chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received on 31 October 2007 from a physician. A female patient (date of birth and age not provided), who denied any concurrent illnesses, and who had past medical history of hypertension and hypercholesterolemia that was being tested with Altace, antihypertensives, and Lipitor, had received a subcutaneous right deltoid dose of FLUZONE SV 2007-2008 (lot number U2491AA) on 18 October 2007. Subcutaneous injections of Fluzone SV 2007-2008 is not a recommended route of administration by the manufacturer. The following day after receiving the vaccination, the patient developed generalized hives, hypotension (blood pressure 90/50, and increased heart rate of 140 beats per minute. The patient did not seek medical attention until the following day (20 October 2007) when she was evaluated by a physician in the office and treated with steroids and then taken to the emergency room. The patient was treated with Benadryl and Epinephrine in the emergency room. A complete blood count was normal. The patient was released the same day on oral steroids. At the time of this report, the patient had recovered.
pt recvd vax; cried, fell asleep during next 4 hrs;apnea monitor went off for both inc & dec levels;mom found pt w/ jerking movements & staring which stopped when mom picked pt up;MD called to report;no recurrence since;
Pt devel a rash 48 hrs p/DTP/HIB/OPV; rash was urticarial, flat & erythematous in nature; Generalized over trunk, face & extremities; Also had fever of 100;
Numbness/loss of sensation in toes began around 4/16/2021: Sensation reduced from the toes up to the hip bilaterally (R<L). Strength 5/5 bilaterally. 2+ reflexes in lower extremities. 2-3 beats of clonus bilateral ankle jerk. Mottling on feet, interior ankles, kneecaps. Decreased cap refill in feet, knees, and interior ankles. Feet extremely cold. Presented to urgent care 4/26/2021. While there, noticed purplish discoloration over knees and feet as well as diminished sensation up to both hips as well as over the right arm and right side of face. Subsequently transferred to emergency department from urgent care for further evaluation. Neurology consulted after examination was notable for brisk lower extremity reflexes and bilateral ankle clonus. CRP mildly elevated at 12.5.
Uncontrolled high blood pressure after second vaccination shot.  Have no history of high blood pressure prior.
First administration of Gardasil in 07/08 with bilateral hand tremor beginning 08/08. Second administration on 12/31/08 with hand pain beginning 02/09 and extending to wrists, elbows, shoulders, back, hips, knees, ankles, feet and toes by 04/09. Final administration is 07/09 with immediate increase in pain. The physician was asked about possible reaction after the first dose. The physician advised there was no connection. Patient has been dx with fibromyalgia; however, no successful tx at this time. Along with the tremor, other neurological involvement is indicated by bilateral clonus and proprioceptive symptoms in her legs. Patient also suffers headache and significant fatigue. Patient has been unable to sleep in bed for several months and does not get solid, consecutive hours of sleep. She has lost 20 pounds since this past Spring. There are days patient requires moderate assistance for sit-to-stand.  12/04/09 Consult note for DOS 01/30/09.  DX: Essential tremor  Pt c/o hand tremor that is bothering when writing for 4-5 mos. On neurological exam: weight, head and height were all above 90th percentile; mild postural tremor BUE. Physician considered this diagnosis of essential tremor as benign and suggested reducing caffeine and stress. Pt to follow up prn.  12/08/09 Follow up consult for DOS 11/09/09. DX: Fibromyalgia  Pt c/o L knee pain, neck pain, inguinal pain, finger joint pain, hand pain, wrist joint pain, elbow joint pain, shoulder joint pain, back pain in Lumbar spine, buttock pain, and hip.  Musculoskeletal exam: confirmed joint pain in L fingers, shoulder, L and R knees, L and R ankles; tx: Soma. Pt c/o pain continuing.
Immediately after receiving first dose I had a medicine like taste in the back of my throat. This lasted for most of the night, and gone the next day
Full body urticaria 14 days after 2nd dose. Hives internally and externally.
This spontaneous report as received from a pharmacist refers to an unspecified patient of unknown demographics. The patient's concurrent conditions, medical history and drug reactions/allergies were not reported. On 09-APR-2018 the patient was vaccinated with expired dose of ZOSTAVAX vial 19400 PFU (dose and frequency were not reported) (lot # M041182, expiry date: 04-JAN-2018) subcutaneously for prophylaxis. The vaccine was reconstituted with a Merck sterile diluent. No adverse effects were reported. No product quality complaint was involved. This is a non-valid report due to lack of patient identifiers. Upon receipt of follow-up information it was determined that this case is now valid because patient identifier was received. Follow up information has been received from the pharmacist on 19-APR-2018. This report concerned a 64 year old female patient. The patient was presented for her ZOSTAVAX vaccination to the outpatient clinic. After an order from the patient's provider was put in, the registered nurse came to the pharmacy to obtain the vaccine. The nurse was given the vaccine and diluent from the freezer. The nurse then went back to the clinic to reconstitute the vaccine with diluent. On 09-APR-2018, the patient was vaccinated with expired dose of ZOSTAVAX subcutaneously, in the left arm. After vaccine administration, the nurse noticed the expiration date was 04-JAN-2018. The provider, pharmacy and patient were notified immediately. The patient was informed of the need for revaccination. No adverse reactions were observed. The error was caused by inappropriate inventory management and not by documenting vaccine information prior to administration.
couldnt breathe, swallow, heart racing, had to use epi pen-2-3 seconds vaccine, high blood pressure
A 21 year-old male patient received, on 03MAR2015 at 15:15 TRUMENBA (lot and expiration date not available) intramuscular on right shoulder at 0.5 ml, single dose. No other vaccines were received. Relevant medical history included left ventricular dysfunction (part of pericardium of left ventricle was missing since birth). Concomitant medications were unknown. On 04MAR2015, at 1:00 AM, the patient was feeling unwell, was sluggish, had slight headache and was feeling very slow (his whole body and blah. No hospitalization was required. The patient did not recover from the events at time of this report. Follow-up (01MAY2015): Follow-up attempts completed. No further information expected.
Severe constipation leading to an emergency appendectomy 5 days after my first vaccination.
injection site pain; headache; body aches - could barely walk; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (injection site pain), HEADACHE (headache) and MYALGIA (body aches - could barely walk) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced INJECTION SITE PAIN (injection site pain), HEADACHE (headache) and MYALGIA (body aches - could barely walk). In April 2021, INJECTION SITE PAIN (injection site pain), HEADACHE (headache) and MYALGIA (body aches - could barely walk) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication was reported  No treatment medication was reported   This case was linked to MOD-2021-325840 (Patient Link).   Reporter did not allow further contact
7/29/02 Received MMR vaccination. 8/11/02 Bloody diarrhea. 8/16/02 More bloody diarrhea. 8/17/02 Colonoscopy - diagnosis - Crohn's Disease.
After administration of MENACTRA and HPV patient felt lightheaded and sat in chair. Had brief episode 10 seconds with tonic clonic motion of extremities patient stable and laid on table and given juice. Able to sit after 40 minutes. Stand after 60 minutes.
Nothing noted at time of injection. Roughly 12 hours after noted pain at the injection site. 16 hours noted extreme fatigue and mild body pain. 20 hours after noted a headache and ringing in my ears. 24 hours after noted fatigue and body pain. 30 hours after noted no headache, very small amount of body pain, still have pain at injection site. slightly fatigues but feel a lot better.
The night of the second vaccine, there was intense pain at the injection site, to the point I was awakened from my sleep, could not sleep comfortably and had to take ibuprofen. The following day I experienced extreme fatigue/malaise, headache, fever, and chills.   I have also had an abnormal menstrual cycle following the vaccine, with break through heavy bleeding and painful cramping.
Very sensitive to light; This spontaneous case was reported by a consumer and describes the occurrence of PHOTOPHOBIA (Very sensitive to light) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PHOTOPHOBIA (Very sensitive to light). At the time of the report, PHOTOPHOBIA (Very sensitive to light) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication and treatment information was reported.
itchy but no pain; Got spacey; Feels lousy; Rash on right arm that looks like Excema; nauseous; vommitting; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy but no pain), FEELING ABNORMAL (Got spacey), FEELING ABNORMAL (Feels lousy), RASH (Rash on right arm that looks like Excema) and NAUSEA (nauseous) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Colitis, Lyme's disease, Immunocompromised and Babesiosis. Concomitant products included LOPERAMIDE HYDROCHLORIDE (LOMOTIL [LOPERAMIDE HYDROCHLORIDE]), CITALOPRAM, TRAZODONE, DOXYCYCLINE and VITAMIN 15 for an unknown indication.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced PRURITUS (itchy but no pain), FEELING ABNORMAL (Got spacey), FEELING ABNORMAL (Feels lousy), RASH (Rash on right arm that looks like Excema), NAUSEA (nauseous) and VOMITING (vommitting). At the time of the report, PRURITUS (itchy but no pain), FEELING ABNORMAL (Got spacey), FEELING ABNORMAL (Feels lousy), RASH (Rash on right arm that looks like Excema) and NAUSEA (nauseous) had not resolved and VOMITING (vommitting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD21-069958 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: Event outcome updated as ongoing, additional event lousy is updated. Patient gender updated from unknown to female.; Sender's Comments:  MOD21-069958:
Patient had the Gardasil series on the following dates: 3/27/14, 7/2/14, and 4/7/15.  On 7/25/15, Mother was awoken on a Saturday to dog barking.  She noted child lying on bed stiff with arms drawn up toward chest, eyes rolling upward and foaming at the mouth with the dog lying on top of the child.  Mother unsure of the length of activity- no loss of bladder or bowel.  Patient was seen over the course of several months for an EEG, sleep study, and had a Head CT done on 7/25/15.  The CT and EEG were essentially normal, and her sleep study showed some sleep apnea, possibly due to enlarged tonsils.  The mother states she has had a total of 4 of these type "seizures", but they have not been witnessed by anyone other than her.  She presented to the clinic today to discuss her concerns with her PCM, as she is concerned that these episodes are related to her receiving the Gardasil series.  It should be noted that on 10/1/2015, she received Menactra and TDaP, and there was nothing said at that time about the mothers concerns to this nurse.
Information has been received from a literature article regarding an adult with diabetes, who was admitted for varicella-related pneumonitis and died of respiratory failure after 11 days in an ICU. In the opinion of the author, the data demonstrated the sizeable and continuing reduction in severe varicella-related morbidity with the use of the varicella vaccine since 1995. It was also noted that the data highlighted the fact that the majority of hospitalizations that occurred during this time period were preventable through implementation of existing vaccination-policy recommendations. The author noted that varicella incidence and varicella-related hospitalizations (VRHs) and deaths have decreased substantially since the implementation of the varicella vaccination program. A copy of this published article is attached as further documentation of the patient's experience.
Right sided facial rash & swelling.  Difficulty breathing swollen eye.  Resolved within 20 minutes after BENADRYL dose.  Pt has multiple food allergies.
Extreme Fatigue and Brain Fog leading to a doctor's office visit. Onset was gradual, without a clear start date. Causality by vaccination  unlikely but possible. Blood results indicated mild iron deficiency. Started iron suppliments (150mg elemental iron, twice daily)
Swelling from bottom of Left arm pit to top side of breast.  "Fits in palm of hand - soft, feels like fluid".  Not warm or red.
Severe jaw and ear pain on left side of face. Diagnosed with neuropathy and possibly early Bell?s palsy from vaccination. The pain started early Friday morning around 2 am and has persisted
Moderna COVID-19 Vaccine EUA: Vaccine recipient reported that approximately 15 minutes after receiving the vaccine she became hot, tachycardic, and felt that she was going to pass out. She stayed for an additional 15 minutes for monitoring. She reported to have developed numbness and tingling in her face. She was sent to the ED for possible allergic reaction. She was administered diphenhydramine and prednisone. Upon reevaluation her symptoms resolved and was discharged to home.
Episodic Headaches with photosensitivity, nausea/chills and dizziness
7/8/14 after vaccine - fever, hives, joint pain, dizziness.
This spontaneous report as received from a licensed vocational nurse refers to unspecified number of patients of unknown age and gender. The concurrent conditions, drug reactions/allergies and medical history of the patients were not reported. On an unknown date, the patients were vaccinated with a dose of 0.5ml of improperly stored GARDASIL 9 either with lot number L040054 with expiration date of 26-DEC-2017 or L037554 with expiration date of 25-DEC-2017 (strenght and route of administration were not reported) for prophylaxis, which was stored at 1.1 celsius degrees for 24 hours. There was no previous temperature excursion. The temperature excursions were detected by a data logger. No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. As of 30-NOV-2016, all telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested. Sender's Comments: US-009507513-1610USA003033: US-009507513-1610USA003034: MERCK 1610USA003032: Mfr number.
Rash  over shoulders and chest area.  Strange red rash on instep of right foot about  3-4 inches in diameter.  Showed up 36 hours after vaccine.  Not too bothersome.  appears to be more rash today 3 days later.
The symptoms started on the 29th. I knew I was exposed. The next day the symptoms got worse. I took a test and tested positive. I called my doctor and he wanted to see me in the office because before prescribing PAXLOVID he wanted to check my kidney function. He prescribed it and I started t that day. I took it for three days and I started to feel better but around the third I started to feel worse. So, I called my doctor again and he agreed that I was having side effects to PAXLOVID. He instructed me to stop. I tested negative on April 4th so I thought I was clear but still had symptoms. I tested a few days later and that was positive. I tested again April 11th and I was negative. I called my doctor again and told him about my symptoms. He gave me three medications to help, ZYRTEC, FLONASE, prednisone 10mg. I am on day three of those medications and they are a miracle.
Kinrix advised for use in patients 4 years of age and older. Provider ordered incorrectly for 15 month old patient.  Provider spoke with the parent and advised of error. No adverse reactions reported.  Spoke with manufacturer and verified Dtap dose valid and no repeat needed. Provider reviewed Kinrix literature and made a personalized 15 month reminder for himself.
No adverse reaction. Patient was pregnant at time of vaccination and didn't know until a few days later. Had a previous dose of Varicella vaccine on August 25, 2015.
About   2 weeks after my second shot I developed a rash on my body started in the genital area and gradually worked up over my whole body very itcy and painful  went to my Rectal Dr. first and he sugested I see a dermatologist which I did she did a biopsy  I than went to my gynocologist
3/1/06 Mother observed tonic clonic seizure lasting 5 minutes 911 called. Child taken to ER continued to have more seizures in PICU. Mild rash DX latex sensitivity stable on Phenobarbital. Discharged 3-3-06 normal EEG, CT head and MRI. Recommendation from neurologist was to hold off on further vaccines until seizures well controlled. 11/22/06-records received and reviewed. krk DC Summary for DOS 3/1-3/3/06-DC DX: New onset seizures. History of twitching type episodes from birth until approximately six weeks of age. Had full neurologic work up by Dr to include  Episodes resolved at six weeks of age. One 3/1/06-tonic clonic seizure.
I developed diagnosed psoriasis after the second dose of my covid vaccine.  The symptoms is moderate to severe with plague psoriasis through my entire scalp, face, chest, back, arms, legs and througho; This is a spontaneous report from a non-contactable consumer (patient himself).   A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number: Not reported) via an unspecified route, administered in Right arm on 17Mar2021 (41-year-old at vaccination) as a Dose 2, Single for Covid-19 immunization. Facility type vaccine was reported as Pharmacy or Drug Store. The patient's medical history included elevated sugar level, elevated cholesterol, chronic ear medical condition and known allergies to Ciprofloxin. The patient's family medical history included genetic predisposed with his father and sister having mild psoriasis or eczema. The patient's concomitant medications were not reported. The patient had not received any other vaccine within four weeks prior to vaccination. The patient was not diagnosed for covid prior vaccination. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number: Not reported) via an unspecified route, administered in Right arm on 24Feb2021 (41-year-old at vaccination) as a Dose 1, Single for Covid-19 immunization. The patient developed diagnosed psoriasis after the second dose of his covid vaccine. The symptoms was moderate to severe with plague psoriasis through his entire scalp, face, chest, back, arms, legs and throughout body. He had never had psoriasis but genetic predisposed with his father and sister having mild psoriasis or eczema. He had been prescribed steroid cream, steroid pills and Tacrolimus but had not healed after 3 months of therapy. Currently he would start systemic injections (Skyrizi, immunosuppressant biologics) due to the fact that it's spreading, and symptoms are not improving. Additionally, he would have to joined a Psoriasis support group on social media and various others have reported psoriasis flare up after their Covid vaccine after being in remission for years. These adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab test and procedure which included Sars CoV-2 test (Nasal swab): result unspecified, post vaccination. The outcome of the event was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Delirious; felt like she had COVID; body ache; fast heart rate; Sneezing; Joint pain; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for COVID-19 immunisation. Medical history included Crohn's disease and synovial cyst (Verbatim: Ganglion cyst). The patient's concomitant medications were not reported. On an unspecified date, the patient experienced delirious, felt like she had COVID, body ache, fast heart rate, sneezing, and joint pain. It was further reported that for 7 days straight, her body ache and had joint pain for 12 days. The outcome of all events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
I had a minor headache; I had some back muscle aches; feel a little sluggish; I have a slight temperature; my shoulder has some soreness; shoulder has some swelling; my pulse is running in the upper 80s. I normally run in the 60-70 range; This case was reported by a consumer via call center representative and described the occurrence of headache in a 70-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th April 2020, the patient received the 2nd dose of Shingrix. In April 2020, less than a day after receiving Shingrix, the patient experienced headache, muscular back pain, sluggishness, fever, shoulder pain, swollen joints and pulse increased. On an unknown date, the outcome of the headache, muscular back pain, sluggishness, fever, shoulder pain, swollen joints and pulse increased were not recovered/not resolved.   It was unknown if the reporter considered the headache, muscular back pain, sluggishness, fever, shoulder pain, swollen joints and pulse increased to be related to Shingrix.  Additional details were provided as follows: The patient took Shingrix shot yesterday (the day before yesterday).  The patient believed have a slight temperature.  The patient had a minor headache last night, some back muscle aches, (nothing serious), and feel a little sluggish. The patient shoulder had some soreness and swelling. The patient's oxygen level was 95 and pulse was running in the upper 80's. The patient normally run in the 60-70 range.  Breathing was fine and do not have any coughing issues. The reporter wanted to know when it would be back to normal.
Pt has swollen skin around the injection site. It looks similar to cellulitis but not as deep.