chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 9:38 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 9:38 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.      Concomitant product was not provided.  On 03-Apr-2021 Excursion time was reported at 09.00 am, with  temperature as 34 degrees Fahrenheit, total doses given for the day was 210, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 30-Mar-2021 , vial was moved to clinic on 03-Apr-2021. 20 vials were sent to clinic. Vaccine BUD date was 29-Apr-2021.  Vial was stored on cooler 1, on 03-Apr-2021, Excursion duration At 8 AM: 38, 9 AM: 34, 10 AM: 38, 11 AM: 42, 12 AM: 41, 1PM: 41, 2 PM : 41, 3 PM: 40, 4 PM: 40 and 5 PM : 41.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was 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.  Treatment medication was not reported.
Arm/ shoulder felt sore after shot, as normal for a few days. Never got better, and after a few weeks noticed even more painful to lift arm up - especially above head almost unbearable. All at home treatments, heat, whirlpool etc.
injection site reaction:  as of today:  5.5 cm red area around injection site.; injection site reaction:  as of today:  5.5 cm red area around injection site.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Apr2022 at 15:30 as dose 4 (booster), single (Lot number: FK9729) at the age of 56 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: PREMARIN; DIPHENHYDRAMINE; CETIRIZINE. Vaccination history included: Covid-19 vaccine (Dose: 1, Manufacturer unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose: 02, Manufacturer unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose: 03, Manufacturer unknown), for COVID-19 Immunization. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious) with onset 06Apr2022, outcome "not recovered", VACCINATION SITE REACTION (non-serious) with onset 06Apr2022, outcome "not recovered" and all described as "injection site reaction: as of today: 5.5 cm red area around injection site.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site erythema, vaccination site reaction.  Additional information: If other vaccine in four weeks reported as No. If covid prior vaccination reported as No. If covid tested post vaccination reported as Yes.  Follow-up attempts are completed. No further information is expected.
Information has been received form a Registered pharmacist concerning an 80 year old female with no  pertinent medical history and no drug reactions or allergies, who on 28-SEP-2007 was vaccinated with ZOSTAVAX (Oka/MERCK) (lot # not reported), via subcutaneously. The patient experienced an out break of shingles. The patient sought an unspecified medical attention. No further information is available at this time. Additional information has been requested.
The injection site is still red, welted; Itching; Injection site is welted.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (The injection site is still red, welted), VACCINATION SITE PRURITUS (Itching) and VACCINATION SITE URTICARIA (Injection site is welted.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (The injection site is still red, welted), VACCINATION SITE PRURITUS (Itching) and VACCINATION SITE URTICARIA (Injection site is welted.). At the time of the report, VACCINATION SITE ERYTHEMA (The injection site is still red, welted), VACCINATION SITE PRURITUS (Itching) and VACCINATION SITE URTICARIA (Injection site is welted.) outcome was unknown.
Pt recvd rubella vax & 10 days post vax devel sl fever, cervical adenitis & a generalized rash;
pneumonia; This is a spontaneous report from a contactable consumer. This consumer reported for a patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, (Lot number and expiry date not reported) via unspecified route of administration on unspecified date as SINGLE DOSE for COVID-19 immunization. Patient medical history and concomitant medications were not reported. After second dose of Covid vaccine, Patient was diagnosed with pneumonia 2 days later. Patient felt fine before vaccination and until day 2 second dose. The outcome of event was unknown.  Information on the lot/batch number has been requested.
15 x 11.5 cm area of redness, (L) upper arm, minimal induration limited to area of injection. No fever, otherwise well.
Had my 2nd shot feb 27 at 11:30am. Lot no. 002A21A. March 2-4 started to swell lump under size of a dollar coin maybe larger. Started to itch really bad. After the 4th each day swelling went down but today its a week later and now its smaller but still bruised.
sick for 3 days; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team.  A 54 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick for 3 days".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recv vax & exp uncontrollable shaking/crying w/o LOC post vax;also elevated temp tx w/motrin;
Dizziness; Abdominal pain; Nausea; Vomiting; Got really really sick, short fever; lymph nodes lit up; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), ABDOMINAL PAIN (Abdominal pain), NAUSEA (Nausea), VOMITING (Vomiting) and PYREXIA (Got really really sick, short fever) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 205A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy, Milk allergy, Food allergy (dairy), Gluten sensitivity and Autoimmune disorder. Concomitant products included FLUTICASONE PROPIONATE (FLOVENT), FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), AMLODIPINE and HYDROCHLOROTHIAZIDE for an unknown indication, ALBUTEROL [SALBUTAMOL].    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced DIZZINESS (Dizziness), ABDOMINAL PAIN (Abdominal pain), NAUSEA (Nausea), VOMITING (Vomiting), PYREXIA (Got really really sick, short fever) and LYMPHADENOPATHY (lymph nodes lit up). At the time of the report, DIZZINESS (Dizziness), ABDOMINAL PAIN (Abdominal pain), NAUSEA (Nausea), VOMITING (Vomiting), PYREXIA (Got really really sick, short fever) and LYMPHADENOPATHY (lymph nodes lit up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient had autoimmune disease told by her doctor. She denied to take second dose.  Patient treated with Antibiotic, pain medicines and nausea medicines
Full body arthritic flare up not experienced in over 2 years. Menstrual cycle disruption.
Saturday had pre-cold symptoms, headache, itchy eyes and face and scalp, later in day temp went below my normal and hive like red marks appeared on face and some of scalp, coughing, stuffiness, sneezing, tiredness.
Patient went for Covid vaccine 4/8/21 Clinic. Reports she noticed 3-4 cm swelling at injection site of left arm soon after. Also reports swelling under left eye. When she got home, she noticed the injection site was slightly purple. She reports she continues to feel mildly itchy 3/10 at the injection site today (4/14). patient email photo of arm on day of injection and 4/14 on 4/14, but provider did not observe sx described in person.
the problem is she has had a herpes like reaction.; She has had blisters all over her mouth and inside.; This is a spontaneous report from a contactable consumer patient herself via Pfizer-sponsored program.   A female patient of an unspecified age received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. Medical history and Concomitant medications were not reported. Patient was calling because she got her 1st shingles dose, then did the 1st dose of the Covid dose and her 2nd dose of the Covid vaccine was due 24Mar2021 and she also needs to get a 2nd dose of the shingles vaccine as well. However, the problem was she has had a herpes like reaction. She has had blisters all over her mouth and inside. She was worried about getting the 2nd dose and wants to know what we recommend. At the time of this report events outcome was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Shingles after chickenpox vaccination last week. Tx acyclovir 80mg tab and acyclovir 5% external ointment.
arm weakness; Sharp pain in the knee; Pain in the hips; headache; brain frog; Felt leg weakness; Felt fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LIMB DISCOMFORT (Felt leg weakness), MUSCULAR WEAKNESS (arm weakness), FEELING ABNORMAL (brain frog), HEADACHE (headache) and FATIGUE (Felt fatigue) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included AMLODIPINE BESILATE (NORVASC) and LABETALOL for Hypertension, ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced FATIGUE (Felt fatigue). On 04-Mar-2021, the patient experienced LIMB DISCOMFORT (Felt leg weakness) and FEELING ABNORMAL (brain frog). On 05-Mar-2021, the patient experienced HEADACHE (headache). On 08-Mar-2021, the patient experienced ARTHRALGIA (Pain in the hips). On 09-Mar-2021, the patient experienced ARTHRALGIA (Sharp pain in the knee). On 11-Mar-2021, the patient experienced MUSCULAR WEAKNESS (arm weakness). On 10-Mar-2021, ARTHRALGIA (Sharp pain in the knee) had resolved. At the time of the report, LIMB DISCOMFORT (Felt leg weakness), MUSCULAR WEAKNESS (arm weakness), FEELING ABNORMAL (brain frog), HEADACHE (headache), FATIGUE (Felt fatigue) and ARTHRALGIA (Pain in the hips) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: other OTHER.         Patient went to the Urgent Care . Urgent care gave her a Norvasc to bring the blood pressure down.
second dose began with 5 days of chills body ache, decreased appetite; second dose began with 5 days of chills body ache, decreased appetite; body ache; runny nose; persistent cough; This is a spontaneous report from a contactable other health care professional. A 71-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRna vaccine, solution for injection), dose 2 intramuscular, administered in Arm Left on 02Apr2021 14:00 (at the age of 71-Years-old) (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included hypothyroidism, arteriosclerosis, arthritis, migraine and ischemic brain disease. Concomitant medication included warfarin sodium (COUMADIN) taken for an unspecified indication, lamotrigine (LAMICTAL) taken for an unspecified indication, levothyroxine taken for an unspecified indication, omeprazole magnesium (PRILOSEC) taken for an unspecified indication, furosemide taken for an unspecified indication and atorvastatin calcium (ATORVASTIN) taken for an unspecified indication. Patient did not receive other vaccine in four weeks. Patient did not had covid prior to vaccination. Patient was not tested for covid-19 post vaccination. No known allergies were reported. The patient was not pregnant at the time of vaccination. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRna vaccine, solution for injection), dose 1 intramuscular, administered in Arm right on 12Mar2021 14:00 (at the age of 71-Years-old) (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation and experienced Fever, body ache, site of injection pain and mild nausea. On 02Apr2021 19:00, the patient after second dose began with 5 days of chills body ache, decreased appetite, runny nose, persistent cough. Therapeutic measures were not taken with respect to event. At the time of this report, the outcome of events chills body ache, decreased appetite was recovered with sequel on 07Apr2021 and other events recovered with sequel on an unknown date in 2021.  The lot number for the vaccine,(Pfizer/BioNTech COVID-19 vaccine), was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021391423 similar report from same reporter
No additional AE details; Nurse called to report temperature excursion and states that the vaccine was administered to patient during the excursion; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 18-DEC-2020, the patient was vaccinated with improperly stored Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) 2 milliliter orally, lot # 1684157 and expiration date 26-JUN-2021 administered as prophylaxis.  The improperly stored dose of the suspect vaccine experienced a temperature excursion of below 2 degree Celsius (°C) for 24 minutes on an unknown date of 2020; a previous temperature excursion was reported of below 2 °C (1.6°C) for 24 minutes.  The call was made due to a digital data logger. No adverse symptoms were reported.
patient reports she was okay for several hours after the shot, but then developed nausea, vomiting, back rash, swelling in hands and face and the feeling of something stuck in her throat
Pt was being observed in hospital for reactions per Dr orders due to Pt's history.  Pt reported "itchy" feeling at 9:50am. At 10:20am Pt reported generalized "itching provider notified at 10:34. 11:05am Pt received Benadryl at this time Pt had itchy watery eyes and generalized itching. 11:50 Pt sleepy but "itching better" dr notified and Pt returned to Assisted Living.
Vaccine leaked on the site of injection; Didn't receive full vaccine; A spontaneous report was received from a consumer concerning a  73-year-old, male patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced the vaccine leaked on the site of injection (vaccination site discharge) and didn't receive full dose of vaccine (underdose).  The patient's medical history was not reported.  The patient received their second of two planned doses of mRNA-1273 (Batch number: Batch number not provided) on 9 FEB 2021, intramuscularly for prophylaxis of COVID-19 infection.  On 09 FEB 2021, Patient reported the vaccine leaked on the site of injection and thinks didn't receive full dose of vaccine.  Action taken with the drug in response to the events was not applicable as the patient received both doses.  The outcome of the events, vaccine leaked on the side of injection and patient didn't receive a full dose, was resolved on 09 Feb 2021.; Reporter's Comments: This report refers to a case of underdose and vaccination site discharge for mRNA-1273.  There were no reported adverse events associated with this case.
Patient was given has second dose of Pfizer. He did not have any reactions with his first dose. He felt dizzy, nauseous and had a stomachache. He was also feeling hot and complained of feeling a tingling sensation in his fingers. This was a few minutes after the vaccine was given and he was sitting at the post-immunization area. We directed him to sit on the floor and gave him 2 cold packs to put on his neck. Patient looked pale and weak so we also gave him some cold water. After a few minutes of sitting, he asked for us to call 911. We called 911 and alerted management. After paramedics came, patient was taken away. Patient seemed to be doing fine as he was leaving. He regained color in his lips, but was still feeling the other symptoms.
Rash with severe itching to L upper arm that started approximately  6 days after receiving the vaccine.  I continue to have the rash and itching .  Today is 2/22.
I am a very healthy person, but after receiving my vaccine, I started to develop Acid Reflux and High Blood Pressure. I am now taking medication for the high blood pressure. I also experience pain and heat in my head. I'm experiencing numbness at the back of my head, a lot of dizziness, I'm short of breath and my ears are constantly ringing.
This case was reported by a healthcare professional (nurse) via a sales representative and described the occurrence of extensive swelling of vaccinated limb in a child of subject of unknown gender (kindergarten age) who was vaccinated with KINRIX (GlaxoSmithKline). On an unspecified date the subject received a dose of KINRIX (unknown route, unknown arm). At an unspecified time after vaccination with KINRIX, the subject experienced extensive swelling of vaccinated limb, welt injection site, injection site pain and injection site hot to touch. The nurse reported another case with adverse events after receiving KINRIX (A1022685A) and stated that this subject had "the exact same injection site reaction." The subject received the "kindergarten shot" of KINRIX and the subject's "arm swelled up where they got the injection." The subject had a "large welt around the size of 3 by 5 inch wide" (76.5 by 127 millimeters). The welts were swollen and painful to the subject. The nurse also stated that the "welt was hot to touch." At the time of reporting the outcome of the events were unspecified. The nurse reported another case with KINRIX. See case A1022685A for details on the other case. The nurse stated that the subjects in both cases were unrelated and the events happened about 1 week apart. No specific dates were provided. Follow-up information was received on 04 June 2013 via healthcare professional, who is also the subject's mother. She clarified that only one subject was involved and not two as previously reported. The subject received 0.5ml of KINRIX intramuscularly, vaccination date was not provided. The extensive swelling of vaccinated limb, welt injection site, injection site pain and injection site hot to touch started on 19 April 2013 and resolved on 25 April 2013. The subject has previously received PEDIARIX; this is the subject's first time receiving KINRIX. The reporting healthcare professional considered the events probably related to vaccination with KINRIX. The events were not considered serious.