chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe unilateral (right) sided headaches that happen multiple times per day. My right eye will water and right nostril will get a burning sensation and will be congested during the headache. Headaches last around 3 hours and happen 3-5 times per day. Headaches feel as if someone is drilling a hole in my right temple. Doctor has diagnosed me with Cluster Headaches. I was prescribed steroids then the standard preventative medication which is Verapamil. Headaches have subsided significantly with the Verapamil but come back if I don?t take them. Cluster cycle has not stopped yet and has been over 3 months. MRIs and MRAs have ruled out aneurysm as well as structural abnormality.
At about 10 am the day following the injection, I began experience intense, shivering chills. I also had mild nausea that came and went throughout the day. At about 2:00 pm, I also began experience body aches. Unsure if those aches were a side effect of the vaccination or the shivering I had been experiencing for most of the day. The nausea had subsided by 6pm, right around when I began showing a fever. I continued to have chills, body aches, and fever until about midnight of that night.
NAUSEA; HEADACHE; TINGLING IN THE LEFT ARM; FEELING HOT; CHILLS; FEVER; This spontaneous report received from a patient concerned a 23 year old female. The patient's weight was 170 pounds, and height was not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 17.00 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced tingling arm. On 08-APR-2021, the subject experienced feeling hot. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, Laboratory data included: Body temperature (NR: not provided) 104.2 F. On 09-APR-2021 02:30, the subject experienced nausea. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tingling arm on 08-APR-2021, had not recovered from fever, chills, nausea, and feeling hot, and the outcome of headache was not reported. This report was non-serious.
Swollen Lymph Nodes enlarged  on solder  and back , Loss of taste . Body Aches and pains
sudden sensory hearing loss; This is a spontaneous report from a contactable nurse (patient) from a Pfizer sponsored program. A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)), first dose via an unspecified route of administration, administered in deltoid left on 16Apr2021 (Lot Number: EW0161; Expiration Date: Jul2021) at the age of 61 years old, as single dose for covid-19 immunisation. Medical history included thyroid, covid-19 from Dec2020. She has no medical history to add. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included ongoing levothyroxine sodium taken for thyroid. The patient experienced sudden sensory hearing loss on an unspecified date. She reported she lost her hearing suddenly. The doctor considered it an emergency. It was sudden sensory hearing loss. During that time she had a series of three injections in her ear. She did receive Lidocaine for those injections. She also received Prednisone injections in her ear. She reported it was a virus in her ear and she received three injections and wait and hope that her hearing resolves. She doesn't recall going on 04May2021 for an injection. She provided the dates of her injections as 22Apr2021, 26Apr2021, and 03May2021. The patient and her husband received letters stating that they may have received lidocaine that has been recalled. The date of the letter is 04May2021 which correlates to the time both her and her husband received their second Pfizer Covid-19 vaccine. The patient stated she received their Covid-19 vaccine on 04May2021, and her husband received his on 05May2021 and they both received the lidocaine recall letter. The patient stated the letter stated the recall drug was lidocaine injection and the company is hospira, with a NDC number and recall lot number, along with an expiration date and it stated some vials may contain another drug. The letter from the insurance company also says the Lidocaine vials may contain another drug. The patient stated her husband also had a dentist appointment on 05May2021 and received a lidocaine injection at this appointment. The outcome of the event was not recovered.; Sender's Comments: Based on the available information and known product profile, the causal relationship between the reported hearing loss  and the use of BNT162B2 cannot  be fully excluded.  There is limited information in this case precluding a more meaningful assessment. The case will be assessed further upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
I got the actual vaccine at Pharmacy  on 10/15/20.  I had a mild flu-like reaction to the injection on 10/17 that lasted for about a day and a half, which is a known reaction to the injection so I wasn't concerned.  However, about a week  later I noticed small red welts on my right torso and upper right thigh.  Red and itchy.  I thought they were bug bites at first and treated them as such.  However they did not improve.   On Wednesday 10/28 I woke up with a bumpy red rash on my left torso, which began to spread to my left back, and my back shoulders on both sides.  My skin turned red and itchy but was not in pain.  I went to my doctor on 10/29 to find out if it was shingles.   He observed the rash and because it was on both sides of my body did not think it was shingles.   He asked me to return in a couple of days to observe before treatment.  I came back on Monday 11/2 and by then the rash was bright red on one side.  We are currently treating with Prednisone and at the moment it seems to be responding.  Please follow up with doctor for final confirmation.
Sudden and severe vertigo and intractable nausea resulting in dehydration. Body aches. Shivering and Trembling
This spontaneous report as received from a pharmacist refers to a 72 year old diabetic female patient with no drug reaction or allergies. On 22-JAN-2018, the patient was vaccinated with a dose of PNEUMOVAX23, intramuscular in unspecified arm for prophylaxis (dose, lot # and expiration date were not reported). There was no concomitant therapy. On 22-JAN-2018, injection site pain, injection site erythema and injection site swelling; and a red band wrapping around the (unspecified) arm below injection site (erythema). The patient sought medical attention by returned to the pharmacy. No treatment was given. No laboratory diagnostic tests were performed. The outcome of erythema, injection site swelling, injection site erythema and injection site pain was reported as not recovered. The relationship between events and PNEUMOVAX23 was not reported.
pain goes around the arm to the inside; feeling hot and swollen at the injection site; feeling hot and swollen at the injection site; Information has been received from a pharmacist via a specialist referring to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not provided.      On 03-FEB-2020, the patient was administrated with 1 dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, frequency and route were unknown; lot # S002582 and expiration date 10-AUG-2020) for prophylaxis.         On the same day, the patient was experiencing side effects following pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) administration, including feeling hot and swollen at the injection site and pain going around the arm to the inside. The outcome of the events were not recovered. The causality between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 11-OCT-2014 the patient was vaccinated with a dose of PNEUMOVAX23 (dose and route was unknown, lot # J006921, expiration date 09-AUG-2014) which was expired on 09-AUG-2014. No adverse effects were reported. Additional information has been requested.
We received via Merck USA the following information from a consumer on 10 OCT 2007: A women, no further data, received a flu shot (manufacturer and batch-number unknown) about ten years ago and experienced a paralized vocal cord and aspiration pneumonia (onset date and duration unknown). No further information available. Company assessment: Seriousness criterion: medically significant. Causality: insufficient date. Expectedness assessment according to SPC: The reported symptoms are not expected after vaccination with Fluvirin. No change in benefit-risk-ratio. No measures necessary.
lip swelling and hives; lip swelling and hives; This spontaneous report was received from a pharmacist referring to a male patient of unknown age. The patient's pertinent medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not provided.  On an unspecified date in 2019 (reported as recently), the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, unit, batch/lot#, expiration date and route were not reported) for prophylaxis.   On an unspecified date in 2019 (reported as recently), the patient had lip swelling and hives after received zoster vaccine live (ZOSTAVAX). Then the patient had oral sex wife on an unspecified date and his wife thought she had herpes simplex 2 (captured in MARRS# 1909USA000568). The outcome of lip swelling and hives was not reported.  Causality between the events and zoster vaccine live (ZOSTAVAX) was not reported.; Sender's Comments:  US-009507513-1909USA000568:
Information has been received from a LPN concerning a 7 yr old male with seasonal allergies and anxiety who on 29Jul04 was vaccinated SC with a 0.5mL dose varicella virus vaccine live (lot646676/0711N). Concomitant therapy included Desloratadine (Clarinex) and escitalopram oxalate (Lexapro). The LPN reported that on 25Jul05 the pt developed a rash all over his body, but was noted to be afebrile. On 26Jul05, the pt was seen in the physician's office and a diagnosis of breakthrough chickenpox was made. No lab/diagnostic tests were performed. The pt was treated with acetaminophen (Tylenol), diphenhydramine HC1 (Benadryl) and calamine (+) pramoxine (Aveeno) baths. At the time of this report, the pt's breakthrough chickenpox persisted. Additional information has been requested.
Rash down left arm, throat closure , trouble breathing, hypotension- seen by emt on side.  Symptoms resolved in 1/2 hour was able to drive home
Left arm red, swollen, and hot from top of shoulder to elbow extending halfway around the arm.  Pt is also complaining of a slight wheeze approximately 24 hours after the injection.  Diphenhydramine oral was ordered and given.  Oxygen was placed intranasally.
Pt received MMRV vaccine alone last week and developed some redness, swelling and feeling firmness. Pt was given BENADRYL and the reaction improved the following day. Dr advised pt it sounded like a mild local reaction, perhaps mild allergy. This is pt's last booster.
SUSPECTED CLINICAL VACCINATION FAILURE; STILL GOT THE VIRUS AFTER VACCINE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, one total start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced suspected clinical vaccination failure, and still got the virus after vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the still got the virus after vaccine and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000204394.; Sender's Comments: V0: 20211161669-COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Nightsweats; Chills; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (Nightsweats) and CHILLS (Chills) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced CHILLS (Chills). On 12-Feb-2021, the patient experienced NIGHT SWEATS (Nightsweats). On 11-Feb-2021, CHILLS (Chills) had resolved. On 14-Feb-2021, NIGHT SWEATS (Nightsweats) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-020483 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-020483:MOD21-035131: Same reporter, reporter herself
Got the first dose of the vaccine on 23Dec2020, this week the patient was tested positive for COVID; Got the first dose of the vaccine on 23Dec2020, this week the patient was tested positive for COVID; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect from a contactable other healthcare professional (HCP) (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 23Dec2020 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient got the first dose of the vaccine on 23Dec2020, this week the patient was tested positive for COVID in Jan2021. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The reported tested positive for COVID  after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported event and BNT162B2 administration.
Pt. received influenza vaccine on 10/2/13, on 10/3/13 starting having hearing lose, ringing in ear, etc. This has remained. She is working with specialist.
sore reaction; neck pain; dizziness; nauseous that went away again after a few days; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program.   A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 18Jan2021 (Batch/Lot number was not reported) as 1st dose, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, patient stated that she received her 1st shot of our vaccine last 18Jan2021 and had a sore reaction that went away after a few days. Then on the 15th day, she had neck pain, dizziness and nauseous that went away again after a few days. She was asking if this was normal. 2nd vaccine was scheduled 08Feb2021. The outcome of the events neck pain and dizziness was unknown and recovered on an unspecified date for other events.  Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Inappropriate sinus tachycardia worsened into POTS with increased incidence of vasovagal syncope-- pacemaker implanted to correct
Developed Autoimmune Hemolytic Anemia after receiving the Moderna vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of AUTOIMMUNE HAEMOLYTIC ANAEMIA (Developed Autoimmune Hemolytic Anemia after receiving the Moderna vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history reported).   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced AUTOIMMUNE HAEMOLYTIC ANAEMIA (Developed Autoimmune Hemolytic Anemia after receiving the Moderna vaccine) (seriousness criterion medically significant). At the time of the report, AUTOIMMUNE HAEMOLYTIC ANAEMIA (Developed Autoimmune Hemolytic Anemia after receiving the Moderna vaccine) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient has not provided with any treatment medication. No concomitant medications were provided  Company Comment  Although a temporal association exists, provided information is not adequate to assess the causal association between the event and mRNA-1273.  Critical details such as the medical history and diagnostic report is lacking. Further information has been requested.
Unconscious by 8pm after shot on Saturday, awoke on Monday after 4pm confused and lightheaded. Fell back asleep until Tuesday around 11am. Barely remember speaking to anyone, didn?t drink any fluid or go to bathroom.
It was reported that a male patient received a TriHibit (combination Of Tripedia and ActHib) and IPOL vaccination on 03/31/00. Reportedly sometimes after the vaccination, the patient developed a local reaction. No specifics provided. Additional information is being requested. From correspondence received on 04/25/00, it was reported that the patient developed erythema and swelling which progressed from the shoulder to elbow,lasting 48 hours and then resolved. The patient was afebrile but anorexia after application but was well when reaction resolved. From mailed follow-up correspondence received on 06/12/01, the patient's age and the adverse event onset date were provided. The case is closed. Follow up 06/14/02; during internal auditing iof all files, it was deemed necessary to amend the report by updating the Adverse Event coding (added anorexia)
No additional AEs no PQCs; Temperature: -13.7C; This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 01-FEB-2021, the patient was vaccinated with dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (rHA) lot # T025222, expiration date: 19-JAN-2022 (formulation, strength, dose, frequency and route of administration were not reported) for prophylaxis. On an unknown date, the dose of the vaccine was exposed to temperature excursion at - 13.7 Celsius degrees (C) for 42 minutes. There was no previous temperature excursion reported. The call was not due to digital data logger. No additional adverse event was reported.
I received both of my COVID-19 vaccines.  Both of these vaccines were the Pfizer vaccinations. My first shot was given on 3/9/21 and my 2nd shot was given on 3/30/21. About 2 1/2 weeks after I received my 2nd shot I began to feel a  lot of pressure in my chest.  It felt like an elephant was sitting on my chest.  After feeling this extreme discomfort for a few days I began to get worried and decided to go to the Emergency Room to get it checked out.  I went to a hospital. They administered an EKG, took a chest x-ray and drew my blood.   The physician on duty looked at the chest x-ray and told me that my heart wasn't enlarged. He also said it looks like I hadn't had a heart attack.   I suppose my EKG came out normal since they didn't seem alarmed at those results.  My blood panel showed I was a bit low in sodium but otherwise everything was normal.  The next day I felt normal again and haven't felt the chest pressure since. I blame the Pfizer COVID-19 vaccines for having that feeling of extreme pressure on my chest for several days.  I'm a bit concerned about receiving any future COVID vaccinations from this result not knowing if the next vaccination might cause a heart attack.
Client was given her covid vaccine in her R arm approximately less than one inch from the acromion process. After receiving the vaccine, the client started complaining of pain that progressively got worse over the next day and has remained constant ever since. Pain is rated as high as 10/10 when extending her limb.
A non-serious spontaneous report of hand and foot disease manifested with tiny bumps, painful rash on hands, finger and palms has been received from a physician concerning a 33-year-old female, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 27-Dec-2011. On 27-Dec-2011, the patient experienced painful rash on their hands. In Jan-2012, the patient experienced fine tiny bumps (1mm), painful rash on their hands, ventral side mostly fingers, but also palms, which looks like hand and foot disease but the rash bumps were very small in comparison to the hand and foot disease. Two daughters have the same complaint. The outcome of event was unknown. Additional information was received on 26-Apr-2012 and incorporated into the narrative: Outcome and event information.
Blurred vision, Nausea.  Vomiting 20-25 mins.  Prior to EMS being called.  Treated with a cold compress until EMS arrived.
pt recv vax 25FEB98 & 26FEB98 T100;28FEB98 irritable;1MAR98 T101, hive like rash on face rt leg;patch dry skin;n/v x 2 followed by passed out x 2sec-fell to the floor brought to ER;vomited x 1;dx virus or rxn to vax;hives;c/o sore throat;
Case previously recorded as MA2009-4397.  Initial case report received from a registered nurse via agency on 16 NOV 2009.  A 3 year-old male patient was accidentally vaccinated with FLUVIRIN 2009/2010 (batch no. 100813) i.m. on 14 NOV 2009.  No adverse effect was reported.  Off label use (child under 4 years old) is unexpected regarding vaccination with S-OIV FLUVIRIN 2009/2010.  No change in benefit-risk-ratio.  No measures necessary.  Agency reference no.: NA09-008317.