chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt bad), COVID-19 (tested positive for Covid-19), PYREXIA (fever) and MYALGIA (body aches) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced FEELING ABNORMAL (Felt bad), PYREXIA (fever) and MYALGIA (body aches). On an unknown date, the patient experienced COVID-19 (tested positive for Covid-19). The patient was treated with PARACETAMOL (TYLENOL) for Feels bad, COVID-19, Fever and Myalgia, at a dose of UNK dosage form. At the time of the report, FEELING ABNORMAL (Felt bad), COVID-19 (tested positive for Covid-19), PYREXIA (fever) and MYALGIA (body aches) was resolving. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. On 04-Feb-2021 patient was feeling better (isolation ends next day of report).
C/O left arm feeling numb 30 mins after receiving flu shot. States same thing happened last year. The follow up states resolved without tx post 4-5 hrs.
anaphylactic shock; she had the booster; she had the booster; This is a spontaneous report from a non-contactable physician via a sales representative. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at dose 3 (booster) single for covid-19 immunization. Medical history included cancer and patient was on immunotherapy. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at dose 1, single and dose 2, single for covid-19 immunization. The patient experienced anaphylactic shock (medically significant) on an unspecified date. Patient was doing well on her immunotherapy before the booster shot. After she had the booster she had immunotherapy and started having these reactions. It took two or more healthcare professionals to be able to stabilize a patient having an anaphylactic shock and the patient may not have time. Doctor was describing that it was dangerous to have unsupervised home infusions for cancer patients. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: As there is limited information in the case provided, the causal association between the event anaphylactic shock and the suspect drug BNT162B2 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.
Patients dad called and states was in last week 8-12-15 for a well child and received the Hep A and HPV, dad states that by Friday his son was broke out from head to toe with hives. His arms at the injection sides were very red, swollen like with some white lump like (Hives). Dad states they gave him Benadryl and didn't seem to help and did Claritin as well, he did state it was mint fest and was outside in heat as well. Took him to ER on Saturday where he was given a steroid shot, and medications as well. Dad said that was told by the doctors and nurses that these two vaccinations really shouldn't be given together for they can cause reactions together. Dad states he wanted us to be aware for he of his allergic reaction and would like a call back today to know if this is true on these two vaccinations, I told the dad I would call him after we called the Health Dept to see what there thoughts are on this.
Please keep in mind that i may have had shingles in Jan (sine herpete) i had a positive IGM, i also has very distinctive nerve pain along upper dermotomes.    Several weeks after my covid shot, i developed a new type of nerve pain that was pins and needles  mostly in my hands and feet. but it could occuer in differnt areas.  It seemed to be clearly related to sugar intake. i first though that i had a diabetic issue, but my A1C and daily blood sugar was within normal limits.  I reduced my daily sugar intake and the pain went away, but it still has been persistant whenever i have sugar the pain comes back.
1-2 days post vaccinations patient experienced what appears to be an injection site reaction. The site is hot to touch, red, and inflamed. He is experiencing some discomfort with pain and itching. Last evening (5/1/18) he had a low grade fever and experienced some body aches and fatigue that kept him up most of the night. He also had some mild bleeding days later from the injection site.
burning in chest; felt very hot; heart racing; high blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (burning in chest), FEELING HOT (felt very hot), PALPITATIONS (heart racing) and HYPERTENSION (high blood pressure) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported. ). Concomitant products included TELMISARTAN, LEVOTHYROXINE SODIUM (SYNTHROID), SIMVASTATIN and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced CHEST PAIN (burning in chest), FEELING HOT (felt very hot), PALPITATIONS (heart racing) and HYPERTENSION (high blood pressure). On 20-Feb-2021, CHEST PAIN (burning in chest), FEELING HOT (felt very hot), PALPITATIONS (heart racing) and HYPERTENSION (high blood pressure) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
pt recv vax 17AUG95 & 25JAN96 pt broke out w/a varicella-like rash;the number of lesions was unk;
This spontaneous report as received from a consumer refers to herself a female patient of unknown age with no pertinent drug reactions. On 22-OCT-2012, the patient was vaccinated with ZOSTAVAX (dose, route and lot provided). No concomitant medications were reported. The consumer stated that on 22-OCT-2012 she received ZOSTAVAX at a local pharmacy and a few hours after receiving the vaccine the injection site became hot, red, and developed a little lump in a circle about 3 inches in diameter, the lump was itchy, and painful. The patient also developed a headache. The patient was put on treatment with ibuprofen for headache. The patient did not sought medical attention and did not performed any laboratory tests. On 25-OCT-2012, the patient explained that she was feeling better. At the time of the report, the patient's outcome was reported as recovering/resolving. The relatedness for adverse events was unknown for ZOSTAVAX. Additional information is not expected.
Shortly after injection, started to have swelling. Within 72 hours, swelling was below right elbow. Arm stiffness. Pt placed on restricted duty for 10 days, missed 2 days of work.
Patient presented with chest pain, palpitations and SOB 4 days after 2nd Pfizer COVID-19 vaccine. Found to have elevated troponin of 8.48 and diffuse non-specific ST changes on EKG. Diagnosed with myocarditis. Echo with no structural abnormalities. Troponin peaked at 9.273. Patient was kept on telemetry monitoring that showed multiple PVCs. Given Prednisone daily and observed for 4 days. CRP on day of admission was 9.8, day of discharge was 2.07. Discharged on 7 day course of Prednisone.
Called s/o with headache, lower abdominal pain, nasal stuffiness, (R) arm numbness. Pt. advised further evaluation in an urgent care.
Information has been received from a medical assistant concerning a 12 year old female with no pertinent medical history who was vaccinated with the first 0.5 ml dose of GARDASIL (IM, lot number 661044/0548X) on 30-JUN-2009 and fainted. Concomitant therapy included MCV4. Unspecified medical attention was sought. There was a "finger stick to check her sugar" (results were not reported). At the time of the report, the patient recovered. Follow-up information has been received from a member of the office. It was reported that the patient received GARDASIL and about 10 minutes later she fainted. However, it was reported that the patient walked to the office that day and it was hot outside. Follow-up information has been received from another member in the office who confirmed the above information as well the patient's birth date, vaccination date and lot number. She also added that the day the patient came into the office it was hot outside, their air conditioning was not working and the patient did walk to the office. Therefore, it could not be certain if the fainting was from the GARDASIL or from heat exhaustion. This is one of several reports from the same source. No further information is available.
weak, tired, stomach ache, chills, nausea, dizziness, feverish, headache, joint/bone aches
Bipolar mixed episode occurred approximately 24 hours after vaccine was received. Mixed episodes are inconsistent with my typical bipolar symptoms/episodes, only occurring rarely. The timing of this episode seemed possible to be related to vaccine. Episode lasted approximately 3 days, did not require any special treatment.
pt had inconsolable crying for 6hr & questionable high pitched cry ? as reported by parent, but not heard by MD over phone; tx APAP; will not give further pertussis vax;
2nd Anthrax shot was given on approx. 5/26/00 and 1 day, post vax, pt developed cold-like symptoms which consisted of sore throat, congestion, persistent cough, malaise, fatigue, canker sores and 1 fever blister.
Endorsing nausea, shortness of breath, throat swelling, tingling in tongue. EMS called and IM epinephrine 0.3 mg given. Follow IM epinephrine she reported improvement in mouth/tongue tingling, worsening nausea and shortness of breath. She was transferred to the ED for worsening/persistent symptoms. In the ED she was observed 2.5 hours, given Decadron, H1 and H2 antihistamine and IV fluids and discharged home.
Patient stated that about 7 hours after receiving the injection she began to shiver. This lasted about an hour. She said it then turned into severe shaking for another hour to hour and a half. She said the entire incident only lasted around 3 hours and then it stopped. She has not had any other reactions since then. When she visited her family doctor for her regular check up, he encouraged her to come back to let us know so it could be reported.
Information has been received from a nurse practitioner (NP) concerning a pt who in approx Jul 2006 was vaccinated PO with the first dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine). The NP reported that in approx Jul 2006, within hours of being vaccinated, the pt experienced a fever of 104 deg. Unspecified medical attention was sought. At the time of this report, the outcome was unk. Additional information has been requested.
Per patient, he received his second dose of Pfizer COVID-19 vaccine on 02/20/2021.  Approximately 48 hours later, he developed left-sided lip paralysis.  He went to his doctor that day, no medications were prescribed and no tests were ordered.  Over the next 24 hours, he states that his symptoms progressively worsened and now the left side of his face seems "completely paralyzed."  He described left ear pain, increased sensitivity to loud sounds, runny nose, and inability to close his left eye.  He saw another doctor the next day, who diagnosed Bell's Palsy and prescribed valacyclovir for 7 days. Patient also noticed a transient "crooked smile" after his first dose of Pfizer vaccine, but did not relate this
side of her face started going numb and tingling/numbness, tingling, and ringing in her ear was occurring on the right side; side of her face started going numb and tingling/numbness, tingling, and ringing in her ear was occurring on the right side; Ears started ringing/ringing in her ear was occurring on the right side; She just got the Pfizer Covid-19 booster; can't hear out of her ear good and it is like it is full of water; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 34-year-old female patient received bnt162b2 (BNT162B2, Solution for injection), administered in arm left, administration date 06Dec2021 16:30 (Lot number: 320308D) at the age of 34 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single, Batch/Lot number: EL9267, Expiry: May2021), administration date: 19Feb2021, when the patient was 33 years old, for COVID-19 immunization; Bnt162b2 (Dose 2, single, Batch/Lot number : EN6202, Expiry date : 30Jun201), administration date: 12Mar2021, when the patient was 33 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 06Dec2021 16:30, outcome unknown, described as She just got the Pfizer Covid-19 booster; TINNITUS (non-serious) with onset 06Dec2021 16:45, outcome not recovered, described as Ears started ringing/ringing in her ear was occurring on the right side; PARAESTHESIA (non-serious), HYPOAESTHESIA (non-serious) all with onset 06Dec2021 16:50, outcome not recovered and all described as side of her face started going numb and tingling/numbness, tingling, and ringing in her ear was occurring on the right side; HYPOACUSIS (non-serious) with onset 06Dec2021, outcome not recovered, described as can't hear out of her ear good and it is like it is full of water.  Additional information: Caller is a consumer that reported that she just got the Pfizer Covid-19 booster dose at 1630 and about 15 minutes after she got it she left and was driving home and reported that her ears started ringing when she left at 1645. HCP: Caller declined.  Follow-up attempts are completed. No further information is expected.
PATIENT RECEIVED A DOSE OF PFIZER BIVALENT BOOSTER DOSE WAS PAST BUD
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 05-DEC-2017, the patient was vaccinated with incorrectly stored dose of M-M-R II (dose, frequency, route of administration were not reported, lot # M000768, expiration date 05-JAN-2018. No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of -14.4 degrees Celsius for 54 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained.; Sender's Comments:  US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742:
1/31/2023 I felt off in the afternoon. Overnight, I woke up with a sore throat and feeling worse. I got up the next morning, I tested with an at home COVID test and it was negative. I was congested like I was getting a cold. I felt worse throughout the day and night. I was sneezing, congested, and started running a fever, chills and had a constant headache. On 2/2/23 I took another at home COVID test and it was positive. I had an appointment with my doctor. They took 2 rapid COVID tests that were negative. I had a flu and RSV test that were both negative. I also had a PCR test that came back the next day positive for COVID. My doctor prescribed PAXLOVID which I began taking on 2/2/23 that night. I was pretty sick on that night and did not feel good. 2/3/23 in the evening and into the next day, I began feeling better. After finishing the PAXLOVID, I had a negative at home COVID test. On 2/11/23 in the afternoon, I was not feeling good, really tired and felt off. I suspected I was having a rebound of COVID. I did not feel good overnight. On 2/12/23 I tested positive with an at home COVID test. I called my doctor's office to let her know I had a lot worse symptoms. I ran a fever over 100, chills, very bad head congestion, very fatigued, a little tightness in my chest and a dry cough, but never a chest cold. I lost my sense of taste. I also had a constant headache. I tested with an at home COVID test about a week later and the test was negative. My symptoms were gone except for still feeling pretty tired. I did not feel like myself again until around 2/22/23 or 2/23/23. I have recovered with those symptoms. I have noticed an issue with my voice has a little bit of hoarseness that I did not have before having COVID.
Developed 2 chickenpox like rashes.  1 on lower left arm and other below neck
This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PRURITUS (Itchiness at injection site) and VACCINATION SITE PAIN (soreness at injection site arm persistently sore at injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039k20A) for an unknown indication.  No Medical History information was reported.    On 31-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 08-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness at injection site) and VACCINATION SITE PAIN (soreness at injection site arm persistently sore at injection site). On 09-Jan-2021, VACCINATION SITE PRURITUS (Itchiness at injection site) had resolved. At the time of the report, VACCINATION SITE PAIN (soreness at injection site arm persistently sore at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment for the event were not known.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Information has been received from a pharmacist referring to a newborns(numbered 86). Background: Since June 2015, there had been 1645 times (30 minutes each time = 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time = 72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 11-AUG-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported) (incorrect product storage). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Right upper arm with 4-5 inches of redness. Swelling, tenderness. Pt also complained of itching.
13APR99 mom reported fever of approx 102 when the family awoke the next morning;pt also cried when was asleep;had 4-5 loose stools/24hr for 1 1/2days;fever persisted x 2 days;
Injection site is red, inflamed, and warm to the touch down to below the elbow, the primary care provider has been contacted.
This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 4-year-old female patient who received KINRIX (batch number 74G79, expiry date 16th August 2019). Concomitant products included PROQUAD. On 2nd August 2017, the patient received KINRIX (intramuscular) .5 ml. On 2nd August 2017, several hours after receiving KINRIX, the patient experienced injection site erythema and injection site swelling. In August 2017, the patient experienced fever. On an unknown date, the outcome of the injection site erythema and injection site swelling were not recovered/not resolved and the outcome of the fever was unknown. The reporter considered the injection site erythema and injection site swelling to be probably related to KINRIX. It was unknown if the reporter considered the fever to be related to KINRIX. Additional details were provided as follows: The patient received KINRIX in the right deltoid. On the same day, the patient concomitantly received vaccination with PROQUAD (batch number: M049122, expiry date 13th June 2018) in the left deltoid. In August 2017, less than a week after vaccination, the patient experienced fever. KINRIX was administered to two patients on different days by two different healthcare professionals at different sites (refer case US2017121958).
both my arms began to tingle and become numb/left arm is still numb and tingling its been almost 24 hours/having trouble with my arm being numb and tingling; both my arms began to tingle and become numb/left arm is still numb and tingling its been almost 24 hours/having trouble with my arm being numb and tingling; left arm is still hurting very bad and feels very heavy; left arm is still hurting very bad and feels very heavy; heart palpitations; felt very tired/overall feel run down; nausea; This is a spontaneous report from a contactable consumer (patient).  A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: FA6780, expiry date not reported), via an unspecified route of administration, in left arm, on an unspecified date, at the age of 55-year-old, at dose number unknown, single for covid-19 immunization. Medical history included high blood pressure and heart issues. The patient was not pregnant during the time of report. The patient's concomitant medications were not reported. Prior to vaccination the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. The patient has not been tested with covid-19 since the vaccination. The patient previously took codeine and experienced allergies. The patient experienced heart palpitations, tired and nausea with overall feel run down on 23Jul2021 01:00. Two hours later (23Jul2021 03:00), both the arms began to tingle and became numb. The patient's left arm is still hurting, felt heavy, numb, tingling and it's been almost 24 hours from the time of report. The reporter assessed the events as non-serious. No treatment was administered for the events. The outcome of the events was unknown.
Seen urgent care 12/15/10 2 day hx (L) arm redness, swelling, pain area "hot" & fever. Started on course KEFLEX 500mg every 6 hrs for 7 days. Cellulitis/abscess.
muscle pain several hours after the shot I had trouble getting warm in bed. In the morning started a shower and got dizzy, felt nauseated, low blood pressure, fainted.
14 month old child was behind on vaccines. KINRIX was administered as 3rd polio and 3rd DTaP.