chrisvoncsefalvay/vaers-outcomes huggingface dataset:
reconstitution was mix in the same syringe with the Pfizer covid vaccines; reconstitution was mix in the same syringe with the Pfizer covid vaccines; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate reconstitution technique in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included COVID 19 VACCINE PFIZER for prophylaxis.   On an unknown date, the patient received Shingrix and COVID 19 VACCINE PFIZER. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate reconstitution technique and underdose. On an unknown date, the outcome of the inappropriate reconstitution technique and underdose were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that Shingrix final reconstitution was mix in the same syringe with the Pfizer covid vaccines, which led to inappropriate reconstitution technique. It was stated that the pharmacist realized that, they leak 0.3ml of the vaccine and administrated to the patient, which led to underdose. No adverse event was reported. The reporter consented to follow up. No vaccination date provided.
mild headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): Moderna.  A male patient received BNT162b2 (BNT162B2), on 02May2022 as dose 4 (booster), single (Lot number: FK9894) for covid-19 immunisation. The patient's relevant medical history included: "Blood Pressure" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing); "Antidepressant" (unspecified if ongoing); "Digestion" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN taken for blood pressure abnormal; SIMVASTATIN taken for blood cholesterol abnormal; SERTRALINE taken for antidepressant therapy; OMEPRAZOLE taken for dyspepsia; VITAMIN D3. Vaccination history included: BNT162b2 (Dose Number: 1, Manufacturer: Pfizer, Lot number: EN6201), administration date: 10Feb2021, for Covid-19 Immunization, reaction(s): "mild headache"; BNT162b2 (Dose Number: 2, Manufacturer: Pfizer, Lot number: EN6198), administration date: 03Mar2021, for Covid-19 Immunization, reaction(s): "mild headache"; BNT162b2 (Dose Number: 3, Manufacturer: Pfizer, Lot number: EW0186), administration date: 12Oct2021, for Covid-19 Immunization, reaction(s): "mild headache". The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "mild headache".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201202012 same patient/event, different dose number;US-PFIZER INC-202201202013 same patient/event, different dose number;US-PFIZER INC-202201202011 same patient/event, different dose number;
Myalgia, Fever, burning eyes, left arm pain Narrative:  fever was 101F  Other Relevant History:
1 1/2 hrs after immunization (flu) c/o itching all over body. 11:30 am self-medicated - Benadryl 50 mg. Symptoms subsided.
The vial was initially stored in the refrigerator on 16-Jan-2023; No adverse event; Patient received expired Bivalent Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Bivalent Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 16-Jan-2023) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 065H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 05-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Bivalent Moderna COVID-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 16-Jan-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired Bivalent Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 16-Jan-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received expired Bivalent Moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 16-Jan-2023).    Concomitant medication was not provided.  Pharmacist reported that the dose administered after 30-day Use By Date. The vial was intact carton and size was 2.5 ml. The vial was initially stored in refrigerator on 16-Jan-2023 . The vial did not undergo any temperature excursion. Treatment information was not provided. This case contains information for the 5th patient out of 6 adult patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-717807, US-MODERNATX, INC.-MOD-2023-717810, US-MODERNATX, INC.-MOD-2023-717812, US-MODERNATX, INC.-MOD-2023-717808, US-MODERNATX, INC.-MOD-2023-717809 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-717807:Adult Patient  US-MODERNATX, INC.-MOD-2023-717810:Adult Patient  US-MODERNATX, INC.-MOD-2023-717812:Adult Patient  US-MODERNATX, INC.-MOD-2023-717808:Adult Patient  US-MODERNATX, INC.-MOD-2023-717809:Adult Patient
- LLE calf pain - chest discomofort - Ultrasound of left leg is pending
Fatigue,headache,gluten intolerance(migraine headache after eating bread),dizziness at least every other day.feeling of pressure buildup in neck,and ears when bending over or laying down.Shortness of breath. Difficulty remembering things and slurring of words.Difficulty verbally constructing sentences.
Tingling lips; mild difficulty swallowing for a short period of time; strange taste in mouth; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient (Non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: en6208), dose 1 via an unspecified route of administration, administered in Arm Left on 12Mar2021 at 12:45 (at the age of 49 years old) as a dose 1, single for covid-19 immunisation at Hospital. Medical history included Addison's disease. Concomitant medications in two weeks included cortisone, levothyroxine, fludrocortisone and vitamin, all were taken for an unspecified indication, start and stop date were not reported. Patient had no known allergies. No other vaccine was received in four weeks. Patient did not have Covid prior vaccination. On 12Mar2021 at 12:45, the patient experienced tingling lips, mild difficulty swallowing for a short period of time and strange taste in mouth. Patient did not receive any treatment for the events. He had not been tested for covid post vaccination and no covid post vaccination. Outcome of the events were recovered on unspecified date of 2021.  No follow-up attempts are possible. No further information is expected.
Rapid heart rate, blood pressure increase, hives on chest and neck, throat tightness, itching on injection sight, blood pressure drop. This started about 2-3 minutes after receiving the vaccine, I was taken to the back of an ambulance and treated with a shot (I believe it was Benadryl) and oxygen and then transported by ambulance to the local hospital. I was told to continue taking Benadryl and to see my regular doctor. On 02/08/2021 I went to my regular doctor and was put on a steroid (prednisone) and switched to 50mg of Zyrtec twice a day for itching on chest and throat and injection site as well as continued throat tightness.
Fever; The left side of my face was swollen; I had a uncontrolable bloody nose; This is a spontaneous report from a contactable consumer, the patient. A non-pregnant female patient of unknown age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 17Apr2021 at 09:45 as a single dose for COVID-19 immunisation. Medical history included fruit allergy to blueberries. Concomitant medications included zolpidem tartrate (AMBIEN) and amfetamine aspartate; amfetamine sulfate; dexamfetamine saccharate; dexamfetamine sulfate (ADDERALL) for an unknown indication from an unknown date. The patient previously took acetylsalicylic acid (ASPIRIN) for an unknown indication on an unknown date and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Apr2021 at 08:00, the patient experienced fever, the left side of the face was swollen, and had an uncontrollable bloody nose. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events (unspecified). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, the left side of her face was swollen and uncontrollable bloody nose were recovered on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Week later extreme lethargy, muscle soreness, injection site reaction, fatigue, joint stiffness and pain lasting several days and currently still present at time of this documentation
3MAY96 swelling rt arm 3cm x 1cm square;1cm induration-erythema & warm to touch;swelling lt arm 6cm x 5cm 1cm induration, erythematous & warm to touch;
After the injection about 15 minutes afterwards I was getting dizzy I was having trouble breathing. Was given a Benadryl. An ambulance was called. I do not remember being transferred to the hospital. I was given solu- Medrol (methylPREDNI solone succinate 125mg IV and 20 mg Pepcid IV for an allergic reaction to the vaccine. I was prescribed an EpiPen. I am still having side effects from the vaccine. Migraines, dizziness, hives, swollen lymph glands.
stomach cramps; hot and cold sensation; fatigue; felt "sick" with colds; fever; shivering; A spontaneous report was received from a consumer concerning a 58-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events felt sick with colds, fever, shivering, fatigue, hot and cold sensation, stomach cramps.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 5 Mar 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 040A71A) intramuscularly for prophylaxis of COVID-19 infection.  On 5 Mar 2021, the patient experienced the events, felt sick with colds, fever, shivering. On 6 Mar 2021, the patient experienced the events, fatigue. hot and cold sensation, stomach cramps.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events were not reported.   The outcome of event(s), felt sick with colds, fever, shivering, fatigue, hot and cold sensation, stomach cramps was unknown.
urticarial rash around neck; eyelids very puffy Epi & DPH given;
I experienced major fatigue, nasal congestion, fever, and headache. I had a cough that lasted about four weeks. I used my albuterol inhaler, DAYQUIL, NYQUIL, and nasal irrigation for treatment.
9:30 client reported feeling unwell, hands and arms cool and clammy,reporting pins and needles sensation in hands,paleness noted,BP143/88,P122,O2 99%Sat. 9:45 AM BP 131/84  P106,O2 99%, c/o overwhelming fatigue,not able to focus well but less clamminess of hands Resp.rate18 breaths per minute.10:15 AM  BP130/85 P90,O2 98%.Client  states she is starting to feel more focused and less numbness of hands.Client's allergist called -she recommend 50Mg of P.O. Bendryl. Bendryl given per MD orders at 10:30 AM. Client called husband to bring her home..11:00 AM BP 130/75 P 78,O2 98%. Client driking sips of water ,still fatigued but color better and able to focus.Sent home with husband driving at 11:15 AM.
NO ADVERSE EVENT OCCURED.  VACCINE ADMINSTERED PAST BEYOND USE DATE.
He reported that the vial label is confusing; No adverse event; Received Monovalent booster instead of Bivalent booster; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (Received Monovalent booster instead of Bivalent booster), PRODUCT LABEL CONFUSION (He reported that the vial label is confusing) and NO ADVERSE EVENT (No adverse event) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2022, the patient experienced INCORRECT DOSE ADMINISTERED (Received Monovalent booster instead of Bivalent booster). On an unknown date, the patient experienced PRODUCT LABEL CONFUSION (He reported that the vial label is confusing) and NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (Received Monovalent booster instead of Bivalent booster), PRODUCT LABEL CONFUSION (He reported that the vial label is confusing) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for INCORRECT DOSE ADMINISTERED (Received Monovalent booster instead of Bivalent booster) and PRODUCT LABEL CONFUSION (He reported that the vial label is confusing).    No concomitant medication was reported.  Reporter had a Dark Blue Cap and a label with purple border. On the vial label it stated, Booster dose only. Reporter stated that the vial label was confusing, so 5 adult Patients received Monovalent booster instead of Bivalent booster of Moderna COVID-19 vaccine.  No treatment information was provided.
11/1 Noted small red area left upper arm near vaccine site, warm and swollen slight tenderness. 11/2 AM Increased redness, warmth down left arm, approx. 4.5" long. Later in day still red, warm, approx. 4.25" irregularly shaped. 11/3 PM Redness less inflamed, fading, size unchanged but margin shifted downward. Slight tenderness injection site.
Child dvlped sore throat the afternoon of 1/13/00; w/i 4 hrs had dvlped extensive Henoch-Schonlein Purpura. Seen in ER & transferred to hosp. Tx w/ steroids.
Inadvertently received a 3rd dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 9th November 2018) and Shingrix (received 2nd dose on 6th February 2019).   On 6th November 2020, the patient received the 3rd dose of Shingrix. On 6th November 2020, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The age at vaccination was not reported but it could be 56 or 57 years. The patient inadvertently received a third dose of Shingrix, which led to extra dose administered. The lot number unavailable as the vaccines were not administered at the pharmacy. No email address available.
I was more tired than usual. About 2 days after receiving vaccination I had a sore arm. I felt yucky for a couple of days. My short term memory and fatigue has gotten worse. I am also having balance issues. My B12 is lower. In March, I fell again and broke my left wrist. I had just came out of surgery for a broken right wrist. I have been put on permanent disability.
This spontaneous report was received from a male patient of unknown age, regarding himself. Patient's concurrent condition included arthritis, HIV infection and herpes. On an unknown date, while trying to administer the GARDASIL 9 with a prefilled syringe, no needle was attached and the patient spilled the medicine on his right shoulder, hand and fingers. The patient had not yet started the therapy with GARDASIL 9. Concomitant therapies included ATRIPLA, valacyclovir hydrochloride, ACIDOPHILUS, gabapentin, naproxen, DEXILANT, propranolol hydrochloride (manufacturer unknown) and zolpidem tartrate (Manufacturer unknown). No adverse effects were reported. Additional information is not expected, no contact details were provided.
Headache, Myalgia, Fatigue, Chills Narrative:  Other Relevant History:
Patient reports today, 11-3-2019,  that his left arm near injection site is sore, firm, red, and it is "spreading" down the bicep.  The patient reports that on 11-2-2019 am he noticed a small lump at the injection site but was not bad, by the end of the day nearly 1700 on 11-2-2019 he noticed that the his left arm was swollen, firm, and warm to touch, not painful but sore. Upon examination the left upper arm is adematous,  red, firm, and warm to touch, the area extends from injection site, medially down the bicep, and stops at the antecubital area. Patient has full range of motion, no numbness, tingling, or severe pain, he reports mild tenderness. The rest of the arm is of normal skin tone for the patient and he denies any other symptoms.
First dose on 1-Jan-2021 and second dose on 19-Feb-2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 1-Jan-2021 and second dose on 19-Feb-2021) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Scoliosis, Neurological disorder NOS, Anemia, Dystonia, Allergy to chemicals, Allergy to antibiotic, Drug allergy (Allergy to most oral antifungals, muscle relaxant: Baclofen.) and Drug allergy (Baclofen muscle relaxant).   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Aug-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On 19-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 1-Jan-2021 and second dose on 19-Feb-2021). On 19-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 1-Jan-2021 and second dose on 19-Feb-2021) had resolved.            Patient stated that she has autoimmune disease but its not official diagnosis.   No concomitant medications were reported.  Treatment information was not provided.   This case was linked to MOD-2021-302183 (Patient Link).
About a week after the vaccine I developed a mild rash between my butt cheeks and treated  it with OTC ointment.  It persisted and got worse  and didn't go away so after about 2-3 weeks I saw my PCP who diagnosed it as a fungal rash.  He prescribed a Clotrimazole 1% ointment and a Nystop powder which did help a little but to date it is still there and I am still using the cream and powder provided.  I also developed chronic severe fatigue about a week after also, it has gotten a little better but it is still bad to date as well
knot at inject site still present. dtp administered at 6 month by another physician. child now 1yr 6mo and lesion of 2cm still present.
Red welts at injection site. Extreme pain, cannot lift arm.  Area is hot to touch.  UTI.
This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy for 3 days) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. No Medical History information was reported. On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced PRURITUS (itchy for 3 days). On 27-Feb-2021, PRURITUS (itchy for 3 days) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. No concomitant and treatment medications were reported.
This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns an 63 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 12-Sep-2016 the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Not reported. Batch number: WT53706. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 12-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage without adverse event). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursions identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. The patients will be contacted for revaccination.
On day 7 my shot arm was sore again, swollen and warm and on day 8 I have a red rash on that arm.
On 12th day after smallpox vaccination he had onset of urticarial macular rash on left shoulder, proximal left upper arm, right shoulder, back and upper chest.  Diagnosis: Erythema multi forms like rash.
Arm soreness for 1-2 days following injection. On Day 7 noticed a swollen lymph node in neck. Day 8 injection site was warm, red spotty rash on left shoulder and lymph node remained swollen.
Patient c/o itchy feet and face. Awoke the next day with swollen itchy face and aching arm.
Body ache; Strong headache; Weak arm; Dizziness; Feeling tired; Rashes on his legs; Blisters at the bottom of his feet; Always sleepy; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (reported for himself). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 11Mar2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Mar2021, the patient experienced body ache, strong headache, weak arm, dizziness, feeling tired, rashes on his legs, blisters at the bottom of his feet and always sleepy. The clinical course was as follows: The reporter would like to know if that is normal and if he will die soon or if he will live long. Reporter also wants to know if his wife and kids will be infected with the side effects that he is experiencing and if there is a compensation program. Dose 2 was scheduled on 06May2021. The outcome of the events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.