chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Respiratory complications; This spontaneous case was received on 07-Jan-2021 from other non-health professional (consumer) via Health Authority (reference number: SEQW21-00081) and concerned an adult, female patient. At the time of this report, the patient was a 39-year-old.    The patient's concurrent conditions included severe asthma and brain tumor that was not cancerous. The patient's concomitant medications were not reported.     On an unknown date in 2018, reported as both 13-Oct-2018 and mid Monday, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine, dose: 0.5 ml, route of administration and anatomical location: not reported) for influenza prophylaxis. The batch number reported was YF41408, expiration date: 30-Jun-2019.    On the same day in the night, after receiving Afluria Quadrivalent, the experienced severe respiratory complications, so she went to the emergency room and was hospitalized. The patient did not exactly remember the treatment measures, but she usually got anything respiratory related, steroid injections, nebulizer, and oxygen.   On an unspecifed date in 2018, a week after the admission, the patient was discharged. She did not remember the admission or the discharge date. The patient stated that since then she had not received any influenza vaccine, but now she was trying to figure out if she will have the same reaction to COVID-19 vaccine.  The outcome of event was not reported.   The reporter did not provide causality assessment.   The event of 'respiratory disorder NOS' was considered serious due to seriousness criteria of hospitalization.  Company comment:The patient developed respiratory disorder (reported as severe respiratory complications) on the same day after vaccination with the suspect product, Afluria Quadrivalent. Chronology is plausible. Causality was confounded by patient's medical history of severe asthma. The patient's concomitant medications were not reported. Since the event was not specified, at this moment causal relationship is assessed as unassessable due to lack of information regarding event characteristics.; Sender's Comments: The patient developed respiratory disorder (reported as severe respiratory complications) on the same day after vaccination with the suspect product, Afluria Quadrivalent. Chronology is plausible. Causality was confounded by patient's medical history of severe asthma. The patient's concomitant medications were not reported. Since the event was not specified, at this moment causal relationship is assessed as unassessable due to lack of information regarding event characteristics.
Initial report was received on 11 October 2011 from a health care professional, which involved a cluster of three female patients who experienced adverse events after receiving FLUZONE Intradermal (lot number not reported). This case captures one of the female patients. The other two patients have been captured in case number 2011-09897 and 2011-0989. Documents held by sender: none.
complains about having or feeling Pins and Needles and pain on her left arm, where injection site was given. States these adverse have not resolved. Additionally stated having a rash and resolved with hydrocortisone cream.
made her sick for a week; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (made her sick for a week) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (made her sick for a week). At the time of the report, ILLNESS (made her sick for a week) had resolved. No concomitant medications were reported. No treatment medications were reported.
Patient developed LEFT shoulder pain within 2 hours, which was progressively worse over several weeks and had continued for several months. She treated with NSAIDS 2-3 times per day, heat and stretching. She denies weakness, numbness or tingling, other than a little tingling to her arm immediately after receipt. She was sitting, vaccinator was standing. The description of the site placement describes appropriate placement. She has no history of adverse reactions with immunizations. No history of injury to the shoulder, which is her nondominant arm. She denies any local site reaction such as erythema, edema. MRI was unremarkable; she was sent for PT. At follow-up 22 JAN 2018 symptoms nearly resolved.
Initial report received from a Health Authority on 05 Jan 2010: This patient was vaccinated with Influenza virus vaccine H1N1 (manufacturer unknown), (dose: unknown) for immunisation on 15 Dec 2009. On 25 Dec 2009 the patient experienced arrhythmia, dyspnoea, tremor, and hypoaesthesia. The outcome of the event was not reported.
About 10 days after my booster shot, I began getting very itchy and hives started appearing all over my body. They would last about 30 minutes then disappear but would come back in a different place later. I went to a walk-in clinic on November 29th and was prescribed Zyrtec. At 4 am the next morning, I woke up with bad chest pain and felt like there was a rock stuck in my throat that was making breathing eating challenging. I ended up going to the emergency room around 5 am that morning because I could not sleep with the pain and discomfort I was in. They did multiple scans around my chest and found nothing wrong. For a couple of weeks, I didn't take anything and was just dealing with the itching and hives. When I would itch, I would get large red lines that would swell up, which I later learned were signs of dermatographia. On December 14th, I went to a Dermatology Center where they told me to take Xyzal twice/day, Zantac twice/day, and 2000 IU of Vitamin D daily. This combination of medication removed all the itching and hives from appearing. I have tried to stop taking the medication once and the hives and itching returned after just a couple of days, so I have returned to taking the medication. In my appointment I had yesterday, I was told to continue the same plan for 2 more weeks, then to switch to once/day for all of them for 2 weeks, then to try to stop taking them again and see if there has been any improvement.
During routine primary care visit at  facility  system was reviewed and it was discovered that this patient had three documented COVID vaccines in the system. Dose 1: 1/7/2021, Dose 2: 2/11/2021, Dose 3: 3/4/2021. This  facility does not have further details on this error as it did not occur here and we do not have full access to the system. At this time it does not appear that patient suffered any ill effects from third dose of vaccine.
When plunging the vaccine into the patients arm, the vaccine liquid came out the side where the needle is attached to the pre-filled syringe therefore the patient did not receive very much vaccine. After discussion with the patient another of the same vaccine was given to the patient. Patient denied ay adverse effects.
Case began filling ill several hours after immunization.  She experienced headache, chills, feverishness, joint pain in legs, nausea, vomited once,   One July 2 about 1600, she experience purple spots on her face and neck.
I got oral thrush 3 days after each covid vaccine.  Used oral thrush lozenges prescribed by dentist
Initial report received on 01 August 2011 from an investigator participating in a trial. A 25-year-old male subject, who has a benign past medical history (blepharitis) experienced dull substernal chest pain and palpitations 30 minutes after receiving ACAM2000, and TYPHIM VI vaccines on 15 July 2011. No lot numbers were reported. The subject was evaluated by doctor, and ECG (electrocardiogram) showed bradycardia and he was referred to the ER (emergency room). In the ER he received IV BENADRYL, prednisone and ZANTAC. At that time he was still having residual symptoms of palpitations, chest pain (2 out of 5), and chest pressure, and dizziness, shortness of breath, headaches, fatigue and muscle weakness. ECG again demonstrated only bradycardia. Rapid troponin test and laboratory troponin tests were normal. The subject was referred to a clinic. The subject was discharged with MEDROL dose pack. He was seen on 19 July 2011 and given PHENERGAN for nausea and acetaminophen for headache. Follow-up on 22 July 2011 revealed his symptoms to still be present, but controlled. VHC was consulted and the subject was diagnosed with allergic reaction to any of the 3 vaccines received. The subject's probable allergic reaction following receipt of the 3 vaccines, including ACAM2000, and his receipt of IV medications, emergency care, and time off from work deemed the event to be a serious adverse event. Per the reporter, given the subject's receipt of the 3 vaccines simultaneously, it was uncertain as to which vaccine he had the allergic reaction to, thought it was highly probable that it was to at least 1 of the 3 vaccines, or the combination of all 3. The relationship of the serious adverse event to ACAM2000, specifically, was determined by the investigator to be "possible" until further information was available. At the time of the report, residual effects were still present. Subject has not recovered. The investigator will submit follow-up report when further records and/or subject reports are available. Documents held by sender: Medical records.
Both eyes turned red immediately after my vaccine shot and was watering. Seen my PCP doctor on Feb 18th and she referred me to a eye doctor. Doctor prescribed Flarex, antibiotics and Tobranyzin bexamethasone. I follow up with my doctor in two weeks but my eyes are still watering a pink color as soon as I come outside. I now have to get my eyes cleaned every two weeks and still an on going issue.
itching not at the injection site but lower than the injection site. - right arm; about a quarter size rectangular shaped rash; a big lump (was swollen) - right arm; redness; body was hurting again; aches on lower back; aches on knees; Pain was unbearable; body aches - on lower back; body aches - on knees; sciatica; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching not at the injection site but lower than the injection site. - right arm), RASH (about a quarter size rectangular shaped rash), SWELLING (a big lump (was swollen) - right arm), ERYTHEMA (redness) and BACK PAIN (body aches - on lower back) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced BACK PAIN (body aches - on lower back), ARTHRALGIA (body aches - on knees) and SCIATICA (sciatica). On 12-Apr-2021, the patient experienced PAIN (body was hurting again), BACK PAIN (aches on lower back), ARTHRALGIA (aches on knees) and PAIN (Pain was unbearable). On an unknown date, the patient experienced PRURITUS (itching not at the injection site but lower than the injection site. - right arm), RASH (about a quarter size rectangular shaped rash), SWELLING (a big lump (was swollen) - right arm) and ERYTHEMA (redness). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of 1 dosage form. On 10-Apr-2021, BACK PAIN (body aches - on lower back), ARTHRALGIA (body aches - on knees) and SCIATICA (sciatica) had resolved. At the time of the report, PRURITUS (itching not at the injection site but lower than the injection site. - right arm), RASH (about a quarter size rectangular shaped rash), SWELLING (a big lump (was swollen) - right arm), ERYTHEMA (redness), PAIN (body was hurting again), BACK PAIN (aches on lower back), ARTHRALGIA (aches on knees) and PAIN (Pain was unbearable) outcome was unknown. 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.   Treatment Benadryl, Three rounds of Tylenol two 500mg tablets every 24 hours.
flu like symptoms; fever; body aches.; Corneal damage; 1 year later / developed / shingles outbreak in October of 2020; October outbreak was severe / able to clear / without further vision loss / ophthalmological shingles; 1 year later / developed / shingles outbreak in October of 2020; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. In October 2020, 1 year after receiving Shingrix and unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant), shingles and injury corneal. On an unknown date, the patient experienced influenza-like symptoms, fever and general body pain. On an unknown date, the outcome of the vaccination failure, shingles and injury corneal were unknown and the outcome of the ophthalmic herpes zoster, influenza-like symptoms, fever and general body pain were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, shingles, influenza-like symptoms, fever, general body pain and injury corneal to be related to Shingrix. It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, shingles and injury corneal to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient was shingles sufferer and thus had to wait for a vaccine until they were completely convinced and was shingle free for 3 months before receiving 1st dose. The 1st dose of Shingrix injection was fine. Less than year after receiving 2nd dose of Shingrix, the patient experienced flu like symptoms, i.e., fever, body aches and stated no problem, patient would take 1 day of misery for protection from shingles. Moving ahead, 1 year later the developed another shingles outbreak in October 2020, then again in December 2020. The October outbreak was severe, the ophthalmologist was certain that the patient would lose the rest of vision. The patient was fortunate, that was able to clear both outbreaks without further vision loss. The patient asked that was Shingrix evaluated for effectiveness against ophthalmological shingles. The patient had severe corneal damage now in left eye and was born legally blind in right eye. The patient was hoping that Shingrix would protect the patient from further outbreaks. The patient understands the blood supply was limited to the eye and asked was this why Shingrix offered no protection from outbreaks.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR061099:Duplicate case-
Approx 16 hours after 2nd vaccination on 1/7/21, I felt nauseous.  Then fever, body aches, joint pain, severe headache. Second day I still have severe headache and nauseousness.
Arm very sore and tender; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of pain in extremity (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The age group was not reported but it was captured as an adult as per vaccine indication. Patient experienced arm very sore and tender after 2nd shot. The patient stated that it was better than getting shingles. The follow up would not possible as no contact details were available; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR104395:Same patient, 2nd dose
Case number PHEH2015US024666 is an initial spontaneous report received from a pharmacist on 20 Nov 2015. This report refers to a 39 year old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514801) intramuscularly at a dose of 0.5 ml on 19 Nov 2015. It was reported that the vaccine administered was exposed to temperatures up to 28 degree Fahrenheit for up to 8 hours. The case was reported as non-serious. No adverse events were reported following the inadvertent administration.
pharmacy mailed the Shingrix to their home for the patient to bring in office to be administered/ No refrigeration was used by pharmacy; This case was reported by a nurse via sales rep and described the occurrence of intercepted product storage error in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient did not receive Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced intercepted product storage error. On an unknown date, the outcome of the intercepted product storage error was unknown.   Additional Information: GSK Receipt Date: 22-Sep-2022 Reporter's comment: The nurse reported that 4 patients that had an prescription which was sent to pharmacy, the pharmacy mailed the Shingrix to their home for the patient to bring in office to be administered. These were patients. No refrigeration was used by pharmacy. In one case the Shingrix vials were put in a pill bottle and mailed. All doses were spoiled, and patients sent back to pharmacy. The nurse was checking with patients to see if the patient had got the vaccination after that. The reporter agrees to follow up from GlaxoSmithKline. Additional Supportive Information: All doses were spoiled, and patient had not received the doses, which led to Intercepted product storage error. This case was 1 of 4 cases for the patient reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR136885:Same reporter-Patient 3 US-GSK-US2022AMR136883:Same reporter-Patient 1 US-GSK-US2022AMR136884:Same reporter-Patient 2
Chills, fever of 101.8, entire upper arm became swollen and red, painful.
Bells Palsy,  chest pain, difficulty breathing, palpitations, dizziness, loss of balance, difficulty swallowing, paralysis of left side of face, nerve pain down left side of back and down the left leg. Severe ear pain, migraines, insomnia.   Was put on 60mg of Prednisone for 7 days. No improvement after finishing coarse.  Now trying therapy?s.
ITCHINESS; SWELLING; REDNESS; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy to tetanus vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included citalopram for drug used for unknown indication, and ergocalciferol for drug used for unknown indication. On MAR-2021, the subject experienced swelling. On MAR-2021, the subject experienced redness. On 12-MAR-2021, the subject experienced itchiness. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from itchiness, and the outcome of swelling and redness was not reported. This report was non-serious.
This spontaneous report has been received from a registered nurse concerning to a female patient of unknown age. Current conditions, medical history and relevant past drug history were not reported. On 26-NOV-2013, the patient was vaccinated with RECOMBIVAX HB, 1 ml, (route and lot # not reported) that was improperly stored but it was not discovered until 27-NOV-2013. Concomitant medication was not reported. On 24-NOV-2013, a temperature excursion involving the vaccine occurred/improperly stored. The reporting nurse stated that the patient denied experiencing an adverse reaction to the vaccine. None relevant laboratory. Additional information has been requested.
Myalgia, NauseaVomiting, fatigue, arm pain Narrative:
Myalgia, Fever, FLU LIKE SYMPTOMS, FATIGUE Narrative:  Other Relevant History:
Patient reported to having a reaction to the Flu shot (has a knot, arm hurts and eyes are itching, feels like have flu, feels weak & dizzy).
Itching at the injection site; Redness; Swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching at the injection site), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE SWELLING (Swelling) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itching at the injection site), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE SWELLING (Swelling). At the time of the report, VACCINATION SITE PRURITUS (Itching at the injection site), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE SWELLING (Swelling) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No relevant concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Left shoulder pain since injection.  Nine days after vaccine was given developed an enlarged left suprclavicular lymph node, then on day 10 developed red warm painful patch below the injection site.
loss of smell / rancid  Slightly  nauseated  Sharp  taste  Loose stool/ cramping Dairy products  > loose bowels