chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received FLUARIX vaccine on 10/29/2018 at 8:00 PM, she called from home at 8:40 PM that she had started severe spasms in her neck about 30 minutes after getting vaccine. She believed that the pain was from the vaccine she just received. She complained that she was in so much pain that she could hardly walk and carry grocery bags. She was advised to go to Emergency Room, but she decided to wait until morning and took ibuprofen for pain overnight. In the morning of  10/30/2018, she went to walk-in clinic and the doctor at walk-in clinic ruled out the muscle spasms relation with vaccination specially when she received vaccine on her right hand and she had pain on left side of neck. Then she was prescribed Prednisone 20 mg, Methocarbamol 500 mg and Tramadol 50 mg for the treatment.
Pt's mthr. reports pt. awoke in the early hours of 4-23-13 with "chills", "weakness", "dizziness" upon standing and emesis x 1. Mthr. states other household members have "head cold" sxs only. Mthr. said she will just watch her closely and take her to pediatrician only if sxs/condition worsen.
No AE/ PQC reported at this time; Caller reported VAQTA (lot T033304 exp 4/2/2022) and ROTATEQ (lot 1741376 exp 3/6/2022) were administered to patients.; This spontaneous report was received from a healthcare professional, referring to a 4-month-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, or allergies were not reported.  On 18-MAY-2021, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) injection (strength, vaccination scheme, anatomical site of vaccination, and route of administration were not reported; lot number 1741376, expiration date 06-MAR-2022) as prophylaxis (product storage error). No adverse effect (AE)/product quality complaint (PQC) reported at this time.  The vaccine experienced a temperature excursion between 36 degrees Fahrenheit (F) to 46F (48.2F) for 0 hours, 15 minutes and 0 seconds. There was a previous temperature excursion between 36F to 46F (46.2F) for 0 hours, 15 minutes and 0 seconds, as recorded by a data logger.
This spontaneous report as received from a registered nurse via company representative refers to a 9 week old patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 07-SEP-2016, the patient was vaccinated with improperly stored dose of PEDVAXHIB, lot # M014926 (strength, dosing details, anatomical location and expiration date were unknown) for prophylaxis. On 01-SEP-2016, temperature excursion of the vaccines occurred in the fridge and was not discovered until 26-SEP-2016. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter source. Additional information has been requested. Sender's Comments: US-009507513-1612USA003706.
Information has been received from a registered nurse concerning a 22 year old female patient with asthma in 2007 and no allergies, who on 02-MAR-2007 was vaccinated with a first 0.5 ml dose of GARDASIL (Lot# 654510/0962F), IM. On 24-MAY-2007 was vaccinated with a second 0.5 ml dose of GARDASIL (lot# 654510/0962F), IM, and on 17-OCT-2007 was vaccinated with a third 0.5ml dose of GARDASIL (Lot# 658488/0930U), IM. Concomitant therapy included DEPO-PROVERA which was reported that she re-started on 04-JAN-2011 and it was not taken in 2010. On 17-OCT-2007 and in 2009 Papanicolaou test were performed and both were negative. The nurse reported that on 16-NOV-2010 a human papilloma virus test was performed that was positive and the patient was sent to a gynecologist. The patient on unspecified date had a colposcopy that was positive for HPV neoplasia. The nurse also stated that this was not present prior to receiving GARDASIL. The nurse reported that these events were related to "pre cancer". The nurse reported that the patient would have a loop electrosurgical excision procedure (LEEP) at the gynecologist's (date not reported). At the time of the report the patient had not recovered from these events. Upon internal review "pre-cancer" was considered to be an other important medical event. The patient sought unspecified medical attention. Additional information has been requested.
Impaired consciousnesses. Progressively worse; past 7 days most noticeable. 03/01/20  -  03/06/20.
Missed period; This is a spontaneous report from a contactable consumer (patient).   A non-pregnant female patient of an unspecified age received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  There was no relevant medical history. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 on unknown date for covid-19 immunisation. The patient stated she has not missed a menses since 13 years old and "on BC". She missed period after second shot of COVID vaccine. The outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Narrative:  11/20/21 Per Center Note, pt reports developing rash after pneumonia vaccine on 11/18/21; states the evening of 11/18/21, he had chills; on 11/19/21, he was sweating and then developed a generalized itchy, raised rash; pt reports using hydrocortisone with some improvement; methylprednisolone and diphenhydramine ordered
body aches, fever, sore throat, SOB, malaise; H1N1 confirmed
stated she felt nauseated right after injection- thought it was a need to eat- after eating she became no better- stated then became dizzy and stayed nauseated-then stated she began to itch-no noted rash-
This spontaneous report as received from nurse refers to a patient of unknown age. On 26-MAY-2014, the patient was inadvertently administered with PROQUAD (lot #, expiry date unknown) injection, subcutaneous. There was not product quality complaint. The outcome of the event was unknown. Additional information is not expected.
p/vax devel hives on arms, abd & some on lt upper arm;denied resp diff but was uncomfortable d/t itching;
Fever; Pain in the injection site; Tiredness; Chills; This is a spontaneous report from a non-contactable pharmacist (patient). An adult female (not pregnant) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number and expiration date unknown as not available/provided to reporter at the time of report completion), via an unspecified route of administration at left arm on 24Jan2021 at single dose for COVID-19 immunization at a Pharmacy or Drug Store. No known allergies, other medical history was reported as none. There were no concomitant medications, no other vaccine in four weeks, no other medications in two weeks. On 25Jan2021, the patient experienced pain in the injection site, tiredness, chills, and fever. Therapeutic measures were taken as a result of the events: acetaminophen. The outcome of the events was not recovered. Patient did not had COVID prior vaccination and no COVID tested post vaccination.  No follow-up attempts are possible;Information on lot/batch number could not be obtained.
pain & discomfort w/redness 1-4d p/inj;ice pack applied on 25JUN94 noted to have inc discomfort w/speckling appearance lt deltoid;pt had fiery red appearance over entire lt deltoid both anterior & posterior w/edema, discomfort;dx cellulitis
HE BROKE OUT IN HIVES FROM HEAD TO TOE. MOM BROUGHT HIM IN TO THE OFFICE ON 1/10/2013 TO BE SEEN. PLAN OF TREATMENT IS ORAL STEROIDS AND A ANTIHISTAMINE.
Huge localized reaction - painful, hot to the touch, swollen, red, bruised, about 4 inches in diameter 2 days after injection. Fever (101.2), congestion, sore throat, hoarseness, fatigue, irritability and stomach pain 5 days after injection
I got a large blood clot on the backside of my arm across from injection site.  My arm hurt within the hour of shot given and got worse over the next 2 days. I did "chat with a doctor" and sent him pictures. He had me take Benadryl thinking it was an allergy Weds. 9/23/2020, by that evening I could not even lift my arm. It was double in size and there was a tennis ball sized lump. I went to the ER and got a ultrasound to find I had a blood clot. I have been on enoxaparin shots and just started Pradaxa yesterday. The lump in my arm is now little marbles.
Patient presented for the COVID-19 booster dose at our clinic on 12/15/21.  Although eligible for the booster dose, she received the incorrect vaccine.  This patient due to her age received the Moderna Booster and should have received the Pfizer booster.  Patient's mother was phoned and spoken to on 12/16/21 at 1600.  I explained the vaccine administration error and the mother was advised to notify her PCP and to notify me (provided my contact information) if her daughter experienced any adverse reactions from the vaccine within the next few weeks or so. Patient's mother did verbalize understanding and her questions and concerns were addressed.
15 minutes after vacination of Anthrax and Flu, patient developed macular-papular puretic rash circumflexing his chest and upper extremities.  No angioedema, SOB, respiratory difficulty, or tachycardia.  Alert and orientient X 3, vital signs stable (115/72, 122/80) during entire event.  Only complaint was itchiness.  Given 50mg IM Benadryl and 4mg of Dexamethasone.  After 1/2 hour rash resolving, puritis resolving, and remained stable.  Patient released accompanied by co-worker.
This spontaneous report was received from 26 year old patient of unknown gender. Concurrent conditions and medical history were not reported. The patient stated that in June 2014, also reported as "had GARDASIL Dose 1 completed more than a year ago", the patient was vaccinated with the first dose of GARDASIL (Lot number, expiration date, dose and route were not reported). Concomitant medications were not reported. The reporter stated that the patient stopped continuing with the second dose and the third dose because the patient had an abnormal pap smear and the patient was told that had HPV. A gynecologist told her/him that once she/he had HPV, getting further GARDASIL treatments would be ineffective since she/he already had HPV. However, the patient read through the company web site that event if someone did have HPV, that person should still get GARDASIL. The patient wondered if he/she needed to restart the series and if she/he had to restart, the last dosage which would occur after the patient's 27th birthday in February 2015. The patient also query if that would affect the effectiveness of the series, also said that she/he had been traveling and would continue to travel, the patient wondered if it would be an issue to get the different dosages in different countries. The outcome of papilloma viral infection was unknown. The reporter did not assess the relatedness of GARDASIL to HPV. Additional information has been requested.
PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 15 year old male. 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 12-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-JUL-2021, the subject experienced product administered to subject of inappropriate age. On 12-JUL-2021, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the product administered to patient of inappropriate age and off label use was not reported. This report was non-serious.
Non-traumatic bruising. Petechiae in random areas of body. Denies history of bleeding disorders in self or family. PLT <3.
Woke up to a rash on the injection site exactly 1 week after 1st dose. The injection site was red, swollen, itchy and hot.
In February patient had the explosive onset of severe paresthesias and subsequently was diagnosed with demyelinating peripheral polyneuropathy in all 4 extremities confirmed by EMG /nerve conduction study.  Work-up was completely negative for all other etiologies and felt to be related to the vaccine.  Things have slowly improved with medication treatment
Information has been received from a registered nurse concerning a 6 week old female with no drug allergies who on 07-APR-2008 was vaccinated PO with a dose of Rotateq (lot# 659913/1702U). On 14-APR-2008 the patient experienced diarrhea and had 5 watery bowel movements within 20 hours. The patient sought medical attention through an office visit. In April 2008, laboratory diagnostics studies revealed a positive results for blood in the stool. Subsequently, the symptoms have since resolved and the patient was recovered on 21-APR-2008. There was no product quality complaint. Upon internal review, positive for blood in stool was determined to be an other important medical event. Additional information has been requested.
Less than 5 minutes after vaccine given, patient became cyanotic, unresponsive cardiopulmonary arrest requiring full CPR. Transported to local ED via ambulance, required additional support including epinephrine, diphenhydramine, Solumedrol.
Child received three vaccines with Rotateq at age 2, 4, and 6 months, however, he contracted gastroenteritis on 3/12/15 and died from dehydration and Rota Virus A infection on 3/13/15 which was detected on autopsy.
ZOSTAVAX vaccine administered 04-25-12 at 856 AM. Pt returned to clinic 04-26-12 at 300pm with a 1" x 25" raised red, itchy patch (directly over ZOSTAVAX admin site). 4/27 - reports spreading of redness.
Cold chills, sweat, nausea, vomiting, horrible headaches, dizziness, and lightheaded, burning sensation around abdominal area, difficulty breathing.
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose number unknown, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "felt dizzy". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Caller was a patient and had been vaccinated with the Pfizer Covid-19 vaccines about six months prior and was interested in the booster vaccine because she wants to be protected against the delta variants. Caller states she has felt dizzy recently and got tested because she was afraid she might be positive for the delta variant, but that her test came back negative. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Headache; Fatigue; Chills; Drowsiness; This is a spontaneous report received from a non-contactable consumer, the patient. A 24-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: Unknown, Solution for injection), via an unspecified route of administration on an unknown date (at the age of 24-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had tested for COVID-19. The patient underwent lab test which included nasal swab test on an unknown date and the test result was unknown. On 17Mar2021, the patient had experienced headache, fatigue, chills and drowsiness. The patient was treated with paracetamol (TYLENOL) for adverse events headache, fatigue, chills and drowsiness. The clinical outcome of the events headache, fatigue, chills and drowsiness was recovered in Mar2021.   No follow-up attempts are possible, information about lot/batch number cannot be obtained.   Amendment: This follow-up report is being submitted to amend previously reported information: Unknown removed from suspect vaccine Lot# field. Final sentence Information about lot/batch number cannot be obtained. No further information is expected. updated as No follow-up attempts are possible, information about lot/batch number cannot be obtained. per SER055.
Headache fever chills muscle aches nausea loss of appetite swollen lymph nodes and breast tissue painful arm at injection  site and rash ?Covid arm?.
Left thigh (site of injection) is edematous and mildly pruritic. No vascular of neuro compromise distally.
Raised red ring, about 4 inches in diameter, around the injection site. Noticed the rash 11 days after the first injection. Cleared up within 24 hours. Not itchy or painful.  Also experienced soreness in the injection arm beginning the day of the injection and clearing up within 3 days.
Rash, starting evening of administration, about 1 inch above and growing to about 6 inches below site. Pt states it happens every year, no egg, latex or neomycin allergy.
Only symptom noted with the first dose was a sore arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 07-Jun-2021 and was forwarded to Moderna on 07-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Only symptom noted with the first dose was a sore arm) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 039B21A) for COVID-19 vaccination.     No Medical history was reported.  Concomitant products included WARFARIN, ONDANSETRON, BUTALBITAL, CAFFEINE, PARACETAMOL (FIORICET), SUMATRIPTAN, CELECOXIB (CELEXA [CELECOXIB]), ETHINYLESTRADIOL, ETONOGESTREL (NUVARING) and BACLOFEN for an unknown indication.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced VACCINATION SITE PAIN (Only symptom noted with the first dose was a sore arm). At the time of the report, VACCINATION SITE PAIN (Only symptom noted with the first dose was a sore arm) outcome was unknown. Not Provided          Treatment information was not provided.   This case was linked to MOD-2021-211542 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested
Systemic: Body Aches Generalized-Mild, Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: pre-syncope-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hyperventilation-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: symptoms started at 1515, EMS called at 1524, EMS arrived at 1534 pt refused at 1540, pt waiting in waiting room till 1556, pt states no more symptoms occurring, family friend coming to pick pt up per EMS request
Extreme lethargy for 21 days.  It felt like someone had placed 3 dental x-ray lead aprons on me.  Had to hold on to the walls to walk and I normally walk full upright with no assistance quickly.  Also lightheaded.
Pt recvd PedvaxHIB on 12MAR91; Pt recvd 2nd dose of vax on 15MAY91; On 27MAY91 pt was hospitalized; Cultures showed growth of HIB; Additional information has been requested;
Tuesday Oct. 13 04 at 2:30 pm I received my Flu shot about 4 hrs later I began to have chills and then fever, felt weak. I covered up after lying down. After about 16 - 18 hrs the flu like symptoms subsided and I began to feel back to normal. Just wanted to submit this info for your benefit.
Administered vaccine at a "homeless" event. Patient stated that he had received Johnson & Johnson in the past.  When entering patient's  information in the database the patient had received Pfizer vaccines in the past.
Was seen by Infectious disease for f/u of living in foreign country x 4 years. Had had dengue fever x 2 during this time. In preparation of going back to foreign country, was updated w/TDAP & oral typhoid. Approximately 1 week later began to notice substantial hair loss in shower.
Labial blisters "cold sores" since resolved but developed cheilitis that persists
An open sore appeared within two days of getting the vaccine on one foot.  The lesion continued to grow grow, and causes chronic intense pain.  Over the past year, multiple lesions have appeared.  After seeing the primary care physician, referral was made to a dermatologist.  The final diagnosis, after much testing, was Pyoderma Gangrenosum.  I have been through three dermatologists, one clinical trial for Pyoderma Gangrenosum, and now seeing a cardiologist.  This issue is ongoing, and worsening.  I have been treated with, prednisone, Humira, multiple antibiotics multiple creams, Dapsone (oral), and just added CellCept and Doxycycline..
Had a ZOSTAVAX vaccination 2/11/15. Around a week later began experiencing very painful left jaw pain, stiffened neck muscles, painful wrists, and hip girdle pain. This progressed to both jaws, neck, shoulders, forearms, wrists, hips, glutes, and thighs. Difficult to walk and general loss of functionality. In May I was diagnosed with Polymyalgia Rheumatica. Per the Merck pharma site PMR is potential rare serious side effect.