chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE; Patient came in and received on 5/3/2023 GARDASIL 9.; This spontaneous report was received from a female patient with unknown age via medical assistant. The patient's concurrent conditions, concomitant medication and pertinent medical history was not reported. The patient had no underlying disease and no previous history of allergy to vaccines.  On an unknown date in 2013, the patient was vaccinated with the first dose and the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose, lot #, expiration date, anatomical location and route were not provided) at age 15 for prophylaxis. On 03-MAY-2023, the patient was vaccinated with the third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose, lot #, expiration date, anatomical location and route were not provided) for prophylaxis (inappropriate schedule of product administration). No additional adverse event (AE) (no adverse event).
Information has been received from a physician referring to a 24 years old female patient with sinusitis and seasonal allergy. The patient had penicillin and cephalosporin allergies. On 25-JAN-2016 the patient was vaccinated with a dose of PNEUMOVAX 23 (strength: 25/0.5Y; lot # L014876, expiration 03-JAN-2017, 1 shot, route was unspecified). Concomitant therapies included SINGULAIR, CLARINEX, ALLEGRA and nasal spray. On 25-JAN-2016, the patient developed redness on the body, chest tightness, dizziness and swelling of the face. The patient got medical attention for the adverse reaction and was treated with BENADRYL, prednisone (manufacturer unknown), epinephrine, and albuterol. No lab diagnostics studies were performed. The outcome of these events was reported as recovering/resolving. Causality was not reported. Additional information has been requested.
Erythematous ring around injection site approx 7/5 cm by 10 cm in diameter.  No signs of infection (blood or exudates) from injection site.  Erythematous ring warm to touch and elicited some minor pain.  Left arm.
Within 15-minutes of vaccination, the patient reported rash, hives, itchiness, and potential swollen lips, tongue, eyes or face. EMS monitored the patient on-site. No further details were provided from clinical site.
Metal taste - on-going  Hot flashes - on-going  (not experiencing prior) Tired - on-going  needing to take a short afternoon nap ( not experiencing prior)
blackout for short time; slit feeling at tip of tounge; Fell down; Weird feeling; A spontaneous report was received from a consumer concerning an 73 year old, male patient who experienced blackout for short time/loss of consciousness , slit feeling at tip of tongue/paraesthesia oral, fell down/fall and weird feeling/feeling abnormal.   The patient's medical history was not provided. No relevant concomitant medications were reported.  The current condition included was blood pressure abnormal.  On 11 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 Batch no: 048A21A for prophylaxis of COVID-19 infection.  On 11 Mar 2021, the patient was fell down, blackout for short time and that was very strange and weird feeling. The patient experienced his tip of tounge is felt like its slit  Treatment information was included Benadryl and He used cold compressor and started feeling good  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the event of blackout for short time was considered Resolved 11 Mar 2021 and slit feeling at tip of tongue was considered resolved on 12 Mar 2021.  The outcome of event fall was unknown and for event feeling abnormal was recovering/resolving.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
had an allergic reaction to the second dose of the 'Covid 19 vaccine'; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for covid-19 immunization. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "had an allergic reaction to the second dose of the 'Covid 19 vaccine'". Additional information: Patient recently started ramipril 5mg and her arms are hurting a great deal, which came on with onset of taking ramipril (unable to clarify if she was on brand name Altace or generic ramipril).  Her arms are sore from the shoulders down, but mostly from the elbow joints, forearms, and down to the hands and fingers.  she also had an allergic reaction to the second dose of the 'Covid 19 vaccine' (unable to clarify manufacturer name) and want to get a third dose but don't know how to go about doing that. Note: phone connection was bad and phone disconnected while customer was talking. No contact information provided at the time of disconnection. No further details available. She sounded like a female patient; age not provided. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
12 hrs. after administration, experienced fever, chills, muscle aches, headache, stomach pain, nausea. Bedrest and pain med (OTC) for 24 hrs.
numbness in one cheek; tingling in head; ill feeling; cold hands; This is a spontaneous report from a contactable consumer (patient). A 47-years-old female non-pregnant patient received first dose bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: not reported) via unspecified route of administration in right arm on 08Mar2021 at 16:00 (at age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included migraines, fibromyalgia and cervical fusion. Concomitant and other medications in two weeks included lansoprazole (PREVACID) and clonazepam. No other vaccine in four weeks. Past drug events included allergy due to sumatriptan succinate (IMITREX), paroxetine hydrochloride (PAXIL), buspirone hydrochloride (BUSPAR) and dairy. No other vaccine received in four weeks. Patient has not been tested for COVID, post vaccination. Patient has not been tested for COVID, since the vaccination. On 08Mar2021 at 17:00 (1 hour after vaccination), patient experienced tingling in head, numbness in one cheek, cold hands and ill feeling. Events resulted in visit to doctor or other healthcare professional office/clinic. Treatment received was unknown. The outcome of all events was not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This case was reported by a healthcare professional and described the occurrence of a 72-year-old female subject testing hepatitis b antigen positive following vaccination with ENGERIX B (GlaxoSmithKline) for prophylaxis. Concurrent medications included phoslo, paricalcitol, unknown medication (Sensepur), erythropoientin, nifedipine, linsinopril, TUMS, nephrocaps, lipitor and enteric-coated aspirin. On 24 October 2006 the subject received 1st dose of Engerix B, two 20 mcg injections intramuscularly in the left arm. (40 mcg, intramuscularly). On 26 September 2006 and 24 October 2006, the subject tested hepatitis antigen negative. On 28 November 2006, the subject tested hepatitis antigen positive.
Sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in an unspecified number of patients who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patients received Flu vaccine. On an unknown date, immediately after receiving Flu vaccine, the patients experienced sickness (Verbatim: Sick). The outcome of the sickness was not reported.   It was unknown if the reporter considered the sickness to be related to Flu vaccine.     It was unknown if the company considered the sickness to be related to Flu vaccine.   Additional Information: GSK Receipt Date: 19-MAR-2023 This case was reported by a patient via interactive digital media. The reporter reported that he or she worked at place that had 750 peoples and everyone in that received Flu vaccine was the ones got sick and experienced other problems immediately after received flu vaccine. The reporter reported that the physician did not investigate the result, cause and effect they just the money kick back in there pocket. Follow-up would not possible as no contact details were available. This case had been linked with US2023AMR055091 by same reporter for different patient.; Sender's Comments:  US-GSK-US2023AMR055091:Same Reporter
Began with painful itching and swelling 10/10 evening at injection site - (L) upper arm midway between elbow and axilla. This AM, erythema, warm to touch, swelling - (L) arm 26 cm circ. TMP - SMX DS bid x 10 days. No fever. No c/o feeling ill. Clindamycin 150 qid x 10 days.
Erythema, induration, and pain 10 cm radius of injection site as evaluated approximately 36 hours after placement. No systemic symptoms.
This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. The patient's relevant medical history was not reported. On 23-DEC-2014 the patient was vaccinated with MMR II (therapy type, route, dose, frequency and lot # were not reported) which underwent an excursion. This is one several reports received from the same source. Additional information has been requested.
Patient developed pain, redness, and swelling at site of injection 8/31/21. Did a telemedicine visit on 8/31/21 and was directed to go to the emergency department as they thought could be a blood clot. Went to ED and received an x-ray and was told to follow up with her primary provider. She was seen by her primary care provider today, 9/2/21, who said based on the appearance of her arm today, 9/2/21, it was the wrong location in the upper arm/deltoid region that the shot was given which is what caused the issue and not the vaccine itself. Patient's primary care provider said appears she is healing just fine at this time.
Pt recv vax on unspecified date; within 24 hr pt exp fever >103F; lasted for 3 dye.
I had a headache, sore arm and fatigued for about week after the vaccination. On 11/01/2022, I had a really bad headache and my sinuses felt block. On 11/03, I had a fever with a headache. I tested strong positive for COVID-19 on 11/04/2022 with a home test. I contacted my doctor and was advised to take a COVID-19 cocktail of vitamin D, vitamin C, zinc and melatonin. I took an expectorant for severe congestion and acetaminophen for the headache too. As of today, I continue to have headaches and blurry vision.
he can barely lift his arm; soreness; pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain), INJECTED LIMB MOBILITY DECREASED (he can barely lift his arm) and ARTHRALGIA (soreness) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced PAIN (pain) and ARTHRALGIA (soreness). On 21-Jan-2021, the patient experienced INJECTED LIMB MOBILITY DECREASED (he can barely lift his arm). At the time of the report, PAIN (pain), INJECTED LIMB MOBILITY DECREASED (he can barely lift his arm) and ARTHRALGIA (soreness) outcome was unknown.      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.   Other medicines: he takes medication for his blood pressure, cholesterol and diabetes.  Treatment: None.
I got vaccinated at 11:30am.  Approximately 9 hours after vaccination (~8:30pm), I started to feel lethargic.  9.5 hours post-vaccination (9pm) my face started feeling warm; my temperature was around 99 and I developed a mild headache.  At 10 hours post (9:30pm)  I had chills and my temperature continued to climb (~101F).  At 12 hours post-vaccination my temperature was 102.2, which is the highest it was that I know of.  This was during the night and I woke up several times due to my fever and chills; my headache worsened and was very severe.  I was extremely lethargic and had trouble getting out of bed.   I did not take any over the counter medications.  The following morning my temperature started coming down and my chills resolved.  My headache has improved but is still present (mild).  At around 19 hours post vaccination (~6am) my temperature was 101.  And 24 hours post-vaccination it was 100.5.
INTERIM HISTORY (04/02/2021). 1st dose of Pfizer COVID vaccine on April 2, 2021. Urticaria then flared 11 days following vaccine . Developed more hives during the day. Severe hives and lip swelling then occurred 2 weeks following vaccine. Hives associated with a lot of flushing and were very uncomfortable, burning. Hives did not respond to benadryl or benadryl spray like they usually do. Sunday April 18th patient fainted two times One time she fell, another time she sat down in a chair. Went to ED on Monday April 19th 2021. Driving home from a friends house when skin became very itchy. Then broke out in hives covering entire body. Hives started in trunk and spread to neck/extremities. She later noticed GI issues and then eventually trouble breathing.  ED history noted c/o tongue swelling, throat tightness, chest pain and shortness of breath.  This was her worst reaction to date since starting her current medication regimen. Called friend to watch her dog and went to ER when she developed trouble breathing.  She did not want to use epi pen if she did not absolutely need to use it. They did not end up giving her epi in the ER per her request. She was given IV pepcid and fluids; tryptase level was drawn.  Symptoms improved with treatment.  Next day she had transient hives but no hives since.  Still with some intermittent flushing.  Over the last few days she has noticed more uncomfortable flushing of her face . Not something that happens normally. She is not sure if she should get the 2nd COVID vaccine but would feel better if she had both.  She had COVID infection in March 2020. She was symptomatic but did not require hospitalization. Rapid antibody test negative in July 2020 at urgent care center in LI.
HPV immunization given 7/19/2011 and on 7/20; pt had double vision, nausea and headache.
Chills, fatigue, aches and pains, fever, and night sweats beginning approximately 14 hours after the vaccine and starting to subside approximately 18 hours after onset (took Tylenol)
pt recv vax 23SEP98 & stating pt was fussy & crying, vomiting x3 p/vax;
pt recv vax 15APR97 mom aware of red area on leg & brought pt to hlth dept;DTAP inj site lt leg  w/scant scab over inj site & red area approx 1/2" diameter & two 1/2" circles off one edge;induration present approx 1/3" around site;t98.2 ax
Patient developed fever up to 103.5 degrees Fahrenheit, chills, rigors, acute chest pain, diffuse joint and muscle pain, fatigue, nausea, severe headache, and lymphadenopathy of the left axial, total submandibular, and left supraclavicular regions. These symptoms lasted approximately 48 hours, and the lymphadenopathy is ongoing, as is the nausea and fatigue.
Upper lip feeling numb/numbness resolving  @ 925 AM vs 138/77 P 66 O2 sat 100% RA
This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (subcutaneous). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The patient received SHINGRIX by subcutaneous route instead of intramuscular route, which led to intramuscular formulation administered by other route. About 1 year ago, the patient experienced injection site pain after a dose of SHINGRIX which lasted for 5 to 6 days. The reporter agree to follow up.
Bleeding in right ear; ear does not necessarily hurt but I feel moisture in it and when I tried to clean the ear with several stops; This is a spontaneous report from a contactable consumer.   A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 27Apr2021 14:30 (Batch/Lot number was not reported) as unknown, single (at the age of 32 years old) for COVID-19 immunisation.  Medical history included depression and anxiety.  The patient stated on 28Apr2021, "bleeding in right ear. I've never had an issue with my ears, I'm a healthy 32 year old woman. My ear does not necessarily hurt but I feel moisture in it and when I tried to clean the ear with several stops, blood is on each stop. It's been 5 days and my ear is still bleeding with unknown cause". Prior to vaccination, was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient received no treatment. The outcome of the event was not recovered.   Information on the lot/batch number has been requested.
Pregnant; This spontaneous pregnancy case was reported by a consumer and describes the occurrence of PREGNANCY (Pregnant) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 030L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 27-Oct-2021. On an unknown date, the patient experienced PREGNANCY (Pregnant). At the time of the report, PREGNANCY (Pregnant) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information provided.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 32year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Breakthrough case admission after two vaccines Pfizer 12/16/21 Lot# FJ8757;  Pfizer 1/7/22 Lot# FJ6369
she is really itchy; This is a spontaneous report from a non-contactable consumer or other non hcp reporting for herself (patient) via Pfizer sponsored program.  A female patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown, expiry date: unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient received a dose of the vaccine a week ago and just said that she was really itchy on an unknown date. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Initial report received from a health care provider on Nov 8 2005. A 49 year old female patient with a possible history of asthma or COPD received an intramuscular deltoid injection of Fluzone no preservative 2005 2006. lot number U1802BA, on Oct 25 2005. Eight days later, she developed sensitivity to touch and an alternate sensation of burning and cold to both lower extremities. On Nov 5 2005, these symptoms became worse with the additional onset of stuttering. On Nov 7 2005, the patient experienced decreased feeling, an inability to move both lower extremities and was hospitalized. Per the reporter, results are pending for an MRI of the brain without contrast and a lumbar puncture culture, VDRL, bacteria, virus, and fungal. At the time of this report, the diagnosis was unconfirmed. The patient was treated with prednisone starting on Nov 2 2005 and discontinued at the time of hospitalization. The patient denied illness at the time of vaccination, and other medications were not reported. Number of previous doses was reported as past years. At the time of this report, recovery status was not reported.
Pt reports she started getting a rash on her chest and abdomen starting the day after her vaccine, which spread to her "whole body" by the end of day 04/14/2023. She treated with Benadryl several times daily until yesterday (04/18/2023) when the visible rash resolved. She tried to skip Benadryl but noted severe itchiness, so she has continued taking Benadryl.
This case was reported by a consumer via call center representative and described the occurrence of gastrointestinal disorder in a female patient who received SHINGRIX. On 12th March 2018, the patient received SHINGRIX. In March 2018, less than a week after receiving SHINGRIX, the patient experienced gastrointestinal disorder. On an unknown date, the outcome of the gastrointestinal disorder was unknown. It was unknown if the reporter considered the gastrointestinal disorder to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. This case was reported by the patient's husband. The patient received the SHINGRIX vaccine this past Monday and she was experiencing gastrointestinal issues.
I lost all the hair at the top of my head. I was already slowly balding/ thinning. Two weeks after the injection my scalp felt like it was on fire and the hair started falling out in clumps easily.; I lost all the hair at the top of my head. I was already slowly balding/ thinning. Two weeks after the injection my scalp felt like it was on fire and the hair started falling out in clumps easily.; This is a spontaneous report from a contactable Other-HCP (patient). A 29-year-old male patient received BNT162B2 (Lot/Batch number and expiry date unknown), via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunization. Medical history included High blood pressure and depression, both from unknown date. Concomitant medication included venlafaxine and lamotrigine. On 30Dec2020, the patient lost all the hair at the top of her head. He was already slowly balding/thinning. Two weeks after the injection, his scalp felt like it was on fire and the hair started falling out in clumps easily. The hair has not grown back. The patient did not receive any treatment for the event. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was not recovered.   Information on the lot/batch number has been requested.