chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of migraine in a adult female patient who received SHINGRIX for prophylaxis. On 12th September 2018, the patient received the 1st dose of SHINGRIX. On 14th September 2018, 2 days after receiving SHINGRIX, the patient experienced migraine. In September 2018, the patient experienced vomiting and nausea. On an unknown date, the outcome of the migraine, vomiting and nausea were not recovered/not resolved. It was unknown if the reporter considered the migraine, vomiting and nausea to be related to SHINGRIX. Additional details were provided as follows: The health care professional did not administer the vaccine and was given in a different state and did not have any additional details about patient or batch number and expiry date. The health care professional was also uncertain of her work address, so address provided was from internet search by pharmacy name. The patient reported a terrible migraine which started 2 days after receiving her 1st dose of SHINGRIX and was persisting till the time of reporting (day 7). The patient's husband was vaccinated at same time with no problems. This case has been linked with case US2018171044 reported by the same reporter. The reporter did plan to instruct the patient to follow up and provide a more detailed report.
Pt fainted after receiving HPV. Pt rolled back onto exam table. No injury noted.
Patient felt hot, reports trouble breathing Patient believes it is anxiety No interventions, left in stable condition @12:40 p.m.
Adverse Event #1: Immediate burning pain at injection site in left shoulder, followed by acute pain in left should. Pain is deep in shoulder joint or ligament, and also comes with a reduction in strength in that shoulder. Pain still continues today, never goes away.  Adverse Event #2: Stiff & sore neck. Pain still continues today. Severity varies day-to-day.  Adverse Event #3: Swelling in both big toes. Swelling that turned into blisters near the edge of toe nails on both big toes. Started a couple days after shot. Swelling still occurs on occasion currently, but not as severe.
The client reported that since receiving the flu injection that she has had limited mobility in the left arm and pain from her biceps to the left elbow that has not been relieved by OTC medications. Reported that she was seeing her personal physician on 10/15/2014. Called client on 10/17/14 to follow up after her physician visit. She reported that the physician did lab work at the visit that indicated that she had inflammation in the left arm. He prescribed medication that she did not recall the name of but indicated that the pain in the arm was improving.
chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and HEADACHE (headache) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced CHILLS (chills) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. In April 2021, CHILLS (chills) and HEADACHE (headache) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications were not provided.   This case was linked to MOD-2021-415851, MOD-2021-415852 (Patient Link).
Felt weakness in legs initially; progessed to the point over 6 weeks of paralysis in legs and arms. Finally diagnosed with CIDP, a form of Guillan Barre Syndrome. Still recovering as of now. In outpatient physical therapy.  Still walking with a walker or in a wheelchair  Nurse follow up on 06/28/04 states: "ADD: DVT, EMG abnormal."  Nurse follow up on 08/04/04 states: "Chronic inflammatory demyelinating polyneuritis
New onset atrial fibrillation occurred 56 hours after receiving the vaccine. No prior history. Seen in emergency department on  1/13/2021 and underwent pharmacologic/medical cardioversion and cardiology consultation.
On August 28th, 2022-I was having breakfast at home with my wife and all of a sudden I had this LOUD ringing in my right ear. I am hearing impaired and wear a hearing aid on my right ear. I had (very mild) ringing in the past but it would go away within hours. As of today, (11/28)-I still have loud ringing and I think it is now permanent. It sounds like music (Drumming) or the sound of a plane's engine. I must point out that I just purchased a new hearing aid a month before I got this ringing in my ear. I am deaf in my left ear so I don't wear a hearing aid on that ear. Last month, I went for my (updated) second booster shot. I also went for my annual flu shot. Last December, when I went for my first booster shot-I
Patient received Pfizer COVID vaccine lot EW0172, exp 8/31/21 today at 220pm and started immediately experiencing numbness and tingling on left side, still able to move arms and leg.  Reports numbness and tingling in left side of face as well.  No facial drooping and clear speech.   Denies breathing issues/throat swelling or eye itching.  Has started to develop a small rash on bilateral forearms, visible on right arm, Allegra 60mg given at 245pm.  Vitals 157/86 and pulse 65.  Patient does report that often reacts to vaccines and has ended in the ER before due to vaccine reactions.  Patient taken to ER via wheelchair with Dr,  RN and MA @1500, did report dizziness and lightheaded on the way to ER.  RN
This case was reported by a consumer (patient) and described the occurrence of pneumonia in a 84-year-old female subject who was vaccinated with Influenza vaccine unspecified (manufacturer unspecified), pneumonia vaccine (non-gsk). A physician or other health care professional has not verified this report. Concurrent medical conditions included chronic obstructive pulmonary disease and pulmonary hypertension. Co-suspect medication included ADVAIR HFA-CFC Free Inhaler for chronic obstructive pulmonary disease. In September 2013 the subject received a dose of Influenza vaccine unspecified (unknown), unspecified dose of Pneumonia vaccine (Non-GSK) (unknown). On an unknown date in 2013 within months of vaccination with Influenza vaccine unspecified and Pneumonia vaccine (Non-GSK), the subject experienced pneumonia and coughing hard. The subject was prescribed ADVAIR HFA for an off label use (chronic obstructive pulmonary disease). This case was assessed as medically serious by GSK. At the time of reporting the pneumonia was unresolved and the outcome of coughing hard was unknown. The subject reported that she "doesn't think the flu shot did what it was supposed to do". She explained that she got a flu shot in September 2013 and the pneumonia shot and has had pneumonia for the past two weeks [2013]. She informed that she "got the flu shot but still got whatever you want to call it". She stated that she does not have a diagnosis of the flu, she was diagnosed with pneumonia. The subject reported that she went to the urgent care because she was coughing hard. The subject stated that she had an X-ray and was diagnosed with pneumonia. The subject indicated she has COPD and pulmonary hypertension and was given a sample of ADVAIR HFA recently. The subject did not state whether she had taken any ADVAIR HFA. It was unclear if she ever used the ADVAIR HFA. At the time of the report, the subject noted that her pharmacist was calling her physician so that she could get the inhaler (COMBIVENT) she had used in the past since she read ADVAIR HFA is not indicated for COPD.
dry heat; sick; throwing up; Dry heaves; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the parent.  A 6-year-old female patient received bnt162b2 (BNT162B2), administered in thigh right, administration date 17Nov2021 14:30 (Lot number: FK5618, Expiration Date: 19Jan2022) at the age of 6 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Flu shot (She had a flu shot in August. Caller doesn't have NDC, lot, and expiry for the flu shot.), administration date: Aug2021. The following information was reported: BODY TEMPERATURE ABNORMAL (non-serious), outcome "unknown", described as "dry heat"; ILLNESS (non-serious), outcome "unknown", described as "sick"; VOMITING (non-serious) with onset 18Nov2021, outcome "unknown", described as "throwing up"; RETCHING (non-serious) with onset 18Nov2021, outcome "unknown", described as "Dry heaves". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: it was reported that the patient got the vaccine on 17Nov2021 after getting the pfizer covid 19 vaccine presented throwing up, and dry heat. She does not want to get another shot. are there any problems by skipping the second dose? The patient further reported that she got the first shot on Wednesday and it made her sick. Yesterday morning, she was throwing up and had dry heaves. She doesn't want to go get the follow up shot. Will there be a problem with skipping the second one? Event Details: at about 4 in the morning, she started being sick with throwing up and dry heaving. It has cleared up and she went to school today. She was pretty adamant that she doesn't want another shot. Prior Vaccinations (within 4 weeks) was none within 4 weeks. Patient had a flu shot in August. Reporter doesn't have NDC, lot, and expiry for the flu shot. AE prior to vaccination was none.  No follow-up attempts are possible. No further information is expected.
overdose of 2cc; p/30-40 mins no obvious adverse effects; had last Td 4 yrs prior; would not provide addtl info;
Symptons:  Sore Arm and Fatigue  Time Course : Occurred day after vaccination, 4/1/2021  One day only
Arm became sore and felt warm. The next morning it was red and seems to be spreading.
Headache & Myalgia Narrative: ha. overwhelmingly exhausted;insomnia took motrin for ha on 1/27; fatigue day 1-3.
ADMINISTRATION ERROR : Pt. received a 3rd Booster of Phizer 11/22/2021, previously had received the Booster 2nd dose of Jansen (J&J) 10/05/2021 and 1st dose of Jansen (J&J) Unknown Date.
Approx 45 min. after receiving vaccine pt's head got stuffy/swollen. Took BENADRYL & was seen at ER. "Ears felt like were about to pop & his throat felt funny" & "stomach really hurt".
On 9/24/2021 received Pfizer booster shot in same left arm muscle as previous 2-dose Pfizer primary series.  On 11/04/2021 received senior flu vaccine and 2nd in series pneumococcal vaccine.  Friday 11/05/2021 morning 3:00 A.M. awoke with pain at injection site and  chills with my body shaking uncontrollably from head to toe.  Lasted 1 -2 hours and suddenly stopped.  All 5 shots this year, 2 Pfizer COVID-19 primary series, one Pfizer COVID-19 booster and  flu and pneumococcal shots intramuscular left arm.  Other than fatigued, fine now.
I woke up at night and could not breathe and my husband took me to the hospital and I was diagnosed with double pneumonia, after I was home my temperature went up to 102 degrees but the doctors office was full and busy for the next four days then afterwards I lost my voice for about thirteen days.
Guillian Barre Syndrome per spinal tap. L facial paralysis. Bilateral lower extremity weakness, hands and feet numbness. Fluogen 10/7/09/ 10/26 c/o hands and feet numbness for several days and anxiety pain; 11/2 c/o increase pain and now by weakness - ascending up and facial numb/ corner of mouth and lower back pain. 11/3 facial weakness (L) and  leg neuralgia.  12/18/09 and 12/28/09 PCP records. Neurology consult. Discharge summaries, ED and hospital records received.  Service dates 9/26/09 to 12/7/09. Assessment: Guillain-Barre syndrome, AIDP. Recent Bell's Palsy. Patient now presents with c/o of worsening tingling in upper and lower extremities. Reflexes hypoactive. IVIG with improvement.
Low grade fevers (99 degrees F) very fatigued, chills, palpitations, warmth at injection site.
This spontaneous report was received from a health care worker concerning a multiple unspecified patients of unknown ages and genders. The patients' concurrent conditions and medical history were not reported. On multiple unspecified dates, ranging from August 2015 up to and including October 2015, the patients were vaccinated with improperly stored doses of VARIVAX (Merck), lot # reported as: 1011083, expiration date: 01-APR-2017, lot#: 1017145, expiration date: 13-MAY-2017 (route, anatomical location and doses were not reported). Co-suspect therapies or concomitant medications were not provided. No adverse reactions were reported. Lot numbers: 1011083 and 1017145 are invalid lot numbers for M-M-R II. This is one of several reports from the same source. Additional information has been requested.
No additional AE reported; Product was administered to patient after temperature excursions; This spontaneous report was received from a medical assistant referring to a 4 year old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.      On 21-JAN-2022, the patient was vaccinated with improperly storage measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) recombinant Human albumin (rHA)  lot # U022729 with expiration date 16-JAN-2023, for prophylaxis (strength, dose, route of administration were not reported). No additional adverse event (AE) was reported. It was stated that the vaccine was exposed to a temperature of 7.4 °F for 0 Hours 25 Minutes 0 Seconds; 6.4 °F for 0 Hours 20 Minutes 0 Seconds; and 5.9°F for 0 Hours 15 Minutes 0 Seconds. Additionally, the vaccine underwent previous temperature excursion as follows: 31. 3 °F for 10 Hours 28 Minutes 0 Seconds; between range of 6°F to 14°F; No exact temperature was provided; for 1 Hour 15 Minutes 0Seconds; and 11 °F for 4 Hours 6 Minutes 0 Seconds.
One week after the first injection (1/22/2021), my arm began itching, getting red and swollen. By the following day(1/23/2021), the swelling was very significant, the arm hard, red and hot from approx 1 inch below the shoulder to the elbow. The swelling was painful and my fingers started to tingle.
Chest pain, left arm pain, pain on left side of neck, heart palpitations, fatigue
On 01/14/2023 I traveled out of state. On 01/15/2023 I started having chest pains that lasted the entire day. On 01/16/2023 I had a horrible sore throat in the morning and again at 3:00PM along with achiness I went to bed and woke up with a very bad headache. 3PM and turned into a achiness. on Monday shortly thereafter I got body aches went to bed and woke up with a bad headache. I'm still feeling pretty awful.
small lesions all over body, forearms, chest, + itching x 1 day; went to clinic 18NOV96 8AM;tx DPH, inc fluids, APAP;
5-7 erythematous, raised lesions on trunk and neck X 24 hours. Complaining of itching. Afebrile.
10 cm area of erythema at injection site right deltoid; urticarial lesions on face, -started evening of vaccination
Severe fatigue, starting one day after 2nd dose on may 21st, worrisome brain fog starting on may 22nd, constantly waking up in the middle of the night since may 20th, dry mouth and eyes since may 20th, slight irritation around lips
Rapid heart rate; Arm tenderness, could not lift arm; Fever; temperature to 102; Chills; Muscle aches; Nausea; Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Rapid heart rate), PAIN IN EXTREMITY (Arm tenderness, could not lift arm), PYREXIA (Fever; temperature to 102), CHILLS (Chills) and MYALGIA (Muscle aches) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029l20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced TACHYCARDIA (Rapid heart rate), PAIN IN EXTREMITY (Arm tenderness, could not lift arm), PYREXIA (Fever; temperature to 102), CHILLS (Chills), MYALGIA (Muscle aches), NAUSEA (Nausea), FATIGUE (Fatigue) and HEADACHE (Headache). At the time of the report, TACHYCARDIA (Rapid heart rate), PAIN IN EXTREMITY (Arm tenderness, could not lift arm), PYREXIA (Fever; temperature to 102), CHILLS (Chills), MYALGIA (Muscle aches), NAUSEA (Nausea), FATIGUE (Fatigue) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Body temperature: 102 (Inconclusive) Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
This medically confirmed spontaneous report (initial receipt: 26-Feb-2016) concerns a 30 year-old female patient. On 02-Oct-2015, the patient received AFLURIA (batch number: U55406; expiry date: 30-Jun-2016 yet reported as 12-Jun-2016) 0.5ml via the intramuscular route. The AFLURIA vaccine was stored at 0.6 to 1.1 degrees Celsius (reported as 33-34 degrees Fahrenheit) multiple times. The last excursion was 0 degrees Celsius (reported as 32 degrees Fahrenheit) for no more than 24 hours. The outcome was not reported.
Patient reported that a couple of days after receiving second Shingrix vaccine she developed itching and a rash at the injection site,underarms,lower hip near buttocks and scalp. She does not recall eating anything unusual or using any new products. She took medication she had on hand for itching and got some relief.  I contacted primary physician's office and they will follow up with her.
Significant chills while trying to sleep. Unable to resolve with blankets.Low grade fever the following morning. Currently taking tylenol.; Significant chills while trying to sleep. Unable to resolve with blankets.Low grade fever the following morning. Currently taking tylenol.; This is a spontaneous report from a contactable Other HCP (patient). A 30-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231) , intramuscular on 05Jan2021 07:15 at the first single dose at arm left for covid-19 immunisation.  Medical history reported as none.  Concomitant medication included hpv vaccine vlp rl1 9v (yeast) (GARDASIL 9) on 04Jan2021, escitalopram oxalate (LEXAPRO), alprazolam.  The patient experienced significant chills while trying to sleep. unable to resolve with blankets. low grade fever the following morning on 05Jan2021 23:00. currently taking tylenol. The outcome of events was recovering.
On February 23 (1 week after 2nd vaccine), I experienced sudden onset of swollen lymph node in left side of neck and sore throat, headache, difficulty swallowing, fatigue, some sinus symptoms and stuffy ears. Today is February 26 and I am still experiencing the same symptoms, somewhat less intense than initially.  I called my primary care doctor's office and was told by the receptionist that this was a reaction to the vaccine and should subside in a few days and if not to call back.
Information has been received from a consumer via Pfizer referring to her husband of unknown age. The reporter explained her husband had injuried to his back prior to the vaccination shot and now he had to have surgery this week. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX 23 (strength, dose, dose number, lot #, route and application site were not reported). Concomitant therapy was not reported. On an unknown date the patient experienced inflammation which started a couple of days after he received the shot. The reporter said that the PNEUMOVAX 23 shot did not cause the back issues but the inflammation from the shot made it worse and made the inflammatory go crazy. The inflammation triggered this terrible condition. The patient could barely walk right now. The outcome of inflammation was unknown. The reporter considered inflammation to be related to PNEUMOVAX 23. Additional information has been requested.
Red ring around the site of injection, Hot to touch, swollen the size of baseball and tender to touch.
Chills, fatigue, headache, muscle/body aches. Went to bed feeling ok.  Symptoms started during the night and lasted throughout the next day.  I pretty much slept the entire day and night following the shot.  The following day I was back to normal.
On 9/19/00 about 17:00, the right arm became painful. Pain radiated to the neck and ran a slight fever late last night. No fever today. Arm is still painful. Taking Aleve.
Starting ~1 hour after administration of vaccine she started to feel a slight tightness in her throat, able to speak and swallow, not progressing. She returned to promptly.   notified provider  about symptoms. Throat exam: normal, no edema.  Vitals at 3:40 pm: O2 99% on RA, HR 113, BP 129/88, Temp 97.8. Liquid benadryl 50 mg administered at 3:45 pm. Lungs CTA b/l, no wheezing. Vitals at 3:48 pm: O2 98% on RA, HR 82, BP 109/92. Pt reporting being able to swallow better and feeling less tightness in her throat at 3:55 pm. Vitals at 4:02 pm: O2 100% on RA, HR 81, BP 120/88, temp 97.8. Pt took sips of water and feels swallowing much easier. Less anxious. Vitals at 4:16 pm: O2 99% on RA, HR 84, BP 104/79. Temp 98.0. Pt observed by a provider or RN at all times.  Was released to return home at 4:25 pm. She was given diphenhydramine to repeat 50 mg in 4 hours. Strict ER precautions givenf or any return of symptoms or worsening at any time
3/21/2023   Woke up with a severe cough, fatigue and an on again off again sinus pressure headache.  Tested with At Home COVID-19 test, positive.  3/22, coughing severely and loss of voice. 3/23 Televisit with Doctor who proscribed Paxlovid, Prednisone, and Promethazine DM.  Doctor recommended albuterol, but allergist recommended increased dose of Symbicort.   Coughing subsided by the weekend, 3/25.  Symptoms gradually diminished until 3/25, but the fatigue lingered another week.  Brain Fog lingers to the time of reporting.
Within 9 few hours of vaccination, (R) upper arm from elbow to shoulder became extremely swollen, hot, painful & red. Reported by pt on 9/14/2012. Tx: ice, elevation, MOTRIN.
8 hrs. after the vaccine had fever 101F, nausea, vomiting and chills for ~ 30 hours. 36 hours after noted that the rosacea I have on both cheeks which was not visible before became apparent. Both cheeks were swollen and red, the left cheek more than the right. This remained hot and red and swollen till today 3/3/21. It is mostly gone today. I did not have sun exposure which is my usual trigger for rosacea.