chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Approx 2 hrs after vaccine, noted warmth in R hand which resolved within minutes, then warmth sensation in R cheek and eventually L cheek.  L cheek warmth sensation resolved within 30 min, R cheek warmth  last 2.5 hrs.  Only monitoring and evaluation, no treatment provided.
Presented with SOB/fever/weakness x 5 days; + Covid 5 days PTA; dx with Covid PNA; tx steroids/Vit C/Vit D/ Remdesivir/ supplemental O2; discharged home refused to use NC O2
Health Department was contacted, who asked staff to come to facility to vaccinate bedbound patient. Once staff returned with signed consent after administering the 1st dose of the Moderna series, it was inputted into Shots. Upon inputting the information into shots we realized that the patient has already been fully vaccinated with Pfizer within the facility. Nurse advised, and she stated she didn't realized that patient had already been fully vaccinated.
PATIENT REPORTS REDNESS, KNOT UNDER THE SKIN, AND WARMTH AROUND THE INJECTION SITE
Patient stated she had chest heaviness and SOB the evening after receiving the vaccine.  She saw her PCP and got a steroid shot and took Benadryl on 1/15.  On 1/17 she came to the ER with complaints of cough and chest heaviness thought to be caused by the vaccine.  She was treated for underlying pneumonia with azithromycin 500mg PO, cefdinir 300mg PO, and a one time dose of methylprednisolone 125mg IM.
Second dose given February 6,2021 about 4pm felt soreness at site of shot slight headache  /February 7,2021 felt tired,fatigue,soreness  at site , slight headache general malaise/ February 8,2021 soreness at site and at 10am noticed a  rash on my arm which was not present evening before . Red , sore to touch rash patch about 2 inches very slight swelling
Has 7X3 cms Erythema, induration X 2days. No fever. Warm compress, po AUGMENTIN 400 PO BIOX 10
I had an extreme increase in neck and back pain for about a 1.5 weeks.  Then slowly decreased.    Just adding to the side effects calculations.
WHOLE BODY HURTS; LUMP AT INJECTION SITE; ARM SORE; ARM SWOLLEN AT INJECTION SITE; FEELING LIKE IN A FOG; COULD NOT HEAR DISTANT SOUND; COULD NOT MOVE; VISION WAS BLINDED IN MIDDLE; EXTREME SLEEPINESS; BOWEL MOVEMENTS AND URINATION AT SAME TIME; TASTE SWEET; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's past medical history included thyroid radiation, and concurrent conditions included diabetic, and sensitive to taste in her mouth.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: EL043A21A and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 17:50 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the subject experienced taste sweet. On 11-APR-2021, the subject experienced extreme sleepiness. On 11-APR-2021, the subject experienced bowel movements and urination at same time. On 11-APR-2021 08:00, the subject experienced could not hear distant sound. On 11-APR-2021 08:00, the subject experienced could not move. On 11-APR-2021 08:00, the subject experienced vision was blinded in middle. On 11-APR-2021 08:00, the subject experienced feeling like in a fog. On 12-APR-2021, the subject experienced whole body hurts. On 12-APR-2021, the subject experienced lump at injection site. On 12-APR-2021, the subject experienced arm sore. On 12-APR-2021, the subject experienced arm swollen at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not hear distant sound, could not move, and extreme sleepiness on 11-APR-2021, and bowel movements and urination at same time on 13-APR-2021, was recovering from vision was blinded in middle, and whole body hurts, and had not recovered from arm sore, lump at injection site, arm swollen at injection site, feeling like in a fog, and taste sweet. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as the case assessed as non-serious.
The day after my shot, I started developing hives. The hives worsened over days and persisted for about 3 months. The hives appeared to come out each evening. I initially consulted my primary care MD who suggested I take Benadryl which I did. It did not help. I then went to an Urgent Care facility and it was suggested I take Allegra during the day and Benadryl at night, which I did. This helped only mildly. I saw an allergist in May and June 2021. Allergy testing was completed. I did not show an allergy to anything. It was doctor's impression that I had an adverse IMMUNE response to the Vaccine.  It is unclear if this response is at all related to my Hashimotos disease which is an auto immune disease.  My bloodwork did show markers for auto-immune disease; however it is possibly a marker  for something in addition to Hashimotos (possibly Lupus). I am scheduled to see a rheumatologist in a few weeks to follow up on this finding.  I continued to take the Allegra and Benadryl through the end of  July 2021/beginning of August. The hives persisted until that time, when they gradually went away.
Student Under Age 18 Received a Dose of Heplisav-B; Initial Report Received on 03-Sep-2019 and 04-Sep-2019   A nurse reported that "two students" under the age of 18 received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization. Of the two students, one was a 16-year-old female, who received two doses of HEPLISAV-B.   Relevant medical history and allergies were reported as none.   Concomitant medications were not provided.   On 07-Jan-2019, the patient was administered with the first dose of HEPLISAV-B (lot # 1032912, expiration date: 15-Mar-2019, and NDC # unknown).   On 28-Feb-2019, the patient was administered with second dose of HEPLISAV-B (lot # 1032912, expiration date: 15-Mar-2019, and NDC # unknown).   On 03-Sep-2019, the nurse reported via email that two students under the age of 18 received a dose of HEPLISAV-B.   On 04-Sep-2019, the nurse reported that of the two students, one was a 16-year-old female, who received two doses of HEPLISAV-B. No other information was provided.  At the time of the report, no adverse events were reported.   The reporter did not provide a serious assessment for the event.   Company comment:   The company assessed the event of product administered to patient of inappropriate age as non-serious. The event of product administered to patient of inappropriate age is unlisted per HEPLISAV-B USPI.; Sender's Comments: The company assessed the event of product administered to patient of inappropriate age as non-serious. The event of product administered to patient of inappropriate age is unlisted per HEPLISAV-B USPI and IB.
where a patient DID develop shingles after receiving SHINGRIX shot(s). /Suspected vaccination failure; where a patient DID develop shingles after receiving SHINGRIX shot(s).; This case was reported by a nurse via call center representative and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 26-JAN-2023 Reporter's comments: The female pharmacist had stated that she had seen a case sometime in the past where a patient did have developed shingles after receiving Shingrix shot(s). The reporter did not remember if the pharmacist used the male pronoun or the female pronoun when discussing this patient (and did not know if the patient in question received only one or both of the Shingrix shots). The reporter did provide the pharmacy name and phone number where the female pharmacist works and where this conversation had occurred.  The reporter did not know the name of the pharmacist. No further details provided.  The reporter had consented to follow-up. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.  This case US2023011716 was not linked with US2023AMR011584 based on the response received from the hub.
Patient was given dose 0.6ml not the 0.3ml in the right deltoid, patient has not had any adverse effects.
eye irritation; eyes turn red; blurry vision; difficulty keeping eyes open; BP 160/85; This is a spontaneous report from a contactable other hcp (patient). A 50-year-old male patient received bnt162b2 (lot number: EL0140), intramuscularly at arm left, first dose on 28Dec2020, at single dose, for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications the within 2 weeks of vaccination. The patient experienced eye irritation, eyes turn red, blurry vision, difficulty keeping eyes open, BP 160/85 on 28Dec2020. No treatment received for the adverse event. The event was reported as non-serious. The outcome of the events was recovering.
My daughter was given the 3 Gardasil vaccinations.  They were given over a 6 month time, beginning in October of 2007.  Shortly after receiving the first injection, she complained of feeling "thick-headed" and had difficulty comprehending things. She had started a new job, that was similar to a previous one, but couldn't seem to grasp what was being told.  Following the second injection, she began having frequent crying spells, continued feelings of confusion, and she broke up with a then boyfriend, and quit her job.  This was the first time she hadn't worked since she was 15 years old.  She began a new job in March, after taking a couple months off.  Things were going OK, until she received the third injection in April.  By July, she was exhibiting confusion and mania.  She was taken to see her family physician, who advised seeing a psychiatrist.  She was told that she was having a "manic episode and was possibly bipolar."  By the end of Aug. it was necessary to hospitalize her for treatment.  In the interim, she was diagnosed with having high mercury levels in her blood and adipose tissue.  A decision was made to treat her for an acute immune response, due to the combination of the reaction to the Gardasil injections, mercury levels and stress.  Every physician who had seen her asked the same questions about her past medical history, and every one of them, consisting of MD's, a DO, and 2 Naturopaths felt that her illness was due to an acute reaction, or a combination of "things" that overwhelmed her body.  She is now on psychiatric drugs, and is receiving supportive care from the Naturopaths.  The hope is to detoxify her body.  She has not had any previous issues with mental instability.  11/21/2008 MR received for DOS 8/29-9/01/2008 with D/C DX: Bipolar Disorder with Manic and Delusion, resolved. Pt presented to ER after escalating bizzare behaviors, mania and delusions. Neurology consult reports changes in mental status and behavior began in Oct 2007 following receipt of HPV vaccine. Impression: Acute manic episode in a person with underlying bipolar disorder.  Started on anti-psychotic meds and D/c for outpt tx 9/1/08. 12/24/08 MR received from naturopathic ND. Pt presented 8/28/08 with c/o progressive behavior changes since receiving Gardasil vaccinations. Pt with manic behaviors, babbling speech, obsessions and fluctuating mood. Pt readmitted 9/8-18/08 for bizzare behaviors.  Tx for mercury and lead toxicity. Pt sx improving by 10/2/08 with new c/w headache/pressure. Dx: Bipolar 2' to mercury toxicity. 1/27/2010 Patient continues to have issues with lethargy, depression, cognitive functions and short term memory recall. She has improved, but is still not "like she was" before the series of (3) of GARDASIL injections.
In July 2016, I went to visit my mother and my childhood dog. Within 24 hrs my eyes became swollen, itchy, and very irritated. I left and came home. 1 and a half months later the same symptoms started to happen around my cats. I had developed an allergy to cats and dogs within 6 months of vaccination. Now I itch non stop and break out in contact dermatitis rashes when I come around either, dogs, or cats. The itching started in December 2016.
The moment I received my first covid vaccine it hurt my arm terribly and I could barely use my arm for the first 3 days and had a lot of pain from the injection site all the way down my arm to my elbow for next 8 days. Over the next 3 months I could point to the exact place the injection was administered and felt intermittent muscle pain from the injection site down to my elbow. It gradually got worse and worse until mid-June when my shoulder began to move around and pop and felt like it was almost dislocating. This began by simply raising my arm above my head. Ever since then my shoulder joint continues to move and pop and the muscles all the way down my arm to my elbow hurt almost constantly and sometimes extreme pain.  I can still point to the exact spot of the injection site and my shoulder continues to move and pop and makes my muscles all the way down my arm to my elbow feel pulled very badly and in addition, the muscle at the top of my shoulder that connects to my upper chest, right at the front of my armpit, is very, very tight and I sometimes now have muscle pain all across my chest and my upper back feels compromised now as well.  This is now 7 months since my first injection and I am still in a lot of pain and sometimes cannot use my arm.  The 2nd Pfizer Covid shot was administered on 3/26/2021 in my right arm and once I told them all the trouble I was having after the first shot, they used a smaller needle and made sure to place it in the right spot.  I have had no problem with the right arm.  It seems to me that the first shot was placed either too high or too deep.  I seem to also be having an inflammation reaction to stress in all the areas described in my left arm so am wondering if the Covid vaccine has caused all this or if it was the placement of the vaccine.  I have been in physical and massage therapy since mid-June, so in therapy once a week now for over 3 months.  I have a little better mobility in my right arm but am still experiencing all the pain and movement in my shoulder daily.  For 4 months there has never been a day my arm does not hurt and for 3 months prior to that, I had intermittent pain weekly.  I feel I am about to have to go to an Orthopedist and certainly hope this vaccine has not caused me to have to have surgery or permanent damage to my left arm muscles, ligaments, or tendons.
Headache and body aches 1-2 hrs after, arm swelled and couldn't bend at elbow and went to ER and diagnosed with cellulitis.
the patient did not have any other adverse events; VARIVAX was administered after a temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapies were not reported.  On 16-SEP-2022, varicella virus vaccine live (oka/merck) (VARIVAX) 1 dose, lot #W011626, expiration date: 06-APR-2024, was administered for prophylaxis (strength, and route of administration were not provided), after a temperature excursion in -10.4 degrees Celsius (C) for 30 hours (product storage error). The patient did not have any other adverse events (no adverse event). No previous temperature excursion.   This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2209USA007227:
Moderna Covid Vaccine given out of approved age range.  Patient was only 14 year old.
Breakthrough case admission after 4 vaccines Pfizer 4/23/21 Lot# Ew0171;  Pfizer 5/15/21 Lot# EW0177;  Moderna 12/7/21 Lot# 060H21A;  Moderna 3/18/22 Lot# 026L21B
Swollen lymph nodes with all 3 Pfizer shots. Swollen lymph nodes on collar, neck, groin,bone/ Went to urgent care and side swollen lymph nodes were due to vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 50-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Nov2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 50 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: unknown), administration date: 24Mar2021, when the patient was 49-year-old, for COVID-19 Immunization, reaction(s): "Swollen lymph nodes"; BNT162b2 (DOSE 2, SINGLE, Lot number: unknown), administration date: 14Apr2021, when the patient was 49-year-old, for COVID-19 Immunization, reaction(s): "Swollen lymph nodes".  The following information was reported: LYMPHADENOPATHY (non-serious) with onset Nov2022, outcome "recovered" (Nov2022), described as "Swollen lymph nodes with all 3 Pfizer shots. Swollen lymph nodes on collar, neck, groin,bone/ Went to urgent care and side swollen lymph nodes were due to vaccine". The events "swollen lymph nodes with all 3 pfizer shots. swollen lymph nodes on collar, neck, groin,bone/ went to urgent care and side swollen lymph nodes were due to vaccine" required emergency room visit.  Additional Information: It was reported swollen lymph nodes with all 3 Pfizer shots. Swollen lymph nodes on collar, neck, groin, bone. Went away after a week each time. Went to urgent care and side swollen lymph nodes were due to vaccine. Stop date was a week after each shot.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Running nose, mild body aches, no fever.  Took Paxlovid and cold/flu medication (Alka-Seltzer Plus). Felt better after a few days.  Still tested positive after a week from first event. Doctor said I may still test positive a few weeks after first infection.
I will briefly describe the typical symptoms I experienced first as I have them noted before talking about the atypical ones.  Injection site soreness, severe exhaustion, and felt very weak, and INITIALLY INTERMITTENT CHILLS  Adverse event 1: I lost nearly all homeostatic ability to endothermically produce body heat such that when I urinated or touched my body with my hands, it was ice, my housemate can attest to this as well.  Adverse event 2: During this time of extreme weakness I was laying down and my heart started to beat extremely fast which is very atypical of me and I actually saw my life flash before my eyes for the first time in my life. Treatment:  This led to me taking ibuprofen to hopefully help alleviate some of the side effects, which I broke into smaller pieces to increase surface area and absorptivity, and either it helped alleviate the symptoms or they subsided otherwise.  Outcome: I was very happy to get vaccinated and am recovered physically from the adverse event, but the ide of getting an mRNA based booster really worries me - even though they would be far < 100 ug.
her hand was slightly swollen and today it is even more swollen; This is a spontaneous report from a   consumer (patients husband).  A 50-year-old female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number), via an unspecified route of administration, on an unspecified date as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included the flu shot on August 29th. The consumer reported that his wife took the second dose of the vaccine on "Monday" morning. Yesterday she noticed that her hand was slightly swollen and today it is even more swollen. The event was non-serious. The clinical outcome of the event swelling of hands was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
This spontaneous report was received from a Registered Nurse regarding unspecified number of patient of unknown demographics. There was no information about concurrent condition and historical medication. Since 01-JUN-2015, the patient was vaccinated with improperly stored ZOSTAVAX (dose strength, route and lot number was unknown). No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 11/18/2021 COPD STAGE 1 MILD (FEV1 80-100%) R09.02 HYPOXIA 11/18/2021 COPD STAGE 1 MILD (FEV1 80-100%)
Patient reported experiencing tightness and itchiness in her throat 20 minutes after receiving the Moderna COVID 19 vaccine dose #1.   The tightness progressed to difficulty speaking and dizziness.  Administered 0.3mg epinephrine IM right thigh, then administered 5omg diphenhydramine IM right arm at site of vaccine injection.   Her throat tightness/itchiness resolved in two minutes.  Continued to have dizziness, then fast heart rate, shakiness and chest pressure after administration of the epinephrine.   EMT was called and was present in  10 minutes.  transported to the ER at 10:10am
This spontaneous report was received from a physician via two company representatives and from a practice manager (support services director) and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 18-NOV-2014, the patient was vaccinated with an improperly stored dose of GARDASIL injection, lot # K005083, expiration date 04-NOV-2016 (dose, route and site of administration were not reported). The administered dose of vaccine was exposed to temperature excursion (date unspecified) lasting for 48 hours, with the lowest recorded temperature of 1 degree Fahrenheit (also reported as 1 degree Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Pt vaccinated with Pneumococcal developed mild local reaction w/erythema & systemic reaction w/chills & fever up to 102. Also lt neck lymph edema. Treated by ENT MD w/Keflex edema disappeared, but chills & fever continued through 28NOV90.
Onset of seizures and developmental delays. Onset Feb. -12, 2001 9 months after vaccine.  10/6/09 PCP medical records, neurology consult, service dates 2/10/02 to 9/09/09. Assessment: Intractable epilepsy and static encephalopathy. Child presents with hx of generalized tonic-clonic convulsion in setting of high fever in Feb 01 dx febrile seizure. In Feb 02 was found limp and unresponsive, vomited twice, and slept for a period of time. convulsive seizure March 02 when ill with otitis media. Tonic stiffening, loss of consciousness, drooling, clonic movements. Similar seizures have continued to occur. Child has been agitated, aggressive with hitting and biting, hyperactive, mood lability. Sometimes prodrome or aura. Chewing movements, c/o knees hurt, behavioral arrest, blank stare, stiffen and fall to floor. Bilaterally syncronous and symmetric clonic movements. Eyes roll up. Perioral cyanosis. Postictal confusion. Cognitively impaired. Limited speech. Not eating or sleeping as usual. Sore throat. Diarrhea. Bends back while walking.