chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information was received on 25-APR-2017 from a registered nurse concerning a female patient who is under 18 years of age. No medical history or concomitant medications were reported. On 06-JAN-2017, the patient received a dose of GARDASIL 9 (lot, expiration, dose and therapy route were not reported) for prophylaxis, while she was pregnant. The patient reports that her last menstrual period was in December 2016. No adverse effects have been observed in the patient. The patient has been seen by her physician. No parity reported. No other information is available. The outcome of the pregnancy is unknown. Additional information has been requested.
Had a diphtheria tetanus pertussis vaccine at the Hospital following a bicycle accident. Still after 5 weeks have pain in that upper outer arm muscle. The pain is chronic.
no adverse event; administration of expired vaccine; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 13-DEC-2021, the patient was vaccinated with an expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (rHA (recombinant human albumin)) (M-M-R II) lot # S039309, expiration date 04-DEC-2021 (formulation, strength, dose, frequency and route of administration were not reported) for prophylaxis (Expired product administrated).  There was no additional adverse event (AE) details reported (No adverse event).
Wave of lightheadedness, sweating, hot flashes that lasted less than 1 hour. Sore arm, not too severe.
Case number PHEH2013US020234 is an initial spontaneous report from the nurse received on 25 Sep 2013 with a follow up information received on 20 Oct 2014. This report refers to a female pregnant patient. The patient's last menstrual date was not reported. This pregnant patient was vaccinated with one dose of frozen FLUVIRIN (batch number: 13371P) from a pre filled syringe, via intramuscular route on 24 Sep 2013. It was reported that patient did not experience any adverse event following this medication error. Upon follow up receipt on 20 Oct 2014, it was reported that multiple attempts were made to obtain follow-up information and outcome of pregnancy event without success and hence the case was considered as lost to follow-up. Follow-up information received on 20 Oct 2014: Lost to follow-up information was updated.
This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 31-OCT-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (Lot# L016427; expiration date: 13-APR-2017) (dose and route of administration were not provided). Concomitant therapies were not reported. No adverse effects reported. The pharmacist explained that the RECOMBIVAX HB doses were not involved in a previous temperature excursions and this time the temperature and time frame were: 1.4C for 22 hours 52 minutes and 8.6C for 112 hours 5 minutes. This is one of several reports received from the same source (original report 1602USA004808). Additional information has been requested.
Information has been received from a Registered Nurse (R.N.) concerning a 61 year old female with migraines, hypercholesterolaemia and allergy to bee stings and flu shots as well as a history of melanoma of right eye who on 14-APR-2009 was vaccinated subcutaneously with a dose of ZOSTAVAX (Merck) (lot# 663639/1707X).  Concomitant therapy included IMITREX.  On 15-APR-2009 the patient developed redness and induration that was 4 cm by 3 cm at the injection site.  She was seen by a physician on 16-APR-2009 and the affected area increased to 4 inches by 3 inches.  She was given KEFLEX.  The outcome was unknown.  Additional information has been requested.
Case number PHEH2013US018994 is an initial spontaneous report received from a nurse on 05 Sep 2013, with a follow up received from a nurse on 10 Oct 2013. This report refers to an 18-year-old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with MENVEO (batch number: unknown) at a dose of 0.5 ml intramuscularly on 01 Aug 2013 at 01:30 pm. It was reported that MENVEO which reached 31 Fahrenheit for 3 days was subsequently administered to the patient. No adverse event was reported following this medication error. Follow up was received on 10 Oct 2013: Updated patient demographics and time of vaccination.
Initial reaction to vaccine 1-3 days following injection: site soreness, mild fatigue, mild redness and bruising at injection site. These symptoms resolved by 1/23 (4 days after vaccine). On day 7 (1/26) woke up with swollen painful lymph nodes in axilla, redness, swelling and itching at injection site which worsened over the course of the morning. Symptoms worsened, raised red patch on deltoid approx. 10cm x 15cm and itching towards armpit chest. Took oral antihistamine and saw only slight worsening throughout the rest of the day. On today, 1/27 increased fatigue and worsening of lymph tenderness, red patch on injection site larger by about 2cm. Symptoms persisting, no outcome to report at this time.
1. Sinus tachycardia and now taking metaprolol 25mg twice Daily 2. Chills and sweating every 2-3 hours even on 11/27/2021 6 days after vaccination 3. Metallic taste, dizziness and not feeling well after vaccination..  Note This is my booster dose, symptoms started much delayed after 1 day. And no fever or not much body ache
This spontaneous report as received from a pharmacist refers to a 66 year old female patient. On 12-DEC-2014 the patient was vaccinated with ZOSTAVAX lot # K015312, subcutaneous. On 14-DEC-2014, 3 days after onset of therapy the patient experienced swelling at the injection site, fever, warmth at injection site, pain at injection site and redness at injection site. The outcome of swelling at the injection site, warmth at injection site, pain at injection site and redness at injection site was reported as not recovered/not resolved. The outcome of fever was reported as recovered/resolved. The patient previously has taken lisinopril with hydrochlorothiazide and citalopram but it was unknown whether she was still taking these. Additional information has been requested.
A dose of Moderna Covid-19 vaccine was given from a vial that was open to room temperature for more than 12hrs; Vial was first punctured on 19 Apr 2022 at 3p, post puncture stored in refrigerator and administered on 20  Apr 2022.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A dose of Moderna Covid-19 vaccine was given from a vial that was open to room temperature for more than 12hrs) and PRODUCT STORAGE ERROR (Vial was first punctured on 19 Apr 2022 at 3p, post puncture stored in refrigerator and administered on 20  Apr 2022.) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 005M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In April 2022, the patient experienced PRODUCT STORAGE ERROR (Vial was first punctured on 19 Apr 2022 at 3p, post puncture stored in refrigerator and administered on 20  Apr 2022.). On 20-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A dose of Moderna Covid-19 vaccine was given from a vial that was open to room temperature for more than 12hrs). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A dose of Moderna Covid-19 vaccine was given from a vial that was open to room temperature for more than 12hrs) and PRODUCT STORAGE ERROR (Vial was first punctured on 19 Apr 2022 at 3p, post puncture stored in refrigerator and administered on 20  Apr 2022.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No information on concomitant medication was reported. A dose of Moderna Covid-19 vaccine was given from a vial that was open to room temperature for more than 12hrs.The vial was initially stored in the refrigerator on 18 Apr 2022. The vial was first punctured on 19 Apr 2022 at 3p. The vial was stored in refrigerator post puncture. The vial did not undergo any temperature excursions. The vial was exposed to room temperature range for greater than 12 hours, less than 24hours.  No information on treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2022: Follow-up information received contains no new information.
Arm became red, hot, swollen and itchy down to  elbow. Experienced worst fibromyalgia flare I have ever had for approximately 24 hours.
Pt given 0.5 ml of H1N1 instead of the 0.25 ml recommended dose for children 6-35 months of age.
I still have a lot of swelling and pain at the injection site and it?s been almost a week. I am also very itchy all over, but there is no rash or hives on my skin.
Breakthrough case after vaccination, C/O fever, cough, N/V, sneezing, & congestion, onset 1/20/2022
Information has been received from a physician concerning a child who, in the past, was vaccinated with Varivax. In approximately 2005, within the last year, the patient experienced a mild case of breakthrough chickenpox. Subsequently, the patient fully recovered. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Burning sensation in my nose; Burning sensation in my nose and my mouth; Stomach is upset; Hardly eat anything; Everything taste terrible; My back seems to be getting a little bit better; Frustrating; Loss of hair; Everything smell gross; This spontaneous case was reported by a non-health professional and describes the occurrence of NASAL DISCOMFORT (Burning sensation in my nose), ORAL DISCOMFORT (Burning sensation in my nose and my mouth), ABDOMINAL DISCOMFORT (Stomach is upset), FEEDING DISORDER (Hardly eat anything) and TASTE DISORDER (Everything taste terrible) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced NASAL DISCOMFORT (Burning sensation in my nose), ORAL DISCOMFORT (Burning sensation in my nose and my mouth), ABDOMINAL DISCOMFORT (Stomach is upset), FEEDING DISORDER (Hardly eat anything), TASTE DISORDER (Everything taste terrible), MUSCULOSKELETAL DISCOMFORT (My back seems to be getting a little bit better), FRUSTRATION TOLERANCE DECREASED (Frustrating), ALOPECIA (Loss of hair) and PAROSMIA (Everything smell gross). At the time of the report, NASAL DISCOMFORT (Burning sensation in my nose), ORAL DISCOMFORT (Burning sensation in my nose and my mouth), TASTE DISORDER (Everything taste terrible), MUSCULOSKELETAL DISCOMFORT (My back seems to be getting a little bit better), ALOPECIA (Loss of hair) and PAROSMIA (Everything smell gross) had not resolved and ABDOMINAL DISCOMFORT (Stomach is upset), FEEDING DISORDER (Hardly eat anything) and FRUSTRATION TOLERANCE DECREASED (Frustrating) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant and  treatment medications were provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jul-2021: Significant FUP- new event added, product details, gender, age, outcome updated
Injected in right upper arm.  The moring after injection I noticed my arm was sore and tender in my arm pit on the right side.  I am swollen and tender, but the swelling is located on my body not on my arm.
Vaccine was possibly given too high on the shoulder, causing the vaccine to go into the shoulder joint.  Patient experienced are stiffness and soreness following injection.  Patient was referred to orthopedic specialists to determine if the vaccine was given in a location that could lead to a frozen shoulder. Patient is dealing with more serious medical issues at the moment, so has not followed up with orthopedics, but has not been concerned with ongoing shoulder issues to my knowledge.
arthritis in hands; ongoing pain; rash on face and chest; This is a spontaneous report received from contactable reporter(s) (Pharmacist).  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Sep2021 at 18:30 as dose 1, single (Lot number: fc3182) at the age of 43 years intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: ARTHRITIS (non-serious) with onset 17Sep2021, outcome "not recovered", described as "arthritis in hands"; PAIN (non-serious) with onset 17Sep2021, outcome "not recovered", described as "ongoing pain"; RASH (non-serious) with onset 17Sep2021, outcome "not recovered", described as "rash on face and chest". The events "arthritis in hands", "ongoing pain" and "rash on face and chest" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of arthritis, pain, rash.  Additional information: Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. Device Date: 18Jul2022.
PATIENT WAS GIVE INFLUENZA VACCINE AT 14:25.  PATIENT REPORTED DIZZINESS APPROX. 5 MINUTES AFTER VACCINATION FOLLOWED BY DRY HEAVING AND SHAKING. HEALTHCARE PROVIDER GAVE BENADRYL 50MG (14:40) IM AND SOLU-MEDROL 125MG (14:47) IM WITHOUT RELIEF OF SYMPTOMS.  EMS WAS CONTACTED  AT 14:45 AND TRANSPORTED  TO THE HOSPITAL FOR FURTHER EVALUATION.
Feeling unwell; nauseated; loss of appetite; sleeping; chills; extreme fatigue; This is a spontaneous report from a contactable consumer (patient). A 91-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: 1515), via an unspecified route of administration, administered in Arm Left on 05Feb2021 14:30 at 0.3 mL, single for covid-19 immunisation. Medical history included Congestive heart failure (CHF), Defibrillator, Diabetes, Peripheral Neuropathy, hard of hearing, Aged Macular degeneration. No Known allergies. The patient received unspecified other medications in two weeks. On 06Feb2021, the patient was feeling unwell, nauseated, loss of appetite, sleeping, chills, extreme fatigue. No treatment was received for the events. The patient did not have covid tested post vaccination. The outcome of events was recovered.
Dizziness, Headache, Myalgia, Arthralgia, NauseaVomiting, chills, fatigue, injection site pain/arm pain, rigors, swelling at injection site, unable to concentrate Narrative:  Other Relevant History:
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old male patient who received SHINGRIX for prophylaxis. On 12th March 2019, the patient received the 1st dose of SHINGRIX. On 12th March 2019, less than a day after receiving SHINGRIX, the patient experienced injection site pain and injection site erythema. On an unknown date, the outcome of the injection site pain and injection site erythema were recovered/resolved. It was unknown if the reporter considered the injection site pain and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The reporter was the patient's wife. The patient received SHINGRIX on the left arm.
Started with feeling itchy across my body, then I began vomiting, followed by breaking out in hives. I took Benadryl to relieve the allergic reaction and was able to get the symptoms under control. This occurred over a 3 hour time frame from the time the reaction began to the time I was able to get the reactions to slow down.
I woke up the day after my second shot completely weak and felt very feverish. I got out of bed and tried to eat yogurt, but felt nauseous and got lightheaded so I had to sit down. I drank some tea and water and went back to bed for 4 hours. I woke up again and still felt terrible and could not even walk short distances without getting very pale, sweaty,  and my vision having spots. I feel chills, a headache, and have been lying down all day. I am most concerned about passing out and becoming unconscious.  I called the Wellness Center and they said to just lie down and stay hydrated
Initial misuse report received from a healthcare professional on 18 March 2013. A patient (no information was provided regarding the patient) had received a dose of MENOMUNE vaccine on 16 March 2013 that expired in September 2012. No adverse event was reported. List of documents held by sender: none.
Nonstop runny nose, nonstop sneezing, wheezing, puffy eyes, no sense of smell or taste, overall allergies-type reaction to a degree I've never before experienced for following 36 hours.
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On 12-JUN-2018, the patient was vaccinated with an improperly stored dose of VARIVAX lot # N026075 with expiration date of 20-SEP-2018 (strength, dose, frequency, route, and anatomical location) for prophylaxis which was reconstituted with a properly stored sterile diluent (MERCK). The vaccine was exposed to a temperature range between 15°F to 46°F, during a time frame of 43 hours, which was called by a data logger. No previous excursions were reported. This is one of two cases from the same reporter. Sender's Comments: US-009507513-1806USA008265.
Pt. was inadvertently given a 1 ml dose of FLUZONE instead of the correct 0.5ml dose.  Pt. reported her arm was a little sore the next day but it has now resolved.
Pt reported delayed onset of adverse reaction: 39 y/o hispanic male pt with NKA to food and drugs received first dose of Pfizer EW0377 on 06/17/21 reported difficulty breathing and ?I felt like my face was swollen.? Symptoms started 24hr post vaccination and lasts x2 days. Second dose was held upon visit on 07/15/21. Pt denies neck swelling, pt did not go to the hospital and ?I just got better after 2 days.
expired dose planned to be given; expired dose planned to be given; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received Herpes zoster (Shingrix) (batch number unknown, expiry date 3rd February 2022) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced expired vaccine used and circumstance or information capable of leading to medication error. On an unknown date, the outcome of the expired vaccine used and circumstance or information capable of leading to medication error were unknown.  Additional details were provided as follows: The case was reported by the registered nurse. The age at vaccination was not applicable for this report. The reporter wanted to administer Shingrix and realised that the dose had expired. The reporter wanted to know for how long would the vaccine be good after expiration date. On 4th February 2022, Shingrix was planned to be given, which led to expired vaccine used and circumstance or information capable of leading to medication error. No demographic details or lot number of Shingrix was given. The reporter did not consent to follow up.
This spontaneous report was received from a healthcare worker and refers to unspecified patients of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On an unknown date the patients were vaccinated with improperly stored PROQUAD (Merck) (strength, dose, frequency and route were not reported) lot # L009207 with an expiry date of 17-SEP-2016 and lot # L030589 with expiry date of 10-FEB-2017. No concomitant medications were reported. Patient did not seek any medical attention. No adverse effects were reported. There was no product quality complaint. This is one of the several reports received from the same reporter. Additional information has been requested.
Syncopal episode after HPV vaccination today.  Patient became Nauseous and fainted while sitting on exam chair.  Pt  laid down on exam table and cool compresses applied. Pt not shaking or convulsing.  No dyspnea or Tachycardia. + diaphoresis. Pt. pale appearing - no cyanosis. BP taken several minutes after episode while pt diaphoretic and supine. Pt's color quickly returned and disposition returned to normal within 10-15 minutes within 10-15 minutes of laying down and drinking water, eating a snack.  Pt did not have anything to eat today far ( episode happened about 12:00pm. Pt stating he was fine to ambulate out-parent requesting a wheelchair. Pt smiling ,alert, and conversant.
4 hours after receiving H1N1 shot developed fever of 103.5 degrees, rectally, relieved with Tylenol, lasting 3 days. Day #4 developed rash on abdomen and diaper area.
Went into anaphylactic shock in the first 15 mins after taking the vaccine while she was still in the doctor's office.
The night of vaccine administration, I developed headached which progressed into the next day. For roughly 24 hours I had fever, chills, total body aches, and headache. Symptoms completely resolved by 5am 1/10/21
One hour minor itching on hands. 12 hrs some hives on body. 24 hrs hives all over, swollen lip, tongue and eye lids. Emergency room. Found no pulse. Anaphylaxic shock. 2 days in ICU, 3rd day-reoccurrence of reaction-ER.   60 day follow up states pt has recovered. It took a good 2-3 months to fully recover. An annual follow up report received 01/14/2004 adds: (from pt): Thank you for your recent inquiry into my health - and since you asked - I would like to report some very uncommon medical problems I've experienced this last year. Prior to my adverse reaction to the flu shot I have been healthy as a horse and never hospitalized. In March 2003 I was diagnosed with an abscess on my liver - cause unknown. It was drained and all was well. Then in June I had a twisted bowel or something - they didn't know exactly what it was, but that was drained too. I was just released from the hospital for premature atrial contractions...further testing to follow because the cause is unknown. I am reporting this because the cause of all my conditions seem to be unknown and curious if there could be any connection to the flu shot complications...my husband thinks I've taken out a time-share at the hospital...Thank you for any light you can shed on this.
Myalgia, NauseaVomiting, Chills ,fatigue Narrative: