chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2013US018993 is an initial spontaneous report received from a nurse on 05 Sep 2013, with a follow up received from a nurse on 10 Oct 2013. This report refers to an 18-year-old female patient. Her medical history and concomitant medication were not reported. Her vaccination history included administration of meningococcal vaccine (manufacturer and batch number: unknown) on 09 May 2006, which was well tolerated. She was vaccinated with MENVEO (batch number: A11077, expiry date: 01 Apr 2014) in the left deltoid at a dose of 0.5 ml intramuscularly on 08 Jul 2013 at 01:45 pm. It was reported that MENVEO which reached 31 Fahrenheit for 3 days was subsequently administered to the patient. No adverse event was reported following this medication error. Follow-up was received on 10 Oct 2013: Updated vaccination history, site and time of vaccination.
felt like spine was being crushed; severe lymphatic swelling in axilla, chest, back and left breast; fever > 102F with tylenol for over 48 h then remained > 100F for 3 days; debilitating extreme pain in every cell for 24 hours; migraine; sores in mouth; lethargy; lt arm swollen hot, red itchy for a week and a half; lt arm swollen hot, red itchy for a week and a half; This is a spontaneous report received from a contactable other health care professional. A 50-years-old non pregnancy female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EN6206) via intramuscularly in left arm on 19May2021 07:45 (age at vaccination 50year old) as single dose for covid-19 immunization. Medical history included hypertension, Hypothyroid, High blood sugar TB test from an un-known date and unknown if ongoing.  Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, patient was not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included hctz (HCTZ), metformin (METFORMIN); levothyroxine sodium (SYNTHROID); ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE); olmesartan medoxomil (BENICAR). For all these concomitant products start and stop date and indication were not reported. The patient previously received first dose of BNT162B2 (Lot: EN6199) on 28Apr2021 09:00 AM (age at vaccination 50year old), via intramuscularly, in left arm for covid-19 immunisation. Historical vaccination include flu shot, and patient had history of receiving seldane for unspecified indication. Patient doent had covid prior vaccination and had not tested positive to covid post vaccination. The patient experienced felt like spine was being crushed, severe lymphatic swelling in axilla, chest, back and left breast, fever > 102f with tylenol for over 48 h then remained > 100f for 3 days, debilitating extreme pain in every cell for 24 hours, migraine, sores in mouth, lethargy, lt arm swollen hot, red itchy for a week and a half on 19May2021 19:15. The patient did not receive any treatment for the adverse events. The patient underwent lab tests and procedures which included body temperature resulted as 102 on 19May2021. The clinical outcome of the events recovered with sequelae on unspecified date in 2021.  Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the 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.
Hives and urticaria on both arms, torso both front and back.  Client observed directly, denied other symptoms of severe allergic reaction. By 2:20 pm hives and urticaria resolved. Student counseled and released at 3:00pm.
MUSCLE/ JOINT PAIN BODY ACHES LOW GRADE FEVER (100.3) UPSET STOMACH (MILD) NO APPETITE
mild pain at injection site; mild body aches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "mild pain at injection site"; PAIN (non-serious), outcome "unknown", described as "mild body aches".  Additional information: The patient was traveling and corporate phone was infected by a virus, resolved but it took over night to get all the apps including system back to functionality.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Swelling and pain in left arm began mildly the day of the shot. Next day pain was extreme. Could barely lift my arm. 2 days after the shot was administered, have nausea and vomiting so much that I was unable to work.
After I administered Comirnaty covid vaccine, I administered Flucelvax.  His arm bled a little so I held a cotton ball against the arm.  Once it stopped bleeding I reached for the bandaid when he got off the chair and fell face forward bumping his head against the sink.  He got up immediately and seemed unware of what just occurred.  I called out for his mother who was in the waiting room and explained what happened.  He sat back down on the chair and I inspected his tongue and lip because I noticed he had bitten his lip.  His tongue was unaffected but his lip was lacerated.  I noticed his head was slightly red where he bumped it but he stated no pain.  When asked if he had a headache he replied no.  He said apart from pain on his lip, he felt completely fine and ready to go.  I asked him if he needed to rest before leaving but he said not needed.  I still recommended that he be seen by a doctor either at urgent care or hospital.  I called both him and his mother but had to leave a message.  I asked for a return call to collect their PCP information so we can notify them of what occurred.  As of this reporting, I have not heard back from them.
This case was reported by a consumer and described the occurrence of death in a child of unspecified gender who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis absorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined for prophylaxis. The reporter is the mother of the subject. A physician or other health care professional has not verified this report. On an unspecified date before 5/27/05, the subject received a dose of Pediarix (dose number not provided). The reporter stated that  her, "child died one day after receiving Pediarix." It is unknown whether an autopsy was performed.
After developing a fever 24 hours following the vaccinations, patient was treated regularly with Tylenol and Motrin.  At 3:15 on 9/22, he had a seizure which lasted for at least a minute.  His mother responded when she heard an odd noise coming from his room, so the total length of the seizure is unknown.  911 was called, and he was taken by ambulance to Hospital.  He was given oxygen, and concentrated Tylenol to take the fever back down.  He was release after 2 hours of observation.  We followed up with his pediatrician on the afternoon of 9/22 who informed us there may potential be link to the high fever and the vaccinations.
Patient  had flushing ,  nausea and high blood pressure .    We laid the patient  down and continued to watch for 20 minutes and called 911.   Patient was given benadryl in the ambulance and steriods in the hospital ER .     Patient was released after 12 hours .
Delayed reaction a few days after administration. According to patient's care-giver - non-localized swelling, fever. Patient ended up in emergency room.
(L) arm with local reaction following varicella vaccination. Redness & swelling with same warmth. Area of redness approx. 5-6 cm. No induration.
Tiredness/was in bed most of the time for two days, but was up some. She was awfully tired; slept a lot; This is a spontaneous report from a contactable consumer. A 77-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on 15Jan2021 (Batch/Lot Number: EL8982) as single dose for covid-19 immunisation.The patient medical history was not reported. It was reported that she is on high blood pressure medication. It was reported that she had chemo years ago. She dont have no product name or NDC/Lot/exp to provide. The patient's concomitant medications were not reported. On an unspecified date the patient experienced tiredness/was in bed most of the time for two days , but was up some. she was awfully tired and slept a lot. The events were considered as non-serious. She had first dose of COVID vaccine on 15Jan2021. She was in bed most of the time for two days, but was up some. She was awfully tired. She guesses she slept a lot. This was from 2PM to 9PM. It was reported that tiredness, she didn't pay too much attention to when it started. Forgot what time of the day it was. She did ok up until she went to bed and then slept. She slept a lot the next day. The COVID vaccine is the first shot she has had a problem with. The outcome of the events was unknown.
17OCT92 very weak & coughing, head not clear; 21OCT92 taken to ER for eval then to daughters home for 4 days; was told @ er that probably had rxn to flu vax; 3DEC91 still coughing;
Patient developed rash around lower right ankle and calf. Rash diagnosed as shingles.
Vaccine given on 2/5 2021 Adverse reaction started Friday evening: involuntary jerking of right leg. Involuntary jerking of right arm started on 2/8/2021
Issued expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED  in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 042LA20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED. On 24-Jul-2021, EXPIRED PRODUCT ADMINISTERED had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Patient details, facility details and dose 1 details updated.
by 730Pm on date of vax face flushed & felt hot; next morning 5 1/2cm x 4 cm bruise, arm also hot; bruise still present on 18MAY95; not seen by MD;
Patient felt faint, syncopal episode, came to and regained consciousness within 2 to 3 minutes. Full recovery at 11:30 am and left the facility.
pt recv vax 16OCT97 & approx 2hr later exp swelling & itching in arm;two days later sx persisted w/redness, warmth, & enlargement of arm w/tense swelling from the inj site down to 2/3 of the forearm;dx non infect lymphangitis;
After  24 hours my right are and right side was extremely itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (After  24 hours my right are and right side was extremely itching) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Reaction to preservatives (patient have rare allergy and Allergic to common preservative that is found in food an sometimes list as non-medical ingredient in some prescription medication.) and Drug allergy (allergic to sorbates in sorbic acid).    In 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PRURITUS (After  24 hours my right are and right side was extremely itching). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itching, at an unspecified dose and frequency. In 2021, PRURITUS (After  24 hours my right are and right side was extremely itching) had resolved.            no concomitant medications are provided by the reporter. patient want to know allergic response interfere with the effectiveness of the vaccination.
it is itching; it is burning; he has knots on his face, neck and chest, and ears; it feels like its on fire; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (it is itching), BURNING SENSATION (it is burning), NODULE (he has knots on his face, neck and chest, and ears) and VACCINATION SITE WARMTH (it feels like its on fire) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced PRURITUS (it is itching), BURNING SENSATION (it is burning), NODULE (he has knots on his face, neck and chest, and ears) and VACCINATION SITE WARMTH (it feels like its on fire). At the time of the report, PRURITUS (it is itching), BURNING SENSATION (it is burning), NODULE (he has knots on his face, neck and chest, and ears) and VACCINATION SITE WARMTH (it feels like its on fire) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications was not provided by the reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow up information was received on 10 May 2021 wherein no new information was added.
Dizziness, Headache, Fever, NauseaVomiting, R side of face / eye swollen. Narrative:
Severe Headache, tightening of throat and chest tingling in arm, muscle spasms, nausea, soreness in joints, blurred vision start 10:30P 10/8/08 subsided some by 1:30P 10/9/08. Headache and tight chest still ongoing.
48 hrs - following vaccine, swelling distal to vaccination site - specifically dorsum of hand & wrist (left arm only); pain and reddish (blanching) discoloration. Symptoms & signs peaked at 3 days, resolving at day six.
10/23 pain at site of injection, swelling to elbow, hot to touch, and firm.  patient states felt bad.  Saw family doctor on 10/24 rx'd Biaxin x 10d plus prednison.  10/27 patient stated doing better.  FMD felt reaction of patient having Hep C
light headedness, dizziness, loss of appetite, headache, weakness, shortness of breath.
Second vaccine shot given March 7th. 25 hours later I expereinced headache, tiredness, fever, aches and chills. March 10th was a normal day. No symptoms; felt great, normal routine for the day. That night at 12:30 am I woke up with chest pain and shortness of breath. I was in extreme pain and felt like I couldn't breathe. My husband took me to the Emergency Room. Nitro and morphine administered. No relief. EKG, Chest X Ray, CT Scan with contrast, cardiac catheterization, Echo, and lots of bloodwork. I was in pain until 5:15 pm on the 11th. My primary doctor came and hospital switched morpine to toradol which provided some relief. I stayed overnight in hospital and was discharged at 6 pm on the 12th.
Experienced pounding headache, body aches under arms for 24 hours after receiving Moderna vaccine.  On March 6 , I experienced pounding headache and rash on my face neck and head resulting in Shingles. I  have never been ill and now  I am on antiviral medication. Wondering if this vaccine could have activated the Shingles..
fever lasting 12-18 hours; redness and extreme tenderness in a 3" x 3" area about 1 inch below the injection site. The extreme redness and tenderness continues to be present; hard swelling beneath the area of redness persists.
Sore Skin, Violent Shakes and Fever, Terrible Migraine, Sweating, Aching All were from 2am to Noon 4/13/2021 then subsided. No hospitalization.
Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 19-Apr-2022; Expired vaccine administered to 155 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 19-Apr-2022) in a 71-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 19-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 19-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that, when the vaccine received to pharmacy on 23-Feb-2022, the pharmacy staff member looked up the expiration date and came up with expiry date of June 2022. However, the correct expiry date for lot was 01-Apr-2022.  The vial was initially stored in refrigerator on 04-Apr-2022 and the vial did not undergo any temperature excursions.  No treatment information was reported
patient presented to the emergency department on 2/22/22 with cough and shortness of breath patient was admitted for further management of covid 19 infection patient was found to be covid 19 positive on 2/22/22 patient was discharged to home on 2/25/22
Mild stroke; Sore arm; A spontaneous report was received from a consumer concerning a female patient of unspecified age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced mild stroke/ transient ischaemic attack and sore arm/pain in extremity.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unspecified date, prior to the onset of the events, the patient received their planned dose of mRNA-1273 (Batch Number: unknown) via unspecified route for prophylaxis of COVID-19 infection.  On an unspecified date, after the vaccination, the patient experienced sore arm and mild stroke. Treatment information for the events was not provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events, mild stroke and sore arm, was unknown at the time of this report.; Sender's Comments: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities
no adverse effects reported; one patient received one dose of VARIVAX that was improperly stored; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No pertinent details regarding the patient's medical history, concurrent conditions and drug reactions or allergies were reported. On an unknown date, the patient received one dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX), lot # R030610, expiration date 23-OCT-2020 (exact dose, strength, dose number, route and site of administration were not reported) for prophylaxis. The dose was reconstituted with a properly stored sterile diluent. The vaccine was exposed to the temperature excursion of 6 to 14 degrees Fahrenheit (8.4 degrees Fahrenheit) for 30 minutes. No previous temperature excursions were reported. The call was because of digital data logger. No adverse effects were reported.
Rash has spread to her abdomen and buttocks; tching in arm spread to her back, chest and under arm; burning on her arm; This case was reported by a consumer via call center representative and described the occurrence of rash in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th November 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced rash, pruritus and burning sensation. On an unknown date, the outcome of the rash, pruritus and burning sensation were unknown.   It was unknown if the reporter considered the rash, pruritus and burning sensation to be related to Shingrix.  Additional details were reported as follows: The patient after vaccination experienced itching and burning on her arm and it began to spread to her back, chest and under arm. The patient also had rash that spread to her abdomen and buttocks. The reporter consented to follow up. This case has been linked to US2020006503, reported by the same reporter.
Elevated D-dimer; This spontaneous case was reported by a consumer and describes the occurrence of FIBRIN D DIMER INCREASED (Elevated D-dimer) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FIBRIN D DIMER INCREASED (Elevated D-dimer). At the time of the report, FIBRIN D DIMER INCREASED (Elevated D-dimer) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       After receiving the vaccine, the patient went to the family doctor for other reasons and they ordered a Ddimer test which resulted elevated. She stated didn't had any side effects from vaccine, but like to know if the vaccine elevated the test. Concomitant information were not reported. Treatment information were not reported.
(L) arm red, hot to touch. To MD 10-24-10 Tx with KEFLEX. Fever 100.4.
With 1st vaccine on 11/09/2021, mom noted that about 4 days later patient developed a bruise type rash around her lower abdomen/buttock area with some petechiae as well as some swelling and pain of fingers.   Improved and resolved over a few days. With 2nd dose on 11/30/22021,, within 8 hours she began to develop bruising/purpura type rash on her buttocks and around her lower legs/ankles and developed swelling and pain of her legs, ankle, and feet.   Upon return from being out of town, she came in to my office on 12/06/2021 at which time the swelling was still evident, but improved and the purpuric rash and petechiae were evident but much improved.  A CBC, Comprehensive Metabolic Panel, and Sed Rate as well as a Urinalysis was normal. On 12/08, and today, 12/09, the swelling on her legs, ankles, and feet has returned and the purpura has also returned.   No fever.  She was seen at Emergency Room, and I spoke with the ER physician, and she felt, as I did, that it appeared to be a Henoch Schonlein Purpuric type reaction.
30 mins p/vax pt exp faint erythematous rash; resolved over 30 mins, eyrthema 30 mm @ site;