chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ITCHY RED RASH OVER AND NEAR INJECTION SITE SINCE MAY 25 THROUGH PRESENT TIME
it was the arthritis/ it was the rheumatoid arthritis/additional swelling in her knees; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm on 12Mar2021 (Lot Number: EN6204, expiry date not reported) as single dose for COVID-19 immunization. Medical history included rheumatoid arthritis from Jan2021 and ongoing (Verbatim: Rheumatoid arthritis/She says she just got diagnosed with arthritis in Jan2021), ongoing chronic obstructive pulmonary disease, breast cancer female from 2006 to 2006 (Verbatim: Breast cancer survivor), and bone density abnormal from an unknown date and unknown if ongoing. Concomitant medications included methotrexate taken for rheumatoid arthritis from 06Feb2021 to an unspecified stop date; cortisone taken for an unspecified indication from 01Feb2021 to 01Feb2021; denosumab (PROLIA) taken for bone density abnormal from 16Mar2021 to an unspecified stop date; and cyanocobalamin (B12 [CYANOCOBALAMIN]) taken for an unspecified indication from 16Mar2021 to an unspecified stop date.  The patient experienced it was the arthritis/ it was the rheumatoid arthritis/swelling in her knees on 24Mar2021. The patient had a rheumatoid arthritis and after she took the first dose of the Pfizer-BioNTech COVID-19 Vaccine shot, about 12 days later she noticed additional swelling in her knees. She had preexisting condition of Rheumatoid arthritis prior to any Pfizer-BioNTech COVID-19 Vaccine. Prior to onset of this event, with her rheumatoid arthritis, she did not have any rheumatoid arthritis problems in her knees. With the rheumatoid arthritis, it has always been in her hands and arms. She was taking Methotrexate for Rheumatoid arthritis. Rheumatologist told her that additional swelling in her knees event was rheumatoid arthritis. She went to the Rheumatologist for the swelling in her knees and they told her it was the arthritis/rheumatoid arthritis. She had second dose of Pfizer-BioNTech COVID-19 Vaccine shot on 08Apr2021. On 11Apr2021 she noticed additional swelling around her waist. She asked if these swelling events are a side effect of the Pfizer-BioNTech COVID-19 Vaccine, or in combination with her rheumatoid arthritis. Clinical outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
No adverse event; who gave a child Moderna Bivalent Booster dose to an Adult male over 65; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (who gave a child Moderna Bivalent Booster dose to an Adult male over 65) and NO ADVERSE EVENT (No adverse event) in a 60-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-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 29-Mar-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (who gave a child Moderna Bivalent Booster dose to an Adult male over 65). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (who gave a child Moderna Bivalent Booster dose to an Adult male over 65) 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 assessment was provided for WRONG PRODUCT ADMINISTERED (who gave a child Moderna Bivalent Booster dose to an Adult male over 65).    No concomitant medication details was reported. No treatment medication details was reported.
no adverse effects reported; Product storage error; This spontaneous report was received from a nurse referring to a patient of unknown age and gender.  The patient's concurrent conditions, medical history and concomitant medications were not reported.  Since an unknown date, the following lot# of varicella virus vaccine live (Oka/Merck) (VARIVAX) were improperly stored between 15 degrees Fahrenheit and 46 degrees Fahrenheit (mainly at 39.7 degrees Fahrenheit) for 2 hours and 20 minutes. Lot# R034391 (expiration date: 27-NOV-2020), lot# S005082 (has been verified to be a valid lot number for varicella virus vaccine live (Oka/Merck), expiration date reported as 28-FEB-2021, but upon internal validation established as 19-FEB-2021) and lot# S000132 (expiration date: 02-JAN-2021). On 05-JUL-2019, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) (dose, frequency and route not reported) for prophylaxis. The nurse was not sure with which of the improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) lot numbers was administered to the patient. No previous temperature of excursion was reported. A digital data logger was involved. No adverse effects were reported.; Sender's Comments:  US-009507513-1907USA004327: US-009507513-1907USA004329: US-009507513-1907USA004242:
Tiredness; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 18Apr2021 at 15:15 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Apr2021 at 20:00, the patient experienced tiredness (fatigue). The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the reported event. The clinical outcome of the event tiredness was resolving at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Arm was sore all day Wednesday, woke up about midnight with arm hurting. Put BIOFREEZE on it. Did not look at arm till Thursday night - after her bath - had a 1-1 1/2 inch band that was red and warm to the touch below injection site. When came into health dept to have it looked at redness was gone.
8/4/04: face pale /cold lips, cyanotic and clammy, not sucking. Last PM at ER, diagnosed with cyanotic spells/ Reflux. 8/6/04: in our office. Child seemed fine. No redness or swelling.
Pt was in her usual state of health. Denied any past hx heart problems, works full time past medical hx sign for dm-2, obesity, htn and crohns disease. lifelong non smoker, no etoh use.  received her 2nd covid 19 vaccination on 3/24/2021 then began having progressive sob starting on 3/28/2021. presented to the emergency room on 4/11/2021 with sign sob. cxr showing b/l pulmonary edema. pt admitted to the hospital with new onset heart failure. She ultimately underwent an angiogram which showed minimal non obstructive coronary artery disease after echocardiogram showed severe global hypokinesia and ejection fraction of 15%. She was diagnosed with idiopathic non ischemic cardiomyopathy.  CT scan of the chest also showed new medistinal lymphadenopathy.
This case involves a 4 years old female patient who received the pentacel vaccine on 08apr2021 but did not use the proper diluent for the act-hib while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB(PRP/T) VACCINE [PENTACEL]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) for Prophylactic vaccination; and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Prophylactic vaccination. On 08-Apr-2021, the patient received a  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ382AA via intramuscular route in unknown administration site. On 08-APR-2021 the patient developed a non-serious received the pentacel vaccine on 08apr2021 but did not use the proper diluent for the act-hib (product preparation error) following the administration of DIPHTHERIA/TETANUS/ 5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. Action taken was not applicable. It was not reported if the patient received a corrective treatment for the event (received the PENTACEL vaccine on 08Apr2021 but did not use the proper diluent for the ACT-HIB). At time of reporting, the outcome was Unknown for the event received the pentacel vaccine on 08apr2021 but did not use the proper diluent for the act-hib. 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
I got COVID symptoms; Back Ache; Dizzy; Stomach Ache; sore arm; muscle aches; chills; head ache for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (I got COVID symptoms), BACK PAIN (Back Ache), DIZZINESS (Dizzy), ABDOMINAL PAIN UPPER (Stomach Ache) and PAIN IN EXTREMITY (sore arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Jan-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced SUSPECTED COVID-19 (I got COVID symptoms), BACK PAIN (Back Ache), DIZZINESS (Dizzy), ABDOMINAL PAIN UPPER (Stomach Ache), PAIN IN EXTREMITY (sore arm), MYALGIA (muscle aches), CHILLS (chills) and HEADACHE (head ache for 2 days). On 28-Jan-2021, SUSPECTED COVID-19 (I got COVID symptoms), BACK PAIN (Back Ache), DIZZINESS (Dizzy), ABDOMINAL PAIN UPPER (Stomach Ache), PAIN IN EXTREMITY (sore arm), MYALGIA (muscle aches), CHILLS (chills) and HEADACHE (head ache for 2 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment medications were provided
pt recvd vax & devel a chicken pox-like rash of 20 or more lesions;no further details were provide;
Slight reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Slight reaction) 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 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 VACCINATION COMPLICATION (Slight reaction). At the time of the report, VACCINATION COMPLICATION (Slight reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  The patient received first dose over an year ago with not serious reaction and did not get the seond dose due to event.  No treatment medication was reported.
Pt developed a welt the size of a golf ball, she went to dr when it became larger and they diagnosed her with cellulitis of the area and prescribed bactrim ds.
doses 50 days apart; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 14-May-2021 and was forwarded to Moderna on 14-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (doses 50 days apart) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 100 mcg. On 26-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (doses 50 days apart). On 26-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (doses 50 days apart) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication, treatment information provided.
Breakthrough case admission after 3 vaccines Pfizer 3/4/21 Lot# eN6205;  pFIZER 3/25/21 lOT# er8733;  pFIZER 10/16/21 lOT# ff2590
Vaccine was administered 2/1/2021 at approximately 9am.  Due to self reporting of allergic reaction (hives) to Augmentin, patient was monitored on site for 30 minutes.  After the monitoring period, she was cleared to go with no issues reported at the time.  We were later informed that the patient passed away from a pulmonary embolism on 2/12/2021.
within 2 hours of shot, my right arm hurt (possibly left- Not sure) and then immediately within an hour I started to feel like my head was shooting small bursts of pain. It felt similar to really bad flu. I asked nurse if I should have any questions and she said "your arm will hurt". I knew the arm pain was due to shot, I did not know where the other symptoms came from or why. From that day forward, my teeth became extremely sensitive to touch and eating food became a painful event. I did not call the doctor, because I had no idea this was related. On June 29th I went to urgent care as my tongue swelled up so bad I couldn't open my mouth except to swallow small amounts of food and water. The urgent care said to go to ER as this could be life threatening. ER said it was an infection of the salivary gland involving the lymph nodes. I was given a prescription for Keflex(?) and told to follow up with the doctor. I spent the next 10 days sick and in pain. I finally returned to work on July 8th. On August 10th I returned to Urgent Care and said I felt horrible. Everything from my neck up hurt and it kept moving around. The doctor said he had never seen this before and didn't know what to do. He gave me a prednisone shot and sent me home.   I finally made an appointment with my primary for August 30th. She referred me to an infectious disease specialist and to a neurologist. I am still waiting until November 27th to see the neurologist. I saw Dr on Tuesday, September 10th. I explained the symptoms again and what I had been through. He diagnosed me with Trigeminal Neuralgia Zoster. He also gave me a prescription for Valtrex. I took if for two weeks and my face swelled up under both lower right and left chins. He referred me to a pain management specialist and told me to stop taking the Valtrex.   I cannot seem to get into see anybody without waiting months and in the mean time I am in tremendous, actually horrific pain and I cannot take pain meds.  My body rejects them. I understand that Trigeminal Neuralgia has no cure. I got this because of the shingles shot, and absolutely no one listened to me when I mentioned when my personal hell started. But apparently, it is true... some people have extremely adverse reations to vaccines, and I am one of them. I feel as it I am on my own and basically with no help or resources. How dare they put out a product with no warning or testing.
swollen lymph nodes axilla of L arm started 1 week after vaccine, lasted 5 days Narrative:
My ears have been ringing ever since. I have never had issues with ear ringing or my hearing previously.
01/20/2023 Itching and burning started on left side of lower back. Pain and burning started from left lower back to left inner thigh and left side of stomach up to umbilical. After 4-5 days blister appear from back to left inner thigh with burning and severe. Contacted doctor.
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 64-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 22-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Dizziness, Headache, Sedation, Phlebitis, Rash & UrticariaPruritus  Narrative:
administered concomitantly Pediarix and Ipol; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 5-year-old male patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis and POLIOMYELITIS VACCINE (IPOL) (batch number BY247, expiry date unknown) for prophylaxis.   On 24th June 2022, the patient received Pediarix, Pediarix Pre-Filled Syringe Device and IPOL. On 24th June 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced overdose. On an unknown date, the outcome of the overdose was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-Jul-2022 Reporters comment: Licensed Practical Nurse called into inquire what to look for and how to proceed. LPN reported they inadvertently administered concomitantly a Pediarix and Ipol (non-GSK polio) to 5 year old patient. Licensed Practical Nurse stated the other health care professional who administered the doses did not know that the Pediarix contains the Polio. The reporter consented to follow up. No other details provided from Licensed Practical Nurse. Additional supportive information: This case was linked to case US2022107758, reported by same reporter.; Sender's Comments:  US-GSK-US2022107758:same report, other patient
Recd DPT @1000 30SEP91; was in good hlth; w/in 30 min p/vax fussy, cranky, & febrile; 7hrs p/vax had onset of generalized szs -> status epilepticus for approx 40 min duration;
Started with onset of fatigue and disorientation shortly after receiving the vaccine. Several hours after the disorientation got worse, a headache came on and my whole body aches fatigue is bad. I feel like the flu just hit me.
Red, hot, painful and hard at right deltoid, injection site. More painful in the morning and got better during the day with movement.
EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: 26-MAY-2021) dose was not reported, administered on 05-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 05-JUN-2021, the subject experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious.
Received PNEUMOVAX vaccine in left arm on 9/22/16 around 12pm. Started developing flu-like symptoms, fever, and the injection site in left arm became very hot, red, and swollen on the evening of 9/23/16. The injection site formed two pus-filled heads and may need to be lanced. The patient went to The Clinic and was prescribed cephalexin, prednisone, and benzonatate. Patient contacted and spoke with us on 9/29/16 and stated that she was doing better.
- Acid reflux - Hypertension - Sleep problems - Anxiety - Impotence - Vision problems - Blood pressure high - Infection- staphylococcal - Depression - Lesion - lungs - Cough - Respiratory problems - Diabetes - Skin infections.
flushing; redness; felt lightheaded and dizzy; the physician thinks it may have went into the vein instead of the muscle; This spontaneous report was received from a pharmacist and refers to a male patient of unknown age. His pertinent medical history included diabetes. His drug reactions or allergies and concomitant medications were not reported. On 03-MAR-2020, the patient was vaccinated with a third dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, lot number and expiration date were not reported) for "age and diabetes". It was stated that the patient had no adverse events with the previous two doses and that no additional vaccines were administered. On 03-MAR-2020, almost immediately after vaccination, the patient experienced flushing, redness, felt lightheaded and dizzy. Paramedics were called, however the patient was not taken to the hospital. The patient's symptoms resolved within 5 minutes without any treatment. The reporter stated that the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was intended to be administered by intramuscular injection but the physician thought that it might have accidentally went into the patient's vein. It was unknown if any lab diagnostics or studies were performed. The relatedness between the events and suspect therapy was not provided.
The last 4 nights since I received the 2ndPfizer vaccine. I have woken up early in the morning with weird sensations in my body. My leg muscles feel like they are moving, even though they are not. My heart feels like it's racing- but when I check my heart rate on my fitness watch- it is normal.
The patient did not experience any adverse event; pediatric patient got an adult dose ofVaqta/got 1 ml dose instead of 0.5 ml dose; This spontaneous report was received from a nurse and refers to a 12 year old male patient. No information was provided regarding the patient's medical history, concurrent conditions, previous drug reactions, allergies and concomitant medications.  On 19-AUG-2020, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) lot # S021449 expiration date 23-AUG-2020, at a dose of 1 mL (adult dose), instead of 0.5 mL dose, intramuscular in the left deltoid for hepatitis A immunization. The patient did not experience any adverse event.