chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable medical assistant via a Pfizer sales representative. This medical assistant reported similar events for 3 patients. This is the third of three reports. A patient of an unknown age and gender received PREVNAR 13 (LOT S06823, Exp. date May2018) at single dose for immunization on an unknown date. Medical history and concomitant medication were not reported. On an unknown date the patient experienced cellulitis. The outcome of the event was unknown.It was reported that some pneumococcal 13-val conj vaccines contained a white substance, however it was unknown if the patient had received or not the same Lot which had the white substance; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017327828 Same reporter/drug/event, different patient;US-PFIZER INC- 2017327795 Same reporter/drug/event, different patient.
Pt positive covid test 8/19/2021 after being fully vaccinated  in 3/2021
Close exposure to COVID-19 virus  Cough Upper respiratory tract infection, unspecified type  ED to Hosp-Admission Discharged  7/28/2021 - 8/2/2021 (5 days); Last attending ? Treatment team Pneumonia due to COVID-19 virus Principal problem  Active Issues Requiring Follow-up Issue: COVID pneumonia and Graves disease What is Needed: Follow-up with PCP Follow-up Appointments Arranged: To be scheduled Comments: Patient tested positive for COVID-19 on 7/28 and received treatment with remdesivir and Decadron.  Patient sent home with Decadron 6 mg for 5 days and nasal cannula to be used at home (2 LPM at rest and 3 LPM on ambulation).  Patient refused RPM. Graves - methimazole was held during hospitalization as patient reports she has not been taking this for several months per endocrinology instructions. TSH: 1.96. Please review home medications with patient.  Hospital Course; Patient is a 66 y.o. female, with a history of COPD, insulin-dependent diabetes myelitis type II, hypertension, Graves' disease, and OSA presents with generalized weakness and shortness of breath and is on current hospitalization day 5 for Pneumonia due to COVID-19 virus.    Severe sepsis secondary to COVID-19 pneumonia-improving o S/p duoneb x1 and 2 L NS bolus in ED.  o Started on remdesivir x5 days and decadron 6 mg daily x 10 days per pulmonology. o Patient's oxygen requirement improved and on day 5 patient clinically stable to be discharged home to complete 10-day course of Decadron.  Desat study significant for 2 LPM at rest and 3 LPM and ambulation.  Patient refused RPM however was sent home with nasal cannula.  Patient clinically stable to be discharged home.
Muscle aches, Vomiting, SOB, Loss of taste, Headache, Diarrhea, Fever, Sore Throat, Fatigue, Chills, Runny Nose All started 3/22/21 No Treatment Received Still having symptoms
Fully vaccinated with Covid vaccine x 2 . Tested positive for Covid on 01/28/2022. 2. Expired on 01/29/2022 at Hospital after arriving to the ER in cardiac arrest.
vaccine was administrated from a vial which was punctured at 12:50 pm the day before (longer than 24 h )
Redness (Injection Site); Itchiness (Injection site); This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Redness (Injection Site)) and INJECTION SITE PRURITUS (Itchiness (Injection site)) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (Redness (Injection Site)) and INJECTION SITE PRURITUS (Itchiness (Injection site)). At the time of the report, INJECTION SITE ERYTHEMA (Redness (Injection Site)) and INJECTION SITE PRURITUS (Itchiness (Injection site)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Extreme pain, swelling, and bruising at the injection site. Bruising/pain subsiding 4 days after injection
Information has been received from a medical assistant referring to a female patient of unknown age. There was no information regarding concomitant medication, medical history or drug reactions/allergies. On 15-FEB-2015, the patient received a first dose of GARDASIL 9 (lot #, expiration date, dose and route were not reported). On 26-AUG-2016, the patient received her second dose of GARDASIL 9 (lot #, expiration date, dose and route were not reported). On 20-OCT-2016, the patient received her third dose of GARDASIL 9 (lot # M003659, expiration date 20-SEP-2017; dose and route were not reported). No adverse effects were reported. Additional information has been requested.
Waves of nausea/passed out/could not eat/low BP, weak, low pulse and head dropped back. Called 911 - 1 ER visit.
no longer have mouth sores; This case was reported by a consumer via interactive digital media and described the occurrence of unexpected beneficial therapeutic response in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included sores mouth.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced unexpected beneficial therapeutic response. On an unknown date, the outcome of the unexpected beneficial therapeutic response was unknown.   Additional details were provided as follows: The age at vaccination was not reported. The patient had the shot, no longer had mouth sores, the patient did not know the connection.
15 mins after injection, head, face, neck and chest  turned bright RED. Felt hot.  Alerted staff . I took 25mg ODT Benadryl.  Observed by staff for 15 mins more.  Skin returned to normal color.  NO Swelling, No Breathing problems.  Went home  , no additional problems.(Slightly sore at injection site, expected).
Mild Asthma Attack (slightly worse with 2nd dose)  and minor allergic reaction. 20 min after shot had to use albuterol inhaler, and took an OTC antihistamine. Symptoms subsided besides a dry throat, and one swollen lymph node near injection site.
administered Sat. Oct. 11, 2008.  Called CVS Sunday, call not returned.  Fever Sat. night, 3x4 inch swelling, hot to touch.  Called CVS referal number also.  Said swelling was normal.  Called minute clinic again Monday, Oct 12, (holiday). Said maybe I should see my Dr.  Swelling was less red.  I did cold packs as suggested.  Took Tylenol.  Did not see Dr.  (holiday).  Improved daily.
Initial unsolicited report received from a consumer via other company (Pfizer, reference number 2016049535) on 03 February 2016. This case involves a 50-year-old female patient who was vaccinated with a dose of FLU VACCINE (manufacturer unknown, batch number, expiry date, route and site of administration were not reported) on an unspecified date of October 2015. Medical history was not reported and patient other conditions were reported as COPD (chronic obstructive pulmonary), Hepatitis C, Thyroid removal, Bipolar disorder, Anxiety disorder, Bursitis, (GERD) Gastroesophageal Reflux Disease, Hysterectomy, Carpal tunnel syndrome and Shingles. Concomitant medications were Xanax (1mg tablet four times daily), Synthroid (50, tablet daily), Requip (4mg tablet three daily), Linzess (145mcg capsule once daily), topiramate (25mg tablet twice daily), hydroxyzine hcl (10mg tablet as needed every 6 hours), B12 injection (1cc injection once a month), Proair hfa (2 puffs every 6 hours), Symbicort (1 puff once daily), Spiriva (1 puff once daily) and albuterol (nebulizer once every 6 hours). On 25 January 2016, following the vaccination patient flu type A and B and also feels like she was about dead. Laboratory investigation and corrective treatment were not reported. The outcome of event was recovering. List of documents held by sender: none.
Booster was administered less than 2 months from previous COVID vaccine.  Last dose was 10/20/2022.
Patient was given flu vaccine 10/16/14 waited 30 min with no reaction. Mom states overnight he broke out in a rash, had swelling of face, and injection site was red, sore to touch. (1st time for non-preserv. free). Hives, localized erythema. Has egg allergy but has had flu vaccine before 2012, 2013.
Very srtong urine odor; Muscle aches; Threw up; rash is very red/rash all over her face; this rash started being itchy; Rash on her forehead/rash appeared on the side of her face as well; Shaky; Loss of appetite; Felt faint/Lightheaded; Headache; Nausea; Fatigue; Chills really badly; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaky), RASH ERYTHEMATOUS (rash is very red/rash all over her face), URINE ODOUR ABNORMAL (Very srtong urine odor), RASH PRURITIC (this rash started being itchy) and DECREASED APPETITE (Loss of appetite) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced CHILLS (Chills really badly). On 06-Feb-2021, the patient experienced TREMOR (Shaky), DECREASED APPETITE (Loss of appetite), DIZZINESS (Felt faint/Lightheaded), HEADACHE (Headache), NAUSEA (Nausea) and FATIGUE (Fatigue). On 23-Feb-2021, the patient experienced RASH (Rash on her forehead/rash appeared on the side of her face as well). On 28-Feb-2021, the patient experienced RASH PRURITIC (this rash started being itchy). On 01-Mar-2021, the patient experienced RASH ERYTHEMATOUS (rash is very red/rash all over her face). On an unknown date, the patient experienced URINE ODOUR ABNORMAL (Very srtong urine odor), MYALGIA (Muscle aches) and VOMITING (Threw up). At the time of the report, TREMOR (Shaky), RASH ERYTHEMATOUS (rash is very red/rash all over her face), URINE ODOUR ABNORMAL (Very srtong urine odor), RASH PRURITIC (this rash started being itchy), DECREASED APPETITE (Loss of appetite), DIZZINESS (Felt faint/Lightheaded), RASH (Rash on her forehead/rash appeared on the side of her face as well), CHILLS (Chills really badly), HEADACHE (Headache), NAUSEA (Nausea), FATIGUE (Fatigue), MYALGIA (Muscle aches) and VOMITING (Threw up) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: significant followup received on 28-jul-2021 in which AE were added and contact details were updated
vaccine administered after temperature excursion; No adverse event; This spontaneous report was received from a medical assistant referring to a patient of unknown gender and age.  The reporter did not provide information on the patient's historical drugs or reactions, historical conditions, current conditions and concomitant medications.  On 19-MAR-2021 date the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rHA) (lot number S037820 and expiration date 24-NOV-2021) for prophylaxis. It was reported that the vaccine was administered after temperature excursion (incorrect product storage). It was reported that the vaccine reached a temperature of 11.7 degree Celsius. This excursion had a time frame reported of 75 minutes. No previous excursions were reported and information was provided via data logger. No additional adverse event was reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2104USA000653:
This case was reported by a consumer via call center representative and described the occurrence of facial pain in a 77-year-old female patient who received SHINGRIX (batch number H547E, expiry date 22nd February 2021) for prophylaxis. On 13th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In September 2018, less than a month after receiving SHINGRIX, the patient experienced skin lesion. On 23rd September 2018, the patient experienced facial pain, pimples, blister, shingles and cold sores. On 26th September 2018, the patient experienced allergic reaction and ear pain. On an unknown date, the outcome of the facial pain, pimples, allergic reaction, shingles, ear pain and cold sores were unknown and the outcome of the blister was recovering/resolving and the outcome of the skin lesion was not recovered/not resolved. It was unknown if the reporter considered the facial pain, pimples, blister, allergic reaction, shingles, ear pain, skin lesion and cold sores to be related to SHINGRIX. Additional details were provided as follows: The patient received the SHINGRIX vaccine on 13th September 2018. On the morning of 23rd September 2018, she noted that the right side of her face was sore and she saw a red pimple on the cheek side of her face in front of where the upper part of the ear connected with the face, that afternoon she noted some blisters appearing on her chin. On Tuesday, 25th September 2018, she had developed two blisters on her upper lip which she initially thought were cold sores. Then a blister appeared on the inside of her lip. By Wednesday morning on 26th septmeber 2018, the blisters had spread up the side of her right cheek. She thought she might had come in contact with something that was causing an allergic reaction so she went to her primary care physician. The physician diagnosed her with shingles and sent her to an ear, nose, and throat physician to assess the ear involvement. No blisters were noted in the ear but the inside of her ear was sore and the skin on her right cheek. She was given medication. The blister that initially presented on 23rd September 2018 was resolving and reduced in size. However, the other lesions were still red, raised, and angry looking. Also, she described that the skin on the right side of her nose was sore. The patient gave permission for her physician's physician assistant to be contacted.
Myalgia soreness at injection site, flushing, fatigue Narrative:  Per nursing report: "took 2nd Moderna vaccine on 1-29-21. Saturday [1/30] c/o bodyaches and feeling flushed, sore left arm and fatigue. States went back to work on Sunday and states feeling better today."
My upper arm continues to be achy/sore.  Not sure when it started but figured it started the day of the vaccination.  I have not had other symptoms other than just feel slightly under par.  I know it is not typical to have soreness for this length of time.  My next shot is scheduled for April 1st.  I need to know if I should get this as scheduled.  I have an appointment with a Rheumatologist on April 7th if I should wait to ask him before getting the next vaccine.  I called my family doctor and he said it just means the vaccine is working, but I am still concerned since this is unusual to go on for this long.  This symptom does not limit my activity in any way.
Within 5 minutes of receiving  the shot, I had stomach cramps and felt extremely nauseous. I had periods of nausea and dizzy spells for the following week. I had an extreme migrane the night of the shot and chills throughout the next week. I did not report the symptoms to  anyone because I had not heard that these were reactions to this vaccine. After I heard that others were experiencing similar symptoms, I felt I should report my experience.
Information has been received from a consumer concerning her 94 year old husband who on 20-SEP-2007 was vaccinated subcutaneously with a 0.65 mL dose of zoster vaccine live (Oka/Merck). Concomitant therapy included amlodipine besylate, atenolol, lisinopril, hydrochlorothiazide and prednisone. On approximately 06-OCT-2007, "16 days after the shot" the patient developed a rash on his chest and back that "came and went". On approximately 09-OCT-2007 the rash on chest and back were gone but he developed a rash on his right leg. The patient's status was reported as recovering. There was no product quality complaint. No further information is available.
Hot shooting pains to (R) upper extremity 15 mins after vaccine, pain and but lasted >1 wk. Temp increased to 101.4 24 hrs after vaccination, decreased to 100 at 48 hrs-controlled with ibuprofen or TYLENOL. Localized inflammation x 6 days, Tests for influenza, UTI negative. Ears no s/s infection. Missed work x 1 day.
Pt received Flu Shield(97-98 formula) & Pnu-Imune23 mixed & injected into 1 site. Devel fever, flu-like symptoms, inject site rxn of redness, raised bumps. Reporter recommends vax's not be mixed, but injected separately.
This case was reported by a lawyer and described the occurrence of Guillain-Barre Syndrome in an adult male subject who was vaccinated with INFLUENZA (manufacturer unspecified). A physician or other health care professional has not verified this report. The following information was obtained from a legal complaint. In December 1996 the subject received an unspecified dose of INFLUENZA (unknown). At an unspecified time after vaccination with INFLUENZA vaccine, the subject developed "an acute and chronic form of GBS syndrome known as chronic inflammatory demyelinating polyneuropathy (CIDP)". The subject reportedly "has suffered from this chronic form of GBS/CIDP for years and will continue to suffer from this disease for the rest of his life". The complaint further alleged that the subject "suffered bodily injury resulting in physical pain and suffering, disability, disfigurement, mental anguish, loss of capacity for the enjoyment of life, the expenses of hospitalization and medical care and treatment, loss of earnings in the past, and loss of the ability to earn money in the future". At the time of reporting the events were unresolved.
mom states arm was sore a couple hours p/vax & became black & blue 1 day to 1 1/2  days later;PHN observation 10/8/99: lt deltoid muscle sl swelling noted;black & blue bruise noted around inj site;tender w/no palpation;
"Symptoms came back"; Fatigue; Headache; Muscle pain in injected arm; Chills; Fever of 103.4; This spontaneous case was reported by a consumer and describes the occurrence of SYMPTOM RECURRENCE ("Symptoms came back"), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain in injected arm) and CHILLS (Chills) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain in injected arm), CHILLS (Chills) and PYREXIA (Fever of 103.4). On 22-Feb-2021, the patient experienced SYMPTOM RECURRENCE ("Symptoms came back"). The patient was treated with PARACETAMOL (TYLENOL) at a dose of Extra strength. At the time of the report, SYMPTOM RECURRENCE ("Symptoms came back"), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain in injected arm), CHILLS (Chills) and PYREXIA (Fever of 103.4) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitant drug details not provided.
Our intern was administering the Moderna vaccine to this patient. She inserted the needle into his arm and the BD syringe plunger malfunctioned so none of the vaccine went into his body, it all came out of the barrel instead of entering his body. None of it entered his body so she re-administered the vaccination. There were no issues with the vaccine itself, just a faulty syringe.
On 1/16/2023, patient presented to the emergency department for evaluation of worsening fatigue and shortness of breath. He was initially diagnosed with COVID-19 on 1/3/2023; He had a positive COVID-19 NAA test on 1/16/2023 in the ED; his chest x-ray showed ill-defined, patchy airspace opacity in the right lower lung, concerning for pneumonia and a small right pleural effusion. Patient had oxygen saturations in the 70s on room; He was placed on 2 L supplemental oxygen with improvement. He was treated in the ED for hypokalemia, hypocalcemia and hypomagnesemia. Patient was diagnosed with acute hypoxic respiratory failure related to sepsis, COVID-19 pneumonia, possible underlying bacterial pneumonia complicated by COPD history. He was admitted to the hospital for further evaluation and treatment. During his hospital stay, patient progressed to acute respiratory distress syndrome; His CT of chest/abdomen/pelvis on 1/26/2023 showed bilateral consolidative opacities greatest in the LLL consistent with pneumonia and diffuse ground glass opacities consistent with ARDS. The patient?s condition continued to deteriorate, and he was placed on comfort care only; He died on 1/31/2023 while an inpatient at the hospital. His death abstract listed immediate cause of death as acute respiratory failure due to COVID and bacterial pneumonia, due to or as a consequence of lymphoma and acute kidney injury. Submitter does not have access to further medical information on this case. If more information is needed, please contact the admitting hospital
Patient received higher concentrated dose than what the dose should have been.  pfizer dose diluted with 0.2ml
Generalized itching w/o hives, HX of asthma. Feels seasonal allergies are getting worse. No airway edema. Given 25mg PO Benadryl. Pt states she usually takes 50 -75mg at home and request that but is driving home, denied by medical team. Feels symptoms have resolved @1140. Reports "tingling" all over body from anxiety.
Pt reported that the day after SHINGRIX vaccine he had severe itching from head to toe but worst on the scalp. He states this along with a low grade fever of 100 lasted for approx 3 days. Reporting the itching as an adverse event as this is not listed in the product information of a reported SE.
Patient called on 10/30/13 and reported that she developed cellulitis at the site of the injection.
Approximately 6 hours after receiving flu vac, noticed swelling and numbness of left face/cheek/jaw.  Took diphenhydramine 50mg PO x 1 with improvement.  Numbness and swelling completely resolved within 3 days.  Had received flu vac in the past w/o problems except for local reaction (soreness/redness at injection site), and generalized malaise, body aches.  This time, in addition to pain/soreness/redness at injection site, generalized malaise, body aches, swelling and numbness were also experienced on the left face/cheek/jaw.
no additional AE reported; the patient received her first dose of GARDASIL 9 two years ago, her second dose in February 2021 and her third dose 21-MAY-2021; This spontaneous report was received from a registered nurse and refers to a 27-year-old female patient. There was no information regarding her medical history, concurrent conditions nor concomitant therapies provided.  On an unspecified date in 2019 (reported as two years ago), the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 milliliter (route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis. In February 2021, she received the second dose of the vaccine (0.5 milliliter; route of administration, anatomical location, lot # and expiration date were not provided) and on 21-MAY-2021 (reported as today), the third dose was administered to her (0.5 milliliter; route of administration, anatomical location, lot # and expiration date were not provided) (inappropriate schedule of vaccine administered). The reporter declined to provide any additional information or verify administration dates. No adverse event (AE) was reported.
Peripheral Neuropathy symptoms from chemo that had resolved suddenly returned: numbness and pins/needles in hands, feet. Weak legs, hands. Bladder pain. Random aches and pains. Sharp needle-like stabbing pains in bones.