chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case involves adult patient (unknown gender) who got the flu (influenza), after receiving INFLUENZA VACCINE. The patient had no medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s), concomitant medication(s) 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 were not reported) via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date the patient developed a non-serious got the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. It was reported "I have only had a flu shot once and got the flu. I asked my Doctor Why? He said influenza mutates into different variants and Science cannot keep up. Kinda like boosters cannot keep up with  corona virus disease (COVID)." There were no lab data/results available. It was not reported if the patient received any corrective treatment for the event. At time of reporting, the outcome was unknown for the event. There will be no information available on the lot number for this case.
Pt arrived to the hospital with nausea, emesis, diarrhea, fatigue, malaise, and chest pressure for 4 days.  She was diagnosed with an NSTEMI, and also found to be COVID positive with no respiratory symptoms.
Every time she move she is in severe pain; Skin hurts; Lost control of my bladder; Lower back pain; Fever; Horrible muscle pain; Some nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Every time she move she is in severe pain), PAIN OF SKIN (Skin hurts), URINARY INCONTINENCE (Lost control of my bladder), BACK PAIN (Lower back pain) and PYREXIA (Fever) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History provided by the reporter.  Concomitant products included ESTRADIOL for an unknown indication.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced PAIN (Every time she move she is in severe pain), PAIN OF SKIN (Skin hurts), URINARY INCONTINENCE (Lost control of my bladder), BACK PAIN (Lower back pain), PYREXIA (Fever), MYALGIA (Horrible muscle pain) and NAUSEA (Some nausea). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and FAMOTIDINE (PEPCID [FAMOTIDINE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN (Every time she move she is in severe pain), PAIN OF SKIN (Skin hurts), URINARY INCONTINENCE (Lost control of my bladder), BACK PAIN (Lower back pain), PYREXIA (Fever), MYALGIA (Horrible muscle pain) and NAUSEA (Some nausea) outcome was unknown.            The patient takes some supplements as regular medication.   This case was linked to MOD-2021-404471, MOD-2021-404326 (Patient Link).
This spontaneous report was received from a back office lead and refers to a 52 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 29-JAN-2016, the patient was vaccinated with the improperly stored dose of RECOMBIVAX HB (1 ml, intramuscularly in the left deltoid, lot # L038499, expiration date 26-JUN-2017). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information is not expected as all the correspondence was returned by the post office.
Patient had surgery on L diaphragm on 1-22-2008.  Vaccines were administered on discharge on 1-29-08. On 1-31-08, patient developed fever and impaired respirations.  She was taken to the local ER where she was diagnosed with large L pleural effusion.  She was admitted to the ICU and chest tube placed.  Removed after 6 days, then had to be replaced due to reaccumulation.  Second tube removed on 2-12-08 and patient released.  On 2-21-08, again developed fever.  Taken to ER where was dx'ed with atelectasis/pneumona.  Treated with enteral antibiotics.  3/11/08 Reviewed hospital medical record for 1/31-2/12/2008 admission which reveal patient experienced fever, respiratory distress approx 2 wks s/p left diaphragmatic hernia repair.   FINAL DX: left pleural effusion & possible left lower lobe pneumonia.  Hypokalemia, respiratory alkalosis & hyponatremia, all resolved. Admitted to ICU.  Chest tube placed left lung & drained 500 ml bloody fluid.  Tx w/IV antibiotics.  Transfused for anemia.  Clinically improved & chest tube d/c. Fever & fluid collection recurred & 2nd chest tube placed.  Eventually chest tube d/c & improved.  D/C to home  6/2/08 Reviewed hospital medical records for 1/22-1/29/2008. FINAL DX: s/p repair paraesophageal hernia Records reveal patient d/c to home with G-tube feedings & J-P drain in place.  Pneumo & flu vaccinations done 1/29/08 but no lot #s included.  Received lot #s verbally from parent. 01/20/2010 Continues to have persistent/recurrent. Left lower lobe atelectasis and recurrent pneumonias.  Left diaphragm does not function properly. This is partially dure to the patch repair of the diapragmatic hernia. Right after surgery, however, muscular portion functioned properly. After the effusion and associated lenes, muscular portion moves paradoxically.
Pt described severe headache and progressive pain that started in head and traveled to back, then legs. She had tenderness at injection site, local erythema and swelling, fever, body aches and confusion over the course of 7/11/12. She came to the ED on 7/12/12 at 9:45 AM. She was found to have a WBC of 16.5K, febrile and with noted local reaction. Pt was given ertapenem 1 gm IV and admitted later that day due to severity of cellulitis and systemic symptoms. Antibiotics changed to cefazolin + Clindamycin on 7/12/12. WBC increased to 21.8K on 7/13 and pt still febrile. She was changed to Unasyn + Vanco for 1 day, then Ertapenem and Vanco on 7/14.  Pt discharged 7/16.
Itchy, red, large lump the size of a racket ball at injection site 6 days after injection.
10-15 minutes after receiving flu vaccine I noticed it was harder to talk and my tongue felt swollen. I had NP look at my tongue and it was swollen. So I left work and got some BENADRYL and it took a few hours to completely go back to normal. But at 6pm that same night while eating dinner I started having swelling again and took more BENADRYL. I notified my surgeon and PCP.
Information has been received from a Registered Nurse concerning a 62 year old female with chronic obstructive pulmonary disease, CELEBREX allergy, CIPRO allergy, LEVAQUIN allergy and LIPITOR allergy who on 17-DEC-2009 was vaccinated with a dose of PNEUMOVAX 23 (lot # 664864/1365Y), 0.5ml, subcutaneously into left arm. On the same day on 17-DEC-2009 the patient received a dose of influenza virus A (antigen type unspecified) vaccine (H1N1) into right arm. Concomitant therapy included multiple medicines. On 17-DEC-2009 the patient experienced a localized red, circular, hot, itching and some swelling reaction. On 20-DEC-2009 the patient recovered from localized red, circular, hot, itching and some swelling reaction. On 21-DEC-2009 the patient sought medical attention contacted the nurse by phone. There were no laboratories diagnostics studies performed. This is one of two reports from the same source. Follow up information has been received from the registered nurse concerning the 62 year old female patient who on 17-DEC-2009 was vaccinated with the first dose of PNEUMOVAX 23, subcutaneous route-left arm (lot # 664864/1365Y), at the private doctor's office/hospital with private funds and 04:30 pm. On the same day on 17-DEC-2009 the patient received the first dose of influenza virus A (antigen type unspecified) vaccine (H1N1) intramuscular route - right arm (lot # 102147P1) at the private doctor's office/hospital with private funds and 04:30 pm. On 17-DEC-2009 the patient experienced a localized swollen, red, itchy, circular and hot reaction at the injection site at 06:00 pm. At the time of the report the patient recovered. No further information is available.
Mom calls today 03-19-2012 @ 11 am.  States child has rash on face and upper torso and on her back. Fever of 101-102. Very fussy.
Primary babysitter of pt contracted guillian barre disease; was on a respirator; had to go through rehabilitation therapy;
Patient with red raised , dry area measuring  3cm long and 2.5cm in width. Mom reports area itchy as child has been itching area.
Left upper arm, arm pit, left upper quadrant swelling.  Left Breast increased to twice normal size.  Swelling continued for 4 days and slowly subsided.
Bilateral knee pain and limp No swelling or redness Resolving but not completely gone on 10/23/09
no additional AEs reported; GARDASIL 9 were administered to multiple unknown patients following temperature excursion; This non-valid, spontaneous report was received from an office manager and referred to multiple patients of unknown age and gender. The patients' concurrent conditions, concomitant therapies and medical history was not provided.  On an unknown date, multiple patients were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.On unknown dates, the doses of vaccines experienced the temperature excursions of 8.55 Celsius degrees for 8 minutes and 9.29 Celsius degrees for 12 minutes (product storage error). There were no previous excursions reported. No additional adverse event (AE) details were reported (no adverse event).  This report is non-valid due to lack of patients' identifiers.  Follow-up information was received from an office manager on 10-MAY-2023:  The patient identifiers was updated such as date of birth, address and gender.  On 03-OCT-2022, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.  Temperature excursion total time was 25 minutes. There was 3 temperature excursions: on 09-SEP-2022 for 8 minutes, on 16-SEP-2022 for 5 minutes and on 03-JAN-2023 for 12 minutes. Excursions were not noted until after the first fact due to employee error of cleaning data logger more than once a day.  The vaccines was purhased with public and privet founds and were given in private doctor's office/ hospital.The medication error occurred in the point of storage in clinical practice.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2304USA002221:
Pt had TD on 1/13/03. Noticed itching on 1/14/03 through 1/16/03. Rash noted on 1/17/03. Evaluated in clinic on 1/17/03 and had local redness, swelling and induration 1 1/4" X 1/2" around injection site with rash under arm (mild).
Information has been received from a healthcare worker referring to two unidentified patients of unknown age and gender. On unknown dates (range between 18-FEB-2015 to 30-MAR-2015) the patients were vaccinated with one dose of improperly stored M-M-R II (lot # J013316, expiration date 22-OCT-2015, dose and route were unknown). No adverse effects reported. This is one of several reports received from same source. Additional information has been requested.
ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY LEFT FACIAL MUSCLE WEAKNESS 1/9/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Patient received vaccine approx 4:25pm. Reported back to RN who administered approx 4:30pm that she was feeling like she was going to faint. RN got her on the floor with her feet propped up in a chair (laying supine). Patient reported feeling better almost immediately. Patient left RN at approx 4:35pm and remained in pharmacy area for her observation period, then left without further incident
Slight fever; Chills; This case was reported by a consumer via call center representative and described the occurrence of fever in a 60-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th January 2020, the patient received Shingrix. On 28th January 2020, 1 days after receiving Shingrix, the patient experienced fever and chills. On an unknown date, the outcome of the fever and chills were not recovered/not resolved.   It was unknown if the reporter considered the fever and chills to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had slight fever and chills. The reporter asked how long should this side effect last.
I got COVID virus and was mostly a- symptomatic; Skin hurt, Head to toe; Fever; This spontaneous case was reported by an other health care professional and describes the occurrence of ASYMPTOMATIC COVID-19 (I got COVID virus and was mostly a- symptomatic), PAIN OF SKIN (Skin hurt, Head to toe) and PYREXIA (Fever) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASYMPTOMATIC COVID-19 (I got COVID virus and was mostly a- symptomatic), PAIN OF SKIN (Skin hurt, Head to toe) and PYREXIA (Fever). At the time of the report, ASYMPTOMATIC COVID-19 (I got COVID virus and was mostly a- symptomatic) outcome was unknown and PAIN OF SKIN (Skin hurt, Head to toe) and PYREXIA (Fever) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment medication was provided.   This case was linked to MOD-2021-272097.; Sender's Comments: This case concerns an unknown age female patient with no relevant medical history, who experienced the unexpected events of asymptomatic COVID-19 and pain of skin and the expected event of pyrexia. The events occurred after the second dose of mRNA-1273 vaccine. Based on the current available information and temporal association between the use of the product and the start date of events of pain of skin and pyrexia, a causal relationship cannot be excluded. For the event asymptomatic COVID-19, based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination, hence causality is assessed as not applicable. The rechallenge was not applicable since no information about the first dose was available and no additional dosing will be given. The event pyrexia is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 in not affected by this report.
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Patient experienced an infection at the injection site, started 8 days after the injection. Urgent care gave her cephalexin and triamcinolone cream
HA x 3 days, right side of face feels numb x2 days. Cough, runny nose, & left ear ache
CONSTANT BODY PAIN; CEMENT HEAD; NO TASTE; UNABLE TO EAT MORE THAN A COUPLE OF MOUTHFULLS OF FOOD OR DRINK THE USUAL 2-3 QUARTS OF WATER DAILY; LOST 6 POUNDS IN ONE MONTH; DID NOT GET OUT OF BED OR GET DRESSED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 05-OCT-2022 for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Non-company suspect vaccine included: influenza vaccine (form of admin, route of admin, and batch number were not reported) dose was not reported, administered on 05-OCT-2022 for prophylactic vaccination. No concomitant medications were reported.  On 2022, the patient experienced constant body pain, cement head, no taste, unable to eat more than a couple of mouthfulls of food or drink the usual 2-3 quarts of water daily, lost 6 pounds in one month, and did not get out of bed or get dressed. The action taken with covid-19 vaccine ad26.cov2.s, and influenza vaccine was not applicable. The patient was recovering from constant body pain, no taste, unable to eat more than a couple of mouthfulls of food or drink the usual 2-3 quarts of water daily, lost 6 pounds in one month, did not get out of bed or get dressed, and cement head. This report was non-serious.
pt recv vax 9OCT96 230PM & 5hr later pt felt sick, redness & swelling (dime size) @ site-very painful;pain in lower back & under rib area in chest;started menstrual period 1wk early;t102.0 9OCT, 10OCT t101.0, cant, eat d/t stomach pain
Today mom noticed swelling of hands, feet, blanching maculopapular rash on trunk
Pt recvd vax 1DEC92 & exp burning @ inject site, nausea,abdo cramping,lightheadedness,disorientation,strange feeling,flushed,sinuses were full w/inc sinus drainage & dripping down throat; also h/a,fluctuations of feelings;balance of was off
Fever; Aches / Pains; Chills / Shivering; Swelling at injection site; Felt like flu; Very tired; This case was reported by a consumer via call center representative and described the occurrence of fever in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th September 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 30th September 2019, less than a day after receiving Shingrix, the patient experienced fever, pain, chills, injection site swelling, influenza-like symptoms and tiredness. On an unknown date, the outcome of the fever, pain, chills, injection site swelling and influenza-like symptoms were recovered/resolved and the outcome of the tiredness was not recovered/not resolved.   It was unknown if the reporter considered the fever, pain, chills, injection site swelling, influenza-like symptoms and tiredness to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix into left deltoid. The patient experienced fever, chills and shivering, aches, pains and swelling at injection site. All adverse events were better on the reporting date. The patient felt like flu and was still very tired.  The reporter consented to follow up.
Left deltoid red, tender, cellulitis. Tx: Keflex 250/5 1 1/2 tab bid x 10 days.
Patient reported swollen throat, feeling feverish, blotchy skin, and fatigue. Onset approximately 2 hours after injection.
Headache, Fever, inj site red, swelling, pain; fever, chills, body ache, headache Narrative:  symptoms lasted x3 days
Loss of balance; Disorientation; Difficult breathing; Was extremely cold; Was trembling; no strength; passed out; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy, Fruit allergy (The patient have allergy towards bananas.) and Pollen allergy. Concomitant products included FENOFIBRATE, SERTRALINE, ASCORBIC ACID, BETACAROTENE, COPPER, NICOTINAMIDE, SELENIUM, TOCOPHEROL, XANTOFYL, ZINC (LUTEIN +) and VITAMIN D3 for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), FEELING COLD (Was extremely cold), TREMOR (Was trembling) and ASTHENIA (no strength). On 27-Feb-2021, the patient experienced BALANCE DISORDER (Loss of balance), DISORIENTATION (Disorientation) and DYSPNOEA (Difficult breathing). On 26-Feb-2021, LOSS OF CONSCIOUSNESS (passed out) had resolved. On 27-Feb-2021, FEELING COLD (Was extremely cold), TREMOR (Was trembling) and ASTHENIA (no strength) had resolved. At the time of the report, BALANCE DISORDER (Loss of balance), DISORIENTATION (Disorientation) and DYSPNOEA (Difficult breathing) outcome was unknown.            Patient wok up 10 to 12 hours after receiving second shot and was extremely cold, trembling or shaking uncontrollably. All limbs and jaw could not stop trembling. Got out of bed to find another blanket and raise thermostat. Could not find thermostat (disoriented) struggled to find blanket. By the time patient found blanket he began to have great difficulty breathing. By the time patient stumbled into bed, he was gasping as if there was no air in the room. Stayed in bed gasping, trembling and freezing till he fell asleep or passed out. Patient had no strength to call for help, thought he was dying. Patient woke up about 8:00 AM with no illness, aches, pains or any physical issues. Patient had no further issues till date of report. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: No specific follow-up information recorded. On 24-May-2021: Follow up received on 25 May 2021 and it contain significant information. Additional new event added and one event upgrade the case to serious. Patient demographics updated. History, concomitant and narrative information also get updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient was in the bathroom at home when she felt dizzy and fainted.  Afterwards she was very dizzy and lightheaded. Patient reports 10/29/14 of bad headache and area where vaccine (Pneumovax) was given she says area is warm and has a hard spot. Also received Fluzone same day in different arm.
On 6-13-17 mother calls to report that child had emergency room visit several hours after vaccines given on 6/5/17. She reports fever of 104.5, emesis x 1 that was black in color, abdominal pain, dizzy, and weakness. Emergency findings were negative, child received fluids and had a negative CT scan of abdomen. Symptoms resolved. I did call the Infection Preventionist at the hospital, and she reports that there was no record of fever in the emergency, and that testing was negative. It was reported to the emergency staff that the abd. pain had started in the morning prior to the vaccine visit. There was no mention during the vaccine visit here of any discomfort or fever.