chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Inappropriate age at vaccine administration; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a patient who received DTPa (Infanrix) (batch number 4L9E4, expiry date 7th February 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th March 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, 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: 13-MAY-2022 Additional supportive information: The patient received Infanrix at inappropriate age which led to inappropriate age at vaccine administration. The reporter consented to follow up. Note: The age of the patient was not provided but as per reported verbatim case was kept as valid with Inappropriate age event.
sore arm; headache; brain fog; sore throat; middle of the night stomach cramps; vomiting; diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA Vaccine; Lot number: EIL8732), via an unspecified route of administration in the left arm on 28Mar2021 at 11:30 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had a history of allergy to codeine. The concomitant medications included atomoxetine hydrochloride (STRATTERA), ethinylestradiol, etonogestrel (NUVARING), amlodipine (MANUFACTURER UNKNOWN) for unknown indications. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 29Mar2021 at 23:45, the patient experienced sore arm, headache, brain fog, sore throat, middle of the night stomach cramps, vomiting, diarrhoea. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of events sore arm, headache, brain fog, sore throat, middle of the night stomach cramps, vomiting and diarrhoea were not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
Vertigo, nausea, weakness, headache, & numbness & tingling in lower extremities, poor balance.
Patient was diagnosed with cellulitis. Swelling, redness and warmth to the touch.
Light sensitivity; Nose bleeding; Migraine headache; This spontaneous case was reported by a nurse and describes the occurrence of MIGRAINE (Migraine headache), PHOTOPHOBIA (Light sensitivity) and EPISTAXIS (Nose bleeding) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced MIGRAINE (Migraine headache). On 08-Jan-2021, the patient experienced PHOTOPHOBIA (Light sensitivity) and EPISTAXIS (Nose bleeding). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MIGRAINE (Migraine headache), PHOTOPHOBIA (Light sensitivity) and EPISTAXIS (Nose bleeding) outcome was unknown.        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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Started with cold / fever coming and going around 8pm, then a fever for the rest of the night until 2am. Lower back, knee jaw and sporadic wrist pains from 8pm through 2am. A migraine came on around 9:30pm and then I took a 500mg extra strength excedrin, which didn?t help. Then I wore a cold wash cloth on forehead which helped significantly with the fever and migraine. Added an ice pack for 2 hours to the lower back which significantly reduced pain in back and also reduced nausea. Eventually wore a migraine ice pack that helped for awhile. Did not sleep entire time until approximately 2am. Took 2 advil and then finally fell asleep around 2am.
tiredness; muscle pain; chills; feeling unwell; This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received BNT162B2 (COMIRNATY, solution for injection; lot number and expiry date were not reported) via an unspecified route of administration, on 11Oct2021, as dose 3 (booster), single for covid-19 immunisation. The patient medical history and concomitant medication were not reported. Historical vaccine included BNT162B2 (COMIRNATY, solution for injection; lot numbers and expiry dates were not reported)  dose 1, single and dose 2, single both given via an unspecified route of administration, on unknown date, for covid-19 immunisation. On Oct2021, the patient experienced tiredness, muscle pain, chills and Feeling unwell three or four times in a day. The outcome of the event was not recovered at the time of report.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
This is a spontaneous report from a contactable consumer (patient) via medical information team. A 69-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EN6206) administered in left arm via an unspecified route of administration on 06Mar2021 (at the age of 69 years old) as dose 1, single for covid-19 immunisation. The patient's medical history included Knee replacement from May2015 to an unknown date. The patient's concomitant medications were not reported. On 06Mar2021, the patient experienced warm rosey cheeks/she also referred to it as a rash, sore arm and on 07Mar2021, the patient experienced she was unable to walk and severe joint pain and severe joint pain was reported as worsened. As a treatment, the patient received Acetaminophen for unable to walk and joint pain which didn't do anything. The patient underwent lab tests and procedures which included x-ray normal as all the knee parts are fine on 09Mar2021. The outcome for the events warm rosey cheeks/she also referred to it as a rash was recovered on 06Mar2021 and sore arm was recovered on 07Mar2021. The outcome of the events she was unable to walk, severe joint pain and severe joint pain was reported as worsened was not recovered. No follow-up attempts are possible. No further information is expected.
Pt. at the observation area felt a heat flash and dizzy, paramedics assessed pt. Once pt. was feeling better, paramedics released her to home.
In April, my WBC was evaluated at 1200. My doctor gave me antibiotics. I went back to my doctor two weeks later. My WBC was still evaluated. In Sept, I went back to my doctor. My WBC still evaluated in 1200. She thinks I had an infection and gave me more antibiotics. I went back and my WBC was still evaluated to 1300. I am going back to my hematologist and get more blood work. They are checking for cancer and other infections. I will found out Monday, what my results are.
Patient states at the time of call that he was experiencing a little bit of chest tightness. It was hard to say the severity of his condition, because he was also speaking normally and ordering other medications on the phone.  I advised that he should go to the emergency room if he has reasonable doubt.
throat swelling; This is a spontaneous report from a contactable consumer (Patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiry date was not reported),via an unspecified route of administration on 22Mar2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiry date was not reported),via an unspecified route of administration on 27Feb2021 as dose 1, single for COVID-19 immunization. On 22Mar2021 the patient experienced throat swelling. The patient had difficulty swallowing and throat swelling after 1st dose, but only had throat swelling after 2nd dose. The patient says throat swelling was not visually verified by health care practitioner. The patient said she was monitored at vaccination site both times by health care practitioner and throat swelling resolved on its own within 30 minutes without need for intervention. The patient would like to confirm if it is okay to take the 2nd dose vaccine today. The patient is asking about taking the vaccine for more than 3 weeks and creating adverse event form since the patient 2nd dose schedule is more than 21 days and experienced side effects. The outcome of the events was recovered.  Follow-up (25Mar2021): This follow up report contains no new safety information.   No follow-up attempts are possible. Information on lot/batch number cannot be obtained.
Information has been received from a health professional concerning a 15 month old female with possible seasonal allergy and a history of bilateral myringotomy who on 07-JUN-2007 was vaccinated subcutaneously with 0.5 ml of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (Lot # 655124/1217F). Suspect therapy, that same day included a fourth dose of diphtheria toxoid (+) pertussis acellular 1-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (DTAP-IPV) (lot # C2569AA). Concomitant therapy included as needed use of both chlorpheniramine maleate (+) dextromethorphan hydrobromide (D-CARE ALLERGY RELIEF COUGH SYRUP) and acetaminophen (TYLENOL). On 08 JUN 2007, the mother reported that patient to be "more irritable" and "acting different". The mother reported changes in the patient's disposition, i.e. hitting her head against the walls and floor, becoming easily agitated and throwing fits. Changes were also observed by her day care providers. The mother reported that the "symptoms lasted about one month", and that the "patient is now her normal self." On 08 JUN 2007 the patient also developed redness on her arm, at the injection site and a slight fever, which resolved. On 18-JUN-2007 the patient was seen and treated for pharyngitis and gastroenteritis. The patient was irritable, had a slightly red throat. She had a fever all week, up to 103 F, and was given a "suppository" the previous evening. The patient's temperature at that time of examination was 98 degrees, weight 20.8. The patient had a decreased appetite, "tummy ache" and had vomited that morning and "Sunday". The patient was placed on OMNICEF 125 mg/5 ml 1 tspn PO daily, TYLENOL and clear liquids. "KUB" was negative. At the time of reporting the patient had recovered from irritability and acting different, but it was unknown if the patient had recovered from the fever up to 103 F and pharnygitis, and gastroenteritis. Unspecified medical attention was sought. There was no product quality complaint.
management of invalid dose. 2ndose moderna wan not administered from  21 to 42 days following the administration of the 1st dose. pt  has received her 1st dose elsewhere. vaccine record card validated vaccine product is moderna and received 1st dose 12/29/20 at clinic. pharmacy made a call and received email by Representative, Moderna Medical Information and  created case. Do not repeat dose. 2nd dose administered>42 days after the 1st dose per pharmacy has informed this information to pt and her son.
Pt had Tdap 5/6/10 got states got redness and area firm below injection site, area on arm was sore and warm for couple of days on 5/11/10 pt reported minimal [pink rash 4x4 6 cm below site.
1. Metallic taste in my mouth. It started about 45 minutes after my vaccination and lasted all day. Resolved by the next day. 2.Extreme fatigue - all day of my vaccination. Resolved by the next day. 3.Fever of 100 degrees, chills, ached everywhere. Especially extreme ache in both of my hands. It all started about 11pm on the day after my vaccination. Lasted all night. Resolved in the morning.  4. Woke up Friday morning, 2 days after my vaccination,  after feverish night to what felt like a busted lip. My lip upon inspection was fine, no abrasions, but felt tingly and like there was nerve damage upon waking. It has lasted 3 days, and began waning on the 4th day. There's just a bit of the sensation remaining. 5.Same time frame as #4. I awoke to left breast pain/ tenderness. I have a cyst with mild pain and tenderness that is monitored, and the vaccination made this area worse for the same time frame as above.
Pt had hives develop to flu shot 2 days after shot was given. The parents called pharmacy, over the weekend, and they informed them to contact us. Per pt's parents, pt is improving with Benadryl and a Oatmeal bath. I informed them to go to urgent care if symptoms get worse.
Patient reported feeling slightly dizzy immediately after vaccine was administered (3:42PM), described it like her head was in the clouds. Vital signs stable: BP 111/72, Pulse 64, O2 sat 98%.  At 4PM some orbital swelling and redness noted, patient reported feeling some numbness & tingling in fingers.  Oral Benadryl 50 mg given at 4:09PM.  By 4:25 patient reported feeling better, periorbital swelling resolved, dizziness and numbness/tingling in fingers also resolved.  Re-checked vital signs, BP 118/76, O2 98%, pulse 60BPM. Patient felt well enough to go home, accompanied by husband. Left clinic at 4:30PM.
Flu-like symptoms; Sweating; Cold; Little bit of body aches; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), HYPERHIDROSIS (Sweating), NASOPHARYNGITIS (Cold) and MYALGIA (Little bit of body aches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), HYPERHIDROSIS (Sweating), NASOPHARYNGITIS (Cold) and MYALGIA (Little bit of body aches). The patient was treated with IBUPROFEN for Flu-like symptoms, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Flu-like symptoms, at an unspecified dose and frequency. On 13-Feb-2021, INFLUENZA LIKE ILLNESS (Flu-like symptoms), HYPERHIDROSIS (Sweating), NASOPHARYNGITIS (Cold) and MYALGIA (Little bit of body aches) had resolved.            No relevant concomitant medications were provided.  The patient did not report and symptoms after first dose. After second dose, the patient had mild flu-like symptoms like (cold, sweating, little bit of body aches) and second day everything was fine.
Approximately 15 mins after injection patient began to experience dizziness, giddiness and light headedness. Around 12pm during observation she reported numbness feeling to her legs, in which resolved as soon as she reported. Pt assessed by MD. Patient with hx DM, Anxiety and Migraines. All symptoms resolved at discharge @ approximately 1215.
2 large rashes on inner thigh, hot to touch, burning and itchy, body aches and random shooting pains
Received 3 vaccines Flu, Tdap, PNEUMOVAX about 3 pm. Later that evening woke up sweating went to bathroom and fainted. Husband called 911 for ambulance.
right away: dizzy, sweaty, flushing  4pm head started throbbing  630pm: headache started in the back and spread to left side, tachycardia   8pm: chills  830:chills and shaking   130am: shaking chills 99.4 temp  5am: 101.5 temp, headache worse   730am: 98.6, headache   11am 97.9, head hot and throbbing  2pm: 98.2 temp   6:50: 99 temp and chills  friday 11/19   9am: 96.3 temp bad headache   -chronic disease has worsened due to this, trouble breathing  10am: glands swollen  11/20 temp 97.2, fatigued, congested   11/21 fatigued, couldn't shower 96.4
pain in abdomen; fever (100.5); productive cough; loss of appetite; pain in injection area
Incorrect diluent volume (i.e., the vial contents were diluted with a diluent volume other than 1.8 ml, but a 0.3 ml dose was still administered)
This case was reported by a pharmacist via call center representative and described the occurrence of shoulder pain in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 3 days after receiving SHINGRIX, the patient experienced shoulder pain, groin pain, joint range of motion decreased, pain in hip and muscle pain. The patient was treated with TYLENOL and anti-inflammatory/antIrheumatic products (Anti-Inflammatory). On an unknown date, the outcome of the shoulder pain was not recovered/not resolved and the outcome of the groin pain, joint range of motion decreased, pain in hip and muscle pain were unknown. It was unknown if the reporter considered the shoulder pain, groin pain, joint range of motion decreased, pain in hip and muscle pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The events had been persisting for almost 3 months, bilateral shoulder pain resulting in the inability to lift either arm upwards, and hip or groin pain. The provider reported that the patient was unable to distinguish between muscle or joint pain. The patient had been using anti-inflammatories and TYLENOL with limited relief. Blood work was inconclusive. The healthcare professional did not have lot number or expiry number or exact vaccination date.
This child had swelling of her hands and redness of the arm administered. Also itching. Immunization given on 03/27/01. Seen in the office 03/29/01, the entire left upper arm. No fever.
Pharmaceutical product complaint; Only the liquid diluent portion of Menveo used; Only the liquid diluent administered; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA722Z, expiry date 31st August 2023) for prophylaxis. This case was associated with a product complaint.   On 29th September 2022, the patient received Menveo. On 29th September 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered and pharmaceutical product complaint were unknown.   Additional Information: GSK Receipt Date: 29-SEP-2022 Reporter's Comment: The reporter reporting a possible 7 patients having received only the liquid diluent portion of Menveo. The reporter consented to follow up. Additional Supportive Information: The reporter reporting a possible 7 patients having received only the liquid diluent portion of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This was 1 of 7 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2022140220:Same reporter- Patient 1 US-GSK-US2022140223:Same reporter- Patient 3 US-GSK-US2022140225:Same reporter- Patient 4 US-GSK-US2022140231:Same reporter- Patient 5 US-GSK-US2022140233:Same reporter- Patient 6 US-GSK-US2022140243:Same reporter- Patient 7
parasthesia in injected arm, blindness in right eye, intense weakness and lethargy.
patient complained of vertigo starting on day 2 and lasting off and on for 1 week.
This case was reported by a consumer and described the occurrence of deathly sick in a about 88-year-old male subject who was vaccinated with influenza vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. The subject was healthy but pretty frail and thin. In 2004 or 2005, the subject received unspecified dose of Influenza vaccine (unspecified) (unknown route of administration). Within a couple of days after vaccination with Influenza vaccine (unspecified), the subject was deathly sick and almost died. He got very severe influenza. After an unspecified period of time, the events were resolved. Four or five years later, the subject died just before turning 94. The subject was old, so the death was not related to the flu vaccine.
Chicken pox and MMR vaccine received and had decreased platelet count, 6 weeks later (ITP). Was hospitalized and received Winrho, prednisone.
Approx 9.5 hours after vaccination, I experienced headache and muscle aches.  Overnight aches increased, had chills and sweats, temp slightly elevated to 99.2, diarrhea and fatigue.  26 hours later at the time of completion of this form, minor aches, fatigue and chills
Patient has large, flat rash at injection site and many small red pimple/pustules on arms and neck.
got her first dose of Shingrix on 19Jun2019 / has not received the 2nd dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 19th June 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: Age at vaccination was not applicable for this report. A patient who got her 1st dose of Shingrix on 19th June 2019 and had not received the 2nd dose yet which led to incomplete course of vaccination. The reporter consented to follow up via email.
Saturday-Tuesday: Severe headaches, body aches, fatigue, oral gums extremely sore, sore/painful arm, Covid arm on days 10-11: 3x5 inch red patch center below injection Wednesday: Severe headaches, oral gums extremely sore and by evening right wrist starts to severely hurt (feels sprained); an hour later left wrist also hurting. Hours later both wrists, hands and all fingers extremely painful and cannot move them or bend joints; inflammation starts. Slight joint paint in right knee, left inside hip, right top of foot and right shoulder (subsides within 24 hours). Talk to medical staff at midnight due to extreme pain in hands. Thursday: wrists/hands/fingers very painful, badly inflamed, skin is red/shiny stretched and swollen; headaches continue, jaw and gums issues now seem secondary.  Sunday: headaches less and movement in hands starting to improve.