chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a healthcare professional and described the occurrence of facial nerve pain in a male subject of unspecified age who was vaccinated with ENGERIX B (GlaxoSmithKline). The subject's medical history included seasonal hayfever. On 28 September 2010 at 13:14 the subject received 1st dose of ENGERIX B (unknown, left arm). On an unspecified date in 2010, 4 or 5 days after vaccination with ENGERIX B, the subject experienced left side facial nerve pain and face pressure. Approximately two weeks after vaccination with ENGERIX B, the subject experienced fever. The subject reported that it was difficult to touch his face due to such pain. He visited a dentist, neurologist and oral surgeon regarding this issue. The facial pain got better with Gabapentin and Vicodin, but never went away. The neurologist did a computed tomography (CAT) scan, magnetic resonance imaging (MRI) and lumbar puncture which were normal. He was placed on antibiotic for the fever and it went away after 10 days. Specific dates regarding when the events occurred or resolved could not be provided. The healthcare professional considered the events were disabling and clinically significant (or requiring intervention). The subject was treated with unspecified antibiotic, Gabapentin and Vicodin. At the time of reporting the outcome of the facial nerve pain improved, fever resolved and face pressure was unspecified. The subject experienced events with the 2nd dose of ENGERIX B, see case A0890416B.
She was supposed to receive the first primary covid 19 shot, but they gave her the bivalent booster.
This spontaneous report as received from a registered nurse refers to a 14 months old male patient with no drug reactions or allergies. The patient's medical history included cleft-lip repair. On 10-APR-2013 the patient was vaccinated with the first and only VARIVAX (Merck) (INJ) (lot number and expiration date not reported) subcutaneous. There was no concomitant medication reported. On 01-JUL-2013, the patient was diagnosed with varicella. The patient sought medical attention and he was seen in the office. Calamine and baking soda paste was the treatment given for the event. No lab diagnostics studies were performed. The outcome of the event was reported as not recovered/not resolved. Additional information has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 71-year-old female patient who received SHINGRIX (batch number P3777, expiry date 20th January 2020) On 21st December 2017, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, chills and tremor to be related to SHINGRIX. Additional details were reported as follows: The event lasted about a day. No further information was provided.
Red and warm to the touch and it is moving to the left arm and very itchy. Ice, Tylenol recommended Benadryl.
Pneumonia vaccination given 5/27/11 at 3:10pm. 5/28/11 early evening breathing problems. Noted approx 3" redness (R) deltoid. Called on call MD at 10:15pm with trouble breathing - sent to ED. O2 Sat 100%, lungs clear, no resp distress. Has asthma. Albuterol didn't help. Given BENADRYL.
between 9:30am and 11am she had excessive discharge/noticed the presence of both blood clots and bright red blood; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of HEAVY MENSTRUAL BLEEDING (between 9:30am and 11am she had excessive discharge/noticed the presence of both blood clots and bright red blood) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced HEAVY MENSTRUAL BLEEDING (between 9:30am and 11am she had excessive discharge/noticed the presence of both blood clots and bright red blood). At the time of the report, HEAVY MENSTRUAL BLEEDING (between 9:30am and 11am she had excessive discharge/noticed the presence of both blood clots and bright red blood) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication included 1 iron pill
Developed itching on the 8th and the 9th she had a red rash that resembled hives but went from her neck to stomach.
No additional AE; HCP calling to report AE for PROQUAD and VARIVAX. HCP reports both vaccines were administered simultaneously to a patient on 29AUG2023. HCP reports no side effects to the patient. Both vaccines were not expired and never experienced temperature excur; This spontaneous report was received from a medical assistant and refers to an 1-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 29-AUG-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, unk, lot #W035460, expiration date: 06-MAY-2024, administered for prophylaxis (strength, and route of administration were not provided); and  varicella virus vaccine live (oka/merck) (VARIVAX) injection, unk, lot #X006983, expiration date: 07-MAR-2025, administered for prophylaxis (strength, and route of administration were not provided) (Overdose). There was no side effects to the patient. Both vaccines were not expired and never experienced temperature excursions.
pt recv vax 9JAN98 & 19JAN98 pt devel a maculopapular rash consisting of approx 20-30 red papules, mainly on the trunk, & a few on extremities;pt also exp itching & T105;also devel pox lesions;
second shot triggered Shingles /Suspected vaccination failure; shingles; marks on his arm; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and skin disorder. On an unknown date, the outcome of the vaccination failure, shingles and skin disorder were unknown.   The reporter considered the vaccination failure, shingles and skin disorder to be possibly related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 24-SEP-2022 Reporter's comment: This case was reported by the patient's wife via interactive digital media. The reporter stated that patient's Shingrix second shot had triggered his Shingles, the doctor said, and he would still have marks on his arm that would never go away. The reporter thought that the event might have been related to the vaccine. Additional supportive information: This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not possible, as no contact, details were available. This case had been linked with US2022AMR137779, reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR137779:Same reporter
Fever, Diarrhea, NauseaVomiting, HYPERtension,  Tachycardia, c/o metalic taste in mouth,sob Narrative:
Pt developed a 2 inch area of red, raised, hot, itchy, "burning" spot on the back of Rt arm at injection site. Symptoms developed within 24 hours, lasting about 1 week. Pt given BENADRYL.
p/vax pt attributed sinus congestion to environmental allergies;took med;later w/swelling, redness on hand & feet & raised lesions on buttocks, legs and ears;sx improved w/DPH but lesions & swelling remain;
Patient came into pharmacy 9/23 - left arm red and swollen told her to go to clinic - the could not see her had to go to primary - they gave her a shot and oral antibiotic and said it was a "bad infection" - cellulitis.
pt recvd vax & exp onset of grunting & straining; pt was taken to ER while in ER, pt had low oxygen saturation & was treated w/oxygen; pt also exp tachypnea; pt was transferred to & adm to another facility for hospitalization;  bilat diff
Dizziness, nausea, arm throbbing and muscle pain and weakness, headache, breathing problem fever, chills.   All within 2 hours of shot. Today is 12/18/2014 and still ill with moderate symptoms.
Chills, headache, muscle aches, nausea, fatigue, injection site pain.  Nausea and headache being the worst two.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 15-MAY-2013, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), at a medical center (by an unspecified healthcare professional) as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster.  On or about 01-NOV-2014, the patient was treated (by an unspecified health care professional) at the medical center for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of these malfunctions, 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. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events is unknown. Additional information has been requested.
Pt exp ax lymphadenopathy w/in 1 hr of receiving Hep B vax; w/in 24 hrs pts sx resolved;
Immediate tenderness and erythema reported by patient, worsening 24 hours later, this persisted 48 hours. At 48 hours less erythema at PPD site.  No induration at PPD site.
Pt fainted shortly after the vaccination. She did not lose consciousness. I laid her on the floor and she felt better.
102 degree temp not able to be controlled by Tylenol or Ibuprofen started 5 hours after vaccination and lasting 7 hours. Elevated heart rate and bounding pulses during that time frame. Extreme body aches. Extreme fatigue days after vaccination. Abdominal tenderness and nausea lasting days after vaccination.  Tylenol and  Ibuprofen used to treat pain and fever.
PT SELF-REPORTS LOCALIZED SWELLING AND PAIN ON RIGHT SIDE FROM 2ND DOSE OF SHINGLES VACCINE SHE RECEIVED AT LOCAL PHARMACY. PT REPORTED SYMPTOMS TO MD OFFICE AND HAS A FOLLOW UP APPT WITH THEM AS CHECK-UP.  PER PT, MD OFFICE ADVISED USING ICE TO HELP WITH SWELLING. ALSO CALLED MD OFFICE TO COMMUNICATE PT REPORTS OF VACCINE SIDE EFFECTS
Fever, headache, chills, pain at injection site, body aches, and fatigue
Redness and slight pain at injection site. Redness approximately 1/2 inch outside of injection site.
Patient states that two days after receiving the vaccine he noticed redness around the injection site. He states that the redness has spread down toward his elbow and the reaction site is about 2 inches wide and 6 inches long spreading toward the elbow. He states that the site is tender to the touch but is having no other symptoms.
Information has been received from a physician concerning a male patient over the age of 65 who on 10/10/05 was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine (lot 65032/1039P). Subsequently the patient presented to the office with complaints of "cellulitis type reaction", swelling, redness and fever. The onset of the symptoms was within 2 to 3 day post vaccination. The patient was treated with acetaminophen (Tylenol), ibuprofen (Advil) or ice packs as needed. The patient was also treated with unspecified antibiotics, and the symptoms improved. At the time of this report, the patient was recovering. The physician expressed concern for lot 650302/1839P and requested that a lot check be performed on lot 650302/1039P. The physician felt that cellulitis type reaction, swelling, redness and fever  were disabling. Additional information has been requested.
Headache (no relief with ibuprofen), fever, chills, nausea (puking), sweats and body aches for 2 nights, 2 days.
DVT; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEEP VEIN THROMBOSIS (medically significant), outcome "unknown", described as "DVT".   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I've had too much stomach upset; Severe heartburn; Persistent mouth dryness; The taste in my mouth changed; Extreme fatigue; This is a spontaneous report from contactable healthcare professional. A 35-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on 27Jan2021 09:15 at single dose (left arm) for COVID-19 immunization. The patient medical history was not reported. The patient had no known allergies. The patient was not pregnant. There were no concomitant medications. The patient had no other vaccine in other 4 weeks. On 28Jan2021, at 12:00, the patient experienced too much stomach upset, severe heartburn, persistent mouth dryness, the taste in mouth changed and extreme fatigue. The patient received therapy for the events included household medication and natural treatment. The patient did not have covid prior vaccination and was not covid tested post vaccination. Outcome of events was not recovered.   Information on the batch/lot number has been requested.
pt recv vax 29MAR96 & 13APR96 pt exp lt parotid swelling which did not occur p/vax;no fever was assoc w/the swelling;pt condition required a MD visit;subsequently pt recovered;
15 month old with history of febrile seizures was noted to have seizure lasting 30 seconds to 1 minute. Seen and examined. Throat slightly red; rapid strep - negative. Child diagnosed with febrile seizure 2 hours to MMR (questionable). Exam normal.
Severe redness, severe swelling, pain, hot to touch, lasting (currently on day 6), shortness of breath, impaired mobility.
Nausea. Light headedness. Slight fever. Headache. Body aches. Lack of taste.
This is a spontaneous report from contactable Nurse via Pfizer Sales Representative. A 66-year-old female patient received PREVNAR 13 (lot # X47910) via an unspecified route of administration at single dose on 04Apr of an unspecified year for immunisation. No other vaccines were given. The patient medical history was not reported. The concomitant medications were none. The patient experienced Guillain-Barre syndrome on an unspecified date after vaccination, for which she returned to clinic on 22Apr (year unspecified). The outcome of unknown. No follow-up attempts are possible. No further information is expected. Sender's Comments: There is no plausible mechanism to implicate PREVENAR 13 to the occurrence of the serious event "Guillain-Barre syndrome" due to the information currently available. More information such as medical history and concomitant medications are needed for fully medical assessment. 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.
About two hours after the vaccine I started experiencing vertigo, nausea, and lightheaded was, which lasted the remainder of the day. About seven hours after the vaccine, I laid down and started having heart palpitations - I could feel my heart beat in my whole body and it was racing. My feet became tingly. The heart palpitations lasted for about 20-30 minutes. Since the vaccine (four weeks ago) I have experienced some vertigo off and on.
itching all over, even in her ears; feeling short of breath; Chest hurting; itching all over, even in her ears; skin was red from scratching it, but thought it had been somewhat blotchy, too, on her legs; This is a spontaneous report from a contactable consumer (patient's grandmother/Guardian). A 15-years-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EW0167, Expiration date was not reported), via an unspecified route of administration, administered in left arm on 19May2021 at 16:30 hours as 1st dose, single dose (at the age of 15-years-old) for COVID-19 immunization. Medical history included seasonal allergy and allergy to cats (from an unknown date and unknown if ongoing). Patient had no covid prior vaccination. Concomitant medication included clonidine extended release (ER) at a dose of 0.1 mg daily taken for an unspecified indication, start and stop date were not reported. Patient was not covid tested post vaccination. 0n 19May2021 at 19:45 hours (about 3 hours after receiving her shot), patient complained of itching all over, even in her ears, patient also mentioned her chest hurting and feeling short of breath. Patient was not sure whether her skin was red from scratching it, but thought it had been somewhat blotchy, too, on her legs, possibly because that was the area uncovered so she could see it. The blotchiness and chest pain resolved quickly, but the itchiness continued. Patient also complained of stomach pain, which occurred after patient's grandmother gave her a loratadine. The loratadine settled the itching down, but patient reported nausea the next morning and shortness of breath, as well. Patient received Claritin 24 Hr for the events as treatment. The outcome of the skin was red from scratching it, but thought it had been somewhat blotchy, too, on her legs and chest hurting was recovered on May-2021 and recovered for rest of the events in 2021  Follow up needed, further information has been requested.
Information has been received from a licensed practical nurse (L.P.N.) concerning a female who was vaccinated with a dose of GARDASIL.  Subsequently the patient developed a seizure disorder.  It was not specified if medical attention was sought or not.  At the time of this report, the outcome was unknown.  Upon internal review, the patient's seizure disorder was determined to be an other important medical event.  Additional information has been requested.
Patient brough to the ED by EMS with shortness of breath, poor appetite, and insomnia on 10/25/22. He had a COVID test done in the ED which came back positive. He was admitted 10/25-10/29 for treatment of acute hypoxic respiratory failure which was felt to be multifactorial with COVID-19 pneumonia, COPD, and CHF.  He initially required supplemental O2, was weaned down. Patient has been vaccinated with initial COVID series but has not yet received the booster.
This spontaneous report as received from a licensed practical nurse refers to an unknown number of patient of unknown age and gender. Since 02-JAN-2015, an unknown number of doses of VARIVAX (Merck), (exact dose, anatomical location, lot # and expiration date were not reported) which underwent supported temperature excursion, have been subcutaneously administered to an unknown number of patients. No adverse effects reported. This is the one of several reports from the same reporter source. Additional information has been requested.
17 year old was given flublok qiv with no reported adverse event; Initial information received on 24-Oct-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 17 years old (unknown gender) patient who was given INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 24-Oct-2022, the patient received suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (strength, formulation, dose, route: unknown) (lot number and expiry date: not reported) in unknown administration site for Immunization and 17 year old was given flublok qiv with no reported adverse event (product administered to patient of inappropriate age) (latency; same day).  It was reported, She says that the patient is fine but they would like to know information about its use to younger patients and if they should revaccinate. This situation is reported as a medication error due to administration to a patient younger than indicated.   Action taken with QUADRIVALENT RECOMBINANT INFLUENZA VACCINE (FLUBLOK) was not applicable.  At time of reporting, the outcome was Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Got Tdap yesterday at office.  By last night, 8 hours later, began to feel right arm pain, then head pounding, balance issues, nausea, chills, shortness of breath.  Now his hips feel pressure, his head feels squished, and R arm hurts like it has been hit by a baseball bat.  Now it is 24 hrs later and he looks ill, face and head & neck are pink and were not yesterday.  Got shot in right arm, left arm just feels fatigue.
Information has been received from a registered nurse concerning an "11 year old" male patient who on 22-JUL-2010 was vaccinated with the second dose of VARIVAX (Merck) (lot # 666863/0467Z). On 23-JUL-2010 the patient returned to the office with discomfort and redness (unspecified where). At the time of the reporting, the patient's status was unknown. This is one of two reports from the same source. The patient's sibling's experience has been captured in WAES1008USA01911. Additional information has been requested.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2013, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2016, the patient was treated at a medical facility for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, 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. Additional information has been requested.