chrisvoncsefalvay/vaers-outcomes huggingface dataset:
did not receive his second dose within the recommended time frame of 2 to 6 months; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: did not receive his second dose within the recommended time frame of 2 to 6 months). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 19-MAY-2023 Due to pandemic conditions, the patient did not receive his second dose of Shingrix within the recommended time frame of 2 to 6 months (late dose). The reporter consented to follow up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
pt had vax 27AUG97 & pt had chickenpox outbreak 30AP98;
after administering vaccines mom came and got me and left leg  where Pediarix given, was red and inflamed.
Chest pain; Shortness of breath; Exhausted; Struggle to function; This case was reported by a pharmacist via other manufacturer and described the occurrence of chest pain in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included TOZINAMERAN (COVID-19 VACCINE PFIZER) (batch number GH9703, expiry date unknown) for prophylaxis.   Concurrent medical conditions included heart disease, unspecified and allergy.   On 27th September 2022, the patient received the 1st dose of Shingrix and the 1st dose of COVID-19 VACCINE PFIZER (intramuscular). On 28th September 2022, 1 days after receiving Shingrix, the patient experienced chest pain (serious criteria hospitalization), shortness of breath (serious criteria hospitalization), exhaustion (serious criteria hospitalization) and feeling bad (serious criteria hospitalization). On an unknown date, the outcome of the chest pain, shortness of breath, exhaustion and feeling bad were recovered/resolved.   It was unknown if the reporter considered the chest pain, shortness of breath, exhaustion and feeling bad to be related to Shingrix.     Additional Information: receipt date: 05-OCT-2022 Reporters comment: The patient receives did not received any vaccines within 4 weeks prior to the COVID vaccine. The patient received Pfizer Covid 19 vaccine on 27th September 2022, 11:30 AM in right arm and received shingrix in right arm on same day. 1 day after Covid-19 vaccine, the patient ended up in the hospital with Chest pain,shortness of breath, exhausted, and struggle to function on 28 September 2022 at 01:45. It was unknown if the reporter considered the chest pain, shortness of breath, exhaustion and feeling bad to be related to Covid-19 vaccine.    The reporter had given permission to contact for follow up.
The shot was administered in the top of my shoulder and hit some sort of nerve that caused an intense pain sensation and a tingling down my arm.  The pain was like when you are at the Dentist and they hit a nerve.  It was so intense it made me feel sick to my stomach. Now my arm is very sore.  I feel that the shot was given too high?  It was way up near the top of my shoulder and I have never had a shot hurt like that in my entire life.
Site: Itching at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: swelling and itching at hands-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Patient called from home to report swelling and itching in both hands, nothing currently reported at site of injection, computer would not let me submit without choosing 1 from that category.  Pt was directed to take benadryl and to call primary physician.  The symptoms happened after patient left the store after her 15 minutes of monitoring.
Fever onset 6/5/21.  Vaginal Ulcer onset 6/6/21. 1st Pfizer dose received 5/14/21. 2nd Pfizer dose received 6/4/21.
Pt recv vax on 4/16/99; on 4/17/99 pt exp erythema/ edema/ papular rash at vax site
Site of injection site was a welt with fever around the area, my arm felt like jello for 2 days, I felt like someone had hit me as hard as they possibly could. (Redness and welt was 2 inches around injection site, hot to the touch) The night after my shot, I started getting a deep pain in my right arm pit, I could not lift my arm much at this point, it felt like a burning charlie horse that would not go away. The next morning I woke up with swelling under my armpit, that went to my breast and wrapped around to my back, with what felt like golf ball sized knots in my armpit. 3 days later and the swelling is starting to go down. I have felt very fatigued with the slightest of activity, and noticed that I get light headed and out of breath a lot easier. My whole body aches.  I have had a slight headache since the injection, but just overall just don't feel very good.
Booster shots were administered to myself and my wife (also 66 Y.o.) by a Pharmacy Technician NOT the Pharmacist (no option offered).  Almost positive we were given more than 1 cc (in a 3 cc syringe)  Did not know it was supposed to be .25 cc until I looked it up at home. Neither my spouse nor myself had ANY reactions to MODERNA injections #1 or #2. I notified the pharmacy (online) of our experiences/reactions) - no response was proffered. REACTIONS:   -  Fever > 101F x 6 hours ((measured oral and topical)   -  Extreme malise x 2 days   -  Anorexia x 2 days   -  Extreme chills to the point of chattering teeth x several hours   -  Headache x 2 & 3 days
At 2:05 AM, vaccines administered. Approximately 2 minutes later, pat complained of feeling dizzy. Stabilized pt to avoid fall. Pt then went limp, had vagal response. Called for hep from co-worker. Gave water and cool compress. Stayed with pt and family until felt better.
Prolonged Diarrhea Issues; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Prolonged Diarrhea Issues) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-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 DIARRHOEA (Prolonged Diarrhea Issues). At the time of the report, DIARRHOEA (Prolonged Diarrhea Issues) outcome was unknown.            No concomitant medication were provided.  No treatment medication were provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Followup received on 12-MAY-2021 & the Prolonged Diarrhea event is updated On 30-Jun-2021: Non-significant follow up
fever as high as 103.4 w/in 10hr p/vax no other sx or physical exam findings, no local skin rxn;
Vax was administered to the left thigh. Thigh started to swell the next morning. Swelling progressed until pt was seen in clinic 2 days later on 02/25. Thigh swelling, tense 1/4 thigh area (anterior) . Pt was started today on OTC Benadryl and prednisone. FU info indicates severe swelling of left thigh - site of DTAP vax, no reaction or problem seen of right thigh - site of HIB vax.
Burning Mouth Syndrome: Hard palate and Tip of Tongue; This is a spontaneous report from non-contactable consumer (patient). A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EW0150) via an unspecified route of administration in right arm on 01Apr2021 at 13:30 (age at vaccination 72-year-old) at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to the vaccination patient did not receive any other vaccines within 4 weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been not been tested for COVID-19. On 07Apr2021, patient experienced burning mouth syndrome: hard palate and tip of tongue. Began 1 week after 1st vaccine dose and had not gone away. It was reported that device date was 07Jun2021. No treatment was given for the event. Outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
swelling at the arm where the vaccine was injected; joint pain (pelvis, knee and wrist); fatigue; high fever; muscles forming a lump; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 36 year-old male patient received bnt162b2 (BNT162B2), administration date 19Nov2021 09:00 (Batch/Lot number: unknown) at the age of 36 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), administration date: 03Mar2021, when the patient was 36 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 19Nov2021 09:00, outcome "unknown", described as "booster"; VACCINATION SITE SWELLING (non-serious) with onset 19Nov2021 21:00, outcome "recovered" (2021), described as "swelling at the arm where the vaccine was injected"; ARTHRALGIA (non-serious) with onset 19Nov2021 21:00, outcome "recovered" (2021), described as "joint pain (pelvis, knee and wrist)"; FATIGUE (non-serious) with onset 19Nov2021 21:00, outcome "recovered" (2021), described as "fatigue"; PYREXIA (non-serious) with onset 19Nov2021 21:00, outcome "recovered" (2021), described as "high fever"; MUSCLE MASS (non-serious) with onset 19Nov2021 21:00, outcome "recovered" (2021), described as "muscles forming a lump". It was unknown if therapeutic measures were taken as a result of vaccination site swelling, arthralgia, fatigue, pyrexia, muscle mass.  The lot number for bnt162b2 was not provided and will be requested during follow up.
c/o h/a, n/v, fainting p/lunch;sx persist;transported to hosp;4DEC98 returned to school;
presented to ED with c/o dyspnea, confusion, known bronchitis (on a Z pack), hypoxic; positive COVID -19 test; severe acute hypoxic respiratory failure; pt intubated; condition worsened where patient died in the hospital; hx of HTN, HL, NIDDM
Pt presents w/Dizziness & sweats, AOx4, VS@ 1025 BP 105/41, HR 60, RR 20 O2Sat 98%; VS @1035 BP 141/67, HR 59, RR 20, O2 sat 98%. Provider concerned about orthostatic hypotension, pt called friend to be taken to urgent care
Nausea; throwing up bile; no appetite; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received BNT162B2, via an unspecified route of administration on 13Jan2021 at single dose for COVID-19 immunization. Medical history included hypertension. No COVID prior vaccination. Concomitant medications included azilsartan kamedoxomil (EDARBI), troxipide (PRESTONE), and torsemide (TORSEMIDE). The patient previously took erythromycin and experienced drug allergy. Patient experienced nausea and throwing up bile, no appetite on 21Jan2021. No treatment received for these events. No COVID tested post vaccination. Outcome of the events was not resolved.  Information on the lot/batch number has been requested.
Woke to loud ringing in right ear and fullness and inability to hear out of right ear.  Saw primary physican, started steroiods, went to ENT continued steroids and had injections into ear.
This spontaneous report as received from an office manager refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot#L035510, expiration date: 13-MAY-2017); lot# L023866, expiration date: 24-MAR-2017; lot# L013193, expiration date: 20-JAN-2017 and lot# L010844, 16-NOV-2016) (dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports from the same reporter. Additional information has been requested.
Roughly a week after I received my 3rd Moderna shot (booster)  I started to get hives all over my body.  I had to go to the urgent care and receive a steroid and Benadryl injection to calm the hives and rashes.  I was then put on a Methylprednisolone 4mg Dosepak for 6 days to help relieve the pain and hives.  I continue to take a Zyrtec twice a day and Pepcid once a day to help.  it's roughly 10 days after I first developed the hives and it still has not gone away or gotten better.
pt recv vax 16OCT96 915AM & 10 min later began to exp runny nose, red eyes & itchy eyes;denied SOB or chest pain;VS 1128/68, 88, 20;950AM epi given & DPH;1005AM VS 118/80, 92, 20;parent notified & 911 called;redness, swelling, itching;
Mild metal taste in mouth approx. 1 minute after shot was administered; Soreness in left arm, around site injection started approximately 6 hours after administration; spread to about 3 inches outward around from site of injection; Migraine started around 24 hours after shot was administered, with pain concentrated behind right eye; Fatigue; ended up sleeping nearly 12 hours; This is a spontaneous report received from a non-contactable consumer or other non hcp. A 40-years-old non pregnancy female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EW0186), via an unspecified route of administration in Arm Left on 28May2021 15:00 (age at vaccination 40years old, No pregnancy at time of Vaccination) as single dose for covid-19 immunization. Medical history included lactose intolerance from an unknown date and unknown if ongoing. Prior to vaccination, the patient was diagnosed with covid-19. Concomitant medication(s) included Vitamin C, Vitamin D, Calcium Citrate, Iron taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination the patient was not diagnosed with covid-19.  The patient received other medications in two weeks. On 28May2021 21:00 the patient experienced mild metal taste in mouth approx. 1 minute after shot was administered; dissipated a few minutes afterward. Soreness in left arm, around site injection started approximately 6 hours after administration; spread to about 3 inches outward around from site of injection; no swelling. Migraine started around 24 hours after shot was administered, with pain concentrated behind right eye. Fatigue; ended up sleeping nearly 12 hours. After 42 hours, migraine has gone away; remaining symptom is soreness - now reduced to half the area and still concentrated around site injection area. Patient was not received treatment for the events. Since the vaccination, the patient has not been tested for covid-19. The clinical outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a healthcare worker concerning an unspecified number of patients of unknown age and gender. Pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown date, the unspecified patients were vaccinated with improperly stored doses of GARDASIL 9 (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). No adverse effects reported. Concomitant therapies were not reported. This is one of several reports received from the same reporter. Additional information has been requested.
51 year old female patient administered expired dose of Tenivac, no AE; Initial information received on 16-Nov-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 51 year old female patient who was vaccinated with an expired dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (expired product administered).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.  Patient did not received other vaccines.  On 06-Oct-2020, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (lot U6101AA and expiry date: 23-Oct-2020) via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency on same day).  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
vaccine-induced immune thrombotic thrombocytopenia (VITT) ~2w post J&J vaccine -admitted for left ICA occlusion (large stroke) and also had thrombocytopenia (platelet 73) -SRA (+) which confirmed VITT
I have a circular red blotch,  about three inches in diameter on my upper right arm that itches. The skin has pimples on it and I've had it for almost a week. I am putting cortisone cream on it to relieve the itching but so far it has done much to do so.
Information has been received from a physician concerning a 19 year old male who on an unspecified date was vaccinated with two doses of MMR II (LOT# not reported). On 08-NOV-2009 the patient experienced mumps. On 10-NOV-2009, the patient was diagnosed with mumps. The patient was afebrile and also experienced left parotitis and "lump under left ear". The blood work was done on 10-NOV-2009 and the results indicated IgM 0.47, IgG 5.51, and serum amylase 358. Follow up information has been received concerning a 19 year old (also reported as 4 year old) male who on an unspecified date was vaccinated with two doses of MMR II (LOT# not reported). On 07-DEC-2009 (previously reported as 08-NOV-2009) the patient experienced mumps. On 07-DEC-2009 the patient was afebrile and was diagnosed with mumps (previously reported as 10-NOV-2009). The patient experienced right parotitis. On 07-DEC-2009, lab results showed that IgM was <1:10 and IgG was 4.18. At the time of the report, the patient's outcome was unknown. No further information is available.
3 months after receiving vaccine, a generalized vaccinia reaction involving the upper extremities and bacl occurred.  His original smallpox vaccination site also became inflamed again.  One week prior to onset of the generalized vaccinia, patient got a tattoo on his back.
I developed shingles after the 2nd shot- burning nerve pain on my torso and slight rash
dizziness\gotten worse; vertigo\gotten worse; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness\gotten worse) and VERTIGO (vertigo\gotten worse) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizziness\gotten worse) and VERTIGO (vertigo\gotten worse). At the time of the report, DIZZINESS (dizziness\gotten worse) and VERTIGO (vertigo\gotten worse) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment was administered.   This case was linked to MOD-2021-100603 (Patient Link).
Headache, tiredness, nausea, body aches and pain on the hands fingers. Treatment: Acetaminophen and rest
pt recvd vax & 3 days post vax felt like skin is crawling; extended to scalp; no fever; referred to PMD;
hypotonic-hyporesponsive episode pt became lethargic almost 2hr p/inj w/diff to arouse;muscle tone was decreased;
patient had with Pfizer Booster; I was very cold and sick; I was very cold and sick; I have been very tried; Light-headed; I was "sore"; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified on Oct2021 as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) dose 1 via unspecified route of administration on Jan2021 (Batch/Lot number was not reported) as dose 1, single and dose 2 via unspecified route of administration on Feb2021 (Batch/Lot number was not reported) as dose 2, single, both for covid-19 immunization. On an unspecified date on Oct2021, the patient had with Pfizer Booster, reported that "I had a reaction in general, I was "sore" (further not clarified the word), I was very cold and sick. I had been very tried and Light-headed sometimes I had that since I had the shot, I just wanted to find out whether the reaction I had with Pfizer Booster (Covid-19 Vaccine) shot normal. I had my shot at noon time a week ago on Friday and I am just concerned. The outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
I did not have an adverse reaction to the vaccine. In 08/2022, I started having pain in my left side and that just got worse and worse. I went to my doctor, and I was referred to a gastroenterologist. I have had multiply test and they don't know what is going on. I was given a list of things I can eat and not eat. Also I am taking medication to help digest my foood.
Had Rota vaccine 10/12/06, vomiting x 2 at 10/16/06 night at home, office visit 10/17/06
reconstituted with sterile water; reconstituted with sterile water; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 2-year-old male patient who received Hib (Hiberix) (batch number 5EP3B, expiry date 7th January 2023) for prophylaxis.   On 11th November 2021, the patient received Hiberix. On an unknown date, unknown after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details provided were as follows: The age at vaccination was not reported. The patient received Hiberix reconstituted with sterile water instead of the diluent portion provided by GSK (GlaxoSmithKline), which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. Health care professional provided limited information about patient. The reporter did not consent to follow-up.