chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt experienced dizziness immediately then approximately 6 minutes later felt lip and tongue numbness.  I gave the patient 50mg of liquid diphenhydramine, after waiting approximately 40 minutes patient stated she felt fine and left.
Got shot at 11:30AM.  Patient called at 3pm, had low blood pressure and was lightheaded.  118/70, pulse 102, at 3:09, 112/65, pulse 71, 3:33, 128/66, pulse 69, 3:40 118/63, pulse 63.  She's feeling better.  She just asked if this could be a reaction to the flu shot.  I said I'd call MD.  Dr. didn't think low BP could be because of flu shot.  He never heard of that.  I called her at 6PM BP 14/82, pulse 56.  She was feeling better and said I must love my job to "put up with customers like her".  She was feeling much better.
RIGHT ANTERIOR THIGH CELLULITIS AT SITE OF INJECTION WITH ERYTHEMA, SWELLING, WARMTH, TENDER TO PALPATION.
Pt recv vax 13JUL92 & exp recurrence of severe ankle pain; lab eval on 27NOV92 revealed that pt was anti-HBs pos; No further details were provided;
POST MENOPAUSAL BLEEDING; ITCHING ON TONGUE AND WHOLE INSIDE OF MOUTH; BURNING ON TONGUE AND WHOLE INSIDE OF MOUTH; This spontaneous report received from a patient concerned a 55-year-old female. The patient's weight was 112 pounds, and height was 62 inches. The patient's concurrent conditions included Crohn's disease, and irritable bowel syndrome. The patient was a non-alcohol user and nonsmoker. The patient had no history of drug abuse or illicit drug usage. The patient experienced drug allergy when treated with ampicillin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: UNKNOWN) dose was not reported, administered, 1 total, to right arm on 08-MAR-2021 for prophylactic vaccination. Concomitant medications included fluoxetine hydrochloride for irritable bowel syndrome. After vaccination on 08-MAR-2021, the patient experienced itching and burning on tongue and whole inside of mouth. On 11-MAR-2021, 3 days after vaccination the patient experienced post-menopausal bleeding and had not bleed in 4 years and bled 3 days after the vaccine and bled for 7 days (like a heavy period). The patient went to gynecologist on 25-MAR-2021 and got a vaginal exam and internal ultrasound and was normal per physician. The physician recommended dilatation and curettage and this had not been as of yet. On 25-MAR-2021, Laboratory data included: Diagnostic ultrasound (NR: not provided) normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from post menopausal bleeding on 18-MAR-2021, and had not recovered from itching on tongue and whole inside of mouth, and burning on tongue and whole inside of mouth. This report was serious (Other Medically Important Condition).; Sender's Comments: V0. 20210435799-covid-19 vaccine ad26.cov2-Post menopausal bleeding. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
CHILLS/SHIVERING; PAIN IN THE NECK MUSCLES; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy to antibiotics, and type 1 diabetes mellitus. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and batch number: 202A21A expiry: 23-JUN-2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. Concomitant medications included insulin for type 1 diabetes mellitus.  On 09-APR-2021, the subject experienced chills.  On 09-APR-2021, the subject experienced pain in the neck muscles. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, and pain in the neck muscles. This report was non-serious.
woke with myalgias (left-sided) and significant pain left axilla.; woke with myalgias (left-sided) and significant pain left axilla.; swollen axilla and golf-ball sized lymphadenopathy; swollen axilla and golf-ball sized lymphadenopathy; mild fever (100.4) in AM; This is a spontaneous report from a contactable physician who reported for herself. A 43-year-old female patient received her second single dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine, lot number EL1283) Intramuscularly at left arm 15:15 on 17Jan2021 for Covid-19 immunization. Patient received her fist shot (Lot number EI0142) intramuscularly at left arm 06:45 PM on 27Dec2020. The patient had a medical history included factor V leiden, and Hashimotos thyroiditis. Patient had no known allergies. Concomitant medications included rivaroxaban (XARELTO), levothyroxine, rizatriptan benzoate (MAXALT). No other vaccines were taken within four weeks. 12 hours post vaccine (around 04:00 AM on 18Jan2021), patient woke with myalgias (left-sided) and significant pain left axilla. It was noted swollen axilla and golf-ball sized lymphadenopathy. Also, she had mild fever (100.4) in AM. The patient had no COVID prior vaccination and had no COVID tested post vaccination. The outcome of the events was unknown.  Amendment: This follow-up report is being submitted to amend previously reported information: Laboratory test "mild fever (100.4)" as "Body Temperature" updated in lab data section in Patient tab.
A report was received from a health care professional on 11/22/02, concerning a group of vaccinees less than 4 years old of unknown demography who inadvertently received Fluvirin from approximately 11/07/02 onwards. There was no reported adverse events. There was insufficient information to determine the reporter's causality assessment. Update (1) 12/10/02: A report was received from a health care professional on 12/10/02, indicating that a 3 and a half year old female vaccine was inadvertently administered Fluvirin intramuscularly on 11/12/02. The vaccinee experienced no adverse reaction. Cross reference: PJP20200848, PJP200200849, PJP200200850, PJP200200851, PJP200200852, PJP200200853, PJP200200854, PJP200200855, PJP200200856, PJP200200857, PJP200200858, PJP200200859, PJP200200860, PJP200200861, PJP2002862, PJP200200863, PJP200200864, PJP200200805, PJP200200866, PJP200200867, PJP200200868, PJP200200869, PJP200200870, PJP200200871, PJP200200872, PJP200200873, PJP200200874, PJP200200875, PJP200200876, PJP200200877.
This is a spontaneous report received from a non-contactable reporter(s) (Nurse). The reporter is the patient. A female patient received BNT162b2 (BNT162B2), on 04Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 22Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: AZITHROMYCIN, start date: 13Jun2022, stop date: 17Jun2022; Z-PAK, start date: 17Jun2022, stop date: 18Jun2022; ALBUTEROL [SALBUTAMOL], start date: 16Jun2022. Past drug history included: Compazine, reaction(s): "Known allergies: Compazine", notes: Known allergies: Compazine. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of vaccination failure, Covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and BNT162B2.
Injection Site Pain; Headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection Site Pain) and HEADACHE (Headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Injection Site Pain) and HEADACHE (Headache). At the time of the report, VACCINATION SITE PAIN (Injection Site Pain) and HEADACHE (Headache) outcome was unknown.            Reporter did not allow further contact
calling for temperature evaluation for VARIVAX and notifed it was administered to multiple patients; This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 28-APR-2020, the patient was vaccinated with an improperly stored dose of  varicella virus vaccine live (oka/merck)(VARIVAX)(strength, dosing schedule, lot#, expiration date and route of administration were not provided)  for prophylaxis. Administered dose of vaccine was exposed to the temperature from -14 Celsius degrees to -10 Celsius degrees for 4 hours 15 minutes. There was a previous temperature excursion noted: from -9 Celsius degrees to 8 Celsius degrees for 2 hours 21 minutes, as recorded by a digital data logger.          This is one of multiple reports from the same reporter.; Sender's Comments:  US-009507513-2007USA003458: US-009507513-2007USA004416:
Soreness at site leading to pain in shoulder.  By mid morning "stabbing pain" radiating down arm. Painful to move arm and shoulder.  "Inability to hold anything in hand due to shoulder pain" Took Tylenol without relief. 11/18/11 Symptoms relieved except for "dull ache".
Beginning 2/25/2021, I experienced severe pain in my left shoulder/neck area. The pain migrated to my right shoulder area over the next few days. My hands became numb, my arms were very weak with pain in my biceps and triceps of both arms. I had very limited range of motion of both arms. Significant weakness in both of my arms. Although less intense today, my symptoms have persisted through today.
Vaccinated with SPV in his left arm and he received anthrax (AVA) # 1, typhoid # 2 and his annual influenza in his right arm. He denied problems with previous vaccinations. Later that night he began to experience numbness in his 4/5th fingers. He sought medical evaluation on 04 Nov and was given NSAIDS. He had f/u visits in Dec, Jan, Feb, and Mar for persistent numbness, and left upper extremity weakness. He had no relief from an ulnar splint. His cervical MRI, revealed a mild disc bulge but no canal narrowing. On 11 Apr 11 he was evaluated by neurosurgery and underwent a repeat MRI. Per neuro, there is no evidence of a compressive neuropathy at the level of the C-spine. Neuro stated that his leading hypothesis is that this is some immune modulated idiosyncratic reaction and assessed as having non progressive subacute left ulnar nerve palsy. He was released with no limitations and was given a trial of a MEDROL Dose Pack. He was seen for follow up on 13 May where he reported that he still has some numbness to his hand and the provider stated that LUE weakness appears to be resolving and his strength has significantly improved from our last encounter.
16 days after immunization, I started having  increased Tinnitus and hearing loss. These condition s still exist today(3/15/2021)
Narrative:  Neutropenia....HX of CLL.Previously treated with ibrutinib,d/c'd 10/20. Transient decrease in patient's ANC: 1/5/21-1746 2/22/21-2019 3/2/21-1260 4/6/21-296 4/22/21-1572
terrible headache; neck pain; hurt everywhere; freezing all night; Flu like symptoms; i had arm pain with all three shots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 30Dec2021 11:00 (Lot number: 331308A) at the age of 64 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "endometriosis", start date: 1969 (unspecified if ongoing); "Hysterectomy", start date: 2001 (unspecified if ongoing); "Gallbladder" (unspecified if ongoing); "Gallbladder removal", start date: Nov2019 (unspecified if ongoing); "menopause" (ongoing); "Hypothyroidism" (ongoing); "muscular pain" (ongoing); "fibromyalgia" (ongoing). Concomitant medication(s) included: ESTRADIOL taken for menopause (ongoing); SYNTHROID taken for hypothyroidism (ongoing); LIOTHYRONINE taken for hypothyroidism (ongoing); CYCLOBENZAPRINE taken for myalgia (ongoing); NAPROXEN taken for fibromyalgia (ongoing). Vaccination history included: Bnt162b2 (Dose: 1st, Date: 08Mar2021, Anatomical Site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot Number: EN6205), administration date: 08Mar2021, when the patient was 63 years old, for Covid-19 immunization, reaction(s): "Itching for 2 months", "arm pain"; Bnt162b2 (Dose: 2nd, Date: 29Mar2021, Anatomical Site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot Number: ER8733), administration date: 29Mar2021, when the patient was 63 years old, for Covid-19 immunization, reaction(s): "plantar fasciitis", "foot pain", "arm pain". The following information was reported: HEADACHE (non-serious) with onset 30Dec2021 22:00, outcome "recovered", described as "terrible headache"; NECK PAIN (non-serious) with onset 30Dec2021 22:00, outcome "recovered", described as "neck pain"; PAIN (non-serious) with onset 30Dec2021 22:00, outcome "recovered", described as "hurt everywhere"; FEELING COLD (non-serious) with onset 30Dec2021 22:00, outcome "recovered", described as "freezing all night"; PAIN IN EXTREMITY (non-serious) with onset 30Dec2021, outcome "unknown", described as "i had arm pain with all three shots"; INFLUENZA LIKE ILLNESS (non-serious) with onset 30Dec2021 22:00, outcome "recovered", described as "Flu like symptoms". Therapeutic measures were not taken as a result of headache, neck pain, pain, feeling cold, influenza like illness.  Additional information: Patient had no prior vaccinations within 4 weeks. The night of the booster which patient got around 11AM. Patient got a terrible headache with neck pain. An hour later patient had hurt everywhere and patient was freezing all night. It eased up in the morning and was gone by that night. Patient had arm pain with all three shots but patient wasn't worried about that.  No follow-up attempts are possible. No further information is expected.
Severe allergic reaction with headache, body pain, swollen tongue, swollen throat,  allergic conjunctivitis, stiff jaw.
Patient passed out and fell to the floor hitting the back of his head before anyone could catch him. He said his vision got black and fuzzy and he fainted. We gave him a bottle of water,  family got him a soda, and he ate a few crackers. After he sat up in the chair we iced the bump on the back of his head and took a wet paper towel to put on the back of his neck and face. He felt really hot initially and pale throughout the time sitting there for about an hour. He was able to walk out without any other issues than the bump on the back of his head.
pt recv vax & for a few minutes p/vax pt exp numbness & tingling in legs & feet;these sx resolved;also exp soreness @ inj site, lt shoulder pain & pain down arm;these sx persist;
Pain at injection site and numbness of left arm immediately after shot.  Numbness and joint pain in the left arm and left hand about 20 min post.  Notable shaking in left and right hands for about 10 to 20 seconds. Increased water intake. Body temperature at 34.9C, 35.6C. Kept warm over night and have been normal since. The day after, additional side effects experienced include muscle spasm, sharp pain that comes and goes,  pain in ovaries, continued numbness and joint pain left arm and hand, and spread of numbness to fingers on the right hand.  3 days after, went to ER to see persisting numbing in left and right arm and hands. MRI scan of brain and neck was done with no major complications found. Numbing and join pain in arms and hands continue to persist.
This spontaneous report as received from a medical assistant refers to a patient of unknown age. On JUN-2017 the patient was vaccinated with GARDASIL 9 lot # M036059 for prophylaxis. On JUN-2017 the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to GARDASIL 9. Additional information has been requested. Sender's Comments: US-009507513-1709USA003437.
Pt temp @ 5PM 19AUG & 3AM 20AUG 104; given APAP @ those times; temp gradually dec; reports diarrhea started on eve of 20AUG pvt MD phoned told mom a virus is going around; no rxn given pt not seen by MD;
Patient received the Covid-19 vaccine today and within approximately 10/15 minutes post vaccination pt reported feeling dizzy. Pt taken to treatment area and vitals signs assessed as followed.  At 1638 157/72, HR 80 O2 100 1642 160/95, HR 86, O2 100 1647 149/95, HR 82, O2 100% 1647 141/98, HR 82, O2 100%.   At 1707 pt's vitals signs improved, BP137/79, HR 73, O2 99%, Pt reported dizziness subsided nd   was discharged home in stable  condition
unconscious for 15 minutes.; two teeth knocked out; lips busted; laid up for 3 days; fainted; This is a spontaneous report from a contactable consumer (Patient). A 71-years-old male patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Lot Number EW0179, expiration date not reported), via an unspecified route of administration on 30Jun2021 as dose 2, single for covid-19 immunization (71 years when vaccinated). Historical vaccine included bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Lot Number EWO170, expiration date not reported), via an unspecified route of administration on 30Jun2021 as dose 1, single for covid-19 immunization (71 year when vaccinated) and had no adverse effect. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. Medical history included multiple sclerosis from an unknown date in Jan2002 to an unknown date (he has been okay for the past 7 years, as reported). The patient's concomitant medications were not reported. The patient previously took Avonex for central nervous system lesion and experienced adverse drug reaction (very bad). On 30Jun2021, the patient received his second dose and after 10mins the patient headed for home and the patient drove for about 400 yards from the country health department, walked in the kitchen and as soon as he got inside the patient fainted. The patient was unconscious for 15min. The fainting resulted in lips busted, two teeth knocked out and was laid up for 3days. The patient was not hospitalized for the events. The patient did not visit any emergency room or physician due to the events. The outcome of the events was reported as unknown at the time of report. Information about lot/batch number has been requested.  Follow-Up (07Jul2021): Follow-up attempts are completed. No further information is expected.
tired; it was spotting like bleeding it looks like bleeding; I had prompt pain/ body ache; I had Spotting; I have gone to menopause; my cycle has stopped; slept; I felt chill; This is a spontaneous report from a contactable consumer (patient).  A 57-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration (at the age of 57-years-old) in Arm right on 10Apr2021 (Lot Number: EP7533) as single dose for COVID-19 immunisation. Medical history included high blood pressure and menopause. Concomitant medications included losartan potassium and hydrochlorothiazide; both taken for hypertension, paracetamol (TYLENOL) taken for prophylaxis ("before I took the vaccine I took some Tylenol (Treatment) so I would not really in a pain"), and unspecified vitamins; start and stop dates were not reported. The patient experienced "it was spotting like bleeding it looks like bleeding" on 11Apr2021, "I felt chill" on 10Apr2021, "I had prompt pain/ body ache" on 11Apr2021, "I had spotting; I have gone to menopause; my cycle has stopped" on 11Apr2021, "slept" on 11Apr2021, "tired" on 12Apr2021. Patient stated, "I am calling I had the Pfizer vaccine (Covid-19 Vaccine) on Saturday on April the 10th and everything was great probably about I would say about 45 minutes after I got the vaccine I felt chill and then the next day, on Sunday the 11th I had prompt pain and I had spotting (before I took the vaccine I took some Tylenol (Treatment) so I would not really in a pain for say). Actually I am a 57 years old woman and I have gone to menopause and my cycle has stopped. On Sunday I had body ache. Most of the day I took it easy and I slept but then next day tired beside that is the only kind of adverse reaction I had. It just trigger emergently it is it's good for everybody if you have any kind of symptoms or whatever you let you informed it's good to be informed. I got the vaccine on 10th got it on Saturday I had this spotting on 11th was sleepy on 11 and was tired on 12th too. And when I say spotting it is like it was having like cycle not, wasn't heavy it was spotting like bleeding it looks like bleeding." No treatment received for events. The outcome of the events was unknown. The event "it was spotting like bleeding it looks like bleeding" was considered as serious (medically significant). Schedule date of second vaccination was on 01May2021.
Could not move arm for one day after receiving the vaccine; A spontaneous report was received from nurse concerning a male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and could not move his arm for one day after receiving the vaccine/ vaccination site pain.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On an unspecified date, prior to the onset of the event, the patient received their dose of mRNA-1273 (Batch Number: Unknown) for prophylaxis of COVID-19 infection.  On an unspecified date, the patient could not move his arm for one day after receiving the vaccine.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event could not move his arm for one day after receiving the vaccine was resolved (for one day after receiving the vaccine) on an unspecified date.; 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.
Headache began in evening; chills and sweats during night; swollen arm; low grade fever next day; flu-like symptoms for 2 days; slept most of the 2 days.
Information has been received from a doctor of pharmacy concerning a 14 month old female patient with eczema and no drug reaction or allergies; who on 27-AUG-2010 was vaccinated with VARIVAX (Merck) (Lot #, dose and route no reported). Concomitant therapy included Hib conj vaccine (unspecified carrier) (manufacturer unknown). The pharmacist reported that on 30-AUG-2010, the patient developed varicella like rash after receiving a dose of VARIVAX (Merck). She developed "pimple" like rash around the face, upper chest and scalp. No laboratory tests were performed. At the time of the report, the patient's outcome was not reported. The patient sought unspecified medical attention. Additional information has been requested.