chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Ankle Pain; 1ST dose on 12-MAR-2021 and 2nd dose on 20-APR-2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1ST dose on 12-MAR-2021 and 2nd dose on 20-APR-2021) and ARTHRALGIA (Ankle Pain) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On 20-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1ST dose on 12-MAR-2021 and 2nd dose on 20-APR-2021). On an unknown date, the patient experienced ARTHRALGIA (Ankle Pain). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1ST dose on 12-MAR-2021 and 2nd dose on 20-APR-2021) outcome was unknown and ARTHRALGIA (Ankle Pain) was resolving.            No concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Chest pain; x3-4 weeks; in hindsight I had mild chest pain after dose number one but it was less severe and did not last as long; I thought it was stress then. After dose number two is was crushing and lasted for a long time.
Left foot was asleep, then severe back pain. Numbness in legs and loss of reflexes. Couldn't walk without aid of wall or furniture. Was finally correctly diagnosed and hospitalized on 01/30/10 and was started on 5 days of intravenous immunoglobulin.
Vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On 01-Apr-2021, the patient received dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment medications were reported. Patient was" not a vaccine person" but decided to get the covid vaccine anyway and now she doesn't know if she wants to proceed with the second dose which is scheduled for April 22, 2021. also reported that she didn't have any reactions, she had heard feedback from a lot of friends and family who are getting reactions to the second dose and this was causing her to have some hesitation. Patient then clarified that no one she knows got the Pfizer vaccine they got the Moderna.
This case was reported by a healthcare professional and described the occurrence of the use of expired vaccine in a 15-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline), Hepatitis B vaccine. There were no concurrent medications. On 6 July 2012 the subject inadvertently received an expired 1st dose of ENGERIX B at 0.5 ml in the left arm. This was technically the 4th dose of hepatitis B vaccine for this subject as she previously completed a hepatitis B vaccination series (manufacturer unspecified) on unspecified dates and did not respond to therapy. Follow-up information was received on 07 August 2012 via healthcare professional who reported the subject did not experience any adverse reactions due to the administration of ENGERIX B.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: Unknown. The reporter is the patient. A 54-year-old female patient received BNT162b2 (BNT162B2), on 13Sep2021 as dose 1, single (Lot number: EC3182), in left arm and on 04Oct2021 as dose 2, single (Lot number: EF8839) at the age of 54 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. No prior vaccinations within 4 weeks. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Positive for Covid, had 2 Pfizer Covid vaccines". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive, notes: Result: positive; Unit: Not Provided. Therapeutic measures were as a result of vaccination failure, covid-19 included Paxlovid (Could be GA5101, BA5101 or DA5101) from 17May2022, with dosage: take 2 tablets nirmatrelvir, 1 ritonavir by mouth, together; 3 tablets morning, 3 tablets at night.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 60 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Coronary artery disease" (unspecified if ongoing); "Tree nuts" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19; The patient received Paxlovid from 08Jan2023 to 13Jan2023. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report was received from a registered nurse and refers to multiple unspecified patients of unknown demographics. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored PNEUMOVAX 23 (lot #, dose and route were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This case was reported by a nurse via call center representative and described the occurrence of joint pain in a 16-year-old male patient who received BEXSERO for prophylaxis. Co-suspect products included MENVEO for prophylaxis. Previously administered products included MENVEO (1st dose received on an unknown date without any adverse reaction). On 28th August 2018, the patient received the 1st dose of BEXSERO and the 2nd dose of MENVEO. On 28th August 2018, 2 hrs after receiving BEXSERO and MENVEO, the patient experienced joint pain, sweating, felt faint and headache. The patient was treated with sulfamethoxazole + trimethoprim (Mortin). On an unknown date, the outcome of the joint pain, sweating, felt faint and headache were not recovered/not resolved. It was unknown if the reporter considered the joint pain, sweating, felt faint and headache to be related to BEXSERO and MENVEO. Additional details were provided as follows: The healthcare professional reported that 2 hours after vaccination with BEXSERO and MENVEO, the patient started experiencing joint pain, severe headache, feeling sweaty and faint. The healthcare professional stated during the course of the call that the patient's mother would be taking him to the emergency room. The healthcare professional stated that she told the patient's mother to give him motrin for the pain and headache.
Severe muscle aches and spasms, chills  nausea, headache, neck pain, congestion . Started around midnight, muscle spasms became severe at 2:00 am. Last until March 11, 2021.
Patient came by today 11/5/18 at 1:30pm to let me know that she has been feeling light headed and unbalanced since she received her shot on 10/31/18. She had even had to use her cane when walking around, as she almost fell. She is very sensitive to medications and believes that this is directly related to the high dose flu shot. She is seeing Dr. tomorrow and will talk to her about it. I told her that I would report the adverse event and put a note on her profile. I counselled her that the symptoms should not last much longer, as they usually resolve within a week.
Patient was in office for vaccine appointment on 1/07/2023. Provider ordered MMR vaccine to patinet, but nurse inadvertently administered  MMRV in stead MMR to patient. patient's mother was informed of error immediately.  Mother reported patient has slight redness and soreness at injection site, otherwise child is doing well, denied other active complaints. Normal activity level. went to school. Encouraged to use cold pack, promote PO hydration and Tylenol as needed. Advised to continue monitor, call back if any questions and concerns.
Patient's father attended clinic with his son to get his son the booster shot. Patient is 13 y.o. male that received Pfizer 0.2ml vaccine instead of the 0.3ml dose.  Patient's father was notified that his son received the incorrect dose for his booster and received a lower dose than he should have.  The vaccinator missed the patient's age.  Additionally, vaccinator was vaccinating children 5-11 years of age only.  I will inquire and confirm what can be done to correct this incident, so the patient is boosted correctly.
First Migraine hours after, then by 11 I had sore throat and chest pain. Now it?s 2 days later and I still have a lump in my throat and coughing.
Havrix given after temperature excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 1-year-old female patient who received HAV (Havrix) (batch number F7X23, expiry date 25th May 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th January 2023, the patient received Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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: 16-FEB-2023 Reporter's Comment: The healthcare professional reported that the patient received a dose of Havrix that had been in a below temperature excursion and was not considered stable.  The vaccine administration facility was the same as primary reporter. The healthcare professional reported that below temperature excursion had happened in October (unspecified year). The reporter consented to follow up. Additional Supportive Information: The patient received a dose of Havrix that had been in a below temperature excursion, which led to incorrect storage of drug. This was one of six cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023026692:Same reporter US-GSK-US2023026695:Same reporter US-GSK-US2023026693:Same reporter US-GSK-US2023026694:Same reporter US-GSK-US2023026698:Same reporter
fever, body aches, redness and heat to left arm at injection site with significant spreading of the redness and heat starting approximately 4 hours after injection.  Fever and body aches resolved after 48 hours.  The redness and heat on the left arm continue and this is why I am filling out this form.  I am told that if the redness and swelling becomes worse I need to go to my doctor and possibly be treated for cellulitis.  The hospital who gave me the vaccine asked me to fill out this form due to the arm reaction.
Expired Havrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number 7YA99, expiry date 30th September 2022) for prophylaxis.   On 6th October 2022, the patient received Havrix. On 6th October 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 18-OCT-2022 Reporter's comment: Medical assistance reported that the patient was administered expired doses of Havrix. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up. Additional Supportive Information: The patient received a dose of Havrix which was already expired, which led to expired vaccine used. This case was one of the 4 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2022149857:Same reporter US-GSK-US2022149859:Same reporter US-GSK-US2022149860:Same reporter
3:30 p.m.--vaccine 5:00 a.m.--chills, sweats, headache, swollen sore glands, ear aches in both ears, fatigue until 3:00 p.m. the following days. Then most symptoms cleared up except for a mild headache for a few days. Ears continued to be a problem. The first two weeks sensitivity to going up and down hill (pain with pressure changes). Sore glands, ear discomfort, ringing in ears on three occasions, rash on inside of left elbow, pain in right ear when hearing certain pitches like the clinking of putting away dishes, singing, child's band concert----The right ear has continued to bother me more than a month later, uncomfortable pressure in ear, pain upon waking, pain with noises that did not hurt my ear in the past
This case was reported by a consumer via call center representative and described the occurrence of porokeratosis in a 78-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included porokeratosis (since 1988 and the condition has been stable for the most part for years). On 29th May 2018, the patient received the 1st dose of SHINGRIX. On 30th May 2018, 1 days after receiving SHINGRIX, the patient experienced porokeratosis (serious criteria GSK medically significant), condition aggravated, swelling, pain and skin red. In June 2018, the patient experienced skin irritation. On an unknown date, the outcome of the porokeratosis, condition aggravated and skin irritation were not recovered/not resolved and the outcome of the swelling, pain and skin red were recovered/resolved. It was unknown if the reporter considered the porokeratosis, condition aggravated, skin irritation, swelling, pain and skin red to be related to SHINGRIX. This case was reported by the patient for himself. The patient received SHINGRIX in the left deltoid. The patient stated that his porokeratosis symptoms worsened a couple of weeks after getting the SHINGRIX vaccination. His skin was redder with more irritation on his legs, arms, chest and back.
Information has been received from an office manager concerning her daughter who on unspecified dates was vaccinated with all three doses (Lot# not provided) of GARDASIL. After getting all three doses of GARDASIL, the patient developed polycystic ovarian syndrome ("PCOS") and diabetes. The patient sought unspecified medical attention. Additional information is not expected.
Initial health care professional (medical assistant) report received on 28 Jan 2011: This patient with an unknown medical history was vaccinated with MENVEO (batch number: 090601A) intramuscularly on 27 Jan 2011. But during she was administered with only Men CYW-135 component without Men A portion. The outcome was not reported.
an expired ADACEL vaccine was given with no adverse event; Initial information received on 14-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age/gender patient who experienced an expired adacel vaccine was given with no adverse event while receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a  dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route in unknown administration site for immunization.  On an unknown date the patient reported a non-serious event an expired adacel vaccine was given with no adverse event (expired product administered) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  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.
Patient experienced redness, warmth, bump, and rash that spread under her arm. She noticed the reaction the next day and the rash has spread over her arm
soreness under her armpit; pain at the front and top of her head; cold sweats; chills; This is a spontaneous report from a contactable consumer (patient). A 51-years-old female consumer patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number and expiry date were not provided), via an unspecified route of administration, on 04Mar2021 (at the age of 51-years-old) as a single dose for covid-19 immunisation. Patient's medical history and concomitant medications were not reported. On an unspecified date, as reported, patient was still experiencing soreness under her armpit where she had the injection, pain at the front and top of her head, cold sweats and chills. The reporter asked was this common and when should she be concern. The reporter asked a question that can she take Tylenol after receiving the Pfizer Covid-19 vaccine. The outcome for the events were not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report as received from a 72 year old patient regarding himself. Patient has an allergy to opaque dye. The patient's medical history included kidney cancer surgery, kidney stones and slow stream. On 14-JAN-2013,the patient was vaccinated with ZOSTAVAX (Lot number, expiry date and route were not reported), 0.65 milliliter (ml). Other suspect therapies included finasteride (manufacturer unknown). Concomitant therapies included tamsulosin hydrochloride (reported as TAMSULOSIN) and CRESTOR. Approximately on 19-JAN-2013 (reported as 5-8 days after vaccination), the patient experienced penile psoriasis, nipple pain and breast pain. The patient stated that he was in extreme pain that was affecting his daily life from these adverse experiences. In addition, the patient had been taking finasteride (manufacturer unknown) when he had received the ZOSTAVAX shot. However, he was directed by this physician to stop taking this medication a week after having the shot because the physician thought that this is what was causing the breast pain. Though, after stopping therapy on this drug approximately on an unknown date in January 2013, it did not alleviate the breast pain. Patient sought medical attention (saw the physician) and was treated with SORIATANE for the event penile psoriasis. The events breast pain, penile psoriasis and nipple pain was reported as not recovered/not resolved. The reporter considered breast pain to be related to finasteride (manufacturer unknown). Legal issue was involved and the adverse event was seen sent to Legal team. Additional information has been requested.
CDC called and requested I complete this report, but I do see these reactions within the normal range reported to us prior to getting vaccine.   6 hrs after 2nd shot fever of 99, headache, and arm pain.  20 hrs after shot significantly worse headache, arm pain and fatigue to point of not getting up, not walking around, and not interested in eating until later in the day.  30 hrs after shot I was up and eating normally, but continued headache 46 hrs after shot but ibuprofen adequate to cover pain today.
Induration at vaccine site <1cm, excoriated, red, macule on leg.  Right thigh.  Seen 07/15/2003: given 1% HC creme to be used at affected area twice daily.
rash lt upper arm by inj site;rt arm both legs, noc of inj;pt gave med;the rash was gone by 17FEB98 PM;
At 11PM  on 4/8/21,  I had sharp, stabbing LEFT UPPER QUADRANT PAIN under the rib cage.  For the 1st 15 minutes, they came EVERY 30 SECONDS.  For the next 15 minutes, the pain came EVERY 30 SECONDS.  For the following 30 minutes, the pain came intermittently for 5 more times until midnight.   On 4/9/21, at 1PM     my LEFT HAND FELT LIKE IT WAS ON FIRE until 12 noon. Since then, no other problems.
Three hours post vaccine, my arm began to  hurt,  I saw lights in my vision, I had  fever. I took Tylenol and I went to sleep. Then I had a headache, back ache, I called the doctor because my  my neck and under my arm , I had swollen lymph nodes and I had fever. I lost my sense of taste. I was given a COVID -19 test and it was negative. I  had surgery on my left arm in the past  and it began hurting again, my back hurt, my bones, the bones in my toes would cramp. My migraines have become worse. I went to the ER, They gave me a COVID-19 test and it was  negative. I told the doctors I had a severe migraine. I received Doradol injection  and another Noslex  injection, and anti-inflammatory medication.    I had my uterus removed. I only have ovaries, and I started my menstruation about 2 or 3 days after my vaccine  and it lasted for 2 days. After the vaccine, I feel like I am an old lady of 100 years old.  My back pain and headache are every day. I also have a lot of nausea and I was prescribed Pepcid.
Purpuric Rash started post vaccine day 5 lasted until post vaccine day 23 with first dose. Second dose caused rash to appear within 24 hours. Thrombocytopenia was revealed on day 3 post vaccine dose 2 and continued to drop for the next 48 hours.
A small, itchy rash started in a few days.  It spread across my arms and legs an chest and back in the first couple of weeks.  One dermatologist suggested it was eczema and gave me a cream.  After a couple more weeks the rash was evolving from 1/8 " itchy spots to 1/2 " scaly itchy spots.  A second dermatologist prescribed a steroid.  It's worse now and nothing has helped!
pt recv vax 22NOV93 & exp no significant inc in titer; No further details were  provided;