chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Trembling, shivering, tremor, Fever 102, weakness, inability  to stand or walk.
This spontaneous report was received from a nurse practitioner via company representative and refers to a female patient of unknown age. Her concurrent conditions, medical history and concomitant therapies were not provided. On 27-SEP-2017, the patient was vaccinated with a first dose of GARDASIL 9 (dose, route of administration, lot# and expiration date were not provided) for prevention of human papilloma virus (HPV). On an unknown date, the patient developed diarrhea that persisted for 10 months after receiving her first and only dose of GARDASIL 9. The patient sought medical attention. Stool culture was performed but the results were unknown. She was referred to gastroenterologist. On an unknown date in 2018, the patient recovered from diarrhea. The relatedness between diarrhea and the GARDASIL 9 was not provided.
Patient started feeling light headed after vaccine was administered.  Patient then fainted a couple of times, coming to about 30 seconds after fainting.  Patient also experienced nausea, blurred vision, ears tingling, throat dry, sweating/chills, shaking, and cold skin.  Patient laid back in chair and drank plenty of fluids while we monitored her.  We eventually called EMS to come check her out and her vitals were all good.  Patient's mother was going to call pediatrician and take her to see them or go to urgent care.  Patient was able to walk out and felt better when leaving.
Had heart palpations last night , today feel like heart is acing , will call the Dr,
1 HR AFTER DEVELOPS HEADACH AT THE BACK OF THE HEAD, REPORT PAIN LEVEL 8 OUT OF 10.  PATIENT TOOK EXEDRIN MIGRAINE, REPORT PAIN LEVEL 5 OUT OF 10.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): CMOD22-01935.  A female patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2021, outcome "unknown" and all described as "COVID-19". Clinical course: Patient reported that she got SARS-Antibody blood test in lab and the last one she had done in mid Jan showed 150 on the range of antibodies. Patient had COVID in mid Nov021. Patient was only half vaccinated with Pfizer when she got COVID.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
A few hours after the vaccine I got hot. About 2 hours later I got really cold. At night when I was sleeping I had very vivid dreams. I was cold all night. When I woke up my arm was sore to touch , to move and both ankles hurt to walk  and I started itching on my face. Started Saturday in the evening( chin, nose) Eyelid and underneath was red and I also had a headache. I had blotches on my cheek. Next day I woke up and no change but I was extremely fatigued.. Monday 10am it started going away. By evening majority of pain was gone. About 98% recovered. I still have some itching and chills.
10/27/21: Patient felt weaker 10/31/21: Started experiencing balance issues and became more weak 11/12/21: Admitted to hospital with anorexia, ataxia, feeling ill and tremors 11/15/21: Consulted neurology due to persistent shakiness with sitting and standing; neurology recommended Solumedrol 1 gram IV daily x 3 days 11/17/21: Saw improvement with Solu-medrol 11/18/21: Neurology recommended IVIG 0.4mg/kg IV daily x 5 days (for possible etiology) and Depakote 15 mg/kg IV x 1 dose, then 500 mg po BID (for myoclonus). 11/22/21: Patient finished treatment. Tremors were less intense. Transferred to acute rehab facility for further therapies.
The immunization was administered at 2:00 PM. Around 5:00 PM, she was aching, had some blotchiness on her arms, and was itching at the injection site.  Overnight (around midnight, she didn't know the exact time) she woke up from the pain and achiness and went to take some aleve. She passed out and fell to the ground. An unknown period of time later, she woke up, took 2 220mg aleve tablets, then believes she passed out again as she woke up in a different position than she remembered.   She woke up the next morning with no aching, no rash, some blotchiness, and some bruising from falling.
Patient states she received 1st dose of Pfizer vaccine oon 3/29; had an allergic reaction with whole body itching,  numbness  on mouth and lips, facial swelling (left eye).  She was given Benadryl and observed for 1.5 hours and sent home.  (at vaccine clinic 3/29/21) Patient reports she is still having some mild  itching, throat is a bit hoarse.  She is using allergy eye drops.  Patient was advised to see her PCP. and not to receive her second dose of vaccine.
had elevated temp daily for 13 days; peaked @ noc to 105-rt arm painful, swollen & red; seen by MD who thought it may not have been due to DTP but a viral infect; recommends DT next dose;
This spontaneous report as received from a registered nurse refers to a patient of unknown demographics. The patients medical history and current condition are not reported. On an unknown date the patient was vaccinated with GARDASIL dose 0.5 ml, via intramuscular route. It was reported that the patient is in the office (unspecified) at the time of the report to receive their second dose of GARDASIL. Also reported that the patient received their first GARDASIL a year ago. No adverse events reported. Product Quality Complaint is not reported. The outcome of the event is unknown. Additional information has been requested.
Pain in all joints,  getting worse, 4weeks now,  Ibuprofen and aleve every 12 hrs
PERSON RECIVED THE MODERNA VACCINE FOR HIS 1ST INJECTION AND RECEIVED PFIZER FOR HIS 2ND INJECTION
fever Tm 102.5 and cellulitis 2 inch diameter of left thigh
Altered sense of smell. A lot of things smell very bad; received first dose/second dose on 06May2021; This is a spontaneous report from a contactable other hcp. A 20-year-old male patient received first dose of BNT162B2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 06May2021 (Batch/Lot Number: EW0167) as DOSE 1, SINGLE and second dose via an unspecified route of administration, administered in Arm Left on 06May2021 (Batch/Lot Number: ER8736) as DOSE 2, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The patient experienced altered sense of smell. a lot of things smell very bad Experiencing this for 3 months and received first dose/second dose on 06May2021. No treatment was received for the events. Outcome of the event altered sense of smell. a lot of things smell very bad was not recovered.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the event Parosmia cannot be completely excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees. and investigators, as appropriate.
Information has been received from a licensed practical nurse concerning a female medical assistant who got Rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human Bovine) in both of her eyes when a baby spit it out during administration. The LPN reported that subsequently, the medical assistants right eye burned. The medical assistant was treated at the splash station in the office. At the time of the report, the outcome was unk. Additional information has been requested.
presented diarrhea that lasted for 7 days / after first dose; This case was reported by a pharmacist via call center representative and described the occurrence of diarrhea in a patient who received Rota (Rotarix lyophilized formulation) (batch number ZY5YH, expiry date 4th July 2022) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On an unknown date, the patient received the 1st dose of Rotarix lyophilized formulation (oral) and Rotarix Oral Applicator Device. On an unknown date, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced diarrhea. On an unknown date, the outcome of the diarrhea was recovered/resolved.   It was unknown if the reporter considered the diarrhea to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient received dose of Rotarix and experienced diarrhea for 7 days. The health care professional was not willing to provide further patient information, nor other detailed until was transferred to 2nd line agent to get an answer if the second dose should be administered. No adverse event details nor follow-up could be requested since health care professional was busy and left the call. Consent for follow-up by safety not requested due to reporter being busy and not being able to complete the call.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021133168:Same reporter
accidentally given/accidentally given outside of label, to a 4 month old; This non-serious case was reported by a other health professional via sales rep and described the occurrence of inappropriate age at vaccine administration in a 4-month-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) (batch number 2YA52, expiry date 30-JUN-2024) for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent .5 ml. On an unknown date, an unknown time after receiving FluLaval Quadrivalent, the patient experienced inappropriate age at vaccine administration (Verbatim: accidentally given/accidentally given outside of label, to a 4 month old). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 30-OCT-2023 The reporter stated the vaccine was accidentally given outside of label to 4-month-old patient which led to Inappropriate age at vaccine administration. The reporter consented to follow up.
Arm and neck swollen and hurting. Also hurting in rib cage. Had nausea and vomiting. Began over the weekend after shot. Symptoms eventually improved.
Parent states "infant had high pitched cry for 3 hours or more after immunizations". "Mother describes a cry like infant was in pain".
At 9:55 AM I saw the child with school nurse in the gym shortly after he received H1N1 vaccine nasal spray at H1N1 clinic.  He was pale, had chills, complained of headache, crying and anxious.  Temp axillary 98.4, pulse 110, unable to auscultate BP.  School nurse called 911 and a school staff member carried him to the school health room to lie down.  EMTs and child's Mother arrived.  Mother stated he was not ill when he left for school that morning. EMTs transported to ER.
J&J COVID-19 Vaccine EUA  Soreness and aches (around whole body), fatigue, headache, chills - Currently taking ibuprofen to address symptoms. Woke me up in the middle of the night (3:00 AM) and had considerable difficulty going back to sleep. Headache persists through the day, but aches and chills seem to fluctuate/come in waves. Currently at 24 hours from receiving injection at time of writing this report.
Only side effect was a sore arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of pain in extremity (received 1st dose on an unknown date and experienced pain in arm, refer case US2021AMR202747) and original shingles vaccine (received it, few years ago of reporting date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than 9 months after receiving Shingles vaccine, the patient experienced pain in arm. The patient was treated with ibuprofen and non-drug therapy (Heating Pad (Nos)). Rechallenge with Shingles vaccine was positive. 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 Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had received original shot a few years ago. The patient received dose of Shingrix vaccine and experienced sore arm. The patient stated that, the ibuprofen and a heating pad worked for the pain.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR202747:Same patient, Dose no 1
pt came to clinic 19AUG96 w/scattered rash on arms, legs, trunk dec fever-maculopapular, warmth to touch, t99.6 R;advised to call PMD;
Developed bronchitis (2/4/03) Varivax 1/21/03. 2/8/03 Fever rash very ill inject site with ????? with yellow area? PVS resolved with augmentation.
Swelling bellowarmpit, 3 inches diameter, fluid-filled; This case was reported by a consumer via call center representative and described the occurrence of blister in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th February 2023, the patient received the 1st dose of Shingrix (intramuscular). On 6th February 2023, less than a day after receiving Shingrix, the patient experienced blister. On an unknown date, the outcome of the blister was not recovered/not resolved.   It was unknown if the reporter considered the blister to be related to Shingrix.     Additional Information: GSK Receipt date: 07-Feb-2023. Reporter's Comment: The patient self-reported this case. The patient received Shingrix on right deltoid. The patient stated that in the evening when preparing to go to bed, she noticed swelling below her right armpit.  It was about 3 inches in diameter and felts like it was fluid filled. The patient was asking if it was something to be concerned about.   The reporter did not consent to follow-up. Note: Time to onset was conservatively capture as less than a day instead of 8 (unspecified unit) reported in structural field.
After the vaccine was administered and paperwork was being completed, vaccinator realized that the vaccine expired on 3/4/23. The nurse at the healthcare facility and the patient were informed, and the dose will be re-administered per CDC recommendations. The patient has not experienced any adverse effects. The pharmacy was notified and staff was re-educated on auditing/removing expired medications.
Red, swollen ,hard, itching , sore area from deltoid to elbow at site of injection. Swollen and tender lymph nodes under left arm
Itching on left leg, few on head hairline. Exposure to chickenpox months ago. VZV: 5 small mild erythematous vesicles on left leg. A few on scalp. 8/26/04: mom states had 30 pox. Doing better now.
Several hours post vax, pt experienced hives and blotches resembling black and blue marks. From additional information received on 12/4/98, it was reported, "tightening of throat, was seen by physician at ER and states received a prescription for prednisone but did not fill it. Client took 2 Benadryl and gradually improved within 3-4 days." It was reported that the pt recovered from this experience.
On the 6th is when I started feelings bad. A lot of malaise, dry cough, and a scratchy throat. the next day I couldn't even get out of bed the symptoms worsened. I had a loss of appetite. I loss my sense of smell. The 6th I tested and was negative. Thursday still the same severe lethargy, scratchy throat, cough was probably the biggest symptom. I had night sweats one night. Thursday the 8th I tested for COVID-19 again and that home test was positive on that date. I continued with these symptoms for another two or three days.   I was prescribed Paxlovid and Tessalon Perles due to my diabetes. I went the rest of the weekend with no smell, cough, scratchy throat. I forced myself to eat. I also noticed my blood sugar went crazy. My blood sugar was running from 190-230 the entire time I was sick. I started on oral medication to try and bring it down. I am just now bringing it back to normal this week. The malaise and fatigue lessened. The shortness of breath lasted until the first week of October. The cough lasted until that time also. In the last few days, I have gotten my smell back. The fatigue, for the last couple of weeks, would kind of come and go. I would find myself napping.
pt devel on 1-4 days p/inj swelling, inflammation (approx 4"-5" wide) area hot to touch & sore; advised pt to use cool compresses to area;
medication error due to accidentally administering expired IPOL to a patient with no Adverse event; Initial information received on 05-Apr-2022 regarding an unsolicited valid  non-serious case received from a other health professional via call center.  This case involves a 5 years old male patient who had experienced medication error due to accidentally administering expired ipol to a patient with no adverse event while receiving vaccine ipv (vero) [Ipol].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP) for Prophylactic vaccination; and measles vaccine, mumps vaccine, rubella vaccine (MMR) for Prophylactic vaccination.  On 05-Apr-2022, the patient received a 0.25 mL to 2 mL dose of suspect ipv (VERO) lot R1F973M frequency: once (strength, formulation and expiry date: unknown)  via intramuscular route in the left deltoid for prophylactic vaccination.  On 05-APR-2022, the patient developed a non-serious event medication error due to accidentally administering expired ipol to a patient with no adverse event (expired product administered) (latency: same day) following the administration of ipv (VERO).   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (expired product administered).  At time of reporting, the outcome was Unknown for the event expired product administered.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
numbness of left side of upper body.  Pt felt hot and flushed.  Symptoms lasted four days.
Patient developed severe congestion and trouble breathing. Air way felt restricted, rattling slung sounds 30 days after second dose of Pfizer COVID-19 Vaccine.
Intense Ear pressure and pain ,  dizziness, bilateral tinnitus (new onset)  Tinnitus not related to trauma, infection. or hearing loss Continue to experience ear pressure and tinnitus similar to high altitude effect without relief.  ENT exam negative for ear disease or TMJ
Patient States that the morning after her booster, she felt weak, sick, sob so much that she fell.  She was subsequently hospitalized for 4 days.
This spontaneous report as received from a Licensed Practical Nurse (L.P.N.) refers to an unspecified number of patients of unspecified age and gender. Medical history and concurrent conditions were not reported. On 29-SEP-2015, the patients were vaccinated with improperly stored VARIVAX (Merck) (lot number L016124, expiry date: 06-MAY-2017, dose, route and site of administration not reported) or PROQUAD (Merck) (captured in MARRS # 1510USA000438). No adverse events were experienced. The outcome of the reported events was unknown. No product quality complaint (PQC) was filed. No further information provided. This is one of two reports from the same reporter. Additional information has been requested.
The private stock Moderna was to be stored in the vaccine refrigerator and discarded at date noted on vial.  Vaccine was refrozen. instead.  Vaccine given with no adverse effect experienced by patient.
Father called 10/1/04 re: s/s swelling, redness, no c/o pain. Mother called 10/04/04 re: s/s cont swelling from RA (deltoid to elbow area). No previous hx of adverse vaccine reaction. Child in good health.
sick; Tired/ exhaustion; sore throat; temperature of 99.8; Red; warm; swelling; numbness; cellulitis on her chin/face; This is a spontaneous report from a contactable other healthcare professional (HCP, patient). A 55-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in left arm on 14Sep2021 at 15:15 (Batch/Lot Number: 2256) (at the age of 55-years-old) as dose 1, single for COVID-19 immunisation. Vaccination facility type was Pharmacy or Drug Store. The patient is not pregnant at time of vaccination. Relevant medical history was none. The patient has no known allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccine in four weeks and did not receive any other medications in two weeks. The patient has no COVID-19 prior vaccination and was not tested for COVID-19 post vaccination. On 16Sep2021 at 06:30 pm, the patient reported that she was very sick afterward. She was tired, had sore throat, and exhaustion. Two days later (in Sep2021), she had a temperature of 99.8. Now after 48 hours, (in Sep2021), she has developed cellulitis on her chin/face; red, warm, swelling, and numbness. The patient received treatment with Benadryl. The outcome of the event was not recovered.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: Considering a temporal relationship, a possible contributory role of suspect product BNT162B2 to the reported events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate