chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1st vaccine in 2018, has not received her 2nd; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (patient received 1st dose of Shingrix in 2018 in unknown arm via intramuscular route of administration).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 15-JUN-2022 Reporter's comment: The reporter reported that, her friend had not received her second Shingrix vaccine. No patient information or reporter information were provided. The reporter did not consent to follow-up. Additional Supportive Information: Till the time f reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
This spontaneous report was received from a pharmacist regarding a 74 year old male patient. Pertinent medical history and concomitant medication was unknown by reporter. Patient had none drug allergies or reactions. On 15-NOV-2016, patient received a dose of unspecified flu vaccine (unspecified manufacturer/intramuscular) and a dose of ZOSTAVAX 19400 PFU, subcutaneous in the same arm (unspecified arm) and a dose of PNEUMOVAX 23 in the opposite arm (unspecified arm) on the same day. On an unknown date in November 2016 the patient experienced soreness at all of the injection sites and became quite ill. The patient was feeling a lot better when asked about present status. The outcome of soreness at all of the injection sites and became quite ill was reported as resolving. Causality was unknown. Additionall information has been requested.
Pt called into clinic to inform PCP that her arm is hot, swollen, painful from shoulder to elbow, can not raise arm.
First Vaccine, no side effects except sore arm for one day and a lot of bruising at injection site which left in 8 days. Vaccine 2 awakened at 2:00 AM in extraordinary pain in my whole body,, dry heaved for 4 hours, sweats and chills, temp only 99 (I usually run 97) Felt sick to stomach rest of  day. Never felt this sick.  By evening it left as quickly as it came.  Was tired for several days but nothing else. On Feb 16th awakened with an very sharp pain in the injection site when I moved my arm up to stretch. This has gotten worse every day. When I move my arm in a certain direction it feels like it is ripping inside. It is not bruised and not painful to the touch. It is inside and in the same location as the injection. Heat and ice make no difference. It seems to be getting more painful and feel it more often. It is painful enough that I let out a yelp when I forget and lift my arm a certain way. As of yesterday I feel it all day, not the sharp pain but more a inside burning, not enough to stop me, but I know it os there.
MY COLD SORES HEAL FASTER WITH VALACYCOVIR PO (VALTREX) AND DOCOSANOL (ABREVA) TOPICALLY.  USUALLY DON'T EVEN GET A COLD SORE NOW, JUST A PRODROMAL SIGN.
Vit D deficient; rashes on both legs; welts on both legs, some spots were chronic; blisters on both legs; This spontaneous case was reported by a patient and describes the occurrence of BLISTER (blisters on both legs), VITAMIN D DEFICIENCY (Vit D deficient), RASH (rashes on both legs) and URTICARIA (welts on both legs, some spots were chronic) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 006B21A) for COVID-19 vaccination.    Co-suspect product included non-company product ROSUVASTATIN for High cholesterol.    The patient did not have any allergies.  Concurrent medical conditions included Rheumatoid arthritis (No meds currently for this since. She stopped the medication for this condition in 2012) since 2009, High cholesterol and Osteoarthritis since 2009.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient started ROSUVASTATIN (unknown route) at an unspecified dose. In June 2021, the patient experienced BLISTER (blisters on both legs), RASH (rashes on both legs) and URTICARIA (welts on both legs, some spots were chronic). In September 2021, the patient experienced VITAMIN D DEFICIENCY (Vit D deficient). The patient was treated with COLECALCIFEROL (VIT D [COLECALCIFEROL]) at a dose of 50,000 cc of Vit D once a week plus Vit D (over the counter and COLECALCIFEROL (VIT D3) at a dose of 3000 international unit once a day. At the time of the report, BLISTER (blisters on both legs), VITAMIN D DEFICIENCY (Vit D deficient), RASH (rashes on both legs) and URTICARIA (welts on both legs, some spots were chronic) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, Vitamin D: deficiency deficiency(after 2 doses of the vaccine).         The patient stated that at the beginning of Jun2021, started getting rashes, blisters and welts on both legs, some spots of which were chronic. Rosuvastatin was taken off before Jun2021 because they were thinking this might be causing the rashes.  Patient did not have positive covid-19 test nor diagnosis.  No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine.  Concomitant drugs were not reported.
The nurse told field employee that 2 adult patients with who have the same age of 43 years old received PROQUAD instead of VARIVAX and MMR II; No additional AEs were reported; The spontaneous case was received from a nurse via company representative referring to a 43-year-old patient of unknown gender.  The patient's concurrent conditions, historical conditions, concomitant therapies, past drug reactions or allergies, and risk factors were not reported.   On an unknown date, the patient received measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) instead of varicella virus vaccine live (Oka/Merck) (VARIVAX) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (wrong product administered). Date rep learned of the situation was confirmed to be on 16-MAR-2023 (also 16-FEB-2023, conflicting information). No further information was provided. No additional adverse events (AEs) were reported (no adverse event).  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2302USA006344:
I didn't have any symptoms at all. I went to have a physical and had some blood work done and they found that I my liver count was a little high. We waited 6 weeks and went back for another blood panel, and it went up even more.
Chills, mild headache, and hives covering my neck, my front and back torso.  On 8Apr, I woke up feeling okay but by 1p I was getting chills.
The patient complained of being unable to walk. Patient's wife came to the pharmacy and two pharmacist went with her where the patient was seated on a bench. Patient said he started having sharp pain in his left lower back radiating all the way down his left leg. He said he had to sit down as the pain was excruciating. Patient said he didn't have any pain when the two pharmacists went to make sure he was doing alright and was able to walk on his own.
sniffles; Initial information received on 10-Dec-2020 regarding an unsolicited valid non-serious social media case from a consumer (patient).  This case involved a patient with unknown demographics who experienced sniffles (rhinorrhea), while he/she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site.    On an unknown date, the patient developed a non-serious sniffles (rhinorrhea) (Unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as unknown, at the time of reporting.  There will be no information available on the batch number for this case.
Could not raise the arm; Is still experiencing pains in the arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Could not raise the arm) and VACCINATION SITE PAIN (Is still experiencing pains in the arm) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 32L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Could not raise the arm) and VACCINATION SITE PAIN (Is still experiencing pains in the arm). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Could not raise the arm) and VACCINATION SITE PAIN (Is still experiencing pains in the arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported. No Treatment information was reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Events outcome updated.
1st dose 2018, 2nd 30Jan2023; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 58-year-old male patient who received Herpes zoster (Shingrix) (batch number XY225, expiry date 27th May 2024) for prophylaxis.   Previously administered products included Shingrix (Received 1st dose of Shingrix in 2018).   On 30th January 2023, the patient received the 2nd dose of Shingrix. On 30th January 2023, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 07-FEB-2023 Reporter's Comment: The reporter consented to follow up.  Additional Supportive Information: The patient received 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule. The case had been linked to US2023019041, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2023019041:Same reporter / female Case
This spontaneous report has been received from a pharmacist regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On an unknown date in 2008, the patient was vaccinated with the first dose of GARDASIL injection for prophylaxis (route, anatomical location, lot# and expiration date were not provided). On 09-JAN-2018, the patient was vaccinated with the first dose (second dose in HPV immunization series) of GARDASIL 9 injection for prophylaxis (route, anatomical location, lot# and expiration date were not provided). No adverse effects reported.
Arm soreness; Headache; Fatigue; Keratosis (Skin Cancer) are faded and completely gone; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Arm soreness), HEADACHE (Headache), FATIGUE (Fatigue) and THERAPEUTIC RESPONSE UNEXPECTED (Keratosis (Skin Cancer) are faded and completely gone) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 013L20A) for COVID-19 vaccination.     The patient's past medical history included Keratosis. Concurrent medical conditions included Iodine allergy. Concomitant products included VALACICLOVIR HYDROCHLORIDE (VALTREX) for Herpes dermatitis, CYCLOBENZAPRINE for Muscle relaxant.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced MYALGIA (Arm soreness), HEADACHE (Headache), FATIGUE (Fatigue) and THERAPEUTIC RESPONSE UNEXPECTED (Keratosis (Skin Cancer) are faded and completely gone). At the time of the report, MYALGIA (Arm soreness), HEADACHE (Headache), FATIGUE (Fatigue) and THERAPEUTIC RESPONSE UNEXPECTED (Keratosis (Skin Cancer) are faded and completely gone) outcome was unknown. Not Provided          treatment to the events not provided. Keratosis (Skin Cancer) are faded and completely gone with 70% improvement.  Action taken with mRNA-1273 in response to the event was not applicable
Arm got swollen "really bad"and swelling of toes; Rock  hard lumps, then they turn into blisters and then there is pus coming out of them; Toes  extremely itchy; Rash on the arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm got swollen "really bad"and swelling of toes), BLISTER RUPTURE (Rock  hard lumps, then they turn into blisters and then there is pus coming out of them), PRURITUS (Toes  extremely itchy) and RASH (Rash on the arm) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy (Patient has a sensitive skin and that she usually gets hives from climate changes.).    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced PERIPHERAL SWELLING (Arm got swollen "really bad"and swelling of toes), BLISTER RUPTURE (Rock  hard lumps, then they turn into blisters and then there is pus coming out of them), PRURITUS (Toes  extremely itchy) and RASH (Rash on the arm). On 09-Apr-2021, PERIPHERAL SWELLING (Arm got swollen "really bad"and swelling of toes) and RASH (Rash on the arm) had resolved. At the time of the report, BLISTER RUPTURE (Rock  hard lumps, then they turn into blisters and then there is pus coming out of them) and PRURITUS (Toes  extremely itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.  No relevant concomitant medications were reported.
Initial Hepatitis B vaccine from County Health received 6/26/95 & 8/3/95.  University took a titer in 2007.   The result was negative.   Hospital then gave the Recombivax HB (Hepatitis B Vacctine) shots 3, 4, 5, 6 on the following dates:  8/3/07, 10/1/07, 12/19/07, 1/18/08.  In between each shot they found the titer to be negative.   All shots were given in the right arm, except for the 1/18/08 shot.   I had them give it in my left arm because of the lump and pain I was having in my right axilla.   In the first week of January I noticed slight pain and marble sized lump under my right arm.  On January 10th visited my primary physician who ordered CT which found a round soft tissue mass in the right axilla measuring approximately 3.3 x 3.7 x 2.2 cm.   Superficial lymph node biopsy performed 1/22/08.  Pathology report poorly differentiated malignant neoplasm.  Histomorphologic features are suggestive of malignant melanoma although the neoplasm does not mark with the one melanoma specific antibody that was used.   Slides were reviewed by facilities and diagnosis was malignant melanoma unknown primary.  Only presentation was in lymph node on right side where multiple vaccines were given.  PET scan and MRI continue to review no primary.  Disease present only in right axillary lymph system.  4/4/08 Reviewed PCP medical records of 2/5-3/20/2008. FINAL DX: locally advanced metastatic malignant melanoma, primary unknown, s/p complete resection right axilla lymph nodes (12 of 45 + w/subcutaneous extension & extracapsular extension) Records reveal patient experienced tender right axillary lymph node which increased in size over approx 1 mo.  Dermatology, surgery & heme/onc consults done.  Obtained second opinion out of state who concurred w/recommended complete axillary node dissection, done 2/26/08.  Recommended radiation & chemotherapy. Got second opinion out of state & was to receive radiation therapy there.  4/11/08 Reviewed hospital medical records:  1/14/08 MRI of right axillary mass abnormal revealed lymphadenopathy & possibly neoplastic disease.  1/22/08 needle biopsy report malignant cells c/w metastatic melanoma.  1/29/08 excisional biopsy report metastatic poorly differentiated malignant neoplasm c/w melanoma Follow-up: Tumors continue.
Began her run at the usual time and route. About 1/3 through, hands began to itch, then ears began to burn and itch. Kept running. Within 30 minutes entire body was red, swollen and itching. Had chills all night. No fever. Shower (cool), Benadryl and rest helped and by morning sxs were improved.
Pt visiting out of country with parents began with persistent crying on 11/25/06. On 11/26/06 awoke with diaper of blood. Diagnosed with intussusception and had partial small bowel resection performed emergency out of country. Unable to assess now. Per 60 day follow up: Currently recovered, however, he did have to have bowel resected so potentially problems later with absorption.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: Wife of patient had syncopal episode w/head strike to shelf. Denied LOCand none observed.  Pt was alert and reponsive. info obtained w/help of person on phone to assist. Pt pale&diaphoretic. Placed in recovery position. Radial pulse steady/70's. no pmh, no medications. Patient was given cool, wet wash cloth for head. 911 called and upon eval states feeling better and agreed to hospital transfer.
Developed a very large red, hot, painful welt at the injection site within a few hours of the vaccine injection. Pain at injection site. Tender to the touch for a few days. Lump took multiple days to reduce in size.
16 y/o patient received Pediatric Pfizer dose ( 5-11 yo) for first dose.  Observed x 15 minutes. No symptoms noted. Instruct to return to receive Pfizer dose (12y -older) in 21 days.
Abdominal pain, vomiting, diarrhea, joint pain, aches, swelling of penis, eye, lip, neck, feet, hives, intestinal inflammation.
Swelling, redness, warmth at the injection site starting approx 15 min after injection was given.  Then severe  itching starting in right arm, right side of head approx 25 min after injection. Then itching progressed through the entire body including toes  Claritin 10mg taken approx approx 2 hours prior to inj Allegra  1 tab Diclofenac 50mg Tylenol 1000mg Pepcid 1 tab Solumrdrol 40mg IM All given at approx 8:30am  Itching continued. Inj site reaction started to improve. At approx 9:20am Benadryl 50mg taken at 10:00am  Benadryl and Pepcid repeated at 6pm due to return of itching  Facial flushing and temp of 100.1 orally noted at 6am the next morning
Patient received her 2nd dose of the Moderna Covid-19 vaccine on 4/20/2021 at 0935. On 4/25/2021, patient presented  to the ER with SOB and mild CP that began after she walked a 1/2 mile to her nephew's home. Pt was diagnosed with bilateral PEs and admitted to the hospital for treatment. At this time patient is stable, improving , and remains admitted to the hospital.
Patient received under diluted dose of 5-11 pfizer vaccine. Had  nausea and vomiting for one day and severe headache for 2 days but symptoms had resolved when parent notified on 6/1/2022.
New, intermittent, sensation of heart palpitations on multiple occasions starting the morning of 9/21/22 continuing through 9/26/22, I have not noticed any yet today (9/27/22). New sensation of mild chest discomfort starting on 9/21/22. Both symptoms seemed to be improving as of 9/27/22. No treatment or medical consultation obtained.
Jan90 pt vax; exp flu-like sx, vomiting, joint pain, fever, h/a, arthralgia, myalgia.  Tx w/ Tigan, APAP, bedrest, & oral fluids.
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a female 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) (Intramuscular) 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. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). At the time of the report, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pregnancy test: positive (Positive) Positive.         No concomitant medication were reported. No treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 01-Mar-2021: Internal review on 20-Jul-2021 resulted in updates to the pregnancy information.
Patient arrived at the pharmacy to receive her Pfizer Bivalent and Fluad. Monovalent Pfizer was administered accidentally instead of Bivalent Pfizer as a booster dose. Patient was contacted and will revaccinate in 2 months for Bivalent Pfizer.
Patient experienced severe pain throughout entire arm which received injection. She required a prescription for ULTRACET to help with the pain.
a dose of GARDASIL-9 may hace exacerbated her preexisting POTS condition; This spontaneous report was received from a physician referring to a 15 year old female patient with postural orthostatic tachycardia syndrome (POTS). The patient's pertinent medical history was not provided and her drug reactions/allergies and concomitant medications were unknown by reporter.    On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 milliliter, by intramuscular route, as vaccination.         On an unknown date, the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) dose might have exacerbated the patient's pre-existing POTS condition (postural orthostatic tachycardia syndrome). She did not sought medical attention and did not receive treatment for the adverse experience.  At reporting time, the outcome of postural orthostatic tachycardia syndrome was unknown and it was considered probably related to HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9).
died; This is a spontaneous report from a non-contactable consumer, this consumer report same events for 5 patients, this is the second of five report.   A patient of unspecified age and gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient died on an unspecified date.  It was not reported if an autopsy was performed. Reporter said they tried to say nurse didn't die, but she had an obituary so she clearly did die so that's just one, reporter had seen 4 self.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101524663 same reporter/product/event, different patient; Reported Cause(s) of Death: died