chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 09-JUN-2016, the patient was vaccinated with an improperly stored dose of VARIVAX injection (lot# L045953; dose, route of administration and expiry date were not reported). There were no concomitant therapies reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Itchy rash; Hives; This is a spontaneous report from a non-contactable consumer, the patient. A 68-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Mar2021 at 16:45 (at the age of 68-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received ranitidine hydrochloride (ZANTAC) for unknown indication from an unknown date and experienced drug allergy. On 06Mar2021 at 07:00, the patient experienced itchy rash/hives which was coming and going on arms, legs, hands, around the neck, under the arms and down her side which worsened after her second shot. The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the events itchy rash/hives which included treatment with prednisone (MANUFACTURER UNKNOWN). The clinical outcome of the events itchy rash/hives was not resolved at the time of the report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Woke up on 3/23 with a sore left arm. Upon further examination my upper left arm was swollen with a circular red rash. The center of the rash had fever, was more swollen, and a slightly darker shade of red. My arm was sore and the area began to itch. This lasted approx. 2 days and slowly faded. My arm still itches in this area but there is no visible reaction remaining.  I took ibuprofen for the soreness and used Benadryl for the rash.
Patient received first dose of Rotateq at 6 months (vaccine 8/2/2023). Merck notified for alternative vaccine schedule recommendations. No harm noted.
Dizziness; having trouble staying focused; not thinking clearly; Muscle pain; body aches; Headache; She was really sick; This is a spontaneous report from a contactable consumer. This 50-year-old female Consumer reported.  A 50-year-old female patient received second dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: EL9269, Expiration date: 31May2021), via intramuscular, administered in right arm on 05Feb2021 (at the age of 50-year-old) as dose 2, single for COVID-19 immunization. Patient received first dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: EL3249, Expiration date: unknown), via unspecified route, administered on 13Jan2021 (at the age of 50-year-old) as dose 1, single for COVID-19 immunization. The patient medical history includes seasonal allergies and concomitant medications were not reported. Patient historical vaccine include flu shot in Oct2020 and patient experienced Pain in extremity. on 07Feb2021, after the vaccination, the patient experienced body aches worse than the activities she did would cause and patient said that she also had a headache. She attributed the headache to the weather change at first, but she does not know, she said that she has seasonal allergies, but this headache is different because it is a dull headache in her whole head, instead of in her sinuses. On 08Feb2021 patient experienced muscle pain and feels like she has done crunches. On 09feb2021 She also reported that she was very dizzy and almost fell over a couple of times. She said that the dizziness started in the morning. She could barely function with it. She was sick and dizzy at about 11:00-12:00. She must watch what she is doing so she does not fall. It is persisting but comes and goes. She was having trouble staying focused because of this. She said that she is not a dizzy person and does not have high blood pressure and is not on any medications. Patient explained she is little confused because of this and she is not thinking clearly. Patient was asking to do anything and worried about vertigo recurrence. The outcome of the events was not recovered at the time of this report.  No follow-up attempts possible. No further information expected.
first dose of SHINGRIX on 01/20/2023 should they get the second dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (On 20th January 2023, received first dose).   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: first dose of SHINGRIX on 01/20/2023 should they get the second dose).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt date: 28-AUG-2023 Reporter wanted to remain anonymous. The reporter was an employee that works at the physician office and asked a question for a patient. Reporter also would not give any information about the patient for whom she asked the Shingrix question. Reporter asked if patient received the first dose of Shingrix should they get the second dose if it was past the recommended schedule. Response was provided as Individual medical guidance for patients should be provided by medical professionals and was not something GSK provides to patients. The FDA approved dosing schedule for Shingrix was the first dose at month 0, followed by a second dose 2-6 months after the first dose. The CDC had provided guidance that if it had been more than 6 months since a patient received the first dose, they should get the second dose as soon as possible; patients did not need to restart the vaccine series however, the efficacy of alternative dosing regimens had not been evaluated. Data regarding the safety of alternative regimens where limited individuals might remain at risk for herpes zoster during a longer than recommended interval between doses 1 and 2, they advised that patients consult with their healthcare provider about this guidance and their individual situation. VAERS details were reported for 1st dose of Shingrix. The follow-up could not be possible as the as no contact details were available. Till the time of reporting, the patient had not received the 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination.
pt recv vax 22NOV96 & exp stomach cramps up to 5hr post vax;w/in 24hr pt exp lethargy, dizziness, nausea, & vomited once;pt cont w/sx of weakness & fatigue to bedtime;next day exp nausea & weakness;no tx given;sx subsided by 25NOV96;
fever of 100.4 [unit unspecified]; Sensitive Skin (all over); pain/tenderness at injection site; generalized aches and pains; This is a spontaneous report from a non-contactable consumer (patient). An adult male patient received his second dose of bnt162b2 (BNT162B2 reported as COVID-19 VACCINE; lot number: EL9264; expiration date: unknown), via an unspecified route of administration right arm on 02Feb2021 at a single dose for covid-19 immunization. The patient medical history was none. The patient has no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications were not reported. The patient received his first dose of bnt162b2 (BNT162B2 reported as COVID-19 VACCINE; unknown lot number and expiration date), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. On 02Feb2021 05:00 PM, the patient experienced fever of 100.4 [unit unspecified], sensitive skin (all over), pain/tenderness at injection site, and generalized aches and pains. He reported that the symptoms cleared up by the following morning (today). It was unknown if the patient received treatment for the adverse event. The events were considered as non-serious. The patient has not been tested for COVID-19 since the vaccination. The outcome of the events was recovered on 03Feb2021.  No follow-up attempts are possible. No further information is expected.
Got second dose 6/4, started normal period 6/5. Period keep going for 3.5 weeks, today it finally shows sign of slowing down and stop.
This case was reported by a consumer via call center representative and described the occurrence of whooping cough in a female patient who received dTpa vaccine. On an unknown date, the patient received dTpa vaccine at an unknown dose. On an unknown date, 61 days after receiving dTpa vaccine, the patient experienced whooping cough (serious criteria GSK medically significant). On an unknown date, the outcome of the whooping cough was unknown. It was unknown if the reporter considered the whooping cough to be related to dTpa vaccine. Additional details were provided as follow: The patient had a whooping cough inoculation many years ago and contracted whooping cough 2 months later.
Shingles; This is a spontaneous report from a Pfizer-sponsored Program Pfizer from a Contactable consumer (patient). A patient of unspecified age and gender received second dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The medical history and concomitant medications of the patient were not reported. the patient previously received first dose of BNT162B2 (solution for injection) on an unspecified date as single dose for COVID-19 immunisation. The patient reported that the chest and back covering case of Shingles received after the second dose of the Covid Vaccine on an unspecified date. No doubt scaring patient for life. If patient knew that this was Even a Possibility, patient Never would have gotten their vaccine. Patient telling everyone to Avoid their Poison injections. The outcome of the events was reported as unknown.  Information about Lot/Batch number has been requested.
The Patient is a 34 year old male. Primary smallpox vaccine adminstered 3/7/2003 with reported normal take/reaction/recovery. 4/11/03 He received PPD and Typhoid VI. Approx 4/15/03 he c/o rash to legs/waist with diagnosis of folliculitis. His rash continued to spread, f/u tx w Dr. Diagnosed him with dermatitis. Referred to Dermatology with presc for creams, wraps and skin care instructins, Rx Atarax.  His itch persisted worse at night.  By Oct 2003 the rash was in both palms L>R.  Rash was dried, scaly, flaky, located to palms, knees. By 2006 he was diagnosed with ECZEMA.  He was referred to Vaccine Healthcare Center for report  filing and questions if SMPX vaccine gave him eczema/folliculitis° No systemic symptoms  o  General overall feeling  °  Feeling fine  °  No lethargy °  No fever °  No chills °  No recent weight changeo  Chronic dryness of the skin o  Localized to both hands anterior L>R knee o  With cracking o  Pruritus localized to area of exposure o  Of the ears had in the past but it's gone now o  Skin cracking to palms of both hands and dry scaley skin to anterior knee. Have some periodically under left axilla but not active now°  No cardiovascular symptoms  °  No pulmonary symptoms  °  No gastrointestinal symptoms  °  No endocrine symptoms  °  No musculoskeletal symptoms  °  No psychological symptoms
Headache within the first 2 hours of 1st dose given. The headache lasted the first 12 hours. Also, feeling a little achy all over my body, as well as a slightly sore arm day of vaccine. Day 2, a red welt appeared (the size of a quarter) next to injection site. Arm became even more intensely sore the second day.
This case was reported by a pharmacist via call center representative and described the occurrence of chills in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced chills, fever, feeling bad, diarrhea, tiredness, lethargy and nausea. On an unknown date, the outcome of the chills, fever, feeling bad, diarrhea, tiredness and lethargy were unchanged and the outcome of the nausea was unknown. It was unknown if the reporter considered the chills, fever, feeling bad, diarrhea, tiredness, lethargy and nausea to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per product indication. The pharmacist reported that she had some patients presented with the reported events but she did not know how many or have other information. This case was linked with US2018145480, reported by the same reporter.
Fine flesh colored papules on upper neck and trunk/back began within hours of receiving vaccine. Not urticarial. Could also be consistent with viral exanthem.
It was reported that a 44 year old female pt was bitten by a dog in 1998. The pt began the Imovax Rabies series on 2/4/98 with dose #1; #2, 3 and 4 were given on 2/6/98, 2/11/98 and 2/18/98. Five days, after dose 3 (2/16/98), the pt developed "paralysis" of the face and was hospitalized. Pt still has damage to optical cortex of left eye, "stroke-like" effects of left side of face (drooping), her sense of smell and taste have been affected. Dx'd by neurologist as Bell's Palsy. The pt did not receive dose #5. From follow-up received on 08/22/2001 it was reported, "On 02/19/1998, the physician advised to take dose #4. After this is when the symptoms worsened and the pt ended up in the hospital. Pt became sensitive to light and noise, experience dhorendous pain and sinuses collapsed on left side of face. Also experienced numbness in extremities and later loss of feeling when intimate. The day pt came home of hospital would be in for her shot. This in itself, was 4.5 hours after the designated time for shot-March 1998-two weeks after 02/19/2001. We are in litigation."
Difficulty breathing, dizziness,confusion,rash.Was given Benadryl and liquids by IV.
Patient given 0.5 mL dose of Hepatitis A pediatric vaccine at approximately 10:00 AM. In 15 minutes, patient report feeling light-headed and weak. In another 15 minutes, nurse at facility reported nausea and vomiting.
9 hr post vaccine: mild congestion, fatigue, low grade fever 13 hr post vaccine:  shaking chills, 102 F fever, severe nausea, piercing headache, fatigue---severe symptoms persisted for 17 hours, then lessened, increased resting heart rate 20 hr post vaccine residual nausea and fatigue
Since receiving his second dose of COVID-19 vaccine (Pfizer) on Sunday 2/21 he has had fever (tmax 103.0 F), headache, and stomach ache. His fever started on 2/21 and had persisted through 2/24.  He woke up from a nap on 2/24 in the afternoon at 1600 had onset of severe chest pain. Then reoccurring multiple times throughout the evening.  He was taken to a local hospital and the transferred to another hospital for higher level of care. Pediatric cardiology was consulted and treatment was started for suspected atypical pericarditis with colchicine 0.6mg BID and ibuprofen 600mg QID w/ famotidine 40mg QDay. His chest pain resolved the day of admission, even prior to starting treatment. Patient was discharged in clinically stable condition to follow up with pediatric cardiology in 2 weeks as outpatient.
I had a hematoma in my left hand from the first vaccine that was the size of a large grape. My entire hand swelled up and bruised. It went away after 3 weeks. After the second vaccine, it came back within 2 hours and my hand swelled up more than the first time. I also had tingling in the veins in my hand and up my arm. It went away after 3 days.
This spontaneous report as received from a medical assistant refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 17-JUN-2016, the patient was vaccinated with an improperly stored dose of M-M-R II injection, lot # M001200 (dose, expiration date, route and site of administration were not reported). This is one of several reports received from the same reporter. Additional information has been requested.
Swelling in other armpit; substantial pain in lymph node under arm on same side; Small lump below injection site; Small lump below injection site + severe swelling; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling in other armpit) in a 42-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8057459) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    No Medical History information was reported.   On 06-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form and dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. On 07-Nov-2023, the patient experienced SWELLING (Swelling in other armpit) (seriousness criterion life threatening), LYMPH NODE PAIN (substantial pain in lymph node under arm on same side), VACCINATION SITE MASS (Small lump below injection site) and VACCINATION SITE SWELLING (Small lump below injection site + severe swelling). At the time of the report, SWELLING (Swelling in other armpit) and LYMPH NODE PAIN (substantial pain in lymph node under arm on same side) had not resolved and VACCINATION SITE MASS (Small lump below injection site) and VACCINATION SITE SWELLING (Small lump below injection site + severe swelling) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant medication was not reported. The patient had covid arm after vaccination for 2nd dose.   The patient received flu shot at same time in same arm during SPIKEVAX 2023-2024 vaccination. The patient developed small lump below injection site, severe swelling and substantial pain in lymph node under arm on same side. Swelling in other armpit was not as noticeable but present.  Treatment medication was not reported.   This case was linked to MOD-2021-138597 (Patient Link).
Vaccine for a one year old child was administered before their due date. RN misread child's age before administering the vaccines.
I received the shot in my right arm  at about 10:15 AM and was told to wait 15 minutes in my car in case of side effects.   After 15 minutes I had none so I left headed home. About 15 minutes into the drive I felt a tightness at first on the left side of my neck which then moved up into my cheek muscle and lip.   My face (left side) felt similar to having received a shot from a dentist but not as numb.  I then began to feel a sensation of numbness in the upper part of my left arm traveling down to my left palm.  The feeling in my arm felt as if I had been punched,  The feeling down the arm to the palm a numb feeling with a slight tingling like the development of pins and needles in my palm.   I got home about 11:00 AM 45 minutes after having received the vaccine and at that point the symptoms were beginning to dissipate..  At the time I am submitting this (12:23 PM) I only have a slight numb feeling in my upper arm.  Everything else is good. The site of the injection in my right arm is fine and I experienced no effects as of this point.
After being fully vaccinated I contracted the COVID virus with in two months. My symptoms was fatigue, nausea, shortness of breathe, and light headedness.
Scared to receive the 2nd vaccine; Shortness of breath; Projectile vomiting; Uncontrollable chills; Headache; Fever of 101.5; Nauseas; Tired; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), FEELING ABNORMAL (Scared to receive the 2nd vaccine), DYSPNOEA (Shortness of breath), VOMITING PROJECTILE (Projectile vomiting) and CHILLS (Uncontrollable chills) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.      Medical history was not provided.     On 19-Apr-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 20-Apr-2021, the patient experienced FEELING ABNORMAL (Scared to receive the 2nd vaccine), DYSPNOEA (Shortness of breath), VOMITING PROJECTILE (Projectile vomiting), CHILLS (Uncontrollable chills), HEADACHE (Headache), PYREXIA (Fever of 101.5), NAUSEA (Nauseas) and FATIGUE (Tired). The patient was treated with TYLENOL at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm), FEELING ABNORMAL (Scared to receive the 2nd vaccine), DYSPNOEA (Shortness of breath), VOMITING PROJECTILE (Projectile vomiting), CHILLS (Uncontrollable chills), HEADACHE (Headache), PYREXIA (Fever of 101.5), NAUSEA (Nauseas) and FATIGUE (Tired) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  Patient stated he is "all good now". AEs have resolved and patient denied any lingering effect, nor does he have anything else to report.   This case was linked to MOD-2021-276204 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: TCR doc: Significant info updated
Since my 2nd shot, I have been having hives on my chest, neck and face.; This is a spontaneous report from a contactable reporter (consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 30Jan2021 at 10:00 (Lot number: EL9265) at the age of 54 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Food allergy" (unspecified if ongoing), notes: Known allergies: Wheat, Yeast. Concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: EL1283; Route of administration: unspecified; Anatomical location: left arm, Administration time: 09:30), administration date: 09Jan2021, when the patient was 53 years old, for COVID-19 immunisation.  The following information was reported: URTICARIA (non-serious) with onset 22Feb2021, outcome "not recovered", described as "Since my 2nd shot, I have been having hives on my chest, neck and face". The event "Since my 2nd shot, I have been having hives on my chest, neck and face." was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient also received bnt162b2 (BNT162B2), administered in left arm, administration date 29Oct2021 at 08:00 (Lot number: FF2590) at the age of 54 years as dose 3 (booster), single for COVID-19 immunisation.