chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effects; Improperly stored (-8.89 Celsius degree for 1 hour)  VARIVAX was administered to the patient; Information has been received from a medical assistant referring to a patient of unknown age and gender. Information about medical history and concurrent conditions were not provided.   On 04-APR-2019, the patient was administered improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number R026547, expiration date 17-SEP-2020; strength, dose and frequency were not reported) was subcutaneously for prophylaxis with properly stored sterile diluent (No lot information was provided). The administered dose experienced a temperature excursion of -8.89 degree Celsius for 1 hour which were detected by a data logger. No previous excursions were reported. No adverse effects was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA005132: US-009507513-1904USA005131: US-009507513-1904USA005130: US-009507513-1904USA004258: US-009507513-1904USA005129: US-009507513-1904USA005630: US-009507513-1904USA005133: US-009507513-1904USA005628: US-009507513-1904USA005631: US-009507513-1904USA005627:
pt had shoulder pain after vaccination, went to md for treatment. will possibly be getting steroid shots for treatment
1st dose, I presented headache and tiredness, 2 gives dose I presented the same symptoms but also strong pain in the joints, mostly in the hip that did not go away, then the intensity decreased but remains although mild, the discomfort persists.
Inflamed and tender left armpit. Have taken acetaminophen the following day. Stiffness also present in neck.
SEVERE JOINT PAIN; FEVER; HEADACHE; SEVERE FATIGUE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included autoimmune disorder. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced severe joint pain, fever, headache, and severe fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe joint pain, fever, headache and severe fatigue was not reported. This report was non-serious.
inconsolable crying x 6 hrs - refused to lay on L  side - HIB vax given on L -
Initial information received on 04-Jan-2019 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a 11 years old female patient who received a 0.5 ml first dose of an expired vaccine MENACTRA (lot number: U5746AD, expiry date: 14-Oct-2018) via intramuscular route in right deltoid on 27-Dec-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included GARDASIL 9 for Immunisation; and ADACEL for Immunisation. It was a case of actual medication error due to expired vaccine used. No Adverse Event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
DOUBLE VISION; LEG SWELLING; ABDOMINAL PAIN; BACK OF TONGUE SWOLLEN; BLADDER PAIN GOT WORSE; VISION GETTING WORSE; LITERALLY DYING; PAINFUL LEG; FEELS WEAK; CHEST PAIN GETTING WORSE; MIGRAINES; This spontaneous report received from a consumer concerned a 47 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetes, no alcohol use, and non smoker, and other pre-existing medical conditions included: The patient had No known allergies and drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On AUG-2021, the patient experienced migraines. On an unspecified date, the patient experienced chest pain getting worse, double vision, leg swelling, abdominal pain, back of tongue swollen, bladder pain got worse, vision getting worse, painful leg, feels weak, and literally dying. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chest pain getting worse, double vision, leg swelling, abdominal pain, back of tongue swollen, bladder pain got worse, migraines, feels weak, vision getting worse, painful leg, and literally dying. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Starting either the night of the vaccine or the next I had a horrible time sleeping. Up and down, back and forth. Then I developed terrible pain in my neck all over. I tried OTC meds that did not alleviate the pain in addition to heating pad, stretching, neck constriction with neck brace. This lasted about a week with the pain mostly in the two front muscles in the neck. I had a day or two of respite but the pain came back as what feels like muscle spasms in my upper left and right shoulder/neck area. Difficulty turning head. Headache.
Swollen armpit, (tennis ball sized) along with pain that radiates onto left ribs.
19 yo M with PMH of asthma and obesity who presents with one week of vision loss in left eye and new onset intermittent headache. Hre ported that he received his first dose of the Pfizer COVID vaccine on 5/3. Then he got the second dose on 5/13. On 5/14 he noticed headaches. On 5/16 he had vision loss in his right eye. This got worse so he came in on 5/19. He had an area of black vision in the upper quadrants of his visual fields and then blurriness in the rest of his vision in that eye. The other eye was unaffected. He had an exam by opthalmology which showed papilledema. He was seen by neurology and had an MRI of the Brain and orbits which showed L optic neuritis as well as a punctate area in the L frontal lobe of unclear significance. CSF with WBC count of 2, normal protein of 23. He had positive oligoclonal bands. Negaitve NMO and MOG. His vision started to improve with high dose steroids. he was discharged home.
Breakthrough case admission after 4 vaccines Moderna 1/28/21 Lot# 026L20A;  Moderna 2/25/21 Lot# 031L20A;  Moderna 11/19/21 Lot# 067F21A;  Moderna 7/6/22 Lot# 037A22B
This case was reported by a physician via sales rep and described the occurrence of sleepiness in a infant patient who received PEDIARIX for prophylaxis. On an unknown date, the patient received the 1st dose of PEDIARIX. On an unknown date, unknown after receiving PEDIARIX, the patient experienced sleepiness. On an unknown date, the outcome of the sleepiness was recovered/resolved. It was unknown if the reporter considered the sleepiness to be related to PEDIARIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced sleepiness after the dose of PEDIARIX and mother was concerned and wanted to know if this was a known reaction. Sleepiness had resolved by the time of adverse event was shared with GlaxoSmithKline. The reporter agreed to follow up with GlaxoSmithKline.
Immediately following vaccination patient complained of arm pain and was holding her arm very rigid. She walked to a chair immediately outside the room because she did not want to see her brother get shots. About 5 minutes later she came back in room and was pale and lethargic. Sat her down in a chair. She said her stomach hurt and she felt like she was going to throw up and that she was not hearing very good. She vomited a large amount. Color immediately came back to her face. She was diaphoretic but stated she was cold. She vomited a 2nd time about 2-3 minutes later and a 3rd time about 5-10 minutes after that. Throughout she described waxing and waning stomach pain, waxing and waning hearing decrease and she would regain color and then become flushed again. These effects happened at least 5 times in the ~45min she sat in the vaccination room. About 40 minutes after her initial symptoms she said her stomach was feeling better but she now had a headache and was dizzy. She was also lethargic. At this time she felt like she was ready to go home. Father was instructed that if symptoms reoccurred to take child to the urgent care for examination. He verbally understood.
Swelling  beginning at injection site 4 hours after injection Chills beginning about 8 hours after injection Headache beginning at 24 hours after injection Rash at injection site 30 hours after injection Rash on left cheek 40 hours after injection All still present at this time!
The patient originally got Pfizer vaccine on 5/14/21 and then returned 21 days later for second vaccine on 06/04/21 but received Moderna Vaccine as second dose. Soke with pt on 06/05/21,  no symptoms out of the ordinary. She reported being "hit" about 12 hours with headache, mild fever, fatigue, chills, still tired but feeling like improving. No PCP to report to at this time.
Hep B #3 given 2/2/11 at 10:30 AM high fever (104 degrees) at 3pm approximately 4 hours later leading to a brief generalized seizure. Brought to ER did well. No URI sx, other cause. On 2/3/11 developed full URI sx.
Patient came into the clinic to receive the Moderna Bivalent but was inadvertently  given the Moderna pediatric 0.5 mL dose. KDHE, CDC and Moderna Helpline were notified this same day for guidance. Patient was notified same day of the  error.
Patient had a flu shot (Fluzone Quadrivalent, P-Free)(Lot: UJ471AA) on 12/29/2020 and was given the Moderna vaccine (Lot: 011L20A) on 1/5/2021. Patient has been notified and is aware. Patient is currently not experiencing any symptoms.
Site: Pain at Injection Site-Severe. Additional Details: Pain in arm, unable to lift arm without pain.
Regular adverse events - bedridden from Friday night until Sunday afternoon - chills, joint pain, muscle weakness, chest pain, lung tightness, shortness of breath, hip trying to pop out of socket due to joint weakness - all experienced with covid in January 2021;Irregular adverse event:  two seizures at approx. 11:30 p.m.  uncontrollable body stiff, shaking, eyes roll back in head, moaning
This case was reported by a pharmacist via call center representative and described the occurrence of peripheral swelling in a 81-year-old patient who received SHINGRIX (batch number G933B, expiry date 22nd November 2020) for prophylaxis. On 2nd August 2018, the patient received SHINGRIX (intramuscular) 50 ug. On 4th August 2018, 2 days after receiving SHINGRIX, the patient experienced peripheral swelling and mobility decreased. On 5th August 2018, the patient experienced ankle swelling. In August 2018, the patient experienced erythromacular rash. The patient was treated with ibuprofen, benadryl (nos) (Benadryl) and prednisone. On an unknown date, the outcome of the peripheral swelling, ankle swelling, erythromacular rash and mobility decreased were not recovered/not resolved. It was unknown if the reporter considered the peripheral swelling, ankle swelling, erythromacular rash and mobility decreased to be related to SHINGRIX. Additional details were provided as follows: On the morning of 4th August 2018, the patient's arms were swollen from her elbows down. Her hands were so severely swollen that she could not close them. She took some Benedryl and ibuprofen to try and treat the swelling. From 5th August 2018 to 6th August 2018, the swelling migrated to her legs so her feet ankles and lower legs were all swollen as well. She developed a rash of bright red spots on her legs up to her mid thigh and also had some spots on her arms. It looked like someone had put random dots with a bright red marker on her. It did not look like shingles. The patient had been to the physician and gotten a prescription for prednisone.
Pregnant; This spontaneous retrospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PREGNANCY (Pregnant) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 021L20A) for COVID-19 vaccination.     Concomitant products included BETAXOLOL and PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 24-Jun-2020 and the estimated date of delivery was 31-Mar-2021. On an unknown date, the patient experienced PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-eighth week of the pregnancy. The vaginal delivery occurred on 25-Mar-2021, which was reported as Full-term. For neonate 1, the birth weight was 2920 grams (6lbs 7oz) with an APGAR score of 9 and 9 at (1, 5 minutes). The outcome was reported as Term Birth w/o Complications. At the time of the report, PREGNANCY (Pregnant) outcome was unknown. Not Provided          Treatment drugs were not provided,  Action taken with mRNA-1273 in response to the event was not applicable.
injection site swelling; injection site redness; injection site warmth; injection site itching; This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th May 2019, the patient received Shingrix (intramuscular). In May 2019, less than a week after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, injection site erythema, injection site warmth and injection site itching. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema, injection site warmth and injection site itching were not recovered/not resolved.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site erythema, injection site warmth and injection site itching to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on the left deltoid. The patient reported to the pharmacist that all week long, she had swelling the size of half dollar at the injection site and redness. Now, the swelling was half the length of her upper arm and it was 4 to 5 inches wide. The area was also warm and itching.
He was very sensitive to any sudden or loud noise for about two weeks and still is to some extent. Let out loud terrified scream at any sudden or loud noise.
She had tested positive for Covid; She had tested positive for Covid; in her 3rde trimester of pregnancy; Debilitating insomnia; 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. A 37 year-old female patient (pregnant) received bnt162b2 (COMIRNATY), administration date 13Aug2021 (Batch/Lot number: unknown) at the age of 36 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "insomnia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "She had tested positive for Covid"; MATERNAL EXPOSURE DURING PREGNANCY (non-serious), outcome "unknown", described as "in her 3rde trimester of pregnancy"; INSOMNIA (non-serious), outcome "unknown", described as "Debilitating insomnia". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient received Pneumonia 23 vaccine on 1-30-08.  On 2-1-08, phoned clinic complaining of pain, redness and swelling of arm down to elbow area.
diagnosed with Covid-19; diagnosed with Covid-19; This is a spontaneous report from a contactable consumer (patient's mother/parent) via the Pfizer sponsored program. This consumer reported similar events for different patients. This is the third of 3 reports. This consumer (patient's mother/parent) reported that a 31 year old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 20Apr2021 (Batch/Lot Number: EW0158) (at the age of 30 years) as DOSE 2, SINGLE; dose 1 via an unspecified route of administration on 20Mar2021 (Batch/Lot Number: ER2613) (at the age of 30 years) as DOSE 1, SINGLE  for covid-19 immunisation. The patient medical history and concomitant medications were reported as none. It was reported that within the past 4 days (as reported), patient's mother, father, and patient himself all have been diagnosed with Covid-19. It was stated that all three have complaints of fatigue and that patient had been more tired. The patient medical history and concomitant medications were not reported. It was reported that within the past 4 days, patient's mother, father, and patient himself all have been diagnosed with Covid-19. It was stated that all three have complaints of fatigue and that patient had been more tired. The patient had his COVID test within days and had breakthrough COVID. Patient did the test two days ago (11Sep2021) that came back positive. Patient had a headache and sore throat so knew he had it, he never had COVID until this breakthrough. The outcome of events was unknown. It was unknown if patient has done any treatment. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 11Sep2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101198193 Same reporter/drug, similar event, different patient.;US-PFIZER INC-202101200288 Same reporter/drug, similar event, different patient.
At night I felt like my back was hurting. When I woke up it was worse, I went to work and couldn't bend over and ended up going to Urgent Care, the Dr. didn't think it was due to the vaccine, he adjusted my back , gave me a shot and pain meds. It helped but the pain stayed on the right side. It was weird because it happened the night of the vaccine.  This also happened with the second does.
Chills; body aches; HA; rash (not uncomfortable); metallic taste; dizziness; difficulty focusing; This is a spontaneous report from a contactable consumer (patient). A 69-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported) via an unspecified route of administration, administered in arm left on 04Mar2021 at 16:15 (at the age of 69-year-old) as a single dose for COVID-19 immunisation. Medical history included tetanus, known allergies: sulfa, red nail polish, and COVID prior vaccination. Concomitant medications included bupropion. The patient did not receive any other vaccine in four weeks. The patient previously took percocet (oxycodone hydrochloride; paracetamol) and linzess and experienced known allergies. Since the vaccination, the patient had not been tested for COVID-19. On 04Mar2021 at 18:30, the patient experienced chills, body aches, ha (headache), rash (not uncomfortable), metallic taste, dizziness and difficulty focusing. The patient did not receive any treatment for the events. The outcome of the events was recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Child erroneously received Kinrix vaccine for his first DtaP and IPV vaccinations. No adverse outcome was noted besides mild fussiness and temp of 99.0 F felt to be consistent with immunization. Error was not discovered until 3 days after vaccine administered. I contacted ACIP and they advised that I should report event to VAERS but that these vaccines would count as part of child's DTaP & IPV series and would not have to be repeated. I have informed the mother of the error today and have taken steps within our clinic to avoid this error from happening again.
This is a spontaneous report from a contactable physician. A female patient of an unspecified age received first dose of BNT162B2(COVID-19 VACCINE; formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 04May2021 as single dose for covid-19 immunisation. The patient s medical history and concomitant medications were not reported. On unspecified day on May2021 the patient went to urgent care to be treated for chest tightness, Her CBC showed her MCH slightly decreased, mean platelet volume decreased to 9.1, and her WBC increased at 11.4. She is concerned that it might not be safe for her to get the second dose this Saturday 29May2021 with her WBC being elevated. The patient wanted to know if it is expected that the WBC level will increase after this vaccine. The patient underwent lab tests and procedures which included mean cell hemoglobin, slightly decreased, mean platelet volume: 9.1, Mean platelet volume decreased to 9.1, white blood cell count: 11.4. WBC increased at 11.4. Therapeutic measures were taken as a result of the patient recently went to urgent care to be treated for chest tightness. No further information found for increased WBCs/lymphocytes. The outcome of the events were unknown. Follow up attempts are needed. Further information has been requested.
FELT EUPHORIC LIKE I WAS ON A HIGH I WAS VERY HAPPY; SLIGHT TENDERNESS ON THE VACCINATION SITE (ARM); This spontaneous report received from a patient concerned a 78 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the patient experienced felt euphoric like I was on a high I was very happy. On 03-APR-2021, the patient experienced slight tenderness on the vaccination site (arm). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt euphoric like i was on a high i was very happy, and was recovering from slight tenderness on the vaccination site (arm). This report was non-serious.
Fever 103.6 2 to 3 hrs; rash over entire body for 1 wk; redness disappeared; limp-screamed constantly for 4 or more hrs 3-4 days;