chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt received flu with PNEUMOVAX 23. A couple of hours later, pt noted pain at site. Next day c/o pain, redness, warmness with swelling at site of injections. Ibuprofen, TYLENOL, ice pack as needed.
Pt. called approx. 15-30mins after she left Health Dept to report she did not have any problems until after she left has tingling in neck and side of face, experiencing different sensations, anxiety excitement, told her to seek immediate medical attention. Call to client next day 11/4/09 says went to Dr and he gave her 2 shots and didn't help, did EKG and it didn't look right and he put her in hospital. She is getting tests to R/o stroke - will continue to follow pt. course, she will call when she is discharged from hospital.  11/24/09 Hospital records and dc summary received for date 11/3/09 to 11/7/09 duplicate copy received 11/30/09. Reaction to vaccine, mild B12 deficiency, cervical spine C4-5 and C5-6 mild impingement, mild renal insufficiency, rt. carpal tunnel syndrome. Pt admitted to hosp. for alternating mental status, poss. allergic reaction, numbness in face, syncope. Pt. c/o receiving vax then had new onset of HA, SOB, nausea, weakness, numbness/tingling of face and arms.
Received vaccine on Wednesday 10/27/04. Arm became painful by Thursday AM ad presented to our office on Friday 10/29/04. Received Keflex 500 qidx7days.
This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 02-OCT-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F: In September 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days)) VAQTA injection, 0.5 ml (lot # L008665, exp. date: 10-FEB-2017) (route and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received for VARIVAX (Merck), a Pregnancy Registry product from a 21 year old female consumer with no known drug reaction/allergies or pertinent medical history who on 02-FEB-2010 was vaccinated with a dose of VARIVAX (Merck) while she was pregnant.  There was no concomitant medication.  It was reported that the patient LMP was three or four weeks ago, approximately on 04-JAN-2010 and the estimated date of delivery (EDD) is on approximately 11-OCT-2010.  A pregnancy test was performed.  The patient sought her physician for medical attention.  Follow up information was received on 01-MAR-2011 from a Registered nurse who reported that the patient had an elective termination on 19-FEB-2010, due to concerns with having received the VARIVAX (Merck), while pregnant (therapy date 02-FEB-2010).  She also reported that the patient was pregnant (LMP 01-JAN-2011 and EDD 07-OCT-2011) (WAES#1103USA00869).  The patient had an appointment on 02-MAR-2011.  No additional information was provided at the time of this call.  Upon internal review elective termination was determined to be an other important medical event.  Additional information has been requested.
Patient experienced large, red, swollen area at the injection site after receiving the vaccine. Patient states the site is sore the to touch, has fever, and is hard to the touch. The irritated area has not subsided after several days (received vaccine 3/24/21, reported 3/29/21) and the red area has got slightly bigger.
Left-sided facial weakness starting within 1 week after influenza vaccine administered (left arm).  12/15/2008 MR received from PCP for DOS 10/31/08. Pt seen by PCP for c/o sore throat/ body aches/ runny nose. DX: URI.  Flu shot given. Seen again 11/12/08 with L sided facial weakness x 1 week.  Dx:  Bell's Palsy.
No additional AE reported; VARIVAX was administered to a patient today in error. He was supposed to get a dose of SHINGRIX; This spontaneous report was received from a nurse, referring to a 66-year-old male patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 19-OCT-2020, the patient was administered varicella virus vaccine live (oka/merck) (VARIVAX) injection (strength, vaccination scheme, anatomical site of injection and route of administration were not reported; lot number T000697, expiration date: 07-JAN-2022) in error, as prophylaxis. The patient was supposed to get a dose of zoster rgE vaccine (mammalian) (SHINGRIX) (wrong product administered). No additional adverse effects reported.
Joint pain; I got 3 days ago. nausea; I got 3 days ago.upset stomach; I got 3 days ago. fever (101 F); swollen lymph under arm where I got the shot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of joint pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of no adverse event (1st dose received on unknown date).   In JUN-2023, the patient received the 2nd dose of Shingles vaccine (unknown arm). In JUN-2023, less than a week after receiving Shingles vaccine, the patient experienced joint pain (Verbatim: Joint pain), nausea (Verbatim: I got 3 days ago. nausea), upset stomach (Verbatim: I got 3 days ago.upset stomach), fever (Verbatim: I got 3 days ago. fever (101 F)) and swollen lymph nodes (Verbatim: swollen lymph under arm where I got the shot). The outcome of the joint pain, nausea, upset stomach and fever were resolved and the outcome of the swollen lymph nodes was not resolved.   It was unknown if the reporter considered the joint pain, nausea, upset stomach, fever and swollen lymph nodes to be related to Shingles vaccine.     It was unknown if the company considered the joint pain, nausea, upset stomach, fever and swollen lymph nodes to be related to Shingles vaccine.   Additional Information: GSK receipt date: 10-JUN-2023 This case was reported by a patient via interactive digital media. The patient had no side effects from the 1st shot but did with the 2nd shot which she/he got 3 days ago the reporting day. She/he had Joint pain, nausea, upset stomach, fever (101 F), and swollen lymph node under arm where he/she got the shot.  Lymph node was still swollen but other side effects had gone. Everything was tolerable but the patient was glad that there was not a 3rd shot. The follow-up could not be possible as no contact details were available.
Prior to January 2023, I exercised 4-5 days a week, ran a 5K in November, took vigorous spin classes, and had no heart or neuropathy issues, nor any history of headaches.   TIMELINE: ? January 13, 2023: 4th COVID-19 shot (mRNA bivalent booster) ? January 19, 2023:  Urgent care with chest pain/heart palpitations, tingling, electric sensations in my feet and ankles, heavy arms.  ? January 24, 2023: Urgent care with chest pain/heart palpitations, tingling, electric sensations in my feet/ankles  ? January 27, 2023: ER with chest pain/heart palpitations, tingling/electric sensations in my feet, ankles ? June 2023: Loss of peripheral vision discovered ? July 2023: Cardiac MRI impression: Suspicious for sequelae of prior myocarditis  ? July 2023: Fingers/joints turning purple   CURRENT SYMPTOMS:  ? Tingling, burning sensation and jabs,?what started in my feet/ankles in January has progressed to my legs/thighs/hips, arms and shoulder, and face.  ? Myocarditis  and 27% PVC burden ? Deep reverberations inside my body ?occasionally awaken me from my sleep; feels like an electric drill left inside my chest.  ? Peripheral vision loss/headaches ? Purple finger; joint issues ? Exercise intolerance?I can no longer work out. ? Excessive thirst?24/7 thirst ? Heart intolerance ? Dizzy in the sun/bright light
Pfizer-BioNTech COVID-19 Vaccine EUA  pain in the arm,  strongest on the second day, gone by the third day. lump in the armpit (similar during past flu shots).
History of syncope with other vaccines. BPs 151/82 (pulse 70), 122/70 (pulse 68). O2 sats 100%, 96%.
a small swelling underneath left armpit; a pain underneath left armpit; This is a spontaneous report from a contactable consumer. This 52-year-old female consumer(patient) reported for herself. A 52-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE; formulation: solution for injection, Lot Number: ER8730 and expiration date was not reported), dose 1 via an unspecified route of administration, administered in left arm on 29Mar2021 as DOSE 1, SINGLE followed by patient also took bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE; formulation: solution for injection, Lot Number: ER8736 and expiration date was not reported) dose 2 via an unspecified route of administration, administered in left arm on 26Apr2021 as DOSE 2, SINGLE (at the age of 52-years-old) both for COVID-19 immunization. The patient medical history included diabetes, and hypertension. Concomitant medications included lisinopril (tablet 12.5 mg, 1x/day) taken for hypertension from an unspecified start date and ongoing, patient did not remember the start date and specified it has been long time, many years ago; and metformin (tablet, 500 mg, 2x/day) taken for diabetes from an unspecified start date and ongoing. On an unspecified date of 2021, the patient experienced a pain, a small swelling underneath left armpit. The patient had side effects from both the doses. From the first, one the patient had the same thing and after second vaccine, the same thing had occurred. The patient did not report the 1st one but did have same dose, the same side effect from the first and the second shot. Therapeutic measures were taken as a result of the events and treatment for events included Tylenol 250 mg, 2 of them once a day orally. The patient queries whether to visit the doctor and stated would go to private practitioner. The patient considered that the events were related to the COVID-19 vaccine. The clinical outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.
Pharmacist incorrectly identified patient for vaccination and mistakenly vaccinated the patient with a Shingrix vaccine when the patient was scheduled for a Janssen COVID-19 vaccine. Pharmacist subsequently realized her mistake and then administered the Janssen COVID-19 vaccine as well in the same sitting.
Injection was given 3 inches above the site that showed reaction; extreme redness, swelling, hot to touch for several weeks. When the site redness resolved, an indentation resulted demonstrating tissue degradation. In other words, there was a 1/2 inch deep hole in my arm. 4 weeks later, there are still a lot of mottled red spots surrounding the hole.
Cold to the point of shivering uncontrollably, headache, aching joints, fatigue; after that, fever, weakness, general malaise.
On 07/17/2001 at approximately 1:30pm the patient became very fussy from then until 5:00pm, when he started with a high pitched cry. He was unconsolable for 5 hours and remained afebrile.
Had COVID 3 months earlier and reported joint pain pronounced and reports extreme pain.  Patient reports she felt as if pain after vaccine was worse and as if he had covid again.  The same initially as COVID vx #1 but did not last as long as the prior VAERs. Biggest symptom reported was pain. Patient reports pain was severe again not versus having other immunizations.
mom states pt has a rash which started evening of 5FEB96;appearing first on cheeks,then on stomach, arms, legs & now all over;no fever-pt is playing & active;no itching;rash just red on body;
11/8/11 noted (L) foot slap, tingling, feet/hands. Admitted to hospital 11/10/11 with progressive weakness, numbness. Ultimately progressed to full paralysis, respiratory failure. EMG consistent with Guillain-Barre syndrome. Received IVIG and subsequent plasmapheresis. Ultimately received trach and transferred to rehab facility on 1/13/12.
arm soreness; temperature which has been on/off; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness) and PYREXIA (temperature which has been on/off) 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 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm soreness) and PYREXIA (temperature which has been on/off). At the time of the report, PAIN IN EXTREMITY (arm soreness) and PYREXIA (temperature which has been on/off) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment information was not provided.
18 weeks pregnant, due date 4/22/22.  Intermittent left sided chest pain for about 10 min. Stabbing/burning. Then had blood tinged sputum and spit up a dime sized clot.
Information has been received from a woman at a medical clinic concerning a 63 year old female who on 26-SEP-2008 was vaccinated with a first dose of PNEUMOVAX 23 (lot # 658074/0961U) IM in left arm. Illness at the time of vaccination included fatigue, arthritis and bursitis. Concomitant therapy included vitamins (unspecified), omega-3 marine triglycerides, trazodone HCl, MOBIC. On 26-SEP-2008 the patient experienced arm cellulitis, red, swollen, painful, warm, tem 102 f. The patient sought medical attention at physician's office. Treatment included KEFLEX, 500 mg, TID for 10 days. Subsequently, the patient recovered on an unspecified date. Additional information has been requested.
She felt sick; Headache; Colds; Fever; Diarrhea; Allergic reaction; Caller asked if it was possible that she had Covid; This is a spontaneous report from a contactable consumer (patient) from a female patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 05Apr2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in Apr2021, the patient felt sick. She had a head-ache, colds, fever, diarrhea, and allergic reaction. Patient asked if it was possible that she had COVID. Outcome of the events was unknown.  No follow up attempts are possible. Information on lot/batch number cannot be obtained.
WOKE UP WITH MIGRAINE FOLLOWING DAY,THEN PROGRESS TO FEVER AND BODY ACHES,FEVER CONTINUE FOR A 24 HOUR PERIOD WITH CHILLS AND BURNING EYE FATIGUE,DIZZINESS AND RAPID HEART BEAT.WENT TO EMERGENCY ROOM ON 8/7 WAS ADMITTED TILL 8/9 WAS GIVEN IV FLUIDS AND ANTIBIOTICS VIA IV CBC COUNT WAS OVER 20 THOUSAND MD DIAGNOSIS HIGH FEVER,SEPSIS INFECTION AND CELLULITIS  WHERE VACCINE WAS ADMINISTERED
Breakthrough case after vaccination. Sore throat, loss of taste/smell, cough and hoarse voice, onset 1/24/2022.
This was a booster shot, third dose of Pfizer (second dose of Pfizer received March 24, 2021) Soreness of injection site and arm; nasal congestion; "lump in throat" feeling; chills and shivers; thumping heart. More importantly, developed chest pain in the morning of 12/03. In the evening of 12/03, dizziness and lightheadedness. Went to the emergency room. Received ECG, complete blood count, metabolites, chest x-ray, troponin, ... All values normal, and discharged the next evening. Dizziness and lightheadness continued into Sunday 12/05, chest discomfort still present at writing of the report 12/06.
5/13/22: Received vaccine and became exhausted and had arm pain almost immediately. Went to be early.  5/14/22: Did not get out of bed, was lethargic, had arm pain, a headache, and later in the day developed a fever (101.3) 5/15/22: Did not want to get out of bed, was hard to rise. Forced him up to take a shower and visit his grandmother. He had a fever (101 and higher) and was very tired all day. He fell asleep around 3pm at his grandmother's house so we came home.  When we arrived home at around 3:30 pm, he complained of chest pain. We decided to take him to the ER. Just before leaving, he told us he needed to throw up and he did. He then said he felt much better. Thinking his chest pain was caused by indigestion due to his diet at his grandmother's house (soda and chips), we let him go to bed early and sleep instead of taking him to the ER.  5/16/22: He woke up at 1:30 am and threw up again. He said he felt ok and went back to sleep. Continued fevers of 102. He woke up again at 4:30 am and told us his chest hurt and it hurt to breathe.  We took him to the doctor that morning. He sent us to the Emergency Room. After running tests and noticing high Troponin and (spikes and lows) on heart rate monitor,  they decided to transport him via chopper to another Hospital, with thunderstorms in the area, he was sent via ambulance at 9pm. He was admitted at 11pm through the ER and we got into a room by 4am on 5/17/22.  Admission diagnosis: acute myocarditis, unspecified myocarditis type Treated with Ibuprofen and Famotidine Released after troponin levels reached 4.  Ibuprofen and famotidine taken until June 2 when levels were somewhat normalized on follow up EKG.  Follow ups in June, September, and April.  Because his inflammation has not gone down, Dr, the cardiologist will follow the patient for the next few years and has recommended he see the cardiac athletic specialist to help him re-introduce some sports; however he cannot swim or participate in contact sports. (As of 10/21/22)
sore arm; fatigue; Headache; general malaise; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid right, administration date 28Dec2020 11:40 (Lot number: EL1284) as dose 1, single for covid-19 immunisation. Relevant medical history included: "benign thyroid cyst", start date: 03Dec2020 (ongoing), notes: thyroid biopsy 13Jan2021; "rosacea", start date: 12Jun2017 (ongoing), notes: vey few flair up.; "latex" (ongoing), notes: Allergies to sucralose and Latex. Family history included: "Breast cancer" (unspecified if ongoing), notes: Mother deceased from Breast cancer. Concomitant medication(s) included: COQ 10 taken for supplementation therapy (ongoing); VITAMIN D 2000 taken for supplementation therapy (ongoing); BIOTIN taken for supplementation therapy (ongoing); VITAMIN A NOS (ongoing). Past drug history included: Sucralose, reaction(s): "allergy to Sucralose".  The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "sore arm"; FATIGUE (non-serious), outcome "recovered", described as "fatigue"; HEADACHE (non-serious), outcome "recovered", described as "Headache"; MALAISE (non-serious), outcome "recovered", described as "general malaise". The event "sore arm" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information included: The patient did not received any prior vaccinations (Within 4 weeks). It was noticed that there was a appointment with doctor in Nov2020 and primary care 30Nov2020 or 03Dec2020.   No follow-up attempts are possible. No further information is expected.
pt exp an inject site react (size of react was 80mm); react occurred w/in 24 hrs post vax;
Numbness and tingling in right arm and right leg with mild tingle in right cheek. Headache responding to Tylenol, mild soreness at injection site. No weakness or gait changes. Symptoms almost completely resolved at 20 hours.
The patient got Kinrix and Ipol injections the same day with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health care professional.  This case involves a 5-year-old male patient who had POLIOMYELITIS VACCINE (INACTIVATED) [IPOL] and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID[KINRIX] on same day (Extra dose administered)  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR), VARICELLA ZOSTER VACCINE (VARICELLA VACCINE), HEPATITIS A VACCINE and HEPATITIS B VACCINE for prophylactic vaccination.  On 20-Jul-2021, the patient received a 0.5 ml second dose of suspect IPV (VERO) (lot: T1D481M, expiry date: 25-Jul-2022) via intramuscular route in the right arm for prophylactic vaccination.  On 20-Jul-2021, the patient received a dose of suspect KINRIX not produced by Sanofi Pasteur (lot number not reported) via unknown route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to Extra dose administered (latency same day).  It was reported "Caller stated she was waiting on recommendations on what to do since IPOL and Kinrix that was administered at the same time. Caller stated she request a call back on her cell phone. She asks how long do you monitor for the potential adverse event (AE)?"   No adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
No reaction, however the pre-covid vaccine questionnaire shows he had only 4 covid shots. The Covid card showed only 4 vaccines.  When I went to chart the vaccine in electronic records, the impact and chart shows they already received the COvid Bivalent and this was his 6th shot-NOT 4th.  He was specifically asked if the last shot was a bivalent and denied.
HEART ATTACK; This spontaneous report received from a patient via social media through a company representative concerned a patient of unspecified age, race, ethnicity and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 total, dose and start therapy date were not reported for prophylactic vaccination. Dose number in series was 1. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced heart attack. The patient reported as "Your COVID vaccine gave me a heart attack". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of heart attack was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211266376-Covid-19 vaccine ad26.cov2.s-Heart attack. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).