chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a prospective pregnancy case. This 32-year-old female subject was enrolled in a study. The subject received Flu Seasonal QIV Dresden (intramuscular) on 16th December 2015. Concomitant products included Prenatal Vitamins. The subject's last menstrual period was on 23rd September 2015 and estimated date of delivery was 21st June 2016. The subject received Flu Seasonal QIV Dresden at week 12 of the pregnancy and during the first trimester of pregnancy. On 17th December 2015, 1 days after receiving Flu Seasonal QIV Dresden, the subject developed pain in arm. Serious criteria included other: as per reporter. Additional event(s) included neck pain on 17th December 2015 with serious criteria of other: as per reporter, back pain on 17th December 2015 with serious criteria of other: as per reporter, chest pain on 17th December 2015 with serious criteria of other: as per reporter and vaccine exposure during pregnancy. The subject was treated with TYLENOL. The outcome of pain in arm was unknown. The outcome(s) of the additional event(s) included neck pain (unknown), back pain (unknown), chest pain (unknown) and vaccine exposure during pregnancy (unknown). It was unknown if the investigator considered the pain in arm, neck pain, back pain and chest pain to be related to Flu Seasonal QIV Dresden. Additional details were provided as follows: The medical assistant reported that, one day after receiving the FLUARIX QUADRIVALENT vaccine (batch number 5MJ7R, expiry date 30 June 2016), the patient started experiencing pain from the tip of her finger, up to her arm, into her neck, back and chest. The patient took some TYLENOL when the pain started and it subsided, but came back as soon as the TYLENOL wore off. The patient called the office about the pain and the office sent her to the emergency room.
her face seems droop; sinus infection; Headache; Ear infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 21-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: FACIAL PARALYSIS (medically significant), outcome "unknown", described as "her face seems droop"; SINUSITIS (non-serious), outcome "unknown", described as "sinus infection"; HEADACHE (non-serious), outcome "unknown"; EAR INFECTION (non-serious), outcome "unknown". The events "her face seems droop", "sinus infection", "headache" and "ear infection" required physician office visit. Therapeutic measures were taken as a result of facial paralysis, sinusitis, headache, ear infection. Clinical course: Reporter stated, was calling for daughter. The patient got the COVID Vaccine shot 11 months ago when they first came out. She has had no health conditions at all. After the two shot, a month later, she had got headache which reporter never thought nothing of it, never thought of about the COVID Vaccine, never thought about the other thing, reporter thought she had a ear infection or may be a sinus infection. Reporter took her to the doctor. The doctor gave her some antibiotic and he gave her a steroid shot even though he didn't find any infection because her face seems droop.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Large area little bigger than a quarter size welt/hive at area of vaccination that was red and hot and itchy first noticed 5 1/2 days after vaccination of yellow fever. Had felt tired/feverish for 3 days after vaccination. (but had polio, yellow fever and Hep A #1 same day).
Mild body aches 10/28 and pain at the injection site as well as swollen lymph nodes. However, 10/29 sweeping of lymph nodes under left arm much worse, extending into left chest and left bicep
Pt recvd vax 17MAR93 & w/in 24 hrs following vax pt devel cold chills, malaise & was not feeling well;
Fever, body aches, nausea began at 0700 1/28/2021. Took Tylenol taken every 4-6 hrs., rest, hydration
8 by 8 rash on the top of the buttocks area in lower back; This spontaneous case was reported by a consumer and describes the occurrence of RASH (8 by 8 rash on the top of the buttocks area in lower back) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 046B21A) for COVID-19 vaccination.     Concurrent medical conditions included HIV positive and Bradycardia. Concomitant products included BICTEGRAVIR SODIUM, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (BIKTARVY), ROPINIROLE, ALPRAZOLAM, GABAPENTIN, NAPROXEN, CITALOPRAM and OXCARBAZEPINE for an unknown indication.   On 26-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 27-Apr-2021, the patient experienced RASH (8 by 8 rash on the top of the buttocks area in lower back). The patient was treated with BETAMETHASONE DIPROPIONATE, CLOTRIMAZOLE (CLOTRIMAZOLE/BETAMETHASONE DIPROPIONATE) for Rash, at an unspecified dose and frequency. At the time of the report, RASH (8 by 8 rash on the top of the buttocks area in lower back) outcome was unknown. Not Provided
Pain and swelling in lower legs (anterior compartment syndrome) which began on 3/15/21, 5 days after vaccination. Pain and swelling continue without abating after 2 weeks of rest, compression, ice, elevation.  Stye in left eye - possibly due to inflammation in eyes. Treating with moist heat.
This spontaneous report as received from a other health professional refers to a 12 month old patient. On 24-JUL-2014 the patient was vaccinated with MMR II (lot # H011885, expiration date: 25-JUN-2014) 0.5 ml, subcutaneously, which was expired. Activity date reported as 28-JUL-2014. This is one of several reports received from the same source. Additional information has been requested.
Headache, Myalgia, Arthralgia, Fever, Rash, Chills, fever Narrative:
Very sore arm.  Achey joints muscles, extreme fatigue, stiff neck, "fuzzy" thinking.  Most gone after one day.  Arm still a little sore.
Patient developed severe arm pain and was seen in clinic on 3 January. He said the pain radiated from the injection site and down his arm. Forearm appeared visibly swollen, measuring 0.5cm larger than the contralateral forearm. Pain with flexion of the elbow, and pronation/supination, slightly improved since onset. Lab/rad workup negative. Pain medication prescribed, will follow-up if it does not improve.
Strong burning sensation upon the injection. Right arm is very painful. Injection site is hot and painful to touch. A lump can be felt at injection site. Area is also reddened. Pain upon any movement with RUE.
Hives, swollen lips, itching. Took OTC anti-histamine medications.
She mentioned she had minor side effects with the past Moderna vaccines; She usually gets a red arm that stays red for a long time, even with the flu shot; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (She mentioned she had minor side effects with the past Moderna vaccines) and VACCINATION SITE ERYTHEMA (She usually gets a red arm that stays red for a long time, even with the flu shot) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: RSV  (RSV vaccine 2 weeks ago) and Flu Shot. Past adverse reactions to the above products included Injection site redness with Flu Shot; and No adverse effect with RSV . Concurrent medical conditions included Penicillin allergy.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (She mentioned she had minor side effects with the past Moderna vaccines) and VACCINATION SITE ERYTHEMA (She usually gets a red arm that stays red for a long time, even with the flu shot). At the time of the report, IMMUNISATION REACTION (She mentioned she had minor side effects with the past Moderna vaccines) and VACCINATION SITE ERYTHEMA (She usually gets a red arm that stays red for a long time, even with the flu shot) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Patient had minor side effects with the past Moderna vaccines. She usually gets a red arm that stays red for a long time. She doesn't have her vaccination card with her.  Patient received the latest Moderna vaccine this past Sunday 01Oct2023.  Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-743516 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-743516:Same patient, SPIKEVAX 2023-2024 Vaccine
Sent to the ER due to hives, some throat and chest tightness. Given epinephrine, steroids and antihistamines. Was seen in the ER x2 and had a doctors visit in follow up.
THE PATIENT EXPERIENCED HIVES 4-5 HOURS AFTER HAVING THE SHOT. THE HIVES LASTED FOR 4 DAYS. THE PATIENT WAS TREATED WITH BENADRYL.
Initial report received on 06 April 2010 from an article. "Pregnant women are at increased risk for severe illness and complications from infection with seasonal influenza and 2009 pandemic influenza A (H1N1). To characterize the severity of 2009 H1N1 infection in pregnant women, the department of health conducted active and passive surveillance for cases of 2009 H1N1 infection in pregnant women requiring intensive care. This report summarizes the results of that surveillance, which found that, during 2009, 16 pregnant women and one who was postpartum were admitted to intensive-care units (ICUs). Two women died. Of the 17 women, 12 had no recognized risk factors for severe influenza complications other than pregnancy. All 17 women received antiviral treatment with oseltamivir; however, treatment was initiated <or=2 days after symptom onset in only one woman and was begun >or=5 days after symptom onset in four women. Because initiation of antiviral treatment <or=2 days after onset is associated with better outcomes, pregnant women should be encouraged to seek medical care immediately if they develop influenza-like symptoms, and health-care providers should initiate empiric antiviral therapy for these women as soon as possible, even if >2 days after symptom onset. Health departments and healthcare-providers should educate pregnant and postpartum women regarding the risks posed by influenza and highlight the effectiveness and safety of influenza vaccination. Obstetricians and other health-care providers should offer influenza vaccination to their pregnant patients." Only one of the 17 patients had received 2009 H1N1 vaccine and seasonal influenza vaccine. This case is further described below. One pregnant adult woman (age unspecified) received an injection (site and route not reported) of INFLUENZA VACCINE (manufacturer and lot not number reported) greater than 8 weeks before hospitalization on an unspecified date and an injection (site and route not reported) of PANDEMIC INFLUENZA VACCINE (manufacturer and lot number not reported) greater than 4 weeks before hospitalization on an unspecified date. The dates of the hospitalization were not reported; however, the patient had 2009 pandemic influenza A (H1N1). The patient's pregnancy information including gestational age was not reported. The outcome of the hospitalization was not reported. Documents held by sender: None.
COVID 19 Treatment; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Feb2021 as dose 1, single (Lot number: EL9264), in left arm, on 23Feb2021 as dose 2, single (Lot number: EN6200), in left arm and on 07Oct2021 as dose 3 (booster), single (Lot number: Ff2589), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SIMVASTATIN, start date: 02Nov2015, stop date: 19May2022. Past drug history included: Cipro, reaction(s): "known allergies: Cipro"; Acyclivir, reaction(s): "known allergies: Acyclivir". The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "COVID 19 Treatment"; COVID-19 (medically significant), outcome "unknown", described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Diarrhea started on fourth day Bitter taste in mouth after taking medication which lasted approx. 6-8 hrs after taking. Treatment start date was 19May2022 and treatment stop date was 23May2022. Indication: Treatment of COVID-19. Patient received other medication in 2 weeks was simvastatin 20 mg daily.
Fever to 103.6 that same evenig; left shoulder swollen to about i/3 larger and erythema to the shoulder and upper arm.
This spontaneous report was received from a pharmacy technician refers to multiple unspecified patients of unknown gender and age. Information regarding the patients' pertinent medical history, drug reactions/allergies and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with improperly stored ROTATEQ (lot # L035510, expiry date: 13-MAY-2017). Pharmacy technician stated that the vaccine underwent temperature excursion at 30.1 F for a duration of 13 hours 50 minutes. No data logger was involved and there was no previous temperature excursion. No adverse effect was reported. This is one of the two reports received from the same reporter. Additional information has been requested.
2/8/16 pt was given 2nd dose of flu too soon. 1st dose - given 1/27/16. 2nd dose - 2/8/16.
Pt. had reaction to vaccine. Whole upper arm was swollen and red. Pt. complained about it being tight and painful.
Within 15 minutes of vaccine being administered I developed itching  then hives on my head which progressed to my upper lip. Took 25 mg benedryl capsule at approximately 25 minutes after vaccine administered. Waited 1 hour at vaccine site to ensure benedryl had been effective at slowing progression of reaction.  Hives remained for several hours but no rash or other reaction noted.  Also had a large broad hive Penny size at the injection site that still remains 19 hours after vaccine injection.
The day after dose, pt stated that she experienced a dry cough and hoarseness. She stated that her cough became more wet/phlegm in nature a few days later
Tachycardia (109 bpm) last night for about 20 minutes - EKG taken at 9:52 PM on 9/13/21 Very slight headache
Both eyes started burning; Both eyes started watering making; Both eyes started burning and watering making it difficult to see/read; This is a spontaneous report from a contactable consumer. A non-pregnant female patient of unknown age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration on 13Apr2021 at 09:45 as a single dose for COVID-19 immunisation. Medical history included asthma, premature ventricular contractions (PVC). The patient was allergic to penicillin and statins. Concomitant medications were not reported. The patient previously took erythromycin (MANUFACTURER UNKNOWN) on an unknown date and experienced allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021, approximately 3 hours after receiving the shot the patient experienced both eyes started burning and watering making it difficult to see/read. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events both eyes started burning and watering making it difficult to see/read was recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
This patient complained of flu like symptoms, ie : chills, mild diarrhea, GI discomfort, back and spinal pain, severe dizziness (spinning room) for almost 12 hours, no fever. The symptoms started 3 days after her injection and lasted about 4 days. No treatment was given.
Information has been received from a physician concerning a 32 year old female who in 2007 was vaccinated on unspecified dates with all three doses of GARDASIL (lot#'s not reported). There was no concomitant medication. On 19-MAY-2008 the patient had a pap test which showed she was at high risk for HPV. Prior to this her PAP tests were negative. The patient's high risk for HPV persisted and the patient sought medical attention by calling the office on an unspecified date. Additional information has been requested.
I tested positive for COVID-19 on 04/30/2022. I started with a mild sore throat and had it for a couple of days.  I was with friends and one of them called and said that they had COVID-19. So, that's when I went and got tested and it was positive.  I have a cough, fatigue, running nose and congestion. My symptoms was very mild and lasted for about 6 days.  My doctor prescribed Paxlovid 5 days pack. I still have a little fatigue but I am feeling better.
Information has been received from a physician concerning a 12 month old female who on approximately 28 Jun 2006 was vaccinated subcutaneously with a dose of Proquad (lot# 653357/0303F). A week and a half later, on 08 Jul 2006 the patient developed lesions on the injection site and had a low grade fever. Two days later the lesions spread to her legs, back, hands and feet. In total the patient had 8 lesions. Unspecified medical attention was sought. Subsequently, the patient recovered. No product quality complaint was involved. Additional information has been requested. Follow-up information has been received from a physican concerning this 12-month old female who on 16-JUN-2006 was vaccinated with a first dose of MMR II (Wistar PA 27/3) + varicella (Oka/Merck). Subsequently, about a week after vaccination on approximately 23-JUN-2006, the patient developed a vesivcular injection site rash. It was reported that the patient was treated to relieve the symptoms. At the time of the reprot, the patient recovered. It was noted that the rash occurred over 2 years ago. There wasno product quality complaint involved.
Throat tightened up. Felt a ?frog n my throat? sensation. And heavy anxiety about 10 minutes after injection. This was followed by profuse swearing in underarm area both sides. Tightness in throat and ?frog? feeling subsided after about 45 min anxiety took about 25 min to subside. It is presently an hour later and I can still feel a little tightness in my throat.
Information has been received from a registered nurse regarding 2 female patients of unknown age. No concurrent condition and historical medication was reported. On an unknown date the patient was vaccinated with GARDASIL 9 (dose-0.5 ml and route-intramuscular) (lot # and expiration date not provided). No concomitant medication was reported. On an unknown date two unspecified patients called the practice seeking medical recommendations/attention regarding the treatment of injection site reactions of swelling and knot. The condition of both the patient's was unresolved after at least 7 days, post administration of GARDASIL 9. Suggestion was given via telephone to apply warm compress and use ibuprofen. No PQC was involved. The outcome of injection site reaction, injection site swelling and injection site nodule was unknown. Causality between GARDASIL 9 and injection site reactions of swelling and knot was not reported. Additional information has been requested.
Left arm (Pneumococcal vaccine) red, hot and painful to touch from injection site to elbow.  Right arm (Zostavax vaccine) hot and hard to touch. Generally did not feel well. Symptom free by AM 02/09/2014.
Scratchy throat - chest tightness - vomiting - extreme malaise - temp 100.2.
I received the vaccine at hospital on 1/6. On 1/20 woke with large raised reddened area on arm that vaccine was administered. 7cm X 14cm. No fever. Contacted my primary - Dr., and this morning went to Urgent Care. I was told a had a severe inflammatory response to the injection. Dr. saw me there, and said it was the most severe reaction she has seen. At this time I am not certain it is in my best interests to take the second dose. I have reservations as to what reaction I might have to that. I look forward to an answer.
1hr p/vax pt devel rt periorbital edema & fits of coughing;seen by MD 5hr p/vax & eyes improving;pt w/end expiratory wheezing;
Asthma attack. Chest tightening and cough. Using rescue inhaler and breathing treatment
Syringe containing Pfizer vaccine was labeled with an expiration of 12/9/21 @ 1600.  The nurse that drew up the vaccine mislabeled the syringe.  The actual expiration time was 12/9/21 @ 1400.  Dose was administered 65 minutes after expiration time.  No adverse reaction noted by patient.
1610: vaccine given  1611: Pt experienced syncopal event, laid down supine on floor. juice given. Pt reports "this reaction runs in the family". VS: BP 131/72, HR 41, O2 95%, RR 12  1618: VS: BP 125/59, HR 66, O2 98%, RR 16. VS: 126/64, HR 71, O2 98%, RR 16.  1621 Patient taken from floor and placed into sitting position. No dizziness noted.  1630:Pt reports return of dizziness. bp: 122/73 HR:74 02: 95% RR:16  1635: BP: 102/58 HR 79 02 100% RR 16.  Pt sitting up and denies any further sx's.  Father denied need for further medical intervention. Pt was helped to standing. VS remain stable. Denies dizziness.  Ambulated safely to personal vehicle and departed to home.
p/vax pt exp lightheadedness, an inability to concentrate, & numbness & tingling in fingers and extremities;
My Myasthenia Gravis had been in remission for about a year.  Two weeks after the second Maderna shot, my MG returned much stronger and  significantly affecting almost all voluntary muscles with substantial weakness.  My lungs and throat were not affected.
9/10/2021: 9:40 a.m. 2nd dose of Moderna Vaccine in L arm. 4:00 p.m. L arm sore and slight headache. 6:00 p.m. chills, 11:30 p.m. woke burning hot, sweating, nauseous,, vomitting, blacked out, eyes rolled back and convulsions. 9/11/2021:  2:45 a.m. burning hot, sweating and nauseous for 15 min.
Information has been received from a nurse practitioner concerning a 7 year old male who on 10-APR-2000 was vaccinated with a dose of Varivax. On 19-MAY-2006, the patient developed five or six lesions. Unspecified medical attention was sought. At the time of the report, the patient had not recovered. A product quality complaint was not involved. Additional information has been requested.
Received Pfizer vaccines on 3/18/21, 4/8/21 Tested positive for COVID 19 by PCR on 6/11/21. Hospitalized 6/11-6/14/21. symptoms of fatigue, myalgias, diarrhea, dysgeusia, cough Received four doses of Remdesivir.