chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Neuropathy; Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of an unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   In or around July 2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose # and route not specified) for routine health maintenance and for its intended purpose: the prevention of singles (herpes zoster). Shortly, on an unknown date, after receiving zoster vaccine live (ZOSTAVAX), the pt. suferred singles and neuropathy(neuropathy peripheral ). As a direct and proximate result of use of defective zoster vaccine live (ZOSTAVAX), the pt's symptoms have resulted in physical limitations, not present prior to vaccination, The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. Further, as a tragic consequence the pt suffered severe and permanent personal injuries, as well as significant conscious pain and suffering, mental aguish, emotional distress, loss of enjoyment of life, physical impairment and injury.  The outcome of singles and neuropathy peripheral  was not recovered.   The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The reporter considered the events to be disabling.  Upon internal review, the event neuropathy peripheral was considered to be medically significant.
02/15/2021, that night I bad headache, chills, and achy all over, took Advil, the headache went away. Chills and achy lasted till noon that next day. 04/01/2021 I could not see well out of my right eye. Like a hole in my vision. On 04/06/2021 I went to see my Ophthalmologist. Still being treated with an injection once a month. 08/16/2021 in the left eye I began to have a glimmer kind of sight out of my left eye, that went away after an hour and half.
This spontaneous report was received from a physician and refers to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On 09-MAY-2017, the patient was vaccinated with an expired dose of ZOSTAVAX, 19400 plaque-forming units (PFU) with an expiry date of 03-MAY-2017 (exact dose, route of administration and lot # were not reported). No adverse effects were reported. Additional information is not expected as no consent to contact the physician was granted.
Left side of tongue went numb Saturday and is still numb today. Monday has effected taste. Received vaccine (flu) Thursday the 19. Given in the right arm.
ALLERGIC REACTION; This spontaneous report received from a consumer 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced allergic reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of allergic reaction was not reported. This report was non-serious.
0837 30 MIN S/P 2ND PFIZER INJECTION. COMPLAIN OF MOUTH ITCHING. NO RASH NO SOB. BENADRYL 25MG PO GIVEN AND WILL OBSERVE. 0906 STATES "BETTER" DENIES SOB, RASH. RETURN TO WORK WITH INSTRUCTIONS TO SEEK MEDICAL ATTENTION IF NEEDED
Provider at local ER states that the patient has suffered a seizure.  Patient is not currently being treated for seizures and has no history of seizures noted.
Approximately 12 hours after injection patient reported having trouble "seeing things " and shivering and chattering teeth without an apparent fever. Reported feeling very cold and once put in bed reported that the bed had become a bed-car and felt like something or somebody was grabbing at his feet. His mother lay with him and reassured him and tried to get him to sleep. He fell asleep after 2 hours but then reported in the morning very vivid nightmares. He had no more chills or hallucinations the next day.
nausea; headache; weakness; muscle pain; stiff neck; difficulty moving left arm (injection site Left deltoid); received her first dose of the Pfizer BioNTech Covid-19 Vaccine in April and her second dose in July; This is a spontaneous report from a contactable consumer (patient herself). A 72-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in left deltoid on an unknown date in April2021 as DOSE 1, SINGLE; dose 2 via an unspecified route of administration, administered in left deltoid on an unknown date in July2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced nausea, headache, weakness, muscle pain, stiff neck, difficulty moving left arm (injection site Left deltoid) for 3 weeks, received her first dose of the pfizer biontech covid-19 vaccine in april and her second dose in july (inappropriate schedule of product administration). The outcome of all the events was unknown. There was no product quality complaint (PQC) present.
Redness, swelling and warmth at injection site noted 2/20/08. Treated with CLARITIN 10 mg, 1x day for 2 days and hydrocortisone cream to site for 2 days. Resolved all symptoms on 2/24/08. On 2/27/08 noted red rash to face in mask-like distribution, affecting forehead, cheeks, chin, nose and around eyes. Treated with hydrocortisone cream with noticeable improvement. Saw PCP on 3/4/08. Lab work drawn 3/5/08. ANA negative. Facial rash resolved 3/8/08.
Felt "woozy" right after injection. Next day legs/arms tingly, throat felt tight & sore the night of inj. Developed shortness of breath.
Extreme exhaustion and muscle aches for about a week after second shot; Extreme exhaustion and muscle aches for about a week after second shot; foggy; soreness with small rash around injection site; soreness with small rash around injection site; very low blood pressure; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 68-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 02Apr2021 14:00 (at the age of 68-year-old) as dose 2, single for covid-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing, urticaria from an unknown date and unknown if ongoing, blood cholesterol increased from an unknown date and unknown if ongoing. Concomitant medications included atorvastatin taken for an unspecified indication, start and stop date were not reported; losartan taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient had no known allergies. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 12Mar2021 14:30 (at the age of 68-year-old) as dose 1, single for covid-19 immunisation and experienced uncontrollable shivering, 101.1 fever, severe headaches, could not stand, weak, dizzy, nausea, vomited once in bed fir 3 days. On 02Apr2021, the patient experienced extreme exhaustion and muscle aches for about a week after second shot, foggy, soreness with small rash around injection site, very low blood pressure. Felt nearly back to normal 8 days later. The patient underwent lab tests and procedures which included body temperature: 101.1 on 02Apr2021. Therapeutic measures were taken as a result of extreme exhaustion and muscle aches for about a week after second shot, foggy, soreness with small rash around injection site included Tylenol. The outcome of the events were recovered on an unspecified date in Apr2021.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Chills began at 0200 on 4/27/21 followed by, Fever, Headache, Muscle Aches that remained for the rest of that day.  Symptoms were treated with Tylenol.  Symptoms were gone by 6AM on 4/28/21.
Client reported a feeling of blood rushing through body, lightheaded, and heart palpitations.  Vitals taken at 1202: HR87, O2 95%, BP 166/99. No difficulty breathing. client denies any swelling in throat or mouth.  Itching in hands and feet. Zyrtec 10 mg given at 1217. Continue monitoring client. At 1240 client reported mild throat tightening and flushing in neck, hands, feet, and top of head.  Denies any difficulty breathing.  Epi pen 0.3 mg given at 1244.  Vitals at 1246. HR94, O2 93%, BP 181/100.  Clients son decided to take client to ER.  I don't know which hospital.  Client left at 1305.
24 hrs post vax uncontrollable screaming 3-4 hrs; Ate -dozing for awhile-began screaming again; no vomiting t102-103; taken to MD CBC & UA nl; hospitalization for observation w/family 65 miles from home; pt given DPH; APAP also given;
Mom reports a blister, smaller than a dime, appeared to back of left arm the day after vaccination.  A smaller blister appeared in same area the next day.  Child only had fever & pain at site a day or 2 after vaccination.  Mom states blisters still present and is just reporting this to us today.  Reports no fever or pain to touch now, no lethargy.
Information has been received from a physician concerning a 13 year old female who in approximately 2010, "recently", was vaccinated with the second dose of GARDASIL 0.5 ml (route and lot # not reported). On the following evening during a basketball game, the patient had a syncope episode and the coach diagnosed it as seizure. The patient was taken to emergency room but not hospitalized. It was reported that the patient's event was improved subsequently but the final outcome was unknown. All attempts to obtain follow up information has been unsuccessful. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested.
Initially on Friday evening I had a runny nose and congestion, and I could tell I was having a cold then on Saturday, Sunday and Monday I went to the doctor because I wanted to make sure I didn't not have COVID-19 and eliminate the possibility but it was negative, so I was told I just had a very bad head cold and on my chest. I still have a little bit of a runny nose but main reason I went was because I needed to know if I had COVID-19 because I watch my grandbaby and I did not wanted to expose her. I honestly didn't think is coincidental.
mom states pt had high pitched screaming most of afternoon;pt was hoarse;pediatrician recommended ped DT;APAP given
stroke; Extensive FLAIR hyperintense signal signal in the cerebral white matter/ Mild hyperintense signal in the brain stem and medial cerebellum; This is a spontaneous report from a contactable consumer. This consumer reported for a 76-year-old female patient (reporter's mother) who received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3302) first dose via unspecified route of administration on 21Jan2021 at 12:00 PM in left arm at single dose for COVID-19 Immunization in the hospital. There was no other vaccine administered in four weeks. Medical history included COPD (Chronic obstructive pulmonary disease), Small Cell Lung Carcinoma with metastases to brain s/p surgery, chemotherapy and radiation in 2014, dementia. Concomitant medications included citalopram at 40mg, levothyroxine at 0.05 mg, salbutamol (ALBUTEROL). The patient previously took Codeine and experienced allergies. The patient was not pregnant at the time of vaccination. The patient did not have COVID prior to vaccination. The patient had what appeared to be a stroke on Saturday, 23Jan2021 at 12:00 PM. A CT, MRI and an Echocardiogram were all performed on 23Jan2021 and there was no acute intracranial hemorrhage, mass effect, midline shift, or extra-axial fluid collection. Extensive FLAIR hyperintense signal signal in the cerebral white matter. Mild hyperintense signal in the brain stem and medial cerebellum. Following contrast administration there is no abnormal CNS enhancement. The adverse events resulted in Emergency room/department or urgent care and hospitalization for seven days from Jan2021. Treatment given was TPA to reverse adverse effects. The patient was not tested for COVID post vaccination. The outcome of events was recovered/resolved with sequel.  No follow-up attempts possible. No further information expected.
Caller wanted to report an adverse event; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Caller wanted to report an adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Caller wanted to report an adverse event). At the time of the report, IMMUNISATION REACTION (Caller wanted to report an adverse event) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported. No treatment details were reported.
A report has been received from a Pharmacist. The report, concerning a Female subject, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. The patient experienced administration of expired FLUMIST which started on 08-Mar-2016. The outcome of the event of administration of expired FLUMIST is unknown. The report was considered to be non-serious by the company physician.
Immediate welt and itching at injection site, rapid heartbeat, lightheaded, upset stomach for several hours. 2 days later felt flu like symptoms by the end of the day had skin outbreak. Now have full blown shingles for 2 weeks & not gone.
SHORTNESS OF BREATH  (SLIGHT AND  NOT ALL THE TIME); VERTIGO; FELT OFF BALANCE; PRESSURE PRIMARILY ON LEFT SIDE OF HEAD; LOCALIZED HEADACHE PRIMARILY TO THE LEFT SIDE; TIRED; ACHES AND PAIN; FOGGY; This spontaneous report received from a patient concerned a 50 year old female. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 11-APR-2021, the subject experienced aches and pain. On 11-APR-2021, the subject experienced foggy. On 11-APR-2021, the subject experienced tired. On 12-APR-2021, the subject experienced pressure primarily on left side of head. On 12-APR-2021, the subject experienced localized headache primarily to the left side. On 14-APR-2021, the subject experienced vertigo. On 14-APR-2021, the subject experienced felt off balance. On 18-APR-2021, the subject experienced shortness of breath (slight and not all the time). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aches and pain, foggy, and tired on 11-APR-2021, and vertigo, and felt off balance on 14-APR-2021, was recovering from shortness of breath (slight and not all the time), and had not recovered from pressure primarily on left side of head, and localized headache primarily to the left side. This report was non-serious.
Pt recv vax in Feb '98; in the same month pt exp rx of injection site; pt tx=antibiotic.  PT RECV VAX INTRADERMAL
Vaccine was administered 30-day Use By Date or after Manufacturer Date of Expiry; No adverse event; 4 doses were administered past the expiration date. Lot number unknown. Expiration date: 12Jul2023 Administration date: 13Jul2023.; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 doses were administered past the expiration date. Lot number unknown. Expiration date: 12Jul2023 Administration date: 13Jul2023.), PRODUCT STORAGE ERROR (Vaccine was administered 30-day Use By Date or after Manufacturer Date of Expiry) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Jul-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 13-Jul-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (4 doses were administered past the expiration date. Lot number unknown. Expiration date: 12Jul2023 Administration date: 13Jul2023.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was administered 30-day Use By Date or after Manufacturer Date of Expiry) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (4 doses were administered past the expiration date. Lot number unknown. Expiration date: 12Jul2023 Administration date: 13Jul2023.), PRODUCT STORAGE ERROR (Vaccine was administered 30-day Use By Date or after Manufacturer Date of Expiry) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (4 doses were administered past the expiration date. Lot number unknown. Expiration date: 12Jul2023 Administration date: 13Jul2023.) and PRODUCT STORAGE ERROR (Vaccine was administered 30-day Use By Date or after Manufacturer Date of Expiry).    Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-733821, US-MODERNATX, INC.-MOD-2023-733824, US-MODERNATX, INC.-MOD-2023-733826 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-733821: US-MODERNATX, INC.-MOD-2023-733824: US-MODERNATX, INC.-MOD-2023-733826:
Given 10mcg/0.2ml in error Give 0.4ml to bring to 30mcg total
I experienced facial numbness around 10 pm on 12/8/2021. The facial numbness has since subsided but I have numbness in my left lower thigh that is constant and not going away.
01/05/2022- runny nose,  sore throat, cough. I work for a hospital and I called the Hotline and they told me to get tested and I messaged my PCP through their chart and asked her some questions. Treatment- over the counter Mucinex DM.  I took an at home test on Wednesday, 01/05/2022- and it was negative 01/06/2022 - I had a COVID-19 test- positive  01/19/2022-I still have a slight cough and a runny nose, other than that I feel fine.
Information has been received from a registered nurse concerning a child who on 02/11/1997 was vaccinated with a dose of varicella virus vaccine live. Subsequently, the pt developed chicken pox. The reporter indicated that there was a chicken pox breakout at a day care in her area. It was reported on 01/04/2002 that 15 children had developed chicken pox since the end of December 2001. The first onset date was 12/31/2001 and the last was 01/03/2002. The number of lesions were reported to be unknown. The pt sought unspecified medical attention. It was also reported that 7 of the children were vaccinated with varicella virus vaccine live (WAES0201USA00351, 0201USA00755, 0201USA00756, 0201USA00757, 0201USA01039 and 0201USA01041). Additional info has been requested.
Severe Calf pain in left leg after 1st shot (week after) and now 2nd shot (week and a half after).  Feels like someone is tasering my leg.
Localized rxn.  Had stepped on a foreign body and was given a tetanus/diphtheria booster since pt had not had a booster within past 10 years on 10/4/07.  She had localized swelling and redness of left arm at the injection site & joint achiness, no breathing difficulty.  2 x 3 cm redness on left upper arm.  Pt given Decadron/Deponechol injection 10/8/07.  Reaction eventually resolved, lower axillary lymph node & left axillary wall lymph node persisted in being enlarged slightly.
1110: arrived for vaccination 1115: vaccinated 1117: honked horn to alert traffic 1118:  (providers) assessed patient and discovered pt in NAD but described mild throat sensation, and she was experiencing flushing and redness through chest with 1 hive on face. 50mg of Bendryl was given to the patient to swallow which she did without issue.   1125:She reported feeling better within a few minutes.  Patient was asked to wait in vehicle with her parents for an additional 20 minutes which at that point we reassessed and pt reported that she felt slightly anxious but fine otherwise.urticaria fading  1138:  left site after infrmed decision where she was given the option for transport/referral
One day after my 2nd Moderna shot I developed severe chest and back pain and was developing a frozen painful left shoulder (where I had an injury from my previous flu shot administration).  It began very shortly after vaccination and by the 2nd day the chest, back and arm pain were so severe I was afraid I was having a heart attack so I had to go to the Emergency Room. It was not a heart attack, but told it was likely a fibromyalgia flare up combined with inflammatory reaction from the Covid vaccine.  This has lasted for one month now, and is only beginning to reduce in severity due to anti inflammatory my physician prescribed for me.
I had the shivers for 4 hours, from 4am to 8am. Took Tylenol to get rid of fever & chills (100.9) On 4/15 evening had fever (100.9) & chills at 7PM for an hour. took Tylenol again. Friday 4/16 had chills with fever (100.9) that lasted for over an hour each time at 3AM ,1PM, & 8PM. On Saturday 4/17 I started to feel pain on my right side of my body under my ribcage, by my groin and in my lower right back. Had 2 more episodes of shivers with fever(100.9) on 4/17 evening and 4/18 in the morning. On Sunday 4/18 went to minute clinic because I do not have insurance and cannot afford to go to ER. Was told that I have a kidney infection. I am now on antibiotics for only 2 days but , symptoms have still not gone away. I would like someone to contact me and let me know if I do have to go to ER, who covers that expense, since I do not have health care insurance.
The date the DTP vax was administered the pt had 3 hrs of high pitched crying during which the pt was not consolable, per mom's history; no medical attention or consultation was sought until pts regularly scheduled well child visit 8JAN93;