chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received 0.25ml of Bivalent booster instead of 0.5 ml; No Adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25ml of Bivalent booster instead of 0.5 ml) 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)) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25ml of Bivalent booster instead of 0.5 ml) and NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25ml of Bivalent booster instead of 0.5 ml) 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 ACCIDENTAL UNDERDOSE (Received 0.25ml of Bivalent booster instead of 0.5 ml).    No concomitant information was reported. It was reported that none of the patients were pregnant. Vaccination date was reported as 01-SEP-2022 to 26-OCT-2022. No treatment information was provided. This case is reported for 16th patient out of 20 patients.
2 days p/vax inj site red, sl indurated, warm to touch, painful pruritus 14x14cm area;
left arm sore; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration, administered in the left arm on 03Feb2021, at 08:50 (at the age of 69 years old) as dose 1, single for COVID-19 immunisation. Medical history included ongoing dust allergy, in which she had to use fluticasone propionate (FLONASE) sometimes; tobacco user, in which she stopped on an unknown date in 2003 (reported as 18 years ago); hepatitis C from an unknown date in 2001 (reported as 20 something years ago) and ongoing, where she had a Fibroscan of liver; some cirrhosis but not a lot; found out she had hepatitis C when she donated blood for the  at work; and pre-lesions of the vagina, where she had a colonoscopy, endoscopy, and laser surgery on an unknown date in Sep2020. She also had a recent Pap smear and everything was good, and she has had last 2 Pap smears were good. Concomitant medication included pneumococcal vaccine (PNEUMONIA BOOSTER SHOT) taken for immunisation on an unknown date in Feb2021 (reported as around 19Feb202, but also 15 days before the first Pfizer COVID-19 Vaccine). On 03Feb2021 in the evening, the patient reported left arm sore. The patient stated that the arm was still a little sore to the touch if she touched in certain areas, but not bad. The patient has not recovered from the event.  No follow-up attempts are possible. No further information is expected.
This case was reported by a healthcare professional and described the occurrence of high erythema in a child subject under the age of 6 years and of unspecified gender who was vaccinated with KINRIX, GalxoSmithKline. Concurrent vaccination included MMR vaccine (manufacturer unspecified) and VARIVAX (Merck) given in an unknown deltoid in January 2009. Concurrent vaccines were given on the same date as KINRIX. In January 2009, the subject received unspecified dose of KINRIX in an unknown thigh. In the evening following KINRIX injection, the subject developed thigh erythema (around the injection site), swelling at the injection site and skin warmth at the injection site. The events worsened the next day and resolved over the next couple of days. The Healthcare professional considered the events were possibly related to vaccination with KINRIX. These events occurred in three different subjects under the  age of 6 years. The children's parent's called to report the events and were told over the phone to treat the redness and swelling with compresses and TYLENOL. The subjects were not seen in the office. Linked cases include A0762587A and A0762589A. Follow-up information received on 27 January 2009 indicated that the subject was 5 year old male. KINRIX was administered to the subject intramuscularly at 0.5 ml in an unspecified date in January 2009. Concurrent MMR vaccine (subcutaneous, 0.5ml) and VARIVAX vaccine (subcutaneous, 0.5ml) were administered on the same date as KINRIX. The events occurred on 03 January 2009 and resolved three days later on 05 January 2009. In the reporter's opinion, the events were related to treatment with KINRIX.
within 5 minutes of getting the shot, I had tingling in my fingers and my arm and hand felt achy and numb. This did not happen after the first shot. I was in tears last night due to the pain. Have used lots of Advil and CBT ointment since getting the shot. Only on day two and I'm exhausted and I can't lift my arm without a great deal of pain. Hope it's gone by tomorrow as we finally are having nice weather! Not worth it. I'll never get another one.
This spontaneous report as received from a medical assistant refers to currently 15 year male patient. The reporter stated that on an unknown date, the patient was administered GARDASIL that was exposed to a temperature excursion (30 degrees Fahrenheit for 2 hours) (lot number and expiration date unknown), dose, route, anatomical location and dose number were not reported for an unknown indication. No adverse event was reported. At the time of the report, date administered, vaccine lot number and expiration date, any treatment received, or possible hospital stay were not available. This is one of several reports from the same source. Additional information has been requested.
I developed a red area on my right arm to the front side of where the Pfizer vaccine was administered.  The red area is about 2 inches in circumference, warm to the touch and itches.
Syringe defective, there was object larger than stopper at end of syringe inside prefilled syringe and it did not dissolve or disintegrate: no patient exposure; The initial case was missing the following minimum criteria: No adverse event. Upon receipt of follow-up information on 19Sep2022, this case now contains all required information to be considered valid.   This is a spontaneous report received from contactable reporter(s) (Other HCP and Nurse) from product quality group.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: FJ2606, Expiration Date: Jul2023) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE ISSUE (non-serious), outcome "unknown", described as "Syringe defective, there was object larger than stopper at end of syringe inside prefilled syringe and it did not dissolve or disintegrate: no patient exposure".  The reporter considered "syringe defective, there was object larger than stopper at end of syringe inside prefilled syringe and it did not dissolve or disintegrate: no patient exposure" associated to pneumococcal 20-val conj vac (dipht CRM197 protein).  Follow-up attempts are completed. No further information is expected.
Sore arm; Dull headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and HEADACHE (Dull headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 072Bor8L70A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic kidney disease stage 3 (Stage 3 Kidney Disease) and Diabetic. Concomitant products included METFORMIN, LISINOPRIL, SIMVASTATIN, ACETYLSALICYLIC ACID (ASPIRIN 81), UBIDECARENONE (COQ 10) and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and HEADACHE (Dull headache). At the time of the report, PAIN IN EXTREMITY (Sore arm) and HEADACHE (Dull headache) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medication included vitamin 400 IU once daily was noted. No treatment information was provided by the reporter. Second dose vaccine given on 21 Feb 2021 in left upper arm deltoid with lot number 012M20A was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-137848, US-MODERNATX, INC.-MOD-2021-137965 (E2B Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Follow-up information received on 17-JUN-2021 contains no newsignificant information. On 16-Jul-2021: Non Significant FU- Follow up included no new significant information. Patient declined further follow up.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-137848:Relative's case US-MODERNATX, INC.-MOD-2021-137965:
I did not have an adverse reaction to the vaccine. I tested positive for COVID-19 via a home test on 09/01/2022. I started having symptoms of a bad cold on 08/30/2022 that just got worse. I contacted my physician and PAXLOVID. I felt so much better after the second day and I took all the prescription. I did have a dry mouth for a couple of days after starting the PAXLOVID. I also had COVID-19 on 04/02/2022. At that time I also took PAXLOVID.
This spontaneous report as received from a consumer refers to unspecified family members whose children. On an unknown date the patients were vaccinated with M-M-R II, (strength, dose, lot# and indication were not provided). The patients had unspecified reaction to the M-M-R II vaccine. The outcome of event and action taken with M-M-R II were not provided. Additional information has been requested.
Exp URI sx on 17MAR92; cough, runny nose & eyes on 23MAR92 exp joint stiffness & swelling, muscle weakness & fatigue; has had intermittent fever ranging from 99.2-100;
There was a burning pain during vaccine injection dissimilar to any prior intramuscular injections (uncharacteristically painful).  Following the 16:30 vaccine administration, patient's entire left arm and shoulder grew increasingly sore and tight.  By about 20:00 the soreness was throughout the arm.   By 21:30 the pain was significant, and throbbing.  Patient self administered 1.5 mg oxycodone (left over from dental surgery) and 1000mg acetaminophen around midnight (12/2/2020) and took another 1.5 mg oxycodone every 3 hours, alternating 600 mg ibuprofen and 650 mg acetaminophen each time.  Throbbing pain was severe even with arm/shoulder immobilized.  Patient could never get shoulder to sit comfortably.  Every position felt like shoulder was trying to dislocate.  Finally throbbing pain subsided (after 5 or 6 mg oxycodone) and according to his Fitbit, patient first fell asleep at 07:10 on 12/2/2020.  Upon waking, lower arm was sore but mobile, but shoulder mobility was limited to around 20-30 degrees in any direction with much pain.  By afternoon, shoulder had loosened up enough to raise arm over the head (slowly, over 2 minutes).  Immobility presented the next morning.  Upon this writing on 12/11/2020, patient continues to feel joint pain and the feeling of inflammation or possible bursitis in the joint.  Soreness extends to the elbow.  There was soreness and difficulty positioning the arm while sleeping.  Symptoms persist daily.
Strong arm pains 48 hours after the shot , in the opposite arm of the COVID-19 vaccine (in that arm had a shingles vaccination a month before); This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Strong arm pains 48 hours after the shot , in the opposite arm of the COVID-19 vaccine (in that arm had a shingles vaccination a month before)) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced PAIN IN EXTREMITY (Strong arm pains 48 hours after the shot , in the opposite arm of the COVID-19 vaccine (in that arm had a shingles vaccination a month before)) (seriousness criterion medically significant). At the time of the report, PAIN IN EXTREMITY (Strong arm pains 48 hours after the shot , in the opposite arm of the COVID-19 vaccine (in that arm had a shingles vaccination a month before)) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication administered included shingles injection. Treatment information included paracetamol (Tylenol).  Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.
Tested positive for Covid 19 on 09May2022; Tested positive for Covid 19 on 09May2022; Fever; Body ache; Runny nose; Cough; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Lot number: EL3248), in left arm, on 31Mar2021 as dose 2, single (Lot number: 3248), in left arm and on 15Dec2021 as dose 3 (booster), single (Lot number: FD7218), in right arm, all intramuscular for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN (non-serious) with onset 09May2022, outcome "not recovered", described as "Body ache"; COUGH (non-serious) with onset 09May2022, outcome "not recovered"; PYREXIA (non-serious) with onset 09May2022, outcome "not recovered", described as "Fever"; RHINORRHOEA (non-serious) with onset 09May2022, outcome "not recovered", described as "Runny nose"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 09May2022, outcome "not recovered" and all described as "Tested positive for Covid 19 on 09May2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19, pyrexia, pain, rhinorrhoea, cough.  Clinical information:No other vaccine in four weeks.No other medications in two weeks. AE were treated with acetaminophen. No covid prior vaccination and no known allergies.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and the suspect drug BNT162B2.
Information has been received from a physician via a company representative referring to a female patient who was 50 or 60 years old. Information about concurrent conditions, medical history and concomitant medication was not provided. On an unspecified date in 2015 (reported as sometime last year) the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX (strength, dose#, lot# and route unknown, frequency was reported as once). Five days later (unknown date in 2015) the patient broke out with shingles. Lab diagnostics studies were not performed. The outcome of the event was unknown. Additional information has been requested.
Headache, Sedation, Myalgia, Arthralgia, Fever, Pain and swelling at the injection site Narrative:
Face swollen on both sides.  So bad on right side entire eye swollen shut almost completely.
Narrative: COVID infection following COVID vaccine series 02/18, Pfizer, dose #1 03/11, Pfizer, dose #2 06/11 COVID swab, result: not detected 06/11 CXR Impression: No acute cardiopulmonary abnormality. 08/11 COVID swab, result: detected 08/11 pt cc: cough, fatigue, headache, myalgias, rhinorrhea, nasal congestion exposure: unknown 08/12-08/17 pt symptoms continue
Mother called 6/14/01 and reported: evening of 5/31/01 noted rash/hive-like area on face, legs, arms, back over next 2-3 days the condition spread. Afebrile non itchy. Child was not hot and not acting sick, but hive like areas although better continue to be on back, arms, legs, especially when hot. Saw PMD 6/5 continues with hives.
EMPLOYEE GRADUALLY COMPLAINED OF FATIGUE, MILD CONFUSION AND RINGING IN HER EARS.
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 18-NOV-2011, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 29-SEP-2014, the patient was treated at a medical facility for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Rash on torso and face.  Swelling in tongue and back of mouth.   Headache.
Pt recvd 1st dose of hep B vax & later exp a h/a which progressed to "migraine" state.
tremor started on her head, with no motion from left to right; she felt cranky; extreme swelling of the lymph nodes on her right arm and armpit after the injection; This spontaneous case was reported by a consumer and describes the occurrence of HEAD TITUBATION (tremor started on her head, with no motion from left to right), FEELING ABNORMAL (she felt cranky) and LYMPHADENOPATHY (extreme swelling of the lymph nodes on her right arm and armpit after the injection) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016J21-2A) for COVID-19 vaccination.  The patient's past medical history included Cancer (There was no recent change in status (such as improvement or worsening)) from 2016 to 2017. Previously administered products included for Drug use for unknown indication: chicken pox vaccine (The patient received chicken pox vaccine around both first 2 doses of COVID-19 vaccine). Past adverse reactions to the above products included No adverse event with chicken pox vaccine. Concurrent medical conditions included Neck discomfort (Start date: 25 years ago and there was no recent change in status (such as improvement or worsening)), Arthritis (Start date: 15 years ago and there was no recent change in status (such as improvement or worsening)) and Scoliosis (Start date: since the patient was born and there was no recent change in status (such as improvement or worsening)). Concomitant products included IBUPROFEN for Neck discomfort, ACYCLOVIR [ACICLOVIR] and VITAMINS NOS for an unknown indication.   On 31-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2022, the patient experienced FEELING ABNORMAL (she felt cranky) and LYMPHADENOPATHY (extreme swelling of the lymph nodes on her right arm and armpit after the injection). On 01-Feb-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEAD TITUBATION (tremor started on her head, with no motion from left to right). On 03-Feb-2022, FEELING ABNORMAL (she felt cranky) and LYMPHADENOPATHY (extreme swelling of the lymph nodes on her right arm and armpit after the injection) had resolved. At the time of the report, HEAD TITUBATION (tremor started on her head, with no motion from left to right) had not resolved.   The extreme swelling of the lymph nodes was lasted for 2 to 3 days. The patient thought that the tremor might be related to previous neck issues. The patient visited to her doctor because of tremor and no treatment was given, but doctor told her that they would watch the symptom for a while. The tremor was still ongoing and worsened as well.  Treatment information for the events feeling abnormal and swollen lymph nodes were not reported by the reporter.   This case was linked to MOD-2022-495240, MOD-2022-495173 (Patient Link).
Description of symptoms after receiving Shingles vaccine: Low grade fever, Burning and tingling in different areas of body, skin super sensitive to touch, to clothing, to anything, painful to take a shower or to pull down pants to go to bathroom, pain/ sensitivity that started in inside of arms and moved to palms of hands, upper body breast area, mid-section, and finally left my body, no energy, life was an effort, some headaches. Given on 8-16-07 symptoms began about 2 weeks later and lasted until 9-18-07. Since then she has been symptom free.
About 6 hours after receiving the vaccine I started getting a headache and felt chills. I was on my way to a hotel before leaving for a flight the next morning and was driving. When I stopped driving and attempted to exit my car, I experienced dizziness and stroke like symptoms. My legs would not hold me up and I felt as if I would pass out in the road. I held on to the car for several minutes until the feeling abated somewhat. Then I made my way unsteadily into the  hotel building and had to sit down for several minutes. My heart was beating rapidly and I felt strange so I took one of my nitroglycerin and also took an extra 12.5 mg Coreg.  After being taken to my room, I laid on the bed and continued to feel  weak, lightheaded and became very nauseous. I got out my pulse oximeter and my pulse was 95.  I took another Coreg and it seemed to slow it down for a little while but again it started racing and I continued to be nauseous and broke out in sweats and my pulse got back up to 100. I took another nitroglycerin and a baby aspirin in case I was having a heart attack. Then I took another Coreg. My pulse rate finally slowed down. I slept intermittently until going to the airport at 5 a.m.  I still felt weak and nauseous and very tired.
dry heaves; up all night; sever nausea; This spontaneous case was reported by a consumer and describes the occurrence of RETCHING (dry heaves), INSOMNIA (up all night) and NAUSEA (sever nausea) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced RETCHING (dry heaves), INSOMNIA (up all night) and NAUSEA (sever nausea). At the time of the report, RETCHING (dry heaves), INSOMNIA (up all night) and NAUSEA (sever nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature increased: 98.8 (Inconclusive) 98.8 F (normal is 97 F).         No concomitant medication was reported.  It was reported the patient was up all night due to severe nausea and dry heaves.  No treatment medication was reported. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.