chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 71 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
The patient received improperly stored VARIVAX; No adverse effect reported; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender.  The patient's concurrent conditions and medical history were not reported. Their concomitant therapies included sterile diluent.     On an unknown date, the patient  was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # R019237, expiration date 19-FEB-2021 or lot# R019237, expiration date 04-JUL-202 (dose, route, frequency and vaccination site were not provided), for prophylaxis.     Temperature: -14°C to -10°C (-9.74 C) Previous temperature excursion? No Was call because of a "data logger''? Yes
the vaccine administered was diluted with sterile water instead of sodium chloride; the vaccine administered was diluted with sterile water instead of sodium chloride; head hurts; This is a spontaneous report from a Pfizer sponsored program Call Center via medical information team. A contactable consumer (patient) reported that a 54-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0182, NDC number: 59267-1000-01), via an unknown route of administration on right arm on 16May2021 at 02.45 PM (at the age of 54-year-old) as single dose for COVID-19 immunization. Medical history included asthma, atrial fibrillation, ongoing anxiety, obstructive sleep apnea, fibromyalgia, thyroid condition, migraine, allergy to shellfish (causes anaphylaxis), bone spurs and plantar fasciitis in her feet. Concomitant medications included blood thinner, cardiac medicine, inhaler, anxiety medicine, arthritic medication on her joints (all unspecified). Historical Vaccine included influenza vaccine (FLU) for immunisation and she got hives after receiving a flu shot. This happened a long time ago when the flu vaccine first came out. Patient received the first dose of the Pfizer-BioNTech COVID-19 Vaccine last Sunday, 16May2021 at 2:45. She received a call on 19May2021 at 1pm (today as reported) from Pharmacy stating that the vaccine administered was diluted with sterile water instead of sodium chloride, and was advised to re-receive the first dose. She wanted to verify if they she get overdosed. Also her head hurts on 16May2021. She asked if it was okay to receive another first dose. She has anxiety and was very overwhelmed that this happens. The outcome of event head hurts was unknown.  follow-up attempts are possible. further information is expected; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021571366 same drug/AE, different patient
Within 1hr following vaccination:  Fevers, Chills, Rigors, Body Aches, Nausea, Vomiting.   Taking Tylenol for fever and discomfort
INR was only 1.5 it was below therapeutic range; Dizzy/light headed; she is very upset; Nausea; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program. A female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included diabetes type 1. Concomitant medication included escitalopram oxalate (LEXAPRO) taken for an unspecified indication, start and stop date were not reported. The patient experienced INR was only 1.5 it was below therapeutic range, dizzy/light headed, nausea, she was very upset on an unspecified date. Event details: The consumer reported that she received the first dose of the vaccine. Two days after the shot her INR have dropped below therapeutic range she did have the blood disorder (Further not clarified hence not captured in tab) and she was upset that all three of her doctor's told her to get the shot and she have blood disorder so she was very upset about that and like to speak to somebody. She felt like little bit light headed, she felt dizzy and a little bit nausea after the first dose. The outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
CLT STATES THAT SHE AWOKE THE MORNING AFTER AND WAS HAVING GENERALIZED PAIN, HOT AND COLD SWEATS WITH HEADACHE AND NECK PAIN.  ALSO WAS BITTEN BY A TICK WITHIN A COUPLE OF DAYS OF IMMUNIZATIONS AND IS CURRENTLY BEING TESTED FOR LYME DIEASE,LABS ARE PENDING.  WILL START ANTIBIOTIC TX IF IS LYME DIEASE BUT NEED TO KNOW WHAT STRAIN SO THEY KNOW HOW TO TX.  CLT HAS BEEN PLAGUED WITH PROBLEMS OF DEPRESSION AFTER THE LOSS OF HER AUTISTIC SON IN AN SAD ACCIDENT AND IS BEING TXED WITH ZOLOFT AND ATIVAN.
really sick; was down for weeks; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (really sick) and DEPRESSED MOOD (was down for weeks) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (really sick) and DEPRESSED MOOD (was down for weeks). At the time of the report, ILLNESS (really sick) and DEPRESSED MOOD (was down for weeks) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant medication information was not provided. Treatment information was not provided.
My long covid symptoms worsened over the coming days and weeks, eventually years. I still have symptoms to this day and developed chronic Epstein Barr Virus, Multiple Anemic (D, B12, Ferretin) Blood Disorders, POTs dysautonomia (diagnosed 6/9/22), Cardiomyopathy and worsening ischemic heart disease, Systemic Lupus (diagnosed 2/13/23) and Adjustment Disorder with Anxiety and Depression (diagnosed 4/11/23).
First dose 3/15/2021 - one week of insomnia, restlessness and anxiety  Second dose 4/6/2021 - ADHD symptoms and inability to concentrate and keep interest.  Unable to sleep and moderate nausea/vertigo sensation.
her lymph nodes were little enlarged after 3 days; It's hard to lift the right arm; Next day after receiving 2nd dose, she had pain at injected arm; She reports joint pain in her right arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (It's hard to lift the right arm), VACCINATION SITE PAIN (Next day after receiving 2nd dose, she had pain at injected arm), ARTHRALGIA (She reports joint pain in her right arm) and LYMPHADENOPATHY (her lymph nodes were little enlarged after 3 days) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Apr-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced PAIN IN EXTREMITY (It's hard to lift the right arm), VACCINATION SITE PAIN (Next day after receiving 2nd dose, she had pain at injected arm) and ARTHRALGIA (She reports joint pain in her right arm). On 25-Apr-2021, the patient experienced LYMPHADENOPATHY (her lymph nodes were little enlarged after 3 days). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 UNK. At the time of the report, PAIN IN EXTREMITY (It's hard to lift the right arm), VACCINATION SITE PAIN (Next day after receiving 2nd dose, she had pain at injected arm), ARTHRALGIA (She reports joint pain in her right arm) and LYMPHADENOPATHY (her lymph nodes were little enlarged after 3 days) outcome was unknown.            Concomitant medication included BP medicines.
I tested positive for COVID-19. The people in my home had already tested positive. I just thought to test myself at home.  Afterwards I had no symptoms at the time. Later on, I did have a stuffy nose. I had a mild case. I feel I was asymptomatic. My doctor prescribed a treatment, but I was not sick enough, I felt to get the treatment. I still have the stuffy nose and other that I am fine. I am still doing normal exercise and activities. It almost it didn't happen any how. I'm pretty sure I still have that.
Swelling in chest spreading from armpit area; Chills; Body aches; Weakness; Pain in the armpit from swelling areas; Pain in the chest from swelling areas; Feeling warm; Pain at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included chickenpox.   On 3rd September 2021 18:00, the patient received the 1st dose of Shingrix (intramuscular). On 3rd September 2021, less than a day after receiving Shingrix, the patient experienced injection site pain. On 4th September 2021, the patient experienced axillary pain, chest pain, feeling of warmth, chills, general body pain and weakness. On 5th September 2021, the patient experienced swelling. The patient was treated with ibuprofen. On an unknown date, the outcome of the injection site pain, chest pain, feeling of warmth, chills, general body pain and weakness were recovered/resolved and the outcome of the axillary pain and swelling were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, axillary pain, chest pain, feeling of warmth, swelling, chills, general body pain and weakness to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient for herself. The patient stated that she received shingrix vaccine and experienced injection site pain on the day of vaccination. The next date, the patient developed chills, body aches, weakness, pain and swelling in her armpit of the same arm of the injection site. The patient also stated that the next to next day of vaccination her armpit swelling was more painful and spreading to her chest. The patient had a call in to her health care professional. The patient stated that she took ibuprofen. Also gave medical disclaimer and rferred to health care professional. The reporter consented to follow up.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age without drug reactions/allergies. On an unknown date the patient at a nursing home facility was vaccinated with PNEUMOVAX23 (lot# H013581, expiry date unknown). On an unknown date the patient developed cellulitis at the injection site that required antibiotic therapy. Treatment was given for adverse event. The outcome of cellulitis at the injection site was unknown. The patient had sought medical attention and she was at nursing home facility. The relatedness for cellulitis at the injection site was unknown for PNEUMOVAX23. This is one of several reports received from same pharmacist. Additional information has been requested.
Felt ill; This case was reported by a pharmacist via sales rep and described the occurrence of feeling unwell in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of malaise (received 1st dose on unknown date, refer case US2019AMR174219).   On 20th September 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced feeling unwell. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the feeling unwell was recovered/resolved.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The batch number was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and felt ill. The reporter would amend report with additional details once received.  The report incomplete as the reporter did not have adequate time to discuss.
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 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 10:35 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 10:35 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.   Age of patient was reported as 32.32 for dose administered on 15-Apr-2021.  No concomitant and treatment medications were reported.  Batch number 044B21A underwent temperature excursion on 15-Apr-2021 with temperature 34 degrees Fahrenheit at 09:00AM. This vial was moved to fridge 06-Apr-2021 and beyond use date for the vial was reported as 09-May-2021. Product moved to clinic on 15-Apr-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour. The vial was not in a frozen state at the time of vaccine administration. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.   This case was linked to MOD-2022-566976 (Patient Link).
I received my first dose of Johnson and Johnson COVID-19 vaccine in April of 2021. Shortly after that I was diagnosed with Rheumatoid arthritis. Since then, I have received two doses of the Pfizer COVID-19 vaccine and my flare ups of the rheumatoid arthritis have become more frequent, they last longer, and I have to take Prednisone to control them. My balance has been affected and I have to go to physical therapy for that. I have also been told I have neuropathy in the feet which has been affecting my balance and has caused me to fall three times since July. Before receiving my third dose, if I lost my balance, I was able to catch myself. Since receiving the third dose, I am no longer able to do that and am taking falls.
Customer stated pain and lack of mobility in right arm.  She went to doctor and he told her that the bursa was inflamed.  she was prescribed tramadol and medrol dosepak for the pain and inflammation.
Patient received Pediarix and Prevnar13 in the right thigh on 1/17/23 per charting. Mother stated that patient has a hard lump in the right thigh shortly after getting the vaccines. Hard lump is still present, measuring 40 mm (width) by 50 mm vertically. No redness, swelling, or warmth to the thigh. Mother denied fever or chills. Mother stated patient does not seem to be in pain when right thigh/lump is touched. Mother did not notice any decreased in ROM or no limited movement in the right leg.  Mother is concerned with hard lump being present for more than 2  months now.
after 6 days bright red area (circular) around injection site (no itching or rash)
Positive Covid test on 3/18. Note: have a request to repeat mammogram, with a Diagnostic Mammogram
This spontaneous case reported by a consumer, describes the occurrence of hyperhidrosis (sweating after the 2nd dose/sweated all night) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# unknown) for COVID-19  immunization. No medical history reported. On an unknown date, patient received the 1st dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient received the 2nd dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced hyperhidrosis (sweating after the 2nd dose/sweated all night). At the time of the report, hyperhidrosis (sweating after the 2nd dose/sweated all night) outcome: unknown. No concomitant medication or treatment information reported.
Pt recvd 3 doses of Engerix-B & did not convert;
Information has been received from a physician concerning an approximately11 year old female who in October 2008, was intramuscularly vaccinated with the first dose of GARDASIL (lot# not reported) and the third dose of 0.5ml GARDASIL (lot# not reported) in February 2009. After the third dose, the patient experienced seizures and developed a lack a motivation to go to school because she was in pain. Heavy metal screen, MRI, EEG and liver function testing were performed with no results reported. The patient sought unspecified medical attention. At the time of reporting, the patient had not recovered. Upon internal review, the seizure was determined to be an other important medical event. Additional information has been requested.
2 days later  Hemoptysis sob  DIB, Hospitalized  7  days
first dose of Shingrix 8 months ago / not received the second dose yet.; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 83-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 0.5 ml of 1st dose 8 months ago in unknown arm intramuscularly).   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 provided were as follows: The case was reported by patient herself. Age at vaccination was not applicable. Till the time of reporting, the patient did not receive the second dose, which led to incomplete course of vaccination. No lot number or expiration date was known. Caller declined to provide health care professional information. The reporter did not consent to follow-up.
This spontaneous report was received from nurse refers to an unspecified patient of unknown age. The patient's medical history, concomitant medication and concurrent conditions were not reported. On an unspecified date, the patient might have received an improperly stored dose of one of the following vaccines for prophylaxis, but he was unsure which of the vaccines the unspecified patient received. Names of the vaccines involved: GARDASIL 9 (N004799, expiry: 15-NOV-2019) or PNEUMOVAX 23 (M047519, expiry: 04-AUG-2018). The vaccines were exposed to temperature of 14 degree Fahrenheit for 7 hours. No adverse effects reported. The temperature excursion was detected by digital data logger. The vaccines had no previous temperature excursion. Additional information has been requested.
Patient reported having Bell's Palsy just a few days after receiving the vaccination and talking to her doctor
rash x 4 days (began 11AUG97) on body;fever @ beginning of rash;no fever as of 15AUG97;no pruritus, acting OK;
patient's wife called that he his arm had severe pain and he could barely lift it within several hours of receiving it.
LARGE REDDENED AREA AROUND VACCINE SITE. WARM TO THE TOUCH. SWELLING AND PAIN.
Pt experienced shingles on the injection arm. There was a cluster of vesicles on an erythematous base on the left palm and left ring finger. There were also scattered edematous papules on the left hand, left upper forearm and left arm. Pts maximum temperature was 102F. Pt experienced pain. This was considered a severe case and pt was referred to a dermatologist. Pt was given acyclovir and acetaminophen with codeine. Pt recovered one an a half weeks after onset.
Within 3 hrs of receiving the flu shot I noticed twitching of (R) side of upper lip and red discoloration of sclera. This lasted for 12 hours then symptoms subsided, Red color of sclera disappeared - occasional twitch of lip noticeable 48 hrs.
chills; mild nausea; headache; body ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in left arm, administration date 23Mar2021 09:30 (Lot number: EL3247) at the age of 46 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162B2 (DOSE 1, SINGLE), for COVID-19 immunisation, reaction(s): "arm pain". The following information was reported: CHILLS (non-serious) with onset 24Mar2021 01:00, outcome "not recovered", described as "chills"; NAUSEA (non-serious) with onset 24Mar2021 01:00, outcome "not recovered", described as "mild nausea"; HEADACHE (non-serious) with onset 24Mar2021 01:00, outcome "not recovered", described as "headache"; PAIN (non-serious) with onset 24Mar2021 01:00, outcome "not recovered", described as "body ache". Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected.