chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a 67-year-old female patient who received Boostrix for prophylaxis. Co-suspect products included Shingrix for prophylaxis. On 15th June 2018, the patient received Boostrix. On 2nd August 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Boostrix and less than a month after receiving Shingrix, the patient experienced shoulder pain, stiff neck, headache and pain in joint involving hand. The patient was treated with Aspirin and Aleve. On an unknown date, the outcome of the shoulder pain, stiff neck, headache and pain in joint involving hand were unknown. It was unknown if the reporter considered the shoulder pain, stiff neck, headache and pain in joint involving hand to be related to Boostrix and Shingrix. Additional details were provided as follows: The age at vaccination was not reported, however, it could be 66 or 67 years. The patient 67 years old at the time of reporting. The patient was healthy who played doubles tennis 3 times per week. The patient never had tetanus or shingles. Sometime after 15th June 2018, the patient experienced pain in both shoulders, stiff neck, headache like feeling and joint pain especially in left hand (the patient was right handed). The patient received 2 Aspirin or 1 Aleve to keep the pain at bay, but she woke up every morning with a lot of pain in my shoulders among other quirky pains. The patient had to stop playing tennis. The patient wanted to find out whether the reaction was to 1 or both vaccines and the cure.
About five minutes after the vaccine, my throat started to itch and a cough began. At 15 minutes I started to get hot, cough persisted, and a feeling of fatigue (I didn?t want to talk...very unusual). At 30 minutes the scratch in the throat turned to a lump, the cough was worse, and itching began on neck & face. The doctor on site gave an oral Benadryl tablet but in two minutes symptoms were worsening and vomiting started. My chest was tight and sweat began. The doctor administered 50 mg benadryl shot & a steroid. The lump was growing bigger, so they administered an epinephrine. Then I was sent to the ER. Upon arrival I received 25 mg of benadryl due to the whole body itching, but throat had relaxed. Also received IV fluids.
2 inch red raised area at site of injection.  Experienced severe soreness and itching.  To date slight redness site remains little sore to touch.
Patient developed a rash on forearms most likely related to a cleaning agent used on the chairs to disinfected between patient use
Developed 102 degrees F x 24 hours 10/22/10 then had inconsolable prolonged crying spells lasting > 3 hours t/o the weekend.
Oto temp 98.1. Redness warmth swelling 10 cm width x 7 cm length above (L) elbow. No redness discomfort at site of injection (L) deltoid. Area started swelling 1 day after injection.
On 12/29/00, had dry throat, hives on right wrist, inside of knees, buttocks and hips. On 12/30/00 and 12/31/00, had sore throat and dry cough.
Patient came into the office today to make us aware of an allergic reaction she had after her second dose of the Pfizer Covid vaccine. About 20-25 minutes after receiving her injection, she 'tasted pennies' in her mouth and her face felt like it was starting to swell. At that time, she did not see any swelling of her face. About 10-15 minutes after the taste in her mouth, patient's face began swelling in patches and turning red. Within minutes, the redness and swelling had spread across her eyes and forehead. She reports that her eyes were almost swollen shut. She did not seek medical attention at that time and the swelling did resolve.
Dizziness; nausea; low grade fever; low grade feverlow grade fever; achy muscles; This is a spontaneous report from a contactable consumer or other non hcp.   A 27-years-old female Non Pregnant  patient received bnt162b2 (BNT162B2(Batch/Lot Number: EM9810), dose 2 intramuscularly, administered in Arm Left on 16Feb2021 08:30 as single dose for covid-19 immunisation. Medical history included hormone level abnormal from 2011 and ongoing, anxiety from 2010 and ongoing, depression, blood iron decreased from 2020 and ongoing, diabetes mellitus, cataract, blood cholesterol increased, iron deficiency. Concomitant medication(s) included metformin (METFORMIN) taken for polycystic ovaries from 2011 and ongoing; bupropion hydrochloride (WELLBUTRIN XL) taken for anxiety from 2019 and ongoing; duloxetine hydrochloride (CYMBALTA) taken for anxiety from Sep2020 to Mar2021; ferrous sulphate (FERROUS SULFATE) taken for iron deficiency from Oct2020 and ongoing. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. It was reported that, the patient experienced dizziness, myalgia on 16Feb2021 13:00 with outcome of recovered, nausea, low grade fever, headache on 16Feb2021 13:00 with outcome of recovered with sequelae. No treatment was received.  No follow-up attempts are possible. No further information is expected.
I received the vaccine in the morning. After receiving it I did my daily activities. I walked 3.5 miles. Just before bedtime I had chills and heavy sweating through the night. The next morning I had a fever of 101.2 degrees. I had 94% oxygen. My blood pressure was 120/84. Last night my oxygen was 96%. I sustained a fever most of the day yesterday. This morning when I woke up there was no fever. My oxygen was 95%. I had temperature of 98.3 degrees. I had an upset stomach and stomach aches yesterday. I resumed my regular diet today. My doctor had called me about renewing my prescriptions, and then I told him the symptoms I was having. He said I was having normal reactions, and told me to take Tylenol for the pain. Yesterday I did take 6 Extra Strength Tylenols throughout that day.
A non-serious report of accidental exposure, numbness and itching has been received from a nurse concerning a female born 27-Mar-1965.  No medical history nor concomitant medications were provided.  The patient administered FLUMIST in a clinic setting.  The employee of a clinic, develops numbness in her lips and nose, as well as itching of her face and scalp within several minutes of administering a dose of FLUMIST to a patient.  The employee was able to administer doses last year without difficulty.  Symptoms resolved 15 to 20 minutes after dose administration is completed.  The patient did not experience a rechallenge while receiving the suspect product.  The reporter provided no causality assessment for the events.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
her face got swollen; Feet swollen; She is worried and don''t want to take her Vaccine second dose; allergic to one of the ingredient of the vaccine; mouth is swollen one side; This is a spontaneous report from a contactable consumer reporting for her friend. This consumer reported similar events for 02 patients. This is the 2nd of 02 reports.  A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration on an unspecified date in 2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. No prior vaccination within four weeks. On an unspecified date in 2021, the patient took first dose vaccine a few days ago and after that her face got swollen and mouth got a little bit out one side, allergic to one of the ingredient of the vaccine, her face is swollen and her mouth is swollen one side, is it like paralysis you know, feet swollen and she was worried and don't want to take her vaccine second dose. No treatment for adverse event, she just took Ibuprofen. On an unspecified date, blood test was done but result was on line. Patient had her annual check. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Patient was given fluzone HD instead of fluzone quadrivalent, patient was notified of this error
This is a spontaneous report from a contactable pharmacist received via a Pfizer sales representative. A male patient of an unspecified age PREVNAR 13, influenza vaccine and TDAP, all via an unspecified route of administration from an unspecified date at single dose for immunisation. The patient's medical history and concomitant medications were not reported. Patient immediately developed a UTI and had blood in his urine. He went to the MD who told him he had an infection. Pharmacist was concerned because she had overheard that another patient had died. Outcome of the events was unknown. Information on the batch number has been requested.
Vaccine administration error.  Gave Tdap instead of DTaP.  No adverse event at this point.
Initial case received from a nurse via Merck (reference number 1-10215440073) on 03 February 2014. A patient, with no reported medical history or concomitant medications, received a dose of FLUZONE (lot number not reported) on an unspecified date. According to the reporter, the patient was later diagnosed with strain A influenza virus. No additional information was reported. Note: This case was forwarded by Merck, who was only able to provide a name for the nurse who reported the event. Since the contact information from the reporter is not sufficient to obtain an address or phone number, no additional follow-up requests can be sent.
Moderate indigestion; constipation; This is a spontaneous report from a contactable consumer(patient herself). A 60-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE solution for injection; batch/lot number and expiry date were not reported), via an unspecified route of administration on 24Jan2021, 12:00pm (at the age of 60-years-old) at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took acetaminophen and experienced drug hypersensitivity. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient has not been diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. At 4:00pm (16:00) of 25Jan2021, the patient experienced moderate indigestion and constipation. Treatment was not received for the events. The outcome of  these events was recovering. The events were reported as non-serious by the reporter.  Information on the lot/batch number has been requested.
uncontrollable crying, fever, cranky, resp distress, trouble breathing, dx w/bronchitis-secondary to polio vax;taken to ER breathing tx x 4;
Local reaction- warmth/erythema induration (mild cellulitis) @ site of injection on left thigh , no systematic sxs, no lymphadenenetes
headache, some what tiered and slightly lost of appetite from what I recall my mom telling me after her first shot and then same symptoms on her second shot a month later.
Initial report received on 10/26/06 from a health care professional. A 49 year old pt, with a history of asthma and allergy to penicillin, Keflex, Ceclor, Anaprox, Clindamycin, Vancomycin, and sulfa drugs, had received an IM injection of Fluzone SV 2006-2006, lot number U2199AA, on 10/26/06 at 14:35pm. The site and route of administration was not reported. Ten minutes post immunization, the pt experienced left side numbness from the lip to the ear that was progressing to the left eye. The pt denied any dysphagia or dyspnea. Diagnostic and treatments received were not reported. The reporter considered these adverse events as other medical important events (OMIC). The recovery of the pt is unk.
redness in inj area (lt upper leg) noted on Wednesday-seen by MD on 8MAY97;no treatment-observe;
I really had no idea what happened. I came home at 4:30 PM after working for about 5 hours and I fell asleep. I could barely move the next day which was 03/15. Wednesday afternoon, my partner suggested that maybe I get tested for COVID-19. It felt like the flu but it also didn't feel like the flu. It also felt like how I did when I had chemotherapy. He tested me and I tested positive. It took 24 hours for my PCP to finally get my attention and get Paxlovid for me. According to the nurse practitioner who I spoke to, she noted that my kidney function was slightly off, so I was given the lower dose of Paxlovid. Today is my last day taking Paxlovid and the last few hours have been the best I've been doing all week. I would say this was a significant case of COVID-19 and it did not feel mild. I'm still in the process of recovering. I've also lost about 5-7 lbs in the last week. I also called office again yesterday to get some cough pearls because I do also have a significant cough right now.
Normal labor and delivery on 11/22/2021. Hospital admission within 6 weeks of receiving the COVID vaccine.
pt recv vax 21JUL98 & 9AUG98 pt exp paresthesia in the trunk, torso & head described as feelings of tingling, a shock going through body & feeling like bee stings;pt to MD & pityriasis rosea & petechia noted 13AUG98;
After pneumovax 23 injection into left arm on 9/16/19: a bad reaction starting 9/17. Left arm: red and swollen from shoulder to elbow all around. Very painful, 8 on 1:10 scale. Fever 101.7 decreased with ibuprofen. Body aches and fatigue. It improved somewhat by 9/19 and was gone on 9/20. I have never had a reaction to a vaccine in the past this was my 2nd pneumonia vaccine, At Pharmacy.
Headaches, joint pain, fatigue, muscle aches and skin condition. Per 60 day follow up:Patient still has not recovered still has headaches, nausea, fatigue, joint pain, muscles aches, and skin condition.
Fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a 89-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st May 2022, the patient received the 2nd dose of Shingrix. On 1st June 2022, 1 days after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.     Additional Information: GSK Receipt Date: 01-JUN-2022 Reporter's Comments: The reporter was the patient's wife who reported an AE (adverse event) on behalf of her husband. The patient received second dose of Shingrix vaccine and this morning (on day of reporting), the patient developed a fever which was not resolved. The reporter provided medical advice disclaimer and referred to HCP (Health care professional). The reporter consented to follow up.
Fever, chills, sweating, dizziness, swollen lymph nodes in neck making it difficult to eat and swallow, lethargy, pain, muscle aches, vomiting, itchy throat, pain
My platelets being evaluated for about a year now.  I went to the doctor about this. They did blood work and they order a bone marrow biopsy.  The biopsy I have not got done yet.
Patient is fully vaccinated and boosted 11/5/2021.  84-year-old female with a past medical history of diabetes type 2, hypertension, hyperlipidemia, chronic kidney disease, JAK-2 mutation on Eliquis, who presented to the hospital with shortness of breath. she was tested positive for COVID on Monday. Shortness of breath is associated with some cough.  No fever or chills. In the emergency room, her vitals were T-max 98.9, heart rate 73, respiratory rate 22, blood pressure 113/40.  EKG, normal sinus rhythm, no ST elevation or T-wave inversion.  Chest x-ray showed cardiomegaly with small bilateral pleural effusion with a consolidation in the bilateral lung bases. Blood work showed sodium 138, potassium 4.2, creatinine 2.62 with a GFR of 16.  White count 9.0, hemoglobin 8.8, troponin 82. Cr 1.41.  Azithromycin given. Patient was also bleeding from the nose and hematuria. HG 6.9. PLTs 15. D dimer elevated. Family decided on comfort care. Patient expired.
5mins post vaccination, pt c/o dizziness, Nausea, and Anxiety.  Vitals BP 117/71, HR 103, RR 22, SpO2 99% RA.  Pt reported having anxiety and nervousness pre-vaccination.  VS Stable and pt felt better after 15mins in med bay.  Pt stable and released from the vaccination site.
Patient reported after vaccination feeling light headed and while walking to the waiting area patient fell to the floor.  Patient was seen on site by EMS.
she was fighting tonsil infection or strep from what doctors assume; she was fighting tonsil infection or strep from what doctors assume; hair started to fall out; had every type of COVID symptom; vomiting; fevers; chills; sore throat; tiredness; headache; sleep apnea; pregnant at time of vaccination/ gestation period were 31 weeks; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that a 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 27-years, via unspecified route of administration at single dose for COVID-19 immunization, first dose in left arm on 25Jun2021 at 12:00 and second dose on unspecified date. Medical history included tonsillitis, functional neurological disorder with clink rare genes with child, GERD, autism. The patient was pregnant at time of vaccination. Patient last menstrual period date was 10Dec2020 and pregnancy due date 09Sep2021, gestation period were 31 weeks. No other vaccine in four weeks. No known allergies. No COVID-19 prior vaccination. Concomitant medications included prenatal (unspecified), folic acid, antibiotics. The patient reported that after her first and second dose her hair started to fall out. She was fighting tonsil infection or strep from what doctors assume. She probably should of waited until she was done taking her penicillin anti biotic. She had every type of COVID symptom but doctor was surprised to find no illnesses to explain her vomiting, fevers, chills, sore throat, tiredness, headache, etc. She saw a tonsil doctor to set up future removal. And sleep apnea testing. Adverse event start date on 20Jun2021 (as reported). Adverse event resulted in doctor or other healthcare professional office/clinic visit. No treatment received. No COVID-19 tested post vaccination. Outcome of the events was not recovered.   Information about batch/lot number has been requested.
Inmate reports a red rash to bilateral legs and shortness of breath starting on 5/15/2021. The rash went from ankle to knee. Was not itchy. Rash has improved. Shortness of breath lasted 24 hours and is no longer present.
diagnosed with hypothyroidism; joints in the patient's right shoulder started to be painful / excruciating joint pain in his right shoulder, elbow, wrist; pain in thumb, hand, fingers; The initial safety information received was reporting only non-serious adverse drug reaction(s), Upon receipt of follow-up information on [12Dec2021], this case now contains serious adverse reaction(s). Information processed together. This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE), administered in arm left, administration date 02Nov2021 (Lot number: FF2593) at the age of 36 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Sleep apnea" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL. The following information was reported: HYPOTHYROIDISM (disability, medically significant) with onset 10Dec2021, outcome "not recovered", described as "diagnosed with hypothyroidism"; ARTHRALGIA (non-serious) with onset 04Nov2021, outcome "not recovered", described as "joints in the patient's right shoulder started to be painful / excruciating joint pain in his right shoulder, elbow, wrist"; PAIN IN EXTREMITY (non-serious) with onset 04Nov2021, outcome "not recovered", described as "pain in thumb, hand, fingers". The events "diagnosed with hypothyroidism", "joints in the patient's right shoulder started to be painful / excruciating joint pain in his right shoulder, elbow, wrist" and "pain in thumb, hand, fingers" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood test: (Nov2021) normal; (10Dec2021) diagnosed with hypothyroidism, notes: full panel; thyroid function test: (12Oct2021) positive; x-ray: (Nov2021) normal. Therapeutic measures were taken as a result of hypothyroidism, arthralgia, pain in extremity. Clinical course: 2 days after getting the Covid vaccine (on 04Nov2021), the joints in the patient's right shoulder started to be painful. At the time of report, patient continued to have excruciating joint pain in his right shoulder, elbow, thumb, hand, wrist, and fingers. Patient had an X-ray done as well as blood work, and those results have come back as normal. The doctor put him on Celecoxib 200MG & Prednisone 10MG. These medications have not helped him much. No Covid test post vaccination. Seriousness of 'excruciating joint pain in his right shoulder, elbow, thumb, hand, wrist, and fingers' from reporter was non-serious (Results in death: No, Life threatening: No, Caused/prolonged hospitalization: No, Disabling/Incapacitating: No, Congenital anomaly/birth defect: No). Patient was diagnosed with hypothyroidism on 10Dec2021 after doing full panel blood work. Thyroid medication was prescribed.
I experienced a breakthrough case of COVID-19 with coughing, runny nose, and fever.
Tightness and pain in chest, swollen painful throat, drainage from eyes, non-productive cough, body/muscle aches, rash on back of hands.
p/vax pt did not feel well 7 stated felt cold;pt just stared ahead & had some shaking p/vax;pt put in supine position;BP 122/64;BP 124/78;then BP 128/80;color around lips very pale;dizzy, weak;
103 degree fever, chills, muscle aches, headache. Most symptoms went away after a few hours. Headache stayed a full day or so.
Muscle ache, neck pain, fatigue, extreme headache, flushing, fever, chills,
4-6 hrs after immunizations were given infant had a hypotonia, unresponsive episode that lasted 5 mins.
Client received Tdap vaccine on October 18th. Friday during the day, client states he was fine. Friday night shoulder felt sore so took some Tylenol PM. Saturday October 19th, client states he felt like he had a fever and didn't feel well. He took some regular Tylenol.  On Sunday October 20th, client state there was swelling in the shoulder and armpit area. The lymph nodes of the armpit swelled to the size of a baseball. He said the left side of upper chest was throbbing, sore, and swollen. He placed ice on it and took more Tylenol. On Monday October 21st, he went to work and iced his shoulder and armpit during breaks. On Monday, shot area was still sore and lymph nodes were still swollen. On Wednesday October 23rd, lymph nodes starting to go down. By Saturday October 26th, everything seemed back to normal. Client stated he took ibuprofen all week twice a day. He stated that he thought the medicine helped.