chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After 1st vaccine my right arm was little bigger than left arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (After 1st vaccine my right arm was little bigger than left arm) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 032M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FLUDROCORTISONE for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-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 PERIPHERAL SWELLING (After 1st vaccine my right arm was little bigger than left arm). At the time of the report, PERIPHERAL SWELLING (After 1st vaccine my right arm was little bigger than left arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient stated that "after 1st vaccine my right arm was little bigger than left arm but after 2nd vaccine it got worst"  Additional concomitant medication included "birth control pills"  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-148267 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Follow up information received on 19 May 2021 contains and does not contain no new information; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-148267:Second Dose Case
Information has been received from a pharmacist concerning an approximately 10 year old female with no pertinent medical history who was vaccinated with the first and second dose of GARDASIL, 0.5 ml (dates, therapy route and lot number not reported). There was no concomitant medication. The patient experienced joint pain after getting first and second dose of GARDASIL. No lab diagnostics studies was performed. The patient sought unspecified medical attention. The outcome of the adverse events were not reported. Additional information has been requested.
Shingles despite being vaccinated/Suspected vaccination failure; Shingles; This case was reported by a physician via sales rep and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient stated that the patient had an episode of shingles despite being vaccinated.  The patient was unsure of dates. The reporter did not agree to follow up from GlaxoSmithKline. This case was considered as suspected vaccination failure, since the details regarding time to onset for event and laboratory confirmation of shingles were not provided.
Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with the first dose of VARIVAX (Oka/Merck). Subsequently, the patient developed a mild varicella-like rash. It is unknown if the patient sought medical attention. At the time of reporting, the outcome was unknown. No further information is available.
Pt given MMR on Wed. Friday pt cranky & fussy. Encouraged supportive care. Sat or Sunday pt developed rash starting on neck to chest. No SOB. Taken to ER & given steroid. Pt has severe milk allergy started coconut milk week prior to vaccines - (presumed cause) cleared after injection.
Extremely high fever over 103, vomiting, excessive crying for more than 2 hours. These lasted 2 1/2 days. Treatment was lukewarm baths, alternating Tylenol and ibuprofen, and plenty of liquids (breastmilk and water). After the initial he was not completely himself until a full week after vaccine.  a
When patient presented for second vaccine he complianed of some shortness of breath starting a few days after his first Moderna vaccine.
hives all over her body; This is a spontaneous report from a contactable consumer (patient's mom). A 16-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in right arm on 22May2021 (Batch/Lot number was not reported) as single for COVID-19 immunisation. Medical history included anxiety and high functioning autism from an unknown date and unknown if ongoing. Concomitant medications included fluoxetine hydrochloride (FLUOXETIN) and hydroxyzine taken for an unspecified indication, start and stop date were not reported. The patient experienced hives all over her body on 22May2021. They look like mosquito bites, but are not, and are on her toes, hands, torso, legs, everywhere. They are little red bumps and itchy. Like dime-sized. Some are dime and some are nickel sized. Hives started about 4, maybe 6 hours after the vaccination. Outcome of the event was not recovered, reported as worsened. Therapeutic measures were taken. She was giving Hydroxyzine and putting on a topical ointment, as Hydroxyzine is an antihistamine, stronger than Benadryl. Event did not require a visit to Emergency Room or Physician Office.  Information on lot/batch has been requested.
Information has been received from a registered nurse concerning an approximately 11 year old male who on 03-OCT-1997 was vaccinated with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (lot# 622625/0085E). Subsequently, the patient developed chickenpox. On approximately 18-OCT-2007 the school contacted the health department to describe the child's chickenpox as severity level 2, categorized as 50 to 500 lesions from the waist up (reported by nurse as varicella outbreak post vaccination with varicella virus vaccine live (Oka/Merck). The child also had a fever. Subsequently, the patient recovered from chickenpox with no problems. There was no product quality complaint. Follow-up information from the reporting registered nurse indicated that the 11 year old male developed chickenpox characterized by a rash of 50 to 500 lesions on the face and truck and presence of fever on 16-OCT-2007 (also reported as approximately 18-OCT-2007). The patient was noted to be recovered before 05-NOV-2007. This is one of four reports from the same source. Additional information has been requested.
Patient supposed to receive a second COVID Pfizer to complete the monovalent series, instead patient received a BIVALENT COVID.
Case received from a non-healthcare professional (patient's mother) on 17-Jan-2014. A male patient (no details provided), with no relevant medical history reported and no reported concomitant therapies, had received his dose of flu vaccine (manufacturer unknown, batch number, route and anatomical site of administration not reported) on 13-Oct-2013. On 15-Nov-2013, i.e. just over 4 weeks post-vaccination, the patient experienced optic neuritis, confirmed on 20-Nov-2013. He was evaluated by a neurologist and a neuro-ophthalmologist. His condition resolved on an unspecified date. The reporter was calling to inquire about his ability to receive another flu vaccine. The reporter did not want to give more information. The patient's condition led to a required doctor visit. Upon internal review, this case was assessed as serious, i.e. as an important medical event.
Pt. called Mon 10/14 and complained of arm hurting during the night. Mostly on the left side of her breast.
My tongue has been stinging ever since; difficult for her to eat because of it; This spontaneous case was reported by a consumer and describes the occurrence of GLOSSODYNIA (My tongue has been stinging ever since) and FEEDING DISORDER (difficult for her to eat because of it) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Lip operation (procedure to her top lip where liquid nitrogen was used).   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-May-2021, the patient experienced GLOSSODYNIA (My tongue has been stinging ever since) and FEEDING DISORDER (difficult for her to eat because of it). At the time of the report, GLOSSODYNIA (My tongue has been stinging ever since) and FEEDING DISORDER (difficult for her to eat because of it) outcome was unknown.            Concomitant product information, if any, was not provided by the reporter.  Treatment information, if any, was not provided.
Patient with cough, low blood pressure, nausea, she said she could not hear nothing left ear.  An alcohol was given and she sniff it and blood pressure was monitored.  started at 3:10 pm and felt very good walking with no symptoms however she and her family was told to have caution take acetaminophen for fever and pain and benadryl if rash appear,  also observation if needed to take to ER..
Pt. became diaphoretic, increased HR, nauseous, c/o hearing and vision being funny, jitteriness 25mg BENADRYL given and water. Parents called and made aware. 1st time this happened.
Client received moderna booster.  Reports within 13 hours, began having local reaction to left arm.  Whole upper part of left arm got red, hot, and warm to touch.  Had COVID symptoms- severe body aches, congestion, and headache (took home test and negative for COVID).  After several weeks, swelling in arm went away.  Five weeks after vaccination, still had body aches and bone aches and saw PCP.  Had bloodwork done to check for inflammation and several marker high including sed rate.  Reports still having bone pain and body aches.  Reports reaction similar to when had varicella systemic reaction in the past.
Left arm became numb after the vaccine injection.  Numbness  all the way  down the arm and left leg. Had chest pain and sharp pain, swollen lymph node in left axilla. Blood pressure also went up. Had to go to emergency room
The following day pt developed a lg area of redness with itching and warmth. Mother gave pt. BENADRYL. Continuing to observe.
Confirmed Breakthrough - Mixed Vaccine Manufacturers   COVID-19 (Moderna) 1 71 Years 4 Months 03/04/2021 Hospital Moderna 015M20A   COVID-19 (Moderna) 2 71 Years 4 Months 04/01/2021 Hospital Moderna 002B21A   COVID-19 (Pfizer) 3 72 Years 11/20/2021 Pharmacy Pfizer FF2590
Medical Assistant reporting a temperature excursion for GARDASIL 9 adminitestered to a patinet; This spontaneous report as received from a physician and a medical assistant, referring to a 12-year-old patient (gender not reported).  No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 31-AUG-2021, the patient was vaccinated with an improperly storage first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # T026323 with expiration date on 22-FEB-2023, at 0.5 milliliter, intramuscularly for prophylaxis.   Administered dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) experienced the temperature excursion above 47 Fahrenheit degrees (47F) for 47 minutes (occurred on 06-AUG-2021). Digital data logger was not involved. There were no previous temperature excursions reported.
Information has been received from a healthcare worker (immunization official) referring to a 15 month old patient. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 06-JUL-2015, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX, lot # K010440 dxpiration date, dose and route not reported), which was improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a  health professional concerning a 7 year old female with no allergies or medical history who on 17-NOV-1999 was vaccinated in the left arm with a first SC dose of Varivax (lot # 631526/1014J). There was no illness at the time of vaccination and no concomitant medications. On 13-MAR-2006 the patient was cranky, had decreased activity, a runny nose and nasal congestion. On 14-MAR-2006 ten spots were noticed on the patient's neck/hairline/scalp. They were non-pruritic and there was no fever. On 15-MAR-2006 10 more spots erupted on the scalp, upper abdomen and arms. The majority of the vesicles were on her scalp. By 16-MAR-2006 the lesions were scabbed and there was no fever. It was noted that the lesions became itchy on the second day. No lab tests were done. The patient developed a stomach virus following the varicella. It was reported that the patient recovered. Additional information indicated that no medical attention was sought after the 18-MAR-2006 visit. The patient recovered on an unspecified date. No further information is available.
Fever, flu-like symptoms, excessive sleeping (22 hours straight), extreme redness and swelling, approximately 5 inches in diameter.
Same day of vaccination for dose 3, I started having chills and fatigue. Two days after vaccination, I started feeling discomfort on the left side of my head and ear. Also, my heart rate would be abnormally high (upper 130's) with exertion/exercise. I was not associating it with my vaccine. In January 2022, I was still having discomfort on my left side of head and ear and heart rate was still elevated in upper 130's with exercise/exertion. I went in to see my PCP on 1-19-2022 and he ran some tests such as bloodwork and EKG. All of my bloodwork and EKG come back fine. He recommended increasing fluids for hydration. That had no impact on my symptoms at all. Symptoms had resolved by end of Feb 2022. I received my 4th vaccine on 4-27-2022 and the same symptoms came back. I am being scheduled for a cardiac stress test, date unknown.
- Significant fatigue - large rash with swelling at injection site developed on 8/28/21  - numbness/tinging L arm for three weeks and counting - hot flashes - hormonal fluctuations - mood swings - joint pain
boils/blister like on feet and legs just appear at random. Have not been out of the house, worn shoes or changed schedule since vaccination
Severe headache, very tired, muscle aches,fever, short periods of dizziness, several hours of the feeling of pressure on my chest which then was replaced by significant burning sensation, bottoms of both feet were very painful and a wrist that i broke a couple of years ago and a knee which has caused pain in the past were very, very painful.
chills, body aches, headache, joint pains, anxiety, numbness in arms briefly
Vaccine had expired 4 days prior. Miscalculated the expiration date. patient given vaccine but no signs or symptoms of any issues. Mom was advised to call with questions or concerns.
Pt was diagnosed with COVID on 11/2 at the walk-in clinic.  She was admitted to the hospital on 11/7 due to a fall from profound weakness due to COVID-19.
Pt received vaccines below and appeared well with no complaints.  Upon exiting, pt collapsed in hallway.  Pt unresponsive for a short time, with slight confusion following.  ABC's intact with no problem.  EMT's called.  Pt taken to ER per ambulance.  Pt discharged after several hours to home.
RASH surrounding vaccinated and slightpain upon tough, it does not itch just is red and bumpy.
On 3/16, I had the Moderna vaccine.  9 days post vaccine, I had a vertigo attack.  This was my second vaccine.  Day 2, I had the usual arm pain and fatigue.   The vertigo was not as severe as the attack that I had 10 days post the first vaccine.
PULMONARY EMBOLISM, UNSPECIFIED. 12/18/2021 CHRONIC POSTTHORACOTOMY PAIN  HYPOTENSION 12/18/2021 CHRONIC POSTTHORACOTOMY PAIN  PULMONARY EMBOLISM, UNSPECIFIED. 12/18/2021 PNEUMONIA  HYPOTENSION 12/18/2021 PNEUMONIA
Patient was vaccinated with Pfizer #1 on 3/16/2021 (lot EN6206. She received a second invitation for vaccine in error, signed up, and was vaccinated a second time with Moderna  on 4/9/2021.  No adverse outcomes or symptoms reported;  counseled by Health Department RN that this is not preferred but is acceptable and he will not need additional vaccine. Troubleshooting: did not present card, volunteer/vaccinator did not utilize translation line. A scribe created a second record for this person so it appeared to be a first vaccine instead of a second. Reported six hours post-event, came through the DoD vaccine line.
10 MINUTE POST VACCINATION DEVELOPED VASALVAGAL SYMPTOMS - MOVE TO TREATMENT AREA WITH WHEEL CHAIR AND ADMINISTERED COLD PACKS SYMPTOMS RESOLVE WITHIN 15 MINUTES.  PATIENT WAS ABLE TO LEAVE ON THEIR OWN RECONNAISSANCE.
11MAY98 fever <102 for 24hr p/vax;@ least 5 large raised reds welts covering legs & back lasting 4-5 days;extreme sleepiness lasting 5 days;
This case was reported by a other health professional via call center representative and described the occurrence of vomiting in a 17-year-old female patient who received BEXSERO (batch number 16D301, expiry date February 2019). On 5th December 2017 15:30, the patient received BEXSERO. In December 2017, 16 hrs after receiving BEXSERO, the patient experienced vomiting and nausea. On an unknown date, the outcome of the vomiting and nausea were not recovered/not resolved. The reporter considered the vomiting and nausea to be probably related to BEXSERO. Additional details were provided as follows: The healthcare professional reported that the patient started with the nausea and vomiting symptoms the next morning of vaccination at school, and the patient's mother had to pick the patient up from school. The healthcare professional stated that they would come in for follow up visit at office but had not been confirmed with mother of the patient at the time of call. The reporter was pretty sure that the vaccine caused the symptoms.
arm soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix and had pain in arm. For tolerances of 2nd dose, refer case US2020003266, reported by same reporter and patient. This case linked US2020003254, reported by same reporter.
CHILLS; FEVER FOR ABOUT 3 HOURS; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced chills, and fever for about 3 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever for about 3 hours. This report was non-serious. This case, from the same reporter is linked to 20211055553 and 20211055134.
Awoke to very red swollen eyes with itching & mattering for three days.  Also had nasal congestion.
2 days after 2nd dose of Gardasil, patient developed dysesthesia in arm and decrease in grip strength, leg weakness, and difficulty voiding urine.  Progressed to inability to ambulate within 5 hours.  Patient admitted to Medical Center.  MRI revealed inflammation around spinal cord consistent with transverse myelitis vs. Guillain Barre syndrome.  Clinical physical exam supported diagnosis of Transverse Myelitis.  Patient treated with IV Methylprednisolone 250mg q6hr x 5 days and subsequent oral steroid taper.  Over course of hospitalization, currently 7 days in duration and continuing, patient has regained some upper extremity strength and improvement in sensory symptoms.  Minimal lower extremity strength recovery at this point.  Throughout course of hospitalization, patient has required bladder catheterization due to inability to void urine.11/13/07-records received for DOS 9/26-10/17/07-DC DX: Transverse myelitis. Urinary tract infection (UTI). Presented to ED with 24 hour history of progressive weakness and numbness. Unable to walk. Received Gardasil 2 dys prior to symptoms and tick bite 2 weeks prior to admission. She was also on a camping trip 5 days prior to admission. PE: weak grip strength, wrist flexors and extensors normal. Right leg proximal flexor strength 2/6 and left leg strength 0/5. Distal right leg strength 0/5. Subjective numbness at T4 and below. Reflexes 1+ bilaterally in upper and lower extremities. No dysarthria. High dose steroid treatment. PlasmapheresisTransferred to rehab facility
Client developed temp 101.6 and headache. Mother states temp went up between 102-103 Friday and began going down on Saturday. Able to go to school on Monday 0 Temp
Pain at injection site. Evolved into heaviness  in left shoulder and numbness in left arm.
On day 8 Red itchy swollen circle on left upper arm No treatment 3 days later no change
Temperature, fatigue, nausea, pain, swollen, hot, red welt on arm going around to underarm
no symptomatic AEs reported; an expired MMR-II vaccine was in advertently administered to a patient; This spontaneous report was received from a health care professional (HCP) and refers to a patient.  The patient's medical history, concurrent conditions were not reported, and concomitant therapies were not reported.  On 09-MAY-2022, an expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, lot #T006165, expiration date: 19-FEB-2022 (strength, route of administration, and indication were not provided), was in advertently administered to a patient. There were no symptomatic adverse events (AEs) reported.
About 10 hours after receiving dose patient began to feel chills. 2 hours later patient checked temperature and confirmed they had a fever at 101.2 degrees F. After going to bed for the night, the patient woke up in the middle of the night no longer with the chills, which was 4 hours after first experiencing them. In the morning, patient checked temperature again and it was down to 99 degrees F.  However, patient was now experiencing a headache which they took ibuprofen for, and the headache went away.
Localized reaction to VARIVAX given SC to Left upper arm 12/15/08- 2x3 cm area arm sl, red, sl warm and swollen. Treatment: warm compress, OTC analgesics pm.
Mother called, daughter is very weak, cannot keep eyes open. Llips are pale. Weak. Told mother to take her to ER. Took to ER -started feeling better, so left and took to MD. MD stated child had "nervous reaction" to shot and not vaccine reaction. Child fine at this time.