chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Axillary lymphadenopathy presents at day 2.; Rapid heartbeat for 2-3 minutes after vaccination, then resolved itself.; This is a spontaneous report from a non-contactable consumer, the patient. A 62-year-old non-pregnant female patient received the unknown dose number of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) in the left arm on 01Apr2021 at 11:00 (at the age of 62-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took pseudoephedrine and experienced allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 the patient had experienced rapid heartbeat for 2-3 minutes after vaccination, then resolved itself. On 02Apr2021, the patient had experienced axillary lymphadenopathy presented (at day 2), which was improving but mildly present even after seven days. No therapeutic measures were taken as the result of adverse events. The clinical outcome of the event rapid heartbeat was recovered on 01Apr2021. The clinical outcome of the event axillary lymphadenopathy was recovering at the time of the report.   No follow-up attempts are possible. No further information is expected.
Headache; Swollen lymph nodes on her neck; Dizziness; Her feet felt swollen and she hurt when she would step down; Loss of appetite; She slept all day; Muscle pain; Chills; Joint pain; Fever; Feeling unwell; Injection site pain; Tiredness; This is a spontaneous report from a contactable consumer (patient). A 63-years-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9264B), intramuscular on 01Feb2021 at single dose for COVID-19 vaccination. The patient medical history and concomitant medications were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3249) on 11Jan2021 for COVID-19 vaccination. Caller was a consumer that was calling about the Covid-19 vaccine and said that she wanted to report her symptoms after the Covid-19 vaccine. Caller reported that she experienced injection site pain, tiredness, headache, muscle pain, chills, joint pain on, fever, feeling unwell, her feet felt swollen and she hurt when she would step down, loss of appetite and she slept all day on 01Feb2021, swollen lymph nodes on her neck and dizziness on 02Feb2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The seriousness was reported as non-serious. The outcome of the events injection site pain, chills, fever, swollen lymph nodes on her neck, dizziness, her feet felt swollen and she hurt when she would step down, loss of appetite and she slept all day were recovered and other events were recovering.
6 days following vaccination, patient was exercising for the first time.  started feeling dizzy. She had some water and realized that her skin was red. She had a rash on face and puffy lips. Mom came to get her she stood up and was extremely dizzy. Mom did not notice that her lips were swollen but did notice that her skin was rashy and red. Mom, who is a nurse, also thought she appeared pale and diaphoretic. By the time they got the ED she was hypotensive.   She got a cocktail of meds in the ED including a couple doses of EPI. She got IV fluids. She started to improve quickly after giving the medications.
Inconsolable. Limping. Fever of 99 - 101° (so far). Won?t leave my lap. In no way is this normal for her she doesn?t cry about anything ever.
Patient was given 3 flu shots by accident. Patient came in with his Mother, and Sister; to all receive their flu shots. Patient was also getting his 4 year old immunizations. (Varicella, DTaP, MMR, and IPV-plus the flu shot- in total 4 shots). MA drew up all of the shots, asked another MA, for assistance to give patient 2 of his shots, and she would give his other 2 shots. MA grabbed the wrong 2 shots from the wrong pocket and gave them to the patient. The incident was recognized immediately, MA asked other MA to step out with her and it was reported to the Dr immediately, and practice administer. The Mother was made aware and was not upset or alarmed at all. She even jokingly stated that he would be protected from the flu for sure this flu season. An incident report was drew up, and MA discussed with Dr., practice administrator, and her fellow MA's what to do to prevent this from happening again.
Fatigue; Shortness of breath; Chest pain; Cough; This is a spontaneous report from a contactable consumer. A 22-year-old female patient (daughter) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 23Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that her daughter had a reaction to the COVID vaccine. The patient received the first dose of the vaccine on 23Dec2020. The adverse reaction has lasted the past three weeks to include fatigue, shortness of breath, chest pain, and cough on unspecified date. The patient is now on inhalers and she was not on inhalers before. The reporter stated that her daughter has been tested for COVID multiple times. Outcome of the events was unknown.   Information on the Lot/Batch number has been requested.
Fatigue; Dizziness; This is a spontaneous report from a Non-contactable pharmacist. This pharmacist reported that a 12-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration on 03Jun2021, as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration on an unspecified date, as single dose for Covid-19 immunization. On 04Jun2021, the patient complained of fatigue and dizziness. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
postherpetic neuralgia; multiple outbreaks of herpes zoster; This spontaneous report was received from a lawyer and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On or around 16-NOV-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (exact dose, site and route of administration, lot# and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. Subsequently, on an unknown date, the patient experienced was treated by providers in for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: multiple outbreaks of herpes zoster and post herpetic neuralgia. The patient claimed damages as a result of injury to themselves, loss of consortium, loss of services and economic losses. The outcome of the events was unknown. The relatedness between the events and zoster vaccine live (ZOSTAVAX) was related.
1/26/2022- Pt presented to received to receive second dose of Moderna Coronavirus Disease 19 (COVID-19) vaccine. Pt received first dose of Moderna Coronavirus Disease 19 (COVID-19) vaccine on 12/29/21; Pt was unable to receive second dose of Moderna Coronavirus Disease 19 (COVID-19) vaccine during visit, due to pt reporting a syncope episode on 12/30/21 while at work. Pt stated that he was told per coworkers that he was not breathing for a period of time while unconscious, pt visited ER for further evaluation. Pt stated that during ER visit they did a full heart workout including EKG, pt was told per attending provider that everything was normal and that syncope episode was likely related to a spike in B/P. Pt was notified during visit, he needs to have his PCP clearance to receive his second dose of Moderna Coronavirus Disease 19 (COVID-19) vaccine, pt acknowledge understanding. LVN
Tongue itchy 1st day. Chest tightness and throat tightness x3days - needed inhaler x3days. Had headache x3 days constantly - still having increase headaches 8 days later, but not constant. Resting heart rate elevated 8 days so far 104 + BPM. Increased blood pressure. Feel tired and more easily short of breath. Increased sweating with light-tasks x 8days. Not yet recovered about 8days but hopefully will.
Burning and pain at time of injection, persisting for about 2 hours.  About a week afterward, redness and tenderness noted to injection site, worsening and consistent with cellulitis.  Prescribed doxycycline by primary care physician.  Starting course of therapy today.
RAPID HEART RATE -109 bpm LAYING DOWN, 154 bpm UP WALKING MUSCLE AND JOINT PAIN FEVER OF 102
Couldnt breath in the middle of the night. Had bad stomach pains. Lasted 3 days
intense erythema & pruritus occurred <24hr p/vax & was present 48hr;tx w/DPH-edema upper arm;
nauseous; This case was received via an unknown source (no reference has been entered for a health authority or partner) on 04-Sep-2021 and was forwarded to Moderna on 04-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nauseous) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced NAUSEA (nauseous). At the time of the report, NAUSEA (nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that, patient chest feels right after 5 hours of vaccine administration. No relevant concomitant medications were reported. Treatment information was unknown.
Injection site red and swollen (referred to as a "lump" by pt.), 2 in by 2 in, denies fever, denies any hotness to the touch. Denies pain, reports "slightly itchy".
Patient got PNEUMOVAX in store on 8/23/17. 1 minute later patient was unresponsive, no breathing, and pulseless. Administered epinephrine and 1 round of compressions with 2 breaths and patient had pulse and breathing again.
She is now positive for HPV; This spontaneous report was received from a physician, concerning a female patient of unknown age. No information was provided regarding the patient's pertinent medical history, concomitant medications and previous drug reactions or allergies.  On an unspecified date reported as "years ago", the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) by intramuscular (IM) route as human papilloma virus (HPV) vaccination (dose, frequency, anatomical location, vaccination scheme, lot number and expiration date were no reported).  In 2021 reported as "now", the patient was positive for HPV. According to the physician, the patient was probably positive with one of the strains that the 4 valent vaccine did not cover.  At the time of the report, the outcome of human papilloma virus test positive was unknown.  Causality assessment was not provided by the reporter.
Patient received his vaccine and was doing well, he proceeded to sit on the chair to wait for 15 mins for us to monitor him. He was with his wife and fainted and fell out of the chair. 911 was called and they came and took him to the hospital
Felt dizzy with blurred vision for a few seconds. Began to have chills for a few minutes, with concurrent shaking.
first her right cheek is little bit swollen and now the left cheek is also little bit swollen; slight reaction around the site (redness); This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (first her right cheek is little bit swollen and now the left cheek is also little bit swollen) and VACCINATION SITE ERYTHEMA (slight reaction around the site (redness)) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWELLING FACE (first her right cheek is little bit swollen and now the left cheek is also little bit swollen) and VACCINATION SITE ERYTHEMA (slight reaction around the site (redness)). At the time of the report, SWELLING FACE (first her right cheek is little bit swollen and now the left cheek is also little bit swollen) and VACCINATION SITE ERYTHEMA (slight reaction around the site (redness)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment information was reported.
Nausea, fatigue, joint pain, fever, chills, headache, dizziness
11/24/2017 PATIENT RECEIVED 3 IMMUNIZATIONS BOOSTRIX-LEFT ARM, PNEUMOVAX, FLUZONE HD PF RIGHT ARM. 11/28/2017 PATIENT CALLS PHARMACY COMPLAINING OF PAIN AND REDNESS. INSTRUCTED TO MONITOR AND CALL BACK TOMORROW. 11/29/2017-PATIENT DOES NOT CALL BACK. PHARMACISTS TRIED CONTACTING 2 TIMES..NO ANSWER. 11/30/2018 PATIENT PRESENTS AT 5:15P WITH 3 RXS TO TREAT ADR FROM IMMUNIZATIONS. RXS FOR CEPHALEXIN, NAPROXEN AND TRAMADOL.
She had a grand mal seizure 2 1/2 hours after medication was administered.  11/30/09 DS for DOS 11/05/09.  Final DX: Pneumonia and generalized nonconvulsive epilepsy.  Pt received H1N1 vaccine on 11/05/09 and 2.5 hrs after Pt had 5 seizures and a grand mal seizure which had not occurred before.  The following week, Pt had more seizures and a poor level functioning.  On 11/25/09, Pt presented to PCP with respiratory symptoms of increased cough for the last few months which got worse the last few days, increased congestion and lots of thick green mucus.  Pt coughed and vomited, but still had lots of mucus that was suctioned frequently by Pt's mother. On physical examination, Pt had significant upper airway congestion, drool and foam from the mouth, intermittent seizures, mild tachypnea, rales of right base, wet rhonci on all lungs.  Pt's physician considered Pt's condition improved and back to her baseline number and type of seizures.
Within 2 minutes of administration patient c/o being "sick" and collapsed was unresponsive x app. 1 minute and had rigidity of extremities, shook and cried out as she regained consciousness. Will follow up with cardiologist and neuro eval.
A rash developed on the patients chest, arms, back, stomach and thighs.  It has been itchy and painful.  The rash has progressed from the patients neck to her toes.  The patient's PCP has recommended the adverse event be reported as secondary to COVID booster administration at this point.
No treatment. Just took tylenol for the headache. The second dose was not as bad as the first dose. Just headache and body ache. I went to the doctor with these bladder infections. My doctor said to do the VAERS report.
Information was received from a physician via a company representative referring to a 13 year old male patient. The patient's concomitant medication, pertinent medical history and drug allergies/reactions were not reported. On 14-OCT-2015, the patient received a dose of GARDASIL 9 (lot#, expiration date, strength, dose, frequency and route unknown). On 01-NOV-2016, the patient received the second dose of GARDASIL 9 (lot#, expiration date, strength date, strength, dose, frequency and route unknown). This was outside the recommendations in the GARDASIL 9 prescribing information. No adverse effects were reported. Additional information is not expected as there is no consent to contact the physician.
Information has been received from a registered nurse concerning an approximate 5-year-old female who on 18-JUL-2005 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (lot # 644252/1155M). ON approximately 06-NOV-2007 ("within the last two weeks") the patient developed breakthrough chickenpox. At the time of the report the patient's status was unknown. A product quality complaint was not involved. This is one of several reports received from the same source. Additional information has been requested.
pt broke out w/chickenpox 8/26/99 p/being exposed @ daycare;rash on abd, groin & legs;tx acyclovir, Aveenobath, calamine lotion;
Erythema, Induration, Pain radiating to R shoulder and into R hand. UE edema.
received 3rd dose on 5/19/2021 (PFizer) and 4th dose on 9/8/2021 (Moderna); initial doses were in Jan & Feb 2021 (Moderna)
Encephalopathy; Covid-19; This literature-non-study case was reported in a literature article and describes the occurrence of ENCEPHALOPATHY (Encephalopathy) and COVID-19 (Covid-19) in a 94-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.       No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ENCEPHALOPATHY (Encephalopathy) (seriousness criterion medically significant) and COVID-19 (Covid-19) (seriousness criterion medically significant). At the time of the report, ENCEPHALOPATHY (Encephalopathy) and COVID-19 (Covid-19) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered ENCEPHALOPATHY (Encephalopathy) and COVID-19 (Covid-19) to be related.    No concomitant and treatment product reported. Company comment: This is a literature-non-study case concerning a 94-year-old female patient, with no medical history reported, who experienced the serious (due to medically significant), unexpected AESI of COVID-19 and the serious (due to medically significant), unexpected event of Encephalopathy. As per source document, she developed COVID-19 encephalopathy four month after the second dose of mRNA-1273. No information on previous Covid-19 vaccination available. No further details on clinical course, lab test results or treatment were reported. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.; Sender's Comments: This is a literature-non-study case concerning a 94-year-old female patient, with no medical history reported, who experienced the serious (due to medically significant), unexpected AESI of COVID-19 and the serious (due to medically significant), unexpected event of Encephalopathy. As per source document, she developed COVID-19 encephalopathy four month after the second dose of mRNA-1273. No information on previous Covid-19 vaccination available. No further details on clinical course, lab test results or treatment were reported. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.
This spontaneous case, initially received from nurse on 07-Dec-2017, concerning a 43-year-old adult female patient. The patient's medical history and concomitant medications were not reported. It was reported that, the vaccine underwent temperature excursion (out of the recommended range) for about 30 minutes at the lowest temperature of 34.7-degrees F on 12-November and reoccurred on 27-November with the lowest 27.5 degrees F (explicitly coded as incorrect product storage). On 29-Nov-2017, the patient was administered with FLUCELVAX QIV (batch number: 195250, expiry date: 30-Jun-2018, dose, route of administration and anatomical location: not reported) (explicitly coded as drug administration error). The reporter assessed the events as non-serious. Follow up report received on 05-Jan-2018: This case was considered as lost to follow up, as nurse does not want to provide any further information.
complained of redness and itching inside of left ear and itching of scalp/hair after 15 minutes
No adverse effects reported; received improperly stored ROTATEQ between 03-OCT-2019 and 28-OCT-2019; This spontaneous report as received from a Vaccine Coordinator refers to a 9 month old female patient.  The patient's pertinent medical history, concomitant therapies, as well as drug reactions or allergies were not reported.   On 28-OCT-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally for prophylaxis (strength, frequency not provided) (lot #S000961 had been verified to be valid lot number; expiration date 19-OCT-2020) (product storage error). The  temperature  excursion was above 9 degrees Celsius (C) (0.6 C, multiple) for a time frame of 5 hours. There were no previous temperature excursion. It was reported that the call was due to data logger. No adverse effects were reported.  This is one of six reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA016835:
At approx 0000 on 1/11 I started running a fever (102.3 oral), having severe body aches, massive headache and uncontrollable shaking and chills
Aches, pains, severe severe severe headache, chills, muscle aches, hot and cold, sweats.  All worsen as the day went by. Did not work on 09/23/2010.  Slept most of 09/23/2010. Woke up at 4:30 p.m. using OTC pain medicine Tylenol for mostly the severe head ache and aches and pains.  By 9:00 p.m. on 09/23/2010 things were back to normal.
Pt received vaccines on 9/29/00. Today on 2/15/01, complaining of area of tissue atrophy and hypo-pigmentation 2" X 1" over injection site.
Chills, malaise, Tachycardia  All tests done at hospital  We have no records
RASH ON LOWER BODY, FOREARMS AND SHOULDERS; This spontaneous report received from a patient via a company representative . 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. No concomitant medications were reported. On an unspecified date, the subject experienced rash on lower body, forearms and shoulders. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash on lower body, forearms and shoulders. This report was non-serious.