chrisvoncsefalvay/vaers-outcomes huggingface dataset:
STRONG HEADACHE IRRADIATING TO EARS AND EYES. IT STARTED 24 HOURS AFTER THE INOCULATION AND IT HAS LASTED FOR MORE THAN 2 DAYS. SKIN RASH ON THE HEAD, NECK AND CHEST AREA; IT STARTED 36 HOURS AFTER THE INOCULATION AND IT HAS LASTED FOR MORE THAN 2 DAYS.
she experienced a metallic taste; This is a spontaneous report from a contactable consumer (patient) reported that a 61-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262, expiration date: May2021), via an unspecified route of administration on the left arm on 30Jan2021 09:00 at a single dose for Covid-19 immunization. The vaccine was administered at the hospital. The patient medical history was not reported. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 09Jan2021 for Covid-19 immunization. On 30Jan2021 09:30, she experienced a metallic taste for about 30 minutes after the injection that lasted about an hour with outcome of recovered on 30Jan2021 10:30.
received both Pediarix and Kinrix/ over dose of DTP, Filamentous Haemagglutinin, Pertactin and IPV; A 4 month old received / Kinrix; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 4-month-old patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis and dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Pediarix, Pediarix Pre-Filled Syringe Device, Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Pediarix, Pediarix Pre-Filled Syringe Device, Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced overdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the overdose and inappropriate age at vaccine administration were unknown.   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 4 month old patient received Kinrix, which led to inappropriate age at vaccine administration. The patient received both Pediarix and Kinrix, which led to overdose of DTP, Filamentous Haemagglutinin, Pertactin and IPV. The reporter did not consent to follow up. No more information was provided by the reporter.
Beginning the day after my shot, I experienced engorging in my left breast. My breast was swollen, hard, and painful to touch. I?m currently breastfeeding my 7 month old, and I wasn?t able to get much milk out. I haven?t had an issue with engorgement since my baby was first born and my milk came in. Since this was unusual, I think it?s related to the vaccine. The engorging only lasted the day after my shot, and it went away that evening (lasted about 12 hours).
This spontaneous report as received from a consumer refers to her 3 years old male grandson. The patient was vaccinated in error with a dose of GARDASIL (Lot # not reported) on an unspecified date. Any adverse effects were reported. Additional information has been requested.
fatigue; chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The patient's past medical history included Myasthenia gravis (The patient has the history of Myasthenia Gravis.) since an unknown date and Type 2 diabetes mellitus (The patient has the history of Type 2 Diabetes Mellitus.) since an unknown date.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced CHILLS (chills). On 21-Jan-2021, CHILLS (chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided No treatment information provided
After receiving my second dose of the Moderna Covid 19 vaccine on 2/26/2021 I woke up around 2 am on 3/1/2021 with very loud ringing in my ears.  This ringing has been constant since then.  I have gone to my primary physician on 3 occasions as well as an ENT on 2 occasions.  I have been treated with Hydroxyzine, Sudafed and Flonasemist.
Pt recvd 1st dose of Hep B vax w/no noted problem; The 2nd of vax was recvd 18AUG92 & w/in an hr following vax pt exp sore arm w/pain @ the inject site; sx resolved w/in 24 hrs; No further detials were provided;
mom reports high pitched cry 5 to 6 hrs p/vax; 3-4 hrs of pt screaming; same time frame; fever 103;
terrible and bad pain from his foot up to his legs; Blood vessels on his neck were also swollen and protruding; His right arm is very itchy and also painful; Injection arm felt very sore as if someone punch him in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (terrible and bad pain from his foot up to his legs), VASODILATATION (Blood vessels on his neck were also swollen and protruding), VACCINATION SITE PRURITUS (His right arm is very itchy and also painful) and VACCINATION SITE PAIN (Injection arm felt very sore as if someone punch him in the arm) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Fruit allergy. Concomitant products included VITAMIN C [ASCORBIC ACID] and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 12-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jul-2021, the patient experienced PAIN IN EXTREMITY (terrible and bad pain from his foot up to his legs), VASODILATATION (Blood vessels on his neck were also swollen and protruding), VACCINATION SITE PRURITUS (His right arm is very itchy and also painful) and VACCINATION SITE PAIN (Injection arm felt very sore as if someone punch him in the arm). At the time of the report, PAIN IN EXTREMITY (terrible and bad pain from his foot up to his legs), VASODILATATION (Blood vessels on his neck were also swollen and protruding), VACCINATION SITE PRURITUS (His right arm is very itchy and also painful) and VACCINATION SITE PAIN (Injection arm felt very sore as if someone punch him in the arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment medications were reported.   This case was linked to MOD-2021-291361 (Patient Link).
Patient c/o redness and swelling around site of injection (left arm, between deltoid area and above elbow). Pharmacist on duty followed with physician, nurse recommended ice pack and BENADRYL.
Patient received Tdap vaccine 0.5ml IM in R deltoid at 1211 on 3/15/16 (GSK Lot # KJ4MS).  Pt woke up on 3/16/16 with headache and body aches, felt severe fever, dizzy, skin sore and warm at injection site and nauseous. Pt's husband called MD office to report but pt declined to come to office at that time.  MD prescribed ondansetron for nausea. Pt reported that her skin looked sun burnt at injection site.  Pt came to MD office on 3/18/16 and felt mostly better, but still felt hot, a little dizzy and nausea.
woke up with a fever; diagnosed with influenza; Initial information received on 01-Nov-2023 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (non-healthcare professional).  This case involves 9 years old female patient who woke up with a fever and diagnosed with influenza after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 27-Oct-2023, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (strength, formulation, dosage, expiry date, lot number- not reported) via unknown route in unknown administration site for Prophylactic vaccination (Immunisation). Information on the batch number was requested.  On 30-OCT-2023 the patient developed woke up with a fever (pyrexia) (latency- 3 days) following the administration of influenza vaccine.  In 2023 the patient developed diagnosed with influenza (influenza) (unknown latency) following the administration of influenza vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for both the events.; Sender's Comments:  US-SA-2023SA283904:Same patient
Left shoulder/arm muscle soreness Left pectoral muscle soreness Tender, swollen lymph node The pain in the Left shoulder and across Left chest is persistent and flares with exertion.  Tender, swollen (presumed) lymph node directly under Left collar bone and to the left of sternum, pain persistent when at rest and flares when exerting force with Left arm (lifting/pushing/pulling), pain when taking deep breathes.
TOP LIP EDEMA WITH INCREASED REDDNESS, DR. ORDERED 3.5ML CHILDREN'S BENADRYL EVERY 6 HOURS AS NEEDED, IF NO IMPROVEMENT AT 2 DOSE TO RETURN TO OFFICE.
he broke out with shingles all over including the lower back, hair line, and head.; This spontaneous report as received from a currently 72 years old male patient via GlaxoSmithKline referring to himself. The patient's medical history included herpes zoster. Information about concurrent conditions and concomitant therapies was not provided.     On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route of administration, anatomical location, lot# and expiration date were not reported) for prophylaxis. On 23-JUL-2021, the patient was vaccinated with the first dose of varicella zoster vaccine rge (cho) (SHINGRIX).  In the months of July and August, the patient broke out with shingles all over including the lower back, hair line, and head. The patient stated that this episode was worse than ever. The patient called to inquire if it was safe for him to receive second dose of varicella zoster vaccine rge (cho) (SHINGRIX) and if it would have any benefit. The outcome of the event was unknown.       The causality between the event and zoster vaccine live (ZOSTAVAX) was not provided.
Vasovagal.  She was given juice, water, crackers, time to rest, and then symptoms improved and she was able to leave after 30 minutes of rest
1.) 5/13 Sore Arm....no concerns 2.) 5/14  Minor  enlargement of glands in neck 3.) 5/15  Increased enlargement of glands in neck....felt minor constriction of throat by 11:00 PM 4.) 5/16 Glands in neck swollen....breathing constriction is increasing.  Will take Benadryl and monitor .....if no better by afternoon then I will head to emergency room
pt recv vax 5DEC97 12PM & 6DEC97 pt had a great deal of diff abducting the shoulder greater than 90 degrees because of pain;tx w/Daypro & APAP#3 for pain;
FEVER; HEADACHE; SHAKING LIKE ALMOST CONVULSIONS; This spontaneous report received from a patient concerned a 20 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known drug allergy and no history of epilepsy. the patient was not pregnant at the time of reporting.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820096 expiry: 23-JUN-2021) dose was not reported, administered on 08-JUN-2021 16:00 for prophylactic vaccination. No concomitant medications were reported. On 08-JUN-2021, the subject experienced shaking like almost convulsions. On 09-JUN-2021, the subject experienced fever. On 09-JUN-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking like almost convulsions, and fever on 09-JUN-2021, and was recovering from headache. This report was non-serious.
Admit for COVID pna. Given O2, steroids, remdesivir. Pt left AMA same day.
No additional adverse events were reported; improperly stored Gardasil 9 and VAQTA administered on 09-SEP-2022; This spontaneous report was received from a Licensed Vocational Nurse (L.V.N.), who was also an office manager/ administrator and refers to a 12-year-old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.   On 09-SEP-2022, the patient was vaccinated with an improperly stored (temperature below 36 Fahrenheit [F] degrees [29.8 F] for 17 hours, 0 minutes and 0 seconds, there were no previous temperature excursions) 2nd dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 2nd dose, lot #1780878 was found to be valid, expiration date: 02-DEC-2023, administered in right deltoid for prophylaxis (strength and route of administration were not provided) (product storage error). The patient experienced no adverse event (no adverse event).  This is one of several reports from the same reporter.
This case was reported by a consumer via call center representative and described the occurrence of insomnia in a 49-year-old female patient who received Hepatitis B vaccine for prophylaxis. Co-suspect products included TWINRIX for prophylaxis. The patient had a Family History of immunodeficiency (to brother, a few years before the date of reporting). Concomitant products included Hepatitis A vaccine, MEASLES MUMPS RUBELLA and MEASLES MUMPS RUBELLA. On an unknown date, the patient received Hepatitis B vaccine at an unknown dose. On 7th December 2018, the patient received the 1st dose of Twinrix (intramuscular). On 7th December 2018, not applicable after receiving Hepatitis B vaccine and less than a day after receiving TWINRIX, the patient experienced insomnia and sleep restless. On an unknown date, the patient experienced therapy non-responder. The patient was treated with sleep medication (nos) (Sleeping Pill). On an unknown date, the outcome of the insomnia was not recovered/not resolved and the outcome of the sleep restless and therapy non-responder were unknown. It was unknown if the reporter considered the therapy non-responder to be related to Hepatitis B vaccine. It was unknown if the reporter considered the insomnia and sleep restless to be related to TWINRIX. Additional details were provided as follows: Around 2007 she was vaccinated for hepatitis B, but when she started her new job it was found she did not had any antibodies to hepatitis B, which was why she was now receiving TWINRIX. In 2013 she got the hepatitis A vaccine and she does not know if she has any antibodies against hepatitis A. She also received the MMR series twice and still did not have any antibodies. The patient received 1st dose of TWINRIX on Friday, and had insomnia since. She had restless sleep Friday, Saturday night and on Sunday night she could not sleep at all. On Monday night she still could not sleep. On Tuesday night, she took a sleeping pill and finally fell asleep after 1.5 hours. Since her brother had common variable immune deficiency, so she was concerned that his might be a problem for her as well. The reporter gave consent to follow up.  Lab Comments: On an unknown date, the patient's antibody test for hepatitis B and MMR were negative.
measles like rash 3 days after vaccination with MMR, varicella, and influenza.  11/24/2008 MR received for DOS 11/14-15/2008 with D/C DX; Vaccine Rash. Pt presented to ER with 3 day hx of maculopapular rash which started on the face and spread to trunk and arms s/p 12 mon shots. PE (+) for mucosal lesions, clear rhinorrhea and maculopapular rash. Pt has been irritable and vomited once.
Fever over 102 and papular rash at injection site of varicella vaccine one week after administration.
Mark at injection site; Mark on the back left shoulder blade; This is a spontaneous report received from a contactable consumer (patient). A 61-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EN6203, expiry date unknown) on an unspecified route of administration on Arm Left on 14Mar2021 (at the age of 61-years-old) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (Solution for injection; Lot Number: EL9269, expiry date unknown), on an unspecified route of administration on 21Feb2021 as single dose for COVID-19 immunisation. Two days after the second dose on 16Mar2021, the patient got mark on the injection site on the left upper arm and in the back of the left shoulder blade. The patient reported that both marks were black in colour and the mark on the arm was bad. She went to the doctor and he couldn't say anything, said it was just a reaction from the injection. She clarified that both marks are black in color, and both on the left arm, she clarifies that one mark is Not on the forearm but what she meant to say was the injection site on the upper arm and the second mark is on the back left shoulder blade. She has taken pictures and is willing to provide it to the safety department. The Marks have no texture to them, but they are getting better, the darkness is fading away, its not as dark. The outcome of the events was reported as recovering.  No follow-up attempts are needed. No further information is expected.
1-2 days after MMR and DTAP immunizations experienced severe pain under right arm pit.  It is now 5 days after injections and the pain remains; it's painful to touch as well as apply pressure to the arm pit.
Patient recived Janssen COVID 19 vaccine. After receiving the shot, patient went stiff and fainted  with rolling of the eyes. Team member was able to help patient to ground. EMS service was called. EMS checked BP and blood glucose which was in normal range and recommended to have caregiver come pick patient up and rest. Patients fiancé came and took  home. Team member escorted patient out
The day after the vaccine, in the evening, patient experienced redness and swelling at injection; arm is still sore, but patient states she has this reaction with flu shots also. Patient has had some fatigue.
Patient went to urgent care clinic which had him take BENADRYL which reduced rash symptoms.
Confused thinking  Could not remember how to get up out of  the chair or how to put clothes on  Loss of Short Memory  Lasted for 5 days . Each day since episode gradually got better
expired DAPTACEL was administered to a patient, with no reported adverse event; Initial information received on 09-May-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 1 years old female patient and it was reported expired diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] was administered to a patient, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitants and family history were not provided.   On 06-MAY-2023, expired diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] Suspension for injection (batch/lot number: C5828AA; expiry date: 30-MAR-2023) was administered to a patient via intramuscular route in the left thigh for immunization, with no reported adverse event (expired product administered) (latency: same day)  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the event.   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 guidelines. 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.
Shoulder pain and discomfort, decrease range of motion.  Pain level varies depending on type of movement being performed. Pain has steadily increased over time, and has not dissipated as was expected. I have not yet received medical treatment or diagnoses.
moderate pain; tenderness; severe erythema; swelling; This is a Spontaneous report from a contactable Physician. A female patient of an unspecified age received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on 29Jul2019 (on day 57) at single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took meningococcal group b rlp2086 for immunization on day 4, after being vaccinated no noted adverse reaction noted. On day 57 after being vaccinated on the left upper arm, subject reported at 17:00 same day, moderate pain, tenderness, severe erythema and swelling measured (12.5x 16 cm).  However, the patient wass able to perform daily activities. She denied any fever or systemic signs. Took Ibuprofen as needed. Resolution of the events was on 02Aug2019 at 09:29. The patient had rheumatoid arthritis from 24Oct2019 to an unknown date.  No follow-up attempts are possible. No further information is expected.
Patient states vaccine placement was incorrect.  She said it was given too low and medial.  Due to the vaccine, she has a rash around the injection site.  She states her physician does not know if it is due to the vaccine, incorrect placement, or cellulitis.
Sudden sensory neural hearing loss in left ear on Monday (12/13/21) evening, confirmed by hearing test at The Hearing Lab on Tuesday (12/14/21). The audiologist recommended I see an ENT doctor. On Wednesday (12/15/21) I started to recover my hearing. By the time I saw Dr on Friday (12/17/21), I had fully recovered the loss, which was confirmed by another hearing test in his office. When Dr asked if I had felt dizzy, I recalled that 5 minutes after getting the vaccine on Sunday (12/12/21) I felt a ping in my head and was suddenly unbalanced. I had to stop and support myself for a minute.
Chills to where I was shaking uncontrollably for a few hours on and off. After awakening at 5:30 AM  12/09/2010 with severe headache and balance was off. Took Motrin at 5:30.  Fever of 100.6 and a dry cough was noticed at 7:30 AM. Had the headache all day and the cough lingers as of today 12/11/2010.