chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information regarding PREVNAR 13 was received from a healthcare professional regarding an unknown number of patients who experienced vaccination site erythema and vaccination site swelling. The patient received a dose on an unspecified date. An unknown number of patients experienced vaccination site erythema and vaccination site swelling following PREVNAR 13 administration. The events last for two or three days. The physician has changed needle size and there was still no improvement in the occurrence of the events. The reporter was unable to specify the number of patients who experienced this event. Additional reports will be generated when identifying information is provided. No additional information was available at the time of this report.
Hives, itching, flushed face, swollen face, tachycardia, shortness of breath.
pt recvd vax & exp swelling, pain in RA; felt warm, no t; pt whining crying;
Patient was given a moderna booster on 12/19. Due to patient's age, they should've gotten a Pfizer one instead. Patient tolerated well with no signs or symptoms 15-20 minutes after administration.
Headaches, nausea, lightheaded.  Started 15 minutes after vaccine administered but not reported until the following day.  Patient treated with ibuprofen, hydration, and rest.
A week after the injection my arm started being itchy about 3 to 4 inches below the injection area. I scratched it through my clothes but when I undressed I noticed an inflammation. The day after it got worse with an area of inflammation about 4 inches tall to 3 wide. Red, hot and swollen. I took a Benadryl in the evening and another one the day after. The inflammation got slowly better. Today  you can still see the "shadow" of where the inflammation was but it's not worrisome . I had a telephone visit with a doctor today who, because the event occurred a week after the injection, said that perhaps it was not directly connected with the vaccine, that perhaps it was not an allergic reaction, that I may unknowingly  have an immune system condition that would have been triggered by the vaccine. The Doctor advised me to get the second injection.
I got terrible migraines; This is a spontaneous report from a contactable consumer, the patient. A 13-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on an unknown date (at the age of 13-years-old) as a single dose for COVID-19 immunisation. The patient had history of known allergies to shellfish. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified allergy medications within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on an unknown date as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 22Jul2021 at 01:00, the patient experienced terrible migraines after he got the second vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the event. The clinical outcome of event terrible migraines was unknown at the time of this report.    The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Patient diagnosed with COVID-19 even though he was vaccinated -- he states vaccine on 3/9 (registered in system) and 3/30 (this dose was not registered in system).  Patient reports that today (5/1/21) heaviness in his chest and felt as if he could not get a deep breath.  He initially was worried that he was experiencing a heart attack therefore presented to the emergency department.  Because of the shortness of breath Covid swab was done and resulted to be positive. Initial EKG and 2 sets of trop's are negative. Remdesivir x 2 doses, no steroids, Pt with room air SPO2 of 98% at rest/awake/sitting in chair.  Pt w ambulatory SPO2 of 96% .
Administered to both arms (R and L).  Dosage administered was twice standard dosing for this patient (40 mcg instead of 20 mcg).  Patient reports prolonged nausea, increased stomach acid, stomach pain and runny nose.
7 days after vaccination my arm became red, itchy and slightly swollen at site for 2 days, then completely resolved
Erythematous macular rash, blanches with pressure, on anterior and posterior torso.
chills; headache; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of CHILLS (chills) and HEADACHE (headache) in a 51-year-old female patient 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills) and HEADACHE (headache). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) for Adverse event, at a dose of UNK dosage form. At the time of the report, CHILLS (chills) and HEADACHE (headache) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-028190 (Patient Link).
Got vaccinated with 3 doses of the vaccine and tested positive; Tested positive; Tested positive; This is a spontaneous report received from a contactable reporter(s) (Physician) for a Pfizer sponsored program.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "Got vaccinated with 3 doses of the vaccine and tested positive"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Tested positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. It was reported that, Reporter had a person visiting her house who got vaccinated with 3 doses of the vaccine and tested positive. Patient's information was not provided. Reporter Dr. (withheld) asking if she can give prescription to her patient for the product Paxlovid, also asking if which Pharmacy it was supplied. Able to provide the answer on her first query then tried to transfer her with her additional question but she said will call another department then said goodbye.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the available reported information, the causal association between the events immunization, drug ineffective and covid-19 and the suspect drug BNT162B2 cannot be excluded.
not adverse effects; improperly stored VARIVAX; This spontaneous report was received from a registered nurse prescriber concerning patient of an unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions/allergies or concomitant medications.  On 13-JUL-2019, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, 1 dose, lot number R029517 with expiration date on 14-OCT-2020 (exact dose, and route of administration were not reported) for prophylaxis (Incorrect product storage).  Administered doses of vaccine experienced temperature excursion between 15 degrees Fahrenheit (F) up to 46 F (32 F) for 3.5 hours and between 6 F up to 14 F (14 F) for 1.5 hours. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported.
Next day and for 4 weeks thereafter, out arm front shoulder to elbow was red, swollen, hot to the touch, hard. Benadryl PO
12 hours post injection, onset of chills with duration of 45 minutes, subsiding 15 minutes after use of 500mg Tylenol. Onset of sweating and discomfort 2 hours later. No intervention. Onset of nausea 3 hours later. Passed within 10 minutes, no vomiting. T 21.5 hours onset of fatigue and chills. Fever measured at 100° 1 hour later and continued until Tylenol 500mg administered at T 25 hours. Dizziness returned 6 hours later and Tylenol 500mg administered with good effect. Dizziness again at T 44 hours resolved with Tylenol 500mg.
Patient is 63 years old and received fluad for 65 and older. Patient reported no side effects as of 9/25/22
This spontaneous report as received from a pharmacist refers to an elderly ("over 80 years") male patient. No medical history provided. On an unknown date the patient was vaccinated with ZOSTAVAX (vial; dosing, indication unknown. No concomitant medications were reported. On an unknown date the patient experienced shingles. The outcome of shingles was reported as not recovered. Medical attention was sought by the patient's wife by going to the pharmacy. Additional information is not expected.
Pt received shot on Sunday 11/2, came down with facial rash on Tuesday 11/4. The rash is red, raised, itchy, and painful.
This spontaneous report as received from a physician refers to a 64 year old female patient with allergies, irritable bowel syndrome, cataracts, satty liver disease, impaired glucose tolerance, joint disease, tremor, tobacco use, obesity, sleep apnea, hypertension, depression, peptic ulcer disease and iodine contrast allergy. patient had previous allergic reaction with iodine contrast. On 11-AUG-2014 the patient was vaccinated with PNEUMOVAX 23 injection 0.05 ml single dose with lot # J010396, expiry date 16-FEB-2015 intramuscular. Concomitant therapies included LEXAPRO, WELLBUTRIN SR, ranitidine (manufacturer unknown), losartan, hydrochlorothiazide (manufacture unknown) and FLONASE. On 12-AUG-2014, the patient experienced a series of adverse events that included pain in her arm when she was trying to raise it and was decreased by next day. Patient developed rashes on her arms, neck and upper chest, rashes described as itchy. Patient sought for medical attention and was prescribed with ADVIL and hydrocortisone (manufacture unknown) cream. No laboratory test was performed. Therapy with PNEUMOVAX 23 was discontinued and was not reintroduced. The outcome of pain in her arm when trying to raise it, develop rashes on her arms, neck and upper chest was reported as recovering/resolving. The reporter did not provide the causality of pain in her arm when trying to raise it, develop rashes on her arms, neck and upper chest was reported as recovering/resolving. The reporter did not provide the causality of pain in her arm when trying to raise it, develop rashes on her arms, neck and upper chest to PNEUMOVAX 23. No further information was provided. Additional information has been requested.
A few days after receiving the vaccine I developed severe fatigue that persisted for months. Just two weeks after receiving the vaccine, I developed a plethora of symptoms, namely pins and needles and burning sensations as well as severe muscle pain that was so debilitating, I could not sleep and was forced to take a month off of work to try to recover.   After undergoing EMG testing and ruling out an autoimmune condition, it was concluded that I likely was suffering from a severe fibromyalgia flare-up, a condition I did not have before the vaccine.  This was explained by pain points (back of the head, kneecaps, shoulder tip, hip, upper back, etc) consistent with fibromyalgia and lack of nerve damage.  Though less severe, I continue to suffer from pain and have painful burning sensations that come and go, including foot pain that feels like I am walking on crushed glass at times and affects my mobility during flare-ups. I never had this reaction to any other vaccine, only COVID. I am relieved to learn there is finally a place to report my experience, as it was life-altering.
hives; swelling; This non-serious case was reported by a other health professional via sales rep and described the occurrence of hives in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In JUL-2023, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced hives (Verbatim: hives) and swelling (Verbatim: swelling). The outcome of the hives and swelling were not reported.   It was unknown if the reporter considered the hives and swelling to be related to Shingrix.     It was unknown if the company considered the hives and swelling to be related to Shingrix.   Additional Information: GSK receipt date: 3-Aug-2023 The patient was the spouse of reporter. The patient had received 1st dose of Shingrix 3 weeks ago and has had hives and swelling since. The physician recommended patient to receive vaccine because over 50 years old and has had significant adverse events related to the skin.  The patient was not going to get the 2nd dose. The reporter consented to follow-up.
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On an unspecified date, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine health maintenance for the prevention of shingles. Shortly after receiving ZOSTAVAX, the patient began to experience tremors in his hands, which progressed into significant cognitive decline including the loss of his ability to speak and walk. In response to these complaints the patient presented to his primary care physician, specialists and local hospital and was ultimately diagnosed with Corticobasal Degeneration (CBD). The patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Upon internal review Corticobasal Degeneration was considered medically significant. Additional information has been requested.
7/7/04: pt experienced joint pain in left elbow, followed by joint pain in left hand. 7/8/04: pt experienced joint pain in right knee. Pt states he has taken Motrin for the pain.
cough moving to the lungs which comes and goes; Disorienting; Very tired (in bed all the time); Feels like a basketball hit in the forehead; Soreness for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough moving to the lungs which comes and goes), DISORIENTATION (Disorienting), FATIGUE (Very tired (in bed all the time)), HEADACHE (Feels like a basketball hit in the forehead) and VACCINATION SITE PAIN (Soreness for 3 days) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Sinus infection (Chronic).    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced VACCINATION SITE PAIN (Soreness for 3 days). On 24-Jan-2021, the patient experienced COUGH (cough moving to the lungs which comes and goes), DISORIENTATION (Disorienting), FATIGUE (Very tired (in bed all the time)) and HEADACHE (Feels like a basketball hit in the forehead). On 21-Jan-2021, VACCINATION SITE PAIN (Soreness for 3 days) had resolved. At the time of the report, COUGH (cough moving to the lungs which comes and goes), DISORIENTATION (Disorienting), FATIGUE (Very tired (in bed all the time)) and HEADACHE (Feels like a basketball hit in the forehead) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment medication included acetaminophen.
Went to the hospital with chest pain. They performed a catheter to check for blockages and instead found an extremely rare blood clot that ultimately caused a mild heart attack.
joint pain; headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (joint pain), HEADACHE (headache) and CHILLS (chills) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and (046A21A)) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced ARTHRALGIA (joint pain), HEADACHE (headache) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ARTHRALGIA (joint pain), HEADACHE (headache) and CHILLS (chills) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Non significant follow up received on 13-MAY-2021
On 11 October 2001, the patient received her third injection of Engerix-B in her left arm. On 12 October 2001, one day post-immunization, the patient developed a three inch red, swollen band approximately 2 inches below the injection site. The area was also itching. The patient was seen by a physician. The events were "improving" as of 15 October 2001.
covid-19; covid-19; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), on 11Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 08Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 41 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Ibuprofen, reaction(s): "Allergy", notes: known allergies ibuprofen. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Apr2022) positive, notes: tested positive 26Apr; (unspecified date) negative, notes: neg home antigen test; (15May2022) positive, notes: 15May developed symptoms and positive home antigen test. Therapeutic measures were not taken as a result of covid-19, drug ineffective.   Clinical course: It was reported that rebound covid, tested positive 26Apr2022 s/p 5 days Paxlovid and neg home antigen test and symptom resolution. 15May developed symptoms and positive home antigen test.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the events drug ineffective and covid19 cannot be totally excluded.
pt recvd vax 17MAY93 & 1JUN93 devel hives & a rash on face & arms; No further details were provided
Upon waking on 1/28/2021: Redness and hives at site injection that spread in surface area coverage over next several days; arm swelling over next several days; increased fatigue (ongoing); severe headache for 24 hours; armpit/axillary lymph node enlargement for 1-2 weeks; submandibular/neck lymphadenopathy (ongoing) that has not resolved  Waited 6-8 weeks to monitor reduction in lymph nodes enlargement at neck, but it increased and I went into my heme/onc in April to have her check it out. I had an ultrasound done in April 2021 and a repeat US in August 2021 with minimal size increase or no change in size. Abnormal LFTs during both lab checks around time of ultrasounds. I was given a steroid regimen over this past week and went in for f/u labs 8/13/21.
This spontaneous report as received from a health professional refers to a 4 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 05-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20.3 degrees Fahrenheit for 72 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
AE: Syncope( at 11am) Treatment: no medication was given. patient was under observation.  Water improved symptoms Outcome: symptoms resolved and patient was sent to POV/Home.
Fever of 100-ish, body aches, chills, blood in urine-all same day onset around 6-7:00 pm
Hives, felt like I could not breathe. It was very difficult to do anything. Could not bend forward, lay down in bed (flat), could not turn to my right side or left side in bed. Sitting up was an effort. I have allergic reactions to meds. Told ER I thought this was all from the "PPV" shot. 1/15/08-rcords received for DOS 11/26-11/27/07-Seen in ED for C/O sudden onset of substernal pain radiation to jaw, chest heaviness. No nausea no vomiting. Pain increased with movement including laying down and moving the chest.  Impresssion: atypical chest pain rule out myocardial infarction. Follow-up: Back to the hospital 11/25/07. Many tests - same as hospital stay. Put me back on med pack last for 5 days. Have had every symptom of pneumonia. After 2 months I'm still having problems. My family Dr. and 2 heart Dr.'s agree all problems point to pnuemonia vaccine.
Swollen Lymph Nodes - first appeared in the armpit of the vaccinated arm, then a few days later other lymph nodes swelled including the other armpit, base of skull, along both sides of neck.  Futhermore, my WBC had a significant jump to 90,000. At this time (9/21/2021) my WBC remains at 90,000 and the lymph nodes have gone down however still present.
sore left arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Apr2021 14:30 (Lot number: EW0164) at the age of 40 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Cat allergy" (unspecified if ongoing), notes: Cat allergy. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "sore left arm". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in extremity. Additional information: No other vaccine in four weeks. No other medications in two weeks. No Covid prior vaccination. Covid tested post vaccination. The patient had no known allergies. The patient had received dose 2 COVID 19 Pfizer vaccine. First Vaccine, the patient had a sore left arm for the first few days. Second Vaccine the patient experienced a sore left arm, sore lymph nodes/armpit (left side), fever, fatigue for 2 days after vaccine (01May to 02May); sore lymph nodes lasted about a week.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200015297 Same reporter and product; different events and dose
Fever, shaking chills, joint muscle and lymph node pain, very sore arm (worse than #1), headache so even hair hurt, fatigue