chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Felt pretty crummy; Fever; Chills; Body ache; A spontaneous report was received from a consumer, concerning herself, a female patient of unspecified age, who received Moderna's COVID-19 vaccine and experienced fever, chills, body ache and felt pretty crummy.  The patient's medical history included COVID-19 since 11-Dec-2020.  Concomitant product use was not provided by the reporter.  On 29-Dec-2020, approximately one day prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot number unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 30-Dec-2020 at 11:00AM, the patient developed fever, chills, body ache and felt pretty crummy until waking up the next day on 31-Dec-2020 and at this time patient was feeling much better.   Action taken with mRNA-1273 in response to the events were not provided.  The outcome of the events, fever, chills, body ache and felt pretty crummy were considered resolved on 31-Dec-2020.; Reporter's Comments: This case concerns a female patient, with a historical medication condition of Covid-19 infection (fully recovered), who experienced a non-serious unexpected event of malaise and pain, non-serious expected events of pyrexia and chills. The event occurred 1 day after first dose of mRNA-1273, lot # unknown. Treatment details was no provided. Very limited information regarding these events has been provided at this time. Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded. Additional information has been requested.
Started out as red spot on skin and turned into a scab. Around day 7 skin around injection site became red, hot, and very itchy. Itchiness persisted for close to a month until the patient decided to take a closer look at injection site. They noticed a spot still present on skin, described as a sliver, foreign body, and "gray line" type of foreign body. Patient is a nurse so they removed foreign body with tweezers. Itchiness got better over next couple days until itchiness fully subsided 7 days after removal.
Child was given 0.2ml dose of undiluted Pfizer 5-12 year old vaccine.  Parent contacted 1/26/2022 by staff and there had been no adverse reaction experienced up to that date and time of contact.
1st dose  9nov2018, 2nd never; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 9th November 2018).   On an unknown date, the patient did not receive 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 Information: GSK receipt date: 28-Sept-2022 Reporter's comment: The registered pharmacist called to inquired that how to proceed with Shingrix series. The patient never receive the second dose. The reporter did not consent to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.
Post COVID-19 Vaccination vulvar aphthous ulcers; Post COVID-19 Vaccination vulvar aphthous ulcers; This is a literature report.  An adolescent patient received BNT162b2 (BNT162B2), in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single), for COVID-19 immunisation, reaction(s): "Without complications". The following information was reported: VULVAL ULCERATION (medically significant), APHTHOUS ULCER (medically significant) all with onset 2021, latency 2 days after the suspect product(s) administration, outcome "recovered" and all described as "Post COVID-19 Vaccination vulvar aphthous ulcers". The event "post covid-19 vaccination vulvar aphthous ulcers" required emergency room visit. The patient underwent the following laboratory tests and procedures: Cytomegalovirus test: negative; Epstein-Barr virus test: negative; Physical exam: was consistent with a dianosis, notes: of vulvar aphthous ulcers with no exceptional characteristics.; Sender's Comments: Based on the information available, the causal relationship between the reported events and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202201056246 Same article/drug/event and different patient:;US-PFIZER INC-202201056247 Same article/drug/event and different patient:;
Subsequent to receiving vax the pt developed an injection site reaction characterized by a large area of redness and itching. She also developed an egg type lump between her neck and shoulder, which felt like a big ball that swelled. A red streak went from her neck to the top of her shoulder. She recovered without treatment.
Pt stated left arm was very swollen and extreme arm pain the night of injection (I do not know the exact time).  Arm on 1/31/13 when examined by nurse was no longer swollen.  Pt stated "it doubled in size" swelling was below the injection site just above the elbow.  When I examined his arm there was only sunburn type redness in that area.  Pt stated pain much improved, although still having some tolerable pain.
Patient states she started experiencing tingling in the arm after vaccination that has not alleviated since vaccination. Called primary care physician to report side effect 10/24/18 at 11:10 am.
HE DEVELOPED URTICARIAL RASH MAINLY ON CHSET AND FACE ABOUT 6-8 HOURS AFTER GETTING VACCINATION. WHEN I SAW PATIENT NEXT DAY IN AM, MOST OF THE URTICARIAL RASH HAS DISAPPEARED AS PER MOTHER. HE WAS FOUND TO HAVE ERYTHMATOUS MACULAR RASH ON CHEST AND FACE. NO MEDICATION WAS GIVEN.
I had mild fatigue, and I was getting cold easy. I went to an annual checkup, and they ran some blood work, and it came back that I had developed Anemia. I received two iron infusions not long after my blood work came back.
A report has been received from a Pharmacist concerning a child patient of unknown gender. The patient's medical history and concomitant medications were not reported. Patient received nasal FLUMIST (intranasal) on an unknown date. It was reported that all the medication came out, past flu season while giving FLUMIST to the child, because the child was laughing and moving the head forward. The outcome of the event of all the medicine came out was unknown. The reporter assessed the events to be non-serious.
No adverse effects reported; a patient, who was over 16 weeks of age, received their first dose of ROTATEQ; This spontaneous report was received from registered nurse and refers to a 6-month-old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 12-SEP-2022, the patient was vaccinated with first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 milliliter, lot #W004501, expiration date: 20-APR-2023, administered for prophylaxis (strength, and route of administration were not provided) (Product administered to patient of inappropriate age).  There was no adverse event reported (No adverse event).
Patient hospitalized due to breakthrough covid-19 infection from 7/18/21 to 7/20/21. Patient completed Pfizer vaccination series in April. Information below is copied from discharge summary:   Patient is a 26 y.o. male patient who is being discharged today.   Hospital Course:    COVID 19 pneumonia causing acute pericarditis and acute respitatory failure (patient was vaccinated against COVID 19) Hypercoagulable state D dimer 1,985 - now at room air - dexamethasone 6 mg daily to complete 7 days - naproxen + colchicine for at least one month, follow up with PCP might need extension of this therapy - cardiology input noted - CT chest reviewed   Sickle cell disease - Hemoglobin stable 11 - Folic acid 1mg daily - Hydroxyurea 500 TID - follow up H/O   Arterial hypertension - Amlodipine 5 mg daily - Metoprolol 25 mg daily   Patient is discharged in stable condition with stable vital signs. All questions regarding hospital course and plan of care after discharge have been answered to satisfaction.
Initial unsolicited report received from a physician (parent) via company representative on 02 October 2015. This case involves a male patient (age not reported), who was vaccinated with an intramuscular dose of FLUZONE QIV (batch number, dose and site of administration was not reported) on unspecified date in September 2015. Medical history and concomitant medications were not provided. On an unspecified date in September 2015, unspecified period following vaccination, the patient had allergic reaction to FLUZONE QIV. Laboratory investigations and corrective treatments were not reported. Outcome of the event was reported as unknown. Follow-up information received from a non-healthcare professional on 09 November 2015. This case involves a 23 years old patient. The patient was vaccinated at private doctor's office/hospital. The pre-existing physician diagnosed allergies, birth defects; medical conditions were reported as none and adverse event following prior vaccination was reported as none. On an unspecified date, following the vaccination, the patient had developed fine erythematous macular rash over torso only and felt little tired. It was reported that the patient went to family doctor who stated that it was due to vaccine. On an unknown date, the patient was recovered from the event. Documents held by sender: none.
Pt was in the hospital treated for NSTEMI in the week after receiving Moderna COVID vaccine. Patient is now out of the hospital.
Continuous crying > 3 hours.  Redness and swelling on most of upper right thigh.  Increased drowsiness.  Patient advised per doctor to use 1/2 tsp Tylenol every 4 hours, 1/2 tsp. Benadryl every 6 hours.
Pt received vaccine on 9-24-13, the next day he stated that his arm was sore and became infected. His PCP prescribed antibiotics. Now the issue is resolved.
COVID 19 positive; COVID 19 positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and 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. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25Jun2022, outcome "not recovered" and all described as "COVID 19 positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: If covid prior vaccination reported as no. If covid tested post vaccination reported as yes. Paxlovid used for the treatment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Arm became swollen at injection site - cl stated she was hot & tingling of fingers, hyperventilating - given 25 mg Benadryl B/P elevated 2 preeclampsia per report. Called her at 8pm - stated she felt fine & swelling down.
Pt began vomiting, severe h/a and lethargy less than 24 hours after injection.
A non-serious spontaneous report of '2 children were each inadvertently administered an expired dose of H1N1 as the second dose' was received from a registered nurse/health professional concerning a 43-month-old female child. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired in 23-Feb-2010. On an unknown date, the patient received first dose of H1N1 vaccine. On 24-Feb-2010, the patient received second dose of expired H1N1, Intranasal, for unknown indication. There was no adverse event associated with this medication error therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Sweating; Tired; This is a spontaneous report from a contactable consumer, the patient. A 40- year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247), via an unspecified route of administration in the left arm on 04Mar2021 at 13:30 (at the age of 40-years-old), as a single dose for COVID-19 immunisation. Medical history included allergies to apples. Concomitant medication included atorvastatin calcium (LIPITOR) from unknown date for unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 05Mar2021 at 03:00, when patient's 04-year-old daughter woke him up, the patient was sweating. It was not hot in the room. The patient did not take the temperature as the patient was tired and went back to sleep. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the events sweating and tiredness was recovered on 05Mar2021.   No follow-up attempts are needed. No further information is expected.
1 of 5 pts immunized from the same vial (lot# 326914) who exp a 1-2" area of induration & erythema @ DTP inject site; reaction occurred in pt w/in 24-48 hrs following immun; required ER/MD visit;
Narrative:  A 67YOM with hx of Metastatic NSCLC (adeno) in 2015 s/p LUL wedge resection, recurrence in 2018 s/p SBRT, PET positive again on 7/2020 with LLL mass, with bil lung and T10 mets, with recurrent malignant pleural effusion s/p pleurex catheter placement 5/19/21. PMH also includes plasma cell leukemia (on CARfilzomib, last given 6/02/21), HCC (dx 2018, s/p RFA 8/2018, MRI 2/2020 concerning for recurrance), chronic Hep C, and chronic LBP admitted for hospice care pain and symptom control. Pt died on 6/28/21. Pt received COVID vaccinations on 2/22/21 and 3/22/21. Death unrelated to vaccinations.
Back in September 4 customer got the flu shot. She just got x-rays back last week. She's been having trouble with her arm for that long. The person who gave her the shot hit a nerve and her arm has been numb and a burning sensation at the injection area this entire time. It was a female employee that gave her the shot. It impacted her job. She's on pain medication, it's disrupted her sleep and whole life.
2 weeks after immunization blacked out during volleyball game and went to ER. Ongoing symptoms of dizziness, passing out, trouble breathing, nausea and headaches. Missing school and working with doctors to relieve symptoms. After 90 days, still having reactions.
About 7 hours after my shot I experienced tingling and radiating pain down my left arm from my shoulder to wrist.   In the two weeks since my shot my symptoms are getting worse, not better.   I used to be able to do two sets of 50 push-ups and I can no longer do one push up.   I used to be able multiple sets of 15-20 pull ups for a total of 50 in a couple of minutes.  I can no longer do one.    I enjoy golf and  can no longer play .
Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: puffy face, swollen eye, 10/5 (chronic fatique/neck pain), aches/pains, constant napping/sleeping a lot, 10/6 pain from neck down the spine to lower back, leaking urine, bent over on 10/9 and could not get back up (er visit), splitting headache, high bp-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Severe, Systemic: Hypertension-Severe, Systemic: Joint Pain-Severe, Additional Details: got medrol in hospital, which helped, may have had epstein barr 2 weeks before this, but was feeling fine at time of shot, cheeks red/hot (no fever), leaking urine continued, hot flashes that lasted for 2 hours, bp high, oxygen 94, hr 50, 10/15 upper right shoulder/spine pain that continued below sternum that moved up to throat (stabbing pain), did head ct at first hospital, sent her home, no back xray, went to a diff hospital after that, she will keep us updated
Onset of Nausea around 9.00pm - servere case of vomiting twice. Once at 10.30pm - 2nd time at 12.10pm. Resulting in a sore stomach and chest when I cough.
This is a 26-year-old female with a history of cerebral palsy, chronic respiratory failure, seizure disorder, GERD, anxiety, nonverbal who presents to the emergency room for vomiting.  Patient did not come with any paperwork therefore all my information is being taken from prior medical records.  According to the ER patient stays in a group home  ( although records from 2017 state she lives w her father.) and may have had a mucus plug.  She has not had any vomiting in the emergency room.  She has a trach and a PEG.  She is positive for COVID and suspicious for pneumonia on the chest x-ray.  She has been hypoxic in the emergency room and her oxygen demands have increased.   8/5/2021 tested positive Unknown vaccination status.   According to prior records in 2000 17 patient has a history of chronic respiratory failure and has been in the ICU numerous times.
Follow-up information provided lot number, expiration date, and age of child. Information regarding Hib-Titer Vaccine (haemophilus B conjugate vaccine (diphtheria crm 197 protein conjugate) injection) was received from a nurse regarding a 7 month old female patient who received a third dose on 28 May 1997 and developed a localized reaction in the left leg following her injection.  Injection site redness, injection site warmth and injection site swelling characterized the local reaction. The patient also experienced decreased appetitie-infant would only take a bottle, irritability and was hard to put to sleep. She was diagnosed on an unspecified date with "hematoma in muscle of left thigh".  Medical History: The patient's concurrent illness includes cardiac murmur functional (Reporter indicated patient was seen by a cardiologist in June of 1999).  Product Details: Indication for Hib-Titer vaccine was immunization. Product was administered on 28 May 1997. Dose regiment was 1 dose (intramuscular). Concomitant Therapy: Concomitant medications were not reported. Event Details: On 28 May 1997, the patient received a third dose of Hib-Titer and on the same day, developed a localized reaction in the left leg following her injection (injection site reaction). Injection site redness (injection site erythema), injection site warmth (injection site warmth) and injection site swelling ( injection site swelling) characterized the local reaction.  The patient also experienced decreased appetite-infant would only take a bottle (decreased appetite), irritability (agitation) and was hard to put to sleep (insomnia). She was diagnosed on an unspecified date with "hematoma in muscle of left thigh" (injection site hemorrhage). The reporter indicated that the patient recovered.  Related Case: See related case(s): HQWYE586112JAN05 (adverse event, non-expedited). No additional information was available at the time of this report.
pt recv vax; 7-10 days p/ shot, pt had sz w/ tightening, biting down,closing eyes, stiffening;MD sent note to give only DT now;
little bit of cough; little bit of headache; little bit of aches; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (little bit of cough), HEADACHE (little bit of headache) and MYALGIA (little bit of aches) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, the patient experienced COUGH (little bit of cough), HEADACHE (little bit of headache) and MYALGIA (little bit of aches). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, COUGH (little bit of cough), HEADACHE (little bit of headache) and MYALGIA (little bit of aches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported.
I received the vaccine at 11:10am...at 11:20am I became very quickly flushed, disoriented, heart racing, was very short of breath and had a rash on my face...I was given epi and put on 8lpm oxygen and taken by ambulance to the loca hospital for observation...I was kept for a few hours and allowed to go home with epi pens...I am very sore today with a migraine, fever, joint pain and chills
Localized swelling, redness and pain. Area apx 1 " in diameter.
Fever, chills, headache, body aches, left axillary lymph node swelling
Vaccine was given beyond BUD of vaccine. Vaccine refrigerated 4/27 1020 and vaccine given 5/28 0820. One day over BUD.  No reported adverse effect after vaccine given which affected 7 patients.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Mar2021 as dose 1, single (Batch/Lot number: unknown), on 16Apr2021 as dose 2, single (Batch/Lot number: unknown), on 09Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 30Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Psoriasis" (unspecified if ongoing); "asthma" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO; AVIANE; SINGULAIR; ZYRTEC ALLERGY. Past drug history included: Ceclor, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Covid rebound 5 days after finishing Paxlovid and 3 days after a negative test result; Negative, notes: Covid rebound 5 days after finishing Paxlovid and 3 days after a negative test result. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course included yes patient received other medication in 2weeks. Covid rebound 5 days after finishing Paxlovid and 3 days after a negative test result. Other medical history: Psoriasis, asthma.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
During observation, at the 30 minute mark, patient reported having numbness on the right arm, tingling on the left arm injection site, heart palpitation, and vertigo.   Patient was placed in reclined position and offered water.  After laying down for 20 minutes, patient reported no more heart palpitation, the numbness went away, and the vertigo was improved.