chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt was given given first dose early afternoon on 8/09/21 and was monitored for 15 minutes after with no adverse response.  Pt then returned to clinic on 8/10 at 10am with rash and hives on torso and lower extremities which included redness and itchiness that he reports began to appear within 4 hours after vaccine. Pt denies SOB, dizziness, confusion, wheezing, palpitations, breathing difficulties, itchiness of tongue, mouth, eyes, nose, or throat.  When pt came to clinic on 8/10, he and family representatives stated that the rash and hives have decreased in size and redness since appearing that prior evening.  Pt reported no changes in body lotion, body soap, laundry detergent or any other products that come into contact with skin.   The pt was advised to take benedryl for symptom and advised about sleepiness that could occur.  Pt was f/u with the next day and reported that the benedryl does help but makes him sleepy however when the medication began to wear off he would begin to be itchy and hives would appear.  He was then given ED precautions but still was denying SOB, wheezing, cough, itchy throat, or swollen tongue.  Pt had an in-person f/u appt on 8/12 in which rash had resolved after treatment with benedryl on 8/11. MD was consulted and recommendation was to not receive second dose of mRNA vaccine.
Information has been received from a pharmacy manager who was also a pharmacist, via a field representative referring to an unknown number of patients. On unknown dates, the patients was vaccinated with PNEUMOVAX23, (lot number, expiry date, route, dose and frequency were not reported). On an unknown dates, the patients experienced a general feeling of being worn down after receiving PNEUMOVAX23. The outcome of the event was unknown. The patients sought unspecified medical attention. Additional information has been requested.
Site was very achy and red. Very painful, I started aching really badly, and there was a headache too along with the body aches. Took Tylenol extra strength for 2 days and then I was fine.
Arm of administration with cellulitis, swollen, red, warm - 24 hrs after shot administered. Treated with antibiotics for 10 days.
Within seconds increased heart rate shortness of breath light headedness and dizziness but thought it could have been anxiety. Did not say anything and sat there for the 15 minutes with continued shortness of breath and high rate think it was anxiety. When the time was up I continued to stay at the hospital for an hour due to fear of bad reaction. Started to become extremely nauseous within 30 minutes and loss of appetite. Went to bed and woke up with a terrible headache, body aches, extreme fatigue and a 100.3 degree fever. Slept for 8 hours during the day waking up due to the pain in my body and chills but the symptoms went away by 5 pm the following day of the shot.
Sore arm after first dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm after first dose) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03(0/6)A21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Allergy to antibiotic (amoxicillin) and Blood pressure high. Concomitant products included METOPROLOL TARTRATE for Blood pressure high, FENOFIBRIC ACID for Triglycerides, OMEGA-3 FATTY ACIDS for an unknown indication.    On 25-Mar-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 PAIN IN EXTREMITY (Sore arm after first dose). At the time of the report, PAIN IN EXTREMITY (Sore arm after first dose) outcome was unknown.            It was stated that batch number 03(0/6)A21A (was not clear if third figure was 0 or 6)  Other concomitant medication included zentrum silver vitamin, daily. No treatment information was provided by reporter.   This case was linked to MOD-2021-274594 (Patient Link).
Red rash and hot to the touch, swelled to the size of a small egg within 3 hours of administration. On the third day, pt went urgent care and the md there determined cellulitis from the PNEUMOVAX. Prescribed mupiricin oint and clindamycin capsules.
The first day I was a little achy and blah feeling then later in the evening I had a little headache with it, into the night I had a low grade fever.  The next morning I had flu symptoms so I took acetaminophen every six hours, drank a lot of water,and rested throughout the day. Next day the body pain and chills are gone but still feel tired.
On 4/10/2021 started itching, with rash on Left Lower back, size of an orange," horrible itchy and raised." Also developed rash on leg, which improved after use of cortisone. Left back has not improved with treatment of cortisone and benadryl. Made appointment with PA on Monday 5/24/2021.
I tested positive for covid on 1/08/21. I had the Moderna vaccine 1st dose 4/12/21 at 8:30am. No significant immediate reaction to the vaccine. Pain worsened at the injection point, but never significant, slight headache, tired, mild flu symptoms grew through the day. At 9:30PM I experienced Fever(101.6 at around midnight after fever had broke was probably higher between 9:30PM and 11:30pm). I experienced chills and violent shaking from approximately 9:30pm to 11:30pm, as bad or worse then the original covid from January. I was unable to sleep and finally took 2 Advil 200mg each at 3:00am. Advil helped and eventually fell asleep around 3:30am. Online information suggests that the 2nd dose generally has more severe reactions. I am concerned how much worse it will be and considering not getting the 2nd dose scheduled for May 10. Tuesday April 13 I experienced slight headache, body aches and exhaustion in the afternoon. Took Nyquil  severe cold and flu Tuesday evening and sleep well. Wednesday experienced lesser symptoms. Thursday had lower back and kidney area soreness. Friday april 15 back to normal.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2014, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2015, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as severe 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.
hot to the touch; she found a big round rash/one inch below where she got the injection; home because she was not feeling well; bed all day/had to lay on the couch; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (bed all day/had to lay on the couch), MALAISE (home because she was not feeling well), VACCINATION SITE WARMTH (hot to the touch) and VACCINATION SITE RASH (she found a big round rash/one inch below where she got the injection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021, the patient experienced ASTHENIA (bed all day/had to lay on the couch). On 30-Nov-2021, the patient experienced MALAISE (home because she was not feeling well). On 01-Dec-2021, the patient experienced VACCINATION SITE WARMTH (hot to the touch) and VACCINATION SITE RASH (she found a big round rash/one inch below where she got the injection). At the time of the report, ASTHENIA (bed all day/had to lay on the couch) had not resolved and MALAISE (home because she was not feeling well), VACCINATION SITE WARMTH (hot to the touch) and VACCINATION SITE RASH (she found a big round rash/one inch below where she got the injection) outcome was unknown.            Concomitant medication information was not provided by the reporter.                            Treatment information was not provided by the reporter.
injection site is red; injection site is swollen; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (injection site is red) and INJECTION SITE SWELLING (injection site is swollen) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to Dosage 2. On 28-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (injection site is red) and INJECTION SITE SWELLING (injection site is swollen). At the time of the report, INJECTION SITE ERYTHEMA (injection site is red) and INJECTION SITE SWELLING (injection site is swollen) outcome was unknown.            No Concomitant medication were provided No treatment were provided
Sick; Initial information received on 05-Feb-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp via social media.  This case involves Adult patient of unknown demographics who was sick while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (formulation, route, frequency, lot number and expiry date was unknown) in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious event "sick" (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported" I stopped getting sick when I stopped getting the flu shot. You clowns peddle your dope to someone else."   Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (Sick).  At time of reporting, the outcome was Unknown for the event sick.
Left thigh. Patchy rash at injection site on Lt ant thigh. Rx'd topical H.C. cream.
No additional AEs; using 2 pediatric VAQTA to equal an adult dose of VAQTA administered to a 19 year old; This spontaneous report was received from a medical assistant and refers to a 19-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 13-APR-2022, the patient was administered 2 pediatric doses of hepatitis A vaccine, inactivated (VAQTA) to equal an adult dose of hepatitis A vaccine, inactivated (VAQTA) (1 ml, for prophylaxis; route of administration, lot # and expiry date were not provided). No additional adverse events were reported.
chills, body aches, uncontrollable shaking, fever, vomiting, night sweats, pain in left arm
Pt has had a rash on neck and face X 3 days. She reports its slightly itchy, swollen and red. Not painful. It started on neck and spread to face. No fever, no trouble breathing. Very slight tight feeling in her throat yesterday with mild difficult in swallowing, but otherwise no issues swallowing/breathing today. Had first dose of covid pfizer vaccine 10 days ago. Has tried benadryl and hydrocortisone (one dose/application each) with no significant improvement.
Patient is taking Humira so she should not have received a live vaccine(vericella).  Patient instructed to hold Humira for 3 week if able. Patient is to watch and report to us any signs of chicken pox.
Fever 99.6 Extreme body aches Nausea Headache Fatigue  Diarrhea Rash at injection site Sore at injection site Pain in the glands on arm of injection site  Lethargy
Headache night of injection, redness, swelling & pain at site of injection, high fever & flu like symptoms 24 hrs post injection; by second day swelling pain & redness extends from armpit to elbow..tingling & numbness extends to hand.
forgot to mix the vaccine; only got the adjuvant injected; This non-serious case was reported by a consumer via call center representative and described the occurrence of inappropriate preparation of medication in a 80-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26-MAY-2023, the patient received the 1st dose of Shingrix (intramuscular, right arm). On 26-MAY-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: forgot to mix the vaccine) and inappropriate dose of vaccine administered (Verbatim: only got the adjuvant injected). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 26-MAY-2023 The patient reported that he received his first Shingrix vaccine, in the right arm and about 5 minutes later the pharmacist called back to tell the patient  that he forgot to mix the vaccine and he only got the adjuvant injected. The patient said he went back to the pharmacy, per the pharmacist request, and received the complete Shingrix vaccine in the same arm, in the same spot, about 15 minutes later.  The patient asked was this vaccine going to be effective. The patient phoned his primary doctor after the pharmacist gave him the second shot and his doctor told him to call GSK. The reporter consented to follow up. The patient received only adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
13 month old female with crying which started 1 hr after immunization. Pt had a 30 minute nap inbetween then continued crying. 1 episode of vomiting (milk that was ingested). Pt seen in office, crying stopped, tolerated PO, playful, active, afebrile.
FATIGUE AFTER SECOND COVID DOSE; SPOT ON LEFT SHIN FLARE UP; FLARE UP ON HANDS/PALMS; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (FATIGUE AFTER SECOND COVID DOSE), SKIN DISORDER (SPOT ON LEFT SHIN FLARE UP) and CONDITION AGGRAVATED (FLARE UP ON HANDS/PALMS) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Jul-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 20-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (FATIGUE AFTER SECOND COVID DOSE), SKIN DISORDER (SPOT ON LEFT SHIN FLARE UP) and CONDITION AGGRAVATED (FLARE UP ON HANDS/PALMS). At the time of the report, FATIGUE (FATIGUE AFTER SECOND COVID DOSE) outcome was unknown and SKIN DISORDER (SPOT ON LEFT SHIN FLARE UP) and CONDITION AGGRAVATED (FLARE UP ON HANDS/PALMS) had not resolved.            No relevant concomitant medications were reported.   The reporter's causality for the events spot on left shin flare up and flare up on hands/palms with humira was reasonable possibility. The reporter's causality for the event fatigue after second covid dose was no reasonable possibility.  It was unknown if patient was enrolled in a COVID-19 vaccine trail  No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Back of (L) arm, swelled on Wed. afternoon.  Very red and itching.  Instructed to apply heat Q3-4hr.  PRN and MOTRIN.  Appt on Thurs.  Warm extremely red, swollen and temp 101.7.  Given IM ROCEPHIN.
On 23Oct91 had 2 febrile seizures assoc /c T 105.Was seen in ER fever etiology unknown. DX FUO
I had a flu shot at 6 o'clock in the evening last Wednesday. At 9, I was really cold so figured I was tired. Well, I had a fleece jacket on, which I left on when I went to bed b/c I was so cold. At 11:30, I woke up shivering. Obviously, I had a high fever but didn't know if I should take anything for it because of the flu shot. So, I just stayed in bed and hoped it would subside and that I'd fall asleep again. I shivered for two solid hours before things settled down and I was able to fall asleep again.   Then, at 4:30 I woke up again (with a headache, aches, and a fever). This time I got up and took my temperature b/c I didn't feel quite as bad as last night: it was 101.4. I still didn't take anything b/c I wanted to speak with a medical person before doing that. At 8 am my temperature was 101.8, and I had a headache and some aches. I called the town health dept. when it opened, and they referred me. The nurse told me to take acetiminophen, not aspirin. I did that and my fever was gone within about 45 minutes. Four hours later, I took two more b/c I didn't feel well, but never got the fever back again. By the next day, Friday, I felt pretty good again.
Pt complaint of bumps and blisters that broke and of a patchy rash that is itchy, and with pain and occurred below injection area on the bend of the arm and elbow.
Two days after my vaccine it was swollen and sore under my armpit on the left arm, same as the vaccine site.  It went away two days later. I did not see this as a listed side effect and report it for your information.
Case number PHEH2015US003135 is an initial spontaneous report received from a nurse on 10 Feb 2015. This report refers to an 11 years old patient whose gender was not reported. The patient's medical history and concomitant medications were not reported. On 14 Jan 2015, MENVEO (batch number: M14071, expiry date: Nov 2015) was at 0.4 degree Celsius for 1 hour and 16 minutes and the patient received 0.5 ml intramuscular dose of this frozen vaccine with excursion on 02 Feb 2015. The vaccine had two more other excursion as follows: on 24 Jan 2015, the vaccine was at 0.8 degree Celsius for 36 minutes and on 31 Jan 2015 the vaccine was at 0.6 degree Celsius for 35 minutes. No adverse events were reported following the maladministration.
Pt receved 3rd dose of Pfizer 12 and up. Was not eligable for 3rd dose or booster. No medical or adverse reaction noted at time of administration or reported since. No medical attenction required.
Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a consumer regarding her 12 year old daughter who experienced gagging, eyes watered, awful taste, headache, stomach ache and runny nose. At 12 years of age, the patient received a dose on 07-Nov-2003. Medical history: relevant medical history was not provided. Product details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on 07-Nov-2003. Dose regimen was 0.5 mL 1 time per day (nasal). Concomitant therapy: Concomitant therapy included Motrin (ibuprofen). Event details: The patient experienced gagging (retching), eyes watered (lacrimation increased) and awful taste (dysgeusia) on 07-Nov-2003. Two days later she developed headache (headache), stomach ache (abdominal pain upper) and runny nose (rhinorrhea) on 09-Nov-2003. Related Case (s): See related case(s): HQWYE944711NOV03 (adverse even, non-expedited) and HQWYE956611NOV03 (adverse event, non-expedited). No additional information was available at the time of this report.
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriasis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medication was provided.  Company comment- This spontaneous case concerns a male patient of unknown age, with no relevant medical history, who experienced unexpected, non-serious AESI Covid-19 which occurred at an unknown time with regards to the mRNA-1273 vaccination. No further information was provided. The outcome of the events was reported as resolving. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a male patient of unknown age, with no relevant medical history, who experienced unexpected, non-serious AESI Covid-19 which occurred at an unknown time with regards to the mRNA-1273 vaccination. No further information was provided. The outcome of the events was reported as resolving. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
This spontaneous report was received from a medical assistant referring to a 15 year old male patient. The patient's medical history and concurrent conditions were not reported. Concomitant medication included sterile diluent (manufacturer unknown). On 01-MAR-2018, the patient was administered an improperly stored GARDASIL 9 (lot: N026814; Expiry date: 15-JUL-2020 and lot reported as "N021572"; Expiry date: 01-MAY-2020) (product storage error) reconstituted with a properly stored sterile diluent (lot and expiry date not reported) for prophylaxis. The vaccine was exposed to 47 degrees F to 77 degrees F (67.3 degrees F) for 10 hours, 30 minutes. There was no previous temperature excursion. There was no involvement of digital data logger. This is one of the several reports linked via same reporter link.
Redness & swollen at injection site, given clindamycin large for first 4 days & 2 inch in diameter & hot to touch after 5 days.
Patient received vaccine on 11/13. Noticed around 9pm the same night of the vaccine, patient noticed redness on her the upper arm toward the front of shoulder. Then developed two blisters filled with clear fluid that patient noticed in the next morning, no pain, no swelling at site, still had redness. On Sunday night 11/15 the blisters burst still no pain, no itching, no other symptoms. Today on 11/16 it is forming another blister. At the site where the injection was given there was no redness, no swelling, but arm was sore. Did report it to dr's office.