chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I have had constant discomfort, sometimes pain, since receiving this vaccine. I am awakened by this every night unless I take ibuprofen before bed. Any motion requiring lifting of the arm is painful. This has continued for 14 months.
Fatigue, followed by muscle aches. Sore at the injections site (left arm), and in the lymph nodes under the left arm. I'm able to do small things for myself with effort, but unable to have normal activity levels. I don't think that I am sick enough to warrant a doctors visit. It feels similar to body aches associated with the flu. There is no information listed after LOT#. The attached printed label doe say "SHINGRIX VIS-02/12/2019 GSK DOSE-0.5ML LOT# ROUTE -I.M."
Mother reported, significant muscle aches, low grade fever, dizziness, nausea and vomiting.
Pt seen 20 Feb 08 for persistent keloid-type lesions on both (R) and (L) anterior thighs. These lesions, one on each anterior thigh, measure approx. 5mm x 10mm, and appeared within a week of vaccination. ** This report relates to the injections given 31 Oct 07, which led to the lesion on the (R) thigh. ** A seperate report details injections given 21 Dec 07, related to the lesion on the (L) thigh.
Alopecia Areata after booster shot (third dose of Moderna). First dose was in March 2021; second dose was in April 2021. Dermatologist prescribed topical steriod to regrow hair.  After 4 months, some regrowth is evident, although the size of the area of hair loss has also grown significantly
This spontaneous report was received from a nurse regarding unspecified patients of unknown age and gender. Pertinent medical histories, drug reactions or allergies and concomitant therapies of the patients' were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot #L019297, expiration date 15-AUG-2017 (dose and route of administration were not reported). The administered doses experienced a temperature excursion of 0.0 degree Celsius for 9 hours. Previous excursions were 1.4 degree Celsius for 14 minutes, 0.0 C for 11 hours and 43 minutes,0.7 degree Celsius for 12 hours and 53 minutes 0.0 degree Celsius for 10 hours and 36 minutes, 0.6 degree Celsius for 46 minutes and 32 degree Fahrenheit for 4 hour and 20 minutes. The temperature excursions were detected by a data logger. No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one three reports received from the same reporter. Additional information has been requested.
Reaction in the site of injection. The skin in the site of injection is red, hard and hot. The patient feel itchy. TX: Hydrocortisone cream 1% QID, and BENADRYL 25mg PO QD.
Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently unknown patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 21-AUG-2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose, dose number, and route not specified) for long-term prevention of shingles and/or zoster-related conditions (prophylaxis). Shortly after vaccination, the patient was treated for shingles. As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX), the patient will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and cost included care for hospitalization, physician care, monitoring, treatment, medication and supplies; diminished capacity for the enjoyment of life, diminished quality life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages, and will continue to suffer such losses, and damages in the future. The outcome of the event was shingles was not recovered.
07/23/19 patine was seen by Dr at his office..  He complained of cough, myalgia, light sensitivity and abdominal pain with fever and chills.  Test for Flu A and B were negative and his urinalysis test was negative.  Levaquin  500mg  daily was ordered .  Dr spoke with patient the next day,   The patient stated he was feeling better and had not taken the antibiotic.
Started with soreness at site of injection. Redness and swelling spread down the arm beginning on Saturday. By Monday, redness and swelling directly above elbow area. Very painful Friday and Saturday.
I had a sore arm, headache and really tired after receiving the vaccine for about a day. On 04/26/2023, I woke up with a rectal bleed. I do have a history of rectal bleeds due to hemorrhoids. I went to the emergency room for observation. I was prescribed a cortisone cream to use twice a day.
During administration, pain, numbness and tingling down medial aspect of forearm into 4th and 5th digits. Lasted approx 1 minute. Later that evening developed pain in left muscle/shoulder near injection site. Tender to touch and very painful to rotate arm. Unable to sleep on left side and will wake up if I roll onto that side. Ten days after vaccination, developed a raised, itchy rash on body. Total of approx 20 raised areas over skin. Still having the same amount of pain and symptoms in arm 17 days later.
Screaming episode for 3 hours during nite. Temp 101.3 okay 12/19/2001.
Redness occurred and has yet to go away. There is no health issues that I am aware. I feel fine. That is yet.
Headache, Diarrhea, NauseaVomiting Chills, neck pain, fatigue Narrative: Patient complains of severe headache, neck pain, vomiting, chills, fatigue and diarrhea post Covid vaccination on 1/06/2021. Treated symptoms with ibuprofen/Tylenol missed work 1/11/2021. She also states she is pushing fluids and states her symptoms are improvind.
Left armpit/axillary soreness 1 week after recdiving vaccine which has not dissipated and a red raised area of erythema to the left deltoid which appeared 1?week after injection
She called on Wednesday on 09/29 and asked about potential side effects of flu vaccine. There is a local irritation on her arm with stiffness all the way to her neck. She was wondering if it is something to do with her vaccine. She denied any new medications or OTC supplements.  Explained to her that it is possible the local side effect from the vaccine. She may take OTC ibuprofen (due to her allergy of tylenol) and use cold compress. Will contact her in couple days to follow up her symptoms. Recommend medical attention if it is getting worse
TIREDNESS/GENERAL FATIGUE; BACK PAIN; CHEST PAIN; INABILITY TO TAKE DEEP BREATHS/BREATHING DIFFICULTIES; FEVER; WEIRD SENSATION; TINGLING IN  FEET AND HANDS; CHILLS; This spontaneous report received from a consumer concerned a 22 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included exercise induced asthma, non smoker, and non alcoholic, and other pre-existing medical conditions included the patient had no known allergies and no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 13-JUL-2021 for prophylactic vaccination. Concomitant medications included salbutamol for exercise induced asthma. On JUL-2021, the subject experienced chills. On 13-JUL-2021, the subject experienced weird sensation. On 13-JUL-2021, the subject experienced tingling in feet and hands. On 13-JUL-2021, the subject experienced fever. On 26-JUL-2021, the subject experienced inability to take deep breaths/breathing difficulties. On 29-JUL-2021, the subject experienced back pain. On 29-JUL-2021, the subject experienced chest pain. Laboratory data included: B-type natriuretic peptide (NR: not provided) no significant findings. Results were considered normal, Bilirubin (NR: not provided) significant results and results were normal, Chest X-ray (NR: not provided) significant results and results were normal, Complete blood count (NR: not provided) no significant findings. Results were considered normal, Comprehensive metabolic panel (NR: not provided) no significant findings. Results were considered normal, Creatine kinase total normal (NR: not provided) no significant findings. Results were considered normal, EKG (NR: not provided) significant results and results were normal, Fibrin D dimer (NR: not provided) no significant findings. Results were considered normal, Respiratory viral panel (NR: not provided) Unknown, SARS-CoV-2 RT-PCR test (NR: not provided) negative, Troponin (NR: not provided) no significant findings. Results were considered normal., and Urinalysis (NR: not provided) no significant findings. Results were considered normal. On an unspecified date, the subject experienced tiredness/general fatigue. Treatment medications (dates unspecified) included: methylprednisolone, and salbutamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from back pain on JUL-2021, and chills, and fever on 19-JUL-2021, had not recovered from inability to take deep breaths/breathing difficulties, and chest pain, and the outcome of tiredness/general fatigue, tingling in feet and hands and weird sensation was not reported. This report was non-serious.
This spontaneous report was received from a medical assistant from a physician office via a company representative concerning a 4 year old male patient with asthma. On 05-JUN-2013, 15-AUG-2013 and 30-OCT-2013, the patient was vaccinated with the first, second and third doses respectively of ROTATEQ orally (dose, lot# and the expiration date were not reported) for prevention of rotavirus. There was no concomitant medication provided. On 23-APR-2017, the patient was admitted to a hospital due to rotavirus. Then on 28-APR-2017, the patient was discharged from the facility on 28-APR-2017. The outcome of gastroenteritis rotavirus was reported as did make a full recovery on an unspecified date. The relatedness between the therapy with ROTATEQ and the event was not reported. Upon internal review, gastroenteritis rotavirus was determined to be medically significant. Additional information has been requested.
Patient's mother diagnosed with Varicella Zoster 2-3 weeks prior to patient breakout with few lesions of varicella in her head. No other sign and symptom.
Drug dose administration interval too long; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 3rd November 2022).   On 30-OCT-2023, the patient received the 2nd dose of Twinrix. On 30-OCT-2023, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Drug dose administration interval too long). The outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date:30-OCT-2023 The patient received the Hepatitis A B Twinrix vaccine on 3rd November 2022.  They did not give him/her any information that he/she would need two more shots and that he/she needed to follow up in six months for the 2nd dose.  The patient learned that within the past week when he/she googled to see if the Twinrix vaccine was an annual thing. So, he/she got the second dose on 30th October 2023.  He/she notified the pharmacist about his/her previous one and how he/she wonder did he/she had to start over because of the time gap.  The pharmacist told him/her that no he/she did not need to start over and gave him/her the second dose.  The patient was wondering that accurate advice because when he/she asked them how long did the last they did not know and it was the same organization but different city who did not advise me properly the first time. The patient received 2nd dose of Twinrix later than the recommended schedule, which led to lengthening of vaccination schedule.
Sore Arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm) and HEADACHE (Headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included FLUOXETINE, AMLODIPINE and ATENOLOL for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore Arm) and HEADACHE (Headache). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) for Headache, at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Sore Arm) and HEADACHE (Headache) had resolved.            Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Follow-up received on 05-MAY-2021 and updated patient demographics, concomitant medications, treatment information and outcome of the events.
Pt filled out consent from for Flumist for 2-49 years old patients. Pt was 51. RN did not catch it until entering in computer system on 10/31/2023
tongue sore; painful to swallow; sore in mouth; painful to talk; This case was reported by a consumer via call center representative and described the occurrence of tongue sore in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th May 2022, the patient received the 2nd dose of Shingrix. On 18th May 2022, 2 days after receiving Shingrix, the patient experienced tongue sore, swallowing painful, mouth ulcer and dysphonia. On an unknown date, the outcome of the tongue sore, swallowing painful and dysphonia were unknown and the outcome of the mouth ulcer was not recovered/not resolved.   It was unknown if the reporter considered the tongue sore, swallowing painful, mouth ulcer and dysphonia to be related to Shingrix.     Additional Information: GSK Receipt Date: 18-May-2022 Reporter's Comments: The patient self-reported this case. The patient had the 2nd shot of Shingrix vaccine on Monday and on the day of reporting the patient had a sore on the edge of her/his tongue that makes it painful to talk and swallow.  The patient wanted to know if it was a shingle sore and if there was anything, he/she could do to treat this sore in the mouth. Additional Supportive Information: The follow-up would not be possible as no contact details were available.
Patient is a 17 year old male presenting for his 1st dose of COVID vaccine. Patient elected Moderna (not currently approved for his age range). Vaccine was administered by medical assistant and the error was not recognized until after the fact. Medical interpreter  was used to express error and reassure safety of said error. Patient instructed to return in 4 weeks for his 2nd dose of a COVID vaccine (Pfizer).
Patient scheduled for second dose after 46 day window; This spontaneous case was reported by a physician and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient scheduled for second dose after 46 day window) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient scheduled for second dose after 46 day window). On 28-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient scheduled for second dose after 46 day window) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided/unknown. Treatment medication were not reported/unknown.
6:50 Pt became light headed, nurse assisted pt down to floor. Lower extremities raised opened eyes when name called. BP 64/42 H.R 70 A&Ox4 56 BP 98-60 HR 74. Recovered within 20 min and discharged with Mom & Dad.
Information has been received from a physician concerning a 13 month old female with congenital neutropenia and no known drug allergies who on 02-MAR-2007 was vaccinated with Varivax (Lot # 652082/0943R) in the left arm. Concomitant therapy included acyclovir. On 05-APR-2007, the patient experienced disseminated herpes zoster on her lower back and her arm and was hospitalized. Further information from the physician indicated that the herpes zoster was on her head, hair, and chest. The patient was treated in the hospital and released recovered, however she had two additional episodes of herpes zoster with the most recent ongoing at the time of the report. Further information from the physician revealed that on 01-MAY-2007 the patient experienced the possible recurrence. The description of the lesions sent for specimen were crusted vesicle and papules. The number of lesions was reported as numerous. Additional information has been requested.
Rash on the arm; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and RASH (Rash on the arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included METOPROLOL SUCCINATE and ATORVASTATIN for an unknown indication.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On an unknown date, the patient experienced RASH (Rash on the arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) and RASH (Rash on the arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Treatment information were not provided.  Patient took second dose on 20-FEB-2021.
Pruritic erythematous Trunk, thigh rash 2 weeks after Menactra. Coincided with out of doors lake exposure minimal response to steroids and antihistamines. No herald patch. Gradually resolved after about 3-7 weeks. Was also treated with Elimite. Doubt relation, but unclear etiology ratio. Additional notes attached from DR. Student with raised chiggeretic itching rash to thighs, buttocks and abdomen minimal excoriation. No gross cellulitis. No definite herald patch identified. Chest clear no respiratory distress. No definite mites or scabies identified. Chest and shoulders free of rash. Rash now of one month duration. Unresponsive to Loratadine and 1% Hydrocortisone. Student with Menactra injection development of rash approximately two weeks after injection rash developed also correlating with fishing out of doors exposure. I think it is more likely that this represents a rash secondary to exposure on the creek bank than a reaction to the vaccine. Though I don't see definite mites in the finger webs or on the feet, will treat with Elimite Cream as recommended. As the majority of the rash is in the areas covered by layers of clothing, I anticipate that being cool, clean and dry will result in reduction of symptoms. Pityriasis remains a possibility, but no definite herald patch identified.
the lumpy, red area is not itchy, but it is tingling, and stings sometimes.; stings; lumpy, red area on the opposite shoulder from where she received the COVID-19 Vaccine/lumpy, red raised up bumps area on her left shoulder; lumpy, red area on the opposite shoulder from where she received the COVID-19 Vaccine/lumpy, red raised up bumps area on her left shoulder; This is a spontaneous report from a contactable consumer (patient). A 68-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date unknown), via an unspecified route of administration on the right upper arm on 25Jan2021 at 11:30 at a single dose for COVID-19 immunization. Medical history was reported as none. Concomitant medications included Influenza vaccine in Dec2020 and Balance of Nature Fruits as supplement since Jan2021 - she started taking Whole Foods brand Balance of Nature Fruits pills and has been taking them off and on for the last couple weeks. On 27Jan2021, the patient had a lumpy, red area on the opposite shoulder from where she received the COVID-19 vaccine. She said she discovered the lumpy, red raised up bumps area on her left shoulder that morning. She said the lumpy, red area is on the back of her left shoulder, neck and hairline area. She said her husband said the lumpy, red area is a couple square inches in size. She said the lumpy, red area is not itchy, but it is tingling, and stings sometimes. She also asked if what she is experiencing is a side effect of the vaccine. The patient declined any treatment for the events saying she didn't know what to do. The event "lumpy, red area on the opposite shoulder from where she received the COVID-19 Vaccine/lumpy, red raised up bumps area on her left shoulder" had not resolved while the outcome of the rest of the events was unknown.   Information on the batch/lot number has been requested.
Initial report was received 10 December 2008 from a health care professional. A 10-year-old male patient with a history of asthma and an allergy to Advair discus, had received an intramuscular injection of FLUZONE SV 2008-2009, lot number U2809AA on an unspecified date and moments after vaccination, he passed out. The event lasted less than five minutes and the patient became alert and oriented with no deficits noted by the physician. The patient recovered from the event. The patient had a prior event where they passed out after receiving FLUZONE, lot number U2449AA last year. This event had been received as a cluster report. The patient experienced a previous event which was captured in case 2008-03955. Documents held by sender: None.
severe fatigue, 2months later had a severe pain and 4 months later pain became worse almost bedridden
First it came on as just tiredness, then it moved in to complete body numbness, sorta like when you lay on your arm and it goes tingly, however when numb I couldn't support my body weight to walk, or even move, this started around 2000. Around 2300  it moved in to sharp pains in my legs, arms, neck, back of head, lump showed up on my neck near my arty. Then it all went away with in seconds, I was fine for a couple hours and got some sleep and around 0300  complete body numbness, trembles, muscle contractions, pelvic area contractions. Through all of this my heart has been racing, at rest heart beat between 100-130... before vacation my resting heart beat was less than 70 typically. Around 0600 when my girlfriend got up to head to work  I showed her the area of the lump, and she "worked me up" and looked for any other bumps over my body, and this alone was the worst pain I've ever experienced, and I've been burnt, broken bones, etc. I waited until around 0900 and talked with a nurse friend and she advised me to go to the ER, which I didn't do as everything started to subside, so more or less felt like I've over came whatever the problem was so I opted not to take up a bed in the ER if the issue was over. Throughout the rest of the day I had multiple spells of numbness and loss of control of motor skills, then as soon as I lost them, they'd come back and no issues. 08/25 evening around 2200 stomach ache and some nausea hit, and mostly went away around 0130 08/26. As far as the time of me writing this no other reactions, and or issues today