chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tested positive for Covid 19 after 7 days; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for Covid 19 after 7 days) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced COVID-19 (Tested positive for Covid 19 after 7 days). At the time of the report, COVID-19 (Tested positive for Covid 19 after 7 days) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
This spontaneous report was received from a physician assistant via company representative and refers to a 15 year old female patient. The patient's current conditions included type 1 diabetes mellitus and medical history was not reported. On 19-SEP-2014, the patient was vaccinated with the first dose of GARDASILI (formulation, strength, dose, route and lot number were not reported). On 07-NOV-2014 the patient was vaccinated with the second dose of GARDASIL (formulation, strength, dose, route and lot number were not reported). Other suspect therapies included the third dose of GARDASIL 9 injection given on 25-SEP-2015 (strength, dose, route and lot number were not reported) and influenza virus vaccine (unspecified) (manufacturer unknown, reported as Quadrivalent flu vaccine) given in the separate arm on 25-SEP-2015. Concomitant therapies doses of GARDASIL. On 26-SEP-2015 and 28-SEP-2015, the patient reporter received a call from the patient's mother. In September 2015, the patient had developed severe reaction, systemic rash, throwing pain and redness greatly above normal, significant fatigue and headache. The patient sought medical attention and on 30-SEP-2015 she was seen in the physician's office and she was much better. On an unknown date in 2015, the patient still had some inflammation around the injection site, unspecified site, rash was mostly cleared up, was still itchy, swelling, pain and redness was still slightly evident. No product quality complaints (PQC) was involved. No further details were noted. The outcome of the events "first two doses of GARDASIL and GARDASIL 9 was administered for the third dose", headache, significant fatigue and severe reaction was unknown. The outcome of systemic rash, some inflammation around unspecified site, some inflammation around the injection site, swelling, redness greatly above normal and throwing pain was reported as resolving. The outcome of itchy was reported as not resolved. The reporter did not provide causal relationship between the events and suspect therapies. Additional information has been requested.
This case was reported by a consumer and described the occurrence of itchy rash in a 75-year-old male subject who was vaccinated with (FLULAVAL, GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject's medical history included pneumonia. Concurrent medical conditions included high blood pressure and high cholesterol. Concurrent medications included Aspirin (Baby aspirin), Lisinopril, Lovastatin and Doxycycline. On 5 November 2008 at 09:00 the subject received a dose of FLULAVAL left arm. On 7 November 2008, two days following vaccination with FLULAVAL, the subject developed an itchy rash all over his body. The subject was treated with CLOBEX, unknown medication (BENOS), PREDNISONE and methylprednisolone, but none of these treatments helped the rash. The consumer reported that the rash flares up on different parts of his body and becomes worse at times. The subject stated that his looked like GROVERS disease. The subject discontinued possible allergens such as artificial sweetener, but the rash is not improving and remains unresolved.
she is having pain from her shoulder to fingers tips in the right arm; This is a spontaneous report from a contactable nurse. A female patient (Age: 75; Unit: Unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection,Lot number was EN6201,Expiration Date: 30Jun2021) dose 1 via an unspecified route of administration, administered in Arm Left on 08Feb2021 as DOSE 1,SINGLE for covid-19 immunisation. Medical history included arthritis from an unknown date and unknown if ongoing. Concomitant medication(s) included levothyroxine taken, ascorbic acid, retinol, tocopherol (OCUVITE [ASCORBIC ACID,RETINOL,TOCOPHEROL]), losartan, amlodipine besylate, furosemide (LASIX [FUROSEMIDE]), krill oil, vitamin D3 taken for an unspecified indication, start and stop date were not reported. On 10Feb2021, Caller stated she received the Pfizer covid vaccine and 10 days later she was having pain from her shoulder to fingers tips in the right arm, but her vaccination site is left arm. She said she takes Tylenol PM at night and takes 2 Bayer's aspirin in the morning. I woke at about 4:30 in the morning and it was such excruciating pain. Therapeutic measures were taken as she had been taken Tylenol and 2 Aspirins, she took Tylenol one time and the next time she was taking 2 aspirins. The clinical outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Broke out with shingles; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 05Jun2021 at 14:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patients' medical history included ulcerative colitis. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. The patient did not receive any medication within two weeks of the vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 18Jun2021 at 01:00, the patient reported that he broke out with shingles. Since the vaccination, the patient had not been tested for COVID-19. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of adverse event and included treatment with valacyclovir. The clinical outcome of the event broke out with shingles was resolving at the time of this report.
1.5 x 2 inch inflamed, hard area on top of left thigh. Patient in no distress, active and playing. Given a prescription of prednisone oral solution 5mg/5ml with instructions. Told to return to clinic on 06/13/2008 if persist.
This spontaneous report as received from a 36 year old female patient, regarding herself. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications were not reported. On 07-APR-2017 the patient was vaccinated with first dose of RECOMBIVAX HB injection 5/0.5 mcrg/ml, on 11-MAY-2017 the patient was vaccinated with second dose of RECOMBIVAX HB and on 27-OCT-2017 the patient was vaccinated with first dose of RECOMBIVAX HB (dose, frequency and route were not reported (lot # M034894, expiry date: 11-NOV-2018) for prophylaxis. The patient reported that, all three doses in the vaccination series were pediatric doses instead of recommended adult dose. No adverse effects were reported. No product quality complaint was involved.
Big Red Spot on arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Big Red Spot on arm) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (Big Red Spot on arm). At the time of the report, RASH (Big Red Spot on arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medications are provided. treatment to the events not provided.
The child received the vaccine on 5/22/00. On 8/28/00 the child broke out in raised red lesions on arms, legs, trunk and face which progressed to pimple-like lesions by later afternoon. Mom denies fever.
By 8pm pt c/o sore arm 12/10/01 tried heating pad 3pm 12/11 - redness and swelling by 8pm 12/11. Pt in to see Dr 12/12 @ 9am. Keflex 250mg tidx5 instructed to ice site.
Itching, hives; seen in ER on 30APR; Given Epi, DPH & Cortisone w/relief;
Janssen COVID-19 Vaccine EUA Vomiting, chills, body aches, fatigue, fever, radiating pain, nauseous, headache, joint pain
red, raised tender area at the injection site, itching and lymph nose-swelling Narrative: ice and Benadryl
COVID AFTER 75 DAYS OF VACCINATION; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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, administered on SEP-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced covid after 75 days of vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid after 75 days of vaccination was not reported. This report was non-serious. This report was associated with product quality complaint: 90000205039.
11/29/2022, 30 minutes after my vaccination, my right arm was hot, from the shoulder down to the elbow. A few days later, I began to feel under the weather, with a scratchy throat and headaches for two days. I improved from those symptoms. I later tested positive for COVID-19 after taking a family member to an emergency room and being exposed in December.
PATIENT EXPERIENCED RED ARM RASH AT SITE OF INJECTION WITHIN 10 MINS OF INJECTION. ALSO, PATIENT EXPERIENCED SEVERE SORENESS IN ARM, PLUS ITCHINESS AT SITE OF INJECTION.  THEN PATIENT ALSO EXPERIENCED RED, BUMPY RASH ON PALMS OF HANDS.  PATIENT TOOK 25MG HALF HOUR PRIOR TO VACCINE ADMINISTRATION AND REPEATED 25MG BENADRYL HALF HOUR POST VACCINE INJECTION. PATIENT MONITORED FOR 30 MINS POST VACCINATION AND RECOMMENDED TO GO TO ER BECAUSE SYMPTOMS DID NOT RESOLVE
I have broken out in a serious rash from head to toe; This is a spontaneous report from a contactable consumer (patient).  A 39-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in the right arm on 01Sep2021 10:00 (at the age of 39-year-old) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Relevant medical history included asthma and penicillin allergy. There were no concomitant medications.  The patient had broken out in a serious rash from head to toe (medically significant) on 09Sep2021 12:00 with outcome of not recovered. Within 10 days of receiving then vaccine, the patient had broken out in a serious rash from head to toe, he has been seen in the Emergency Room, where a benadryl shot and a steroid shot was given to him; he has seen no relief from either. The patient never had a rash like this in his entire life. The event resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. If covid prior vaccination: No. If covid tested post vaccination: No.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Fever, pain, swelling, heat, redness of (L) shoulder & pain & swelling (L) axilla.
Patient received Adacel (adult Tdap) in Left deltoid muscle on 7/31/07.  Patient called office this morning c/o increased pain, inability to move arm away from body, pain in the neck and left shoulder area.  Patient given appointment to have follow-up in office.  At follow-up arm is noted to have a small red area at injection site no increase in swelling of left arm.  No increase in temperature.  Patient unable to have normal ROM of the left arm without severe pain. Treatment plan:  Tordol 60mg given IM in office apply sling to left arm.  Script for prn Darvocet N-100 given along with instructions for patient to apply warm soaks to the arm.  Follow-up on Friday as to condition even if condition has improved.  Patient understands if symptoms worsen to follow-up sooner.  Patient also expressed understanding of instructions given.
flu like symptoms; fever; headache; This is a spontaneous report from a non-contactable consumer (patient herself) via a medical information team. A 78-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that, received first dose Saturday. The patient experienced flu like symptoms fever, headache on an unspecified date and stayed in bed yesterday (08Feb2021). The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
pt recvd vax; devel redness,swelling, tenderness at inject site,lasted x 2 days;
Swollen lymph nodes in my neck. Sore swollen neck. Constantly feeling a lump inside my throat. This has been happening ever since I received the vaccine.
Information has been received from a healthcare worker concerning a patient who was vaccinated with measles virus vaccine live (Enders-Edmonston) (+) mums virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). Subsequently, the patient experienced a rash with warm swelling at the injection site. A product quality complaint was not reported. No further information was available. This is one of two reports with the same source. Additional information has been requested. A lot check was requested by the reporter. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released.
Pt. complaining of redness, pain and swelling, also itching increasing over last 3 days. She was Rx'd KEFLEX 500 mg 1 po QID x 7d. Dx: cellulitis.
Broke out in severe itching from head to toe varies places lasting 7-8 days.
Severe itching at the site where she had the flu shot and there is a little welt.
Complaint of nausea on 5/12/2000. Pt reports fever, states woke up at night sweats. Local reaction noted, redness, warmth and swelling at site.  Follow up on 12/22/2000: "Impossible to provide time of event."
She has started developing rash all over her neck and now coming on to arm, it's a very bad rash; Right now it is getting kind of worse; She is feeling very bad after the vaccine; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient started to receive bnt162b2 (BNT162B2 also reported as Pfizer Covid vaccine, lot ENS318), via an unspecified route of administration from 30Jan2021 to 30Jan2021 at SINGLE DOSE for an unspecified indication. The patient's medical history was not reported. Concomitant medications included diclofenac, gabapentin, losartan, levothyroxine sodium (SYNTHROID), vitamin C (ASCORBIC ACID) and ergocalciferol (VITAMIN D). On 31Jan2021, she was feeling very bad after the vaccine administration and started developing rash all over her neck and now coming on to arm. Reported that it's a very bad rash and right now it was getting kind of worse (no treatment). The outcome of rash aggravated was not recovered; for other event was unknown.
VACCINES ADMINISTERED ON 4/5/07. DEVELOPED HIGH GRADE FEVER (106) ON 4/6/07. WAS SEEN IN ER AT TMC ON 4/6-4/7/07. DIAGNOSED WITH LEFT OTITIS MEDIA RX WITH ROCEPHIN AND BREATHING TREATMENT.  WAS SEEN IN OFFICE ON 4/9/07. NO FURTHER FEVER BUT SOME COUGH AND PULLING AT EARS.  TM'S MOBILE WITH A DISPERSED LIGHT REFLEX BILATERALLY. TREATED WITH AUGMENTIN, AURALGEN, AND ALDEX D.
pt recv vax 16JAN96 & 6FEB96 pt exp numbness in feet, lower legs & fingers, spotty vision like looking through a screen, aphasia (wrong words coming out) & fatigue;pt was felt to have a flare up on MS;
Headaches, blurry vision right after she took the vaccine. She has history of migraines but these headaches and blurry vision are more frequently occuring.
This spontaneous report as received from a pharmacist refers to a 65 year old female patient. No medical history or concurrent conditions were reported. The patient was vaccinated intramuscular with 0.5 ml of lot # (1071AA, expiration date 20-MAR-2013) PNEUMOVAX 23 on 18-OCT-2012. No other co-suspects were reported. There were no concomitant medications. It was reported that the patient developed a "knot" at injection site, "shortly" after vaccination in October 2012. Furthermore, the patient was "now" complaining of warmth and itching at the injection site (reported on 01-NOV-2012). The patient sought medical attention by calling the pharmacy. The event was treated with compresses placed at the injection site. No lab test was done. The outcome the events was reported as not recovered/not resolved. The reporter relatedness for "knot" at injection site, itching and warmth at the injection site is unknown for PNEUMOVAX 23. Additional information has been requested.
Stated that shot stung really bad. Around 6:15 she had diarrhea.  Had 3 episodes. By 8:30 she stated that she felt very weak. Neck muscles were very weak, could not lift her head. Could not walk. Arm was very sore and she could not lift it. At 9:30 she had a temp of 103. Around 12:30 she vomited, only one time. At 1:00 PM on 11/8 she was at work but very lethargic and was having episodes of feeling hot and then cold. On 11/9/13 she felt back to normal. Her husband wanted to take her to the hospital but she said she felt too weak to go.
Inappropriate schedule of vaccine; Mild case of shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On 28th October 2019, the patient received the 2nd dose of Shingrix. In October 2019, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles. On 28th October 2019, the patient experienced drug dose administration interval too long. The patient was treated with acyclovir. On an unknown date, the outcome of the shingles was recovered/resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the Fall of 2018, sometime between October December and 2 weeks before reporting date developed a mild case of Shingles.It was treated with Acyclovir and the shingles has resolved.  The patient received the 2nd dose of Shingrix which has been over a year since the 1st dose, which led to lengthening of vaccination schedule. The reporter consented to follow up.
killing all the young people, the 21 year old (further not clarified who are dropping dead on sacred pillar, 'baseball field and football field'; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 21-year-old patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "killing all the young people, the 21 year old (further not clarified who are dropping dead on sacred pillar, 'baseball field and football field'". The date and cause of death for the patient were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300118631 Same product and event, different patient;; Reported Cause(s) of Death: killing all the young people, the 21 year old (further not clarified who are dropping dead on sacred pillar, 'baseball field and football field'
General feeling of unwell, fatigue, injection site pain radiating to armpit, edema at armpit, discoloration/rash at site, on shoulder and under armpit.  Shooting pain in left shin, temperature at 99.7.
Pt vax; w/in 24-48 hrs devel erythema, swelling, warmth & tenderness at inject site.  Sx subsided over 3 days.  Given following superficial laceration.
This case was considered medically important. Information regarding PREVENAR was received from a healthcare professional regarding a 2-year-old male patient who received a dose on an unspecified date and failed to seroconvert with PREVENAR. On an unspecified date, the reporter noted that the patient failed to seroconvert with PREVENAR (decreased immune responsiveness). The patient was evaluated by the physician in the office. The patient's outcome was unknown. No additional information was available at the time of this report.
Patient came to clinic today for an appointment with the provider and covid vaccine #1. Patient received his vaccine in his left deltoid at 1105 and then came to the observation area to be observed this RN. At 1107 mom asked patient how he was feeling. Patient stated " I feel a little dizzy" and denied any other symptoms. Patient had ran to the restroom with sibling a couple minutes prior and was standing in the observation area; no distress noted. RN advised patient to sit down in chair to rest and continued monitoring him. At 1134 patient stated he continued to feel a little dizzy. Mom and sibling present. RN and vital signs taken at 1135- BP 105/65, RR 20, 99HR, 99 Spo2 on RA. Provider called to observation area RN at 1140. Provider offered gatorade and encouraged fluids and rest today. Before leaving, repeat BP taken on patient- 113/66 and RN advised mom to call back for any worsening symptoms or concerns. Mom verbalized understanding.
A couple of minutes after the injection, the father was trying to put patient in her car seat when he noticed that she stiffened and when he looked at her, she was pale and seemed to be gagging. I was called to the room to check on patient and when I saw her, she was pale and limp. She did not have tonic clonic movements or eye deviation. She had secretions coming out of her mouth, kind of foaming. Oxygen was placed over her face and after a few minutes, her color improved and she was alert. She was transferred by EMS to the emergency room where she was monitored for an hour and was doing better.
Moderate severe swelling of upper and lower lips approx 45 minutes after adm. of both meningococcal vax #2 and HPV #3.
Started to develop rash on back then progressively has gotten worse. Now rash all over body and face
Patient received injection in left deltoid. The lymph node under his left arm in the armpit became swollen the next day. Mother has been using Ibuprofen with no relief. She was advised to continue NSAID's and add in hot compresses.
Pt presented to office on 04/13/05 with mom. HX of lesions x 48 hours. Over 75 lesions mostly concentrated on face and trunk. Advised Benadryl, Aveeno, Calamine, No ASA. Isolation, re-check PRN.