chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tingling around cheek bones area/mild tingling around cheek bones area; This is a spontaneous report from a non-contactable consumer (patient) reported in response to non-HCP letter sent in cross-referenced case. A 71-years-old patient of an unspecified gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiration date: unknown) intramuscular, administered in left arm on 17Mar2021 at 10:50 am (age at vaccination was 71 years) as 2nd dose, single for COVID-19 immunization. The patient did not have any medical history. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiration date: unknown) intramuscular, administered in right arm on 24Feb2021 at 10:55 am (age at vaccination was 71 years) as 1st dose, single for COVID-19 immunization. On 24Feb2021 at 11:10 am, after the 1st dose, the patient experienced mild allergic reaction to the first shot, tingling hand & face and hips turned numb. Duration of symptoms was 3.5 hrs. The facility where the most recent COVID-19 vaccine was administered was other. The vaccine was not administered at  Facility. The patient did not receive any prior vaccinations. On 17Mar2021 at 11:35 am, after the 2nd shot, the patient experienced mild tingling around cheek bones area. No treatment was received for the adverse event. The patient did not have any relevant tests. The seriousness criteria was reported as Important medical event. The outcome of the event was resolved on an unknown date in 2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient received the fluarix vaccine on 9/24/18 and 2 days later he broke out in hives all over his body after he participated in PE class at school.  Hives went away 2 hours after they began with no medication.  Since he had the flu vaccine, Patient still breaks out with hives all over body any time he exerts himself and his body tempo rises.  So in PE class or playing basketball or running outside.  He has been to a allergy specialists and they diagnosed him with Chronic Uticaria.  But there has to be answers of why and how long this can go on.  We thought by now this would have gotten better.  We can control it a bit by taking high doses of antihistamines before doing activities.
A marked increase in existing tinnitus in both ears; This is a spontaneous report received from a contactable consumer, the patient. A 64-year-old male patient received his second dose of BNT162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 23Mar2021 at 13:45 (at the age of 64-years-old), as a single dose for COVID-19 immunisation. The medical history included bipolar disorder, erectile dysfunction, tinnitus from an unknown date and patient had known allergies to opioids. Concomitant medications included simvastatin (MANUFACTURER UNKNOWN), lamotrigine (MANUFACTURER UNKNOWN), bupropion (MANUFACTURER UNKNOWN) and sildenafil (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient previously received his first dose of BNT162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 02Mar2021 at 13:45 (at the age of 64-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. On 24Mar2021 at 10:00, the patient experienced a marked increase in existing tinnitus in both ears and would estimate the intensity has doubled. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The patient did not receive any treatment for the events. The outcome of the event tinnitus aggravated was not recovered at the time of reporting.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date in 2013, the patient was vaccinated with a dose of ZOSTAVAX (exact dose, route of administration, anatomical localization, lot # and expiration date were not reported) for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 17-JUL-2016, the patient was treated for a vesicular outbreak, which was diagnosed as herpes zoster or shingles (onset date unspecified). As a direct and proximate result of 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 had suffered and would continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of vaccination failure and herpes zoster was unknown. The reporter considered vaccination failure and herpes zoster to be related to ZOSTAVAX.
Pt recv vax in July '97; 2 - 3 day following  vax pt exp impotence.
A report has been received from a Health Professional concerning a 5th patient of 42 patient, male, born on 19-Sept-2002, who had been receiving Nasal FLUMIST QUADRIVALENT (INTRANASAL). FLUMIST QUADRIVALENT started on 16-Jan-2014. The patient was gave expired FLUMIST QUADRIVALENT. The outcome of the event of gave expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Very bad arm muscle pain  in upper arm, swollen red welt and inching at injection site.
The lymph nodes on the left side of my neck/collar bone became extremely swollen to about the size of a tennis ball again. The lymph nodes under my left arm became swollen. There was also pain in the back of my neck up to the base of my skull.
This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle ache), CHILLS (chills) and NAUSEA (nausea) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle ache), CHILLS (chills), NAUSEA (nausea) and PYREXIA (fever). On 07-Apr-2021, the patient experienced CHEILITIS (sore lip) and LIP SWELLING (swelling lip). At the time of the report, FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle ache), CHILLS (chills), NAUSEA (nausea), PYREXIA (fever) and LIP SWELLING (swelling lip) had resolved and CHEILITIS (sore lip) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications was not provided by the reporter. Treatment for the events included dermal fillers.
pt recv vax; 1 wk later, c/o numbness in hands & feet; had severe falls & unable to step up the stairs or up a curve; dx by neurologist-GBS; absence of leg reflexes;
Information has been received from a registered pharmacist concerning a 64 year old female with no medical history or a drug allergy who on 16-Mar-2009 was subcutaneously vaccinated with a 0.65 dose of ZOSTAVAX (Merck) (lot#663775/1789X) in the left deltoid area. There was no concomitant medication. On 18-Mar-2009 the patient developed a red raised area 3 inches wide at the site of injection after administration of ZOSTAVAX (Merck). She did not recover at the time of reporting. The patient contacted with physician concerning the female patient with aspirin (ASA) allergy, osteopenia, migraine, mitral valve prolapse (MVP) ,and spondylolisthesis who was vaccinated with a dose of ZOSTAVAX (Merck) at a pharmacy. The patient also was intramuscularly vaccinated with the first dose of pneumococcal vaccine (unspecified) (manufacturer unknown) at 09:20 on 24-Feb-2009. The patient did not have illness at time of vaccination. The patient developed 4-5" area at injection site that was light swelling and warm to touch. There was no pain. Subsequently, the patient recovered on unspecified dates. There was no lab test. No further information is available.
Information has been received from a registered nurse concerning a 31 year old female with allergies to penicillin, erythromycin, and sulfa, who on 27-Sep-1999 was vaccinated SC with the first dose of varicella virus vaccine live in the left deltoid. Concomitant therapy icluded ibuporfen. On 19-Oct-1999 the pt experienced herpes zoster on the right side of the face. Pt also experienced pain with the rash, painful lymphadenopathy on the right side of the face and a lesion on the right brow. The pain was evaluation by the patient as 5-6 on a scale of 0-10. On 19-Oct-1999, varicella zoster virus IgG antibody test was negative (after one dose). CBC, ESR, and sinus x-rays were performed (results not reported). On 25-Oct-1999 sge was seeb bt a physician for facial and preauricular lesions, and then was evaluated by an ophthalmologist (results not reported). Subsequently, the patient recovered. No further information is available.
elevated fever 103 & 104 even w/APAP was taken to ER approx 6hr to get fever down;future vax of DT rather then DTP;
4 days after vaccine, a migraine headache and fatigue came on. In the night at 3 am , fever was 100.1 and stayed there about between 99.0 and 100.5 from then until present (7 days after shot). Swollen lymph nodes in armpit and groin. Body aches , terribly painful raised rash all over body but especially at armpits. All symptoms continue now at 1 week since shot.
Initial report received on 27 November 2006, from a healthcare professional. A 13 year old female patient received on 15 November 2006 Adacel (lot number C2340AA), first dose, intramuscular, Vaqta (lot number 0613F), Fluvirin (lot number 69424). On the same day (15 November 2006), the patient eyes closed for a few minutes and she seemed faint, but then fully recovered. Her arms moved in tremor. The patient's parents reported low grade temperature of 100 (Fahrenheit), headache, earache and sore throat. Corrective treatment was not reported. The patient outcome was not reported. The patient's medical history was not reported.
Injection site, red, swollen, itching over past 6 days. Swelling has improved but pain and sensitivity and rash remain at injection site.
Pt had intestinal cramping rash to face shoulders back and neck, weak and tired after receiving vaccine same day.
Swelling, red left elbow above shoulder painful to touch after pt had shot approx 2 hrs after 2 hours after vaccine - myalgias severe - it pain x 2 days -> cold sweats pink/red rash around site tender and swelled (L) axilla.
pneumonia; urinary tract infection (UTI); talking nonsense and not being clear; The reason the patient did not have the second dose one month from the first dose is because she got ill; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (pneumonia), URINARY TRACT INFECTION (urinary tract infection (UTI)) and COMMUNICATION DISORDER (talking nonsense and not being clear) in a 94-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medication history was provided). Concomitant products included ASCORBIC ACID, BETACAROTENE, COPPER, TOCOFERSOLAN, ZINC (OCUVITE [ASCORBIC ACID;BETACAROTENE;COPPER;TOCOFERSOLAN;ZINC]), ASCORBIC ACID, CALCIUM, MINERALS NOS, RETINOL, TOCOPHERYL ACETATE, VITAMIN B NOS, VITAMINS NOS, ZINC (CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]), METOPROLOL TARTRATE (METOPROLOL TARTRATE ACCORD), CLOPIDOGREL and DULOXETINE for an unknown indication, ACETYLSALICYLIC ACID (ASPIRIN 81).    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (pneumonia) (seriousness criterion hospitalization), URINARY TRACT INFECTION (urinary tract infection (UTI)) (seriousness criterion hospitalization), COMMUNICATION DISORDER (talking nonsense and not being clear) (seriousness criterion hospitalization) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The reason the patient did not have the second dose one month from the first dose is because she got ill). At the time of the report, PNEUMONIA (pneumonia), URINARY TRACT INFECTION (urinary tract infection (UTI)), COMMUNICATION DISORDER (talking nonsense and not being clear) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The reason the patient did not have the second dose one month from the first dose is because she got ill) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       While hospitalized she was diagnosed and treated for a UTI, with intravenous fluids and antibiotics. Patient was discharged from the hospital with Foley's catheter and rehabilitation was advised. While hospitalized she was due for her second dose but she got pneumonia, so she was not given the second dose. The reporter assumes the pneumonia was bacterial, because the patient was treated with antibiotics.  Very limited information regarding the events has been provided. Further information was requested.; Sender's Comments: Very limited information regarding the events has been provided. Further information was requested.
The patient was 7 at the time of the vaccination and inadvertently received the adult dosage of Pfizer vaccine instead of the pediatric dosage.
This medically confirmed report concerns a 1 year 2 month old male patient with medical history of eczema, adenoidectomy and ear tubes placed bilaterally in SEP-2009. The patient had no concomitant medications. On 28-OCT-2010, the patient received flu vaccine (manufacturer unspecified). The patient also received on the same day VARICELLA, MMR II, VAQTA and PREVNAR. On 03-NOV-2010 and 04-NOV-2010, 7-8 days post vaccination, the patient experienced a fever as high as 105.5F and extreme irritability. On 05-NOV-2010 and 06-NOV-2010, the patient developed a red rash over his trunk and his fever was low grade. On 07-NOV-2010, the patient did not have a fever or rash but developed 'ataxia' where he 'was falling everywhere' and had difficulty ambulating without assistance. The reporter stated that the irritability and fever have subsided but the ataxia persists. The ataxia is worse when he stops walking and when he looks up. On 19-NOV-2010, the reporter states that the patient seems not to be falling as much but is running into objects. When he moves his head he seems to fall. The patient has a wide based gait. The patient has been evaluated by a pediatric neurologist who believes that he has acute cerebellar ataxia. The event outcome was not recovered. Reporter comments: The reporter considered the case to be serious due to significant disability or incapacity. The reporter states that 'it will be two weeks this Saturday (20-NOV-2010) from when his ataxia started and he is not really improving'.
Swelling of lips at night with severely swollen lips in the morning. Chapped dry lips that?s burn and itch. This has been on going since about 2 weeks after my shots. Last week we trialed a weeks dose of prednisone and loratadine but once the meds were done the swelling and itching have returned
Patient came to us for 18 mo WCC. No records transferred or hand carried. Mom stated UTD and wanted to continue with 18 mo shots. Vaccine given. Records received later on and patient already had immunization at 15 mo WCC: Mom and doctor aware no harm done.
was taken to the hospital ER on 7/29/2022 with numbness in her lower extremities.  She has been in the hospital since that day.  Friday  August 5, 2022, she was diagnosed with Guillain-Barre Syndrome and is totally paralyzed from the chest down at this point.  Doctors are sending her to a rehab center aftercare in the next few days.  She has no use of her legs and has no feeling from just under her breast to her ankles with extreme neuropathy in both feet.
shake/shaking, but very mild; I had a wave of chill; I had fatigue after first and second shot; ears were red; mild allergic response; my cheeks were beat red; This is a spontaneous report from a contactable Physician. This female Physician reported for herself that: A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation; Solution for Injection,Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as Dose 2, Single for Covid-19 immunization. The patient medical history was not reported. Concomitant medication(s) included Diphenhydramine Hydrochloride (BENADRYL) taken for an unspecified indication, start and stop date were not reported. Historical vaccination included the patient previously received  bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation; Solution for Injection, Batch/Lot number was not provided) via unspecified route of administration on an unspecified date as Dose 1 Single for COVID-19 immunisation and experienced Fatigue. On an unspecified date,the patient experienced Shake/Shaking, But Very Mild and I had a wave of chill, I had fatigue after first and second shot, Ears Were Red, Mild Allergic Response and My cheeks were beat red on an unspecified date. The events were assessed as non serious. The outcome of events for Shake/Shaking, But Very Mild and I had a wave of chill was recovered on an unspecified date while the outcome of the rest of the events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Started having fever, body aches, nausea, fatigue, numbness/tingling in right arm, right shoulder pain, painful to light touch and cold sensation in arm within 3 hours of injections. Started with rash 1.5 days later in affected arm. Prescribed baclofen and gabapentin for pain and neuropathic pain. TYLENOL EXTRA STRENGTH for aches and pains.
DIARRHEA; This spontaneous report received from a consumer concerned an 88 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, once a total administered, start therapy date was not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of diarrhea was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna Vaccines on 3/8/2021 and 4/5/2021. On 1/3/2022 presented to ED with acute hypoxemic respiratory failure due to COVID-19 with multiple comorbid conditions. Developed severe acute encephalopathy and dysphagia with inability to tolerate oral intake c/b aspiration. Treated w/antibiotics and decadron for his covid pneumonia. He was not a candidate for other therapies. Continued to decline and required continuous NIPPV for several days. Expired 1/14/22.
Moderna COVID-19 Vaccine   Around 8 hours after the shot, my left shoulder started to hur, when I raised my arm. Over the next few hours I grew more tired than usual with a very low-level, generalized ache. I went to sleep at 11. I woke up at 2 in quite a bit of generalized pain, left shoulder so painful I could not lie on my left side, unable to get comfortable in any position, feeling worse and worse. At 2:30 I got up, which immediately made me feel a bit better. I took an acetominophen, a half codeine acetominophen #3, and around 5 ml promethazine/codeine syrup. At around 4:00 I had some cheese and bread. At around 4:30 I was able to go back to sleep. I got up at 8:30, still achy/hurting, but distinctly better. I am writing this at 11 a.m. One other thing to note: after the shot I seemed to be having a  very odd, mild allergic reaction intermittently, when I ate some foods that I eat every day. Mostly it was a case of my hard palate itching.
rt post auricular swelling & tenderness 21SEP98;bilat neck lymphadenopathy;sore throat/hoarseness 28SEP98;runny nose/nose 2OCT98;fine rash forehead;blotchy neck 3OCT98;dull h/a 3OCT-MAY98;cough 3OCT98;
This spontaneous report as received from a medical assistant, referring to an unspecified number of patients of unknown genders and ages. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored dose of VAQTA which had Lot number  M040421 with expiry date on 26-MAY-2017 and lot # M036459 with expiry date on 18-JAN-2018 (strength and route were not reported) for prophylaxis, however no adverse effects reported. It was reported that the vaccines were exposed to temperature of > 8 but <25 Centigrade range for a time frame of 1 hour and 4 minutes. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA008046: US-009507513-1703USA008047: US-009507513-1703USA008048: US-009507513-1703USA008049: US-009507513-1703USA008050: US-009507513-1703USA008052: US-009507513-1703USA001827:
Extreme swelling,redness,itching starting 8 days after injection starting 1/21/2021 and still have symptoms. Not going away.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 15 years old adolescent patient and unknown gender. On 12-SEP-2014 the patient was vaccinated with a dose of an improperly stored VARIVAX (Merck) (lot J009002, expiration date 19-JUL-2015 reported) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Rash began day after immunization. Not itchy, no pain. Erythematous papule with central firm papule, scattered on extremities. No vesicles. No pustules. No treatment given.
Pfizer 2/26/21, 3/19/21, 9/21/21, 4/2/22, 10/24/22. Positive on 12/16/22
pt recv vax 16MAY96 245PM & 30min p/vax pt & mom returned to nurse because of hives on both arms & face;nurse called pt pvt MD who said to use DPH & report rxn;
Itchy large welts on back and side of right leg from buttocks to ankle. Took 50 mg of Benadryl and applied Afterbite to leg  immediately.  Most welts subsided within a few hours.  Took another 50 mg of Benadryl Saturday night. Still have a few small areas of redness. Between the time of vaccination and outbreak, I did not eat anything new, no new clothes detergent, no changes.