chrisvoncsefalvay/vaers-outcomes huggingface dataset:
respiratory infection; rash; headache; nausea; stiff neck; cellulitis at injection site; Vaccine Administered at Inappropriate Site; exposure via skin contact; overdose; This case was reported by a pharmacist via call center representative and described the occurrence of respiratory infection in a female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero at an unknown dose and the 2nd dose of Bexsero. On an unknown date, not applicable after receiving Bexsero and unknown after receiving Bexsero, the patient experienced respiratory infection (serious criteria GSK medically significant), injection site rash, headache, nausea, stiff neck, injection site cellulitis, intramuscular formulation administered by other route, exposure via skin contact and accidental underdose. On an unknown date, the outcome of the respiratory infection, injection site rash, headache, nausea, stiff neck, injection site cellulitis, intramuscular formulation administered by other route, exposure via skin contact and accidental underdose were unknown.   It was unknown if the reporter considered the respiratory infection, injection site rash, headache, nausea, stiff neck and injection site cellulitis to be related to Bexsero.  Additional details were provided as follows: The age at the vaccination was not reported. The patient told reporter that some of the vaccine liquid ran down her arm during the vaccination, so the person who administered the vaccine gave her a second Bexsero vaccine in the same location. The pharmacist said her niece subsequently had a rash form at the injection site, developed headache, nausea and a stiff neck.   The patient's doctor contributed the headache, nausea and stiff neck to a respiratory infection. He diagnosed her rash as cellulitis due to the vaccination.   The pharmacist stated she wonders if the vaccine might have been given subcutaneously, rather than intramuscularly, but she did not know for sure, which led to intramuscular formulation administered by other route. The reporter did not consent to follow-up. Nurse did not wish to provide further details, other than what she stated during course of conversation. She did not know other details, including batch number of product. She did not want to be contacted in the future regarding this event.
Skin infection; Received second dose more than 42 days after first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of SKIN INFECTION (Skin infection) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose more than 42 days after first dose) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21A and 038C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose more than 42 days after first dose). On an unknown date, the patient experienced SKIN INFECTION (Skin infection). The patient was treated with CLINDAMYCIN on 07-Aug-2021 for Adverse event, at a dose of 150 mg and MUPIROCIN for Adverse event, at an unspecified dose and frequency. On 27-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose more than 42 days after first dose) had resolved. At the time of the report, SKIN INFECTION (Skin infection) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported. The patient had recently started an antibiotic for a skin infection  It was reported that patient was not immunocompromised.
I gave the influenza vaccine to the patient 3 days ago. Today the patient came to ask about the rash and soreness it caused to her arm. There is about 2 inch diameter of redness around the injection site which is normal; however, there is a much bigger blotch of light colored redness about 3-4 inches down of the injection site and it is approximately 5 inches in diameter. The patient has been taking benadryl twice daily but she didn't use any other treatment for it, and she has not seen any medical doctor regard it yet. With her permission, I used a sharpie to mark the edges of both red areas and to see a medical doctor like urgent care tomorrow afternoon if it doesn't seem to fade down or get bigger in size. Although there is pain involved which could be an indication of cellulitis, the patient stated that last year's influenza vaccine made her feel sick for 3 days straight so both of us are leaning towards a possibility of allergic reaction to the components of the vaccine rather than an infection. I told the patient that next time she should get a different type of flu vaccine than the one she had (eg. Flublok instead of Fluzone HD). We will follow up with the patient tomorrow for a clearer outcome. Update from 11/7/22: I talked to the patient and she is doing better as the swelling is getting smaller, she did use ice compresses last night and it helped. This concludes that it is not cellulitis to the shot but it could be either an allergic reaction to the vaccine or something entirely different since the spot was about 3 inches away from injection site.
Pt w/ dizziness, pre-syncope, shakes, muscle weakness, pallor.  BP 121/72, HR 83, RR 16.  Pt stable and released from the vaccination site.
Years back I had A-fib/flutter issues. In 2015 an Ablation solved the issue beautifully--no on going issues. On Feb 5, the day after receiving the 2nd shot, my heart began to jump around. Sometimes very slow beat, then very fast, the slow and so on back and forth. I got it under control by coughing forcefully, breathing slowly but mostly stopped the problem by elevating my heart rate doing simple exercises like marching slowly in place. Took about 4 hours to stop. The rest of the day was fine and the next day an occasional flop flop. Electro physiologist wonders if the reaction pushed me back into steady A-Fib. A cardio version was done successfully  on 8/6/21.
Severe spell of Vertigo that feels endless. Dizziness, Nauseous, Vision Spinning, Spinning Sensation, Inability to hold head up and hard to look at anything without being overwhelmed by all symptoms. Same happened with the first dose and lasted for 3 months which contributed to my decision not to get the second dose until regulatory authority took it upon themselves to threaten peoples livelihoods if not fully vaccinated. So I had 5 months between doses and having the same side effects again only stronger this time and will have to push myself as hard as I can just to function in everyday life and work dealing with these symptoms that I know are long term from previous experience.
Patient was to receive Moderna Booster 0.25ml but actually received Moderna 0.5ml, Patient notified, no adverse effects noted
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age. The patient's pertinent medical history, concurrent condition and concomitant medications were not reported. On 16-MAY-2016, the patient was vaccinated with improperly stored M-M-R II (lot # was reported as L027591, expiration date 23-JUL-2017 or L030182, expiration date 11-AUG-2017). The reporter did not know which of the aforementioned lot was administered. The vaccine was exposed to a temperature of 50F for 5 hours. There was no previous temperature excursion. No adverse events reported. This is one of the two reports received from the same reporter. Additional information has been requested.
No adverse reaction; Patient got vaccinated after BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient got vaccinated after BUD) and NO ADVERSE EVENT (No adverse reaction) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 084J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 03-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient got vaccinated after BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse reaction). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient got vaccinated after BUD) and NO ADVERSE EVENT (No adverse reaction) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse reaction) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient got vaccinated after BUD).    No concomitant medications were reported.  It was reported that, the patient received vaccine after the beyond use-by date.  No treatment medications were reported.
by 5PM c/o achy all over, nausea, fever 103 which lasted x 3 days;
Hands feeling rough to the touch; Her hands started itching; Nausea; A lump; Eczema; Arm cramped all the way down into her hand; No energy; Arm pain her arm hurting, but moving it; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Arm cramped all the way down into her hand), ASTHENIA (No energy), PAIN IN EXTREMITY (Arm pain her arm hurting, but moving it), DRY SKIN (Hands feeling rough to the touch) and ECZEMA (Eczema) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030H21B, 002C21A and 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Flu (Flu several years ago with absolutely no energy). Concurrent medical conditions included Heart disorder (Heart condition).   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced MUSCLE SPASMS (Arm cramped all the way down into her hand), ASTHENIA (No energy), PAIN IN EXTREMITY (Arm pain her arm hurting, but moving it), ECZEMA (Eczema) and VACCINATION SITE MASS (A lump). On 01-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced NAUSEA (Nausea). On 02-Dec-2021, the patient experienced DRY SKIN (Hands feeling rough to the touch) and PRURITUS (Her hands started itching). At the time of the report, MUSCLE SPASMS (Arm cramped all the way down into her hand), ASTHENIA (No energy), DRY SKIN (Hands feeling rough to the touch), ECZEMA (Eczema), PRURITUS (Her hands started itching), VACCINATION SITE MASS (A lump) and NAUSEA (Nausea) outcome was unknown and PAIN IN EXTREMITY (Arm pain her arm hurting, but moving it) had resolved.            No concomitant medications were mentioned. Treatment medication reported included Organic cream for eczema. Patient stated that she has been using hand sanitizer more regularly.   This case was linked to MOD-2021-404769 (Patient Link).
Information has been received from a consumer concerning her daughter who in approx. 4/95, at 18 months of age, was vaccinated with MMRII and subsequently, her daughter developed the "symptoms associated with autism". It is noted that she has speech problems, physical problems, only weighs 44 pounds and is in special education classes in school. It was reported that she cannot afford to have the testing done to officially confirm that she has autism. Unspecified medical attention was sought. It was noted that the pt is currently on therapy with loratadine (Claritin). Follow up information from a woman in a physician's office indicated that the child first visited the office in March 2000 for shingella when she was 6 years old. It was noted that she visited the office a second time, also for shingella. On 2/16/01 the child had a well visit with the physican and the question of autism was raised. The mother reported to the physician that the child was seen several times by a neurologist and, at that time, they had not diagnosed the child with autism. It was reported that the mother requested a referral to another neurologist, but that the child had never returned to his office since 2/16/01. It is unknown if the child was ever seen by another neurologist. Shingella was considered an incidental finding. Upon internal review, Autism was considered an "Other Important Medical Event". Additional information has been requested. F/U information from a woman in a physician's office indicated that the child 1st visited the office in 3/00 for shigella when she was 6 years old. It was noted that she visited the office a 2nd time, also for shigella. On 2/15/01, the child had a well visit with the physician and the question of autism was raised. The mother reported to the physician that the child was seen several times by a neurologist and, at that time, they had not dx'd the child with autism. It was reported that the mother requested a referral to another neurologist, but that the child had never returned to his office since 2/16/01. It is unknown if the child was ever seen by another neurologist. Shigella was considered an incidental finding. Upon internal review, Autism was considered an "Other Important Medical Event". Additional information has been requested.
The night of the vaccine she had soreness from the top of shoulder to below the elbow of the L arm. She was achy in the arms and both hands ice cold. Fri a little better then Sat the s/s were the same. Sun NOC slept better.
Patient was given 2nd Pfizer vaccine 5 days before the recommended time between the 1st and 2nd dose.
Patient claims the vaccine was given too high up on her arm and was injected into her joint.  She said she has soreness and thinks she had frozen shoulder.  However, the next day and later on that day she was able to move her arm with some soreness.
FEVER, HEADACHE, BODY ACHES, FEELS WEAK, FEELS ILL
Patient came in to receive PREVNAR 13 vaccination. Immediately after giving vaccination, the patient's arm swelled and bled at injection site. At the injection site blood pooled to the size of a silver dollar. Patient says she is only taking aspirin and has had no previous reactions to any shots in the past. After checking back in with patient she did say she experienced something similar in the right arm at Dr. office after receiving a shot. Patient is feeling fine, and having no symptoms of an allergic reaction. Patient applied pressure with ice and stayed in the pharmacy for 30 minutes so we could observe her for any other symptoms. Patient and son left voluntarily after checking on her again, and swelling had not changed. Throughout the incident the patient did not report any pain. Will follow up with patient this evening and again tomorrow morning. Also called Dr.  and had to leave message, to keep them informed of the incident.
I received the first dose of the Pfizer vaccine on 30Dec2020 and got covid on 04Jan2021 via positive nasal swab test; I received the first dose of the Pfizer vaccine on 30Dec2020 and got covid on 04Jan2021 via positive nasal swab test; This is a spontaneous report from a from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received first dose of BNT162B2 (Lot number and Expiration date not provided), via an unspecified route of administration on 30Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications was not reported. The patient had her first dose of COVID vaccine on 30Dec2020. She had a positive COVID test via Nasal swab test on 04Jan2021. She will be off of quarantine on 18Jan2021. For some reason her second dose of COVID Vaccine is not scheduled until 29Jan2021. She asked if she is COVID positive when should she get that next dose; and also the second dose scheduled her out 30 days which is a long time which she was questioning that as well. The outcome of the events was unknown.  Information on Lot/Batch number has been requested.
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. No concurrent conditions, medical history, and allergy/drug reactions were reported. Approximately in 2017 (reported as between June 2017 and 21-AUG-2017), the patients were vaccinated with improperly stored PROQUAD lot # N004631 with expiry date: 07-AUG-2018, lot # M041083 with expiry date: 04-APR-2018 (dosing details, route, anatomical location were unknown) for prophylaxis. The vaccines were administered with sterile diluent that was properly stored (lot#, expiry unknown). It was reported that the vaccines were exposed to a temperature range of 6 F to 14 F for a duration of 10 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1708USA010667: US-009507513-1708USA009612.
Patient received 1st dose of Moderna COVID-19 vaccination. It was found the vial expired 10/10/2021. Dose administered 10/12/2021. Patient has had no symptoms/illness since the vaccination.
Bitterness; Runny nose; Joint pain; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA, RHINORRHOEA, ARTHRALGIA, and MYALGIA in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A211A and 001C21A) for COVID-19 vaccination.     The patient's past medical history included Sleep apnea. Concurrent medical conditions included Type 2 diabetes mellitus, Blood pressure high, and Allergy. Concomitant products included METFORMIN, OMEPRAZOLE, METOPROLOL, ATORVASTATIN, GLIPIZIDE, and LOSARTAN/HYDROCHLOORTHIAZIDE for an unknown indication.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-May-2021, 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 experienced DYSGEUSIA, RHINORRHOEA, ARTHRALGIA, and MYALGIA. At the time of the report, DYSGEUSIA, RHINORRHOEA, ARTHRALGIA, and MYALGIA outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test positive antibodies test for covid-19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was reported by patient.  Patient reported that he got the Moderna covid-19 vaccine and some time later he got a positive antibodies test for covid-19, doctor suggested that might need to change the statin because it might be the culprit.
PARENT REPORTED VOMITING A FEW DAYS AFTER VACCINES WERE GIVEN. ALSO HIVES APPEARING ON FRONT AND BACK OF TORSO AFTER VACCINES WERE GIVEN.
By 6 PM my arm was tender.  By next day it was red, swollen, hard and febrile.  I took Advil as recommended by pharmacist who observed it.
several days after 2nd vaccine, pt. had shingles outbreak.  Her PCP stated was directly related to vaccine
Large lump on back of arm, circled by a dark redness. Swelling of injection area with burning sensation. Lump existent for five days following injection.
Patient got her 1st COVID shot around 1:30. States she was a little itchy at injection sight about 1 hr after. Around 5pm when leaving work felt like she wasn't swallowing like normal and her throat felt a bit swollen. She works in our clinic and presented to the nurses before leaving work. Injection site without redness, swelling or rash. no rash anywhere else. Throat didn't appear swollen. Able to speak and swallow. No drooling noted. Provider assessed patient. 50 mg oral Benadryl given at 5:05pm and monitored. No worsening symptoms. Patient said completed resolved by 7pm. Nothing ever got worse. She spelt well and woke the next morning with no complaints.
PATIENT HAD RECIEVED 2 DOSES OF MODERNA AND HAD ARRIVED FOR THEIR 3RD DOSE OF THE MODERNA VACCINE. THE PATIENT WAS SEATED AT THE TIME. IMMEDIATELTY AFTER THE ADMINISTRATION OF THE BOOSTER DOSE OF THE MODERNA VACCINE, THE PATIENT LOST BRIEF CONSCIOUSNESS AND CONVULSED FOR APPROXIMATELY 3 SECONDS WHILE SEATED. PATIENT REGAINED CONSCIOUSNESS IMMEDIATELY AND REMAINED SEATED WHILE BEING ATTENDED TO. NO MEDICATIONS WERE ADMINSITERED TO AID THE PATIENT. THE BLOOD PRESSURE WAS TAKEN ABOUT 5 MINUTES POST-EVENT, AND READ 123/76. PATEINT  WAS GIVEN WATER, AND WAS MONITORED FOR 30 MINUTES. PATIENT DID COME WITH THEIR PARTNER AND WAS TAKEN HOME AFTER OBSERVATION ON SITE AT THE PHARMACY.
Pt vac with DTP/OPV/MMR/HIB developed fever of 104, pain swelling rt leg. Body rash. Fever/temp cont until 21DEC90. Started on amoxicillin for  "red throat".
This spontaneous report was received from a registered nurse and refers to a 4 year old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 28-SEP-2016, the patient was vaccinated with an improperly stored dose of VARIVAX, lot # reported as M010476 with expiration date of 01-SEP-2017 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 1 day. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1705USA014053:
TOOK DOSE ABOUT 15 MINUTES AFTER SHE DRANK COFFEE AND CREAM; This spontaneous case report (PVX2019-1749) was received from a healthcare professional on 05-Jul-2019. It describes a 47-year-old female consumer who "took dose about 15 minutes after she drank coffee and cream" (PT: Product administration error), while being on Vivotif for typhoid prophylaxis.  Case report: The consumer took a dose of Vivotif about 15 minutes after she drank coffee and cream on 06-Jun-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took dose about 15 minutes after she drank coffee and cream" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took dose about 15 minutes after she drank coffee and cream" was considered as not applicable.
Ulcers and cold sores inside and outside of mouth. Headache for 3 days. Armpit lymph node swollen and in pain.