chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional adverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided.  On 06-JAN-2020, the patient was vaccinated with an improperly stored (product storage error), pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (Therapy type: Digital Data Logger), lot number S006210 and expiration date 22-DEC-2020 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided).  The vaccine was stored at a temperature above 47 degree Fahrenheit (47.1 Fahrenheit), for a timeframe of 8 to 16 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA009007:
30AUG95 pt recvd vax & about 5PM that evening had a nap gen itching noticed hives next morning on lt & rt elbow & lt & rt upper thigh;hives lasted til 5SEP when they completely disappeared;hives were localized to areas described above;
pt had both shots on same day in same arm. she later developed redness from the shoulder down to the elbow and swelling in the arm near the elbow. she went to the er where they gave her a shot(s) for treatment and told her she would be ok.
soreness in the tongue; This is a spontaneous report received via Medical information team from contactable consumer (patient herself). A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route of administration on 19Mar2021 at single dose for COVID-19 immunization. Medical history and Concomitant medication were not reported. It was reported that patient got the first dose of the Pfizer COVID-19 vaccine today and about 40 minutes after getting injected, she developed soreness in the tongue on 19Mar2021. She emphasized that it wasn't swelling but only soreness. She said that she was sure that it came from the vaccine because she was fine before coming in the vaccination centre. Outcome of the event of soreness in the tongue was unknown.  Information on the lot/batch number has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), on 12Mar2021 at 13:00 as dose 1, single (Lot number: EN6208), in right arm, on 02Apr2021 at 13:00 as dose 2, single (Lot number: ER8733), in right arm, on 07Nov2021 at 13:00 as dose 3 (booster), single (Lot number: FG3527), in right arm and on 29Apr2022 at 13:00 as dose 4 (booster), single (Lot number: FM9992) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Ciprofloxacin, reaction(s): "known allergies: Ciprofloxacin"; Amoxicillin, reaction(s): "known allergies: Amoxicillin"; Naproxen, reaction(s): "known allergies: Naproxen". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I never completely tested negative after my last dose. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information expected.
an episode of shingles; Initial information was received on 24-Jan-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case is linked to cases 2023SA031061 and 2023SA029739 (CLUSTER).  This case involves a 61 years old female patient who experienced an episode of shingles while receiving vaccine MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI].  The patient's past medical treatment included ACYCLOVIR with takes acyclovir daily prophylactically. The patient's past vaccination(s) included MMR in NOV-2022 and MENACTRA with on a 5 year cycle. The patient's past medical history and family history were not provided. At the time of the event, the patient had ongoing Asplenia with since JUN2012 and Diabetes mellitus with has had DM for two years.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 20V (CRM197) (PREVNAR 20) for Immunisation.  On 19-Jan-2023, the patient received total, 0.5 ml of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE (lot U7459AE and expiry 03-Nov-24) ) (formulation and strength: unknown) via intramuscular route in unknown administration site for immunization.  On an unknown date the patient developed a non-serious an episode of shingles (herpes zoster) (unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE.  Action taken with MENINGOCOCCAL VACCINE (MENQUADFI) was not applicable.  It was not reported if the patient received a corrective treatment for the event (an episode of shingles).  At time of reporting, the outcome was Unknown for the event an episode of shingles.
Started with headache around 3pm the day after the vaccine administration. Took Advil around 4pm, with no relief. Nausea started shorty after eating dinner at 6pm. Around 7pm, went to bed and started getting chills and felt feverish (did not have thermometer to record temp). Napped for 3 hours and felt better after. Next morning, feeling milder headache.
Patient received DTap, Hib, PCV, IPV, Hep B.  Had fever to 103F and macular rash on face.  Had co-existing bronchiolitis, which may also explain rash and fever.
Injection site soreness; A spontaneous report, was received from a  consumer concerning a female patient, , who was administered Moderna's COVID-19 vaccine (mRNA-1273) and experienced injection site soreness.  The patient's medical history and concomitant history was not provided by the reporter , no lab data was reported .    on  22 FEB 2021 the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in left arm for prophylaxis of COVID-19 infection.  On 22 FEB 2021, the patient experienced  injection site soreness. the outcome of the events was unknown.   The treatment history was not provided.  The Action taken with the first dose of mRNA-1273 in response to the event was not reported.  The  outcome of the events were considered as unknown.
Both MMR and Varicella were given subcutaneously with a 25g 5/8" syringe in the abdomen. The MMR was given in the right subcutaneous abdomen with a 25g 5/8" syringe. The Varicella was given in the left subcutaneous abdomen with a 25g 5/8" syringe. No adverse reactions were reported or observed.
Received shot and now have agonizing breakouts/ suspected vaccination failure; Agonizing breakouts of shingles; Agonizing; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Received shot and now have agonizing breakouts/ suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Agonizing breakouts) and pain (Verbatim: Agonizing). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 25-MAR-2023 This case was reported by a patient friend via interactive digital media. The reporter reported that the patient never had shingles before received shingles vaccine. The reporter stated that the patient now have agonizing breakouts of shingles. The reporter stated that probably there was nothing to pay attention to here. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. This case had been linked with US2023AMR059716 by same reporter for different patient.; Sender's Comments:  US-GSK-US2023AMR059716:Same reporter
24 hours after injection patient developed hives to bilateral legs, arms, and trunk, followed 24 hours later by facial flushing and swelling WITHOUT effecting the airway.
Developed weakness, chills, shaking rigors, shortness of breath, lower abdominal cramping, headache and low grade fever about one hour after receiving pneumococcal vaccination.  The patient also developed induration and swelling at the injection site by day 2.  The patient was admitted to the hospital about 6 hours after vaccine was administered at patient's clinic.  He was placed on telemetry and treated with IV hydration, and ice packs to injection site.  Phosphorus was also replaced by IV.  Patient improved by day 2 and was released from hospital. 9/15/08-records received for DOS 9/2-9/3/08-DC DX: Pneumococcal vaccine adverse reaction, both local and systemic. Left upper arm induration and swelling secondary to Pneumovax. Transient thrombocytopenia, resolved. Admitted through ED with C/O low grade fever, chills, rigors and generalized weakness 1 hour after receiving vaccines.
2 days after receiving the 1st dose,  I woke up with palpitations. I noticed also that I've been burping too much and have frequent indigestion as if the good stays in my chest area or my upper stomach area. Not comfortable. 5 days after I felt weird so I checked my BP and it's high which goes up to 180's/98.  I don't have headaches nor chest pain.  When I told my husband he told me our BP machine is broken.  So I just diverted my attention to something else. 2 weeks after at around 12:30pm-1:30 pm I was working that time at the hospital, I felt my left eye felt weird so I ask my co worker to look in my eye. I had a bloodshot. My charge nurse told me to check my BP and it was 158/85. I called my doctor and spoke to the office clerk. I went to eat lunch and at around 3:30-4pm, I rechecked my BP it was around 173/95. I called my doctor and was prescribed with clonidine. My husband picked up from pharmacy and I took it.
edema in my right foot; broke out in these water blisters on foot; This is a spontaneous report received from a contactable consumer. This 66-year-old-female consumer (patient) reported that she received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 26Feb2021 (Batch/Lot Number: EN6201) as SINGLE DOSE for covid-19 immunisation.  The medical history and concomitant medications were not reported. Historical vaccine included the first does of BNT162B2 on 06Feb2021 (66-year-old) (Batch/Lot Number: EL1264) for covid-19 immunisation. Patient didn't have any side-effects immediately for about 2 weeks later after it she felt having some edema in her right foot only and broke out in these water blisters on foot on 14Mar2021 with outcome of unknown, and she wondered if anything was connected with vaccine.  No follow-up attempts are needed. No further information is expected.
Patient developed redness and itching at the injection site which had spread down to her elbow by 11/25/2014.  Patient was encouraged to take Zyrtec for the redness and itching and to followup with her doctor if the problem spreads further.
Dizziness, Headache, Myalgia, Fever, CoughWheeze,
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Information regarding drug reactions or allergies and medical history was not reported. On 20-JAN-2015 the patient was administered with PNEUMOVAX 23 (route, dose, anatomical location, lot# were not reported) that had expired on 18-JAN-2015. Concomitant therapies were not reported. No adverse events were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
GAVE VACCINATION WITH EXPIRATION OF 11/01/2023 ON 11/17/2023. CALLED MERCK AND SPOKE TO STAFF AND WAS INFORMED IN HOUSE DAT SHOWS EFFICACY/POTENCY IS INTACT AND VACCINE IS VALID. ANY SIDE EFFECTS WOULD BE SIMILAR TO THAT OF SIMILAR VALID VACCINE. SPOKE TO PATIENT AND LET HER KNOW.
Became faint immediately following J&J covid vaccination. Extreme diaphoresis. Taken to quiet treatment room by wheelchair. pulse ox 96, pulse 72, given food and water as well as put into supine position, monitored x 20 min. Left ambulatory and dizziness and diaphoresis abated.
Fully vaccinated by 1/19/2021, COVID (+) end of Aug 2021, dx'd w/ "long covid" including increased difficulty breathing, chronic sob by Jan 2022 could no longer work as a nurse due to breathing difficulty. Around mid April need for suppO2 increased, then developed fever, severe chills, severe fatigue, severe body aches, severe headache, nausea/diarrhea and went to hosp, admitted from ED. Given remdesivir, decadron steroid, nebulizer txs, and cont suppO2.
This spontaneous report as received from a physician via a field representative refers to a female patient of unknown age. About 3 or 4 months ago, approximately in June 2013 the patient was vaccinated with a dose of ZOSTAVAX (dose, frequency, lot# and route unknown). There was no pertinent medical history. The patient after getting ZOSTAVAX developed a hard, painful nodule at site of injections about 3 or 4 months ago, approximately in June 2013. This reaction occurred "right after" vaccination and lasted "about" 2 days. No lab diagnostic studies were performed. The patient didn't seek medical attention. The patient was recovered from the event at the time of reporting. Additional information has been requested.
itching on legs, back, arm, and back of neck; feeling tired; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching on legs, back, arm, and back of neck), FATIGUE (feeling tired), CHILLS (chills) and HEADACHE (headache) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concomitant products included CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), ACETYLSALICYLIC ACID (ASPIRIN 81) and LEVOTHYROXINE for an unknown indication.    On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced PRURITUS (itching on legs, back, arm, and back of neck), FATIGUE (feeling tired), CHILLS (chills) and HEADACHE (headache). At the time of the report, PRURITUS (itching on legs, back, arm, and back of neck), FATIGUE (feeling tired), CHILLS (chills) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   Reporter did not allow further contact
Fully vaccinated with Moderna, last dose being 02/03/2021 provided at Hospital. Positive COVID Rapid collected on 08/13/2021.
Metallic taste and smell after second dose; Metallic taste and smell after second dose; This is a spontaneous report from a contactable consumer (Pfizer colleague). A 17-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: ER8730) via an unspecified route of administration in left arm on 26Mar2021 at 09:30 (age at vaccination 17-year-old), single dose for covid-19 immunisation. The patient's relevant medical history included vasovagal syncope and Covid-19. The patient did not have any known allergies. The patient's concomitant medications included ethinylestradiol, norethisterone acetate (JUNEL). The patient previously took first dose of BNT62B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EN6203) on 05Mar2021 at 12:00 via an unspecified route of administration in left arm at single dose for covid-19 immunization. Prior to vaccination patient was diagnosed with Covid-19. Patient did not receive any other vaccines within 4 weeks prior to covid vaccine. Since the vaccination, the patient had not been tested for COVID-19. Reporter stated that patient texted her that, on 26Mar2021 at 09:30, after getting her second dose, she had metallic taste (tasted metal in her mouth) and smell. Patient did not receive any treatment for the adverse event. The outcome of event was recovering at the time of reporting.  No Follow-up attempts are needed. No further information is expected.
Diagnosed with new onset Diabetes Mellitus, Type I (December 11, 2005).
Child ran a fever at night of 103 F, 11 days after vaccine administered.  Fever resolved with Ibuprofen and child was fine.  Then, 14 days after vaccination the child awoke in the morning with a red, raised rash on trunk, mouth and tongue.  He presented to the Health Dept. yesterday (04/25/07) afebrile, irritable and active.  Appetite good, taking fluids.
PATIENT EXPERIENCED SYMPTOMS OF FEELING "HOT/WARM", NAUSEOUS, LIGHTHEADEDNESS, AND HEADACHE WITHIN 1 MINUTE OF ADMINISTRATION OF THEVACCINE. SHE CONTINUED TO FEEL THESE SYMPTOMS BUT SAT DOWN FOR 10 MINUTES. AFTER 15 MINUTES PATIENT BEGAN FEELING BETTER AND LEFT.
Welts around her eyes, mouth, and on her neck. Throat is swollen. Tongue numb, scalp is itchy, lips are numb and tingling - onset occurred 4 days after receiving the immunization. Still symptomatic as of Jan 28, 2013.
arm swelling, itching, hard knot, went to MD who treated for cellulitis,
8 year old patient rec'd Fluzone High Dose, no treatment necessary, no adverse reaction.
CHILD'S DATE OF BIRTH WRITTEN INCORRECTLY AND AGE WRITTEN AS 12 ON CONSENT SIGNED BY INDIVIDUAL IDENTIFYING AS MOTHER.  CHILD IDENTIFIED IN DATABASE WITH A BIRTH DATE WHICH MAKES CHILD TOO YOUNG FOR VACCINE IN 5/15/2021.
Patient came in for swelling and pain to left calf, he also had a nodule to the medial posterior aspect of the calf.  He reported the symptoms were since approx the 5/17/21. Pt said it possibly started sooner on the 15th. Pt came in  today 5/21/21 because he received an ultrasound at a clinic by referral from his pmd and was dx with a DVT to the left calf. His pmd then referred him to come to ER where I triaged him in the triage department. He mentioned that began feeling bad after the Moderna Shot he received on 4/28/2020 and stated the now he has this new problem that he never had in the past. Only hx was mild htn he said.
One day after receiving vaccine I could not raise my arm past 50%. This lasted for about two days, but am no longer having trouble raising my arm. Three days after receiving the vaccine, I started having axillary pain. I am still experiencing this pain.
significant side effects/things are coming up that I didn't have issues with in a long time; very sick; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (significant side effects/things are coming up that I didn't have issues with in a long time) and ILLNESS (very sick) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (significant side effects/things are coming up that I didn't have issues with in a long time) and ILLNESS (very sick). At the time of the report, ADVERSE EVENT (significant side effects/things are coming up that I didn't have issues with in a long time) and ILLNESS (very sick) outcome was unknown.            No concomitant medications were reported.  Treatment medications were not provided by the reporter.
Systemic: Weakness-Medium, Additional Details: Patient states that he felt weak a few minutes after the vaccination and wanted to lay down on the floor, which was the position I found him in. He claims he did not fall, or lose conciousness. He states that he did eat a light meal before coming to get the vaccine, but did not have any liquids. I offered him some water. I also took his blood pressure, which was 158/89. I offered to call an ambulance or have him taken to a local urgent care clinic, but he declined both offers.
Regular chills, fatigue, fever etc. from the first dose in Feb; Regular chills, fatigue, fever etc. from the first dose in Feb; Regular chills, fatigue, fever etc. from the first dose in Feb; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2 (BNT162B2), on 14Feb2021 as dose 1, single (Lot number: WN6201) at the age of 45 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: CHILLS (non-serious), FATIGUE (non-serious), PYREXIA (non-serious) all with onset Feb2021, outcome "recovered with sequelae" and all described as "Regular chills, fatigue, fever etc. from the first dose in Feb". The event "regular chills, fatigue, fever etc. from the first dose in feb" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of chills, fatigue, pyrexia.  Additional information: The patient not had other vaccine in four weeks. No other medications in two weeks. The patient not had COVID prior vaccination. The patient tested for COVID post vaccination. The patient had no known allergies.
Flu symptoms consisting of body aches, chills, and fever up to 101.4. Malaise for 3-4 days. Fever stopped three days after the vaccine and pt reports taking ibuprofen/acetaminophen with fever resolution.
Temperature of 101.0 for about a day.  My child was inconsolable for 6 hours after the vaccination. He cried the entire 6 hours nonstop. At birth he was given the same vaccine without my knowledge and as a result had a high fever and was given IV antibiotics. My son now has an Autism spectrum disorder.
Onset of redness at site and slight fever (99.5) on 12/14. On 12/15 he has a linear raised lesion 1/2x1cm, with a triangular 6cmx6cm area of redness, warm to touch. Family reports this has decreased since yesterday. Patient sent in by school nurse.
I started feeling bad in my body. This morning when I was come home and go to bed to sleep, I had a fever.  I do not know which Covid vaccine I received.  Today when I go to work, I am going to go to the ER.
shaking, muscle spasms, eyeball spasms, fatigue, tightness in thigh and arms, come and go rash on back of arm, headache, fuzzy-headed, ringing in ears that sometimes sounds like an ambulance siren, had menstrual cycle 1 week after shot and haven't had one in two years. intermittent chills, cold and sweat at same time, takes longer to find words, brain seems slower - something I've been doing for years I have to look up because I can't remember.  severe shakes from waist up I think it's called convulsions but only once so far, chest tight and shallow breathing, forgetfulness
I started having hives last night. It started on my scalp and then spread to my torso.
A nurse reported that a 3 month old male received Prevnar, Comvax, IPV and DTAP vaccines on 2/2/01. That day, he developed an injection site reaction on the left leg characterized by swelling, redness and tenderness. He experienced extreme fussiness, screaming and crying when any part of his left leg was touched. Prevnar and Comvax were both injected into the left leg. He was treated with ibuprofen. He recovered.