chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of Guillain Barre Syndrome in a female patient who received Influenza vaccine Quadrivalent. On an unknown date, the patient received influenza vaccine quadrivalent at an unknown dose. On an unknown date, unknown after receiving influenza vaccine quadrivalent, the patient experienced Guillain Barre Syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the Guillain Barre Syndrome was unknown. It was unknown if the reporter considered the Guillain Barre Syndrome to be related to influenza vaccine quadrivalent. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional (HCP) had no documentation of when or what flu shot the patient received.
covid 19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (covid 19) in a 72-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: SPIKEVAX (Dose 1), MODERNA COVID-19 VACCINE (Dose 3) and SPIKEVAX (Dose 2). Past adverse reactions to the above products included No adverse event with MODERNA COVID-19 VACCINE, SPIKEVAX and SPIKEVAX.    On 22-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In October 2022, the patient experienced COVID-19 (covid 19). At the time of the report, COVID-19 (covid 19) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-736299 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-736299:Patient 1
Patient is a 77-year-old male with past medical history of nonischemic cardiomyopathy with EF of 60%, paroxysmal AFib on Eliquis, PE in 2020, prostate cancer, chronic obstructive pulmonary disease on 3 L nasal cannula baseline who was admitted for acute hypoxic respiratory failure secondary to COVID. The patient initially was positive on 4/6 with symptoms starting 2 days prior. He was fully vaccinated and boosted.   On admission, the patient was hypoxic in the 80s and required high-flow nasal cannula. He was initially hypotensive but responded well to IV fluids. He was started on IV Solu-Medrol and remdesivir, empirically treated for CAP. Sputum culture grew only normal upper respiratory flora. Legionella and Strep pneumo urine antigens negative. Due to the patient being on high-dose steroids he was started on a basal bolus insulin regimen of Lantus 10 units with moderate dose corrective.  He was given a 1 time dose of IV Lasix 40 mg with appropriate urine output, Cr increased mildly after. Lasix holiday on 4/10. Resumed home dose on 4/11 of 20 mg PO. Was taking every other day at home but discharged on daily to maintain euvolemia. Weaned back to baseline O2 requirement of 3 LPM NC and transitioned to PO steroids on 4/11. Received 5 days of IV CTX for CAP and received remdesivir until day of discharge.    Patient was discharged home in stable condition on 4/11/2022. He was tolerating a general diet and back to his baseline O2 requirement, maintaining appropriate oxygen saturation with ambulation. Blood cultures drawn 4/7 were NGTD x4 days.
Diarrhea; General pain; Chills; Aches; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), PAIN (General pain), CHILLS (Chills) and MYALGIA (Aches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 39A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2021, the patient experienced DIARRHOEA (Diarrhea), PAIN (General pain), CHILLS (Chills) and MYALGIA (Aches). On 05-Apr-2021, DIARRHOEA (Diarrhea), PAIN (General pain), CHILLS (Chills) and MYALGIA (Aches) had resolved. Not Provided          No relevant concomitant medications reported.  No treatment information was provided.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable       This case was linked to MOD21-070310 (E2B Linked Report).; Sender's Comments:  MOD21-070310:Wife's Case
This spontaneous report was received from a nurse refers to multiple unspecified patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored GARDASIL 9 lot # L007560, expiry date 15-JUN-2017, (dose, frequency and route of administration were not reported). No adverse effect reported. No product quality complaint (PQC) was involved. This is one of four reports received from the same reported. Additional information has been requested.
Dizziness and mental fogginess within minutes of injection followed by extreme sharp pain in arm. Later fatigue and next day full flu symptoms sore throat congestion low grade fever achy pain cough stuffy the following day sick in bed right eye swollen plus headache congestion and full flu illness extreme fatigue with inability to concentrate.
Vaccine given 10:30 AM 10/17/15. By 4 pm of same day felt increased tenderness at inject site and widespread joint pains. Later in evening spike temp 101 and vomiting. By 10/19/15 symptoms resolved except waning nausea. Took TYLENOL.
Patient received Varivax vaccine in right arm SC on 08/04/11.  Mother noticed 08/05/11 approx 3:00 that area was red and hard.  Patient evaluated in office 08/05/11.  Treatment course recommended ice and Benadryl.
Chills, sweats, headache 12 hrs post, lasting 48 hours total.  Redness, firmness, pain about 4 inches below injection site, starting  48 hours after shot.
Vaccine give 09:15, pt. noticed tongue swelling about 15:15 and reported to ward RN at 14:00 when swelling increased to lower lip then upper lip.  Unable to speak, lungs clear, no wheezing and maintained 02 Sat.  MD noticed - ordered 100mg Solumedrol IV and 25 mg Bendryl IM. Transferred to ER for monitoring.  Returned to ward same evening.
Swollen knee, pain in shoulder , neuropathy day 3 in feet,  headaches and 2 weeks after broke out in Hives all over (have pictures ) delayed  allergic reaction and yeast infection. Stomach pains
SWOLLEN HANDS; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (SWOLLEN HANDS) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Rheumatoid arthritis.    No Medical History information was reported.   On 25-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PERIPHERAL SWELLING (SWOLLEN HANDS). At the time of the report, PERIPHERAL SWELLING (SWOLLEN HANDS) had not resolved.            No concomitant medication was reported.  The patient had swelling hands due to lack of medication.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of SWOLLEN HANDS with SKYRIZI(RISANKIZUMAB) was a reasonable possibility.  No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Pt recv vax on 10/21/98; on 10/23/98 pt exp headache, nausea & body aches
Injection site:  Soreness, raised (welt-like) and red area about the size of a silver dollar,
The team was their for the Father's first dose but he was busy and the mother asked if her children could get vaccinated while they waited. The mother stated that this was everyone's first dose so they were all inputted as a walk-in for their first dose. When the RN was filling out their vaccination card for their first dose, the mother then stated that she already had a vaccination card for patient and that it was actually his second dose today. The mother first stated that they received their first dose on June 17th but actually it was July 17th.
Approximately 15 minutes after the patient received her vaccination, she complained of feeling thirsty, cold, and tingly all over.  She had no difficulty breathing, loss of consciousness, or hives.  I spoke with her and asked if she wanted me to call the ambulance and she stated no because she wanted to wait to see if she would feel better after drinking a bottle of water.   I contacted Pfizer customer service number to see if they had any advice but the agent stated that Pfizer's medical reporting line is only open Monday thru Friday from 8-9pm.  Minutes later the patient   began having convulsions and we immediately contacted the emergency number and they came to the store to provide further medical treatment.  It took approximately 45 minutes before the patient was transported to the hospital.
went back for the second dose and had minor reactions.; They got really ill after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (went back for the second dose and had minor reactions.) and MALAISE (They got really ill after the first dose) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (went back for the second dose and had minor reactions.) and MALAISE (They got really ill after the first dose). At the time of the report, IMMUNISATION REACTION (went back for the second dose and had minor reactions.) and MALAISE (They got really ill after the first dose) outcome was unknown. Not Provided      For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Reporter mentioned that back when the vaccines first came out she spoke to 4 people who told her that they experienced strange reactions with the Moderna vaccine. They got really ill after the first dose, and 2 of them didn't go back for the second dose. Two of them went back for the second dose and had minor reactions. No treatment medication reported.  This case was for the fourth patient out of four reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-743464, MOD-2023-743551 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-743464:Master Case MOD-2023-743551:Patient 4
Fever for 5 days with two days of temps reaching 104-105 degrees, vomited during high fever, rash/itchiness around neck and hairline, sore glands, loss of appetite, lethargic, diarrhea. GI was not back to normal for about 3 weeks.
Vaccines were administered in room without complication. Staff left the room with patient safely with parents. Within 2-3 minutes after leaving the room, Mom came running out with patient in her arms asking for help. She was shaking him trying to wake him up saying she needed help. Said he just went limp in room(was not visualized by staff). Patient was limp but breathing. I asked mom to not shake him. Other staff member gently grabbed him and patient awoke upon transfer. Was acting fine and responding appropriately.
Pt had swelling of the left eye, under eye, in the corner of eye, and on eyelid. It started at 1:30am the morning after receiving the vaccine and it persisted until 7/11/21 (2 days later).
In early August I got a UTI and went to urgent care and was seen by a PA. He did a urine sample and prescribed antibiotics. Less than a week later it came back. I went in again and saw a doctor. He said it was the same UTI but it never cleared up. He prescribed me a stronger antibiotic and it cleared up. I have only had 2 UTI's in my whole life. This is not common for me at all. The end of August, I also got a really bad cold while traveling which I haven't had in years. My only treatment was OTC meds and it lasted about 10 days. I got a covid test and it was negative.
Severe headache 4hrs after injection of second dose. Blood pressure spike up to 154/102 pulse90. Stayed elevated until afternoon of Sunday Apr 25 2021. Took extra lopressor and one tizanidine to help reduce blood pressure which was almost normal on Sunday evening Apr 25. BP was then 124/73 and pulse 69
Employee received MMR SC in right arm on 6/30/04. On 7/3/04 she began to experience itching, redness, swelling and warmth at the injection site. Presents to clinic on 7/6/04 with 45mm of induration and warmth to touch. Denies any systemic reaction.
One hour after recieving twinrix and japanese encephalitis this patient felt dizzy and lightheaded this lasted 45 min. For the next 24 hrs she felt joint aches and discomfort in lt upper arm.
Information has been received from a healthcare worker referring to multiple unspecified patients of unknown age and gender. The patient's concurrent conditions, concomitant medication and medical history were not provided. On unknown dates the patients were vaccinated with improperly stored LIQUID PEDVAXHIB (Lot# K008879, exp. 30-MAR-2017; Lot# L004738, exp. 10-NOV-2017; Lot# J013943, exp. 14-AUG-2016; Lot# J015435, exp. 13-OCT-2016; Lot# J010382, exp. 28-MAY-2016; Lot# was reported as J008091, exp. 04-APR-2016) (dose, route and dose number were unspecified). No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected because there was no consent to contact physician.
Pt had a fever of 104 degrees Fahrenheit (rectal) the night she received her 4 month old vaccines. She was previously healthy. She also began projectile vomiting that continued for 3 days.
Shock-like (Hyporesponsive) episode lasting approx 20 mins;
lmpropely stored vaccine administered; administered IM instead of SC; This spontaneous report was received from a nurse referring to a 6 years old (also reported as 5 years old) female patient. The patient's medical history, concomitant medications, drug allergies, or reactions were not reported.    On 17-AUG-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # T002847 has been verified to be valid, expiration date reported as 23-JAN-2023, but upon internal validation established as 23-JAN-2022, intramuscular (IM) in the left thigh for prophylaxis in a clinic (dose and strength were not reported) (product storage error and incorrect route of product administration). There was 1 previous dose. Temperature exposure detected. Data logger was involved. Vaccine was removed immediately. No further vaccine was administered. Parents were being noticed and this dose of vaccine would  be repeated with new vaccine stock.     This is one of several reports received from the same reporter.
Left arm red, warm to touch, sl. tender, swollen about 8-10 cm.
I woke up on 12/26/2020 with adverse reaction.  On 12/30/2020, I was diagnosed with Bell's Palsy at Emergency room.  17 year ago, I received my flue shot (don't recall the type) and was also diagnosed with Bell's Palsy.
12/26/2020 Generalized body urticaria/rash, itchy, Fever 100.9°, headache, GI s/s, Sore arm  12/25/2020 2pm-nighttime Fever 101.1° (continued throughout evening), GI s/s, fatigue , Sore arm/shoulder  12/24/2020 7pm Scalp Itch, Sore Arm
bad local reaction / injection site hurt; bad local reaction / injection site / was swollen; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   In January 2020, the patient received the 1st dose of Shingrix and Influenza vaccine Quadrivalent 2019-2020 season. On an unknown date, less than a year after receiving Shingrix and Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced injection site pain and injection site swelling. On an unknown date, the outcome of the injection site pain and injection site swelling were unknown.   It was unknown if the reporter considered the injection site pain and injection site swelling to be related to Shingrix and Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were reported as follows: The patient received the 1st dose of Shingrix and developed a bad local reaction. She mentioned that she received the dose along with flu shot (could not specify which one) and the injection site hurt and was swollen. The reporter consented to follow up. For toleranace of 2nd dose, refer case US2020AMR201322.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR201322:same patient (2nd dose)
PT SLEEPING AND WOKE UP VOMITING , LETHARGIC AND NOT MAKING GOOD EYE CONTACT PER MOTHER, UPON ARRIVAL TO ER, STILL LETHARGIC, SHORTLY BECAME MORE ALERT AND TALKATIVE WITH PARENTS.
This spontaneous report from a contactable medical assistant. This medical assistant reported similar events for two patients. This is the second of two reports. The case is non-serious. The first case is serious. A 2-month old male patient received a first dose of PREVNAR13, intramuscular, on 25APR2011 along with a first dose of ROTATE$Q, oral, on 25APR2011. Relevant medical history, concomitant medications and past product history were unknown. On an unspecified date, the patient developed a gastric problem. On 03MAY2011, ,the patient experienced 6 bowel movements in 24 hours. The event of 6 bowel movements in 24 hours recovered on an unspecified date with no treatment provided. The outcome of the event of gastric problem was unknown. Follow-up (23MAy2011): New information reported from a contactable medical assistant includes: Birthday with updated age. Product details including dose number, additional suspect vaccine, additional event details leading to a change in the event from bowel problem to 6 bowel movements in 24 hours, onset date of the event,  updated recovery status and information noting that no treatment was given for the 6 bowel movements in 24 hours. Follow-up attempts completed. No further information expected.
"Covid Arm": rash-like effect appeared about a week after the initial dose. Around the injection site, a raised lump formed about the size of a mango. It was super itchy, firm, red, swollen, and hot to the touch. In general, the arm that was injected was sore and achy.
pt. daughter called pharmacy on May 18, 2021 (approximately 5:00pm MST) stating pt. passed away and wanted info on reporting incident to authorities=Technician gave pt. daughter phone # to report incident.
Right Arm (Shingles vaccine): Very sore and painful, red, inflamed, sore, top part of arm feels cold and numb. Skin very red. Feel tired.
Period is late and still delayed. I've taken numerous pregnancy tests and am not pregnant. I usually have a very regular cycle but period has not arrived since I got the vaccine.
Approximately 30 hrs after immunizations, the pt had a 5-10 second episode where her face got red, arms extended behind her legs and torso stiffened and her eyes did not roll back-no jerking.
Started feeling tightness in through and went to the vaccine site and thought she was having antifalius Blood pressure  166/90 Pulse was 103.
This case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a 19-year-old female patient who received BEXSERO. Concurrent medical conditions included allergy. On an unknown date, the patient received BEXSERO. On an unknown date, unknown after receiving BEXSERO, the patient experienced injection site erythema, injection site induration, injection site swelling and generalized urticaria were unknown. It was unknown if the reporter considered the injection site erythema, injection site induration, injection site swelling and generalized urticaria to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient received BEXSERO on left deltoid. The patient received allergy injections concomitantly but no further clarification was provided. The patient experienced an injection site reaction, described as a softball size, hard, red, raised reaction at the injection site, and hives all over her body. The patient was seen in the emergency room and discharged on the same day.
On 11/13/20 at 1330, mother called in to the clinic reporting her son who received vaccinations 11/12/20 awoke in the morning with raised red rash across his back and his right eye was swollen. Denied anaphylaxis and any respiratory distress. Mother stated child was eating and acting normally. Nurse recommended children's Benadryl and for further concerns to notify PCP.
Called health system call center to report the following symptoms post vaccination on 4/30/21:  fatigue and minor sore throat since 5/2/21, Joint pain and muscle aches since 5/1/21. No fevers or respiratory symptoms. Pt scheduled for urgent care visit on 5/4/21. Pt was advised to go to ED if worsening of symptoms. Pt verbalized understanding.
The patient presented with a red rash on both legs and abdomen that was extremely itchy. The rash then changed to bruising with no itching. We recommended BENADRYL for itching.
103.9 Fever, severe body aches, shortness of breath, migraine, extreme fatigue, diarrhea, lethargic and I had vomiting on the 5th day after vaccine was given. Basically all the symptoms I had when I had Covid 19 in late December and was sick for over 3 weeks.
Headache, Myalgia, Arthralgia & Angioedema Narrative: Ipsilateral axillae nodes positive
DEATH; This spontaneous report received from a consumer via social media company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose were not reported, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient died from an unknown cause of death. It was unknown if an autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20211049949-covid-19 vaccine ad26.cov2.s-Death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Rash both arms day of injection and still present when seen 1/11/21 with additional rash noted on legs. Also bruising on legs (?timing).