chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Pediatric patient received the Moderna COVID-19 bivalent vaccine as 2nd dose instead of the monovalent vaccine dose.; This spontaneous case was reported by a consumer and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pediatric patient received the Moderna COVID-19 bivalent vaccine as 2nd dose instead of the monovalent vaccine dose.) and NO ADVERSE EVENT (No adverse event) in an infant male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Feb-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 15-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (Pediatric patient received the Moderna COVID-19 bivalent vaccine as 2nd dose instead of the monovalent vaccine dose.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pediatric patient received the Moderna COVID-19 bivalent vaccine as 2nd dose instead of the monovalent vaccine dose.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Pediatric patient received the Moderna COVID-19 bivalent vaccine as 2nd dose instead of the monovalent vaccine dose.).    No concomitant information was reported. It was reported that patient received the correct dosage of the bivalent vaccine but the incorrect product as 2nd dose. No adverse reactions had been reported by the patient at this time. Age of the patient was 8 months. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-711015 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-711015:same reporter
PATIENT BEGAN TO EXPERIENCE A RASH ALL OVER THE BODY AND ITCHIN ON THURSDAY, OCTOBER 19TH
This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), EYE PAIN (eyes and ears ache), ASTHENIA (feels very weak), EAR PAIN (eyes and ears ache) and MYALGIA (whole body is aching) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024A20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-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 INFLUENZA LIKE ILLNESS (flu like symptoms), EYE PAIN (eyes and ears ache), ASTHENIA (feels very weak), EAR PAIN (eyes and ears ache), MYALGIA (whole body is aching) and HEADACHE (head hurts). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), EYE PAIN (eyes and ears ache), ASTHENIA (feels very weak), EAR PAIN (eyes and ears ache), MYALGIA (whole body is aching) and HEADACHE (head hurts) outcome was unknown. No concomitant medications were reported. The patient reported symptoms were just steady and not getting better for 3 weeks now. He had not yet reported them to his HCP. No treatment medications were reported. Action taken with the product mRNA-1273 was not Applicable.
cellulitis; big red circle swollen at the injection site (left deltoid) / swollen at the injection site (left deltoid) which was spreading down her arm; was uncomfortable; big red circle swollen at the injection site (left deltoid; This case was reported by a consumer via call center representative and described the occurrence of cellulitis in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Prior history of live shingles vaccine (received live shingles vaccine on an unknown date) and Prior history of seasonal flu shots with an associated reaction of injection site swelling (received flu shot on unknown date, refer case US2020AMR211753). Concurrent medical conditions included hard of hearing. Concomitant products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season).   On 16th October 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 20th October 2020, 4 days after receiving Shingrix and an unknown time after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced cellulitis (serious criteria GSK medically significant), extensive swelling of vaccinated limb, discomfort and erythema of extremities. The patient was treated with sulfamethoxazole + trimethoprim (Bactrim Ds). On an unknown date, the outcome of the cellulitis, extensive swelling of vaccinated limb, discomfort and erythema of extremities were recovered/resolved.   It was unknown if the reporter considered the cellulitis, extensive swelling of vaccinated limb, discomfort and erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. It was reported that the patient had the flu shot one month prior Septmber 2020). The patient did not have the lot/exp of the Shingrix. The patient had no issues with the flu shot received in September 2020 but that in the past she has had flu shots that sometimes swelled (at the injection site). The patient received dose 1 of Shingrix 0.5 ml injected into left deltoid intramuscularly. The pharmacist told her that the Shingrix shot could hurt more (than the flu shot) and warned her that she was likely to get a (injection site) reaction.  On 20th October 2020, the patient went to the doctor because she had a big red circle swollen at the injection site (left deltoid) which was spreading down her arm and was uncomfortable. The doctor diagnosed her with cellulitis and prescribed oral Bactrim DS (double strength). The patient said within 2 days (of being on the antibiotic) it went down and now it was almost resolved.  The physician advised patient not to get the second dose in the Shingrix series. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020211096:same reporter US-GLAXOSMITHKLINE-US2020AMR211753:Same patient
Patient received booster shot of Moderna on 11/4/21. Patient presented to emergency room with chest pain on 12/15/21.  Patient was monitoring HR at home and noted to have HR over 100 at rest and close to 160 with activity.  He was having shortness of breath as well.  EKG showed sinus tachycardia with T wave changes.  Diagnosed with clinically suspected myocarditis with 3 clinical findings and 1 diagnostic finding. Cardiology consulted and agreed with diagnosis Admitted with observation status on 12/15 and discharged on 12/17/21 Metoprolol added and amlodipine increased.  Patient discharged to home to follow up with cardiology. It is unknown if the Moderna vaccine is the causative agent to the patients myocarditis
S: I feel faint, I wanna lie down; feel hot O: patient c/o lightheadness post vaccine BP: 148/100 P: 76 O2: 99; mild diaphoresis A/P monitor x 30 min, gave water, check BP 11:05AM B/P 120/84; pt ambulating with no problems no complaints d/ced @ 11:10AM.
pt recv vax 22OCT96 & 29OCT96 exp n/v, vomiting blood, & diarrhea w/o fever;pt hosp & condition has been described as grave;pt has not yet recovered;
This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age (reported as a teenager). On an unknown date in January 2014 the patient was vaccinated with GARDASIL dose 1, intramuscular (lot number and expiration date was not provided). On an unknown date in 2014, after the administration of GARDASIL the patient experienced reaction at the injection site described as a knot and bruising. Patient sought medical attention at an emergency room where she was treated with "steroid shot". The outcome of the events was reported as recovered/resolved. Additional information is not expected.
t>105 R, crying freq during 1st noc, inc leg swelling 3x nl size;
not feelingwell; arm pain; This case was reported by a other health professional via interactive digital media and described the occurrence of feeling unwell in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st July 2019, the patient received Shingrix. On 21st July 2019, less than a day after receiving Shingrix, the patient experienced swelling arm. On 22nd July 2019, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell and swelling arm were unknown.   It was unknown if the reporter considered the feeling unwell and swelling arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient did not feel good in morning of reporting, after his shingles shot day before reporting. The patients arm swollen from shingles shot day before reporting. The patient asked could he apply warm or cold compress.
on 4/23/21 patient phoned the pharmacy to say he had tested positive for covid 19
SINUSITIS, ALLERGY, NERVOUSNESS (ANXIETY). MEMORY LOSS, NASAL:RUNNY NOSE, VISION PROBLEM, WEIGHT GAIN, SLEEP PROBLEM, ACHE:JOINTS, IMPOTENCE, BLOOD: HIGH CHOLESTEROL, CRAMPS LEG.
soft edema noted to left lateral chest inferior to axilla measuring approximately 10cm in diameter and approximately 3-4cm in height. No erythema, no increased warmth, no streaking, no drainage, no lesion, no induration. Does have left deltoid "tightness" and left low back "tightness."
Sore throat; Left ear started to hurt; I am really in a lot of pain; This is a spontaneous report from a contactable consumer (patient).  A 29-year-old patient of an unspecified gender received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 14Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  Medical history was none.   The patient's concomitant medications were not reported.  On an unspecified date the patient experienced sore throat, and left ear started to hurt; i am really in a lot of pain. The event sore throat was treated with cough syrup and 2 lozenges. The events were non-serious with outcome of unknown.  The patient underwent lab tests and procedures which included Covid test: negative on unknown date.   No follow-up attempts are possible. Information about Lot/batch number cannot be obtained.
This spontaneous report was received from a licensed practical nurse and refers to a pediatric patient of unknown age and gender. There was no information about the patient's pertinent medical history, concurrent conditions, and drug reactions or allergies. The nurse reported that her facility received a shipment of PROQUAD which was mistaken for M-M-R II, and additionally, it was improperly stored on 10-NOV-2016. The temperature was maintained between -9 and 8 Celsius degrees (with a maximum of 6 Celsius degrees) for 143 days. There was no previous temperature excursion. Subsequently on 20-FEB-2017, the patient was vaccinated with a dose of PROQUAD lot number: M033612, expiration date: 14-JAN-2018 (strength, anatomical location, dose, frequency, and route of administration were not provided) for prophylaxis, which was reconstituted with a properly stored sterile diluent, instead of a dose of M-M-R II. Additionally, on the same date and as a concomitant therapy, the patient was vaccinated with a dose of VARIVAX (strength, anatomical location, dose, frequency, route of administration, lot number, and expiration date were not provided) which was reconstituted with a properly stored sterile diluent, also for prophylaxis. No adverse effect reported. The call was not because of a "data logger". There was no product quality complaint involved. This is one of four reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA002246: US-009507513-1704USA014145: US-009507513-1704USA014147:
For the first hour or hour and a half, I felt fine. During this time I felt no pain or arm soreness around vaccination site. After, at about 2 hours I felt a slight pain and soreness in my arm at the vaccination site that started to intensify. At about the time, I started to feel tired. At about 3.5 hours I felt slightly more tired and fatigued but it was manageable. Later that evening at about 6, the symptoms of fatigue, confusion, arm pain, and lightheaded-ness started to really hit me. This is where it was at it's worse and I felt like I was actually sick. However, whether it was due to the vaccine or not, I did not sleep very much this evening.   Today, 12/30, I feel better and noticed that my fatigue had mostly subsided.
Patient did not have vaccine card with her today, so Lot number was unavailable  Sepsis- developed on day 1 post-2nd-vaccine  Thrombocytopenia  B-cell lymphoma  Henoch-Schoenlein purpura/IgA vasculitis
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Nov2021 at 14:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 55 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2022) Negative; (Apr2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Were you/Was the patient taking any other medications/products within 2 weeks of starting COVID-19 treatment?: No. Did you/the patient previously receive a COVID-19 Vaccine?: Yes. Reported Event: Took Paxlovid got a negative test-5 days later symptoms returned-tested positive AGAIN-remained positive for another 5 days-struggling with dizziness and nausea ever since-same thing happened to spouse  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I had an extremely heavy period after my first moderna vaccine. My period was earlier than expected and I passed larger clots than normal.
Patient had a covid vaccine today at 1:45 pm and it was discovered at 4:45pm that the vaccine given was expired. It was reconstituted yesterday 8/10/2021 at 9:50 am.
Moderna Covid-19 Vaccines (Lot#002C21A; expiration date 10/14/21) were sent to our facility from a larger facility within our enterprise. The vials were sent in a bag with a sticker on the bag indicating the expiration date from the removal of the freezer which was 6/24/21. An RN drew up vaccines from these vials without realizing/seeing the expiration date on the bag. The RN labeled the drawn-up syringe with the expiration date/time since puncture of the vial. The vial itself did not have an expiration date on it. This patient was given this dose of the Moderna vaccine on 6/30/21.
Very sore leg at injection site for 7 days, residual pain for 14 more days.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 39-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. No Medical History information was reported.On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.The  concomitant medications on use were not provided. No treatment information was provided.The vaccine was stored in freezer and taken out one or two vials and placed in fridge each day as needed.
redness at injection site/ large red circle and progressed up to the shoulder and down past the elbow; swelling at injection site; injection site area was hot as well; Rash; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th June 2019, the patient received the 1st dose of Shingrix. On 13th June 2019, less than a day after receiving Shingrix, the patient experienced injection site erythema, injection site swelling and injection site warmth. In June 2019, the patient experienced rash. In June 2019, the outcome of the injection site erythema, injection site swelling, injection site warmth and rash were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site warmth and rash to be related to Shingrix.  Additional details were provided as follows: The patient received the first dose in the left arm.  The patient experienced redness and swelling at injection site. It was described as a large red circle and progressed up to the shoulder and down past the elbow with a small amount of swelling. The area was hot as well.  The patient went to urgent care for treatment on 16th June 2019 and was provided with medication.  The symptoms resolved within 10 days after vaccination.  The reporter did not consent to follow-up. For tolerance of 2nd dose, refer case US2021AMR030053.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR030053:same reporter
pt devel severe h/a which lasted until 1NOV93; p/taking medication sx resolved;
After the vaccination she had sore arm, and just kind of felt bad. The next day she had aches and [pains, chills, and a slight fever 101. These symptoms continued for 3 days and she remained inactive and read books on her tablet for those 3 days. At 10PM Monday night, she told me she told me she had a flashing light in the left outer corner of her eye. She didn't have a headache, but she said her eye ached. The next morning, I called her doctor and spoke with the nurse and we made an appointment for her to be seen at 5PM that day. The nurse asked if she had a headache and she didn't, she only had an ache in her eye. She instructed me to give her TYLENOL 325mg. I did, and within 40 minutes the flashing lights stopped, and the ache in her eye was gone. 4 hours and 20 minutes later, the flashing light returned as well as the ache in her eye. We went to the doctor and she said she seemed to be ok neurologically, and felt that she had done too much reading and strained her eye. She suggested we go home and she stay quiet for a day or two and call her if things got worse. As of today she has no flashing lights, no ache in her eye, and her temperature is 99.9. I notified her eye doctor about these symptoms as well.
Migraine headache within 3 hours of vaccine. This was the exact same headache I had described a couple days after my first COVID-19 vaccine on 12/24/20. The pain started in the base of my skull, and radiated up around the outside and back of my head and in the front by my eyes. This lasted about 6 hours this time. I used iced, heat, and Excedrin Migraine. That did help this time. I also had hot flashes for about a week afterwards. My face, ears, chest and palms of my hands turned bright red off and on during the day. I took some Benadryl and that seemed to help.
Pt recvd 1st series of Hep B vax in 1988 & a 2nd series of vax Engerix-B in 1989; 10MAR92 titer test performed-not protected;
After about 20 minutes of observation of the patient, she approached the pharmacy and told me that she was not feeling well. She said that she felt light-headed and that she was itching all over. I gave her Benadryl 25 and asked her wait around. After about 10 minutes she said that she needed my help. She said that she needed an EpiPen shot because her heart was racing, she was sweating, and her tongue was beginning to feel swollen. I gave her the EpiPen shot and called 911. She was released from the hospital about midnight.
pressure headache, nausea (vomited once), chills, fever, congestion, muscle aches, joint pain, lymph node pain, swelling and pain at vaccination site (48 hours in)
A non-serious report of administration of expired FluMist has been received from a nurse concerning a 39-month-old male. This case is submitted in accordance with manufacturer's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. Neither medical history nor concomitant medications were provided. The patient received FluMist on 13-Mar-2008. The FluMist had expired on 10-Mar-2008. The reporter stated that she received 100 doses of FluMist from the program on 22-Feb-2008 and the vaccine expired on 10-Mar-2008. The clinic did not realize the expiration date on the product and continued to given it from 11-Mar-2008 to 17-Mar-2008 to 26 patients. The patient had no adverse events at the time the report was received. Neither as of 18-Apr-2008 when the office was contacted for follow-up information. No adverse events were reported. The event has resolved. It was not reported whether or not FluMist was re-administered. The reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. Follow-up information received 18-Apr-2008 and incorporated into the narrative: no adverse event occurred. This case is linked to following 25 other cases reported from the same reporter: MEDI-0006660; MEDI-0006661; MEDI-0006662; MEDI-0006663; MEDI-0006664; MEDI-0006665; MEDI-0006666; MEDI-0006667; MEDI-0006668; MEDI-0006669; MEDI-0006660; MEDI-0006670; MEDI-0006671; MEDI-0006672; MEDI-0006673; MEDI-0006674; MEDI-0006675; MEDI-0006659; MEDI-0006677; MEDI-0006678; MEDI-0006679; MEDI-0006680; MEDI-0006681; MEDI-0006682; MEDI-0006683; MEDI-0006684.
Patient received vaccine at approx. 1500, then an hour later the patient checked himself into the ER.
Everything felt normal till the third day my armpit started hurting in one specific area. When I put my arm down and twist back a little bit my veins hurt feels like needles poking my arm and if I raise my arm above my head my armpit starts to hurt. Once in awhile I get a sense of numbness on my left side where I got my shot from my ribs to my neck.
Moderate Pain at injection site, severe headache, chills, all over body aches, low grade fever, nausea, vomiting