chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effect reported; patient received improperly stored PROQUAD; This spontaneous report was received from a medical assistant referring to a patient of unknown age. The patient's pertinent medical history, concurrent conditions and drug reactions/allergies were not provided.   On 05-SEP-2019, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # S002494 (verified to be a valid lot number), expiration date reported and established as 23-JUL-2020, for prophylaxis. The measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was reconstituted with a properly stored sterile diluent.  The vaccine was improperly stored at a temperature between 6°F to 14°F (10.2°F, multiple) during a time frame of 50 minutes. The call was because of a data logger and no adverse effect neither previous temperature excursions were reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1909USA005231:
In my arm there are 2 lines identical, it maybe an inch to an inch and a half and it has tiny little scabs on it; Sore throat; My back is very itchy; Diarrhea; Constipation; I am just getting tired; This is a spontaneous report from a contactable consumer (patient) reported that. A 71-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 21Jul2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunization. The patient past Medical history included Kidney failure from an unknown date and unknown if ongoing, chronic obstructive pulmonary disease from an unknown date and unknown if ongoing, cardiac failure congestive from an unknown date and unknown if ongoing, Bladder problems from an unknown date and unknown and diverticulum from an unknown date and unknown if ongoing. On an unspecified date the patient experienced where she received her injection, in my arm there are 2 lines identical, now I don't understand how I got the 2nd line, it's almost identical to the 1st line, it may be an inch to an inch and a half and it has tiny little scabs on it, on both of them but I don't understand it because I only got 1 injection and I have 2 lines that have the similar, the same markings, that's the first problem, second is I have a little bit of sore throat and my back is very itchy. I have 2 cases of diarrhea and I have been very constipated for last few months (Further clarification was unknown, hence constipation was captured as event) so, that's very uncommon for me to get diarrhea. The event outcome was unknown.  Consumer was informed about the Medical Information department.   Consumer was provided with the number of Pfizer Medical Information as # and was requested to select option 3, timings as and 8 am to 8 pm Monday to Friday as per EST.  Information on the lot/batch number has been requested.
redness at the injection site; itching at the injection site; rash at the injection site/rash up to elbow; shingles in the eye; COVIDARM; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (redness at the injection site), VACCINATION SITE PRURITUS (itching at the injection site), RASH (rash at the injection site/rash up to elbow), HERPES ZOSTER (shingles in the eye) and VACCINATION COMPLICATION (COVIDARM) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (redness at the injection site), VACCINATION SITE PRURITUS (itching at the injection site), RASH (rash at the injection site/rash up to elbow), HERPES ZOSTER (shingles in the eye) and VACCINATION COMPLICATION (COVIDARM). At the time of the report, VACCINATION SITE ERYTHEMA (redness at the injection site), VACCINATION SITE PRURITUS (itching at the injection site), RASH (rash at the injection site/rash up to elbow), HERPES ZOSTER (shingles in the eye) and VACCINATION COMPLICATION (COVIDARM) outcome was unknown.            No concomitant medications was reported No Treatment medications was reported   This case was linked to MOD-2021-322897 (Patient Link).
Confirmed Miscarriage; This is a spontaneous report from a contactable nurse (patient). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 16Sep2021 07:15 (Lot Number: FP8448) at the age of 29-year-old, as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. No other vaccine was administered in four weeks. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=FP8448) via an unspecified route of administration, administered in Arm Left on 26Aug2021 at 08:00 AM at the age of 29-year-old at single dose for COVID-19 immunisation. The patient had confirmed miscarriage on 26Sep2021. The event resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Abortion spontaneous 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 and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
EVENT: LARGE AREA OF SWELLING AT INJECTION SITE WITH RASH ON ARM.  TREATMENT: rec'd shot of dexamethasone 4mg/ml inj solution & RX of Methylprednisolone 4mg dose pack 21  OUTCOME: 03/16/2023 Lg knot going down, soreness leaving and rash /redness is better.
Several hours after my shot I began having severe heart palpitations and became shaky and dizzy. It felt like my heart was going to beat out of my chest. Many hours later my body began to feel increasingly odd. Sore. Within an hour all of my joints were inflamed and painful and I felt like every inch of my body was on fire from the inside out. I was delirius and couldn't string words or thoughts. I fell asleep on the floor in the fetal position in front of the toilet because I was certain to vomit but nothing ever came. I couldnt really see well and my brain felt swollen. Each of my joints took turns feeling like they were trying to explode out of my body. My psoriasis lesions on my joints would suddenly feel as if I was suddenly being stabbed from the inside out causing me to scream out in pain. I've never felt so awful in my life. The headache wasn't severe because I sometimes have debilitating migraines. And the nausea wasn't severe because I've had norovirus twice. That said, I've given birth 3 times without pain meds and nearly entirely silent.. and THIS VACCINE REACTION was the worst thing I've ever experienced. Glad I might not die from COVID now but sweet jesus I thought I might last night.
Chest pain, latex reaction to  all shoes, with rubber, it burns my feet, and legs. I have to take benadryl-dye free, to remove the reactions.
Pfizer BioNTech COVID 19  Immediately upon injection patient got numbness and tingling in the left arm. No other S&S of distress. Had patient wait 30  minutes for monitoring . Feeling came back, tingling subsided and patient left with grandmother.
I received a Moderna booster (BA4-BA5 variant) on September 10, 2022. It was my second booster following the initial two-dose vaccination. I received the first booster on November 19, 2021. All vaccinations and boosters have been Moderna.  On September 21, 2022 I broke out in hives that continued acutely for several days. I have never had hives in my life and have no allergies that I know of.  After two days of migrating hives that featured intense itching and swelling, I went to my family doctor and she advised using an OTC antihistamine. There was little to no effect, so two days later she prescribed a Prednisone cycle for 9 days (30mg for 3 days, then 20g and 10g). The Prednisone calmed down the hives so that they no longer appear spontaneously, and since then I have been managing with a daily Zyrtec tablet and an occasional Benadryl tablet.  Although the hives are managed, in their place I have what appears to be dermatographia. Any scratching or friction results in distinct welts that go away in about 30 minutes. It seems to me that the symptoms are very slowly improving, but they are far from resolved.   I thought that my symptoms could be a reaction to a Covid infection, but I repeatedly tested negative on at-home antigen tests and on the PCR test administered during my doctor's visit. The only change I can identify is the Covid booster I received on September 10, which is why I am reporting my symptoms here.
This spontaneous report has received from an other health professional refers to a 47 years old female patient. The patient vaccinated with GARDASIL on 17-APR-2012 at age of 47. It was unknown if the patient sought medical attention and if treatment was given to patient. Additional information has been requested.
Patient had left vaccination center at 3:37 PM and returned at 3:52 pm with complaints of facial flushing and scratchy throat.  BP 149/122; HR 81; O2 97% on RA. 25 MG of IM Benadryl given at 3:53 pm. Evaluation per NP and EMS. Re-assessed at 3:57.  Symptoms improving. Facial flushing improved and scratchy throat resolved. 4:16 pm BP 128/82; HR 73.  Discharged home at 4:20 pm. Recommended patient receive follow up in ER if symptoms return and to notify her PCP.
Developed extreme pain in my left leg.  Went to emergency room   Ultrasound showed I have a blood clot in left calf.  Doctor prescribed a blood thinner, told me to elevate my leg and apply moist heat.
Left arm 50 x 60mm (2 1/2" x 3") red, warm to touch. Noticed swelling today - fever 102 after Tylenol. Child able to play with sisters. Mom alternating Tylenol and Motrin. Used warm pack on arm. Used liquid Benadryl.
After pharmacy lead RN drew up all 6 doses of vaccine (each containing 0.3ml), she realized that there was more than usual amount of vaccine left in the vial. RN says only 1.8 ml of diluent was added.  All 6 syringes were verified by other clinic members. The remaining 5 doses were wasted and patient (who had left) was called and notified. Patient advised at this time to continue as planned to receive her 2nd dose in 21 days.
Nerve ends feel like they are on fire; Heart racing in chest and throat.; Raised spots on legs, arms, stomach and back; Itching; This is a spontaneous report from a contactable other healthcare professional, the patient. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3180) via an unspecified route of administration in the left arm on 26Aug2021 at 10:30 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. The patient had known allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included alprazolam (XANAX), oxycodone (MANUFACTURER UNKNOWN), ezetimibe (ZETIA), levothyroxine (MANUFACTURER UNKNOWN) and BUTALB; all for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0187) via an unspecified route of administration in the left arm on 05Aug2021 at 13:15 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination.  On 27Aug2021 at 12:00, the patient experienced itching, nerve ends felt like they were on fire, raised spots on legs, arms, stomach and back and heart racing in chest and throat. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events itching, nerve ends felt like they were on fire, raised spots on legs, arms, stomach and back and heart racing in chest and throat were not resolved at the time of this report.
This spontaneous consumer report (initial receipt 08-Oct-2015) concerns a patient (unknown demographics). On 06-Oct-2015, the patient received AFLURIA (batch number U59508) 0.5mL once via the intramuscular route. AFLURIA was stored correctly and indication for use was approved as per the Product Information leaflet. On 08-Oct-2015, the patient experienced shingles which persisted to date (at the time of reporting). Action taken with AFLURIA was discontinued. The outcome was not yet recovered. Reporter's comments: The reporter assessed the event as non-serious.
Initial reaction was lethargy, fever, chills, and body aches (day after shot for approximately 2 days). Chronic cough and congestion began in mid-May. Rash on stomach and shoulders for approximately six weeks (sometimes severe, from early June through mid-July) and later on the tops of my legs in August. Chronic cough returned end of July and has persisted ever since. I took a Z-Pack in early August and then augmentin and prednisone when that didn't work. I noticed hair loss that began in early August. It has been steady ever since and I have lost 50% or more of my hair so far. I have been suffering headaches off and on and have had great difficulty sleeping for the past two months. (continued)
rash in both cheeks; hot sweats at night; Can hardly move my neck; extremely thirst at night; mouth feels very dry; aching all over; low grade fevers in the evening; Chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (hot sweats at night), MOBILITY DECREASED (Can hardly move my neck), THIRST (extremely thirst at night), DRY MOUTH (mouth feels very dry) and MYALGIA (aching all over) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thrombocythemia (central thrombocythemia). Concomitant products included INTERFERON for Thrombocythemia.   On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Feb-2021, the patient experienced MYALGIA (aching all over), PYREXIA (low grade fevers in the evening), CHILLS (Chills) and PYREXIA (fever). On 09-Feb-2021, the patient experienced HYPERHIDROSIS (hot sweats at night), MOBILITY DECREASED (Can hardly move my neck), THIRST (extremely thirst at night) and DRY MOUTH (mouth feels very dry). On 22-Mar-2021, the patient experienced RASH (rash in both cheeks). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 09-Feb-2021, MYALGIA (aching all over), CHILLS (Chills) and PYREXIA (fever) had resolved. At the time of the report, HYPERHIDROSIS (hot sweats at night), MOBILITY DECREASED (Can hardly move my neck), THIRST (extremely thirst at night), DRY MOUTH (mouth feels very dry), RASH (rash in both cheeks) and PYREXIA (low grade fevers in the evening) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Feb-2021, Body temperature: 101 (Inconclusive) 101 degrees Fahrenheit fever.         Action taken with mRNA-1273 in response to the event was not applicable.  Patient received treatment of Muscle Relaxant.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: TCR updated email address, NNI
pt states he had a sore left arm that hurt for about 3 days.   Pt says his both ankles were swollen and as of today 4/7/2021 they are still this swollen.  He has developed fatigue a couple of days later.  He still has these symptoms and will reach out to his PCP for medical advice.
Child had fever x 1 day and painful arm swelling to 8 cm by 4cm with axillary adenopathy. All tender-possible cellulitis.
This spontaneous report as received from a physician refers to a patient of unknown age. The patient was vaccinated with a dose of ZOSTAVAX (route, dose, lot # and exp date not reported) on an unknown date. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the physician noted that a patient may have been administered a dose of ZOSTAVAX that was stored improperly. The physician noted that no specific storage condition for the ZOSTAVAX were available. No adverse effect was reported. No patient specific information is available so most appropriate fields in the adverse experience screen were NA. No further information is available. Additional information has been requested.
covid vaccine breakthrough case  dose 1 Moderna 2/20/21 001A21A dose 2 Moderna 3/20/21 001A21A dose 3 Moderna 10/23/21 017F21A
Difficulty breathing & swallowing. Treated in ER w/ IV medication; albuterol nebulizer (I believe the IV med. was a steroid & BENADRYL). Then discharged w/ prednisone 20mg 2x day x3 days & BENADRYL 25mg q4h x 24 hrs then prn.
Developed rash on entire upper body covering upper chest and back and neck. Still present  Treated with steroid cream to no avail. Currently taking Hydroxichloriquin. So far no improvement
Shortness of breath, throat swelling, tongue swelling. 11:10  Given 50mg IM Benadryl resolved
she and her Husband got a common cold; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (159558).  A male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number: Unknown; Manufacturer: Unknown), for COVID-19 immunization.  The following information was reported: NASOPHARYNGITIS (non-serious), outcome "unknown", described as "she and her Husband got a common cold".  Additional information: Caller (Name withheld) would like to cancel their appointment for the 2nd booster dose of the vaccine. Because she mentioned that she and her Husband got a common cold.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Itching/Hives that last for a few minutes to an hour and move around. Antihistamines generally help but they're very annoying.
Pt did not have any adverse reaction. Before given Varivax vaccine, pt did not report that he had gotten MMR vaccine 6 days ago. Pt  saw his doctor today and MD was not concerned about him receiving 2 live vaccines 6 days apart
Chills, fever, severe body aches, exhaustion and severe axillary lymph node swelling in left armpit.  5 days
1/11/21 woke up feeling tired, muscle aches, took migraine medicine, and ibuprofen.  Back pain toward the kidney, stomach area. Felt like she would pass out. Dizzy, nausea. Seeing a patient she had to leave the room and go sit on the floor. Blood pressure was very low, couldn't stand up. Painful to have clothes touching the skin all over.  Felt like she need more air, panting. Didn't sleep 8-10 hours. Started with sever H/A and muscle pain. Sensitive to light and sound.  Fatigue.  Out of work 1/12-1/13. Skin sensitivity is gone. Talk big dose of ibuprofen. Still fatigue. H/A is better.
became tachycardic with heart rate of 105-130 bpm; slight fever; This is spontaneous report from a contactable healthcare professional (patient). A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EL3246, unknown expiration), intramuscular in right arm on 11Jan2021 at 09:15 at a single dose for COVID-19 immunization in a hospital. Medical history included migraine headaches.  The patient has no known allergies.  Concomitant medications included ethinylestradiol, norgestimate (ORTHO TRI-CYCLEN); zinc; colecalciferol (VITAMIN D); and vitamin c.  About 12 hours after vaccine, the patient became tachycardic with heart rate of 105-130 bpm (Jan2021). This was accompanied by a slight fever (Jan2021). Heart rate is still slightly elevated at 90-100 bpm about 24 hours after vaccine. The patient did not receive other vaccine in four weeks.  The patient did not have COVID prior to vaccination and was not tested for COVID post vaccination.  The patient had not yet recovered from the event tachycardia, while unknown outcome for event slight fever.
This 15 month old was given a Kinrix(DTap/IPV) instead of Infanrix (DTaP). Mom and provider notified.
One day post vaccine, I could not rise from the bed or chair without assistance. I could not walk without holding onto walls. I felt very weak. Incontinent. Confused. These were all symptoms I had not had before.
Patient states she started to get a headache several hours after receiving this vaccine. She said she had a small episode of dizziness that evening which went away but headach lasted 3 days. Patient notified the clinic 3 days later. When nurse talked to the patient, the patient said these symptoms may or may not have been caused by the vaccine because she experienced these symptoms before in the past (9 moths ago). Patient said she feels fine today but is not sure if she should get the second dose of Shingrix.
I got the shot at the end of my shift at work, came home and went to bed at 8a.m. At 10a.m. I woke up and felt like something was stuck in my throat, but could get no relief from coughing. I went back to bed and was freezing. At 12:15p.m. I awoke again with the same feeling in my throat and still freezing, now my bottom lip was swelled, I had a little nausea, felt weak, and my arms were really heavy. I called since they were the ones that gave the shot. The lady there said I should take some Benadryl and not be alone. I made my way to the bathroom and got some Benadryl, while in there feeling really dizzy like I was gonna pass out. I called my husband to come home. At 1:30p.m. I took 2 Benadryl. At 2:15 I was still freezing, but my eyes started burning, now I was running a fever of 100.7. At 3:30 I went to the Dr. now my temp was 101.4 and feeling really bad. The Dr. told me it was not a reaction, that a reaction takes 2-3 days to onset. On the handout I received with my shot it says the opposite. The Dr. gave me an antibiotic and sent me home. I am very confused NOT knowing what happened with me yesterday. I am going to miss 2 days of work with NO pay and disciplinary points on top of it. I believe it was a reaction, but how do I find out for sure?