chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2015US026852, is an initial spontaneous report received from a nurse on 22 Dec 2015. This report refers to a 57-year-old male patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: 1514501 and expiry date: May 2016) into left deltoid on 07 Oct 2015 which was stored out of recommended temperature range (temperature excursion at 34 degrees). The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day the temperature was fine. It was a new refrigerator and there have not been any problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. No further information was provided. Follow up information received from the nurse on 26 Jan 2016: Reported comment updated.
Pt recv vax on 1/5/98; on 1/7/98 pt exp red, swollen, warm right leg of 3x5 in area
raspy throat; red ears; a temperature; Headache; lip swelling; tongue swelling; This is a spontaneous report from a contactable consumer (patient). A 29-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3302), via an unspecified route of administration on the left arm, on 14Jan2021 at 05:15, at a single dose for Covid-19 immunization. Medical history included asthma and uses an inhaler, glaucoma, nonsustained ventricular tachycardia for which she takes no medication. When she was a baby she had a reaction to the pertussis vaccine, she thought it was just a rash. Concomitant medications included topiramate (TOPAMAX) and bupropion hydrochloride (WELLBUTRIN). On 14Jan2021, the patient had a reaction after getting the vaccine. She reported that she had lip and tongue swelling. On the day of the report she still has the lip swelling. On 15Jan2021, the patient also had a raspy throat, red ears, a temperature, and headache. The center where she got the vaccine gave her diphenhydramine hcl (BENADRYL) through injection and the swelling went down. She noted she can breath, that has been complete fine. She explained that the lip and tongue swelling had gone completely down last night after the diphenhydramine hcl, but the lip swelling has come back as she has not taken any diphenhydramine hcl yet at the time of the report. She plans on taking some soon. The outcome of the event of tongue swelling was recovered on 14Jan2021 and outcome of other events was not recovered.
Pt presented to ED w/N/V, coughing, headache, fevers, fatigue x 1 week and inability to keep PO intake down. Started developing symptoms on 4/16, tested negative for COVID on 4/19.  Was found to be COVID positive despite getting Pfizer vaccines (3/11/21 & 4/1/2021).  Was admitted for additional management of acute hypoxic respiratory failure due to COVID-19 pneumonia and N/V/D with electrolyte imbalances. Treated w/remdesivir and dexamethasone.  Her N/V and electrolyte imbalances improved w/IVFs and zofran. Was discharged on 4/28 w/follow-up in 5-7 days.
broke out in hives/rashes on elbows, eyelids, stomach, arms, legs (head to toe). Took benedryl 5/6/21 7:30 am. Went to urgent care 8:10 am 5/6/21 given steroid injections and told to continue benedryl nightly, sent home. No c/o SOB/difficulty breathing, only skin reaction.
Fever of 103.5, chills, headache, body aches all over. Took naproxin, applied cold compresses, sleep. Resolved within 24 hrs.
Had flu like symptoms about 12 hrs after shot. Hot flashed chills and would shiver uncontrollable everytime I moved. Woke up the next  morning with a dry non productive cough and body aches and a headache
tenderness at injection site; Redness; Swelling; Flu symptoms; This case was reported by a pharmacist and described the occurrence of injection site tenderness in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site tenderness, injection site erythema, injection site swelling and flu symptoms. On an unknown date, the outcome of the injection site tenderness, injection site erythema and injection site swelling were recovered/resolved and the outcome of the flu symptoms was unknown.   It was unknown if the reporter considered the injection site tenderness, injection site erythema, injection site swelling and flu symptoms to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and had redness, swelling, tenderness at injection site and flu symptoms. The reporter stated the patient had scheduled to receive her 2nd Shingrix shot but postponed it because she described her reaction after the first shot. She claimed the effects lasted over 7 days. She did not describe anaphylaxis.The reporter asked should she receive a 2nd dose. Did not consent to follow up. The Health care professional disconnected the chat before the reporter was able to probe further for details.
Information has been received from a physician concerning a 2 year old female with steroid therapy, absence of corpus callosum and pan-hypopituitarism, developmental delay and hospitalization with no recent exposure to chickenpox or shingles, who on 23-OCT-2008 was vaccinated with a dose of VARIVAX (Oka/Merck) (date, dose, site and route not reported).  Concomitant therapy included (LOTRIMIN), hydrocortisone, TYLENOL, pyridoxine and an unspecified inhalant.  On 10-NOV-2008, post-vaccination, the patient developed a vaccine associated rash with no fever, 6 scattered lesion crusted papules type.  At some point the child was hospitalized.  On 11-NOV-2008, a VARICELLA direct fluorescent antibody test was positive.  The patient was enrolled in the VARICELLA ZOSTER Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine VZV strain.  The sample of the lesion was collected on 13-NOV-2008.  The sample was taken from a papule lesion on an unspecified site.  The PCR results for the specimen from a papule lesion on an unspecified site identified the presence of VZV VACCINE STRAIN.  Additional information was received in the form of medical records on 31-DEC-2008.  The 2 year old female born full term with questionable global developmental delay, who does not walk or talk, vocalizes but no words, went to pediatrician on 22-OCT-2008 and basic workup yielded a sodium level of 168.  Patient was admitted to the hospital on 23-OCT-2008 for a workup.  Patient was otherwise well with only tactile fever over past couple days.  Father of patient thought that urine looked normal but patient urinated in 10 diapers per day (consistent over past 2 months).  Patient was on no medications and father believed behavior was at baseline, not more agitated or cranky.  Emergency dept exam revealed the patient had upper airway congestion.  Medications included: INH 190 mg daily, B6 25 mg PO daily, LOTRIMIN, TYELENOL PRN, hydrocortisone 2.5 mg TID (baseline dose) (5 mg po TID for fever; 7.5 mg po TID for fever >102).  On 23-OCT-2008 patient was vaccinated with VARIVAX (Oka/Merck).  On 10-NOV-2008, the patient developed a rash.  10-NOV-2008 VARICELLA culture was performed and serum VARICELLA ZOSTER virus antibody test was positive.  The patient outcome was not reported.  Additional information is not expected.
first dose in 2019, has not received second; Shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. In September 2021, more than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the shingles was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional Information: GSK Receipt Date: 19-JUL-2022 Reporter's Comment: The case was reported by the patient. The reporter who called in to report that, she received her Shingrix some time in 2019 (exact date unknown) and had not received second dose.  The patient also stated that, she developed a case of shingles in September 2021 (exact date unknown). The provided medical advice disclaimer. The reporter did not consent to follow-up. Additional Supportive Information: Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination.
After patient received Moderna vaccine, patient stated to feel faint and "flush". Patient was seen by a provider who recommended patient stay an additional 5 mins and drink water and OJ. 20 minutes after the vaccine, patient felt better.
pt presents to ED from dialysis where she was told her BP was low; states had a positive COVID test earlier in the week; c/o weakness and fatigue x 2 days; admitted to hosp; pt experienced cardiac arrest; ACLS was done but unable to revive pt; she passed away in the hosp
13 days p/vax pt devel sparse, red, papular rash on face & upper trunk. rash was classic monilial diaper rash.
covered in hives/ broke out in hives everywhere/hives developed the same day that the vaccine was given; This is a spontaneous report from a contactable consumer (patient). A 69-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6198, Expiration date not reported), via an unspecified route of administration on 26Feb2021 (at the age of 69 years old) as dose 1, single for COVID-19 immunization. The patient medical history included hands stinging and burning on 25Feb2021, on Thursday night (night before getting 1st dose of vaccine). Patient had no other medical history and received no concomitant medications. On 26Feb2021, same day after taking vaccine, the patient was covered in hives/broke out in hives everywhere. It was reported that, patient went to the emergency room and with the hives she did not think she got hives from the shot because she had the feeling coming on her hands that night before. Patient received treatment with steroids for the hives. At the time of reporting, the hives were gone and did not appear at all, but patient had to take steroids. Patient reported that, the doctor at the ER told her they didn't think it was from the shot itself, but she was concerned if she should take that next shot on 20Mar2021. The outcome of event was resolved on an unknown date in 2021.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained. No further information is expected.
A report has been received from a Pharmacist concerning, subject of unknown gender, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on 05-Nov-2013. It was reported that FLUMIST was given to few patients who were over 50 years old which started on 05-Nov-2013. The outcome of the event of gave FLUMIST to a few patients who were over 50 years old is unknown. The report was considered to be non-serious.
Complaints of dizziness and headache 15 after administration of vaccine.  Given fluid, orange juice and crackers, monitored vitals which were stable,  After observing for a total of 30 minutes plus patient still dizzy and unstable walking.  Transported to ER
No Adverse effect noted. Resident received expired modern vaccine, expired on 10/13/2021.
Hives on both sides of face/hives on both sides of the face about 48 hours after injection; This is a spontaneous report from a contactable consumer (patient). A 64-year-old non-pregnant female consumer (patient) received her first dose of BNT162B2 (Pfizer COVID-19, Solution for injection, Lot number: UNKNOWN) via an unspecified route of administration into the left arm on 12Mar2021 14:45 (at the time of 64-year-old) as single dose for COVID-19 immunisation. Medical history included celiac, obese, dust and mite allergies and known allergies to sulfa drugs. Prior vaccination, the patient had no covid. Post vaccination, patient not tested for covid. Facility type vaccine was hospital. No vaccine received in four weeks. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), zolpidem (MANUFACTURER UNKNOWN) and clozapine (MANUFACTURER UNKNOWN), all for an unspecified indication, from unknown dates and unknown if ongoing. On 14Mar2021 14:00, the patient reported of hives on both sides of the face about 48 hours after injection. She received treatment with Benadryl itch original strength itch cream. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Child has hives all over body - onset 17 hours after vaccine. Per mom's report, no fever, seems well.
The patient received a 1st dose Moderna previously weeks earlier.  He came for his second dose of Moderna, and also brough his two sons with him.  The vaccinator called for patient's name and he stood up and went to the vaccination table.  He and his son have the same name.   The vaccinator had his son's paperwork and clipboard. Patient received a Pfizer dose instead of Moderna because the vaccinator was holding the form for Pfizer for the son.  After the shot was given, patient announced that he had noticed that the form was for his son before the shot was given.  He did not have any immediate reactions to the vaccine.   He was monitored for about 30 minutes before leaving.  The Health Department was called and they advised that his series is now complete.
Pt recieved 1st Pfizer vaccine on 2/25/21 and her 2nd one on 3/18/21 Pt went to the ER on 3/23 via 911 in full cardiac arrest Per daugher, she c/o lightheaded this A< she came out of her room snad fell down, was vomitting and labored breathing paramedics were called, she went to Hospital and later died
pt recvd vax;began screaming high pitched 4 hrs p/ vax;unable to comfort pt,lasted 2-2 1/2 hrs;had rapid breathing & t;apap given q/ 4 hrs;contacted MD via telephone;8sep problem resolved;
Anaphylaxis, hives, headache, blood pressure spike, labored breathing, lips swelling, itching, abdominal pain
Arm sore at injection site for a few days.  I noticed several days later that my neck (part between neck & shoulder) was swollen.  I had a few lumps.  I had swollen lymph nodes.
rhabdomyolysis; This is a spontaneous report from a contactable consumer (patient). A 32-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 02Apr2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient stated, "These symptoms could be unrelated to the vaccine, but I believe they are worth reporting as they occurred after the vaccination." On 16Apr2021, the patient experienced rhabdomyolysis and currently have ongoing muscle pain. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care and hospitalization for 1 day. The outcome of the events was not recovered. No treatment was given to the patient for the events.  Information on the lot/batch number has been requested.
He had his first Covid vaccine yesterday. Last night he fell to the floor and was crawling around. When his girlfriend got to him he had a bump and laceration on his right cheek and his mouth was bloody. Today he is shaky and off balance.
Rash; Rash; Flu like symptoms; This case was reported by a consumer and described the occurrence of influenza-like symptoms in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced influenza-like symptoms, red rash and rash. On an unknown date, the outcome of the influenza-like symptoms, red rash and rash were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, red rash and rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After vaccination with dose of Shingrix, the patient had flu like for 3 days. The patient had rash with large red circle on arms back and chest. For tolerance to 2nd dose, refer linked case US2019AMR191591.
Patient called back to clinic the next day to report that he had a fever in the morning but had resolved by afternoon, headache, pain all over and his legs were swollen especially knees and feet. The patient declined an appointment with his provider or going to the local ER.
Generalized rash 1 week. Prednisone, Epi, Benadryl. SOB and wheezing for 4 hours. Temp 99.9 for 3 days. Took Tylenol. Pulse 106 BPM 1 week on exertion.
Fever 102.4, sz went to ER had nl neurologic exam & OM; no hospitalization required; pt has prev hx of febrile seizure;
Patient broke out into hives on 2/20/21 and called the physician office to report. Patient was advised to see an allergist doctor.
cellulitis on the same arm; Swelling; Edema; Lymphadenopathy; A spontaneous report was received from a (Reporter like HCP or Consumer) concerning a  77 Years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and ON 30 JAN 2021 he experienced cellulitis on the same arm, swelling, edema, lymphadenopathy. Patient has systemic luposistic inflammation.  The patient's medical history was not reported.   On 21 JAN 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (030L20A) intramuscularly on the right arm for prophylaxis of COVID-19 infection.  On 30 JAN 2021, the patient started experienced cellulitis on the same arm, swelling, edema, lymphadenopathy, patient has systemic luposistic inflammation. He thinks that the symptoms may not be related to the vaccine but he reports it. Event cellulitis on the same arm was considered medically significant.  No laboratory details provided.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.  Outcome of the events are progressing Not Recovered/Not Resolved; Reporter's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Received 12 mo vaccines 1/13/22, then the following day developed fever.  Was diagnosed with bilateral otitis media so started amoxicillin. Fever persisted, and re-evaluated. Noted to have L otitis media on day 7 of illness, so stopped amoxicillin and started cefdinir.  2.5 days later developed urticaria multiforme. Stopped cefdinir, started benadryl and zyrtec and rash is improving. Fever ended 1/24.
5/12/08 Pt. called to report "bump" w/redness & itching approx size of a quarter at site of Tdap inj. L deltoid given on 5/9/08. Pt. used LIDEX cream with relief.
Patient had a severe localized inflammatory response of the left upper arm, left shoulder, and left side of neck accompanied by extreme pain and heat in those areas starting a few hours post injection. Patient also experienced raised red rash on and around injection site. The following morning and for 3 more days the patient had mild grade fever between 100-101 and experienced nausea off and on. I am completing this report on day 5 post injection and patient still has some swelling but no fever or nausea.
COVID-19; COVID-19; currently pregnant; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 33-year-old female patient (pregnant) received BNT162b2 (BNT162B2), on 11Sep2021 as dose 3 (booster), single (Lot number: ff2588) at the age of 33 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. Relevant medical history included: "Drug allergy" (unspecified if ongoing). Date of last menstrual period: 03Sep2021. The patient was 1 weeks pregnant at the time of exposure to BNT162b2. The patient was 1 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 10Jun2022. Concomitant medication(s) included: 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], start date: 04Aug2021.  The following information was reported: MATERNAL EXPOSURE DURING PREGNANCY (medically significant) with onset 11Sep2021, outcome "unknown", described as "currently pregnant"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Apr2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Apr2022) Positive; (10May2022) highly positive, notes: day 13. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 28Apr2022 to 02May2022. Clinical course: The patient completed Paxlovid treatment on day 5 from positive PCR, symptoms had completely resolved. On day 10, symptoms returned but much worse than prior. A repeat rapid antigen test remained highly positive on day 13. No hospitalization Prolongation. The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment.; Sender's Comments: The reported COVID-19 positive after both the doses of COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Weeks 1 . Extreme dizziness and headaches.  Week 2.- Brain fog, disorientation, double vision, headaches, depersonalization, dizziness, heart palpitations. Week 3-Brain fog, painful nerve pain in feet, legs, arms, hands. Hand/eye tremors. Double vision, headaches. Week 4-Brain, persistent nerve pain, leg weakness, hand weakness, disorientation , double vision, headaches , depersonalization, persistent tremors.
I had soreness in the arm I received the vaccine which lasted three days. I tested positive for COVID-19 on 08/15/2022 via a home test.  I had a sore throat, increased/productive cough and general aches/pains. I contacted my doctor and I had an appointment. The doctor recommended that I start taking Zinc and Vitamin D. I took Tylenol 3 to relieve my symptoms. I was sick for 5 days and stayed isolated. After the isolation, I wore a mask when I went out.