chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 30-AUG-2017, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the long-term prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster or shingles. Later in 2017, the patient was treated at a hospital (not specified whether he was admitted; therefore, considered an Emergency Room visit until follow-up is received) for the onset of a vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Diarrhea; throwing up; very bad migraines; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EK5730, expiration date: Mar2021), via an unspecified route of administration on 27Dec2020 at single dose shot left arm once for COVID-19 immunization in hospital. The patient's medical history and concomitant medications reported as no. Patient stated that she got her Covid vaccine on Sunday (27Dec2020) and had experienced very bad migraines on 27Dec2020, diarrhea and throwing up as well on 29Dec2020. Stated that the diarrhea was not as common as the migraines. Stated that she had not thrown up but did last night (30Dec2020) at 2 AM. Investigation Assessment reported as no. No treatment was received for the events. The outcome of event migraines was unknown, outcome of the other events was recovering.
more than 3 hrs of inconsolable crying w/in 48 hrs of vax;
Brain fog and memory loss, since vaccine 1st dose, 04/07/2021 On 04/08/2021 I woke up to find my left eye with filled with blood over most of the sclera.  Severe joint pain. Muscle pain, and lethargy.  Extremely forgetful with new onset 04/07/2021. Eye pain left eye. L eye hemorrhage is not resolved yet.
This spontaneous report was received from a medical assistant (who was also a nurse) and refers to 3 patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medication and drug reactions or allergies was reported. On unknown date, the patients were vaccinated with improperly stored doses of VAQTA lot # M017982, expiration date 13-SEP-2017 (dose, route of administration and anatomical location were not provided). No adverse effects were reported. This is one of two reports received from the same reporter. Additional information ahs been requested.
Fainted twice in a 1/2 hr. Was evaluated at the office with in 1 hr. after episodes. Normal exam.
Patient reports left sided arm swelling at the injection site. Patient reports left sided swelling of her neck and back muscles, and swelling of her left chest muscles.
Prior to March 18 2021 I did not have any heart conditions. After the second vaccination I went to my Doctor for a prescription refill and they heard something in my heart which has led to the discovery of a sever aortic valve regurgitation.
Child awakened from nap had a few seconds where he stopped breathing, had a bout of emesis. Came to emergency department and had ultrasound confirmation of intussusception.
Left arm swollen inner elbow area, not at vaccination site; This is a spontaneous report from a contactable consumer (patient). A 65-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EN6261, expiration date was not reported) via an unspecified route of administration, in left arm, on 07Mar2021 11:15 (at the age of 65-years-old), at dose 2, single for covid-19 immunization. Medical history included fibromyalgia, hypothyroid, asthma, hypertension, and high cholesterol. The patient had known allergies to Prevacid and mangoes. The patient had taken other medications in two weeks (unspecified). Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EL9269, expiration date was not reported) via an unspecified route of administration, in left arm, on 14Feb2021 11:15 (at the age of 65-years-old), at dose 1, single for covid-19 immunization. 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 after the vaccination. The patient experienced left arm swollen inner elbow area, not at vaccination site on 07Mar2021 14:00. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken included Icing swollen area and taking Tylenol. The outcome of the event was recovering.  No follow-up attempts are possible. No further information is expected.
This is a spontaneous report received from a non-contactable reporter. A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headaches".  Additional information: The reporter said he talked to 200 people who have a headaches from that booster shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Nov 10- headache  Nov 11- sore throat, headache, cough, phlegm Nov 12- Sore throat, cough, headache, fever, phlegm (+ positive antigen at home test)
I experienced a metal taste in my mouth, heart palpitations, and balance issues. I went to see my doctor and she ordered a series of tests to find out why I was experiencing issues. I was diagnosed with Tachycardia showed heart palpitations (no more than 30 seconds off). I could not stand up for long periods and failed the test that my doctor had me perform in her office.
Pt recv vax on 11/20/98; 45 min post vax pt exp Rt Arm heavy & numb; pt imp 11/22/98
Pt felt nauseous and lowered her head.  she them vomited into a trash can.  she was provided with a cold pack for the back of her neck.  pt felt better a short while later.  She stated that she gets nervous around needles.  She failed to dislose this prior to receiving the vaccination.
2nd dose in April; by May noted a right breast mass; diagnosed with breast cancer in June; needed chemo and surgery
SkinRash & This was reported in January, but occurred in December. Drug was given 1 month prior to rash.
Temperature 102, strange feeling of wonline $, chills.  2000 mg acetominepnine over 6 hours resulted in no fever, return to normal the next morning.
Patient was hospitalized . Presented to the emergency department with hypoxia. Was inpatient for 2 days.
No additional AE/PQC reported; HCP reported that a patient was administered an improperly stored vaccine; This spontaneous report was received from Other Health Professional and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 10-JUL-2023 (conflicting information, year of administration reported as 2024), the patient was vaccinated with an improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23)(Product storage error) injection (lot #W015900, has been determined to be valid for pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), with an expiration date of 20-OCT-2023), administered for prophylaxis (strength, and route of administration were not provided). No additional adverse event was reported.
The patient received her 1st booster in error. Her 2nd dose of Pfizer was 4/22/22. She shouldn't have received her 1st booster until 9/22/22, but I administered her 1st booster on 7/8/22.
Head ache and shivers, lasting 12 hours for shivers and still lasting for headache, after 16 hours
Extremely sore shoulder, pain in armpit, severe joint pain down entire arm similar to tendinitis. Minimal response to pain medication (Tylenol). 15 hrs duration at time of reporting without decrease in symptoms.
numbness feet & lower legs & inc leg weakness, mild dysarthria, mildly reduced resp capacity;still unable to ambulate as of 11/4/99;tx plasmaphoresis IVIG;states 11/2 dx GBS; 60 day follow-up dated 10/16/00 provided no additional data.
Patient was participating in an "offsite COVID clinic" in which pharmacy personnel were vaccinating pediatric patients with the 0.2 ml Pfizer Moderna 5-11 yreas. It was not caught at clinic that patient was 12 years old at the time and should not have received the vaccine being given according to FDA/CDC guidelines.
noticed change in swallowing; Yellow coat on tongue; noticed stomach gurgling and gas bubble pressure in chest; Dizzy; Head pain left side. Symptoms gone after eating; pain in shoulder and neck; pain in shoulder and neck; Pain left ear & base of neck btwn shoulders; This is a spontaneous report from a contactable consumer (patient).    A 54-years-old female (54 years age at vaccination) patient received first dose of BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: EUBK7), via an unspecified route of administration, administered in left arm on 07May2021 at 10:15 as single dose for COVID-19 immunisation. The patient's medical history included tonsillar abscess (she was recently there for an event of tonsillar abscess) and food allergy (Soy causes bumps on forehead). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 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's concomitant medication included 4mg nicotine gum (taken before two weeks of vaccination for an unspecified indication). After vaccination, at 10:15 (07May2021), the patient experienced pain in left ear and base of neck between shoulders (for 30 mins). She felt dizzy and head pain on left side at 11:00. Symptoms went off after eating. She noticed change in swallowing at 15:30. The patient noticed stomach gurgling and gas bubble pressure in chest. There was no pain of any kind and felt like gas. She assumed the cause might be due to recent weight gain. The patient experienced slightly difficult to swallow at 18:00. She checked for it, and no swelling was there, but found yellow coat on tongue. She googled and concluded it as typical vax symptoms. The patient was advised by a nurse (on phone) to go to urgent care to get checked. In urgent care at 18:30, the nurse did not look at her throat, despite she informed the nurse, that she was recently there for an event of tonsillar abscess. The nurse's notes incorrectly stated chest pain. The patient's underwent lab tests which reported all vitals as normal, EKG was normal, and BP was reported as 139/77. The patient was advised to go to the ER, because COVID was "too new" for them to know what was going on or how to treat. They never explained what they thought was wrong. The patient went home at 19:00. Therapeutic measures included Pepto Bismal and gargled with salt water and symptoms went off. The outcome of all the events was reported as recovered.  Information on Lot/Batch number was available. Additional information has been requested.
AT 12:00am on 04/10/2021 I started throwing up and it went on until 1:00am. I was finally able to sleep and was find the next day. No more issues since.
Flu like symptoms starting ~36 hrs after injection.  Aches in joints, muscles, congestion, cough, headache.  No fever.  This day 2 of symptoms that prevented me from going to work.
The patient developed "Covid toe" with an erythematous zone starting 2/3 up the toe in an expanding width to several inches and restrictied to mid foot (I have picutes) and a 2nd erythematous patch about 3x3" on the opposite ankle region. The patient was placed on 81 mg Aspirin daily and 7 days of prednisone 40 mg per day to taper over 3 days . He had a full and complete resolution of the rash.
Pt complained of arm numbness post vaccination x20 minutes, no shortness of breath, no rash. Called pt at home at 1:35pm, pt reported symptoms subsided.
Information has been received from a health professional concerning a patient who on 25-JAN-2006, received his first dose of RECOMBIVAX HB (lot# 651494/0504R). The patient received a second dose on 21-FEB-2006 of RECOMBIVAX HB (lot# 651494/0504R), and his third dose on 26-JUL-2006 (lot#650889/0143R). It was reported that on an unspecified date, that the patient's hepatitis B antibody test was negative. Current patient status was not reported. A product quality complaint was not reported. This is one of three cases from the same source. Additional information has been requested.
A non-serious spontaneous report of administration of expired product was received from a Registered Nurse concerning a child.  FLUMIST was administered on 24-Jan-2009 and the dose had expired on 18-Dec-2008.  There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of th eflu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 09-Apr-2009; product complaint investigation results.
Pfizer-BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization/Death. Patient received Pfizer-BioNTech on 2/02/21, 3/02/2021 and 10/05/21. Pt received Pfizer- BioNTech Bivalent on 10/23/22. Pt presented to ED on 10/29/22 with SOB and hypoxia. Pt had been diagnosed with COVID-19 4 days prior to admission and was taking paxlovid. Pt was chronically on 2L of home O2. In ED pt had shorter O2 saturation and was placed on non-rebreather at 15L then deescalated to 6L. ABG showed severe metabolic acidosis. Pt had an event with sinus bradycardia and evetually systole. Pt expired on 10/29/22. Pt treated with remdesivir and decadron.
I had no AE to the vaccine but on 12/18 I was exposed to a Covid positive individual.   On 12/20 I began having various mild cold symptoms a headache, muscles and body ache and my legs and body just felt very heavy, so  I took a rapid Covid test on 12/21, but it was negative.  On 12/21 later that evening I developed a 99.8 fever that didn't last too long.  12/22 I took another rapid Covid test that was positive at that time.  I had a PCR test that I performed as well on 12/29 which confirmed the rapid test.  I only had one night of fever which subsided.  Fatigue, muscle weakness, the feeling of being very tired and body heaviness and not just not feeling well overall has been experienced since. The lymph nodes under my arms were a little swollen.  And today when returning from the restroom my body got super shaky, my HR elevated, my hands were trembling and it feels as if my whole body has a mild tremor  so I am currently laying on the flood to help my body relax and hopefully these symptoms will subside soon.  This has affected my sleep patterns resulting in me not being able to sleep well and I'm startled at the slightest of noises I hear.  It feels as if my body has a high level of adrenaline running through me at times.  My usual resting HR has usually between 60-70 BPM, but since the day after my Covid exposure my HR has elevated over that 70 mark near the 80's which remained elevated until after about a week then finally started lowering on its own, but is still slightly above normal but has lowered since the exposure
Started feeling really anxious and shy of breath about 5 minutes after receiving second shot but I only thought I was nervous from receiving it so I thought nothing of it. Common side effects such as chills, headache and severe drowsiness lasted 2 maybe 3 days but the anxious feeling in my chest is still there. Heart palpitations is what I am having and it?s constant. There have been times at work that I can feel my heart beat in my pant legs, temples, wrists and forehead from ordinary stress that I?ve have no issues handling in the past 4 years. Every 30-60 seconds I have to take a deep breath to catch my breath regardless of what I am doing. Suddenly severe drowsiness. I?m sure there?s more that I?m forgetting.
dose administered from vial >12 hours post puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered from vial >12 hours post puncture) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: J and J vaccine (First dose). Past adverse reactions to the above products included No adverse event with J and J vaccine.    On 04-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered from vial >12 hours post puncture). On 04-Jan-2022, EXPIRED PRODUCT ADMINISTERED (dose administered from vial >12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided.  The vail was initially stored in refrigerator on 03 JAN 2022 and first punctured on 03 JAN 2022 at 2:10 PM  and administered on 4JAN2022 around 11:00 AM. Vial was stored in room temperature. The vial did not undergo any temperature excursions.  Treatment information was not provided.
ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a pharmacist concerned a patient of unspecified age 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) dose was not reported, administered on 03-FEB-2022 15:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 03-FEB-2022, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious.
had normal fatigue and couple day after injection. Upper and lower Extremity weakness on the 10th, 11th, and 12th day after vaccine.
Patient reported numbness of lips and tongue and tightness of throat 18  minutes after receiving vaccine.
Approximately 3 hours after second shot I experienced mild flue like symptoms," chills, fatigue and sore arm" for approximately 36 hours afterwards. Next day I felt fine.
On Mar, 25th , around 4.30 pm I got vaccinated. I went back home. I ate my summer and Took Tyelenol as I was tired and arm was little sore. I slept around 7.30 pm and got up at 7 am. I felt weakness and after I had my break fast , my body pains started. Every muscle ached and every joint ached. I had weakness and lethargy. I took tyelenol extra strength so the pain was subsiding . I had temperature 100.3 since Fri , Mar 25th. When the tyelenol was wearing off the pains used to become horrible. I was not able to move and I was on my bed bed most of the time. On 28th I even tried Ibuprofen as Tyelenol was not helping a lot with pains but Ibuprofen did not work at all. I sent messages to my dr who thought these side effects are expected. On Mon she replied if the side effects did not resolve I can go to Immediate Care. My arm was sore but that soreness was nothing compared to body aches I had. I called off from work on Fri and Sat. My employer wanted return to work clearance. I went to discuss with Immediate care doctor as I had same weakness and tiredness and little walking was making me breathe heavily. As it was almost the end of 4th day after I got my vaccine they tested me for Covid and my results were negative.  I still have to be in quarantine for 7 days from yesterday.  I was tested Covid positive in Mar 2020 around mar 24th. I had same horrible pains but had high temperature like 1049.8 and with tyelenol it was 102.5. I am scared to take the second dose that might trigger same reaction. I suffered a lot like people suffered after 2nd dose. First dose is sensitizing dose but I showed such reaction that means my body recognized the threat and began to fight in first dose then what is the need of second dose that is actually a booster dose. My main concern is I might feel the same way how I felt now. I am still weak and cannot perform my daily activities like cooking and I have 4 kids aged 7- 12 yrs age.
The morning following administration patient woke with an extremely sore arm.  I saw her that afternoon.  Arm was not red at administration site, however bright red, swollen and hot starting approx one inch below injection site all the way down to elbow at the inside of the arm.
Pain in arm, muscle and joint aches, headache, fever, nausea, muscle cramps, fatigue
This spontaneous report was received from a healthcare worker, refers to multiple unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored (temperature 6.5 Fahrenheit, for 6 months) doses of PROQUAD, lot # L021599, expiry date 10-DEC-2016 and lot # L024123, expiry date 30-DEC-2016, (dose, frequency and route of administration not reported). No adverse effects reported. Vaccines were back in range. Previous temperature excursion was reported as no. It was because of a data logger. No product quality complaint (PQC) was involved. No additional information was provided. This is one of three reports received from the same reporter. Additional information has been requested.
Patient received 1 dose of Pfizer COVID19 vaccine on 4/24/21, then 1 dose of Moderna on 5/14/21, then another dose of Pfizer on 5/27/21, then another dose of Moderna on 6/14/21. No adverse effects observed, but a medical facility was notified of other vaccinations 15 minutes after the patient received the second dose of Moderna
at 1420 pt reports having a runny nose, sweating, feeling hot and having sever lightheadedness.  BP=127/85, P=83, T= 99, O2 sat 98%.  Appears anxious.  Stating "Oh my god.  I can't believe I am having a reaction" multiple times.  Fanning herself with her vaccine card frequently.  Placed in front of a large fan by this RN.  Pt states that the wind feels good.  has stopped fanning herself.  At 1430 reports mild lightheadedness, no sweating  and reports she is ready to go .  When this RN turned around pt was gone.
Flu like symptoms: started getting week and tired. Went to bed about 11pm and could barely get up in the morning at 4:30 am. Headache, low grade fever of 99.7, achy all over, a bit of nausea.