chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a licensed practiced nurse refers to a 18 year old male patient. The patient has asthma. The patient had no drug reactions or allergies. On 22-MAY-2013, the patient was vaccinated with dose 1 of 0.5 ml (milliliter) GARDASIL, (lot # reported as H017698, expiry date 02-JUL-2015, route was intramuscular). Other suspect therapies included MENACTRA which was administered on 22-MAY-2013 in the opposite arm. Concomitant therapies included FLOVENT as needed. On 22-MAY-2013, the patient experienced dizziness and nausea. The patients blood pressure also dropped. These symptoms occurred immediately after administration of both vaccine while the patient was still in office. The vaccinations were administered later in the afternoon and the patient mentioned he had a very little to eat during the day before coming to office. The patient observed for 30 to 40minutes after the GARDASIL and MENACTRA were administered and was given a cup of water. Blood pressure readings were taken. On 22-MAY-2013. The outcome of all the evenrs were repored as recovered. The patient sought medical attention(was in the office). Additional information has been requested.
Information has been received from a physician concerning a 10 year old male, weight 107.8lb height 52.5 inches, who on 03-AUG-2005 was vaccinated with the second dose of VARIVAX (Merck) subcutaneously in the right arm. There was no concomitant medication. On 27-AUG-2007 the patient developed varicella infection. Subsequently, the patient recovered from varicella infection. Additional information is not expected.
Woke up during the night of 10/8 with severe arm pain/ redness, swelling and lymph node tenderness.  Felt terrible.  Not sure which vaccination it was seeing the nurse gave them to me in the same arm.  I do know the 2nd one really hurt and I asked her which one that was and she replied, I don't know. Called doctor office on 10/9 and told RN who had administered the shots how I felt and was informed to give it a day or so.  That I wa having a mild reaction.  Although I knew better. Went home and checked temp. 101.  Went to bed.  Miserable night, much worse in morning. Went to urgent care at 8:00 am on 10/10.  Much closer to work, plus they opened at 8:00 am vs. waiting another hour (9:00 AM DR. office opens then)Saw dr. and was diagnosed with cellulitis.  temp 102.2 now. Was given an injection and two scripts.  One for Keflex and another for percocet. Dr. traced armed before I left around the red/swelling area.  Told to come back if it got worse.  Head and neck were killing me at this time. Called dr. at 1:00 pm on 10/10 and told him I was worse.  He told me to wait a couple of hours to give the meds a chance to kick in.  Left work at 3:10 pm and went back to urgent care. Took one look at my arm and told me I needed to be admitted to hospital.I was admitted on 10/10/08 with severe cellulitis and was discharged on 10/15/08 after 6 days of living hell. Had needle remove some of the infection. I sure would like someone to be responsible and reimburse me for my hospital stay, loss wages and ongoing dr. visit.  Today is 10/23/08 and my arm is still not back to normal!!! unfortunatly, all I have is the shots lot number.  There is nothing else indicated on my medical records which I received after I decided NEVER to return to family dr. again.  10/31/2008 MR received for DOS 10/10-15/2008 with D/C Dx: Cellulitis and abscess of upper arm and forearm.  Coronary atherosclerosis of native coronary vessel. Unspecified hyperlipidemia.  Essential hypertension, unspecified benign or malignant.  Unspecified chronic bronchitis. Pt presented with c/o of L upper arm pain radiating into the shoulder which began immediately after vaccines.  PE (+) for LUE swelling, warmth and tenderness. ID consult reports redness and fevers in addition to above with dx: severe cellulitis. Tx with abx
Dizziness, Headache & NauseaVomiting Narrative:  2/9-Arm soreness;Headache ;Dizziness ;Nausea 2/10- Arm Soreness;Headache ;Dizziness;Nausea/ Heartburn/ Indigestion 2/11- ha  Other Relevant History:
light headed, sweating, tried feeling started right after getting vaccine  dry mouth/throat  had little trouble breathing, 1 dose of epinephrine was given
Left upper arm was very painful, and a bit inflamed, for about 24 - 36 hours after injections.  At the same time, I couldn't lift my left arm any higher than a 5 o'clock position without upper arm pain (in approx the same area as injections). I was told that the pain would probably disappear over time, but it has now been over a year and the pain upon raising my left arm above the 5 o'clock position remains; just as intense as ever. No treatment received.
Patient received rabies and Tdap vaccines on 1-10-08.  Five days later, on 1-15-08, she developed an itchy rash all over her body.  It was described by an Urgent Care physician as a "circumscribed, raised, and erythematous eruption with central pallor on her trunk and extremities that are blanchable."  She was instructed to use Benadryl but did not do this.  Instead, she used a home accupuncture kit.  Sx were markedly improved at the time of follow up on 1-17-08.
About 5 hours after vaccination, I started feeling very tired that I had to tell my employer that I wouldn't be able to continue working much longer.  I work from home at a computer.  After 6 hours after vaccination (4 pm), I was so exhausted that my mouth muscles were too weak to be able to speak strongly.  My muscles were too relaxed that I needed to lie down at this point.  Inside my mouth, near my lips, there was a warming sensation (no pain).  I've never experienced that before.  It didn't last long.  After about 6.5 hours after vaccination as I was in bed, I felt a little pain in my right thigh for an unknown reason.  For a few seconds I felt a little nauseated so I kept a kidney dish near my head in bed.  I slept in a deep sleep for at least 2 straight hours.  I woke up groggy and with a very dry mouth.  I usually drink a lot of water in my typical day, but after my vaccine I do not recall being unusually thirsty.  I may have inadvertently dehydrated myself.  That night after my vaccination I had a very dry mouth while sleeping.  When I woke up each time, I would drink a little water.  That carried over to the 2nd night after my vaccination, despite drinking a lot of water that day.  Meanwhile, I had not had any alcohol, coffee, nor any caffeine during this entire time.
This spontaneous report as received from a medical assistant refers to an infant male patient of unknown age. On an unknown date between 13-MAY-2013 and 14-JUN-2013 the patient was vaccinated with RECOMBIVAX HB (2.5/0.5 units not provided), (0.5 ml intramuscularly, dose number unknowm) (lot # H020604 exp. date 10-FEB-2015). RECOMBIVAX HB that had a temperature excursion. No adverse effects were reported. This case is related with the following cases on same reporter link: 1307USA007921; 1309USA012210; 1309USA012211;  1309USA012213; 1309USA012214; 1309USA012215; 1309USA012216; 1309USA012217; 1309USA012218; 1309USA012219; 1309USA012220; 1309USA012221; 1309USA012222; 1309USA012223; 1309USA012224; 1309USA012225; 1309USA012226; 1309USA012227; 1309USA012228; 1309USA012229; 1309USA012230; 1309USA012231; 1309USA012232. Additional information is not expected.
Sick after second Shot; Chills after second Shot; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick after second Shot) and CHILLS (Chills after second Shot) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced ILLNESS (Sick after second Shot) and CHILLS (Chills after second Shot). On 19-Feb-2021, ILLNESS (Sick after second Shot) and CHILLS (Chills after second Shot) had resolved.            No concomitant medication was provided. No treatment medication was provided. Patient was Out of it, after second Shot.
SM developed redness, pain swelling at injections site of ANTHRAX vaccine, approx. 6 hrs post vaccination.  Edema @ injection site > 120mm not beyond elbow
fever in 17Aug2021 at 5:15 AM 99.1°C, 5:30 96.7°C, 5:40 98.4°C, 6:00 97.8 °C, 6:30 99.0°C, 7AM 97.6°C, 10:30 95.1°C, at 2PM 99.4°C.; chills; he was one sick SOB last week; he was one sick SOB last week; mucus out of his lungs; sore shoulder/joint pain in his body, shoulders and my knees; feeling blah/pin needy feeling; coughing; feeling a little weak; This is a spontaneous report from a contactable consumer. A 67-year-old male consumer (patient) reported for himself that he received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number FC3181) via an unspecified route of administration in right arm on 09Aug2021 (at the age of 67-year-old) at single dose for COVID-19 immunisation. Relevant medical history included ongoing chronic obstructive pulmonary disease (COPD) and cancer in the left arm. Concomitant medications were not reported. The patient reported a sore shoulder and "feeling blah" on 09Aug2021, his highest temperature was 99.4 on 17Aug2021. He felt like someone punch him in the shoulder, he didn't feel up to par. He also experienced coughing and mucus out of his lungs on 09Aug2021. Clinical course was provided as follows. He went in and had the shot. He waited for 15 minutes. He didn't feel anything at first. The next day he felt like somebody hold off and punch him real hard in the shoulder. He was feeling a little weak and "pin needy feeling" on 09Aug2021. The patient had joint pain in his body, shoulders and knees. He monitored his fever on 17Aug2021 at 5:15 AM 99.1, 5:30 96.7, 5:40 98.4, 6:00 97.8, 6:30 99.0, 7AM 97.6, 10:30 95.1, at 2PM 99.4. It was fluctuating like that sometimes he got chills temperature vice versa. The patient was one sick SOB (as reported) the week before and had most of the symptoms, felt blah, wasn't that fun (as reported) and didn't feel up to par on 09Aug2021. The patient was being coughing and trying to get the mucous out on 09Aug2021. After his shoulder got sore and he felt blah, the next day he felt worse and the next he felt worse. The patient was treated with arthritis pain relief pills, robitussin and albuterol. Case was reported as non-serious. Feeling a little weak was not resolved, pyrexia resolved in Aug2021, outcome for chills was unknown and other events were resolving.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101097451 same reporter/drug, different patient.
Patient received first shot of Moderna vaccine at age 16 years; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient received first shot of Moderna vaccine at age 16 years) in a 16-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient received first shot of Moderna vaccine at age 16 years). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient received first shot of Moderna vaccine at age 16 years) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information provided.
Client c/o not feeling well and had nausea, then she said she had chest pressure 5 on a scale of 10. Her heart rate was 54. She was pale and diaphoretic.
Narrative:  77 yo M pt new to medical facility had only been seen for dental exam by medical facility. No information in data system on pt including vo vitals, no med list, no problem list. Pt did receive one covid vaccine at pharmacy noted in data system. Pt died of unknown causes on 7/15/21. Not able to assess if pt's death related to vaccine. Likely was not related given > 90 days btwn vaccination & pt's death.
This spontaneous report as received from a medical assistant refers to unspecified patients of unknown age. On an unknown date the patients were inadvertently vaccinated with GARDASIL which had been improperly stored (lot #, expiration date, frequency, dose and route were unknown). And no adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 07-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 56-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis. No Medical History information was reported. On 07-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 07-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 07-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 07-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 07-Jul-2022). No concomitant product use was reported. Patient received half dose. The number of doses/vials administered were 35 vials On 04-Jun-2022 the vials were initially stored in the refrigerator. The vaccines were administered from the 04-Jun-2022 until the 26-Jul-2022. Vial did not undergone any temperature excursions. No treatment information was provided.
Information has been received from a registered nurse (R.N.) concerning a female with human papilloma virus who on an unspecified date, was vaccinated with a dose of GARDASIL and her human papilloma virus had gotten worse. At the time of reporting, the outcome was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 at 12:00 as dose 4 (booster), single (Lot number: GH9693) at the age of 56 years, in left 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: High blood pressure; "Seasonal allergies only" (unspecified if ongoing), notes: Seasonal allergies only; "Stool softener" (unspecified if ongoing), notes: Stool softener. Concomitant medication(s) included: LAXACLEAR taken for abnormal faeces, start date: 01Jan2021, stop date: 04Dec2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No known allergies. COVID 19 Treatment Paxlovid (treatment start date: 28Nov2022 and treatment stop date: 03Dec2022). Other medication in 2 weeks were cold medicines and Dayquil/Nyquil.
The pharmacy received Moderna vaccine (lot number 069H21A, expiration 4/6/22) from the Department of Health on 12/6/21 at 3:23 PM. The pharmacy miscalculated the beyond use date as 1/6/22, when it should have been 1/5/22 (30 days from the date received). It appears the pharmacy did not account for December having 31 days, which lead to the miscalculation. Patients administered vaccine after 3:23 PM on 1/5/22 received product that was past its beyond use date.
On day  two of dose two I started feeling a dull pain in my shoulder. One week later more pain and arm use limited. Week 6 no range of motion severe pain. Attended doctor visit had a X-ray, it was determined arthritis. Given 500 mg Ibuprofen 1 pill three times a day. I reduced the dosage to two times in week two,then 1 pill per day in week 4 to one pill three days in week 5 to 1 pill per week to present. Pain has subsided 90% range of motion is 96% at present.
Patient came into pharmacy to report redness and swelling on her right arm. Patient received an immunization for prevnar on November 10, 2019 and started to experience some redness about two days afterwards.  She opted to watch and to observe if redness will dissipate but ultimately it did not. She presented to pharmacy with a round, red, slightly swollen area on her right arm where she said she received the vaccine. Patient also indicated slight itching.
On the evening of 6/18/21 a golf ball sized lump appeared on the left armpit. By 6/20/21 the lump enlarged to the size of a softball. Was prescribed oxycodone for pain and Zyrtec for the immune response. The patient took Tylenol and Motrin for the pain instead due to work obligations. On 6/22/21- the swelling had decreased back down to a golf ball and felt that the issue would continue to resolve.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age. The patients were vaccinated with a dose of MMR II on unspecified date (lot number, dose and route not reported). The medical assistant reported that the office did not monitor the temperature of the freezer and refrigerator from 18-JUN-2012 through 01-JUL-2012 so the office did not know for sure if their vaccines were stored at the proper temperature. No symptoms were reported. This is one of several reports received from the same source. Additional information is not expected.
Patient became agitated, confused and verbally combative 1.5 hours after receiving vaccine. This lasted 6-7 hours. By the next afternoon, he developed spreading erythema at the vaccine site. By that evening, he had extensive erythema from his shoulder to his elbow and it was extremely sore.
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with (Oka/Merck) VARIVAX dose 1, (dose, lot # and expiry date unknown). On 17-NOV-2011, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX dose 2, (dose unknown) from lot # 669601/0138AA with expiry date of 26-JAN-2016. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review of records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provided 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
large sore area on lt arm inject on 21OCT size 4" went to MD on 29OCT93 was given ATB for 5 days;
Right sided facial numbness and tingling started 4 days post vaccination. Treatment: OTC Zyrtec with mild improvement Outcome: Does not interfere with ADLs.
Swelling and itchiness appeared after 6 days of injection with size about 5cm diameter, now it has been two days since the reaction and the size almost doubled with heat.
At about 2 PM started to develop mild pain in arm at injection site. Had muscle spasm in upper left arm at 4 PM. She stretched out arm and then dislocated left shoulder. She was able to reduce herself. Continues to have pain in shoulder w/ movement restriction. Dislocated right shoulder 6 times in the past; last episode in 2019
Blisters on skin.  This started not quite 2 weeks after the injection.  Rash on upper torso including back and buttocks and back of legs.  Severe itching. It took me 1 year going to my PCP, Allergist and dermatologist to confirm the s&s were allergy related.  I even had skin biopsies to rule out other pathology.
7:30 PM Vomiting, fever 101.7, limp, groaning, not coherent. Taken to ER. Blood work, MOTRIN, discharged home. 12/2/09 3 PM Still running temp 100 degrees, coherent, on TYLENOL, MOTRIN and albuterol currently.
Patient got vaccine at 1pm. Called be back around 5:45 stating she went to the gym after the vaccine, did her normal upper body workout, and came home. When she was changing, she noticed she had 2 black and purple bruises covering both of entire shoulder blades. She does not think anything else would have caused this and the only thing out of the ordinary was her COVID vaccine. The bruises do not hurt and are not swollen. I told her to ice her shoulders to help with the bruising and to prevent swelling. I also told her to have her husband take pictures and draw a line around the bruises so we can monitor them and make sure they are not getting bigger. Told her if she starts to feel unwell or something urgent changes to go to an emergency room.
CHIEF COMPLAINT:   heart transplant 2016. COVID+, did recieve antibody tx. comes in today reporting "massive amounts" of dark red rectal bleeding, independent of BM. also, pt has not had dialysis x8 days.   HISTORY OF PRESENT ILLNESS:     71-year-old male with history of heart disease, end-stage renal disease on hemodialysis, not on any anticoagulation medications, comes to the ER for evaluation of GI bleed.  Patient tested positive for COVID-19 11 days ago.  He has been quarantined past 10 days.  He says that he has been recovering well from Covid but still complains of a moderate cough.  To that he had 3 episodes of large maroon-colored stools.  No abdominal pain no fevers chills nausea vomiting.  No history of GI bleed no history of intra-abdominal surgery.  Patient also says that he has not had dialysis for 8 days because they want him go back because he tested positive for Covid
PT RECEIVED PEDIATRIC MODERNA BOOSTER ON 09/08/2022 AS OPPOSED TO NEW MODERNA BIVALENT. CALLED AND LVM. THIS IS AN ADMINISTRATION ERROR, NOT AN ADVERSE EVENT
Information has been received from a health professional concerning a patient who on 04-NOV-2004 was vaccinated with a dose of Varivax (Oka/Merck) (Lot # 645166/0347N). On 05-FEB-2006 the patient developed a generalized rash of <50 lesions. This was not localized at the injection site. A fever was noted for 1 day. No cough was noted. The patient was not hospitalized. There was no known contact with another case of varicella. This was noted to be vaccine failure. This was MD documented/evaluated. Follow up information indicated that no further information was available. No additional information is expected.