chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Large itchy rash on arm near injection site.  Treated with topical hydrocortisone and hydroxyzine for 3 days
66yr old patient presented on 10/14/21 to clinic. During visit patient was administered FLUZONE HIGHDOSE QUAD 21-22 PF (LOT # UJ747AB) IM via right deltoid and PNEUMOVAX-23 (LOT # T040202) IM via left deltoid by CMA. CMA noted patient tolerated both vaccines well during administration. Patient presented on 10/18 to be assessed for possible vaccine reaction. Patient endorsed skin rash, redness, discomfort and mild pain in left arm after administration of Pneumovax-23 vaccine. Patient denied fever or chills. MD noted left upper arm mild erythema, approximately 1cm x 1cm. No warmth or pain to palpation. MD noted no evidence of infection. Recommended warm compresses, Tylenol PRN.  Injection site pain and reactions common side effect.
UNKNOWN TO US, MR RECEIVED JANSSEN j&j ON 04/06/21 AT ANOTHER FACITLITY, .
Malaise; Discomfort; Feeling abnormal; Pain in extremity; Myalgia; Pyrexia; Tingling in her feet/had a tingling and zapping sensation all over her body such as her head, cheeks, eyelids, sides, buttocks, and thighs; Constant nerve pain all over/ when it is in her face, she can touch it and rub it so it goes away; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling in her feet/had a tingling and zapping sensation all over her body such as her head, cheeks, eyelids, sides, buttocks, and thighs), NEURALGIA (Constant nerve pain all over/ when it is in her face, she can touch it and rub it so it goes away), MALAISE (Malaise), DISCOMFORT (Discomfort) and FEELING ABNORMAL (Feeling abnormal) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included SIMVASTATIN, VITAMIN D [VITAMIN D NOS] and VITAMIN B12 [VITAMIN B12 NOS] for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced PARAESTHESIA (Tingling in her feet/had a tingling and zapping sensation all over her body such as her head, cheeks, eyelids, sides, buttocks, and thighs) and NEURALGIA (Constant nerve pain all over/ when it is in her face, she can touch it and rub it so it goes away). On an unknown date, the patient experienced MALAISE (Malaise), DISCOMFORT (Discomfort), FEELING ABNORMAL (Feeling abnormal), PAIN IN EXTREMITY (Pain in extremity), MYALGIA (Myalgia) and PYREXIA (Pyrexia). The patient was treated with GABAPENTIN in March 2021 for Adverse event, at a dose of 100 mcg, 3 at night and 1 in the morning. At the time of the report, PARAESTHESIA (Tingling in her feet/had a tingling and zapping sensation all over her body such as her head, cheeks, eyelids, sides, buttocks, and thighs) and NEURALGIA (Constant nerve pain all over/ when it is in her face, she can touch it and rub it so it goes away) was resolving and MALAISE (Malaise), DISCOMFORT (Discomfort), FEELING ABNORMAL (Feeling abnormal), PAIN IN EXTREMITY (Pain in extremity), MYALGIA (Myalgia) and PYREXIA (Pyrexia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Consumer mentioned treatment with Gabapentin helped some events, but she had to increase the dosage to 3 at night and 1 in the morning. She stated that she was still miserable night and day. She had an upcoming appointment with the neurologist to do a nerve conduction test and may undergo a small nerve biopsy test.  Consumer did not provide consent to Safety to follow up with her healthcare provider.   This case was linked to MOD-2021-268369 (Patient Link).
Expired doses administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired doses administered) in a male patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 067H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 04-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired doses administered) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment medications reported
I went to an event on Saturday afternoon that I suspect that I got CVOID at: really drowsy; beginning to lose my sense of taste on Monday; fatigue really set in on Tuesday and Wednesday. I took tests on Monday - two of them -and they came back negative (Rapid test); Rapid test again on Thursday when I had completely lost sense of taste and that was positive.  I wasn't coughing or anything, I was just really tired and my sense of taste was completely gone at least 2 days and it slowly came back after a time of 2 weeks. I  was really weak. Hard to do workout with cardiovascular.  Residual - chest tightness - onset - mid September - a full month after I had COVID - chest x-ray shows tight. Steroids for the chest pain and the pain has pretty minimal since then. My lung and heart look fine according to x-rays. Recommending I go to cardiologist and I will be doing that soon.  No treatment for COVID symptoms before the chest tightness occurred except Ibuprofen and rest.
On 1/25/2021, a large red area (4? x 5?) appeared around the site where the  injection was administered. It grew larger over the next two days, approximately an inch or so, each day. In addition, I began itching on the left side of my body and in the middle of my back. My provider,  PA-C, advised my to take Benadryl at bedtime and Zyrtec during the day. I began that on 1/26/2021 and by 1/29/2021 the redness disappeared as well as the itching.
"I receive my flu vaccine on 11/09/2022 at 1:20pm in my left arm. Today 11/10/2022, I noticed this morning a little numbness and tingling in left arm and hand. Didn't think too much of until this afternoon. I'm really feeling the numbness and tingling progress more since this morning".  Ice Tylenol
received first dose on 9/30/2020 and is on schedule for the 2nd dose; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 30th September 2020).   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 patient received 1st dose of Shingrix and was on schedule for the 2nd dose. Till the time of reporting, the patient did not receive the 2nd dose of the Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up via mail or email.
Pt developed redness and whelps around injection sites of MMR and varicella vaccines about 10 minutes after injections were given. Pt given 1.25 mL, Childrens BENADRYL 12.5,g/5mL orally. Approximately 15 minutes after medication given, redness and whelps had completely resolved.
Metallic taste in mouth within minutes of injections, throat felt swollen at 40 minutes but both resolved without intervention.  Diarrhea within 24 hours of shot. Runny nose that started 24 hours later and lasted for 24 hours.
Erythematous rash 5x4 cm (1 cm below) injection place. Fever 103 degrees on day of injection and severe pain in injection site.
Shingles outbreak on left thigh; This is a spontaneous report from a non-contactable pharmacist. This 35-year-old female pharmacist (patient) reported for herself that:  A 35-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration, administered in Arm Right on 26Mar2021 17:30 as DOSE 2, SINGLE for covid-19 immunisation. The patient previously received dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration, administered in Arm Right on 26Feb2021 14:30 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 02Apr2021, the patient experienced shingles outbreak on left thigh. Event resulted in Doctor or other healthcare professional office/clinic visit. No treatment received for the event. The clinical outcome of event was not recovered.  No follow-up attempts are possible. No further information is expected.
Patient reports that 24 hours after vaccine she broke out in a rash that required no treatment and went away after 2 days.
COVID was mild: sore throat, congestion; COVID was mild: sore throat, congestion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 13-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), in Sep2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID was mild: sore throat, congestion". Clinical course: 13-year old son received Pfizer vaccine Sep2022 and got COVID 4.5 months later Covid was mild: sold throat, congestion.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a consumer concerning her 11 year old daughter with asthma and no drug reactions or allergies, who on 03-OCT-2010 was vaccinated with the first dose of GARDASIL (lot # not reported). Concomitant therapy included ADVAIR, montelukast sodium (MSD) and CLARINEX. The consumer mentioned on 14-NOV-2010, "6 weeks later" her daughter's asthma had acted up and her daughter was sick on and off. The consumer did not feel this was due to GARDASIL. No labs/diagnostics studies were performed. The patient was given cortisone and albuterol treatments for the events. It was reported that the patient recovered and was fine on 21-NOV-2010 "after 1 week" of treatment. The patient sought medical attention via an office visit. Additional information has been requested.
9 days after injection I became very tired, not wanting to get out of bed for three days with a fever the first day as well as purple toes several days previously
Case number PHEH2014US019651 is an initial spontaneous report received from a pharmacist on 29 SEP 2014. This report refers to a 64 years old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN 2014/2015 (batch number: 14515P) intramuscularly at a dose of 0.5 ml on 29 SEP 2014. It was reported that he received vaccine after it reached 49 F for up to a maximum duration of 1 hour. No adverse events were reported following the maladministration.
Within 12 hrs starting getting severe chills , then a fever started of 101. for over 48 hrs. Finally went down. Also had a very bad headache and tired. I did not know that I should have waited 3 month because I had Covid a month earlier and now am questioning if I should get the second dose
Got Shingles within few days of second shot.; rash; This is a Spontaneous report from a contactable consumer. A 50-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0172), via an unspecified route of administration on arm right on 26Apr2021(Age at Vaccination: 50 years) at single dose for COVID-19 immunization. The patient medical history was not reported and had no known allergies. The patient has not received other vaccine in four weeks. if covid prior vaccination was reported was unknown. The patient Concomitant medications included Fluconazole. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0151), via an unspecified route of administration on Left arm on 05Apr2021 at single dose for COVID-19 immunization. On 29Apr2021, the patient experienced Shingles within few days of second shot. Went to emergency Care on 11May once rash appeared and was confirmed to be shingles. If covid tested post vaccination was reported as no. The adverse event resulted in Emergency room/department or urgent care. Therapeutic measures were taken and treatment included Valacyclovir HCL 1gm, prednisone 20 mg. The outcome of the events was Resolving.  Other relevant history notes:  1st Dose brand=Pfizer, lot number=EW0151 lot unknown=False administration date=05Apr2021 dose number=1
I was walking down the street and a very loud ringing in my right ear started to happen. It was the only thing I could hear out of that ear. I rubbed my ear and it got quieter but ever since then there has been a ringing in both my ears.  I went to an ENT on Oct 29th at 1 pm and he said I don't have any hearing damage and the tinnitus is most likely a reaction to my Pfizer dose.  My left arm (site of both injections) is still slightly sore.
Fever given influenza vaccine Saturday drive thru 9-24-11 & received email from patient on 9/26/11 notifying his primary care physician evening at 12 PM 9-24-11 he developed fever 103.2 lasted 3 hrs & then resolved.
Extreme headache, with a vise-like grip on the back of my brain.; Temperatures fluctuating between 101 and 103.5; Tired; Slept for 33 hours; This is a spontaneous report from a contactable consumer, the patient.  A 60-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the left arm on 21Apr2021 at 13:15 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 02Apr2021 at 13:15 (at the age of 60-years-old), as a single dose for COVID-19 immunisation. On 22Apr2021 at 02:15, 13 hours after the vaccination, the patient had extreme headache, with a vise-like grip on the back of the brain and temperatures fluctuating between 101 and 103.5. The patient was tired and slept for 33 hours. 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. On 22Apr2021, the patient underwent body temperature test and the result was found to be between 101 and 103.5 degrees. The clinical outcome of the events extreme headache, with a vise-like grip on the back of the brain, temperatures fluctuating between 101 and 103.5, tired and slept for 33 hours was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Information has been received from a physician concerning a 72 year old female patient with diabetes and with not known allergies, who on 08-FEB-2010 was vaccinated intramuscularly in the left arm with a 0.5 mL dose of PNEUMOVAX (lot number 665402/1339Y).  There was no concomitant medication.  On 08-FEB-2010 the patient experienced redness, swelling and soreness at the injection site.  The physician stated that it looked like a local reaction and did not look like an infection.  On an unknown date, the patient was told to use a cold pack followed by a hot pack.  On an unknown date, the patient recovered from redness and swelling but the patient was still experiencing soreness at the time of reporting.  No labs or diagnostics were performed.  Patient sought medical attention through an office visit.  Redness, swelling and soreness at the injection site were considered to be disabling by the physician, since the patient had difficulty moving her left arm.  Additional information has been requested.
Around February 2022, I started to experience pain in my arms, back, neck and thighs. I was extremely stiff in the morning. I was given prednisone for that. I started with 5mg and now I'm down to 1mg. I can still feel the pain in my right shoulder. I couldn't raise my arms over my head, it was that bad. I was diagnosed with PMR (Poly Myalgia Rheumatica). I've never experienced anything like this in my life. I'm not sure where it came from. After receiving my COVID-19 vaccine, I also received the flu shot on 10/11/2021, Shingles on 11/17/2021 and 2nd shingles shot was 02/05/2022.
Nausea; Intestinal cramping; This is a spontaneous report from a non-contactable consumer reporting for herself. This female patient of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 14Jan2021 at single dose for COVID-19 immunization.  Medical history and concomitant medications were not reported. In Jan2021, the patient was experiencing nausea/intestinal cramping. Outcome was unknown. No follow-up attempts are possible, information about lot/batch number cannot be obtained.
SHE FELT DIZZY, HOT SWEATING DRY THROAT AFTER SHE TOOK THE VACCINE. ON SITE EMS RESPONDED. BP 135/88 TEMP 97.4 F. SHE WAS MONITORED FOR 20 ADDITIONAL MINUTES AND SHE WAS OKAY. SHE WAS RELEASED TO HOME
i administered pfizer 1st booster at 3:55pm and pt was sitting in the waiting area when his friend alerted me that he was feeling dizzy. i went out to him and laid him on the ground with his feet elevated. we put ice packs on his forehead and on his neck. he also had some tingling in his hands.he stated that he hadn't had anything to eat all day. we gave him orange juice and within 15 minutes he was feeling back to normal
Information was received on 06-OCT-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's medical history, concurrent conditions or concomitant medications. It is complained and alleged that the patient was inoculated with a dose of ZOSTAVAX vaccine (dose, route and lot # were not reported) on or about 25-NOV-2014 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. It was reported that the vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 04-MAY-2015, the patient was treated in the office by her physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. On or about 11-MAY-2015, the patient sought subsequent treatment in the office by her physician for ongoing and worsening outbreaks of shingles. The patient has been prescribed acyclovir and NORCO for management of her painful condition. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information has been requested.
various spots on brain; Fatigue; sixty pound weight loss; memory issues; tachycardia; cold like symptoms; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4388298-00.  A 49-year-old female patient received BNT162b2 (BNT162B2), in Sep2021 as dose 2, single (Batch/Lot number: unknown) at the age of 49 years and in 2022 as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unk, citrate free, subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose-1, Intramuscular), administration date: 03Aug2021, when the patient was 49-year-old, for Covid-19 Immunization, reaction(s): "Suspected COVID-19"; BNT162b2 (Dose-1, Intramuscular), administration date: 03Aug2021, when the patient was 49-year-old, for COVID-19 Immunization, reaction(s): "Drug ineffective". The following information was reported: ENCEPHALOPATHY (medically significant), outcome "unknown", described as "various spots on brain"; FATIGUE (non-serious), outcome "unknown"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "sixty pound weight loss"; MEMORY IMPAIRMENT (non-serious), outcome "unknown", described as "memory issues"; TACHYCARDIA (non-serious), outcome "unknown"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "cold like symptoms". The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging: Unknown; Weight: weight loss, notes: sixty pound weight loss. The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "various spots on brain", "fatigue", "sixty pound weight loss", "memory issues", "tachycardia" and "cold like symptoms" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case, an association between the reported events and the suspect product BNT162B2 cannot be ruled out.  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.
Injection site swelling, injection site erythema - Information has been received from a pharmacist concerning an unidentified patient who was vaccinated subcutaneously in the forearm with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation.  Subsequently the patient developed a huge red swelling at the site of injection.  The patient sought unspecified medical attention.  Attitional information has been requested.
Per Observer RN; Caregiver reported feeling "flushed." Observer noted facial flushing.  Caregiver reported "blurred vision, itchiness all over body as well as dizziness."  Approx. 10 minutes later also reported "chills."