chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist via company representative refers to a male patient (reported as pharmacist's father) of unknown age with none drug reactions and allergies. In approximately 2013 (reported as about a year ago) the patient was vaccinated subcutaneously with shot of ZOSTAVAX, vial (lot# and expiration date not provided) (dose not reported). In approximately 2013 (reported as happened instantaneously) the patient experienced an injection site rash. The reporter stated that the rash disappeared shortly after it appeared. No diagnostic tests were reported. The patient did not seek medical attention. The outcome of injection site rash was reported as recovered/resolved (date unspecified). Additional information has been requested.
Moderna COVID-19 Vaccine EUA Red rash at site of injection 8 days post vaccination of first dose.  Area increased in size for two additional days.  Size of rash area 2" x 4"
can hardly move arm / arm feels as if it needs to be in a sling; Muscle pain; injection was painful; Headache; feeling tired; Arm Pain / arm is still very painful; difficulty sleeping; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th August 2020, the patient received the 1st dose of Shingrix (intramuscular). On 10th August 2020, immediately after receiving Shingrix, the patient experienced injection site pain, headache, tiredness, pain in arm and muscle pain. On 11th August 2020, the patient experienced injected limb mobility decreased. In August 2020, the patient experienced insomnia. The patient was treated with paracetamol (Tylenol) and non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the injection site pain, headache, tiredness and insomnia were unknown and the outcome of the pain in arm, injected limb mobility decreased and muscle pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, headache, tiredness, pain in arm, injected limb mobility decreased, insomnia and muscle pain to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix on right arm. It was reported that the injection was painful unlike any other vaccine ever received. Within 6 to 8 hours after receiving Shingrix, the patient was feeling tired and then developed a headache.  The patient went to bed but woke up in the night with arm pain. The arm pain was much worse on the second day (1 day later after administration of Shingrix) as she reported that holding her arm, could hardly move arm causing difficulty sleeping, and arm felt as if it needs to be in a sling. The patient reported taking Tylenol and icing kept on arm but arm was still very painful.  The patient reported not having shivers, fever or upset stomach. The onset date for mobility decreased was discrepantly reported as 10th August 2020, however it was updated to 11th August 2020 as per the description. The reporter consented to follow up.
No Adverse event; 5 Pediatric patients received Moderna Covid-19 vaccine 30 days past its beyond use date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 Pediatric patients received Moderna Covid-19 vaccine 30 days past its beyond use date.) and NO ADVERSE EVENT (No Adverse event) in a 6-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9237B) for COVID-19 vaccination.     No medical history was reported.     On 06-Sep-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 Pediatric patients received Moderna Covid-19 vaccine 30 days past its beyond use date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 Pediatric patients received Moderna Covid-19 vaccine 30 days past its beyond use date.) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (5 Pediatric patients received Moderna Covid-19 vaccine 30 days past its beyond use date.).    No concomitant and treatment medication was reported. The patient's height was 2ft 3 inch (68.58 cm). The patient received the vaccine after the 30 days use by date and the vial passed by 34 hours.  The vial was initially stored in the refrigerator on 05-Aug-2022. The vial did not undergo any temperature excursions. No adverse event was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-642057, US-MODERNATX, INC.-MOD-2022-642060, US-MODERNATX, INC.-MOD-2022-642052 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-642052:Same reporter US-MODERNATX, INC.-MOD-2022-642060:Same reporter US-MODERNATX, INC.-MOD-2022-642057:Same reporter
began with a thick throat and lips and face began to swell - left side was more swollen than the left, began taking Benadryl but it took almost 3 full days for it to go down.
Patient complained of numbness and tingling a long L side of jawline within 15 minutes of receiving vaccines. Pt also described a feeling of droopiness on L side of face. All symptoms have resolved. No Tx required.
I have a blood clot in hurry I have blood clots regularly; Blood is way too thick so he give triple dose; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2), via an unspecified route of administration on 01May2021 (batch/lot number and expiration date not reported) as UNKNOWN, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated, "I received COVID 19 vaccination on 01May2021 at my Doctor's Office and yesterday (12May2021), I went to see my Oncologist. I am on blood thinners, its Coumadin. I get Warfarin which is you know (incomplete sentence, thus, not clarified and was not captured). Anyway, I take Coumadin, my blood is way too thick, so he gave triple dose and I went back today, and it is still bad, and I am taking another triple dose tonight and going back. What are the safety issues in getting Coumadin and getting that vaccination?" When probed for follow up, consumer stated, "Yes, it be great if they did. I need to find something we need to correct because I have a blood clot in hurry. I have blood clots regularly if I do not keep my blood thin." Patient stated, "Have you heard other people reporting this problem or was it the concern in the beginning or what can be done in other words?" Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Missed the second dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed the second dose of the Moderna COVID-19 vaccine) 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 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed the second dose of the Moderna COVID-19 vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed the second dose of the Moderna COVID-19 vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No laboratory details were  provided. No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.
In mid-March 2021 I started experiencing paresthesia in my legs and arms, it got progressively worse daily and started to spread from my feet up my legs and from my hands up my arms and then on my torso. On March 28th I started to feel like I could not control my body temperature, I was sweating profusely when it was cold in the room, and then my skin became red and blotchy, this went on for several days and my temperature was fluctuating between 95-102 rapidly. I tested weekly for covid at work due to working in a health care setting, so covid was ruled out weekly. My symptoms progressed rapidly through the first week of April 2021, I developed a cold sore in the same location I have always gotten them but it was bigger and more painful than it had ever been. I felt fatigued, the paresthesia was worsening and had spread to my face and I had pain everywhere. April 9th, 2021 I completely lost feeling in my feet and the following morning on April 10th, 2021 I woke up unable to walk and had paralysis in my legs. I had 3 subsequent visits to the ER due to paralysis and severe mid back pain and was hospitalized on April 14th, 2021. I was diagnosed with Guillain Barre Syndrome on April 15th, 2021 following a lumbar puncture.
IgA Nephropathy vaccine (booster) given 10/21/2022. Seen 10/25/2022 with concern for IgA nephropathy. Low renal function and gross hematuria. Labs improving . Monitoring closely.
This medically confirmed spontaneous report (initial receipt 20-Oct-2014) concerns a female patient who was allergic to eggs. On an unspecified date, the patient received an unknown flu vaccine (manufacturer and batch number not reported). On an unspecified date, the patient was hospitalised after developing flu like symptoms and dehydration after receiving the unknown flu vaccine. Outcome was not reported.
1 of 4 pt  exp an inj site rxn described as hot, red & swollen approx 3x3" in size day p/vax;sx resolved 3-4 days later;
Patient had almond size knot in left leg where he received the DTaP and Hep B vaccines.
Swelling that spread on (L) deltoid, fever, warmth, painful, decreased ROM of (L) arm Pain started same day of injection fever swelling to follow, had been getting worse
Weakness, congestion, rhinitis, with mild difficulty breathing which worsened progressively. Originally thought it was an allergic reaction to the environment but a dose of Claritin didn't resolve. I never have trouble breathing and when that that became worse and worse and couldn't take a deep breathe and was getting lightheaded, I knew it wasn't regular allergies. It only remitted once I used my son's inhaler. (I'm a physician.) I'm sure I would have gone to the hospital if I didn't have the inhaler or if it didn't work.
Really high fever, headache, chills, diarrhea, nausea and developed Shingles. All symptoms lasted two weeks. Had to go to an a clinic for medical help. Took Tylenol for the headache and fever. The doctor wrote a prescription for pain and also something for the Shingles. Tested positive for Covid 19 in December.
Injection site reaction; injection site on her upper arm is red, itchy, big and round; injection site on her upper arm is red,itchy, big and round; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Injection site reaction), VACCINATION SITE PRURITUS (injection site on her upper arm is red, itchy, big and round) and VACCINATION SITE ERYTHEMA (injection site on her upper arm is red,itchy, big and round) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016J21-2A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu vaccine. Past adverse reactions to the above products included No adverse event with Flu vaccine.    On 14-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2022, the patient experienced VACCINATION SITE REACTION (Injection site reaction), VACCINATION SITE PRURITUS (injection site on her upper arm is red, itchy, big and round) and VACCINATION SITE ERYTHEMA (injection site on her upper arm is red,itchy, big and round). At the time of the report, VACCINATION SITE REACTION (Injection site reaction), VACCINATION SITE PRURITUS (injection site on her upper arm is red, itchy, big and round) and VACCINATION SITE ERYTHEMA (injection site on her upper arm is red,itchy, big and round) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported.  Patient had not applied anything on the site of reaction. Patient never had a reaction to the flu vaccine. Patient was scared to proceed.  Second dose due on 11 Feb 2022.
Pt experienced needle, prickly like, itchy sensation all over with headache. Pt also experienced some pressure/uneasiness in throat/breathing.
Fever 99.8. Baseball size red lump at site of injection. Dizziness. Very bad headache. My shortness of breath increase and I had to use my inhaler multiple times. Very tired for 3 days after the injection. Symptoms are still present but are decreasing each day.
Approximately 24 hours following flu injection, patient experienced soreness in the left arm where shot was given; this persisted for more than a week and was somewhat relieved by Motrin for the pain. When the soreness at injection site persisted past 2 weeks, accompanied by stiffness and decreased range of motion in the arm, patient notified Employee Health and was advised by the personnel there to apply warm compresses to relax muscle and relieve local soreness. Symptoms worsened and patient notified person at Employee Health, and person advised her to seek medical evaluation. Patient was seen at Urgent Care on 1/5/2012 and the Nurse Practitioner there speculated that the symptoms appeared to be "brachial plexus neuritis" and prescribed Motrin and Flexaril for same. NP advised that patient see a Neurologist, which she will schedule in the very near future. As of January 11, 2012, patient reports some persistent decreased range of motion and soreness in the left arm.
hand tingling and shaking starting around 10am. after 30 minutes of observation and rest, family, patient, and healtcare team determined patient was well enough to travel home for continued monitoring by family.
General malaise, sore arm, chills, headache, loss of appetite, swollen lymph nodes in neck
C/O sore arm on 7-21-04.  7-22-04 awoke at 8:30 Am with red, swollen arm with blisters mom describes these appear to have fluid, denies fever - eating, sleeping, playing without problems, no other sign of illness.
Injection site red, swollen 2 vesicles - one on inner left arm and one on upper left shoulder.
Weakness, muscle aches, headaches, sore throat, runny nose, and those subsided after about 10 days, however, there is still a cough that hasn?t fully gone away since 6/16/22 it is now 7/7/22 it was a dry, full body cough, it got to the point where I was wheezing with these coughs, lost my voice completely for 4 days. All of the symptoms got worse with every day from the 16th to the 20th on that day I went into an urgent care, got prescribed a cough suppressant Promethazine and an Albuterol Sulfate inhaler. I had to halt the cough suppressant due to adverse side effects to my other medications, I am still using the inhaler as needed. The cough was almost constant, it?s gone down substantially, but still comes up, I use the inhaler, and it goes away until it randomly shows back up.
Chest pain at 15 minutes with associated nausea, vomiting, chills within 30 minutes.
Sore arm; Tingling to lower part of face; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and PARAESTHESIA (Tingling to lower part of face) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia. Concomitant products included FAMOTIDINE, CLOPIDOGREL BISULFATE (PLAVIX), ATORVASTATIN and HYDROCHLOROTHIAZIDE for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and PARAESTHESIA (Tingling to lower part of face). At the time of the report, PAIN IN EXTREMITY (Sore arm) and PARAESTHESIA (Tingling to lower part of face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient is in her 70's. Treatment information was not provided.
slight sore arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (slight sore arm) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (slight sore arm). At the time of the report, PAIN IN EXTREMITY (slight sore arm) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported.  It was reported that patient declined providing information regarding the side effects because they were so minimal.  No treatment  medications were reported.   This case was linked to MOD-2022-578384 (Patient Link).
Hospitalized From COVID; Hospitalized From COVID; This is a spontaneous report from a contactable consumer. An adult male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE),  via an unspecified route of administration, on an unspecified date as dose 1, single (Lot number: Unknown, Expiration date: Not reported) and dose 2, single (Lot number and expiration date were not reported) for COVID-19 immunization. The most recent COVID-19 vaccine was administered in a facility reported as unknown. Medical history included kidney transplant in 2011 which was reported as 10 years ago and the patient was immunocompromised. It was unknown if the patient had relevant past drug history. It was unknown if the patient received concomitant medications/any other medications the patient received within 2 weeks of vaccination. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. It was reported that the patient was hospitalized for COVID-19 after receiving both the doses of Pfizer vaccine. He had fever and was hospitalized on an unspecified date. He's being treated with remdesivir and sleeping with an oxygen tube. These events resulted in emergency room/department or urgent care. The patient had no prolonged hospitalization. Since the vaccination, the patient had been tested for COVID-19 with positive result on an unspecified date. The outcome of these events was unknown at the time of report.   The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
To ED on 2/8/2022 with c/o shortness of breath and weight gain. BNP 708. Admitted with systolic Congestive Heart Failure for diuresis with IV Lasix.
PATIENT  REQUESTED PHARMACIST CONSULTATION ON 06/23/2021 FOR BLOOD SUGAR IRREGULARITES. HE STATED DURING THE CONSULTATION THAT THE IRREGULARITES STARTED ON 06/03/2021 AFTER THE ADMINSTRATION OF THE PFIZER VACCINE FOR COVID-19. PATIENT STATES THAT HIS BLOOD GLUCOSE HAS REMAINED UNDER CONTROL FOR THE PAST FEW YEARS WITH DIET AND EXERCISE ONLY. AS OF 06/03/2021 THE PATIENT BLOOD GLUCOSE LEVELS HAVE BECOME EXTREMELY ERRACTIC. PATIENT STATES THAT HIS AVERAGE BLOOD GLUCOSE LEVELS ARE NOW WELL OVER 200. AFTER REVIEW OF THE PATIENTS PROFILE, WE HAVE CONFIRMED THAT THE PATIENT DID RECEIVE HIS SECOND DOSE OF THE PFIZER COVID VACCINATION ON  06/02/2021. PATIENT WAS ADVISE TO FOLLOW UP WITH MD FOR FURTHER EVALUATION. THE PATIENT WAS ALSO ADVISED TO FILL OUT V-SAFE REPORT.
* I'd had shingles from back to chest left side Oct. 2017 - pain continued in back and chest area until approx. Feb 2019 - when my G.P. advised that I should have the vaccine, not to get shingles again. The day after the vaccination pain came back and has persisted since. I'm now taking acupuncture to try stop it!! the arm where the vaccine was administered - was red, painful and hot for several days
Heaviness in both legs, muscle twitching in both legs, aching all over and neuropathy in both legs and right fingers
Flu-like symptoms after 1st and 2nd dose; Sore arm after 1st and 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms after 1st and 2nd dose) and PAIN IN EXTREMITY (Sore arm after 1st and 2nd dose) in a 49-year-old female patient 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 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms after 1st and 2nd dose) and PAIN IN EXTREMITY (Sore arm after 1st and 2nd dose). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms after 1st and 2nd dose) and PAIN IN EXTREMITY (Sore arm after 1st and 2nd dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.  Patient experienced sore arm  and flu-like symptoms for 1 day   This case was linked to MOD-2021-427781, MOD-2021-427798 (Patient Link).
pt recvd Hep B vax 26JAN93 eve of 27JAN pt reports began w/temp of 103, vomiting, severe h/a; pt reports was seen in ER 27JAN & md felt it was a vax reaction;