chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt reported on 01-11-18 at 7:12 pm that he experienced a canker sore, lymphadenopathy, and body aches. Administration site had no redness or swelling. Pt is following up with PCP on 01-12-18 to inquire about any recommended treatment. Pharmacist on duty advised Pt to take ibuprofen or acetaminophen if needed for discomfort. Pt will contact pharmacy to discuss PCP suggestions/input.
Have since been diagnosed with cold urticaria. Break out in hives from exposure to cold. It is ongoining. Instructed to take antihistimines and avoid cold exposure (weather, surfaces, food, etc.)
Arm swollen at injection sight (6 days), arm felt hot in the area swollen (3 days), nausea, diarrhea (for 3 days), extreme fatigue and tiredness (6 days) and headache (6 days). The symptoms have improved but have not completely subsided as of 6/18/14. I still feel very tired, nauseated and my arm is still swollen at the injection site on 6/18/14.
bad case of hive; allergic reaction; This case was reported by a consumer via interactive digital media and described the occurrence of allergic reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th October 2020, the patient received Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced allergic reaction and hives. On an unknown date, the outcome of the allergic reaction and hives were unknown.   It was unknown if the reporter considered the allergic reaction and hives to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported.  The age group was not reported but was captured as adult as per vaccine indication.  After receiving dose of Shingrix, the patient experienced allergic reaction and bad case of hive for 4 weeks. The patient was asking how long does or when will it go away. The reporter did not consent to follow up.
Swollen lips, mouth sore, lips reddened and look like they are bleeding, feel "grainy", headache.
Tinnitus - high pitch ringing in both ears.  Started approximately 4 days after receiving vaccine.  Continuous and has not resolved after two weeks.
This spontaneous report was received from a licensed practical nurse (L.P.N) via a telephone call, concerning a 12 month old male patient. No concurrent conditions or medical history were reported. On 11-JUN-2015, the patient was vaccinated with an improperly stored dose of (Oka-Merck) PROQUAD (Lot # K018142 Expiration date: 10-APR-2016) (dose, frequency and anatomical location of administration were not reported). No concomitant therapies or adverse experiences were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Patient reported area around injection site was still bruised. Reported black/blue bruise around the site and had been slow to heal back to normal. Patient is on PLAVIX, antiplatelet therapy, and pt advise that any injection may increase risk of hematoma while on that medication. Patient advise to follow up with prescriber and we also discuss with nurse, at Dr office of the adverse event.
Extreme upper body joint pain (arms-shoulders) for the last 6-months.  No treatment yet!  Severe arthritic symptoms, mostly at night (sleep) and in the early morning.
Headache, shivering, nausea, vomiting. Replaced fluids. Patient feeling somewhat better today.
This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (knee hurting so bad I can't walk) and MYALGIA (sore arm, not as bad as yesterday) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination. No Medical History information was reported. On 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jun-2021, the patient experienced ARTHRALGIA (knee hurting so bad I can't walk) and MYALGIA (sore arm, not as bad as yesterday). At the time of the report, ARTHRALGIA (knee hurting so bad I can't walk) and MYALGIA (sore arm, not as bad as yesterday) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No treatment information was provided. No relevant concomitant medications reported. Most recent FOLLOW-UP information incorporated above includes: On 05-Jun-2021: Follow-up received and contains no new information.
Redness and swelling local to both vaccination sites-increased over 2 days. Started approximately 2 hrs after shots.
Patient reports feeling a little dizzy, mild lightheadedness, feels a little tired.  Patient reports she feels anxious a little bit. Patient was seen and cleared by EMS.  Patient with a history of HTN (she did not take her BP medications this morning). .  Instructed patient to call her family physician, 911, or go to the nearest emergency room for any further issues.
This spontaneous case reported by a non-healthcare professional, describes the occurrence of injection site erythema (redness at the injection site), injection site swelling (swelling at the injection site) and injection site induration (hardness at the injection site) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 046B21A) for COVID-19 immunization. No medical history reported. On Apr 22, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 23, 2021, patient experienced  injection site erythema (redness at the injection site), injection site swelling (swelling at the injection site) and injection site induration (hardness at the injection site). The patient treated with Tylenol (paracetamol), at an unspecified dose and frequency. At the time of the report, injection site erythema (redness at the injection site), injection site swelling (swelling at the injection site) and injection site induration (hardness at the injection site) outcome: unknown.  The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medications reported.
Generalized flushed skin with tingling, slight feeling of swelling in hands and feet. Was held for extended watch time for about an hour. R arm turned into large cellulitis with hard lump for 4 days, day 4-10 body/muscle was extremely weak, achy, shortness of breath, no energy and lethargic. Also acquired restless leg syndrome and cramping.
Additional information was received that provided medical confirmation of the events, and also included patient demographics, and recovery status. Information regarding PREVNAR was received from a consumer regarding a 6-month-old male patient who experienced fever up to 104.6 rectal and rash on forehead, shoulders, hands and legs. The patient received a dose of DTaP (manufacturer unknown) and a dose of ROTARIX (Glaxosmithkline) on 09-Jul-2008. Additional suspect medication included Hib. The patient experienced fever up to 104.6 rectal on 09-Jul-2008 and rash on forehead, shoulders, hands and legs on 10-Jul-2008. On an unspecified date, the patient recovered from the events. No additional information was available at the time of this report.
Headache Day 2 through Day 14. Flu like symptoms Day 3&4. Dizziness/pressure in head upper neck and ears and ringing in ears Days 6 through present. Was in ER on 5/4 and treated with vertigo. Seen by ENT on Friday, 5/7, he started me on steroids. Pressure in eyes and dizziness still present today(Day 4 of prednisone).
Fever of 100.4 starting at 10:22am on 4/5/21 with body aches and chills. Used thermometer and app to track. Took no Tylenol until 11:40am after my fever went up to 101.1.  Fever continued between 100.2 and 100.4 until 8:10am on 4/6/21.  Took Tylenol last at 5:00am on 4/6, went back to bed and the fever never returned.  Felt fine just a little weak/tired the rest of that day.
DOB reported at vaccination appointment different than DOB in vaccine registry.  Vaccine given to an 11 yo when only authorized by FDA to age 12.
Pt received Moderna booster on 11/5/21 on her left shoulder & came and reported 11/15/21 her left shoulder still very painful and her arm movement is still limited due to the vaccination
PATIENT REPORTED FEELING HOT, FEVERISH (TEMP 100.1), FLU LIKE SYMPTOMS, ACHES, STARTED THE MORNING AFTER VACCINATION.
Headache, Myalgia, Diarrhea, NauseaVomiting, CHILLS Narrative:  Other Relevant History:
Heart rate shot up to 150 beats per minute while quietly watching TV. Went to the ER for evaluation. 12-point ekg didn't show anything of concern so was sent home. Heart rate remained elevated at 100+ beats per minute for several hours. Rate lowered by the next morning. Was given Beta Blocker to take one hour prior to second Moderna jab, which I did on May 25th. 12-hours post-jab heart rate again rose to over 100 beats per minute. Took another beta blocker about 3 hours later and heart rate lowered to a closer to normal level. Before taking the Moderna vaccine my average resting heart rate was around 67 beats per minute. Since receiving the vax my daily rate now ranges from 70-76 bpm.
cough and decreased appetite began around 3/8/2021, tested positive for SARS-CoV-2 on 3/10/2021
Patient reports having shooting arm pain up her left arm and neck the day after her vaccination. Difficulty sleeping and pain in her arm.
After vaccination, patient reported that she was pregnant.   12/16/09 Medical records received for DOS  10/27/09. Included are OB/GYN notes. Final DX: Acute non-specific HA, medication reaction C/O  HA. 25 weeks gestation. HA 1 hr s/p nasal mist.  OB notes show pregnancy unremarkable thus far.
Local reaction to MENACTRA; red, a little swollen, itchy - about size of a golf ball.  CRNP - told her it was localized, and use ice and TYLENOL.  Warm to touch.
This case was reported by a healthcare professional and described the occurrence of a 65-year-old male subject not responding to therapy following vaccination with Engerix B (GlaxoSmithKline). The subject completed his initial Engerix B series in 2000. Following an "exposure" the subject was  tested and his titer came back negative. On 27 November 2006 at 15:40 the subject received a 4th dose of Engerix B at 10 mcg. This was considered to be an inappropriate dose of Engerix B. The subject should have received the adult dose of Engerix B at 20 mcg as indicated. No adverse events were reported.
Pt experienced lightheadedness, hypotension to 70's /30's, and coughing episode ~10-15 min after receiving dose of Pfizer vaccine. Pt appropriately waited in immediate waiting room and began to feel unwell. Patient taken to ED via EMS.
p/vax pt exp an urticarial rash, periorbital puffiness & heavy nasal discharge;exp itchiness;resp rate 18/min;T98, BP 90/75;02 saturation 96% & chest clear;
The nursing home resident received the vaccine at 11:00 am. At 11:45 am she had an episode of non-bloody, non-bilious vomiting. At 12:00 pm she had an episode of loose stool. At 12:15 pm she was noted with generalized tonic-clonic seizure-like activity. Oxygen was applied via non-rebreather mask and resident was transferred to the Hospital Emergency Department for further evaluation. At the time of this report, she is stable in the ED and awaiting imaging studies. (head CT)
Red, raised, warm, painful (feels like a rug burn) 4 x 6 area with circle around injection site.
had a lot of pain in his left shoulder; This is a spontaneous report from a contactable consumer. An 83-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL8982, Expiration date: unknown) via an unspecified route of administration on 02Feb2021 at SINGLE DOSE for COVID-19 immunization. The patient medical history included psoriatic arthritis and diabetes. Concomitant medication was not reported. Upon Follow-up on 16Feb2021, it was reported that, the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was on adalimumab (HUMIRA) for his psoriatic arthritis, but he didn't take this medication since he had the first dose of the BNT162B2 vaccine. Patient supposed to start adalimumab (HUMIRA) in February. Patient would take the second shot of the BNT162B2 vaccine on 02Mar2021. On an unspecified date in 2021, patient experienced pain in his left shoulder, at first no trouble at all. The last week his left shoulder started hurting, it maybe arthritis. The patient did not have Emergency Room/ Physician Office visit due to the event. The patient also received Humira for Psoriatic arthritis on an unspecified date. The outcome of the event was unknown.  Upon Follow-up on 16Feb2021: The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on (16Feb2021), this case now contains all required information to be considered valid. This is a follow-up spontaneous report from a contactable consumer included patient's information (age, height, weight), medical history, event, outcome and clinical information.  No follow-up attempts possible. No further information expected.
Small red bumpy rash size of a quarter starting on Thursday around 12:45.  Doubled in size in one day. Now the size of a softball.
Very very lethargic; Joint pain; Chills; Headache; Muscle pain/ Felt sore; Stuffy nose; Runny nose; Sneezing; Short of breath; Could barely walk; Ears ringing; Blood pressure 149/82; No appetite; Nausea; Low grade fever 99.9; Threw up; Light sensitivity at night; Tired; Felt weak; Dizzy; A spontaneous report was received from a consumer, concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced multiple events of headache, fatigue, chills, muscle pain, joint pain, felt dizzy, felt weak, tired, no appetite, nauseous, threw up, low grade fever 99.9 temp, short of breath, could barely walk, ears ringing, blood pressure was 148/82, felt sore, sneezing, runny nose, stuffy nose and light sensitivity.  The patient's medical history included autoimmune disease, psoriatic arthritis and psoriasis. No concomitant medications were reported.  On 29 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection. 30 minutes after receiving the vaccine, the patient experienced felt dizzy, weak and tired.   On 30 Dec 2020, the patient experienced, felt weak, tired, no appetite, nauseous, threw up and low-grade fever 99.9 degree fahrenheit and light sensitivity at night. No treatment was administered at this point.  On 31 Dec 2020, the patient experienced, short of breath, could barely walk, ears ringing, and blood pressure was 148/82 mmHg. The treatment information included nyquil.  On 01 Jan 2021, the patient reported she felt sore. The treatment information included celebrex.   On 02 Jan 2021 and 03 Jan 2021, the patient experienced sneezing and runny nose.  On 06 Jan 2021, the patient stated she only had stuffy nose and weakness.   On an unknown date, the patient experienced, headache, fatigue, chills, muscle pain and joint pain.  Action taken with mRNA-1273 in response to the events was not provided.  The events, felt dizzy, tired, no appetite, nauseous, threw up, low grade fever 99.9 temp, short of breath, could barely walk, ears ringing, blood pressure was 148/82, felt sore, sneezing and runny nose was considered resolved on an unknown date.   The outcome for the events, headache, fatigue, chills, muscle pain and joint pain was unknown.  The outcome for the events, felt weak, stuffy nose and light sensitivity at night was not resolved.; Reporter's Comments: This case concerns a female with psoriasis and NS unexpected hypertension, dizziness, dyspnea, nasal congestion, rhinorrhea, sneezing, asthenia, lethargy, photophobia, tinnitus, decreased appetite, gait disturbance and expected fever, chills, fatigue, headache, myalgia, nausea, vomiting, arthralgia. Event onset Day 1 after 1st dose. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Normal labor and delivery on date. This admission was within 6 weeks of receiving the COVID vaccine.
Menstrual cycle is irregular and have missed two months at least; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 11Apr2021 at 15:00 (at the age of 30-years-old), as a single dose for COVID-19 immunisation. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ED6955) via an unspecified route of administration in the left arm on 17Mar2021 at 16:45 (at the age of 30-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 01May2021, the patient experienced irregular menstrual cycle and the patient had missed two months at least. Since the vaccination, the patient had not been tested for COVID-19. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of events. The clinical outcome of the event irregular menstrual cycle and missed two months at least was unknown at the time of this report.
scratch throat which progressed to the soar throat; runny nose; cough; Initial information was received on 19-Feb-2021 regarding an unsolicited valid non-serious case from a consumer/non-Healthcare professional.  This case is linked with 2021SA064195 (same reporter).  This case involves male patient (unknown age) who experienced scratch throat which progressed to the soar throat (oropharyngeal pain), runny nose (rhinorrhoea) and cough, while he received vaccine INFLUENZA VACCINE.  Past medical treatment(s), vaccination(s), concomitant medications and family history were not provided. The patient had no medical history, concomitant disease or risk factor.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date were not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious scratch throat which progressed to the soar throat (oropharyngeal pain), runny nose (rhinorrhoea) and cough (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for all the events.   There will be no information available on the lot number for this case.
VOMITING; ACHINESS; CHILLS; FEVER; HEADACHE/SEVERE PAIN IN TEMPLES; This spontaneous report received from a consumer concerned a 23 year old male. 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: 40Z1AZ1A, and batch number: 40Z1AZ1A expiry: not reported) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced vomiting. On 06-APR-2021, the subject experienced achiness. On 06-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced fever. On 06-APR-2021, the subject experienced headache/severe pain in temples. Laboratory data included: Body temperature (NR: not provided) no fever. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, achiness, chills, fever, and headache/severe pain in temples on 06-APR-2021 13:00. This report was non-serious.
This case was reported by a healthcare professional, via a GSK representative, and described the occurrence of swelling injection site in a female of unspecified age who was vaccinated with BOOSTRIX (GlaxoSmithKline). During the week of 16th August 2011 the subject received a dose of BOOSTRIX (.5 ml, unknown route and site). Less than one week after vaccination with BOOSTRIX, the subject experienced swelling at injection site. The event was described as a local reaction. likely swelling based on the healthcare professional's questions to the GSK representative. At the time of reporting the outcome of the event was unspecified.
girl died after getting second dose of Moderna vaccine it was thought to be fault of Tylenol.; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (girl died after getting second dose of Moderna vaccine it was thought to be fault of Tylenol.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            No concomitant and treatment information was provided. Company comment:This is an age unknown, female patient who received mRNA-1273 vaccine (batch no. unk) who died, after receiving second dose of vaccine.  No medical history and conmeds were provided. Existing comorbidities probably could have been the causative factor in her death. Very limited information has been reported at this time. Further information is expected.; Sender's Comments: This is an age unknown, female patient who received mRNA-1273 vaccine (batch no. unk) who died, after receiving second dose of vaccine.  No medical history and conmeds were provided. Existing comorbidities probably could have been the causative factor in her death. Very limited information has been reported at this time. Further information is expected.; Reported Cause(s) of Death: Reporter mentioned that a girl died after getting second dose of Moderna vaccine.that it was thought to be fault of Tylenol.