chrisvoncsefalvay/vaers-outcomes huggingface dataset:
16 year old got 2 shots of pfizer and booster dose of moderna; No Adverse Event; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old got 2 shots of pfizer and booster dose of moderna) and NO ADVERSE EVENT (No Adverse Event) in a 16-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer and Pfizer (2 shots of Pfizer COVID vaccine). Past adverse reactions to the above products included No adverse reaction with Pfizer and Pfizer.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old got 2 shots of pfizer and booster dose of moderna) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old got 2 shots of pfizer and booster dose of moderna) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old got 2 shots of pfizer and booster dose of moderna).    No concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Fever of 103 degrees.  No focal problem noted.  Treatment: Tylenol/Motrin.
I present my situation as follows wondering if the Covid 19 is triggering false positive  HTLV-I/II results at a higher rate than usual.  I've donated blood multiple times (15'ish units) and after the last donation I tested HTLV-I/II Reactive and the followup test was inconclusive.  I had the test redone at the Dr's and the first test is Positive and waiting for the second/followup W-Blot test results.  I've never tested HTLV-I/II positive/reactive for prior blood donations.  When I look at  HTLV-I/II risk and transmission factors I do not fit.  The risk should be very very low.
pt recv vax & w/in 48hr of vax pt devel a rash & severe sickness;
Low grade fever; Tired; Swelling and redness on injection site; Swelling and redness on injection site; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the right arm on 24Apr2021 at 11:45 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included arthritis. The patient had known allergies to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified concomitant medications taken for unknown indications from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW015-PAA 166261) via an unspecified route of administration in the right arm on 03Apr2021 at 11:45 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. On 25Apr2021, the patient experienced low grade fever, tired, swelling and redness on injection site. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events low grade fever, tired, swelling and redness on injection site was not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
6AUG98 pt recv vax;21AUG98 few pimples noted;22AUG98 full blown chickenpox;
shingles/symptoms of shingles; This case was reported by a nurse via sales rep and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported showing symptoms of shingles within 2 weeks of getting shingrix. The reporter did not consent to follow up.
This spontaneous report as received from a healthcare worker refers to a 57 year old patient with no pertinent medical history or drug reactions/allergies. Approximately on 17-NOV-2014 "one day last week" the patient was vaccinated IM with a 0.5ml dose of PNEUMOVAX 23 (lot # K010523, expire date 25-FEB-2016). There was no concomitant medication. Healthcare worker stated patient returned couple days later. Healthcare worker stated according to nurse practitioner that patient was experiencing cellulitis from injection site on left arm around arm to back the back of her elbow. Healthcare worker stated patient was treated yet treatment unspecified at this time. No lab diagnostics studies were performed. The patient was now "doing better". The patient sought medical attention via office visit. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to multiple, unspecified patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. On unknown dates the patients were vaccinated with improperly stored doses of VAQTA via unreported route (batch# L041676, exp. 15-MAR-2017; L045713, exp. 14-JAN-2017). Concomitant medication was not mentioned. The vaccines underwent a temperature excursion by being stored at 0.9 degree centigrade for a time frame of 11 hours 35 minutes (Incorrect product storage) on 18-MAR-2016. The call was a result of "data logger". There was no previous temperature excursion mentioned. No adverse effects were reported. Product quality complaint was not filed. Additional information has been requested. This is one of the four reports received from the same reporter.
Narrative: RN found pt panicking while being monitored after 2nd COVID-19 VACCINATION. States she was dizzy and lightheaded. Epi was given IM in left thigh @0955 by RN. No VS prior taken. @0958 RN took vitals BP- 148/103 HR- 214 O2 sat-87% RR-24 At this time pt was physically shaking and moved to lay flat on the floor. @1000 Pt no longer shaking, pt stated she felt better BP- 143/63 HR-119 O2 Sat-100% RR-24 @1006 RRT arrived on seen BP-143/86 HR-101 O2 sat-100% RR-24 Taken by stretcher to ED
Multiple small erythematous target like spots on legs with one larger macular spot on (L) leg. 2 tiny blister like lesions on (R) hand. Close monitoring, resolution with 1 week expected outcome.
20 minutes after vaccination, patient became achey, experienced jaw tightness and difficulty speaking.  Her speech was hesitant and she had trouble forming words.  Patient also on effexor and topanax since 06/10/2003, which may have been responsible or contributed to the reaction.  Exam normal.
Red, warm 2-3inch by 1/2 inch area at RD injection site, little red dots noted, not c/o pain or discomfort, no fever. Advised ibuprofen and cool pack, if no improvement see PCP.
feeling bad, tired, hives sick for 3 days;stayed home for 3 days;
Woke up the day after receiving FluMist with abdominal pain, headache, and cough.  He's now developed some diarrhea and lightheadedness.  Questionable subjective fever.
This spontaneous report as received from a physician via employee refers to unspecified patients of unknown age and gender. The patients' medical history included splenectomy. The patients' concurrent conditions and concomitant medications were not reported. On an unknown date, patients were vaccinated with PNEUMOVAX 23 (dose, route and site of administration, lot # and expiry date were not reported). The physician was administered the vaccine every 10 years to patients who had splenectomy. No adverse symptoms were reported. Additional information has been requested.
14FEB febrile sz generalized t103.5;15FEB serous otitis media-sl stuffy
received dose 1 of the Moderna vaccine past the 6 hr used-by time; A spontaneous report was received from a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and received dose 1 of the Moderna vaccine past the 6 hour used-by time.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 31 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number 025L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 31 Dec 2020, the patient stated that he received 1 dose of the vaccine past the 6 hour used-by time. He stated that his dose of the vaccine was administered 48 hours after the bottle was opened on 29 Dec 2020.  No treatment information was reported.   Action taken with mRNA-1273 in response to the event was not reported.  The event, received dose 1 of the Moderna vaccine past the 6 hour used-by time, was considered resolved on 31 Dec 2020.; Reporter's Comments: This case concerns a male patient who received their first of two planned doses of mRNA-1273 (Lot 025L20A), reporting Out of specification product use without any associated adverse events.
pt recv vax & devel localized lumbar tenderness just lateral & lt of the spine;had some guarding;liver enzymes were elevated;TSH sl depressed;viral illness;spleen enlarged;given couple liter lactated Ringer's inj;dx hepatitis;back pain;
Taste of salt/metal in the back of throat. Noticeable when not speaking or eating. Most intense at days 3 and 4 following vaccine. Seems to be less so today (day 5)
Shingles rash appeared. Where the rash was, I had severe back/nerve pain. I've had shingles several times in the past, so I immediately contacted my doctor. I had a video appointment and she looked at the rash and said it's shingles. She prescribed an antiviral, gabapentin, for the intense nerve pain and an antiviral cream that has cortisone in it. I was extremely sick from the shingles, this was day 2 or 3 after the first dose of Pfizer. Extreme fatigue, shingles rash, and the worst nerve pain I've ever had in my life. I nearly went to the ER (it was that bad). Over the course of 2 weeks it got better. But boom, 2 days after the second shot the shingles rash made a comeback. Same spot. Doctor called in an extra two weeks of shingles meds. The nerve pain got better than it was, but I'm still not 100 percent well. I'm still having bouts of fatigue and severe nerve pain from the shingles.
Patient recently received both his annual flu shot and a RSV vaccine on the date note (9/25/23). starting 09/28/23 started having issues with stroke like symptoms and ultimately was hospitalized 10/1/23-10/3/23 and diagnosed with a stroke.
Allergy on skin; This is a spontaneous report from a contactable consumer (daughter). A female patient received an unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via an unspecified route of administration on 10Jun2021 as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had a little bit allergic on the skin and she at her home. The reporter stated that she did not know how to speak English and wondering what was happening or what can she do and if this reaction was normal or not. The reporter hung up the call abruptly, so limited information available over the call. The outcome of the event was unknown.  Information on Batch/Lot number has been requested.
Narrative: Pt reports that he received his first Covid vaccination this morning at 8:15. He is a diabetic and has a meter. Pt states that his Blood Sugar has been higher today in the range of 264-300 and he was inquiring if this could be r/t the vaccination. Pt states that he took rapid acting insulin to bring the Blood Sugar down to 264. He states he will take his usual 50 units of long actin insulin and will continue to monitor his Blood Sugar and Vital signs. Pt will call back if he has further concerns this evening. Please f/u with the pt.
EMPLOYEE RETURNED TO WORK REPORTING RASH AND HIVES ON BILATERAL ARMS AND LEGS
Beginning 6 days + 5 hours after vaccination, patient noted pain/soreness in left armpit.  So far, this has persisted for  ~24 hours (continues at time of report).  No treatment has been given.  PCP advised that anti-inflammatory (ibuprofen) may be taken.
Rash at injection site-3 days after injection (reported 12/19/03).  Complained of tenderness at site, mild symptoms still resolving.
Delayed rash; fever; tired; sore arm; This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th April 2019, the patient received the 1st dose of Shingrix (intramuscular). On 26th April 2019, less than a day after receiving Shingrix, the patient experienced pain in arm. On 27th April 2019, 1 day after receiving Shingrix, the patient experienced fever and tiredness. On 28th April 2019, 2 days after receiving Shingrix, the patient experienced injection site rash. On 28th April 2019, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the injection site rash was not recovered/not resolved and the outcome of the pain in arm and tiredness were recovered/resolved.   It was unknown if the reporter considered the injection site rash, fever, pain in arm and tiredness to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on left arm at 4:00 pm and he experienced a delayed rash reaction. The patient had a little fever the day following the vaccination and next day around 99 degree F. The patient claims that his arm was sore with arm pain the first night. The event fever was resolved but rash started on the injection site. The patient described the rash as 3 inches in circumference at the injection site on his left arm. It was also reported that he was tired the next day and in bed most of the day after receiving the Shingrix dose. The reporter did not consent to follow-up. The patient refused follow-up and preferred to remain anonymous.
vertigo; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced VERTIGO (vertigo). At the time of the report, VERTIGO (vertigo) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.   Reporter did not allow further contact
Midsternal chest pain radiating to clavicles, occasional to neck and arms.  Occasional shortness of breath.  Called PCP who told her to monitor symptoms, and if it worsened to go to ED for cardiac evaluation.  Some symptoms improved.  Two cardiac labs WNL.
I had a cold around New Years and it reminded me I should get a COVID booster. Got my booster and it kicked my ass, I spent the next week mostly in bed feeling awful. Earlier this week (around 13th of June), I had recently gotten over another cold (made sure it wasn't COVID via home test) but my left arm has been sore since, and a strange sore has developed at the injection site.
Moderna COVID-19 Vaccine:  02/07/2021 Total loss of hearing in right ear and diminished sense of taste. 02/10/2021 Hearing test and prednisone 60mg for 10 days.   02/19/2021: Hearing test Hearing did not improve,  but further declined.  Blood work, steroid injection into middle ear 02/26/2021:  MRI, hearing test
started with hormone-related insomnia (only got 2.5 hrs sleep saturday night and 5 hours last night), then period came very early on sunday (cycle day 25, meaning my cycle was 24 days when it is usually 28-29 days), also got menstrual cramps that I have not had in at least a year (haven't had menstrual cramps since before I became pregnant with my almost 15 month old), too soon to tell whether period is heavier.
other_medical_history: Covid; other_medical_history: Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Mar2022 at 15:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 56 years, in right arm and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), 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) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "extremely mild blood in urine (micro something)" (unspecified if ongoing); "some trees" (unspecified if ongoing). Concomitant medication(s) included: ADVIL [IBUPROFEN], start date: 12Aug2021; TYLENOL, start date: 12Aug2021. Past drug history included: Novacaine, reaction(s): "known allergies:Novacaine", notes: known allergies:Novacaine. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "other_medical_history: Covid". Therapeutic measures were taken as a result of suspected covid-19. Clinical Course : Have taken 3 doses worth. Patient also stated, the metallic taste in her saliva after the body processes the dose is annoying. Stated, "I can tell it comes from the 2 pink pills."  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
patient did not received 2nd dose two months after initial dose; No further AE reported; This spontaneous report has been received from a pharmacist referring to a 21 year old female patient. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.     On an unspecified date in 2017, the patient was vaccinated with the first dose hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscularly (strength, indication, dose, route, frequency, anatomical location, lot # and expiration date were not provided) for prophylaxis. The patient did not received the second dose (inappropriate schedule of product administration and no adverse event).
3-4 days after the vaccine patient developed chest pain, nausea, weakness. Patient was seen in ER on 12/11/21.
t102 x 3 days w/APAP (that was the lowest temp w/treatment); lethargic & cranky for those 3 days also; MD told mom not unusual;
Headache, Myalgia, Fatigue, insomnia, fever 101.4 for 2 days, had past covid positive test,
? febrile sz on 1/16/09 - started seizuring, eyes open wide, then shaking all over, then fell asleep for approximately 1 hr.  Had 2nd febrile episode shortly after that.
left underarm swollen to golf ball size assuming it is the lymph node; cold sweats; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 13Dec2021 (Lot number: FD7218, Expiration Date: Feb2022) at the age of 44 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (first dose:, LOT-ER8729; EXP JUL 2021, unknown injection site, MANUFACTUERER UNKNOWN), administration date: 08Apr2021, when the patient was 44 years old, for COVID-19 immunization; Covid-19 vaccine (second dose:, LOT-EW0173; Expiration Date- Aug2021, left arm, MANUFACTUERER UNKNOWN), administration date: 29Apr2021, when the patient was 44 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 13Dec2021, outcome "unknown", described as "Booster"; LYMPHADENOPATHY (non-serious) with onset 14Dec2021, outcome "not recovered", described as "left underarm swollen to golf ball size assuming it is the lymph node"; COLD SWEAT (non-serious) with onset 14Dec2021, outcome "not recovered", described as "cold sweats".  Additional information: The patient had no relevant medical history. Patient stated she had got her third dose, the booster, Pfizer Covid shot, Comirnaty on Monday, 13Dec2021. States her underarm is extremely swollen, assuming it is the lymph node, golf ball sized swollen, and she has been having cold sweats, thinks it because of her lymph nodes been. Patient has had no other vaccines within 4 weeks of this vaccine. States she will be calling her doctor for medical advice. It was reported that aware of the golf ball size swelling on Wednesday 15Dec2021.  No follow-up attempts are possible. No further information is expected.
12/24/2020- morning-  noticed pain in R deltoid at site of injection (expected) and also L ankle pain not associated with any type of trauma and with no hx of injury to ankle in past.  Also noticed mild aching pain to R knee (which has had extensive surgical repair several times) 12/24/2020- by midday,  limping noted due to pain in L ankle, negative for swelling, bruising, or decreased range of motion 12/24/2020- 8pm- moderate to severe pain to L ankle, still no swelling or bruising. 12/25/2020- midday- still noticeable limp, however pain was moderate and tolerable all day 12/26/2020- increased pain in L ankle as day progressed, still no bruising, decreased ROM or swelling 12/27/2020- woke at 3 am due to pain, elevated L leg.  Swelling noted in lateral aspect of ankle by 7am,  decreased ROM and point tenderness had developed around lateral and anterior ankle joint.  Took 2 Aleve for pain.  Went to walk-in orthopaedic clinic when they opened at 9am for assessment,
Red, swollen area, warm to touch; swelling occurred immediately; redness a couple of hours later.
Within 12 hours of getting the second dose I had elevated temperature, flu like symptoms, vomiting, diarrhea, lethargy, and headache. I basically got through this myself. After that I went to the ER because of a TIA. They did CAT scans, MRI, echocardiogram, blood work. They prescribed Lisinopril, 81 mg Aspirin, and 2 other medications.
Arm soreness, Chills throughout the day on 03/13, Swollen and painful Lymph Node near left armpit 03/14. Shot was administered to Left arm.