chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She woke up at 3:00AM and was really wheezy; Trouble catching breath; This spontaneous case was reported by a consumer and describes the occurrence of WHEEZING (She woke up at 3:00AM and was really wheezy) and DYSPNOEA (Trouble catching breath) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Aug-2021 at 5:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Aug-2021 at 3:00 AM, the patient experienced WHEEZING (She woke up at 3:00AM and was really wheezy) and DYSPNOEA (Trouble catching breath). On 30-Aug-2021, WHEEZING (She woke up at 3:00AM and was really wheezy) and DYSPNOEA (Trouble catching breath) had resolved.            No concomitant medications were mentioned. The events  cleared up completely in 15 to 20 minutes No treatment details were reported.   This case was linked to MOD-2021-304211 (Patient Link).
This spontaneous report was received from a registered nurse refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On unspecified dates, the patients were vaccinated with improperly stored GARDASIL (# lot K009482, expiry date 06-MAR-2017, dose, strength, dose number, vaccination site, route not provided). No adverse effect were reported. Product quality complain (PQC) was not involved. No further information was provided. Additional information has been requested.
Severe chills and shaking for 5 hours.  Did not take temperature.  After 23:00 had sweating all night.  Next day has about 1/3 energy, body aches, stuffy nose, sore throat.  On 11/04/2003 started taking Zinc tablets and Claritin 10mg daily as needed.  Started both in evening.  Did not contact doctor or hospital.  Told nurse on 11/06/2003.
The pt developed hives and redness over trunk, arms and legs. Treated with Benadryl and resolved.
patient did not advise he had already received a full 2 shot series of the Moderna COVID-19 vaccine on 2/5/21 and 3/5/21 and indicated he wanted a first dose Pfizer COVID Vaccine. No reaction noted. It was discovered after patient left clinic
blood pressure was as high as 155 (systolic); got up sluggish; nausea related to high BP; lightheaded; Low grade fever, his temperature went from 97.3 up to 99.2; Soreness in arm; This is a spontaneous report from a contactable consumer reporting for himself. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration on 06Mar2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced blood pressure was as high as 155 (unit not provided) (systolic), got up sluggish and, nausea related to high BP on 07Mar2021, low grade fever, his temperature went from 97.3 up to 99.2, soreness in arm, lightheaded on an unspecified date in Mar2021. It was reported that, patient received his first dose of Pfizer-Biontech Covid19 vaccine on Saturday 06Mar2021. His blood pressure (BP) was as high as 155 (systolic) on Sunday (07Mar2021). Patient asked that had it been reported that being vaccinated can increase your blood pressure. Other adverse events reported included nausea related to high BP which resolved after taking his blood pressure medications, sore arm that had since resolved, and a low-grade fever of 99-degree Fahrenheit. Took BP med and down to 146; 138/117 on the day of this report. Low grade fever as well. 99F- nauseated then took BP med and went down. Soreness in arm, kind of went away. Patient was unwilling to complete the report and lot number was not provided. It was reported that he was curious. He woke up the day before this report and his blood pressure was up to 155. Patient asked that could the vaccine cause the blood pressure to go up and just wanted to know if it was a possibility. It was 137 on 06Mar2021 before he got the vaccine. The day before this report he got up sluggish. The home monitor didn't monitor like the doctors. After taking his blood pressure medication it went down to 146 (systolic). In the morning of the day of this report, it was like 138/117 (unit not provided). He didn't write it down, but he thought that was what it as. He was really lightheaded the day before this report. His temperature went from 97.3 up to 99.2 and it was not bad. Patient stated he would have gone to his doctor this morning, but he wanted to see if it was possibly related. Therapeutic measures taken as the result of the event blood pressure was as high as 155 (systolic); BP medication (unspecified). Clinical outcome of events soreness in arm, nausea related to high BP was recovered on unspecified date in Mar2021, outcome of the events blood pressure was as high as 155 (systolic), and low-grade fever was recovering, and outcome of the event got up sluggish, lightheaded was unknown.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Swelling in fingers; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling in fingers) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Swelling in fingers). At the time of the report, PERIPHERAL SWELLING (Swelling in fingers) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No Concomitant medications were reported. No Treatment information was reported.
C/o fever, left arm redness, body ache, nauseas, vomiting, diarrhea, headache, lock jaw and swelling at injection site.
pt recv vax 24MAY96 & w/in 12hr p/vax pt was irritable;sx resolved p/4th day;no tx was given;
Cold symptoms; Sinus pressure; congestion; dizziness; headache; positive Rapid COVID test; positive Rapid COVID test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing); "hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 18Nov2021, outcome "unknown" and all described as "positive Rapid COVID test"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "Cold symptoms"; PARANASAL SINUS DISCOMFORT (non-serious), outcome "unknown", described as "Sinus pressure"; NASAL CONGESTION (non-serious), outcome "unknown", described as "congestion"; DIZZINESS (non-serious), outcome "unknown", described as "dizziness"; HEADACHE (non-serious), outcome "unknown", described as "headache". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (18Nov2021) positive. The patient was fully vaccinated with 3 Pfizer shots. The booster was given on 24Aug2021.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Extremely heavy period for several hours. I went through 14 super heavy pads. This has never happened before and I was terrified.
swollen upper and lower lips; horrendous itching; I broke out in large hives, (palm sized); had swollen earlobes; swollen palm on my right hand; This is a spontaneous report from a contactable consumer (patient). This 70-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6200, Expiry date: unknown) via an unspecified route of administration, administered in left arm on 18Feb2021, 12:00 pm at a single dose for covid-19 immunisation (age at vaccination was 70 years). The patient was not pregnant. Medical history included colon polyps and diverticulosis. Allergies to medications, food, or other products included premarin, ambien and many seasonal allergies. Co-suspect medication included amoxicillin sodium, clavulanate potassium (AUGMENTIN) for diverticulitis. Concomitant medication patient received within 2 weeks of vaccination included acebutolol hydrochloride (SECTRAL), allopurinol, rosuvastatin calcium (CRESTOR) and amitriptyline. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9262, Expiry date: unknown) via an unspecified route of administration, administered in left arm on 28Jan2021, 13:00 pm at a single dose for covid-19 immunisation (age at vaccination was 70 years). No other vaccine was received within 4 weeks prior to the COVID vaccine. On 18 Mar2021, 4 weeks after second vaccine, the patient took Augmentin for recurring diverticulitis. For the last few years, the patient has taken the Augmentin once or twice a year to treat the problem (alternative to the flagyl/cipro regimine) and she have never had any problems. This time, on the 3rd day of the Augmentin, the patient broke out in large hives, (palm sized) and had swollen earlobes and a swollen palm on her right hand. The next day on 19Mar2021 she had swollen upper and lower lips. The patient took lots of Benadryl and Zyrtec, and by the 5th day her hives and horrendous itching went away. The patient does not know if the vaccine played any role in this at all. She just thought she should report since prior to the vaccine she never had a problem with Augmentin. The patient had absolutely no reaction at all to the Pfizer Covid vaccine itself after either of the doses. No covid prior vaccination and no covid tested post vaccination was reported. The outcome of all the events was recovered on an unknown date in Mar2021.  No follow-up attempts are possible. No further information is expected.
chills; bad fatigue; vomiting and nausea; vomiting and nausea; This spontaneous case was reported by a nurse and describes the occurrence of CHILLS (chills), FATIGUE (bad fatigue), VOMITING (vomiting and nausea) and NAUSEA (vomiting and nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 CHILLS (chills), FATIGUE (bad fatigue), VOMITING (vomiting and nausea) and NAUSEA (vomiting and nausea). At the time of the report, CHILLS (chills), FATIGUE (bad fatigue), VOMITING (vomiting and nausea) and NAUSEA (vomiting and nausea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Localized swelling next day. Induration 45x25mm. 90x50 erythema. Follow up redness only.
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 70-year-old female patient who received SHINGRIX (batch number EK279, expiry date 31st March 2020). On 30th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In April 2018, 14 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovering/resolving. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on right arm. On 16th April 2018, the patient came to the pharmacy with a possible case of Shingles. The pharmacist was unsure if the patient developed shingles or another form of rash and she was advised to consult a physician.
patient passed away, due to what was being told as possible blood clot in lungs; This is a spontaneous report from a contactable consumer.  A 70-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06May2021 (Lot Number: ER8633) (at the age of 70-year-old) as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient did not experienced COVID-19 prior or post vaccination.  The patient passed away, due to what was being told as possible blood clot in lungs (on 07May2021). The event was serious (fatal) and required emergency room visit. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: blood clot in his lungs
Mom states 3 hrs p/vax 8JAN92; pt had a high pitched uncontrollable cry lasting 2 hrs in duration; mom contacted MD next day;
the headaches started as mild and occasionally,  approximately mid to late February the headaches have increased in  frequency and duration.   I have headaches everyday, and many times have to lay down so that it doesn't worsen.
14y 7 m/o M who reports recurrent intermittent hives since GARDASIL vac on 9/9/14. Clinically dermatographia - not previously noted in patient.
Pt developed 101.5F fever on 3/19/03 about 00:30 hours. Took 650mg Tylenol. Tossed and turned while sleeping. Awoke at 05:30 and temperature was 100.6F and felt tired, weary and decreased appetite. Fever persisted between 100.5F and 100.9F yesterday, despite Motrin 400mg. Developed full constant headache over eyes about 08:00 on 3/20/03. Temperature was 99.8F. Pt looks nontoxic but looks as if she doesn't feel well. Right axillary.
administered the liquid portion of the PENTACEL, but not the powder with no reported adverse event; Initial information received on 11-Jul-2023 regarding an unsolicited valid non-serious case received from Nurse.  This case involves a 15 months old male patient who was administered the liquid portion of the diphtheria/ tetanus/ 5 hybrid AC pertussis/ IPV (vero)/ HIB(PRP/T) vaccine [Pentacel (Vero)], but not the powder with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine conj 15V (CRM197) (Vaxneuvance) for Prophylactic vaccination.  On 11-Jul-2023, the patient received 0.5 mL dose 4 of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(vero)/HIB(PRP/T) vaccine, suspension for injection (batch number: UJ842AA; Expiry date: 22-Feb-2024) via intramuscular route in the left thigh for immunization, the liquid portion of the pentacel, but not the powder with no reported adverse event (product preparation error) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event administered the liquid portion of the pentacel, but not the powder with no reported adverse event.  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 the guidelines. 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.
This case was reported by a physician and described the occurrence of maculopapular rash in a 2-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Previous and/or concurrent vaccination included HIBERIX; GlaxoSmithKline; unknown; unknown given on 10 September 2010; PEDIARIX; GlaxoSmithKline; unknown; unknown given on 10 September 2010; PREVNAR; Wyeth labs; unknown; unknown given on 10 September 2010. On 10 September 2010 the subject received unspecified dose of ROTARIX (unknown). On 22 September 2010, 12 days after vaccination with ROTARIX, the subject experienced maculopapular rash and fussiness. At the time of reporting the events were unresolved.
Sore and achy with muscle weakness, lower respiratory congestion, cough, temperature over 100 degrees farenheit, nausea,  loss of appetite,  indigestion, diarrhea, headache, delirious, brain fog, bedridden 2 weeks. Treated at home with bed rest, ice packs, increased fluids, ventolin inhailer, and otc meds including tylenol, mucinex, and antacids. Discussed situation with medical professionals.
Welts on left hand, itching on lower left arm, sore left hand, left wrist pain. Symptoms have continued for 3 weeks since the injection.
Pt spiked a fever then had a febrile seizure about 6-8 hours after vaccines were given.
This spontaneous report was received from a nurse practitioner referring to an unspecified multiple patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M005714, expiration date on 03-OCT-2017 (strength, dose number, route and anatomical location were not provided). Concomitant therapies were not provided. No adverse events reported. Additional information has been requested.
Approximately 2 weeks after vaccination, vaccine site became pruritic, erythematous, and warm to touch. Pt also experienced subjective fever, nausea, vomiting
5-7min p/vax pt had dizziness, fell down & hit rt side of face w/mild contusion of face;became fully recovered in 40-60seconds p/putting lollipop in mouth;
Adverse event:  Next day after vaccine administration (August 20, 2021) patient experienced "dull pain" in area of heart . He describes the pain as an "ache".  On day 26 after receiving vaccine- he describes sensation of pressure in area of heart, hard to breathe and lightheadedness. He did not mention any treatment.
On the arm where the vaccine administered: soreness in arm and hand, initially. Proceeded to  tetanus  in fingers on that hand. Since 10/20, pain has spread from right arm up to right side of neck.
Rash on back itchy, especially on ABD. Trunk/Buttocks groups of vesicular/ papules/few tiny pustules on erythem. base.  Clinically - varicella (status post 2 immunization).
24 hours later had all the side effects and feels like my rectum is swollen, and ears are burning, belly is swollen, feels like I have the flu, I feel hot but don't have fever, and I started feeling better and it all came back at one week later, is this normal and will it pass.  Lymph nodes hurt from back of head down shoulders, constipation, voice different, smells are different, taste is different, and skin feels half numb.
Case number PHEH2014US005514 is an initial spontaneous report from a consumer received on 18 MAR 2014. This report refers to a 10-years-old female patient. Her medical history included allergy to food colors. Her concomitant medications were not reported. This patient under 18-years-of age was vaccinated with FLUCELVAX (batch number: not reported) on 06 JAN 2014. No adverse events were reported following the maladministration.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 18 MAR 2014. The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "adult product administered to child".
Excessive sleepiness, fever. Parents report they first noted fever at approx 2100, was 103.1 rectally; went to ER and there was 101.7 rectally no TYLENOL given prior to that visit; since the ER visit, no further fever whatsoever; nursed well while in ER; has continued to nurse well since then. Became sleepy yesterday during day; has continued to be sleepier than usual this AM-no prolonged wakeful periods although does wake up to nurse vigorously. Had forceful spitup at 1600 yesterday; had another at ER's brief series, no spitting  up this AM.
This spontaneous report was received from a registered medical assistant and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date in April 2016 (healthcare worker stated that vaccinations occurred between 01-APR-2016 and 07-APR-2016), the patients were vaccinated with RECOMBIVAX HB injection, lot # L033343, expiry date 13-SEP-2017 (dose, route of administration and administration site were not specified). Administered doses of RECOMBIVAX HB underwent temperature excursion at 50.5 Fahrenheit degrees for two hours and 42 minutes. There was no previous temperature excursion. No adverse effects were reported. This is one of several cases received from the same reporter. Additional information has been requested.
Pustules 4 on body 2 right underarm 1 arm 1 back (tiny red) occurred 14 days after administrated 1 vaccine.
doses administered after more than 1 temperature excursion; doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021 at 8:56 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 17-Feb-2021 at 8:56 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient age was reported age 70.22.  No concomitant medication was provided.  On 17-Feb-2021, Excursion time was 8 AM and 9 AM, temp was 20 and 22, total doses given for the day was 62, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 11-Feb-2021, vial was moved to clinic on 17-Feb-2021. Vaccine BUD date was 13-Mar-2021.  Vial was stored on cooler 2, on 17-Feb-2021, Excursion Temp at 8 AM: 20, 9 AM: 22, 10 AM: 37, 11 AM: 41, 12 PM: 42, 1 PM: 39, 2 PM: 40, 3 PM: 42, 4 PM: 41.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.    Vials only punctured right before administration.  No treatment medication was provided.   This case was linked to MOD-2022-566976 (Patient Link).