chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a Health care worker, for GARDASIL a pregnancy registry product, concerning a 16 year old female with no reported drug reactions/allergies and medical history who on 30-JUL-2007 and 18-JUN-2008 was vaccinated with a first and third dose respectively of GARDASIL (route, dose and lot number of the first dose was not reported) (route IM, 0.5ml and lot number: 660555/0279X for the third dose). There was no concomitant medication. The health care coworker stated that after the third dose of GARDASIL shot was given (on 18-JUN-2008), the reporter found out that the patient was 14 weeks pregnant (approximately LMP: 11-MAR-2008, EDD:17?-DEC-2008 date approximately) at the time she received the third vaccination. Also the Health care worker reported, the patient was not pregnant at the time of the first and second shots. The baby was given up for adoption so they did not have access to any additional information on the baby. The patient had not been in the office since "June 2008" so they did not know the present status. A pregnancy test was performed. No adverse effects reported. The patient sought medical attention at the physician's office. Follow-up information has been received via telephone call from an other health professional on 05-NOV-2010 regarding pregnancy outcome information of the patient. Patient's mother was called to find out the outcome and she reported that they decided to terminate the pregnancy (date not provided). The patient and her family did not have the pregnancy terminated due to GARDASIL, rather because the patient was so young. Upon internal review termination of pregnancy was determined to be an other important medical event. No further information is available.
attempted to administer vaccination in left arm pt immediately grimaced and complained of pain, removed needle and replaced with new needle and vaccinated in right arm.  patient complains of extreme pain in right arm, and unable to lift.  patient did speak with primary care provider.  Patient also experienced fever of 102 the evening of vaccination.  Per advise from patients primary care provider patient is treating pain and fever with ibuprofen
Vaccine administered on 1/19/21 at 2:15pm and patient began having seizure activity on 1/20/21 at approximately 4pm  Patient sent to ER for evaluation. Temperature of 102 was noted at ER. Seizure eventually resolved and he returned to his residence.  He has a prior history of seizures.
VERY SICK; VOMITING; 103 FEVER; This spontaneous report received from a parent via a company representative concerned a 20 year old male. The patient's height, and weight were not reported. The patient's past medical history included: covid-19. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on JUL-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced very sick, vomiting, and 103 fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103 F. The action taken with covid-19 vaccine was not applicable. The outcome of very sick, 103 fever and vomiting was not reported. This report was non-serious.
Information has been received from a health professional concerning a 7 year old male with no known medical history or allergies who on 8/26/1998 was vaccianted with a dose of varicella virus vaccine live (lot 625133/0055H). On 6/3/2005 the patient presented to the clinic with mild case of chickenpox breakthrough. Unspecified medical attention was sought. No treatment was needed. Subsequently, the patient recovered. There was no product quality complaint involved. Additional information has been requested.
Low grade fever (100.9 peak temp);; mild nausea; mild arm soreness; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: Ep6955, Expiration Date: not reported) via an unspecified route of administration in right arm on 25Mar2021 11:30 as dose 2, single for COVID-19 immunization (at the age of 58-year-old). Historical vaccine in four weeks included first dose of BNT162B2 (Lot number: EL3247, Expiration Date: not reported) via an unspecified route of administration in left arm on 02Mar2021 for COVID-19 immunization. The patient medical history was not reported. Concomitant medication(s) (within 2 weeks of vaccination) included adenosine (TRICOR [ADENOSINE]), fish oil and multivitamin. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient became aware of the symptoms on the afternoon of Friday 26Mar2021. The patient experienced low grade fever (100.9 peak temp), mild nausea, mild arm soreness on 26Mar2021 15:00. The patient underwent lab tests and procedures which included body temperature: 100.9 on 26Mar2021. Patient did not received treatment for the events. The outcome of the events was recovered on an unspecified date.  No follow-up attempts are needed. No further information is expected.
A few hours after my shot, my left arm and lymph nodes under my left armpit became tender and swollen. I initially developed a fever around 99F (oral) around 10pm on the same day as the shot. Early the following morning for several hours (ongoing current time 10am, 01 Dec 21) my fever has remained around 102.6F (oral).   I began shaking with chills around 2am (01 Dec 21) and developed full body aches/pain, neck/base of head pain, full body joint pain (especially in knees, hips, back, and fingers), headache, sore throat, stomach upset (nausea and diarrhea - unsure if related), sore eyes. The symptoms were flaring my chronic medical conditions, as my bp sitting was 91/61 (wrist  cuff - usually reliable as determined by Neurologist) and standing it would drop very low that bp would often not ready it (error - occurs when too low). When it did read by bp was 78/45 plus or minus a few points. My tachycardia was ongoing as well, ranging from 114-130bpm sitting. LE nerve pain becoming more acute - hesitant to use neurostimulator due to body aches. Struggled to sleep due to shakes, body pain, fever and headache. Minimal appetite and thirst. Mild nerve pain sensations in armpit developed around 6am and is on and off. I have a spinal cord stimulator implant in my lower back and the area around the device is very tender and achy as well.   I have taken 500mg of Tylenol every 8 hours and tried to hydrate with water. Continuing to move arm in attempt to reduce soreness. Eating soup, watermelon, and herbal ginger tea for fluids. Took only Lysine, Wellbutrin, and Multivitamin during this time. Cough drops to ease sore throat. Symptoms still ongoing.
heart beat little bit fast/at this point he is on 119 and he is on he is been risking all day; This is a spontaneous report received from a contactable consumer (patient's parent).   A 13-year-old adolescent male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration on 19Jun2021 (at the age of 13-year-old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient's historic vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) received on 28May2021 (at the age of 12-year-old) for covid-19 immunisation. On 20Jun2021, the patient experienced heart beat little bit fast/at this point he was on 119 and he had been risking all day. It was reported that patient was 13 years old just yesterday, he had the second dose of Pfizer for COVID and today he had been feeling the little bit like a with a heartbeat little bit fast. Heartbeat rate was checked and on the day of this report (reported as this afternoon) with 109 and then just checked again increased to 116, so for somebody on his age the range should be in between the 60 and 100 and at this point he was on 119 and he had been risking all day. The patient underwent laboratory tests and procedures which included heart rate: 109 on 20Jun2021 and heart rate: 116 on 20Jun2021. The outcome of event was reported as not re-solved.   Information on the lot/batch number had been requested.
Pt recvd vax 27OCT @ 1030; 27OCT 10PM had h/a, neck pain & fever 101; sx lasted about 1/2 day or 28OCt; still having h/a; seen by MD who felt this was stress related h/a;
Pt developed angioedema with rash and swelling less than 24 hours, post vax.
This spontaneous report as received from a physician refers to a 4 month old patient. On 23-AUG-2017, the patient was vaccinated with PEDVAXHIB (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On 23-AUG-2017, the patient experienced incorrect product storage. Sender's Comments: US-009507513-1708USA013219.
Patient developed full body urticaria and emesis around 30 minutes after receiving vaccine. Patient instructed to give Benadyl po. Phone call follow up with patient throughout weekend showed no progression of allergic symptoms which eventually fully dissipated.
Fever of 101; Headache; Sore arm; Cold symptoms/runny nose like cold; This is a spontaneous report from a contactable consumer or other non hcp. A 15-years-old adolescent male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch Number/Lot Number: Not reported),via an unspecified route of administration on 23Jul2021 as  Dose 2 ,Single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch Number/Lot Number: Not reported)via unspecified route of administration on 01Jul2021 as  Dose 1,Single for COVID-19 immunization. The patient experienced fever of 101, headache, sore arm and cold symptoms/runny nose like cold in Jul2021. The patient underwent lab tests and procedures which included body temperature with result 101 fahrenheit on an unspecified date. The outcome of the events were reported as unknown.  Information on lot/batch number has been requested.
Arm where got vaccination is red; Arm where got vaccination blew up; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Arm where got vaccination is red) and VACCINATION SITE SWELLING (Arm where got vaccination blew up) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Arm where got vaccination is red) and VACCINATION SITE SWELLING (Arm where got vaccination blew up). At the time of the report, VACCINATION SITE ERYTHEMA (Arm where got vaccination is red) and VACCINATION SITE SWELLING (Arm where got vaccination blew up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was reported.  Action taken with mRNA-1273 in response to the events was not Applicable   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: follow up received on 28 April 2021, second dose received, no adverse events and no information on vaccine was provided.
I have an IUD that has prevented me from menstruating for 6 months or more. More than 2 weeks after receiving my first shot, I started having a heavy period with cramps, clots, and bright red blood. I have read that this is a side effect and I want it reported that it definitely has been for me.
After receiving the vaccine it became hard to swallow. She had COVID symptoms and it made her Lyme Disease flare up. The following week she felt like she was having a heart attack. Couple days later she couldn't walk up 3 stairs without being winded. Went to doctor after and was sent to the ER.
Injection site pain; Tiredness; chills; headache; injection site swelling; redness; nausea; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208), via an unspecified route of administration in the right arm on 18Mar2021 at 14:00 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. Medical history included multiple sclerosis, lung disease, vitamin B deficiency and coronary artery disease. The patient was allergic to promethazine (PHENERGAN), prochlorperazine (COMPAZINE), metoclopramide (REGLAN) and tetanus toxoid (TETANUS). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EM9810), via an unspecified route of administration in the right arm on 25Feb2021 at 14:00 (at the age of 73-years-old) as single dose for COVID-19 immunisation. The patient received other medicines (unspecified) within two weeks prior to the COVID-19 vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient was not tested for COVID-19. On 19Mar2021 at 16:00 the patient experienced injection site pain, tiredness, chills, headache, injection site swelling, redness and nausea. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events injection site pain, tiredness, chills, headache, injection site swelling, redness and nausea were not recovered at the time of reporting.   No follow-up attempts possible. No further information expected.
states awoke this AM w/face swollen, throat sore, tongue felt thick, aching in rt arm below inject site, & aching in back & neck;
Pancreatitis episode, after two years with no episodes .  I had 2 drinks the evening before,  but do not have alcoholic pancreatitis,  due to gall bladder surgery
VACCINE SIDE EFFECTS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced vaccine side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vaccine side effects. This report was non-serious.
Loss of hair, diagnosed alopecia areata, steriod injections every month provided by healthcare professional.
positive for Covid; positive for Covid; suspected COVID-19 Virus symptoms from 15Apr2021 to 18Apr2021; She said she came in contact with someone on 10Apr2021 who was sick (with the COVID-19 Virus).; This is a spontaneous report from Medical Information. A 20-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 08Apr2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation (Age at vaccination: 20 years). The patient's medical history and concomitant medications were not reported. The patient reported that she had received her first COVID-19 Vaccine dose on 08Apr2021. She said she came in contact with someone on 10Apr2021 who was sick (with the COVID-19 Virus). She said on 13Apr2021 she started to quarantine. She also stated that she had suspected covid-19 virus symptoms from 15Apr2021 to 18apr2021 on 15Apr2021. She said she found out on 21Apr2021 that she was positive for the COVID-19 Virus. The patient underwent lab tests and procedures which included COVID-19 PCR test: negative on 15Apr2021 and 19Apr2021 and tested positive on 21Apr2021. Outcome of the event suspected covid-19 was recovered on 18Apr2021 while outcome of the remaining events was unknown.   Information on the lot/batch number has been requested.
Ten patients were administered an expired dose of the Moderna COVID-19 vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Ten patients were administered an expired dose of the Moderna COVID-19 vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Ten patients were administered an expired dose of the Moderna COVID-19 vaccine). On 17-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Ten patients were administered an expired dose of the Moderna COVID-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications provided. No treatment medications provided.
Patient experienced a large bruise at injection site still present 6 days post vaccination. she said it was not painful but bruising around injection still present today
Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Hypotension-Mild, Systemic: Nausea-Mild, Systemic: Shakiness-Mild
Day 10 after vaccines man noticed 1.5" red warm indurated area on right thigh. Afebrile. Tx with Keflex 250 mg/tsp. Sig: 2/3 tsp TID for 7 days.
I had a very intense headache for which I needed to miss work. This lasted 3 days.
pt recvd vax; pt started screaming when recving inject & cont screaming constantly; no inc t;apap given;called hlth dept to report screaming & had just started throwing up;
Feeling tired/weak for about 1-2 days; slight fever (1-2 degrees above normal) for about 1 day.
The following symptoms began 12 hours after receiving the 2nd vaccine (approx. 2 months after the 1st vaccine was administered).  Uncontrollable shivering  (no fever noted) and nausea began 1/8/2020 at 9p and lasted for 14 hours (1/9/2020, 11a). Headache began about 24 hours after receiving the vaccine (1/9/2020, 9a) and continued for about 23 hours (1/10/2020, 8a). Light headed/dizziness began 1/10/2020, 10a. Fatigue began 1/8/2020 and continued for the next 48 hours. Treatment of ibuprofen didn't relieve shivering or headache.
About 7-10 days later, I started breaking out from the knees down with a horrific rash especially on my left side. It was multiple itching points. I was up at 3am pouring alcohol on the itchiness. I contacted the doctor who prescribed steroids. I did not take it because my doctor suggested it might compromise the shot. It lasted about 2-3 weeks and I still have scars. I missed work for 3 days due to the itchiness. I am left with little scars on my body from the itchiness.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 16-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment  medications were reported.  Date of refrigeration of vial was 7 May 2021.
Deep pain at injection site for 4 days, beginning the evening of the injection; fatigue, weakness, and dizziness the day following the injection; red, itchy hive (about 3" in diameter) at injection site that lasted for 12 days
Inadvertent SQ/tricep injection with subsequent redness induration swelling and warmth growing in size from mid arm to elbow.
warm and dry large raised red patches x 5 of varying size below the site of injection. Slightly warm to touch.
pt recv vax & exp gross edema of lt arm from inj site to wrist;MD visit was required;pt was treated w/DPH;sx cont;
About 3-4 days after the first dose, developed a new rash on backs of my hands. They were small, raised, very itchy bumps. I used benedryl cream that helped short term. The itching gets worse as the day goes on. I initially didn?t think anything of it, thought it might have been a new plant I brought home but after looking back over the timeline, it didn?t match up. Assuming it was the plant when I went in for the second dose, I never mentioned anything to the nurse because I hadn?t realized the connection. That dose was on 3/31/21, same location but opposite arm. Itching and bumps got worse within a few days, spread to my ankles, back, chest, forearms and tops of feet. Painful, areas feel bruised from scratching.
numbness in my fingers; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness in my fingers) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (numbness in my fingers). At the time of the report, HYPOAESTHESIA (numbness in my fingers) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.
This spontaneous report was received from a physician via company representative refers to a 11 year old male patient. On an unknown date, the patient was vaccinated with AFLURIA (dose, route and frequency was not reported) and first shot of GARDASIL (route and frequency was not reported) at the same time. On an unknown date, after receiving both the vaccines at the same time, the patient experienced swelling at the injection site. It was also reported that the patient had not yet received the second and third dose of GARDASIL. The outcome of the event swelling at the injection site was unknown. The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested.
Pt developed generalized vaccinia across neck and both upper arms and a few lesions on chest and back.