chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients, after the manufacture date of expiration) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Vial did not undergo temperature excursion. Total of 102 doses were given from LOT 026C21A. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live non significant follow up. No new clinically significant information received.
Starting 11/27/2022, I got up and my head was stuffy and my throat was a little sore and I felt achy all over. After eating breakfast, I checked my blood pressure and blood sugar since I still felt poorly and they were normal. My nose felt stuffy and my throat was scratchy so I did an at-home COVID-19 test which was negative. So, I thought I had a cold. The next morning I still felt congested and lightheaded. I took another at-home COVID-19 test (11/28/2022) which was positive. I called my doctor to see what I could do. I was having a headache, body aches all over, some neck pain and no shortness of breath. My doctor sent in a prescription for PAXLOVID that evening. I wouldn't return back to work until 12/11/2022. I started feeling better by about 12/03/2022 and I started testing negative for COVID-19 by 12/09/2022. My right ear was bothering me during this time and, to this day, it is still aching from time to time.
Information has been received from a school nurse concerning a female child with no known medical history or allergies who in 1999 was vaccinated with varicella virus vaccine live. The lot number was not available because the child was not vaccinated at school. On approximately 16SEP2003, the patient developed chickenpox which was described as mild with 30-50 lesions on the her trunk and under her arms. Unspecified medical attention was sought and there was no product quality complaint involved. Additional information has been requested.
pt recvd vax 21FEB93 1130PM & exp t105 & inconsolable crying 4 hrs taken to ER:
Shingles.  Patient reports she had shingles last year shortly after receiving influenza vaccine.
Moderna COVID-19 Vaccine EUA  I was in the shower at 5:45pm when my left arm began to itch.  I scratched my arm a few times.  Then, I looked at my arm and noticed that it was red.  There was a red area in the exact place where I received my Covid vaccination 8 days earlier.  There were also red scratch marks from where I itched the site.  A few minutes later, the itching had subsided, but the red mark was still visible.  I got out of the shower and took pictures of this mark.  The mark was on my left arm, where I received my Covid vaccination, and was in the shape of a defined square/oval.  At the time of this report, it has been approximately 3 hours since I first noticed this reaction.  At this time, the red mark is still visible, but the it does not itch.  The red mark on my arm looks similar to images of "Covid Arm" I have seen reported online.  Additionally, a few days (1-3 days) before this reaction, I had the feeling of discomfort in my left armpit.  From my personal experience, this feeling was consistent with the feeling of a swollen lymph node under my armpit area.  I felt this feeling for approximately 1 day total.  I thought nothing of the discomfort at the time.  The uncomfortable feeling in my armpit subsided approximately 1-2 days before the skin reaction on my arm occurred.  I do not know if these events are related, but they occurred in the same arm (left arm) where I received my Covid vaccination.
Swelling right arm - later that evening - still slightly swollen 2 days post-immunization.
Vaccine was administered at 0840. While waiting, pt reported shortness of breath, feeling faint, and hot flashes beginning at 0852. B/P was checked at 0854 and nurse unable to hear clearly. Patient wears O2 continuously at 2L/min via N/C. Patient, herself, increased O2 to 4L/min. Cool rag was given to patient and patient was taken to a separate room. Ambulance was called. Two nurses were present through this point, LPN and RN.  Upon ambulance arrival, LPN left room, RN remained in room with patient and ambulance personnel.  B/P was rechecked upon ambulance arrival and recorded at 182/88. Heart rate 101 bpm but recorded as high as 124 bpm at different times. RN reported lungs to have crackles throughout and labored breathing. Patient refused multiple times to be taken by ambulance. Family was contacted by ambulance crew and nephew arrived on scene. Patient's nephew took patient home by private vehicle. Ambulance personnel and RN continued to encourage patient to seek medical attention as a precaution. Patient insisted when she got home she would take a nebulizer treatment and would feel better.
Moderna dose 1, received 01/14/21.  By 5 pm of same day, Left deltoid muscle was very painful, swollen, red, very warm to the touch.  Latex bandaid has left a mark. Aching at left trapezius and left clavicle. Day 2:  Same side effects, still very painful.   Day 3: No pain, injection site, left deltoid, still swollen, red, warm to the touch and itchy.  Right elbow joint pain. Days 4 -8: Left deltoid/Injection site: Still swollen, red, itchy, warm to the touch. Still have red mark from the bandaid.
BLOOD PRESSURE SHOT UP 60 POINTS WITHIN 15 MINUTES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced blood pressure shot up 60 points within 15 minutes. Laboratory data (dates unspecified) included: Blood pressure increased (NR: not provided) Shot up by 60 points. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood pressure shot up 60 points within 15 minutes was not reported. This report was non-serious.
Patient came in for her first scheduled Moderna vaccine. When the pharmacist went out to give the vaccine, the patient was visibly scared. She was crying and bouncing her leg nervously. When asked if she still wanted to get the vaccine, she said yes. Once given Moderna the patient felt dizzy. She was instructed to set back into the chair to prevent a fall. While dizzy, the patient again started crying. She did not actually lose consciousness. The patient was attended to closely (the pharmacist stayed with her throughout the duration). After 10 minutes the patient said she was feeling warm and was given a cold wet paper towel. After 10 more minutes the patient said she was doing okay and wanted to leave to get a drink. She left and was instructed to come back around 5 (she would be on lunch at the time). The patient returned and said she was fine.
VOMITING, FAINT, INTENSIFIED MY BACK PAIN SIGNIFICANTLY, HEAD WAS SPINNING, LOSS OF APPETITE. 2 DAYS LATER, THE SAME.
Started feeling cold and got chills around 9 PM. Started getting severe muscle pain EVERYWHERE. Took temp and it was ok at 98. Went to bed after taking 1000mg Tylenol.  Could not get warm, shivering and shaking. Extreme body pain in neck, back, toes, heels, hips, head. Burning pain sensations.  Had this same type reaction from the first shot in November but thought it could be flu.  Still in the midst of the reaction right now, but the other reaction ended with profuse sweating in the morning and then it was basically gone, except I did continue with the Tylenol.  Feeling extremely painful now so took Alka Seltzer. I can not tolerate NSAIDS, so could not take ibuprofen.
Discoloration of the skin with some peeling and a large boil that is yellow in color
Excessively tired from covid booster; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Excessively tired from covid booster) 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) injection for Psoriatic arthritis and Plaque psoriasis.    No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced FATIGUE (Excessively tired from covid booster). At the time of the report, FATIGUE (Excessively tired from covid booster) was resolving.            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.  No concomitant medication was provided.  No treatment medication was provided. It was unknown if the patient was enrolled in COVID-19 vaccine trial.
Lack of drug effect; Outbreak of herpes simplex virus 1; Condition aggravated; Pain; This case was reported by a consumer via call center representative and described the occurrence of lack of drug effect in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included valaciclovir hydrochloride (Valacyclovir) unknown for herpes simplex type i.   Concurrent medical conditions included herpes simplex type i.   On 9th April 2019, the patient received Shingrix. On an unknown date, the patient started Valacyclovir 500 mg at an unknown frequency. On 12th April 2019, 3 days after receiving Shingrix and not applicable after starting Valacyclovir, the patient experienced herpes simplex type i, condition aggravated and pain. On an unknown date, the patient experienced lack of drug effect. The action taken with Valacyclovir was unknown. On an unknown date, the outcome of the lack of drug effect, herpes simplex type i, condition aggravated and pain were unknown.   It was unknown if the reporter considered the herpes simplex type i, condition aggravated and pain to be related to Shingrix. It was unknown if the reporter considered the lack of drug effect to be related to Valacyclovir.  Additional case details were reported as follows: The patient received Shingrix vaccine in left arm. Patient did not know the route of administration. Patient had terrible outbreak of herpes simplex virus 1 with pain.  The patient had a prescription of Valacyclovir (manufacturer not specified). The patient took 2 doses of Valacyclovir and as per patient "that was not enough", then took 4 doses of Valacyclovir and "that was not enough" which led to lack of drug effect. Then the patient took 6 doses for 4 days, which helped it to calm down.  The prescribed dose was not specified. The reporter did not consent to follow up.
Starting 24 hours after PENTACEL injection pt with redness/swelling & bruising of thigh extending out 4 x 4 cm in size - nontender.
Mom noticed swelling and redness at injection site 5/27/2009. Prescribed keflex and benadryl.
4 yo EPSDT visit. DTaP #5, IPV #4, MMR #2 given.  4 minutes after injections, patient flushed, red rash, wheezing.  Benadryl, epi, decadron given, IV started, albuterol-svn; paramedics arrived,  SAT 97%; transported @ 1620 to Hospital.  Child discharged home 1/28/03 stable
mother reports patient developed a fever 03/09/2023, 101.8F, shortly after experienced a seizure. Movements described as eyes rolling back, arms and legs shaking. Taken to emergency room via ambulance. Patient lethargic after seizure. Given Tylenol for 24 hours after seizure, had one more episode of fever (102F) no report of seizure. No history or family history of seizures.
pt fretful @ 7AM morning following vax, no fever noted;fed & put back to bed discovered by mom 10AM in bassinet lifeless, lying prone w/face in pool of saliva & blood
Coughing, wheezing, shortness of breath, tachycardia, @0530, treatment included Bi-pap, iv steroids, breathing treatments, chest xray, blood work, antibiotics, po steroids, inhalers.
AA FEMALE PT C/O FACIAL MUSCLE TIGHTENING ON LEFT SIDE OF HEAD, FACE, NECT AND SHOULDER THAT PROGRESSED TO THE RIGHT SIDE OF HER HEAD AFTER 10 MIN OF CLOSE OBSERVATION. PT STATES SHE HAS EXPERIENCED A SIMILAR REACTION WITH OTHER INJECTIONS (IE BLOOD DRAWS). SHE WAS COMFORTABLE WITH CONTINUING HER THERAPY AT HOME AND TOOK PO EXTRA STRENGTH TYLENOL. PT IS AWARE TO CONTACT URGENT CARE IF HER SYMPTOMS WORSEN. PT LEFT OBSERVATION SITE WITH FRIEND DRIVING.
Patient admitted with cough and shortness of breath. Utilized nasal canula and bipap during admission. Patient received remdesivir and prednisone during stay.
Patient called us 10/13/2021 said she developed rash all over chest and arms one week after receiving vaccine which was on 9/3/2021. She saw her primary care MD Dr. and stated she was treated with a shot of something at his clinic on 9/10/2021.
pt recvd vax; devel t of 103.7 R 24 hrs p/ vax; septic W/U neg; no residual problems;
Patient stated arm was swollen and in pain the evening after the vaccination. Patient self-treated with naproxen and 2 days later, when they called to inform us of the reaction, the pain has since subsided, however their arm is still swollen.
Patient had vaccine at pharmacy.   Patient states that within hours of receiving Shingrix her arm was sore, she got a headache, nausea, slight fever, and fatigue (tiredness).  The next day she states she had hives on her arm, chest, and forehead. Patient took Benadryl for a few days.  Now need to know if she can have the second dose?
2 days after vaccination patient experienced redness, itching and hives at location of injection site and then the rash spread all over torso and body. Patient spoke to physician and was put on OTC hydrocortisone 1% and BENADRYL. Patient's have subsided since the treatment, still have a few hives and redness, but the severity has subsided.
Moderna COVID?19 Vaccine EUA  Rash appeared on the arm around the injection local
bi-lateral Orbital swelling, though more pronounced on right eye, indicative of allergic reaction
had little circle with small lymph on it at injection site on her left arm; approx 5-6 days later the following week the redness started to spread from topical side and past; hard to touch; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE LYMPHADENOPATHY (had little circle with small lymph on it at injection site on her left arm), VACCINATION SITE ERYTHEMA (approx 5-6 days later the following week the redness started to spread from topical side and past) and INDURATION (hard to touch) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 immunization.     The patient's past medical history included Multiple sclerosis (from last 40 years).    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE LYMPHADENOPATHY (had little circle with small lymph on it at injection site on her left arm), VACCINATION SITE ERYTHEMA (approx 5-6 days later the following week the redness started to spread from topical side and past) and INDURATION (hard to touch). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, VACCINATION SITE LYMPHADENOPATHY (had little circle with small lymph on it at injection site on her left arm), VACCINATION SITE ERYTHEMA (approx 5-6 days later the following week the redness started to spread from topical side and past) and INDURATION (hard to touch) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided by reporter.
She was standing and fell straight backwards, she hit the floor with her head and her eyes rolled up and remained open as she began to convulse for about 12 seconds. She stayed still for a second with her eyes open and then appeared to come back, she did not know what happened to her. For the next 3 days she had a fever 100-102, and has been very tired.
PATIENT PRESENT REDNESS IN THE AREA OF ADMINITRATION WHICH SEEMS TO BE A CELLULITIS ACCORDING TO PRIMARY CARE PHYSICIAN.
Patient has a red welt on left thigh at injection site about 4 cm in circumference. The area is itchy, painful, dry and very red. The welt developed the same day he received the vaccine. It did start to improve after the 6th day.
11:00 pm - ish: Site of injection began burning which became more intense throughout the night. Cold sweats, severe aching and muscle weakness especially in legs, nauseous, severe headache. I tried to drink a little water. Didn't have enough energy and was too cold to get up to  get any medication. Slept a little. I was awake early in the morning, but too cold to get out of bed. At 8:30 a.m. I got up and could hardly walk. Dizzy, muscle weakness as if muscles had turned to Jell-O.. Sat down and threw up, mostly dry heaves, which lasted a few minutes. Fitful sleep until 11:00 a.m. when I began to feel better. Drank more water and just rested for a few hours. I ate some applesauce and made a batch of white rice which I ate around 6:00 p.m. Achiness in lower extremities continued until bedtime (10:00 p.m.) when I took a Meloxicam (15 mg) which my GP prescribed for achiness in my neck due to arthritis. I take this drug only when needed and thought it would help the aching in my legs. Maybe it did...maybe it was a coincidence that the achiness was alleviated enough for me to go to sleep. I am almost 100% today. It takes a little longer at my age to fully recover from any illness however slight. I would like to add that I am grateful to be vaccinated.
Patient administered vaccinations while unknowingly pregnant (last menstrual period was 27 June 11); reporting solely due to exposure while pregnant
I had my first J&J shot on April 11, 2021. I had no reaction or side effects beyond some slight soreness at the injection point.  I got my seasonal flu shot in early October. I don't know which one it was. It was administered at the Pharmacy. I then got my booster. I selected the Pfizer shot for my booster and had it administered at another Pharmacy (see previous info).   When I took the Pfizer booster, I had some side effects. The first 24 hours were fine. Then during the day, I found myself continuously yawning and feeling tired, but not like I couldn't stay awake. I went to bed at my normal time. I awoke in the middle of the night drenched in sweat and knew I was running a fever. I went back to sleep and when I woke up felt fine. I attributed this to the normal course of side effects from the booster. I didn't think anything more about it.  Through a series of events my pharmacy screwed up my prescription for my Lo Loestrin renewal in November. It took time to sort out with my doctor. When it was sorted out I thought it would make sense to start my new pack of pills when my period came. I have been on LoLoestrin for about 4 years. Recently, I haven't been getting my period. I know this is a normal side effect of the pill. My OB0GYN is aware of this and confirmed there is nothing to worry about. As I was going through December I still haven't gotten my period. I did experience two occasions where I had significant cramping that made me think I would get my period, but nothing happened. I took a pregnancy test to verify I wasn't pregnant. The test came back negative. I recently learned the COVID shot may impact your periods.   In thinking more about my lack of period I was reminded that I have noticed my ability to taste food and spices has been impacted. I noticed this in December while making holiday dishes. I thought my sense of taste was being impacted by Invisalign, but when removed my trays I still wasn't able to taste things to the degree I used to. I am an amateur chef and normally I would consider my sense of taste to be very refined. I can usually identify what spices are in almost any dish even if I didn't make it. I also know how to adjust seasoning based on time of cook and what needs to be adjusted based on taste. I still have the ability to taste, but it is dulled and not as refined. I can still taste wine. Some examples - I wasn't able to fully taste the curry I made for chicken tikka marsala. I also got the seasoning wrong for a NY Strip steak. I used the same seasoning and techniques that I usually use but it didn't taste good to me. The spices seemed like they hadn't melded correctly. These symptoms have continue until now. It is of concern to me and the only big change has been the Pfizer booster.
12 year and 8 day old patient. Adult pfizer (12+) was documented per lot number but dose seemed to be initially be written as 0.3 mL but visibly changed to 0.2 mL. Unclear documentation of dose administered.
24 YO otherwise healthy male presented to clinic on 29 NOV 2018 for a chief complaint of a diffuse rash without systemic symptoms. Rash first appeared approximately 10 days after vaccine administration of smallpox, JEV, and influenza. He had undergone routine screening prior to vaccination. He had no prior history of atopic dermatitis, no personal or family history of autoimmune disorders, and he had been previously vaccinated for varicella as a child. He had a diffuse pustular rash throughout the torso and extremities. The case, including pictures, was discussed with Dermatology on 29 NOV who believed this was likely generalized vaccinia. CBC, HIV, and Treponema pallidum were unremarkable. Punch biopsies obtained were nonspecific (spongiotic dermatitis) viral cultures obtained after the patient had recovered was negative for orthopox viruses, but was inconclusive for generalized vaccinia. After presentation on 29 NOV the patient was placed on quarters for two weeks, treated with ZYRTEC, and fully recovered; however, he does have post inflammatory hyperpigmentation and he ultimately may have scarring in the future.
This spontaneous report as received from a phlebotomist refers to 2 different unspecified patients of unknown age. Information on pertinent medical history of patients was not reported. On an unknown dates, the patients were vaccinated with improperly stored VARIVAX (Merck) (dose not reported, lot # L026406, expiry 15-JUL-2017). No adverse effects reported. No further information was provided. This case is one of the several reports received from the same source. Additional information has been requested.