chrisvoncsefalvay/vaers-outcomes huggingface dataset:
16 month old male received a dose of Kinrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 15-month-old male patient who received DTPa-IPV (Kinrix) (batch number 24T2N, expiry date 07-MAY-2023) for prophylaxis.   On 07-MAY-2023, the patient received Kinrix. On 07-MAY-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 16 month old male received a dose of Kinrix). 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: 17-May-2023  The reporter reported that the 16 month old child patient received Kinrix vaccine. The reporter stated that the patient did not experienced any symptoms. The vaccine administration facility was the same as primary reporter. The reporter did consent to follow up via email. The patient received Kinirix who was younger than the indicated age which led to inappropriate age at vaccine administration.
pt recv vax 23APR94 & the following day devel swollen & sl numb hands; 28APR94 pt devel swelling & a rash of both forearms, tenderness of the wrist joints; pt presented to MD on 12MAY94;pt extremities were remarkable for swollen, hands;rash
Symptomatic covid confirmed by PCR; Symptomatic covid confirmed by PCR; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient. A 35-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 05Nov2021 (Lot number: FH8020) at the age of 35 years as dose 3 (booster), single, intramuscular, administered in arm left, administration date 04Feb2021 (Lot number: EL3247) as dose 2, single and intramuscular, administered in arm left, administration date 14Jan2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. On 23Jan2022, the patient experienced symptomatic covid confirmed by PCR (medically significant) with outcome of recovered on an unspecified date in 2022. The event "symptomatic covid confirmed by PCR" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: Abbott Alinity m Resp-4-Plex assay (PCR) (24Jan2022) negative, notes: Nasal Swab; (27Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Additional information: The patient had no other vaccine in four weeks. The patient did not have covid prior to vaccination.
throat tightness, 7/7/22 at 9pm-skin broke out in hives, injection site bruised, swollen, lump between neck an shoulder blade, dizzy, fatigued, weak, dehydrated
At 4:30 pm (2 1/2 hr post inj) tickling in throat, cough, neck tight and back of tongue swelling. Benadryl shot - slept- left hospital at 9:30 pm.
fever; body aches; nausea; diarrhea; fatigue; canker sores in mouth; canker sores on roof of mouth; eft side of face puffy; This spontaneous case was reported by a health care professional and describes the occurrence of PYREXIA (fever), PAIN (body aches), NAUSEA (nausea), DIARRHOEA (diarrhea) and FATIGUE (fatigue) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever), PAIN (body aches), NAUSEA (nausea), DIARRHOEA (diarrhea), FATIGUE (fatigue), ORAL PAIN (canker sores in mouth), STOMATITIS (canker sores on roof of mouth) and SWELLING FACE (eft side of face puffy). At the time of the report, PYREXIA (fever), PAIN (body aches), NAUSEA (nausea), DIARRHOEA (diarrhea), FATIGUE (fatigue), ORAL PAIN (canker sores in mouth), STOMATITIS (canker sores on roof of mouth) and SWELLING FACE (eft side of face puffy) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102.2 °f 102.2 °F and 101. On an unknown date, COVID-19: (Negative) Negative.     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 reported. Treatment included steroid and magic mouthwash
Headache, NauseaVomiting, chill,s fatigue Narrative:
Covid19 breakthrough.  1st vaccine received on 04/21/2021.  85 y/o with PMHx of Type 2 DM, Dementia, HLD, HTN, and CVA/ICH presents to ED via EMS for behavioral changes, abdominal pain, back pain and knee pain.  Covid test performed after several days in hospital in preparation for SNF placement.  Pt afebrile, Room air sats 96%, asymptomatic, no treatment ordered.
This is a spontaneous report from a contactable consumer (patient). A 31-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: EW0167, Expiration Date: not reported), via an unspecified route of administration, administered in left arm on 12May2021 at 08:30 (at the age of 31 years old) as first dose, single for COVID-19 immunisation in a hospital. Medical history included overactive bladder from an unknown date and unknown if ongoing. The patient has known allergies with beeswax. Prior to vaccine the patient was not diagnosed with COVID-19. Concomitant medications included tolterodine, xantofyl (LUTEIN), fish oil and vitamin d, all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines in 4 weeks. When the patient got his shot of BNT162B2, the patient  felt no pain when the nurse administered the shot. On 12May2021 at 21:00, the patient started to feel numbness occasionally in the thenar muscle on the radial side of the patient's left hand. The numbness was most obvious during complex hand movements such as hand washing and but it wasn't persistent. It was further described that it felt like the sudden numbness the patient gets when he accidentally hit his elbow against the wall but less intense. The patient woke up the next day with persistent numbness in his entire left hand, affecting the wrist, palm, and all 5 fingers. This persistent numbness the patient had felt was like the numbness he gets when he was sleeping on his side with his hands under his head. It extended to the patient's distal forearm on 15May2021. At the day of the report ,the 5th day after vaccination (as reported), the soreness of the injection site had subsided but both types of numbness in the patient's left hand remained. They're were not as bad as "pins and needles" and there was no tingling sensation but it was concerning the patient. No treatment was received for the adverse events. Since vaccination, the patient has not been tested for COVID-19. Outcome of all events was not recovered.
A 24 year old female patient was found in the observation area after receiving the second dose of Moderna at 6:20 pm. While waiting the 30 minutes in the observation area  started to feel itchy on neck and extremities and dizziness. The patient had not notified the paramedic and became aware the moment the patient was discharged. The patient reports that at approximately 5:20 pm they took Benadryl 50mg since it was her first dose. Afterward, was taken to the incident observation area at 7:00 pm to take vital signs which were 110/70 B/P, 94 DXT, 95 saturation and 73 frequency. Newly, at 7:45 pm vital signs were taken which were: 100/60 B/P, 79 DXT, 99 Saturation and 55 frequency. Case was consulted with Dr. and was authorized to administer Dexamethasone 4mg/ ml intramuscular.
3rd 06Mar2023; 2nd Oct2022; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 54-year-old female patient who received HAB (Twinrix) for prophylaxis.  Co-suspect products included HAB (Twinrix) for prophylaxis and HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX) for prophylaxis.  On 06-MAR-2023, the patient received the 3rd dose of Twinrix. On 04-OCT-2022, the patient received the 2nd dose of Twinrix. On 03-AUG-2022, the patient received the 1st dose of TWINRIX. On 04-OCT-2022, not applicable after receiving Twinrix and an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: 2nd Oct2022). On 06-MAR-2023, the patient experienced drug dose administration interval too long (Verbatim: 3rd 06Mar2023). The outcome of the drug dose administration interval too long and drug dose administration interval too long 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 Information: GSK Receipt Date: 20-MAR-2023 The patient received 1st dose of Twinrix on 3rd August 2022. The patient had asked that he would like to know influenza have anything to do with the hepatitis shots. He went to get my third shot last week for hepatitis and they were trying to tell me that the influenza was part of the hepatitis. All they said was influenza and he had to figure it out so it does not mess me up so they could start the treatment on the liver. On Saturday 11th March the patient went to emergency room. The patient had received the second and third dose later than the recommended interval, which had led to lengthening of vaccination schedule.
Not able to take her last dose on day 7; Spontaneous report received on 04FEB2020.  A pharmacist reported that a female consumer was "not able to take her last dose on day 7" (PT: Product dose omission) while being on Vivotif for immunisation. The consumer took her first, second and third dose of Vivotif on 29JAN2020, 31JAN2020 and 02FEB2020 respectively. She was unable to take her last dose on 04FEB2020; instead, she would be able to take the last dose on 05FEB2020. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer was not able to her last Vivotif dose on day 7 (missed dose) as per the schedule. The consumer would be able to take her last dose on day 8. Vivotif doses should be taken on every other day. Considering the nature of the event, the causality of missed dose is assessed as not applicable to Vivotif.; Sender's Comments: A consumer was not able to her last Vivotif dose on day 7 (missed dose) as per the schedule. The consumer would be able to take her last dose on day 8. Vivotif doses should be taken on every other day. Considering the nature of the event, the causality of missed dose is assessed as not applicable to Vivotif.
Pt. experienced difficulty breathing, chest congestion, increase mucous-started about one hr after immunization.
This spontaneous report was received from a pharmacist, referring to a 52-year-old female patient. The patient's concurrent conditions and concomitant medications were not provided. Her medical history included allergy to "sulfa" (sulfonamide). On 16-JAN-2019, the patient was vaccinated with a dose of M-M-R II, lot # R019391 and expiration date 05-JUL-2019, for prophylaxis (frequency and anatomical location were unknown). This dose of the vaccine was administered intramuscularly (incorrect route of product administration). Other suspect therapies included sterile diluent (MERCK), used with the vaccine and administered intramuscularly as well. On an unspecified date in 2019, after been vaccinated, the patient experienced soreness and a tingling sensation at the injection site. The outcome of injection site pain and injection site paraesthesia was reported as not recovered. The causality assessment between M-M-R II and the aforementioned events was not reported.
Side of right foot got very red and swollen, then turned to large bruise covering little toe, and part way down foot.  Next bruised spread out.
Swelling around ankles, started with left on 6/23/21 and moved to both ankles by 6/23/21 later that day.  Severe pain, inflammation, red skin around both lateral and medial malleolus.  Decrease of mobility and range of motion.  Swelling has not gone down in 4 days.
Severe headache, significant left arm and site of injection pain, sit of injection swollen, red and hot to the touch
No additional AE details were available.; an adult patient was administered the pediatric dose of RECOMBIVAX; This spontaneous report was received from a medical assistant and refers to a 46 year old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions were not reported. On 22-APR-2021, an adult patient was vaccinated with pediatric dose of hepatitis b vaccine (recombinant) (thimerosal free) (RECOMBIVAX HB) lot # R034547, expiration date not reported, but upon internal validation established as 09-JUN-2021, 0.5 milliliter of 5 microgram (route of administration was not reported), for prophylaxis (underdose). No additional adverse event details were available.
Moderate dizziness when not laying or sitting down that resulted in severe nausea for 4 days post vaccine. Dizziness worsened over day 2 and 3 and included periods of profuse sweating. Symptoms required call to MD and improves with sublingual zofran 8mg and increase in fluids . Symptoms disappeared completely by day 5 post vaccine. Dizziness and nausea started to reoccur again today (3/12/21).
Multiple bruises on both arms, not at the injection site. They started to improve after two days but you can still see where they were.
Soreness, red, hurting in both arms. Hoarseness, sore, red itchy eyes/still problem cough, fever aches, headache, itching, very fatigue and tired. Hands burned and shedding skin.
Flat itchy rash about size of "mosquito bites" on hands, feet, back and stomach noted on 6/27.   Took to physician on 7/1.  Received BENADRYL and Calamine lotion.   Decreased itching noted on 7/02.
No adverse event; Incorrect product/dosage was administered, resulting in a lower-than-authorized dose of Moderna; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (Incorrect product/dosage was administered, resulting in a lower-than-authorized dose of Moderna) and NO ADVERSE EVENT (No adverse event) in a 13-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR4504B) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 23-Aug-2022, the patient experienced INCORRECT DOSE ADMINISTERED (Incorrect product/dosage was administered, resulting in a lower-than-authorized dose of Moderna). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (Incorrect product/dosage was administered, resulting in a lower-than-authorized dose of Moderna) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT DOSE ADMINISTERED (Incorrect product/dosage was administered, resulting in a lower-than-authorized dose of Moderna).    No concomitant medication was reported.  It was reported that they inadvertently gave lot AR4504B 0.5ml IM instead of Regular Moderna. On 23-Aug-2022, a patient received the first dose of the Moderna COVID-19 vaccine from a vial authorized for use in a different age group. The patient had not reported any adverse reactions.  No treatment information was reported.
Patient recevied Varivax vaccine SC in right arm on 08/3/11.  Redness was noted in the area 09/01/11.  On 09/02/11, patient developed fever and warmth in area of administration.  Patient was evaluated in office and was noted to have a 3 x 4 cm area of erythema, swelling, warmth, slight induration (non-tender) with irregular borders, surrounding vaccine site on RUE; also very tiny superficial scratch in middle of swelling.  Patient was treated with antibiotics.
pt recvd vax; pt devel malaise, diarrhea, generalized achiness, muscles aches & fatigue; pt exp also chills & devel t 99.9; ducks of both hands itched
fever ,muscle aches, chills, headache, weakness, tires, muscle tightness, couldn't move , barely walk,  fast heart beat.
acute mental status change; orientated to self, but not place/time; found wondering in yard looking for wife, who died 3 months ago;
Got shingles vaccine / my arms are in pain since then; 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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   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 the case. The age at vaccination was not reported. The patient received Shingles vaccine few months ago and experienced pain in arm. The follow up would not be possible as no contact details available.
Fainted and had a slight seizure.  Left hand seized up.  Lasted for about 45 seconds.  Lost color in face and sweating all over.
Tuesday Mar 30, 2021 ~ 30-45 minutes after I got my first dose, i felt shortness of breath, and my throat felt tight. I called 911, was talken to the hospital. These symptoms started going away on their own. The doctor thinks I probably had an allergic reaction to the shot.
2 am (13 hrs after shot)  the following day, i awoke with intermittent shooting type pain down my arm into my finger tips and a sore upper arm at injection site. 1:30 pm (24 hrs after shot) i had a bad headache and queasy stomach, approximately 1/2 hr later had the chills and a fever of 99.8.  I slept for approximately 3 1/2 hrs.  Upon awakening  I still had chills but no fever 98.8 and all my joints ached.  6 pm I took 2 Ibuprofen and by 7:30pm I had warmed up but was extremely tired.   10 pm I took 2 more Ibuprofen and went to bed.  I slept until 7 am and feel wonderful.  My arm is a little tender yet but no trouble using it.
Headache, Myalgia, Fever, sore, red swollen site, fatigue Narrative; missed one day of work
Little queasy; Swelling arm; Pain in arm; Little headache; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on (16Jan2021), this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EK5730), via an unspecified route of administration on an unspecified date in Jan2021 for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported that he was better during administration (Thursday) and by Friday (Jan2021), the patient had a little pain in his arm and little headache. Morning of 16Jan2021, the patient felt a little queasy. The patient reported that he felt a little bit different on Friday. The swelling in his arm was not a problem that's gone down and little pain not much. The patient would like to know the extent of effects the shot could take. The outcome of the event swelling arm was unknown; all other events was unknown.
chills; swollen arm; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients (Reporter and his wife). This is 2nd of two reports. This consumer reported for a female patient(wife) that. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date at dose number unknown, single for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date the patient experienced chills and swollen arm. Verbatim and event description: Swap from FC - 1/6 first  and the 2  on 1/27 he had no side effects to the shot. His wife who is HCP had side effects of chills and swollen arm. So he went and had an antibody test because he had no side effects and the results were negative. He is asking what that means. Outcome of the events was unknown.  Information about lot/ batch number has been requested.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.; Sender's Comments: Linked Report(s) : -PFIZER INC-2021191709 Same drug, different patient and event.
States she had mild Charlie horses in her legs and hands starting 7 days post vaccination with the 2nd dose of Pfizer. On day 9 post vaccination she developed these Charlie horses in her ribs and  arms and legs stating she felt like she was on her way out. Did not take any meds not went to the doctor for the symptoms. Started taking calcium/zinc product and as of today she states she is well. She just wanted someone to talk to about the side effect and make sure this was documented
2JUL92 AM rash began on neck, back, torso & perineal area; no temp x/appetite poor; 3JUL92 began w/temp; taken to ER t104-rash; pt lethargic, would not take any fluids; dx pharyngitis/fever;
Headache, Myalgia, Fever, CHILLS, RIGORS Narrative:
shingles despite being vaccinated/Suspected vaccination failure; recurrent shingles; This case was reported by a other health professional via sales rep and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving 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.     Additional Information: GSK Receipt Date: 30-AUG-2022 Reporter's Comments: Personal Assistant (PA) had asked, whether there was a way for his/her to get an advice on a patient with recurrent shingles 1-2 times per year despite being vaccinated. It was not clear whether the patient was vaccinated with Shingrix or not (but the question was coded as Shingrix by field representative). There was no additional information available with regard to this adverse event. The reporter had consented to follow up. Additional supportive information: This case was considered as suspected vaccination failure since details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles was reported at the time of reporting.  Suspect coded as shingrix as given in structured field conservatively.