chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician refers to a pediatric patient of unknown demography. Patient's concurrent conditions and relevant medical history was not reported. On an unknown date in 2012, the patient was vaccinated with first dose of GARDASIL (dose, frequency and route unspecified). On 22-APR-2015, the patient was vaccinated with second dose of GARDASIL. The reporter was enquiring whether the patient can be give third dose in 4 months or should not count the first dose. The outcome of the event was unknown. The causality of the event with GARDASIL was not reported. Additional information has been requested.
Client complained of severe edema, redness, and generalized aching.  This began by waking up the client at approximately 3 a.m. on the day following receiving the vaccine.  Also c/o large baseball-sized lump at injection site. The site was this size when reported to the Health Department 4 days after the vaccine was received.
Erythema muliforme - (diagnosed by personal physician) - rash very systemic armpits, thighs, knees, ankles, wrists, chest & waist.
Face started tingling like someone sticking me with pins; Mouth started swelling; Face started swelling around mouth and cheeks; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the right arm on 15Apr2021 at 11:00 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. Medical history included juvenile asthma as a child that no longer affected her and known allergies to tree nuts cosmetics and perfumes. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included colecalciferol (VITAMIN D3), boron (MANUFACTURER UNKNOWN), prunus cerasus (TART CHERRY) and Ascorbic acid, Pyridoxine hydrochloride, Biotin, Folic acid, Colecalciferol, Retinol, Pantothenic acid, Riboflavin, Phytomenadione, Nicotinamide, Betacarotene, Iron, Magnesium, Manganese, Potassium, Chromium, Copper, Zinc, Calcium, Iodine, Phosphorus, Selenium, Vitamin b12 nos, Xantofyl, Lycopene, Vitamin b1 nos, Vitamin e nos (CENTRUM SILVER); all for unknown indication, on unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the right arm on 22Mar2021 at 01:00 (at the age of 72-years-old) as a single dose for COVID-19 immunisation and the patient also previously received guaifenesin/pseudoephedrine hydrochloride (SUDAFED), alendronate sodium (FOSAMAX) and experienced drug allergy. On 15Apr2021 at 11:15, after waiting 15 at site, the patient started driving home and her face started tingling like someone sticking her with pins, mouth started swelling and face started swelling around mouth and cheeks. This was all in a matter of 15 to 30 minutes. The patient reported that she always carried diphenhydramine hydrochloride (BENADRYL), because of allergic reactions to different things. The events had not resulted in doctor/other health care professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the events and included treatment with diphenhydramine hydrochloride (BENADRYL). The clinical outcome of the events face started tingling like someone sticking her with pins, mouth started swelling and face started swelling around mouth and cheeks was resolved on 15Apr2021.  No follow-up attempts are possible. No further information is expected.
Headache, fever, dizzy,  felt horrible, lasted 48 hours..  Felt like a lot of the same symptoms as when I had a severe case of COVID in July 2020.
Pt reports outbreak of chicken pox at school Presents with <50 lesions. at this time 48 hours since onset. Afebrile.
Large red like hive, applying warm compresses2-3 times daily along with cream to put on 3-4 times daily.
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 02-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
12 hours after inoculation I suffered lightheaded ness, chills, and muscle pain throughout my body.  The next morning I had fever, shivering, body aches, and lost my appetite.  On the third day I still had a low grade fever, headache, and lightheadedness.
Dose -1  Moderna       Pain in the left arm for 2 weeks.   Dose -2  Moderna fever - 102  Body Pains  Sore throat  Burning eyes  Rash on left arm  ( Took Tylenol) Fever, bodypains subsided after 3 days. Sore throat, Rash and burning eye sensation still persists.
Vaccine received 6/1/2021 at 12:20pm. Tingles on right side of my face was occurring within an hour of injection. Tingles occurred for 24 hours then progressed to tingles, stiffness and somewhat "numb" like sensation  all along the side of my cheek up to my right eye. I was straining to talk and noticed I had to move my mouth differently to talk Thursday 6/3/2021 afternoon + evening. Went to my primary care doctor on the morning of 6/4/2021 and was diagnosed with Bells Palsy. I then began a prescription for steroids - Prednisone (60 mg for six days with tapering down over 10 days). The Bells did not get worse but now that I have completed the steroids the the tingle, stiff, and numb sensations remain.
21MAR91 t101.6 w/hives, started day of immun; Mom took to Hosp-ER where pt examined & released;
had the shots, dealing with shingles/ Suspected Vaccination Failure; shingles for over 5 months; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included covid-19 (had Covid).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 08-AUG-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient stated that, he/she agreed and there were studies now that, claim if you had Covid, you had a higher risk of getting shingles.  The patient had the Shingles shots and he/she was now dealing with shingles for over 5 months. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Lips tingling, throat feels thicker, chest pressure, numbness in fingers. Evaluated by EMS-cleared
major drop in blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of HYPOTENSION (major drop in blood pressure) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced HYPOTENSION (major drop in blood pressure). On 18-Feb-2021, HYPOTENSION (major drop in blood pressure) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Pt recv vax on 9/10/98; on 9/11/98 pt exp red/ swollen vax site, swollen lymph nodes in neck
Received call 12:10 pm. Pt's mother called saying "he's breaking out in hives". No distress advised BENADRYL: go to hospital if worsens.
Patient began to feel swelling in facial area, hives appeared on upper torso, flushing occurred to facial area at approx 10:45. Benadryl and Epi administered per protocol.
Off Label Use; Fatigue; Seasonal Allergy; Feeling Abnormal; Dizziness; Depression; Anxiety; Dyspnoea; Malaise; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from Regulatory Authority. Regulatory number: 19368306 (RA). Other Case identifier(s): US-GLAXOSMITHKLINE-US2021AMR114910 (RA).  A male patient received bnt162b2 (BNT162B2) as dose number unknown, single for covid-19 immunisation; fluticasone propionate (FLONASE) (Batch/Lot number: unknown); treprostinil sodium (TYVASO) (Batch/Lot number: unknown); fluticasone propionate (FLUTICASONE PROPIONATE) (Batch/Lot number: unknown); treprostinil (TREPROSTINIL) (Batch/Lot number: unknown). The patient's relevant medical history was not reported. Concomitant medication(s) included: AMBRISENTAN; SILDENAFIL CITRATE.  The following information was reported: OFF LABEL USE (non-serious), outcome "unknown", described as "Off Label Use"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue"; SEASONAL ALLERGY (non-serious), outcome "unknown", described as "Seasonal Allergy"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Feeling Abnormal"; DIZZINESS (non-serious), outcome "unknown", described as "Dizziness"; DEPRESSION (non-serious), outcome "unknown", described as "Depression"; ANXIETY (non-serious), outcome "unknown", described as "Anxiety"; DYSPNOEA (non-serious), outcome "unknown", described as "Dyspnoea"; MALAISE (non-serious), outcome "unknown", described as "Malaise".  No follow-up attempts are possible. No further information is expected.
pt recv vax 16NOV98 & pt reported fine rash that started on trunk & was moved to different areas of body starting 15min p/inj;
This spontaneous report was received from a pharmacist regarding 7 patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX lot # L021216, expiration date- 10-JUN-2017, lot no. L034369, expiration date 08-SEP-2017. No adverse event was reported. The outcome of the event was unknown. Yes there was a previous temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested.
No additional AE; VARIVAX was delivered on 07JUN2022 after the receive by date of 06JUN2022 and was administered to a patient; This spontaneous report was received from a medical technologist lab manager and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 16-JUN-2022, the patient was vaccinated improper stored with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #W002599, expiration date: 24-JAN-2024, administered for prophylaxis (dose, strength, and route of administration were not provided). The receive by date of the varicella virus vaccine live (oka/merck) (VARIVAX)  was 06-JUN-2022; however, the varicella virus vaccine live (oka/merck) (VARIVAX) was not delivered until 07-JUN-2022. After the varicella virus vaccine live (oka/merck) (VARIVAX) was delivered, it was unpackaged and stored and not administered to the patient until 16-JUN-2022 (product storage error). There was no previous temperature excursion. No additional adverse event reported. No additional information provided.
Client noticed on 1/27/21 that arm was itching, then noticed on 1/28/21 that arm was red and warm to touch.  redness progressed to lower arm by 1/31/21.  Saw MD on 2/1/21.  Advised she was ok and client was ok to get 2nd dose.  Client started using Benadryl and cool compress on 1/29/21 or 1/30/21.
Patient reports pain in her side "almost like a bubble between her ribs" and shortness of breath starting the day after vaccinations. She said she has never experienced these symptoms before.
This spontaneous report as received from a physician refers to a 19 year old patient with mentally challenged. Medical history was not reported. Physician reported patient, who was 19 years of age, received a dose of VAQTA, 0.5 ml, intramuscular (lot number and expiry date were not provided) on 23-OCT-2014. No adverse effects were reported. Concomitant medication was not reported. The outcome of patient, who was 19 years of age, received VAQTA 0.5ml dose was unknown. Additional information has been requested.
April 17, 2021 I developed a severe sore throat April 21, 2021 went to an urgent care.  Negative strep, negative Covid, sent home to take Tylenol April 23, 2021 telemedical with primary physician, put on AmoxClav anti-biotic for severe sore throat and swelling April 24, 2021 went to see an ear, nose and throat specialist who diagnosed Shingles in my throat Prescribed Prednisone (20 mg x 2 daily) for inflammation Prescribed Clarithromycin (500 mg x 2 daily) to avoid any bacteria such as pneumonia from shortness of breath and trouble swallowing Prescribed Valacyclovir (1G x 3 daily) for Shingles IRONY:  Shingrix vaccine July 13, 2018
first dose in October and the last was May 1st (5/1), patient was late by 10 days; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in October 2020).   On 1st May 2021, the patient received the 2nd dose of Shingrix. On 1st May 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional information was provided as follows:  The age at vaccination was not reported. The patient received 2nd dose of Shingrix, more than the recommended interval, which led to lengthening of vaccination schedule. The nurse asked if patient received 2nd dose 10 days late, then was there a need to take the 3rd shot. The reporter declined to provide any patient or vaccine details. The reporter did not consent to follow up.
Patient experienced soreness in the mid-point of his back/spine beginning the night of the first injection.  He felt this predominantly when sitting (vs walking).  The type of pain was similar to the injection site (of which we expected the injection site, but not the back), along with significant fatigue.  The back pain site dissipated after a couple of days, and the injection site pain took longer to dissipate.
Starting on 8/5 pt experienced joint pain, weakness, aching, fatigue, abdominal pain, headaches. These symptoms lasted until 8/5-8/11. Had one more severe episode of epistaxis which she has weekly. Also had 6 days (six) of temp of 100. Concern of extreme fatigue this week.
arm was a little sore after the vaccine; The initial case was missing the following minimum criteria: Adverse event. Upon receipt of follow-up information on 11Mar2021, this case now contains all required information to be considered valid. This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 10Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Prolia. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "arm was a little sore after the vaccine". Additional information: The patient stated that she received the first dose of the Pfizer covid 19 vaccine on 10Mar2021 and was getting Prolia injection on Monday. She has not had the Prolia since 2017. She wanted to know if she can get the Prolia.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Rapid heart rate starting 30 minutes post-injection, lasting roughly 4 hours. Fever starting about 12 hours after the injection, still ongoing as of now (30 hours post infusion), arm pain at injection site (still ongoing as of yet, 30 hours post injection) chills and weakness (still ongoing as of 30 hours post injection)
Itchy, woke with hives on Monday. Hives lasted four or five days and continued to spread. Was prescribed prednisone and took benadryl.  Left arm was very sore for about a week. Experienced dizziness immediately after vaccine and was kept at the facility for an extra 30 minutes or so.
Information has been received from a physician concerning a female who was vaccinated with a 0.5 ml third dose of GARDASIL (lot# not provided). The physician reported patient about 6 months after receiving her third dose of GARDASIL experienced genital warts. Unspecified medical attention was sought. The patient's outcome is unknown. No product quality complaint was involved. Additional information has been requested.
Hard, round welt immediately after injection and sore arm, lasted 3-4 days, mildly itchy. That went away on the 4-5th day and then on the 7th day I woke up with a painful arm, large round, hard and itchy welt at injection site. It feels hot to the touch. I've been icing it off and on. It's achy feeling but not so bad that it's preventing me from doing daily activities or working. Today it looks less red and irritated, less achy, less itchy but the welt is slightly larger.
Mild injection site soreness; more tired than usual which extended into the following day; This is a spontaneous report from a contactable consumer (patient's parent). A 26-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from 12Jan2021 11:00 to 12Jan2021 11:00 at SINGLE DOSE for covid-19 immunisation. The patient's medical history was not reported.  Concomitant medication included etonogestrel (NEXPLANON). On 12Jan2021, the patient had mild injection site soreness and 3-4 hours after receiving the vaccination and noted being more tired than usual which extended into the following day. The events were assessed as non-serious as per the reporter. The patient did not received any treatment for the events. The patient is not pregnant at the time of the report. Outcome of the events was recovered on an unspecified date.   Information on the lot/batch number has been requested.
Body pain; Joint ache; Loss of appetite; Nagging cough; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 22Apr2021 at 08:45 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. The patient had unspecified medical history. The patient received unspecified medications within 2 weeks of vaccination. The patient previously received first dose of 0.3 ml of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 01Apr2021 at 08:45 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Apr2021 at 20:45, 12 hours after vaccination the patient experienced severe body pain, nagging cough, loss of appetite, fatigue and joint pain. It was reported that the joint ache and loss of appetite went away 48 hours after injection, but nagging cough and fatigue continue until an unknown date in May2021. The clinical outcome of the events loss of appetite and joint pain were resolved on 24Apr2021. The clinical outcome of the events nagging cough and fatigue were resolved on an unknown date in May2021 while the event body pain was resolving at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
pt recv vax; lt arm became swollen w/ redness; approx quarter size surrounding inject site;
I had reaction (102 fever); Coronavirus concerns; This case was reported by a consumer via call center representative and described the occurrence of fever in a 65-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 24th September 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced fever and social problem. On an unknown date, the outcome of the fever and social problem were unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. After receiving 1st dose of Shingrix, the patient had a strong reaction. The patient had 102 fever. The reporter wanted to know could he/she wait longer than 6 months for the second dose due to Coronavirus concerns. It's already been just over 6 months since first dose. The reporter wanted to know should wait until June and it still be effective or would need to start over with the process, which led to social problem. The physician still wanted to have 2nd dose but wait for flu season to slow so there wouldn't be confusion over whether had flu or reaction to shingrix.      Lab Comments: On an unknown date, lab test was performed.
Felt achy about 2 hours after immunization. Noted fever about 5:30 PM. Temp 102. Developed chills, nausea, vomiting. To ER about 10 PM. Evaluated and treated with Tylenol. Better by 1 AM; fine by 5 AM.