chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Diarrhea; loss of appetite; Swelling on her right side of face/Swelling in right cheek; Muscle weakness on her right side; Tremor in right leg; Headache in right side/Headache in total head; A spontaneous report  was received from a consumer concerning a 29-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events swelling on her right side of face/swelling in right cheek/swelling face, muscle weakness on her right side/muscular weakness, tremor in right leg/tremor, headache in right side/headache in total head/headache, diarrhea, loss of appetite/decreased appetite.   The patient's medical history included liver transplant eight years ago and from eight years she was on immunosuppressant medication. Concomitant medications reported were adivant, sertraline hydrochloride, all used for unknown indication.  On 3 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 010A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 5 Mar 2021, the patient experienced the event(s) swelling on her right side of face, muscle weakness on her right side, tremor in right leg, headache on right side, swelling in right cheek, diarrhea, loss of appetite.   On 11 Mar 2021, these symptoms got worse  progressively and the patient was hospitalized on 11 Mar 2021 and hospitalization was prolonged.   On 15 Mar 2021, the patient experienced the event(s) headache, swelling in right cheek, diarrhea, loss of appetite.   Laboratory tests performed included, MRI scan ,neurologist looked at her spinal fluid, got tested for meningitis, did reading on CMS.   Treatment details included morphine and hydrocodone.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of event(s), swelling on her right side of face, muscle weakness on her right side, tremor in right leg, headache in right side, swelling in right cheek, diarrhea, loss of appetite, headache in total head was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Intermittent loss of vision in left eye from 2/28/2021 through 6/2021.  Diagnosed with Optic Neuritis. No treatment.
patient developed stroke/TIA like symptoms  O 3/28/21 AT 13:00, No significant risk factors. symptoms resolved. Patient hospitalized for 3 days.
Sore at injection site; Headaches; Muscle soreness; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 04-APR-2023, the patient received the 1st dose of Shingrix (intramuscular, left arm). On 05-APR-2023, 1 days after receiving Shingrix, the patient experienced injection site pain (Verbatim: Sore at injection site), headache (Verbatim: Headaches) and muscle soreness (Verbatim: Muscle soreness). The outcome of the injection site pain, headache and muscle soreness were unknown.   It was unknown if the reporter considered the injection site pain, headache and muscle soreness to be related to Shingrix.     It was unknown if the company considered the injection site pain, headache and muscle soreness to be related to Shingrix.   Additional Information: GSK Receipt Date: 05-APR-2023 The case was self-reported by the patient. The patient received first dose of Shingrix vaccine in evening and woke up on the day of reporting with headaches, muscle soreness and sore at injection site. The reporter consented to follow up.
Approximately five hours after receiving the shot, I developed a headache. Within 12 hours, I had chills, sweats, and fever for approximately 12 hours. The morning after receiving the shot, I developed neck and shoulder pain which became more sever on the next 2-3 days. The neck and shoulder pain has been ongoing for 5 weeks since receiving the shot on the injection side. I have seen my primary care physician twice, most recently to rule out a blood clot (yesterday 4/13). I have also received physical therapy. There was no neck injury or pain prior to the vaccine.
fever 103 (oral)-4hr p/vax;malaise, h/a;sore throat-48hr p/vax;rash on legs-72hr p/vax;
MUSCLE ACHES, HEADACHE, LOSS OF APPETITE, JOINT PAIN, CHILLS
Pt stated arm was dead and heavy, continued, was able to move it, no numbness or tingling. pt called next day arm felt fine.
Around 2/24, Pt's home health care provider found her unresponsive on bathroom floor, transport to Hospital by ambulance, hospital stay for 2 wks, dx of sepsis and Pn with sxs of <O2 and severe SOB, treated and d/c to LTC then back to home, and on 3/29, then 3/30 re-admitted to hospital again with severe SOB.
broke out / confirmed to be Pleva; Heart issues / has a heart monitor and reports extra beat; Drug dose administration interval too short; This case was reported by a consumer via call center representative and described the occurrence of pityriasis lichenoides in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had past medical history included shingles). Previously administered products included Shingrix with an associated reaction of parapsoriasis (1st dose received on 14th August 2020, refer case for 1st dose US2020199106).   On 6th October 2020, the patient received the 2nd dose of Shingrix. On 6th October 2020, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On 7th October 2020, the patient experienced pityriasis lichenoides and heart rate increased. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pityriasis lichenoides, heart rate increased and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the pityriasis lichenoides and heart rate increased to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, the patient had break out after 2nd dose administration. The patient saw dermatologist and breakout was biopsied and confirmed to be Pleva. The patient reported extra beat happened at the same time as Pleva breakouts. The reporter did not confirmed if heart issue related to Shingrix. The reporter stated that, the patient received 2nd dose earlier than the recommended schedule (2-6 months) which led to shortening of vaccination schedule.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020199106:same reporter
Presents to the hospital secondary to worsening shortness of breath, was diagnosed with COVID-19 pneumonia first positive 8/14/2021, acute on chronic hypoxic respiratory failure secondary to infection, treated with dexamethasone, remdesivir and baricitinib. Discharge Condition: Stable and Improved. Disposition: She will be discharged today to skilled nursing unit.
Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. On unknown dates, the patients were vaccinated with an unspecified number of improperly stored doses of GARDASIL 9 (lot # L016428, expiration date: 30-JUL-2017, dose and route were unknown). The patients' concomitant medications were not reported. No adverse effects reported. Additional information has been requested.
24 hours after my second covid vaccine I came down with a very intense headache like many; it was deep in my eye sockets, my ears, jaw, and teeth, a radiating, pulsating type pain. By the next morning I was better. That night, April 11, I was awoken in the middle of the night with the same kind of pulsing pain in my teeth. It became progressively worse over the next two weeks to the point where I could not rest my top and bottom teeth together or eat any kind of solid food. By Monday April 19, I went to an urgent care clinic to see if there was anything wrong with my sinuses, nothing (the doctor said at the time that if it wasn't my teeth that I should see an ENT). At this point I was taking 800 milligrams of ibuprofen every 4 hours and slathering my teeth with orajel numbing gel. By 4/21 I was able to get an emergency appointment with my dentist- she did x-rays and saw nothing. She said if the pain continued for another 2 weeks she would send me to a root canal specialist. She also encouraged me to wear a mouth guard to help. By Friday, my 2 weeks after my 2 shot, I was able to get through the day without medication. Today is Monday 4/26 and while I am almost fully better, the teeth are still sore and I can only eat mushy solid foods.
approx 1min p/vax pt slumped to rt side, hit rt side of face/temple area on refrigerator door handle;became rigid for approx 30 seconds;per PNP no LOC, pulse thready;pt c/o head & neck & lt arm pain;pt flat on floor vs monitored-911 called;
Softball size swelling at injection site lasting 3-4 days. Treated at home with ice/ cold compresses
Moderna monovalent was incorrectly administered instead of moderna bivalent as the patient's booster.
h/a, dizziness & disorder in ears are reported in pt receiving 1 dose of fluogen; pt described ear disorder as ears feeling full; sx treated w/Darvocet;
pt noticed soreness, swelling, & fever around site of vax recv  15JUL96;area 1inch in diameter by 3 inches in length, purplish-red bruising appearance on outer aspect of lt arm;seen @ clinic;affected area appears whelp-like & warm to touch;
Pt. received 2nd HPV dose, vomited after leaving facility, felt pain in side and felt "cloudy headed". Returned to Health dept. for observation. Pulse was 88, BP was 120/60, O2 was 98%. Pt. did not vomit anymore but felt faint for 5 minutes. Pt. left health dept. walking, talking o.k. Pt. was at store when she vomited.
Inadvertently mixed 1.8mL 0.9% sodium chloride into Pfizer vial 5y to 12y. Vaccine given to a adult female 28yrs. per Pharmacy director, Health center consult with Pfizer manufacture, patient to return to clinic and administer a adult Pfizer vaccine. Vaccine given to patient at 4:15pm 12/15/2021.
After vaccination, the injection site was sore but a few days later I started having pain at injection site that progressively got worse. I started having a burning that went down my whole arm to my back and up shoulders and back area, and there was numbness in my fingers.  I told the pharmacist I didn't know if I should get the 2nd dose in the same arm, but I did and everything intensified and the pain increased after I had my second dose. I reported it to my doctor and he thought it was just my muscle but it started after my vaccine. the doctor gave me Gabapentin and it kept getting worse and I couldn't use my arm, the doctor increased the gabapentin but it still didn't work and he referred me to a neurologist. I couldn't sleep at night, couldn't use the arm or lay on the arm and the doctor gave me prednisone and it helped a little, but when I stopped taking it, I went back to the same pain. I have tremors in the arm as well and it feels like there is a burning under the skin but it's not swollen, it feels like there is some numbness in it. He referred me to a specialist and I see them tomorrow.
Stomach ache; Wide noise/ ringing noise in left ear; Diarrhea; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach ache), TINNITUS (Wide noise/ ringing noise in left ear), DIARRHOEA (Diarrhea), HEADACHE (Headache) and NAUSEA (Nausea) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach ache), TINNITUS (Wide noise/ ringing noise in left ear), DIARRHOEA (Diarrhea), HEADACHE (Headache) and NAUSEA (Nausea). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at a dose of 1 dosage form. On 18-Mar-2021, ABDOMINAL PAIN UPPER (Stomach ache), DIARRHOEA (Diarrhea), HEADACHE (Headache) and NAUSEA (Nausea) had resolved. At the time of the report, TINNITUS (Wide noise/ ringing noise in left ear) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Follow-up information included no new information.
Diffusely scattered red raised areas of various sizes on both arms and right leg.  Highly pruritic.  Areas appeared 2 to 3 days after vaccination.
Summary: Abdominal pain (similar to that experienced years previously, but not experienced approx. 2 years previous to Pfizer COVID-21 vaccination) recurred after first vaccination, worsened after second vaccination, leading to 2 ER admission and hospital admission. Ultimate cause still not determined or successfully treated; pain continues treated by opoids, gabapentin, anti-nausea medication.  Patient has not been able to work since March 4th, 2021 (currently March 23rd, 2021).  Details: The day after the first vaccination, abdominal pain similar to that the patient had previously experienced, but which had not presented severely for around a two years, recurred quite severely for 4-5 days.  Missed 2 days of work. Pain reduced enough to resume work after 4-5 days.  The day after the second vaccine dosage (2 Feb 2021), the abdominal pain worsened again, becoming more severe and more prolonged than after the first dosage. Missed four days of work (not consecutive).  Pain worsened. 12 March 2021 visited PCP, who recommended immediate ER/hospital admittance.  ER could not any definite cause of pain (though 8cm fibroid present, thought to be causing lower abdominal pain but not upper abdominal) and released patient.  Abdominal pain became somewhat better but still continued.  March 6th, abdominal pain greatly increased, leading to ER visit and hospital admittance March 6th-March 9th, 2021.  CT scan 6 March 2021.  Relevant results:  Bowel: Multiple dilated loops of distal small bowel with fecalization of small bowel contents and a slow transition to normal caliber at the terminal ileum. The appendix is not visualized. The stomach is unremarkable. The colon is not dilated.   Mesentery/Peritoneum: Small indeterminate density fluid adjacent to dilated loops of bowel in the right lower quadrant.   Nodes: Scattered small abdominal nodes, none meeting CT criteria for pathologic enlargement.   Pelvis: Large uterine leiomyoma.  Uterine fibroid identified as probably source of pelvic and lower abdominal pain.  Mid and upper abdominal pain thought not to be related, however, and may be related to dilated loops of distal small bowel and adjacent fluid.  Pain treated with opoids, gabapentin, anti-nausea drugs, patient released 9 March 2021.  Abdominal pain continues, partially controlled with pain medications.  Lower pelvic pain has not recurred (birth control pills started at end of hospital visit).  Patient has been been able to work since March 4th (currently March 23rd, 2021).  Patient is applying for short-term disability due to extended absence from work caused by these issues.
at 11 hours past the vaccination time (COVID #2) I developed a rapid heartbeat > 90 and body aches.  They intensified 18 hours later and lasted another 24 hours.  I also had dry heaves(once only) and loose bowels.  I am diabetic and my sugars also went crazy.  I had to visit my cardiologist for an EKG to make sure there wasn't a problem with my heart.  I had to call my diabetes doctor several times for help with how to handle my numbers.
at 12 years 8 1/2 x 7 cm. reaction to Menactra Today (L) arm-5 x 7 cm red, indurated itchy Rx Clarinex, Cortan
Vaccine (ZOSTAVAX) given 9/10/12. About 24 hours after pt. developed rash, redness about 3 inches around vaccine area. Slightly raised complained of itching. Today 9/13 she still has rash, counseled pt. to use Hydrocortisone cream and/or BENADRYL. She has no SOB or other discomforts. (Rt. arm).
Swelling, pain, erythema, high grade fevers; limited range of movement arm.
adverse reactions; quite ill for 3 to 4 days; in bed; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (adverse reactions), ILLNESS (quite ill for 3 to 4 days) and BED REST (in bed) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (adverse reactions), ILLNESS (quite ill for 3 to 4 days) and BED REST (in bed). At the time of the report, VACCINATION COMPLICATION (adverse reactions), ILLNESS (quite ill for 3 to 4 days) and BED REST (in bed) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Reporter did not allow further contact
Information has been received from a physician and a practice manager via company representative referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 08-MAR-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ lot # L008057 and expiration date 01-DEC-2016, 2 ml administered orally. No adverse effects were reported. The vaccine had five temperature excursions one of 24 hours with a lowest recorded temperature of 8.3 Fahrenheit (F) (8.3 Celsius (C)), the second one of 8 hours with a lowest recorded temperature of 9 F (9 C), the third one of 24 hours with a lowest recorded temperature of 8.4 F (8.4 C), the other one of 24 hours with a lowest recorded temperature of 8.1 F (8.1 C) and the last one of 24 hours with a lowest recorded temperature of 8.5 F (8.5 C). The storage criteria and the type of excursion for this vaccine was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Immunization administered on 12/27/2020. On 01/04/2021 I began to break out in full body urticaria with facial edema and joint pain. Followed up with allergist and rheumatology. Both ruled out allergy or rheumatological causes. Elevated CRP of 116. Ongoing urticaria outbreak since onset.
Fever, chills, patient is being treated with TYLENOL and monitored by husband.
This spontaneous report as received from a nurse refers to an 18 year old (also reported as 19) male patient. Medical history and concurrent conditions were none. Illness at the time of vaccination was none. On 24-AUG-2015 at 09:555 am, the patient was vaccinated with a fourth dose of improperly stored GARDASIL (lot # K011562, expiry date: 08-APR-2017) intramuscular in the left arm. No adverse effect was reported. No concomitant therapy was reported. This is one of the six reports received from the same reporter. Additional information is not expected as all correspondence was received.
NUMBNESS MAINLY IN MY ARMS AND HANDS, SOMETIMES IN MY LEGS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included acetylsalicylic acid, and cyanocobalamin/pyridoxine hydrochloride/thiamine mononitrate. On an unspecified date, the subject experienced numbness mainly in my arms and hands, sometimes in my legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of numbness mainly in my arms and hands, sometimes in my legs was not reported. This report was non-serious.
This spontaneous case was reported by a consumer and describes the occurrence of VITAMIN D DEFICIENCY (NEEDS MORE VITAMIN D) and VACCINATION SITE PAIN (SORE ARM AFTER VACCINATION) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis. No Medical History information was reported. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced VITAMIN D DEFICIENCY (NEEDS MORE VITAMIN D) and VACCINATION SITE PAIN (SORE ARM AFTER VACCINATION). At the time of the report, VITAMIN D DEFICIENCY (NEEDS MORE VITAMIN D) and VACCINATION SITE PAIN (SORE ARM AFTER VACCINATION) had resolved. No concomitant medication was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality with Humira for the events of NEEDS MORE VITAMIN D and SORE ARM AFTER VACCINATION was not provided. No treatment medication was reported. 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.
I started having visions of light and disturbances on 11/19 and it became worse on 11/20. I called my optometrist for an emergency visit. She said that I was having a large vitreous detachment around my optic nerve around the center of my left eye. Right now, I have a large constellation of floaters in the center of my vision with a blurry area next to it. It was actively occurring and would likely continue over the next few weeks. I have a follow up with her in December. The other adverse event that I am experiencing is a rash. On 11/22 I went to my PCP, and she diagnosed me with Pityriasis Rosea. I noticed the rash on my torso, and my husband noticed it on my back about a week and a half after receiving the third dose. I never had a reaction after the first two doses, so I was surprised to have such a reaction after receiving a half dose for my booster.
Flu vaccine, TDaP, and Hep A given 10 min, 2 min apart. Pt passed out after Hep A vaccine. EPI given. Pt regained consciousness. Sent to ER.
Headache--which did not go away with rest or eating something; took Ibuprofen 600mg at 6:00pm. Ibuprofen helped, but headache lingered until bedtime at 10:00pm. No headache this morning 9-17-2010.
Case number PHEH2014US022649 is an initial spontaneous report received from a healthcare professional on 07 Nov 2014. This report refers to a female patient of unknown age. Her medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 1413701) intramuscularly from a multidose vial on an unknown date. On an unknown date following vaccination, she experienced pain in shoulder, pain in neck, pain in back, pain on the side of face and flu like symptoms on one side of her body. Final outcome was unknown. The seriousness and causality were not reported. No additional details were available.
Hallucination 4 hours later (saw black spiderwebs between fingers and toes and then multicolor balloons on the ceilings surrounding bedroom}
Mom reports pt devel rash on chest & both arms w/itching & burning early Sunday AM 20MAR92; pt was taken to ER & given shots;
Patient was given expired vaccine. Vaccine expiration date 09/30/2022. Vaccine administered on 10/27/2022. No adverse effects reported so far
Generalized urticaria-onset 6 hrs /p injection of 1st dose. Treatment oral Benadryl