chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt requested vaccine, received counseling and review of VIS, and was vaccinated IM with first dose of SHINGRIX. Counseled to stay in waiting room for 15-20 minutes following vaccination, but patient left to shop. She returned in ten minutes to report she felt "out of breath". Pt evaluated and pharmacist found no symptoms of respiratory distress (BP 138/82, 68 bpm, and 14 respirations).  Pt had excellent color and negative for respiratory exertion. Pt has history of anxiety and stated this type of reaction often occurs when she tries new medication. She improved to baseline with observation and in an isolated, quiet environment (in counseling room). Pharmacist followed up with her later in the afternoon (4 pm) and she stated she was fine.
One day after Varicella vaccine administered in right arm, patient developed a vesicular patch on that upper arm. The rash spread across right side of chest & neck. The rash was painful. Clinically, it appeared like shingles. It also grew a small amount of methicillin-sensitive staph aureus. The rash was (+) for varicella on PCR.
pt recv vax lt deltoid, two days later upper arm red swollen & hot to touch down to just below elbow;seen in office;tx motrin PRN;also high fever present;
Immediate muscle tension in left arm  following vaccine shot in left arm.  The soreness persisted for several days. Painful to lift left arm higher than my shoulder.  The morning of day 3, I woke up to feel a pronounced skin irritation under my left armpit.  Later that day, I noticed a small welt on my left arm and the irritation had grown to include my upper left arm front and back. Over the next few days, the number of welts increased and the pain was increasing from the skin irritation. The tension in my shoulder started to give way to feeling tightness in my left chest.   I reported the symptoms. I tried to report to the Health Department, but they wouldn't take a report stating that the symptoms I was reporting did not match "known symptoms".  On 4/13/21, I went to the Urgent Care to have the rash examined. The doctor tentatively diagnosed as Shingles. However, because of the chest pain, he referred to the Emergency Room for blood tests to rule out a possible Pulmonary Embolism.  The blood tests came back normal. I was prescribed 12 Hydrocodone-Acetaminophen for the pain and discharged.  On 4/15/21 I returned to Urgent Care because the welts were continuing to spread and the pain was increasing. Including sharp pains associated with the shingles. At this visit I was prescribed 21 tablets of Hydrocodone-Acetaminophen and 21 tablets of ValACYclovir.
I noticed that my arm was warm, the following day I had a rash all over my arm. I went the same week and I had to go see my PCP, the rash was coming from the injection site so my doctor prescribed me antibiotics. She did not want to prescribe me steroids because she didn't want to risk mixing steroids with the vaccine.
Difficulty in breathing; Body ache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty in breathing) and MYALGIA (Body ache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Difficulty in breathing) and MYALGIA (Body ache). At the time of the report, DYSPNOEA (Difficulty in breathing) and MYALGIA (Body ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported.
uncomfortable dreams; I had some itchiness and redness at the site; had some itchiness and redness at the site; felt woozy; fever 100.5; chills; nauseous in the morning; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (felt woozy), ABNORMAL DREAMS (uncomfortable dreams), VACCINATION SITE PRURITUS (I had some itchiness and redness at the site), PYREXIA (fever 100.5) and CHILLS (chills) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure increased, Sleep apnea since 08-Jan-2017, Penicillin allergy, Allergy to antibiotic, Fruit allergy and Allergy to antibiotic. Concomitant products included IRBESARTAN from 01-Jan-2000 to an unknown date for Blood pressure high, ESTROGEN NOS;PROGESTERONE from 01-Jan-2003 to an unknown date for Hormone replacement therapy, VITAMINS NOS for an unknown indication.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced DIZZINESS (felt woozy), PYREXIA (fever 100.5), CHILLS (chills) and NAUSEA (nauseous in the morning). On an unknown date, the patient experienced ABNORMAL DREAMS (uncomfortable dreams), VACCINATION SITE PRURITUS (I had some itchiness and redness at the site) and VACCINATION SITE ERYTHEMA (had some itchiness and redness at the site). At the time of the report, DIZZINESS (felt woozy), ABNORMAL DREAMS (uncomfortable dreams), VACCINATION SITE PRURITUS (I had some itchiness and redness at the site), PYREXIA (fever 100.5), CHILLS (chills), NAUSEA (nauseous in the morning) and VACCINATION SITE ERYTHEMA (had some itchiness and redness at the site) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, Body temperature: 100.5 (High) fever 100.5.         This case was linked to MOD-2021-042134 (Patient Link).
feeling bad; chills; A spontaneous report  was received from a consumer concerning a 77 year old female patients who received   Moderna's  Covid 19 vaccine(mRNA1273) experienced chills and  feeling bad.  The patient's medical history was not provided.Products known to have been used by the patient, within two weeks prior to the event, included Amlodipine and Valacyclovir.  The patient received second of two planned dose of mRNA-1273 (Batch Number 012M20A) intramuscularly  in right arm on 03-FEB-2021  for prophylaxis of Covid 19 infection.  On 03-FEB-2021, the patients experienced chills since night of vaccination  and was feeling bad. The treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable. The outcome of the event s chills and feeling bad were considered as unknown.
confusion; absent minded; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (confusion) and DAYDREAMING (absent minded) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Insomnia, Hypertension and Acid reflux (esophageal). Concomitant products included PANTOPRAZOLE for Acid reflux (esophageal), LISINOPRIL for Hypertension, TEMAZEPAM and HYDROXYZINE PAMOATE for Insomnia.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced CONFUSIONAL STATE (confusion) and DAYDREAMING (absent minded). At the time of the report, CONFUSIONAL STATE (confusion) and DAYDREAMING (absent minded) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was reported    Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021
did not give the ACT-HIB portion of the vaccine with no reported AE; Initial information received on 12-Jan-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 2 months old and unknown gender patient who was not given the act-hib portion of the vaccine with no reported ae after receiving diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 05-Jan-2023, the patient received a  dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine  (Suspension for injection) at a dose of 0.5 ml  via unknown route in unknown administration site for Immunization (strength, batch number and expiry date: unknown). Batch/lot number requested  On 05-Jan-2023 the patient was not given the act-hib portion of the vaccine with no reported ae (product preparation error) (latency same day).  Action taken: not applicable  At time of reporting, the outcome was Unknown for the event did not give the act-hib portion of the vaccine with no reported ae.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
1 to 2 days post vaccination patient experienced high fever (104 degrees), extreme fatigue, weakness, dizziness, along with chills and sweats. Symptoms lasted for approximately 5 days, and client returned to clinic on 08/21/2003 for following symptoms:  sore throat, earache, HA x 3 days plus elevated HR and BP---tested positive for Strep A.
Patient got an allergic reaction (rash on cheeks and forehead) the day after the first dose of the Moderna vaccine. Patient came to pharmacy to let us know today. We recommended benadryl to help with his allergies.
Violent nervous system reaction; lingering fatigue; joint pain; vision and hearing impairment; vision and hearing impairment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 06Apr2021 at 19:00 as dose 2, single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Gout" (unspecified if ongoing), notes: other medical history: Gout. There were no concomitant medications. Vaccination history included: BNT162b2 (Prev dose product: COVID 19 , Prev dose brand unknown: True , Prev dose brand name unknown: COVID19 Vaccine , Prev dose lot unknown: True, Prev dose lot unknown reason: Unable to locate or read the details, Prev dose administration date: 16Mar2021 , Prev dose administration time: 07:00 PM , Prev dose dose number: 1, Prev dose vaccine location: Left arm), administration date: 16Mar2021, when the patient was 62-year-old, for Covid-19 immunization. The following information was reported: NERVOUS SYSTEM DISORDER (disability) with onset 07Apr2021 at 21:00, outcome "not recovered", described as "Violent nervous system reaction"; ARTHRALGIA (disability) with onset 07Apr2021 at 21:00, outcome "not recovered", described as "joint pain"; FATIGUE (disability) with onset 07Apr2021 at 21:00, outcome "not recovered", described as "lingering fatigue"; VISUAL IMPAIRMENT (disability), HYPOACUSIS (disability) all with onset 07Apr2021 at 21:00, outcome "not recovered" and all described as "vision and hearing impairment". The events "violent nervous system reaction", "lingering fatigue", "joint pain" and "vision and hearing impairment" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2022) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of nervous system disorder, fatigue, arthralgia, visual impairment, hypoacusis.  Clinical information: Facility type vaccine was other. No other vaccine in four weeks. None other medications in two weeks. Medical episode 24 hours after second dose. Violent nervous system reaction with lingering fatigue, joint pain, vision and hearing impairment Symptoms continue to this day. Patient received treatment for adverse event. Adverse event treatment included Saw 3 MD's and 5 specialists and no relief. No covid prior vaccination. He had no Known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Immediately after vaccination @ 15:34, pt reported ringing in the ears and decreased vision.  Resolved within 5mins. Vitals: 15:42 95/53, 64, 14, 100% -- > sitting 15:52 106/65, 75, 14, 100% 3:42 pt placed in trendelynburg position Mom states that the patient had a similar episode w/ first vaccine dose.  Pt ate and drank well.  Advised to notify providers of rxn for injections/blood draws.  Pt asymptomatic by 16:00. Pt stable and released from the vaccination site @16:00.  Pt ambulatory, mom and brother by his side.
(R) thigh 1 Indurated area of cellulitis. (L) thigh - 2 Indurated areas of cellulitis x 24 hours. Warm compress x po antibiotics.
Fever to 102F beginning within 8 hours of immunization and large local reaction about 20cm x 20cm distal to site of injection beginning 1 day of shots. Increased temperature persisted x 3 days. Was treated with Bactrim on 10/14/07.
On Jan 31, I had a bad sore throat and tested neg for COVID-19. Then on Feb 1, I tested  positive for COVID-19 with 101.2, chills, sore throat, and fatigued. I got Paxlovid prescribed and began dosing that evening. I took the full dose for 5 days. The next day I didn't have a fever but was very tired/fatigued. On Feb 6, I tested negative for COVID-19.  I received  also received the  Pfizer Bivalent vaccine 9/2022, GH9694 Pharmacy
p/vax pt devel an inj site rxn characterized by a small amount of swelling which turned purplish & devel into a large mass;
This spontaneous report as received from a healthcare worker refers to an unspecified number of unspecified patients. On an unknown date the patients was vaccinated with VARIVAX (Merck) (strength, dose, frequency, route, lot # and indication were not provided). On unspecified dates, that were exposed to temperatures outside the proper storage range. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Severe rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Severe rash) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Depression, High cholesterol, Vaginal dryness, Weight loss, Falling and Gallbladder removal. Concurrent medical conditions included Multiple sclerosis, Optic neuritis, Blood pressure high, Dysarthria (Takes a little longer to pronounce words.), Hypothyroidism, Gastrooesophageal reflux disease, COPD, Iron low, Drug allergy (Allergic to prednisolone), Drug allergy (Allergic to mobic), Fruit allergy (Allergic to strawberry) and Pain. Concomitant products included HYDROXYZINE, LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D), METHYLPREDNISOLONE (MEDROL DOSEPAK), AMLODIPINE, LOSARTAN, LEVOTHYROXINE, TRAMADOL, ATOMOXETINE, OMEPRAZOLE, ESCITALOPRAM, GABAPENTIN, SIMVASTATIN, ACETYLSALICYLIC ACID (BREOPRIN), ESTRADIOL (VIVELLE DOT), FISH OIL (OMEGA 3 FISH OILS), ALBUTEROL [SALBUTAMOL] and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, the patient experienced RASH (Severe rash). At the time of the report, RASH (Severe rash) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication was not provided. Concomitant medication include unknown cream.  Patient current condition include use of assistive device and trouble remembering.
Per mother: one hour after administration pt. began to have emotional outbursts and cried a lot. Was consolable. Then for 3 weeks since (so far) had irregular emotional ourbursts, temper tantrums and memory loss about once a day. No reports from school teacher as of yet. No fever. Mother taken the pt. to see alternative physicians, and health care workers. Given many herbs and supplements.
Pneumovax injection given in right deltoid and experienced hives all over her body. (OMIC)
I came down with a cold. I had ear pain, scratchy throat runny nose, congestion and coughing. It was a predictable cold for me except symptoms were worse and lasted longer than any other cold. It lasted for 3 weeks. Then I was okay for 2 days and then the ear pain started again and 9 days later I went in to be checked and was diagnosed with an ear infection in both ears. I am currently taking antibiotics for the ear infection.
In May I started noticing my blood pressure was really high. My normal 130/85 and since Feb it kept going up. March wasn't so bad but in May I notice I had to take deep breaths and my heart rate was really high.  The resting heart rate was above 90 which is abnormal. I had to really take deeper breaths. I had to tightening in my chest or chest pain. Went to the doctor in may and all test came back normal.
sty on his eye (unspecified); rashes on his face/rashes recurred; This spontaneous case was reported by an other health care professional and describes the occurrence of HORDEOLUM (sty on his eye (unspecified)) and RASH (rashes on his face/rashes recurred) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A.) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HORDEOLUM (sty on his eye (unspecified)) and RASH (rashes on his face/rashes recurred). The patient was treated with SULFADIAZINE SILVER (SILVADENE) for Stye, at an unspecified dose and frequency. At the time of the report, HORDEOLUM (sty on his eye (unspecified)) outcome was unknown and RASH (rashes on his face/rashes recurred) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment included Topical antibiotics for rashes on his face which failed. The patient was subsequently given oral steroids which resolved the condition but the rashes recurred when the steroids was stopped.
No symptoms reported by any of the patients; a temperature excursion that occurred on 8/11/2021 / VARlVAX lot: T037643 has been administered to (3) patients; This spontaneous report was received from a nurse and refers to a 12-month-old patient. No information regarding the patient's medical history, drug allergies/reactions or concomitant therapies was provided.  On 11-AUG-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX), dose reported as 1 (unit not provided), lot # T037643, expiration date 06-NOV-2022 (route of administration was not provided) for prophylaxis. No adverse symptoms were reported. Administered dose of vaccine experienced the temperature excursion of 8 Fahrenheit degrees for 2 hours and 15 minutes. There were no previous excursions reported.  This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA003810: US-009507513-2108USA003979:
Pt is a 34 year old male s/p Pfizer COVID-19 vaccination : dose one on 4/2/21 and dose two on 4/23/21. Pt underwent voluntary COVID-19 testing on 6/24 after exposure to a COVID positive person and test resulted back negative. On 7/3, patient was retested with new onset of symptoms such as fever, chills, fatigue, muscle aches, headache and congestion. Test on 7/3 resulted back positive.
(Per parent) She was extremely irritable.  She was wheezy, broke out in a rash and had a temperature of 101.3.  Child was born premature.
This spontaneous report was received from a licensed practical nurse, referring to a 12 year old, female patient. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On unknown dates the patient was vaccinated with the three dose series of GARDASIL (dose, route, lot # and expiration date were not reported). Then, on 17-JUL-2015, the patient was vaccinated with an additional dose of GARDASIL 9 by intramuscular route in the right arm (reported as RD), lot # K026247 (expiration date was not reported), because a company representative mistakenly told that it was the Centers for Disease Control and Prevention (CDC) recommendation. No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information has been received.
Shot administered at 10:00 am. Pt contacted Rph at 3:30 PM to inform tha lips began to swell. Referred pt immediately to E.R. and Rph informed PCP. Pt saw PCP - swelling resolved without tx.
anaphylaxis; Initial information received on 12-Nov-2019 regarding an unsolicited valid serious case received from a Pharmacist.  This case involves patient of unknown demographics who experienced anaphylaxis (anaphylactic reaction), while he/she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history included alpha-gal allergy and patient cannot tolerate mammalian products.  The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported via unknown route in an unknown administration site.  On an unknown date, the patient developed serious anaphylaxis (anaphylactic reaction) (Unknown latency), following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. This event was assessed as medically significant.  Lab data was not reported.  Final diagnosis was anaphylactic reaction.  It was not reported if the patient received a corrective treatment.  The patient outcome was reported as Unknown for anaphylaxis.  Information on the batch number was requested.; Sender's Comments: This case concerns a patient of unknown demographics presented with anaphylaxis (anaphylactic reaction) after vaccination with FLUBLOK QIV. The time to onset is unknown. Patient's medical history includes alpha-gal allergy and patient cannot tolerate mammalian products. Moreover, medical condition at time of vaccination, previous immunization history, allergy testing and lab test ruling out alternate etiologies were not reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Information has been received from a 69 year old female with severe stomach acid and allergy to wheat, soy and dairy who on 22-DEC-2010 was intramuscularly vaccinated with a 0.5 ml dose of PNEUMOVAX 23 (lot # not reported). Concomitant therapy included SYNTHROID, PRILOSEC and loratadine. The reporter stated that after receiving the PNEUMOVAX 23, on approximately 27-DEC-2010 ("last week") the patient experienced right above the injection site, a lemon size red area with a white streak. Then from the top of her shoulder to her elbow was swollen and painful, about 3 times the normal size. At the time of reporting, the patient was recovering. No lab diagnostics studies were performed. The patient was treated with pain medication and ice packs. The patient sought unspecified medical attention. Additional information has been requested.