chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hoarseness within 16 hours of injection, dizziness, weakness. These symptoms continue and I have a doctor's appointment tomorrow.
Patient was seen at providers clinic on 05/22/2003 with cellulitis in left deltoid region.  Swelling 7cm - 6cm with erythema.  Started on Zithromax.
After the first dose I had arm pain that lasted for three days. After day 7 of the first dose, I developed redness, itching and rash on the shoulder where I had my vaccine. The redness got worse after 2 days with no treatment. After a doctor's visit, I started using cortizone cream and the redness went away 6 days after. After the second dose I also had arm pain that laster for three days. After about 48 hours (or less) of the second dose I started developing redness and itching on the shoulder again. This time I started applying the cortizone cream immediately. The redness went away after three days.
Head ache, nausea, rash on arm around the site and down arm close toward elbow
Outside of the arm hurting; fever; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Outside of the arm hurting) and PYREXIA (fever) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054A22A, 939909, 001B21A and 024M20A) for COVID-19 vaccination.     Patient had not tested or diagnosed positive for covid-19.  Previously administered products included for Drug use for unknown indication: Prevnar (perhaps 1-2 months ago) in 2022. Past adverse reactions to the above products included No adverse event with Prevnar.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Outside of the arm hurting) and PYREXIA (fever). At the time of the report, PAIN IN EXTREMITY (Outside of the arm hurting) and PYREXIA (fever) outcome was unknown.            No concomitant medications was reported.  No treatment medications was reported.   This case was linked to MOD-2022-670586 (Patient Link).
pt reports T103 p/24hr of vax; along w/violent vomiting;went to ER w/in 4hr & had IV fluids;recovered well;
Pt's Pfizer 2nd dose was given 6/25/21.  Pt was administered 11 days early (given 4 day grace period).
Systemic: Headache-Medium, Systemic: Lymph Node Swelling-Medium, Additional Details: Patient also reported fatigue and sore throat.
client called and stated approx 1 hour after receiving immunizations ( td and yellow fever) she began feeling faint, coughing, eyes and lips were swelling began itching all over, had some hives and then blacked out. 911 was called, they responded and she was given some benadryl. she stated her BP was 118/82. she declined to go to the emergency but called her doctor when she got home. she was instructed to go to the emergency room if her symptoms became worse. client stated she called her doctor and she was continuing her benadryl. client was called in the AM and she stated she is feeling fine all symptoms have left her. all components of vaccines were reviewed ruled out yellow fever ( no allergy to eggs, gelatin,or sorbitol) after reviewing td possibility of sensitivity to preservative thimerosal. client states that it could be a possibility since she has been developing allergies in recent years.
The vial was initially stored in the refrigerator on 4-JUN-2023 and expired on 11-MAY-2023.; She states that no adverse reactions have been reported by any patients; doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 4-JUN-2023 and expired on 11-MAY-2023.) and NO ADVERSE EVENT (She states that no adverse reactions have been reported by any patients) 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. AS7143C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Jun-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-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 4-JUN-2023 and expired on 11-MAY-2023.) and NO ADVERSE EVENT (She states that no adverse reactions have been reported by any patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 4-JUN-2023 and expired on 11-MAY-2023.) and NO ADVERSE EVENT (She states that no adverse reactions have been reported by any patients) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (She states that no adverse reactions have been reported by any patients) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 4-JUN-2023 and expired on 11-MAY-2023.).    No concomitant medication was reported.  Suspect product dosage text was reported as unknown. It was reported that no adverse reactions have been reported by any patients. The vial was initially stored in the refrigerator on 4-JUN-2023 and did not underwent any temperature excursions. No treatment medication was reported. This case is reported for patient 2 out of 50 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-735331 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735331:Master case, Patient 2 out of 50 (Lot AS7143C was administered on 5Jun2023)
This spontaneous report was received from a pharmacist regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patient was vaccinated with ZOSTAVAX. No concomitant medication was reported. On an unknown date the patient developed  a hard lump at the injection site. Patient contacted pharmacist to seek medical attention. The outcome of developed a hard lump at the injection site was unknown. Causality between developed a hard lump at the injection site and ZOSTAVAX was unknown. Additional information has been requested.
This spontaneous report was received from a patient's mother refers to her child of unknown gender and age. The reporter stated that on an unknown date, her child was vaccinated with a dose of unspecified vaccine that she believed might have been the chicken pox vaccine-(Oka/Merck) (Manufacturer unknown). Consumer stated that her child developed rashes, diarrhoea and colitis after receiving the unspecified (Oka/Merck) (Manufacturer unknown). Consumer stated that her child's stomach was a mess and they had to see a specialist who performed colonoscopies and endoscopies. Specialist prescribed the child with Crohn's medications to control symptoms. Outcome of the events were not reported. No product quality complaint (PQC) was reported. Causality assessment was not provided. Additional information has been requested.
diarrhea; crumping muscle on back and neck; lost test and smell; severe headache; muscle and body aches "worse than during COVID or flu 3-4 times"; fever; fatigue; sore arm; node in injection site; cough; shortness of breath; muscles crumps; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), VACCINATION SITE MASS (node in injection site), COUGH (cough), DYSPNOEA (shortness of breath) and MUSCLE SPASMS (muscles crumps) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History Information was reported.  The patient's past medical history included COVID-19 (The patient was exposed to COVID on August2020.) in August 2020. Concomitant products included ALPRAZOLAM, ASPIRIN [ACETYLSALICYLIC ACID], CLONAZEPAM, CALCIUM CARBONATE, COLECALCIFEROL (CALTRATE 600 + D), CETIRIZINE, CLONIDINE, CYCLOBENZAPRINE, FLUOXETINE, FLUTICASONE, GABAPENTIN, INSULIN LISPRO (HUMALOG), SITAGLIPTIN PHOSPHATE (JANUVIA), EMPAGLIFLOZIN (JARDIANCE), LANSOPRAZOLE, LISINOPRIL, MELOXICAM and VITAMIN D NOS for an unknown indication.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm), VACCINATION SITE MASS (node in injection site), COUGH (cough), DYSPNOEA (shortness of breath), MUSCLE SPASMS (muscles crumps), AGEUSIA (lost test and smell), HEADACHE (severe headache), MYALGIA (muscle and body aches "worse than during COVID or flu 3-4 times"), PYREXIA (fever) and FATIGUE (fatigue). On 19-Apr-2021, the patient experienced MUSCLE SPASMS (crumping muscle on back and neck) and DIARRHOEA (diarrhea). The patient was treated with IBUPROFEN at a dose of 800 mg. On 19-Apr-2021, PAIN IN EXTREMITY (sore arm), VACCINATION SITE MASS (node in injection site), COUGH (cough), DYSPNOEA (shortness of breath), MUSCLE SPASMS (muscles crumps), AGEUSIA (lost test and smell), MYALGIA (muscle and body aches "worse than during COVID or flu 3-4 times"), PYREXIA (fever) and FATIGUE (fatigue) had resolved. At the time of the report, MUSCLE SPASMS (crumping muscle on back and neck), DIARRHOEA (diarrhea) and HEADACHE (severe headache) outcome was unknown.            Treatment also included using cold pack.   This case was linked to MOD-2021-081393 (Patient Link).
Patient noted diarrhea, fever, chills, fatigue and felt mildly forgetful.
several hr p/vax pt became white, blue, limp while mom was changing monitor leads;needed CPR;pt was successfully revived, but needed ventilator assistance for a few days & supplemental 02 several more;
Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: RIGHT ARM AND SHOULDER PAIN-Medium, Systemic: Joint Pain-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: PATIENT STATES RIGHT ARM PAIN UP INTO NECK AND NUMBNESS DOWN TO HAND
Itching around the face and neck immediately after the vaccine was administered.  I often have these reactions so was not alarmed.  The itching stopped approximately 2 hours later.  I did not break out in hives, which has happened in the past from medicines (e.g., chemotherapy).
Significant pain and tenderness at injection site beginning 4 hours after injection. Nausea beginning 4 to 5 hours after injection. Headache and fatigue beginning day after injection, and continuing into day 3 post injection. Significant chest pain and pressure 24 hours after injection.
Information has been received from a clinical medical assistant referring to unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with VAQTA (lot # K004856, expiry date 07-DEC-2016; dose and route were not reported), which were involved in a storage issue. This is one of several reports from the same reporter. Additional information has been requested.
muscle cramps in bilateral calves, toes, fingers.   Pain in trunk and thorax.  Occurred mostly at rest and with changing positions
The pharmacist gave me a shot in the upper left arm, and was pushing very hard on the syringe. I could feel a burning in my arm. She then  indicated that the syringe was not working and that she would need to try again with a different syringe in my right arm. When she pulled out the syringe, there was blood at the site. She retrieved a new dose and administered in my right arm. That evening both arms were very sore. The next morning I had difficulty raising my arms. I took advil and that reduced the pain. 4 days later, I still have limitations on my range of motion on both arms but the left is worse than the right.
Fever, body aches, joint aches, weakness for 36 hours treated with alleve
This case was reported by a consumer via (Facebook) interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and post herpetic neuralgia. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the post herpetic neuralgia was not recovered/not resolved. It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingles vaccine. Additional details were provided as follows: The case was self-reported by the patient. The age at vaccination was not reported. The reporter stated that, he/she had the Shingles shot and the shingles and still had the nerve endings pain daily. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
This serious case was received on 01 April 2009 from a health care professional. An approximately 3 week old patient (gender not specified) received FLUZONE SV 2007-2008 (lot number not reported) transplacentally on 15 November 2007. The patient was born on 14 May 2008 at a gestational age of 39.7 weeks. Apgar score at one minute and five minutes were both 9. On 07 June 2008 the patient had pyloroplasty for pyloric stenosis. The child recovered from the surgery. On 13 November 2008 the patient was diagnosed with pneumonia. No further information was reported. This case has the same reporter as case number 2009-01354.
pt recvd vax & devel a weakly pos Hep B core antibody; No further details were provided;
A report has been received from a Health Professional concerning an Adult, subject of unknown gender, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on an unknown date. The health professional reported that the had two patients that received FLUMIST quadrivalent who are over the recommended age of 49 by mistake which started on 09-Oct-2013. No symptoms reported. The outcome of the event of patient over 49 years old received FLUMIST is unknown. The report was considered to be non-serious.
My leg has been asleep for about an hour after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (My leg has been asleep for about an hour after 2nd dose) 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 25-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 HYPOAESTHESIA (My leg has been asleep for about an hour after 2nd dose). At the time of the report, HYPOAESTHESIA (My leg has been asleep for about an hour after 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medications were reported. no treatment drugs were reported.
Varicella - Information has been received from a registered nurse concerning a 12 month old hispanic female patient with no pre existing allergies or medical conditions who was vaccinated with a first dose or varicella virus vaccine live on 25 apr 1999 sc in the right arm.  On 03 may 2000 the patient developed several vesicular lesions on her trunk mostly in the diaper area with no fever, the patient sought unspecified medical attention follow up information from a registered nurse indicated that on 04 may 2000 the patient mother indicated that the patient developed approxmiately 60 vesicles from head to toe.  it was determined that the patient had a case of chickenpox .
I have administered pediatric Pfizer vaccine for an eligible patient who was of at age for adult Pfizer vaccine. No reactions or symptoms presented during observation for 15 minutes after vaccine administration.
This spontaneous report was received from a physician referring to a 34 year old female patient with no pertinent medical history or drug allergies/drug reactions. Information regarding concomitant medications was not provided. On an unspecified date in 2007 (reported as ten years ago) the patient was vaccinated with two doses of GARDASIL (frequency, route of administration, lot number and expiration date were not reported) for prophylaxis. However, the physician reported that the patent's third dose was missed. Physician reported the patient was diagnosed with invasive lobular carcinoma of the breast stage 1b by mammogram, MRI (magnetic resonance imaging) of the breast, and breast biopsy in January 2016. It was also reported that the patient received unspecified chemotherapy. The outcome of invasive lobular breast carcinoma was unknown. The reporter did not assess the causal relationship between therapy with GARDASIL and invasive lobular breast carcinoma. Upon internal review, invasive lobular breast carcinoma was considered to be a medically significant event.
Positive diagnosis of Covid-19; Positive diagnosis of Covid-19; Mild cold-like systems; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received second dose of BNT162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose, and received first dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced positive diagnosis of COVID-19 associated with mild cold-like systems. The patient underwent lab tests and procedures which included sars-cov-2 test: positive. The outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Patient was brought in to have a well child immunizations completed. In the process of drawing up the immunizations. Offered to help. When I informed that I needed PCV serum the PPV was brought out and drawn up instead if checking these in the immunizations were administered.
This spontaneous report was received from a nurse and refers to a 12 month old patient. The patient's pertinent medical history, drug reactions and allergies were not reported. Information regarding concomitant therapies was not provided. On 29-SEP-2017, the patient was vaccinated with properly stored VARIVAX lot # M039316 with an expiration date 20-SEP-2018, subcutaneous for prophylaxis dose was not reported) and PROQUAD lot number N001488 with an expiration date 12-JUL-2018 for prophylaxis (dose and route of administration were not reported). No adverse effects were reported.
Pt devel erythema, induration, crying-sore; tx ice pack to buttocks 20min, APAP, soaks tepid water;
Right deltoid erythema, tender swollen - not specific firm abscess or subQ infection noted
swollen gland on left side. lump on left arm on vaccine site, total of about 7-10 days
Pt recvd 1st dose of Hep B vax 7OCT91 & on 12OCT91 devel paresthesia, pain & dermatomal type rash @ inject site; pain radiated from lt arm to side of lt breast; pt recovered;
hand was swollen and itchy on the same arm where the injection was; back of hand was swollen and itchy on the same arm where the injection was; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), via an unspecified route of administration (Deltoid Right) from 26Dec2020 15:00 at single dose for Covid-19 immunization. The patient's medical history included chronic pain and insomnia. Concomitant medications included hydrocodone and temazepam. The patient reported, "On 26Dec2020 I got my first immunization for COVID and today (30Dec2020) I woke up and the back of my hand was swollen and itchy on the same arm where the injection was". The patient further stated "It never have happened before I don't have any reaction at the injection site but it was kind of odd that it kind of showed up on the back of my hand, it feels like an allergy kind of thing." The patient tried the Voltaren Gel to try and get the inflammation down, but it didn't help, and she took some Benadryl it doesn't seem to help much. The patient's next shot is due on "12Jan2021". The outcome of events was unknown.
Lightheadedness; Patient reported lightheadedness which subsided after 10minutes .her vital remained stable BP 137/80,P68,RESP 18,02SAT 99%.Patient left vaccination ambulatory and reminded to seek medical help if new symptoms. She communicated clear understanding.
Pt had global urticarial rash with flushing and mild, coarse expiratory wheezes and noisy breathing. Given Epinephrine and Benadryl.
No additional adverse events reported; a dose of PROQUAD was given during a temperature excursion; This spontaneous report was received from a medical assistant referring to a 5 year old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug allergies and reactions were not provided.    On 28-DEC-2020, the patient was vaccinated with a dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength and route of administration were not provided; lot# was T021638 and expiration date was 21-DEC-2021) 0.5 ml for prophylaxis (product storage error ). No additional adverse events were reported.   The vaccine underwent temperature excursion of 5.6 degree Celsius for 16 hours 20 minutes. There were no previous temperature excursions. The digital data logger was not involved.
Parent of pt reports redness, swelling & hot to touch at Var injection site. Child relates area to back of area is tender to touch only. Noted around 430pm on 6/7/11. Health Dept recommended cool compresses to site, BENADRYL dose to child age & wgt. May be seen by doctor if symptoms persist.
dibilitating pain, headache, nausea, injection site pain/head, arm swollen, diarrhea, chills, fatigue, fever