chrisvoncsefalvay/vaers-outcomes huggingface dataset:
expired moderna vaccine mistakenly administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered). On 02-Nov-2021, EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment medications were not provided.  It was reported that the vial was kept in refrigerator on 14-Oct-2021 and reported no temperature excursion.   This case was linked to MOD-2021-372310 (Patient Link).
Blood Clots, 5:20 PM, 7 hours Abdominal Pain, 5:00  PM, 7 hours Tiredness, 5:00 PM, 7 hours Back Pain, 6:50 PM, 5 hours
patient received moderna vaccine at 12:15.  at approx. 12:20 patient stated that he "felt weird" patient appeared pale, diaphoretic, and complained of losing hearing and blurred vision.  we sat the patient down and took his vital signs and called 911 at 12:20.  Patients blood pressure was 88/42, heartrate was 55 BPM, SPo2: 99%. Patient never lost consciousness and was talking to us throughout the entire event.  Retook vital signs at 12:22 BP: 88/55 HR: 53  Retook vitals at 12:25 to BP :94/54 HR: 57 O2: 99%.  At 12:30 Ems arrived, and assessed patient, patients mother was called at 12:25 to notify of event, patient declined going to the hospital.  Patient stated he would wait for mother to arrive and leave with her.  Mother arrived and drove patient home at 1:00 pm  Patient stated before leaving HD that he didn't eat any food today but he felt a lot better.
31 year old  female asthmatic who upon several episodes of SOB went to ER , where she was told that Dimers were elevated and she considered a possible pulmonary embolism patient. She was placed on low dose aspirin, prednisone and Tessalon.
10 days after the vaccine I got a shingle type looking rash from my pubic area. radiating outward along my left upper leg, in the crease where your upperleg meets your torso.  11 days after the vaccine i started to get spots like chicken pox on my left flank and back.  12 days after the vaccine i continued to get pox on my left ankle, totally around my entire ankle.   went to doctor to have rash evaluated and was told that I had a case of chicken pox, possibly a rare side effect from the shringix vaccine I had received. I started taking the prescription,  Valacyclovir HCL 500 mg (2 tabs 3 times per day for 7 days) on 8/18/20. As of today, 8/22/20 some of my pox are scabbing over, no pain, just some itchiness and not many new pox are emerging. I use coconut oil with essential oil of tea tree, lavendar and geranium on the spots every morning, I take a colloidal oatmeal bath at night and then apply calamine plus to the pox.  I also experienced a slight headache , fatigue and some lightheadedness on the first 4 days of pox emerging.
Symptoms - ?approximately 1 hour after vaccination, mild HA.  Approximately 3 hours after vaccination, worsening HA and generalized body aches.  Approximately 7 hours after vaccination:  chest soreness and achiness, denies airway issues or SOB. Last day of work and shift ? currently at work Home remedies? -   naproxen 500 mg at 0730 Any improvement? ? mild improvement Recommendation? EE encouraged to continue to monitor symptoms and to call vaccine support line with further questions or concerns.  EE verbalized back understanding and denied further questions at this time.
This case was reported by a consumer via call center representative and described the occurrence of swelling of legs in a 37-year-old female patient who received DTPa (DTaP vaccine) for prophylaxis.  Previously administered products included Dtap with an associated reaction of induration (1st dose received at 3 month of age, other events were skin warm and erythema. refer case US2018228793.) and Dtap with an associated reaction of induration (2nd dose received on unknown date, other events skin warm and erythema, refer case US2018GSK232635). On an unknown date, the patient received the 3rd dose of DTaP vaccine. On an unknown date, unknown after receiving DTaP vaccine, the patient experienced swelling of legs, leg pain, fever and screaming. On an unknown date, the outcome of the swelling of legs, leg pain, fever and screaming were recovered/resolved. It was unknown if the reporter considered the swelling of legs, leg pain, fever and screaming to be related to DTaP vaccine. Additional details were provided as follows: The age at vaccination was not reported. After the third shot, the entire leg swelled up and was sore and she had a fever. The baby screamed for hours. It took 10 days to resolved. The reporter reached out through the whooping cough website and was instructed to call the agency. The reason for reporter call was to advocate for vaccines not to report an adverse event (AE). She had 3 kids and at the advice of the physician, she did not vaccinate the other two because of the reactions her first child experienced but now she wishes she had vaccinated them as well because the other 2 kids had bad cases of whooping cough but the first child (the patient in this report) never had it.
Severe abdominal pain; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (Severe abdominal pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN (Severe abdominal pain). At the time of the report, ABDOMINAL PAIN (Severe abdominal pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment medication was not provided.
RIGHT ARM REDD ITCHY AND WARM TO TOUCH . MD ADVISED AND GAVE 25 MG OF LIQUID BEANDRYL TO PATIENT IN OFFICE. SYMPTOMS RESOLVED IMMEDIATELY AFTER BENADRYL. PATIENT STATYED IN OFFICE FOR 15 MINUTES AFTER BENADRYL DOSE GIVEN AND DISCHARGED WITH INSTRUCTIONS TO GO TO ER IF SYMPTOMS RETURNED. FATHER VERBALIZED UNDESTANDING  INSTRUCTIONS.
varied from 13 to 18 months since their first dose / Second dose had not been given at time of report.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter mentioned that, no patient or vaccine /vaccination information was available since it was not received since it was not given at reporter's location. The reporter consented to follow up. This case was 1 of the 3 cases, reported by the same reporter. ; Sender's Comments:  US-GLAXOSMITHKLINE-US2021136326:Same reporter US-GLAXOSMITHKLINE-US2021136324:Same reporter
Patient came in reporting painful swelling of right upper arm since 10/29 evening. She took Advil every 4 hours and used ice and it has not gotten better. It is currently red, hot and swollen. Mostly inner arm from below elbow to tender axilla. Temp 98.4 at 1:20 pm. Referred to urgent care for evaluation and treatment.
Patient said that about 6-12 hours after her first Pfizer vaccine, she broke out in hives on the left side of her body. She said it spread all the way down her left side and was starting to slowly move to her right side. She has been using Benadryl and a paste (chamomile and zinc combo) to treat. She says she still has the hives, 9 days post-vaccine. She said she tried to contact her doctor but her PCP is out of town and the nurses told her to continue Benadryl and go to urgent care if need be.
Approximately 10 hours after receiving the vaccine (12/2) I experienced fatigue and minor muscle ache. I took Advilpm. 4-5 hours later these symptoms became severe and I also had a minor headache and nausea. These symptoms (minor headache, minor nausea, fatigue, severe body/muscle ache continued on 12/3 and my temperature rose to 100.9. I took 2 Advil. By the end of the day 12/3 my fever returned to normal 98 but I was still not feeling well. By the morning of 12/4 I awoke drenched (a fever broke?) and my symptoms were gone and I felt much better.
Patient had a brief vasovagal episode about 10 min post vaccination with symptoms of lightheadedness, dizziness, sweating and brief syncope lasting about 2minutes.  Girlfriend present during episode as well as nurse.  Nurse practitioner was called to site during reaction. Patient advised to lay on bed.  Symptoms completely resolved. Advised to wait the full 15min. onsite.
Pt c/o tickle in throat which began a few minutes after vaccine administration. Tickle/ dry sensation in throat alleviated with water. Throat itchiness better, discharged home. ED precautions given.
Pt developed a fine rash on face, forehead and mouth within 24 hours post vax. By 72 hours post vax rash traveled to neck and hairline. Mother called PMD who suggested over the counter Benadryl, which she began taking.
On 7/23 developed red raised spots and continued to break out. Was exposed to cousin with chicken pox.
Light-headed, dizzy, all over body aches started about 15-20 hours post-dose.  Experienced a syncopal episode, which caused a fall and injury to the head. Lost of consciousness occurred prior to fall (syncope), which then caused the fall.
Itching all over; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching all over) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced PRURITUS (Itching all over). At the time of the report, PRURITUS (Itching all over) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included lotions and anti allergy medicines. No concomitant medications provided.
Redness, swelling, itchiness and only on left leg-thigh decreased by 4 cm no pain tenderness.
Muscle aches and extreme fatigue; tired and lethargic; lasted about 5-7 days.  Just not herself; felt "fluish".
pain behind my left knee in the bend; severe headache; lethargy; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two doses. This is the second of two reports for second dose. A 33-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Batch/Lot Number and expiration date were not reported) via an unspecified route of administration in the Left arm on 16Jul2021 14:30 (at the age of 33-years-old) at single dose for covid-19 immunisation. The patient was not pregnant. The patient was not pregnant at time of vaccination. The patient medical history included Anemia from an unspecified date. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no list of any other medications received within 2 weeks of vaccination. The patient concomitant medication was reported as none. The patient was not diagnosed with COVID-19 prior to vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Batch/Lot Number and expiration date were not reported) via an unspecified route of administration in the Left arm on 25Jun2021 (at the age of 33-years-old) at single dose for covid-19 immunisation and experienced pain behind left knee in the bend on 26Jun2021. The patient experienced after second dose, metal sticks to the patient's injection site she was not too worried about it. Just reporting what she observed. Both post injections she had pain behind her left knee in the bend. After second dose she had severe headache and lethargy. No treatment was received for the events. The patient had not been tested for COVID-19 since the vaccination. The outcome of the events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100909585 same patient, different dose vaccine and similar event.
In late December I experienced a rattling in my lungs that was diagnosed Pulmonary Edema. I also had shortness of breath and was very fatigue. My symptoms did not go away in fact they got worse and by the end of January I was in the emergency room. I spent the remainder of the day in the emergency having several test ran.
headaches; Muscle fatigue in his leg and Back; feels like a load on the muscles; sharp pain or something weird; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN (sharp pain or something weird), MUSCLE FATIGUE (Muscle fatigue in his leg and Back), MYALGIA (feels like a load on the muscles) and HEADACHE (headaches) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  No Medical History information was reported.  On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced MUSCLE FATIGUE (Muscle fatigue in his leg and Back). On an unknown date, the patient experienced PAIN (sharp pain or something weird), MYALGIA (feels like a load on the muscles) and HEADACHE (headaches). At the time of the report, PAIN (sharp pain or something weird), MUSCLE FATIGUE (Muscle fatigue in his leg and Back), MYALGIA (feels like a load on the muscles) and HEADACHE (headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medicines were reported and no treatment medicines were given.  Patient stated he received the 2nd vaccine and reported his symptoms were worse. Patient also stated he had some lingering symptoms   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Additional information received, added events
About 11 hours later, severe weakness in muscles causing her to fall in her apartment.  She was admitted to hospital, and had fever and cough which progressed to pneumonia.  Event  further weakened already weak kidney function.  After a week in hospital was transferred to nursing home long term.
06/28/18 - Patient woke with diffuse itchy rash. 2 - 3 days prior to visit, experienced temp to 102 degrees, headache, and cough. She has taken ibuprofen and acetaminophen. Today's visit was Rx'd prednisone. Rash improved as of 7/2/18. Parent states she recently took Amox. for Dental procedure.
A few hours after getting the second dose of SHINGRIX I began to get the chills and body aches along with a cough. The chills, body ache and fatigue lasted for 2 days, 2 weeks later I still have the cough. A very persistent dry cough with no other symptoms (no congestion, no sore throat, no shortness of breath). The cough began at the same time as the onset of the chills and body ache.
Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Appeared to be an immune reaction to the shot, but patient was convinced it was cellulitis. She believes that bacteria got into the injection site. The pharmacist who gave her shot to her used an alcohol swab before administering the shot.
Patient was seen at walk in clinic within the organization with s/s of intussusception; including, bloody stool, diarrhea, green vomit, pale, and lethargic. Patient was sent to ED for higher care. Parents stated first diarrhea and decrease in eating occurred on 2/27. Patient was transferred again and ultimately had surgery for intussusception on 3/1/21.   Patient was also given a Fluarix booster dose on 2/23/21 in the left thigh lot number B9BT5
test positive for COVID 19; test positive for COVID 19; coughing; Muscle aches; Fatigue; Sore throat; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the second dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EL3302), via an unspecified route of administration, administered in Arm Left on 16Jan2021 10:30 as single dose for covid-19 immunisation. Medical history included high blood pressure, migraines, inflammatory arthritis, penicillin allergy. Concomitant medications included eszopiclone (LUNESTA) (MANUFACTURER UNKNOWN); valsartan (MANUFACTURER UNKNOWN); sumatriptan succinate (IMITREX) (MANUFACTURER UNKNOWN). On 8Feb2021, the patient experienced coughing, muscle aches, fatigue, sore throat. On 23Feb2021, the patient experienced test positive for covid 19. There was no direct adverse reaction from the vaccine, but I did test positive for COVID 19 on 23Feb2021 (yesterday) with symptoms of coughing, muscle aches, fatigue and sore throat. The patient underwent lab tests which included sars-cov-2 test: negative on 19Feb2021 and sars-cov-2 test: positive on 23Feb2021. The patient did not receive any treatment for the events. The clinical outcomes of the coughing, muscle aches, fatigue, sore throat, test positive for covid 19. No follow-up attempts are possible.
COVID arm; Rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID arm) and RASH (Rash) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced VACCINATION SITE REACTION (COVID arm) and RASH (Rash). At the time of the report, VACCINATION SITE REACTION (COVID arm) and RASH (Rash) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient is not on any concomitant medications.  Patient experienced adverse event 10 to 12 days later with her first dose.  Treatment medications included antihistamines.   This case was linked to MOD-2021-424489 (Patient Link).
Patient got vaccine at 9:30 am and called around 11:15 am to report an irritated eye.  I asked if it was dark red like a blood vessel popped or if it was more pink and irritated.  Patient said it was pink and irritated.  We are unsure if this is related to the vaccine or not, but wanted to report anyways.  Advised patient to call us back if anything changed.
I know this was a meningitis vaccine, but I don't know exactly which one of the above it was. The day after the vaccine was given, her arm started feeling weak to the point that she couldn't raise it. It was causing great pain. It was swollen, red and very painful to the touch.
Rashes/itch appear few days after second shot (chest/torso) - been ongoing for 10 days now
COVID positive; COVID positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4341426-00.  A 44-year-old female patient received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown) and in May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 43 years, all intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Dec2021, outcome "unknown", COVID-19 (medically significant) with onset Dec2021, outcome "recovered" and all described as "COVID positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2021) Positive. Clinical Course:It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Event abate after stopping drug  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE PERIPHERAL NEUROPATHY HYPOTENSION 12/3/2021,  3/3/2022,  4/9/2022,  5/9/2022,  6/14/2022,  6/29/2022,  7/5/2022,  7/6/2022,  7/19/2022,  8/25/2022,  9/29/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Narrative: Patient reported a feeling of "something flowing" across his upper back immediately after receiving the vaccine. The feeling only lasted one minute. Nurse observed patient, who drank 16oz of water but received no other treatment Vital signs were normal and patient reported feeling fine.
This spontaneous case reported by a pharmacist, describes the occurrence of administered expired product (received vaccine beyond 30 days) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 037F21A) for COVID-19 immunization. No medical history reported. On Sep 27, 2021, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Sep 27, 2021, patient administered expired product (received vaccine beyond 30 days). At the time of the report, administered expired product (received vaccine beyond 30 days) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. This case linked to MOD-2021-338604 (patient link).
Report flu-like symptoms that includes:  body aches, no appetite, fatigue and temp of 99.6  Treatment: Alternate between Tylenol and Ibuprofen. Outcome: Symptoms resolved. Did not interfere with ADLs.
This case was reported by a consumer (subject's father) and described the occurrence of wrong vaccine administered in a neonate male subject who was vaccinated with FLUARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent vaccination included ENGERIX B; GlaxoSmithKline; unknown; unknown given on 28 October 2013. Concurrent medications included Vitamin K. On 28 October 2013 at 18:00 the subject received unspecified dose of FLUARIX (.5 ml, unknown) and experienced wrong vaccine administered and inappropriate age at vaccine administration. The newborn subject mistakenly received an adult dose of FLUARIX instead of hepatitis B vaccine. The hospital kept the subject and mother for one and half days following the birth for observation due to the maladministration. The time of birth was 15:40 on 28 October 2013 and the vaccine was administered approximately three hours after birth. The subject was healthy and alert; Apgar score of 8-9. There were no complications at birth. No adverse events have been reported.