known drug allergies and no medical history, who on 06-MAR-2008 was vaccinated IM with a 0.5 ml first dose of Gardasil (lot# 655670/1459U).  Concomitant therapy included meningococcal ACYW conj vaccine (dip toxoid)  (MENACTRA) and  diptheria toxoid (+ pertussis acellular 3-component vaccine (+) tetanus toxoid (BOOSTRIX).  On 06-MAR-2008 within five minutes of the vaccination, the patient fainted.  The patient hit her head on the tiled floor.  The patient was observed and rechecked by the physician prior to being discharged home.  The patient was recovered.  No product quality complaint was involved. Follow up information indicated that the patient fainted in office waiting room after receiving the dose of Gardisil (lot # 655670/1459U). The patient was observed by staff and reevaluated by the physician. The patient was given some juice and observed for about 15 minutes and left when felt better. Additional information has been requested.
16Jun2021: I got the 2nd dose of the Moderna Covid-19 vaccine./6 month span between 1st & 2nd doses.; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (16Jun2021: I got the 2nd dose of the Moderna Covid-19 vaccine./6 month span between 1st & 2nd doses.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (16Jun2021: I got the 2nd dose of the Moderna Covid-19 vaccine./6 month span between 1st & 2nd doses.). On 24-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (16Jun2021: I got the 2nd dose of the Moderna Covid-19 vaccine./6 month span between 1st & 2nd doses.) had resolved.            No concomitant medication was provided. No treatment medication was provided.
Received flu vaccine 11-24-08; c/o fatigue, behavior changes begging 11-27-08 in AM that worsened until 11-30-08 in pm. C/O began to slightly improve beginning 12-1-08. Pt. has been afebrile entire time.
The pt had a localized reaction. A quarter sized area with redness, blister and lump was experienced. The pt's mom stated he had a fever of 102 with the 1st and 2nd dose and with the 3rd he had a smaller red localized reaction and no fever.
Client states she began to be "shakey and quivery." She developed a headache with pressure behind her eyes. She felt "heavy and sore all over." Her blood pressure went up to 178/80 something and it is usually 130/60. It lasted about 2-3 hours, then symptoms went away except for "soreness." Today (the next day) she feels fine except for "soreness all over." She did not attempt to contact her doctor or to seek medical attention during this time. She requests that a report be made.
FELT BAD; This spontaneous report received from a patient concerned a 53 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced felt bad. The action taken with covid-19 vaccine was not applicable. The outcome of felt bad was not reported. This report was non-serious.
Patient was driving into holding/observation post vaccination and complained of dizziness and then had a brief syncopal episode losing consciousness for a few seconds as reported by his wife.
Information has been received from a physician concerning a 13-month-old male patient born prematurely at 36 weeks with a positive Coombs test, and "photo treatment days 3 to 5", who on 19-DEC-2006 was vaccinated with a first dose of hepatitis A virus vaccine inactivated. On 18-JAN-2007 the patient was mistakenly vaccinated intramuscularly in the deltoid with a second dose of hepatitis A virus vaccine inactivated (lot# 656000/1095F). There was no apparent illness at the time of vaccination. Subsequently, one day after the second dose, the patient developed a fever up to 103 degrees Fahrenheit and a severe, deep, wet cough. It was reported that the symptoms lasted over four days and that he was re-examined on day four. He had a temperature of 101 degrees Fahrenheit without any local findings on physical examination. It was reported that at the time of this report the patient had recovered on an unspecified date. No product quality complaint was involved. Additional information is not expected.
Rash developed on face, by 8:00 AM (11/14/2013) rash had spread to torso and arms. Rash moved down my body, I was covered from head to toe by 8:00 AM the 16th of November. The rash began to fade yesterday November 18th, in the same way it spread, (Head to Toe) The rash felt hot/feverish, and included some swelling.  My temperature was between 99 and 100. I still have the rash on my abdomen, legs, and feet. As the rash subsides it itches.
Blood clots; headache; nervousness; anxiety; This is a spontaneous report from a non-contactable consumer (patient). A 34-year-old female patient not pregnant received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 03Apr2021 09:00 (Lot Number: ER8733) as single dose (at the age of 34-years-old) for covid-19 immunisation. Medical history included allergies (known allergies: yes). Concomitant medications in two weeks prior to the vaccination included vitamin B complex (B-COMPLEX), magnesium (MAGNESIUM), chlorophyll (CHLOROPHYLL), vitamin D NOS (VITAMIN D NOS). Patient did not receive other vaccine in four weeks prior to the COVID vaccine. It was unknown if patient had COVID prior vaccination. Patient was not tested for Covid post vaccination. On 03Apr2021 patient experienced blood clots, headache, nervousness and anxiety. Events resulted in Doctor or other healthcare professional office/clinic visit. No treatment was required. Outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information, the known safety profile and the temporal association of BNT162B2 administration to the event of Thrombosis, a possible contribution of the drug to the event cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.