chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning her daughter who was vaccinated with a dose of GARDASIL vaccine (yeast) and manifested pseudoseizures. At the time of the report the outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Pfizer-BioNTech COVID-19 Vaccine EUA Swollen lymph node in armpit of vaccinated arm
ACHES, HEADACHE, STIFF NECK, CHILLS/SWEATS, SORES THROUGHOUT MOUTH  PATIENT STILL HAS MUSCLE ACHES, STIFF NECK, BAD HEADACHE (WORSE THAN MIGRAINE) SORES IN MOUTH LASTED 48 HOURS THEN RESOLVED
Pt was administered the incorrect vaccine in series.  No adverse effects with previous covid vaccinations or with vaccination just received
Big bright, feverish, red spot about the size of an orange @ inj site;whole body ached x 2 to 3 days;very painful & stiff up around shoulder, down into armpit & chest area;
Patient reported flushing of the ears and face with bumpiness on the face also, I advised her to take benadryl and seek medical attention if her condition worsened.  She reported that this started about 40 minutes after the vaccine was administered.  I called her back 1 hour after instructing her to take the Benadryl and she reported that the bumpiness and flushing was subsiding.
leg and "quad" pain; right shoulder and bicep pain/ left shoulder pain; bicep pain/ qud pain; swallow issues; "coughing and choking"; choking; flu like symptoms; voice changes, hoarseness; slurred speech; This case was reported by a consumer via call center representative and described the occurrence of choking in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th August 2019, the patient received the 1st dose of Shingrix. On 29th August 2019, less than a day after receiving Shingrix, the patient experienced choking (serious criteria GSK medically significant), influenza-like symptoms, voice alteration, slurred speech, swallowing difficult and cough. On 6th September 2019, the patient experienced shoulder pain and muscle pain. On 25th September 2019, the patient experienced leg pain. The patient was treated with cortisone (non-proprietary) (Cortisone Injection). On 1st September 2019, the outcome of the influenza-like symptoms was recovered/resolved. On an unknown date, the outcome of the choking, voice alteration, slurred speech, shoulder pain, muscle pain, swallowing difficult, leg pain and cough were not recovered/not resolved.   It was unknown if the reporter considered the choking, influenza-like symptoms, voice alteration, slurred speech, shoulder pain, muscle pain, swallowing difficult, leg pain and cough to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the right arm and within two to three hours he developed voice changes, slurring, hoarseness, coughing, choking, and swallow issues. The patient stated that he also developed flu like symptoms and those resolved in two or three days. On 6th September 2019, 8 days after vaccination, the patient developed right shoulder and bicep pain.  He stated that on 25th September 2019, 27 days after vaccination he developed left and quad pain.  On 5th December 2019, he developed left shoulder pain. He stated that the leg and shoulder issues all continue at the time of reporting, unresolved.  The patient reported that the shoulder pain was treated by physician with cortisone injections.  The patient had endoscopy, barium swallow studies and saw a neurologist regarding these symptoms and all this tests were normal. Emergency room visit was required. The reporter consented to follow up.
pt recv vax 23FEB98 & exp a red, raised, itchy rash on upper thighs, lower arms, neck, & upper back;no SOB noted;
Pfizer Bivalent Booster was given to patient in error when patient was supposed to get the first dose in the primary series.  No adverse effects were reported.
Migraines, blurred vision, irregular menstrual cycle. Start from time of injection to present.
Information has been received for the pregnancy registry for VARIVAX from a 26 year old female registered nurse with no known pertinent medical history or drug reactions/allergies who on approximately 11-AUG-2008, "4 weeks ago," was vaccinated with a dose of VARIVAX 0.5 ml. There was no concomitant therapy. On approximately 11-AUG-2008, "4 weeks ago," the patient underwent a pregnancy test which was noted to be positive. The last menstrual period was 01-Aug-2008. The estimated due date is 08-May-2009. Follow-up information was received from the registered nurse. She had a miscarriage at 12 to 13 weeks gestational age. Upon internal review the miscarriage was considered to be an other important medical event. No further information is available.
At 7:00 pm on Dec. 31, I began with severe diarrhea. At 9:00 pm I began to feel bloated. By 9:20, I had severe chills that I have never experienced before. By 10:00 I was short of breath, dry heaving, shaking, and severe body pain. Symptoms resolved by 12:00 am. On January 1, I awake with moderate headache and fatigue.
Recently when climbing stairs or bending down would keep me out of breath. It would take longer than usual for my breathing to get back to normal. I would have to take pumps of my inhaler.
Period began 3 weeks early and lasted for longer than usual period: usual period length is 5 days, the period I experienced was 1.5 weeks long
Patient reports having horrible symptoms such as sweats, chills, bad HA, nausea and vomiting, arm pain, extreme fatigue and tachycardia. She states she feels much better now and is taking Motrin for the HA.
Bells Palsy; This is a spontaneous report from a contactable consumer (the patient).  A 67-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot #: EM9810), via an unspecified route of administration, in the right arm (at the age of 67 years) on 09Feb2021 at 10:30 AM at single dose for COVID-19 immunization. The patient medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination included lisinopril (LISINOPRIL ACTAVIS), rosuvastatin, acetylsalicylic acid (ASPIRIN 81). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took Penicillin and experienced rash,  Sulphamide and experienced nose bleed. On 10Feb2021 at 08:30 AM, the patient experienced Bell's Palsy.  The patient visited the emergency room Therapeutic measures were taken as a result of Bell's Palsy and included tape left eye closed and use wetting gel. The clinical outcome of the bells palsy was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
NO REPORTED SYMPTOMS, BUT DUE TO RECENT COMPLICATED MEDICAL HISTORY REQUESTED ADDITIONAL TIME TO BE OBSERVED AFTER RECEIVING THE VACCINE.
Information has been received from a pharmacist referring to a female patient of unknown age. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 01-DEC-2016, the patient was vaccinated with ZOSTAVAX (lot #, expiration date, dose and route were not reported) for prophylaxis. On 02-DEC-2016, the patient had redness on her arms, legs, and face, and her oxygen level was low. The pharmacist described the patient as being "incoherent" (start date: unspecified date in December 2016) and was later hospitalized for an unspecified amount of time in an unspecified location. The patient was discharged from the hospital on an unspecified date in December 2016. At the reporting time, it was unknown if the patient was still experiencing the symptoms. The causality was not reported. Additional information has been requested.
Received Tdap vaccine on 6/27/08.  Severe swelling in left arm, especially at injection site where large mass increased in size over last 72hrs.  Severe pain in lymph nodes under arms, first occurring under left arm where injected with vaccine, then spreading to severe pain in left breast.  Just over 24 hours later, pain spread across chest and extreme lethargy set in along with muscle weakness and body aches.  A little over 24hrs hours, chills set in and I was falling in and out of restless sleep with the left arm pain being so severe that unable to rest.  Called health care center and they reported that half the symptoms were normal, half questionable.  Most severe reaction was just a little over 24hrs after being vaccinated on 6/28/08 and also not only left me in sever pain, but also in state of confusion since unable to obtain medical treatment.  I had no issues prior to vaccine.  These symptoms have only slightly lessened just a little more than 72hrs later.  I still have much concern and may need to make a trip for urgent care.
LEG CRAMPS; STOMACH PAIN; ALMOST FAINTED AT WORK; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1808609 and expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAY-2021, the subject experienced leg cramps. On MAY-2021, the subject experienced stomach pain. On MAY-2021, the subject experienced almost fainted at work. The action taken with covid-19 vaccine was not applicable. The outcome of the leg cramps, stomach pain and almost fainted at work was not reported. This report was non-serious.
68-year-old female presenting with shortness of breath and hoarse voice after her first Moderna COVID vaccination today. She took Benadryl at onset of symptoms and received additional by EMS. She now feels better but has persistent hoarse voice and shortness of breath although with unremarkable physical examination.   Given her history of similarly presenting anaphylactic reactions to foods, as well as symptomatic airway involvement, advised treatment with epinephrine for probable anaphylactic reaction.  Patient expressed agreement to this.  She received epinephrine as well as Solu-Medrol, with improvement in symptoms.  On reevaluation, she is breathing more comfortably and says that she feels almost entirely improved.  Repeat vital signs have remained stable.   Prescription for prednisone given for home.  Advised her to discuss symptoms and next steps with her primary doctor, although she probably should not receive her second vaccination.  She does have an EpiPen at home.  Strict emergency department return precautions for recurrent symptoms were reviewed and she expressed understanding and agreement.
received Menactra vaccine that had expired; Initial information received on 31-May-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves 11 years old male patient who received an expired dose (1 dose) of vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] lot U5866CF, expiry date-22-May-2019 via intramuscular route in the right arm on 31-May-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE (HPV VACCINE) for Immunisation.  It was a case of actual medication error due to Expired vaccine used.  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 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.  Documents held by sender: none.
Information has been received from a Medical Assistant concerning a female patient who on 02-APR-2009 was accidentally vaccinated with ZOSTAVAX (Merck) (Lot# not reported) instead Varicella. No adverse effect was reported. Additional information has been requested.
Red, hot to touch, swollen arm. Fever, body aches, runny nose, and headache
Initial report received from a health care provider on Nov 16 2005. A 52 year old male patient with a medical history of migraines received a left deltoid injection of Fluzone SV 2005-2006, lot number U1772AA, on 10/13/2005. Route of administration was not reported. On approximately 11/11/2005, the patient developed numbness and tingling in his hands and feet that moved up the extremities and muscle weakness. On 11/14/2005, the patient was examined in an ER, and thereafter, admitted to the hospital. Admitting diagnosis was not reported. The results of a CT and MRI were unknown. At the time of this report, the patient continued to be hospitalized and not recovered.
The patient recieved 2 doses of COVID vaccine, on 2/26/21 & 3/26/21, she lost her card and insisted she needed 8/20/21 dose which was given, no adverse reaction was noted. Upon looking in state immunization database the error was found.
Soreness, redness 5" x 5" redness - cellulitis. Rx: KEFLEX 500 mg QID x 10d.
Two days of burning chest pain on one side of thorax and small pain blisters on the same side. Treatment prescribed Valtrex (1 tablet 3x for 7 days).
(R) arm where vaccine was administered w/erythema and warmth about 4 cm diameter noted 12/20/13.
SHE RECEIVED BIVALENT INSTEAD OF DOSE 1 OF PRIMARY SERIES. REPORTING FOR FLOATER PHARMACIST WHO ADMINISTED VACCINE ON 10-31-22 AT MY PRIMARY PHARMACY LOCATION
2 weeks after receiving the Moderna vaccine I started to have rheumatoid arthritis (RA) joint pain in my hands, shoulders, feet, knees, elbows. My RA has been stable for over a year. The only change was getting the vaccine. I started taking prednisone to help with the flare ups at the instruction of my doctor - . I am currently taking 10mg a day. I started taking prednisone on 2/18/21.
07/18/02-Mom brought child to Health Dept. to have left arm checked, Arm is swollen from shoulder to elbow,red and hot to touch. Mom stated 07/19/02, child broke out with raised rash on arm swelling persisted even though using compresses. She took her to her pediatrician who prescribed a steroid ointment, Zyrtec and Benadryl. Today 07/23/02, she saw she is doing better and rash is fading. Doctor felt like reaction to pertussis component of vaccine.
Death   4/21/2021 Causes of death listed on death certificate: 1) respiratory failure  2) covid 19 pneumonia
felt something popped in her hip/knee area when she stepped upstairs; chills; This is a spontaneous report from a sponsored program. A contactable female consumer (patient) reported that A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiration date: unknown), via an unspecified route of administration on an unspecified date at single dose and second dose received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, expiration date: unknown), via an unspecified route of administration on 13Feb2021 12:30 PM at single dose for COVID-19 immunization. The patient medical history and concomitant medication were not reported. Patient experienced after first dose felt something popped in her hip/knee area when stepped upstairs, and patient was taking meloxicam every day. Patient felt something cool in chest, it was like water whooshing through body. It occurred for about 5-6 minutes and patient went to the emergency room to have it checked and the HCPs said that patient was having chills. The outcome of event felt something popped in her hip/knee was unknown and other outcome of event chill was recovered.  Follow-up (13Feb2021): This is a follow-up spontaneous report from a sponsored program.  Information on the lot/batch number has been requested.
Starting 20 minutes after injection, my left hand went numb for 2 hours. Starting 1 day after injection, my left arm ached for 2 days and I was mildly fatigued.
102.1 Fever, 117 bpm from 9pm-11:50pm, soreness, numbness in limbs, weakness, fatigue, nausea, fever chills, pain in lower back and right armpit, sore throat, ear ache, sporadic pain in left arm  Took Ibuprofen and drank fluids, cold then warm compress, rest
administer expired vaccine to 450 patients, after the manufacture date of expiration.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to 450 patients, after the manufacture date of expiration.) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to 450 patients, after the manufacture date of expiration.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to 450 patients, after the manufacture date of expiration.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported  No treatment medications were reported  It was unknown if the vial was initially stored in the refrigerator The vial did not undergo any temperature excursions    Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received contains Non significant information.
This spontaneous report was received from a medical assistant refers to patients of unknown age and gender. On an unknown date, 1 to 3 days before the six month scheduled booster, an unspecified number of patients were vaccinated with dose 2 0.5 milliliter (ml) VAQTA (lot # and expiration date not reported) intramuscularly. No adverse effects have been reported. Additional information is not expected.
ADMINISTRATION ERROR/INCORRECTLY STORED VACCINE ADMINISTERED; VACCINE STORED OUTSIDE OF THE RECOMMENDED STORAGE CONDITIONS; This spontaneous report received from a health care professional concerned a 35 year old male. 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 not reported, batch number: 213D21A, and expiry: 11-APR-2022) dose was not reported, administered on 08-DEC-2021 15:27 for prophylactic vaccination. No concomitant medications were reported.  On 08-DEC-2021, the patient experienced administration error/incorrectly stored vaccine administered. On 08-DEC-2021, the patient experienced vaccine stored outside of the recommended storage conditions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration error/incorrectly stored vaccine administered and vaccine stored outside of the recommended storage conditions was not reported. This report was non-serious.
Generalized vaccinia, diffuse maculopapular rash on torso and extremities with vaccine site as exposed for 10 day smallpox vaccine site. Treated by conservative measures. Quarters x 72 , Tylenol, Benadryl, Calamine Lotion, Rest.
12 hours after injection, developed shaking, violent shivers and freezing cold. Could not get warm. Aching all over. Resolved next day. Some local tenderness at the shot.
Rash throughout body, swelling of hands, pain in hands, rash spreads when skin is scratched
sickness; haemorrhoids; tremor; felt bad; cold flashes; tired and worn out; felt like she is going to throw up; blood present when she blew her nose; diarrhea; hot and cold flashes; really weak; Dry mouth; lots of mucus; no appetite; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (blood present when she blew her nose), DIARRHOEA (diarrhea), HOT FLUSH (hot and cold flashes), ASTHENIA (really weak) and DRY MOUTH (Dry mouth) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TREPROSTINIL SODIUM inhalation vapour, tablet for Pulmonary arterial hypertension.    The patient's past medical history included Tremor. Concurrent medical conditions included Primary pulmonary hypertension (primary pulmonary arterial hypertension). Concomitant products included RIOCIGUAT (ADEMPAS), APIXABAN (ELIQUIS) and AMLODIPINE for an unknown indication.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) Dose 1. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to Dose 2. On an unknown date, the patient started TREPROSTINIL SODIUM (Nasal) at an unspecified dose once a day. In April 2021, the patient experienced EPISTAXIS (blood present when she blew her nose), DIARRHOEA (diarrhea), HOT FLUSH (hot and cold flashes), ASTHENIA (really weak), DRY MOUTH (Dry mouth), SECRETION DISCHARGE (lots of mucus), DECREASED APPETITE (no appetite), FEELING ABNORMAL (felt bad), CHILLS (cold flashes), FATIGUE (tired and worn out) and NAUSEA (felt like she is going to throw up). On an unknown date, the patient experienced TREMOR (tremor), ILLNESS (sickness) and HAEMORRHOIDS (haemorrhoids). At the time of the report, EPISTAXIS (blood present when she blew her nose), DIARRHOEA (diarrhea), HOT FLUSH (hot and cold flashes), ASTHENIA (really weak), DRY MOUTH (Dry mouth), SECRETION DISCHARGE (lots of mucus), DECREASED APPETITE (no appetite), TREMOR (tremor), FEELING ABNORMAL (felt bad), ILLNESS (sickness), HAEMORRHOIDS (haemorrhoids), CHILLS (cold flashes), FATIGUE (tired and worn out) and NAUSEA (felt like she is going to throw up) outcome was unknown.            This case was linked to MOD-2021-074797 (Patient Link).
My left side above my collarbone started to bother me around 8pm the same day I got my vaccine on my left side. I left the gym and the seatbelt was bothering me on my left side. I got home and around 10pm I noticed I had a small bump about half an inch above my collar bone right by my neck on my left side. The bump was painful when I tried to move it or touch it. By 11pm I had chills and aches throughout my body.  I work at a clinic and when I arrived the next day, I went downstairs to the clinic and one of the nurses told me that it was a swollen lymph node and gave me an ice pack. It continued to be painful and it caused my neck to feel very stiff. I could not turn my neck very much without my neck hurting. Around noon on 11/11 my lower back also started aching. I left work around 2:30pm and went home to sleep. On 11/12 (today) I woke up and the bump felt a little better but it is still painful when I touch it and I cannot move my neck normally, I have a little more movement than yesterday though
This is a spontaneous report received from noncontactable consumer or other non-HCP (patient). A patient (no qualifiers provided) received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), single dose, for COVID-19 immunisation. The patient experienced vomiting (threw-up) and headache, with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.