chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning a 13 year old female patient with no previous medical history reported who in 2007 was vaccinated, from another office, with the first and second dose of GARDASIL. As of 23-DEC-2008, the patient had not received the third dose. There was no concomitant medication. Subsequently, the patient developed headaches after her first dose of GARDASIL. The headaches are unilateral on the left side of her head and occur daily. The patient was referred to a neurologist. The patient's headaches persisted. The patient sought medical attention at office visit. Additional information has been requested.  2/3/09 Received OB/GYN medical records of 12/22/2008. FINAL DX: fibrocystic disease Patient had experienced enlarging right breast mass w/tenderness x 1 year.  During discussion of completing HPV vaccinations (had not had #3) patient revealed also had HA for approx 1 year.  3/11/09 Received PCP medical records of 7/19/07-11/1/2008. FINAL DX: fibrocystic breast disease; dysmenorrhea Records reveal patient experienced good health on 7/19.  RTC 10/25 w/sports injury & dx w/sprained right knee.  RTC 11/8/07 w/improving right knee.  RTC 6/20/08 for skin eval of moles on neck whose size had incresed x 1 year & were tender w/stinging sensation. Dx w/pigmented nevus & referred to Derm for eval.  RTC 8/13/08 w/right breast lump that was tender esp during menses.  Dx w/fibrocystic breast disease & dysmenorrhea.  RTC for breast pain recheck but patient refused exam.  No further records available. Information has been received from a registered nurse concerning a 13 year old female patient with a medical history of asthma when younger and who NAPROSYN caused breathing diffuculty, who in 2007 was vaccinated from another office, with the first and second dose of GARDASIL. As of 21-DEC-2008, the patient had not received the third dose. The registered nurse reported that the patient's mother stated that the patient had stopped GRDASIL after the second dose secondary to onset of headaches. There was no concomitant medication. Subsequently, the patient developed headaches after her first dose of GARDASIL. The headaches are unilateral on the left side of her head and occur daily. The reporter stated that after one year the headaches continued. The patient was referred to a neurologist. The patient sought medical attention at office visit. Additional information is not available.
Localized redness, swelling/lump, discomfort experienced for a duration of 1 month. Pt. stated that she had difficulty using arm to lift bowling ball/heavy objects d/t discomfort, but otherwise unaffected. Denied weakness, numbness of extremity. Symptoms resolved on its own w/o intervention.
Ex husband got so sick after second dose with flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Ex husband got so sick after second dose with flu like symptoms) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Ex husband got so sick after second dose with flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (Ex husband got so sick after second dose with flu like symptoms) outcome was unknown.            No concomitant medications were reported.  Treatment information was not provided.   This case was linked to MOD-2021-297997 (Patient Link).
Initial report was received on 29 September 2011 from a consumer, who is also a company representative. A 10-year-old female patient who had received several previous doses of influenza vaccine, had received "sometime the week of 12 September 2011" FLUZONE (lot number, route, site and exact date of administration not reported) and 24 to 36 hours later, experienced bumps and hives on the arms which then spread to the legs and trunk. The patient was treated by her physician with Prednisone and two other unspecified medications. The patient was to see an allergist. No further information was available at the time of the report. The patient's outcome was reported as recovered. Documents held by sender: none.
Patient reports this particular episode of chest pain started yesterday (2/19) around 12?noon. He reports that it initially started as "jolts" of pain, some "sharp and dull". He reports that he woke up this morning with a "tight" chest pain. He reports that he has also had "hot and cold sweats" all morning. Patient reports that this is not a burning pain, and does not feel like GERD or heartburn. He denies anything making this pain better or worse. Patient denies any nausea. He does note a lower?mid back pain that he has not had before as well.
Shingles left side of face  Eye swollen  Severe headaches now in fifth week
Approximately 5 minutes after administration of vaccine patient was observed to have small red indurations that were in close proximetry to both injections sites. Varicella site greater than MMR site. Areas of redness rapidly increased in size with several macular areas of approximately 1 cm at varicalle site and 1/2 cm at MMR site. Patient was alert and playing with no SOB or other observable problem.  Patient was given 12.5mg of benadryl and redness and macula resolved after approximately 10 minutes. Patients lungs reamined clear and patient was discharged with no symptoms of reaction after 40 minutes of observation.
Psoriasis flare-up/plaque psoriasis out break in scalp; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis flare-up/plaque psoriasis out break in scalp) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    patient had no known allergies. No relevant medical history was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) citrate free. On an unknown date, the patient experienced PSORIASIS (Psoriasis flare-up/plaque psoriasis out break in scalp). At the time of the report, PSORIASIS (Psoriasis flare-up/plaque psoriasis out break in scalp) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   On an unknown date, the patient experienced plaque psoriasis out break in scalp. On an unknown date, plaque psoriasis out break in scalp resolved. Moderna was also considered suspect.   It was unknown if patient was enrolled in a COVID-19 vaccine trial.   No treatment medication was provided.  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.
15 minutes after initial Hep B complained of throat hurting and this cleared rapidly 2nd dose - 10 minutes after administration began crying hysterical complained of throat hurting, stated it felt like she could not swallow "nothing in my neck will move".  Mother did attempt ER care but symptoms subsided. Before 3rd dose Hep B consulted their MD who advised not to receive any further injections.
Feeling unwell; This spontaneous case was reported by a non-health professional and describes the occurrence of MALAISE (Feeling unwell) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-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 ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. On an unknown date, the patient experienced MALAISE (Feeling unwell). At the time of the report, MALAISE (Feeling unwell) had resolved.            No concomitant medication information was provided. No treatment medication was provided. 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.
77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.; product storage error; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and PRODUCT STORAGE ERROR (product storage error).    This case contains information for the 38th patient out of 77 patients described by the reporter. No concomitant medication information provided. It was reported that 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion. The doses were administered before it was known if the vaccine was ok to use after the excursion. No treatment information provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:case
Pt has 5 cm x 5 cm area of cellulitis. Surrounding varicella immunization site.
Numbness in arms and hands, headache, high heart rate, slight fever, red welts on chest and back.
3/30/2021: lost consciousness for hours at a time for 36 hours extreme pain in lower back and side 4/10/2021 extreme pain in lower back, down left leg, shin, top of left foot.  Could not stand or walk or lift anything without enormous difficulty.  Restricted movement.  Pain in all joints throughout body.  Ongoing.
Covid moderna  vaccine given from vial that was expired by a couple of hours (vial was refrigerated the whole time). No adverse effect reported.
pt recvd vax & 3hrs later felt itching all over & exp redness all over body;these sx resolved w/in 24hrs of vax;
Woke up at around 3 am with headache and pain in  left arm, neck and upper back.  Got up to walk to bathroom and was weak and dizzy...nearly passed out. Walked to bathroom and became nauseous and then dry heaved.  Had to lie on the floor for 15 minutes from dizziness.  Had low grade fever 99.8.  Took Tylenol and went back to bed.   Improved over the course of the day and felt back to normal by evening except for a very sore arm and bruising at the injection site. Arm soreness lasted for 3 days.  Bruising is still there.
Patient ended up in the hospital with Chest pain; shortness of breath; exhausted; struggle to function; Off label use; Product use for unapproved combination; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 71-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 at 11:30 as dose number unknown (booster), single (Lot number: GH9703) at the age of 71 years intramuscular, in right arm for covid-19 immunisation; varicella zoster vaccine rge (cho) (SHINGRIX), on 27Sep2022 as unk, single (Batch/Lot number: unknown), in right arm. The patient's relevant medical history included: "Heart Disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Series of primary immunization completed. Unknown manufacturer), for Covid-19 immunization. The following information was reported: OFF LABEL USE (non-serious) with onset 27Sep2022, outcome "unknown"; PRODUCT USE ISSUE (non-serious) with onset 27Sep2022, outcome "unknown", described as "Product use for unapproved combination"; CHEST PAIN (hospitalization, medically significant) with onset 28Sep2022 at 01:45, outcome "recovered", described as "Patient ended up in the hospital with Chest pain"; FATIGUE (hospitalization, medically significant) with onset 28Sep2022 at 01:45, outcome "recovered", described as "exhausted"; DYSPNOEA (hospitalization, medically significant) with onset 28Sep2022 at 01:45, outcome "recovered", described as "shortness of breath"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (hospitalization, medically significant) with onset 28Sep2022 at 01:45, outcome "recovered", described as "struggle to function". The events "patient ended up in the hospital with chest pain", "shortness of breath", "exhausted" and "struggle to function" required emergency room visit.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events Chest pain, Fatigue, Dyspnoea and loss of personal independence in daily activities and  and the suspect drug cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Right arm broke out in fine red rash approximately 5-10 minutes post vax. Rash was above elbow and below shoulder area.
Night of shot - extreme pain at injection side radiating down into hand and up into shoulder.  Day after shot - pain radiates into armpit and left breast. Two days after shot - pain has lessened but still present at the injection side, arm pit, and breast.
This case was reported by a pharmacist via call center representative and described the occurrence of Shingles in a 53 year-old adult male patient who received SHINGRIX (batch number ML532, expiry date 13th July 2020) and (batch number A4X57, expiry date 13th July 2020) for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, the dose was an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced intercepted medication error and inappropriate preparation of medication. On an unknown date, the outcome of the intercepted medication error and inappropriate preparation of medication were unknown. Additional details were provided as follows: The vaccine was not administered (intercepted medication error). The age at vaccination was not applicable for this report. The health care professional reported she reconstituted a dose of SHINGRIX with poor technique and had to waste the dose due to having a very low volume, which led to inappropriate preparation of medication and intercepted medication error. The health care professional could not remember how much was in the vial. The health care professional did not administer vaccine to the patient. No patient information was available. Follow up information received from pharmacist on 1st June 2018: The reporter's contact details were updated. The patient's demographic were updated. On 28th March 2018, the patient received 1st dose 0.5 ml of SHINGRIX vaccine intramuscularly. Less than a year after vaccination, the patient came down with Shingles on his back. The VAERS details were updated. Follow up information received from pharmacist on 24th July 2018: The patient had previously experienced Primary Herpes Zoster (Chicken pox). In 2018, less than month after receiving 1st dose of SHINGRIX, the patient experienced dermatomal pain with rash, itching and altered sensitivity to touch. The patient was not hospitalized. The diagnosis of Herpes Zoster was confirmed and it was specified to be classical herpes zoster (unilateral, involving no more than three adjacent dermatomes). This was the first shingles episode. Right shoulder blade area was the specific affected dermatomes. There were no complications of herpes zoster present or specific organ system involvement. On 7th April 2018, all events were resolved.
lack of appetite; headaches; extreme fatigue; low-grade fever (99.5-99.9 degrees); This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (lack of appetite), HEADACHE (headaches), FATIGUE (extreme fatigue) and PYREXIA (low-grade fever (99.5-99.9 degrees)) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In June 2021, the patient experienced DECREASED APPETITE (lack of appetite), HEADACHE (headaches), FATIGUE (extreme fatigue) and PYREXIA (low-grade fever (99.5-99.9 degrees)). At the time of the report, DECREASED APPETITE (lack of appetite), HEADACHE (headaches), FATIGUE (extreme fatigue) and PYREXIA (low-grade fever (99.5-99.9 degrees)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2021, Body temperature (97.7-99.5): 99.5 - 99.9 degrees fahrenheit (High) High.         No concomitant medications were reported. No treatment information was provided by the reporter.    Reporter did not allow further contact
8/11/2021 client received an expired dose of Moderna.  10/4/2021 3:34 pm called patient, left message to return call. 10/18/2021 11:29 am called patient, left message to return call. Client received Moderna on 9/8/21 can receive a dose after  10/6/21.  10/18/2021 Client returned call. Will come in today at 1 pm for repeat dose.  12/23/2021 3:38 pm Viewed vaccine portal. Client did not return for Moderna.  Message sent via vaccine portal to call. Note left in vaccine portal to give client a full dose of Moderna at the next vaccination visit.
5 year old female child received FLUMIST 10/6/09. She had history of pneumonia in infancy, but no other pre-existing medical conditions prior to vaccination. After a week, she developed fever, shortness of breath and a cough. Symptoms did not resolve after a few days, so sought medical care. Subject diagnosed with pneumonia per chest X-ray, treated with AUGMENTIN. Symptoms did not improve, subject desaturating in low 90s and antibiotic changed to ZITHROMAX. Symptoms improved in - 5 days. No further problems. Subject received seasonal flu IM in past without any issues. Mom doesn't think pneumonia is related to vaccine. No chronic conditions
PT IS UNDER 18 Y/O AND RPH HAS GIVEN INJECTION OF (0.25 ML)MODERNA INSTEAD OF  PFIZER BOOSTER
Chills; Slight fever; very sore with swelling on the left arm; aching of the upper body; very sore with swelling on the left arm; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 63-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Batch/Lot Number: EN6204), via an unspecified route of administration, administered in Arm Left on 10Mar2021 11:15 (at the age of 63-years-old) as dose 1, single for COVID-19 immunisation. Medical history included malaria (over 30 years ago) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient was unaware of allergic reactions. It was reported that she was not a pregnant at the time of vaccination. She did not take any other vaccine in four weeks prior COVID -19 vaccine. She was not diagnosed with COVID prior vaccination and not tested with COVID post vaccination. On 11Mar2021 09:30 AM, the patient experienced chills, slight fever, very sore with swelling on the left arm and aching of the upper body. No therapeutic measures were taken. The outcome of events was recovering.  No follow up attempts are possible. No further information is expected.
Patient was very very anxious to receive the IMZ. Pharmacist calmed the patient down and administered the IMZ. Patient went over to wait 15 minutes in the post IMZ waiting area . Patient started to become very anxious again while waiting and vomited. Pharmacist came out & assisted and calmed the patient down. Provided water to patient and after patient calmed down & feeling OK patient left with her father. Patient was feeling fine when left with her father.
28JAN awoke w/discomfort in both feet-no visible abnormalities;by 29JAN was unable to walk d/t pain & purple & red nodules visible on feet,including soles;was seen by MD 30JAn,who indicated that it might be d/t arthritis;dx dyshidrosis
Pt received third Shingrix dose in error. Reports having typical pain at injection site following administration, but is experiencing no related pain now.