chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse practitioner concerning a 25 years old female patient, who on 06-JAN-2011 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (Lot # 665607/1333Y). Concomitant therapy included desogestrel/ethinyl estradiol (MSD) for contraception. The nurse reported that after vaccination with GARDASIL, the patient had immediately experienced pain in the arm at the injection site and that the pain continued for over a month and got worse. The patient did not seek medical attention. No treatment was given for the event. At the time of the report, the patient's outcome was not recovered. Follow-up information has been received concerning a 25 years old female patient, with no pre-existing allergies, birth defects or medical conditions reported, who on 06-JAN-2011 at 14:00 was vaccinated in the left deltoid with the first 0.5 ml dose of GARDASIL (Lot # 665607/1333Y). It was reported that patient complained of severe pain in her left arm at the injection site that lasted from the day of the injection 06-JAN-2011, through the follow-up visit on 14-FEB-2011. Patient had not been seen since 14-FEB-2011 to determine if symptoms had resolved. There was no illness at time of vaccination. A physical exam was performed on 14-FEB-2011, the result was normal without neurological, vascular or muscular deficits found. At the time of the report, the patient's outcome was unknown, previously reported as not recovered. Additional information has been requested.
Received moderna vaccine on 08/23/21 and 9/20/21. Presented to ER on 1/11/22 and found to be COVID positive. Addmitted on 1/11/22. Presented to the ed for covid 19 infection and concern for UTI. Labs remarkable for hyperkalemia and UA nitrite positive. Patient given insulin, dextrose, bicarb and calcium for hyperkalemia. Started on ceftriaxone for UTI. Urine culture growing e. Coli. Blood cultures 1/11 1/2 bottles positive for strep, likely contamination.  Patient was waiting for SNF placement but she did not participate much in therapy and she was getting up and walking with staff in the room, and patient was denied due to behaviors. Therefore, patient is discharged back to her group home. Discharged on 1/20/22
Pt here for 1st dose of Pfizer vaccine.  Pt started exhibiting syncopal episode. Clinician made EMS aware. Within 30 secs pt was responsive. BP 103/61 P 65 O2 95 %  SPC02 23. Observed for 30 mins by EMS. Pt sent home. Pt was passenger in car
This spontaneous report as received from a nurse refers to a 11 months 9 days old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Patient came to receive the Pfizer booster shot. He presented his COVID vaccination card and it stated that he received the first two doses on 1/6/21 and 1/27/21. A booster was indicated and administered to the patient. Upon billing the vaccine, a rejection showed that he also received the Janssen vaccine on 8/13/21 at a different pharmacy chain. Patient had no reaction at time of administration.
Patient awoke at 3am with a severe headache the night of the vaccine. The next 2 days she reports that she felt flu-ish symptoms of fever with chills and headache/body aches etc. Those symptoms resolved but then on day 4 she developed a raised red bumpy, itchy rash on the back of her neck and shoulder blades. She treated it with oral diphenhydramine and hydrocortisone cream. It resolved without and further treatment after a few days. She is concerned about an allergy and possibly a more severe reaction with second dose.
2 days after receiving the vaccine patient experienced redness in the face, hot sensation, and itching. The next day patient reported red bumps on the face and continued itching. she took Zyrtec to help with the itching. She was advised by the pharmacy to start Benadryl, call her Dr, and if symptoms worsen or she has difficulty breathing to call 911. Patient reported no other symptoms, such as redness at the arm, swelling, difficulty breathing.
Information has been received from an 82-year-old female consumer with a history of vertigo who "2 weeks ago" on approximately 25-JUL-2007 was vaccinated with a "single dose" of Zostavax (Oka/Merck).  On approximately 25-JUL-2007 the patient experienced itching all over her body.  Unspecified medical attention was sought.  No laboratory or diagnostic tests were performed.  The outcome is reported as not recovered.  No product quality complaint was involved.  Additional information has been requested.
Moderna Covid-19 vaccine that expired on 3MAY2022 was administered to 3 patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that expired on 3MAY2022 was administered to 3 patients) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 083J21 A, 064H21A, 024M20A and 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that expired on 3MAY2022 was administered to 3 patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that expired on 3MAY2022 was administered to 3 patients) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  The vial was initially stored in the refrigerator on 21-Apr-2022. The vial didn't undergone any temperature excursion.  No treatment medications was reported.
mom states pt devel wheeze&barking cough wk p/vax;mom called MD who put pt on pediapren&told mom not to get any more DTP;no fever noted;
sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An adult male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, single, lot number unknown), for COVID-19 Immunization, reaction(s): "Sore arm"; BNT162b2 (Dose 2, single, lot number unknown), for COVID-19 Immunization, reaction(s): "Sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : PFIZER INC-202300012926 same patient, events after different doses of the vaccine;
PATIENT RECEIVED PFIZER 5-11YR MONOVALENT COVID BOOSTER AFTER 10/12/2022----NO ADVERSE REACTIONS
KINRIX-DTaP and IPV administered on 3/28/16 and was non-viable due to exposure of out of range temperatures.
Injection site.  Swollen and red and at times itchy.   Bigger than a golf ball.   Low grade fever and some aches and chills
I began loosing my hair but didn't realize the severity until my hair dresser who I've seen for 5 years told me I needed to see a doctor. Since I have been to my doctor and a dermatologist twice, months apart, and my hair is still falling out!  It's coming out on several strands to 15-20 strands at once, it has continued to thin and now shows bald spots in my hair line. I've had blood work and neither my doctor nor dermatologist can determine a cause other than the vaccine, due to timing that my hair loss began.
Trouble breathing with stridor, chest and throat were sucking in, rapid breathing and retractions. Felt very hot and couldn't breath. Hard time talking. Asthma inhaler given but didn't improve symptoms, oral steroids were then given and seemed to help.
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date place in refrigerator 22/09/21 No concomitant medication were provided No treatment details were provided
JANSSEN COVID-19 VACCINE EUA: The patient received her vaccine dose on 030221 and within 3 hours, shortly after lunch, complained of not feeling well and nausea. She subsequently went home early from work. At about midnight, approximately 12 hours post-dose, she awakened with fever to 102.  She subsequently presented to an emergency department at about 01:30 on 030321. She remained there for about 3 hours during which time she was monitored and received IV fluids, ibuprofen and acetaminophen. She returned to work on 030421 with improvement of symptoms.
Dizziness, extreme fatigue, debilitating. Diag6with POTS 12/13/21
13x14cm bright red pink, warm to touch local reaction on left arm with central puncture.
Painful swollen fingers; This spontaneous case was reported by an other health care professional and describes the occurrence of PERIPHERAL SWELLING (Painful swollen fingers) in a 23-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.    No Medical History information was reported.   On 25-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form and dose of INFLUENZA VACCINE (FLU VACCINE VII) (unknown route) 1 dosage form. On 25-Sep-2023, the patient experienced PERIPHERAL SWELLING (Painful swollen fingers). At the time of the report, PERIPHERAL SWELLING (Painful swollen fingers) was resolving.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Patient had painful swollen fingers in same arm as vaccinations. Unclear if this was from spikevax or the flu vaccine. The patient did not experience any additional symptoms/events.  Treatment medications were not reported.
Immediately after getting the vaccination, he had a recurrence of his panic attack. He does have an aversion to needles.  Taken to a private area of the arena and monitored.
Systolic dysfunction; This is a spontaneous report received from contactable reporter (Other HCP).  A 65-year-old male patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), on 25Oct2019 as dose number unknown (0.5 ml), single (Lot number: AG8347, Expiration Date: 31May2021) at the age of 65 years intramuscular for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYSTOLIC DYSFUNCTION (non-serious) with onset 27May2020, outcome "unknown".
Information has been received from a physician concerning a 7-year-old female with no pertinent medical history or drug reactions/allergies, who on 25-Mar-2008 at approximately 15:00 was vaccinated subcutaneous in the right arm with a second dose of VARIVAX (Merck) (lot# 659943/1800U). There was no concomitant medications or no illness at the time of the vaccination. On 26-Mar-2008 the patient developed lemon size knot at the injection site after receiving a dose of the vaccine. There were no lab diagnostic studies performed. Unspecified medical attention was sought. On an unspecified date the patient recovered. There was no product quality complaint. Additional information is not expected.
Syringe leaked down her arm during injection; Syringe leaked down her arm during injection; This spontaneous case was reported by a consumer and describes the occurrence of UNDERDOSE (Syringe leaked down her arm during injection) and DEVICE CONNECTION ISSUE (Syringe leaked down her arm during injection) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced UNDERDOSE (Syringe leaked down her arm during injection) and DEVICE CONNECTION ISSUE (Syringe leaked down her arm during injection). At the time of the report, UNDERDOSE (Syringe leaked down her arm during injection) and DEVICE CONNECTION ISSUE (Syringe leaked down her arm during injection) outcome was unknown. Not Provided          No concomitant medications provided. No treatment information provided.   This case was linked to MOD-2021-085895 (Patient Link).
Patient was sitting in observation and felt dizzy and passed out.  Patient fell forward out of chair and hit the right side of his forehead on the floor.  11:34 am patient laying on ground, unconscious and pale.  Vital signs:  BP  R arm 112/70,  77 HR, 94% RA.  1136 sitting up.  Vital signs:  BP 119/78, 86 HR, 93% RA.  Ambulance was called.  Paramedics showed up at 1145 and evaluated him.  Patient refused to go to hospital.  Patient stable, given water.  Patient requested to leave on his own.  Patient was wheeled out to his car.
a little tired; her arm is sore; received a dose of the Johnson and Johnson vaccine on 02Apr2021/received her first dose of the Pfizer covid 19 vaccine on 25Aug2021; received a dose of the Johnson and Johnson vaccine on 02Apr2021/received her first dose of the Pfizer covid 19 vaccine on 25Aug2021; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A 68-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 2 via an unspecified route of administration on 25Aug2021 (Batch/Lot number was not reported) as DOSE 2 (INITIAL PFIZER DOSE), SINGLE for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. Caller reported that she received a dose of the Johnson and Johnson vaccine on 02Apr2021 (Dose: 1st (Johnson and Johnson Covid vaccine)). The patient received a dose of the johnson and johnson vaccine on 02apr2021/received her first dose of the pfizer covid 19 vaccine on 25aug2021 (off label use) and (interchange of vaccine products). Patient was a little tired and her arm was sore on an unspecified date in Aug2021. It was reported that, she was at withheld last night when she heard the announcement that the Pfizer covid 19 vaccine was available there. Caller went to ask questions about the vaccine on behalf of her unvaccinated niece and was informed by the pharmacist that the J&J vaccine was not effective against the delta variant and she should receive a dose of the Pfizer covid 19 vaccine. Caller also said that she did not have any side effects after her dose of the J&J vaccine. Caller asked if she should receive the second dose of the Pfizer vaccine. It was reported that daughter was upset that she got the other shot, states she and her daughter had gotten Johnson and Johnson vaccine with her. Informed caller that Pfizer was the manufacture of the vaccine; the distribution of the vaccine was determined at the state and local levels. Recommended if caller was concerned about the information she received from the local pharmacist, to pass her concern through the chain of command or through the state/local health departments as Pfizer was the manufacture of the vaccine; the distribution of the vaccine was determined at the state and local levels. After Pfizer Covid vaccine, patient wanted to know if she needs to be worried or not. The reporter wanted to know if there could be any interaction or anything between the two vaccines. Outcome of events were unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Patient went to bed and woke up having something like a grand mal seizure around 10 p.m.. She felt hot but didn't take her temperature. She is perimenopausal and couldn't say for sure if she was having a hot flash or a fever. Her previous seizure was a year ago she said. Around 2:00 a.m. she woke up with stretching movements with her arms over hear head that she couldn't control, but didn't feel like a seizure to her. Patient went back to bed, but woke up around 5:30 a.m.. with temp of 102 degrees F. She took 2 ibuprofen 200mg (total dose 400mg) every 4 to 6 hours starting at 5:30 a.m. for a total of 3 doses. She felt better by later afternoon. She complains that her arm is still sore today. She just reported this to us this morning when she was back in the pharmacy.
PATIENT DEVELOPED WATERY DIARRHEA 3/1/08, VOMITED ONCE 3/2/08 AND AGAIN ONCE 3/3/08.  SALIVA WAS THICK.  HAD 4 EPISODES OF APNEA, SETTING OFF MONITOR 3/2/08 DURING THE NIGHT, THEN MOM NOTED HE HAD NUMEROUS TIMES OF NOT BREATHING FOR UP TO 13 SECONDS THE MORNING OF 3/3/08.  PATIENT WAS TOLD TO GO TO THE ER.  PATIENT WAS CONTINUING TO BREASTFEED WELL Q2-3H AND GET PEDIALYTE IN BETWEEN FEEDINGS PER INSTRUCTION GIVEN BY DR. WHEN PARENTS CALLED HER 3/1/08.  ACCORDING TO FATHER, PATIENT DID NOT HAVE ANY APNEA EPISODES OR VOMITING IN THE ER, O2 SATS WERE GOOD.  TOLD THE VOMITING/DIARRHEA WAS LIKELY REACTION TO THE ROTAVIRUS VACCINE RECEIVED 2/28/08.  PATIENT DID NOT HAVE ANY DIARRHEA OR VOMITING AFTER LEAVING THE ER 3/3/08 ABOUT 5 PM.
pneumonia; This spontaneous case was reported by a patient and describes the occurrence of PNEUMONIA (pneumonia) in a 73-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.  Concurrent medical conditions included Heart disorder (Congested heart disease).  On 29-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2022, the patient experienced PNEUMONIA (pneumonia) (seriousness criterion medically significant). At the time of the report, PNEUMONIA (pneumonia) was resolving.  No concomitant medications were reported. On 29-Apr-2022, the patient received second booster dose of Moderna COVID-19 vaccine. The patient developed pneumonia with very severe symptoms just after receiving the second booster dose of Moderna vaccine. Currently, the patient started getting the patient's strength back. The patient was very concerned and was hesitant on receiving another Omicron variant vaccine booster dose after suffering like the previous time. No treatment medications were reported.  Company Comment: This spontaneous case concerns a 73-years-old patient, with medical history of Congested heart disease who experienced the unexpected seriousness criterion medically significant event of pneumonia unknown days after a dose of mRNA-1273 vaccine.  At the time of the report, the events was resolving. The benefit-risk relationship of mrna-1273 is not affected by this report. Events seriousness was assessed based on medical judgement.; Sender's Comments: Company Comment This spontaneous case concerns a 73-years-old patient, with  medical history of Congested heart disease who experienced the unexpected seriousness criterion medically significant event of pneumonia unknown days after a dose of  mRNA-1273 vaccine.  At the time of the report, the events was resolving.   The benefit-risk relationship of mrna-1273 is not affected by this report. Events seriousness was assessed based on medical judgement.
Extreme tired and fever within 15 mins, fever on and off for 4 weeks and exhaustion.  By week 5 fever woukd not go away.  Got covid test, negative, still constant fever after 7 days but didnt feel like a had a cold or anything.  Called 811 and they suggested i go to emergency at hosp in case i have an infection.  Hosp confirmed i had fevee, gave me another covid test which was negative.  Did urinalysis to see if i had unrinary infection, i did not.  Sent home and if fever persists see family dr.  After three more days i still had fever so made dr appt.  The day i saw dr, my fever was starting to go away (constant fever lasted two weeks).  Dr sent me for bloodwork.  Bloidwork showed a had liver inflammation.  A week after this lymohnodes on neck swelled.  Went for more in depth bloodtest for various virus's, and auto immune tests, those were negative.  Ct scan for my organs looked normal, ultrasound of lower organs looked normal.  Finally after 5 mos i started to feel like i did before vaccine and bloodwork showed liver bloodwork normalling.
PALPITATIONS, TACHYCARDIA FROM 120S TO 130, SHORTNESS OF BREATH, FATIGUE, RIGHT ARM PAIN. OCCURS MULTIPLE TIMES PER DAY. WORSENING OVER THE LAST MONTH. FOUND TO HAVE SED RATE OF 123. CXR, ECHO, MYOVIEW OK. HOLDER MONITOR PENDING; STARTED ON METOPROLOL.
Patient passed out three times, starting 15 minutes after injection given. All happened over 10-15 minute time span. She was given food and drink. Felt better. Reported feeling tired. All happened at patients home.
HYPOTENSION ACUTE RESPIRATORY FAILURE HYPOXEMIA SHOCK, UNSPECIFIED 3/18/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Patient presented to clinic with father for #1 COVID-19 vaccine. Vaccine administered today: Moderna. Dose given today: Dose #1. Patient monitored for 15 minutes. Since patient is under 18 years of age, he should have received Pfizer vaccine. Incident discovered after patient and parent left clinic. Incident report completed. Clinic manager notified. Called patient's father. Discussed error and to follow-up in 28 days for Pfizer vaccine. Per vaccination guidelines, "if age 5 to 17 years and Moderna was given in error, consider the age-appropriate Pfizer-BioNTech formulation as the second dose (based on the recipient's age on the day of vaccination) at least 28 days after the Moderna dose."
I have been experiencing severe shoulder pain and reduced range of motion in my left arm ever since I received the injection. It is a dull, aching pain that feels like a "bruise" right on my deltoid muscle at the injection site. The pain is somewhat alleviated by ibuprofen and ice, but it has persisted for several months since receiving my last flu shot. The pain is exacerbated by movements that involve lifting my arm above my head or putting weight on my deltoid/shoulder muscle (as in a push-up).