chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a physician via sales rep and described the occurrence of pain in a 18-year-old female patient who received BEXSERO for prophylaxis. Previously administered products included BEXSERO (1st dose received on 28th December 2018, refer case US2019GSK031816). On 8th February 2019, the patient received the 2nd dose of BEXSERO. In February 2019, less than a week after receiving BEXSERO, the patient experienced pain. On an unknown date, the patient experienced swelling and enlargement of lymph nodes. Rechallenge with BEXSERO was positive. On an unknown date, the outcome of the pain, swelling and enlargement of lymph nodes were unknown. It was unknown if the reporter considered the pain, swelling and enlargement of lymph nodes to be related to BEXSERO. Additional details were reported as follows: The patient experienced more severe swelling and extreme pain along with a line up to her lymph nodes per the patient's dad as the physician told the reporter. There were no other vaccines given at the same time and BEXSERO both times was given in the same arm.
3/29-69 year old female received the 2nd dose of the Pfizer COVID-19 vaccine at Campus on 03/27/2021 @ 13:00. Evening of 03/27/2021 pt started experiencing fatigue, light headache, and a low grade fever 99F. Pt took APAP for symptom relief. Pt takes lisinopril, levothyroxine, and loratadine. Pt is diagnosed with hypertension and hypothyroidism. Pt is allergic to shellfish. Pt is still experiencing symptoms. Pt was advised to continue taking APAP and if symptoms do not resolve or worsen in 2 days to contact primary doctor. DR was consulted and Dr. was notified. What happened as a result of the adverse event? (doctor visit, ED or urgent care visit, hospitalization, life threatening illness, disability/permanent damage, death, none of these):   None of these.
Flu like symptoms; Felt feverish; Chills; Felt fatigued; All over body aches; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), PYREXIA (Felt feverish), CHILLS (Chills), FATIGUE (Felt fatigued) and MYALGIA (All over body aches) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 13-Nov-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), PYREXIA (Felt feverish), CHILLS (Chills), FATIGUE (Felt fatigued) and MYALGIA (All over body aches). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), PYREXIA (Felt feverish), CHILLS (Chills), FATIGUE (Felt fatigued) and MYALGIA (All over body aches) was resolving.            No concomitant medications were provided. No treatment medications were provided.
Patient has swelling of whole arm about 5 hours after injection. It was the arm that was vaccinated and it swole from her shoulder all the way down to her fingers. Patient also reported pain from the injection as well. The patient was then told to take Benadryl upon calling the pharmacist and to go to an after hours clinic to be evaluated and some possible steroids. The after hour clinic sent the patient home and advised patient to take Benadryl for the reaction as well.
Same patient given Arexvy twice on the same day in different arms. Patient noted sore arms and tiredness the next day. Checked status of patient one week later with no change in status and doing fine.
Patient received dose 1 of the Pfizer COVID vaccine (lot EW0187) at 1400. At 1445, after completing the observation period, the patient reported to Ancillary  and Paramedic that she was experiencing symptom of an "itchy throat" and requested her blood pressure be taken. PHN  approached to assess. At 1445, vital signs: pulse 75, O2 99%, respirations 18, blood pressure 132/86. Allergies include penicillin, aspirin, and sulfas. Patient denied medical conditions or medication. Patient was given water and granola bar. PHN encouraged patient to stay for monitoring for 30min, educated on following up with provider, and when to call 911. Patient reported symptom had resolved at 1447. Patient reported she was going to leave and felt safe to drive home. Patient left walking with steady gait at 1449.
patient got a first dose of the Pfizer vaccine and a second dose of the Moderna vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (patient got a first dose of the Pfizer vaccine and a second dose of the Moderna vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No medical history information was provided.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (patient got a first dose of the Pfizer vaccine and a second dose of the Moderna vaccine). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (patient got a first dose of the Pfizer vaccine and a second dose of the Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received a Pfizer vaccine for the first dose; patient came to the pharmacy and requested a Moderna vaccine for the second dose. Pharmacist did not follow protocol and administer the Moderna vaccine for the second dose.  Concomitant product use was not provided. Treatment information was not provided.
Muscle tightness in neck upon waking up in the morning. There was also redness and swelling at the site of injection. As the day progressed pt was unable to move neck and states she had a headache radiating to her neck. She was given Motrin and Flexeril for headache and muscle tightness. She was sent home on 24hr quarters.
10-18-21 night tiny bruise, nothing noticed 10-19-21 morning, after school on 10-19-21 redness, hot to touch, more bruising noted, 10-20-21 more red, more swelling, more redness around arm.  10-20-21 on physical exam large area of redness surrounding the shot site on L upper extremity, area of redness extended up to should and towards elbow as well as around and under upper extremity, warm, slightly firm and tender to touch, FROM of upper extremity, nickel sized area of bruising in center where shot site was.  Dx:  Cellulitis and treated with Cephalexin 250mg/5ml give 10ml bid x 10 days
10 day bruise at site. Red and itching 2 in below site for 7 days. General unwell feeling in joints. Arm was feverish.
Guillain Barre Syndrome within 24 hours of receiving vaccine. Was unable to stand or walk, fell several times.
pt recvd flu vax on 3DEC92 & on 4DEC92 devel general muscle stiffness all over body; 5DEC92 exp a fever; by 7DEC92 pt's sx subsided;
Approximately one minute after giving immunization patient began to show signs of dizziness, eyes rolled back into her head, began shaking as though she was having seizure and she became unconscious for approximately one minute. She became responsive and continued to shake. EMS arrived and checked her and reported normal BP and HR. Mother refused transport by EMS.
On 11/09/2000 the patient experienced greater than 30 lesions on his body. The lesions were described as pruritic fluid-filled vesicles. Additional information has been requested.
Expired Fluarix administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2021-2022 season) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Fluarix Tetra 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Fluarix Tetra 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 21-Nov-2022 Reporter's comment: The pharmacist called to ask for information about the administration of Fluarix season 2021-2022 to a patient instead of the current Fluarix 2022-2023.  The reporter asked if the patient had to be re-vaccinated. The reporter did not provide patient identifiers nor data about the expired dose of Fluarix. Did not consent to follow-up. Additional supportive information: The patient received an expired dose of Fluarix, which led to expired vaccine used.
blood clots; Their period has also become "messed up" that became longer and heavier with cramping and nausea and vomiting; Their period has also become "messed up" that became longer and heavier with cramping and nausea and vomiting; Their period has also become "messed up" that became longer and heavier with cramping and nausea and vomiting; Their period has also become "messed up" that became longer and heavier with cramping and nausea and vomiting; This is a spontaneous report from a contactable consumer via a Pfizer sponsored program. The reporter reported similar events for 2 patients. This is one of the 2 reports. A female patient in her 20s received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The reporter stated issues about the vaccine were being suppressed such as issue with bell's palsy and mentioned that she according to the nurse where her mother was currently admitted; they saw a 50-60% of hospitalization among vaccinated people. The reporter also knew 3 young women in their 20s that have been vaccinated as well. The one was hemorrhaging in the hospital while the two had blood clots on an unspecified date. Their period has also become "messed up" that became longer and heavier with cramping and nausea and vomiting. There was also one woman suspected to be pregnant has a miscarriage. Outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101202716 same reporter, drug and event, different patients
On 7/2/07 advised from department of health that patient was hospitalized with diagnosis aseptic meningitis. 7/18/07-records received, no discharge summary on chart. REcent HX of ataxia, lower extremity weakness as well as headaches and fever. Worst headache of his life on 6/14/07 with photophobia, multiple episodes of vomiting on 6/22-27 at which time legs began to feel weak and tender. Seen in ED with both numbness in feet and weakness in legs.  Temp 38.4. Can not rule out viral meningitis, viral encephalitis most likely.  9/28/07-DC Summary received for DOS 7/3-7/7/07-Chief complaints: weakness and ataxis.
Rash near injection site. Severe itching, swelling, and heat on the rash
Leg became numb and one of her toe became numb; Numb and tingling; Felt like a liquid or something going through her body, arm, leg. She was really freaking out; Headache; Not feeling well at all; Got injection on left side and everything seems to be sore and numb on left side; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm left on 19Sep2021 16:45 at 58-year-old (Lot Number: FE3592) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. Medical history included blood cholesterol increased from an unknown date and unknown if ongoing, hypothyroidism from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing (hypersensitive to unknown medication). Concomitant medications included levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported and an unspecified statin for high cholesterol. Patient did not take any other vaccine within 4 weeks before. The patient experienced leg became numb and one of her toe became numb (medically significant) on 19Sep2021 with outcome of not recovered, numb and tingling (medically significant) on 19Sep2021 with outcome of not recovered, got injection on left side and everything seems to be sore and numb on left side (medically significant) on Sep2021 with outcome of unknown, felt like a liquid or something going through her body, arm, leg. she was really freaking out (medically significant) on 19Sep2021 with outcome of unknown, headache (medically significant) on 19Sep2021 with outcome of unknown, not feeling well at all (non-serious) on Sep2021 with outcome of unknown. Therapeutic measures were taken as a result of leg became numb and one of her toe became numb, numb and tingling, felt like a liquid or something going through her body, arm, leg. she was really freaking out, headache and included treatment with two Benadryl. All the events required physician office visit.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101236214 Same reporter/patient, different drug/events
Approx 15 minutes after getting vaccines, the patient kicked the MA to get her attention. He kicked twice - when she looked his legs were shaking. Then his arms shook. He closed his eyes for 1 second. Then he returned to normal.
Feeling very tired after first shot; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Feeling very tired after first shot) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX) for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Feeling very tired after first shot). At the time of the report, FATIGUE (Feeling very tired after first shot) outcome was unknown. Not Provided    Treatment medication was not provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.     This case was linked to MOD-2021-114678 (Patient Link).
This spontaneous report has been received from a physician referring to a 15 year old patient of unknown gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. In February 2015, the patient was vaccinated with the first dose of GARDASIL (strength, dose, route, lot #, expiration date or anatomical location were not reported) for prophylaxis. Then in February 2016 (reported as 1 year later), the patient received his second dose of GARDASIL 9 (strength, dose, route, lot #, expiration date or anatomical location were not reported) for prophylaxis. No adverse effect was reported and no additional information was provided. Additional information has been requested.
Cheeks & inside underneath the tongue's swollen. 10/14/20 9pm - she took Benadryl at night. It's gone in the morning.
Bleeding with stool; This is a spontaneous report from a contactable consumer (patient). A 66-years-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534), via an unspecified route of administration, administered in Left arm, on 15Mar2021 at 12:30 (at the age of 66 years old) as a single dose, for COVID-19 immunisation. Medical history included moderate high blood pressure. The patient did not have any known allergies. The patient did not experience COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. Concomitant medications included lisinopril, montelukast, vitamin C and vitamin D. The patient did not receive other vaccines in the four weeks prior to receiving the BNT162b2 vaccine. The patient experienced bleeding with stool on 18Mar2021 at 09:00am. The patient did not receive treatment for the event. The event resulted in a doctor or other healthcare professional office/clinic visit. The clinical outcome of the event bleeding with stool was unknown.
This spontaneous case was reported by a consumer and describes the occurrence of PANCREATITIS (inflamed pancreas) and HAEMORRHAGE (severe vomiting that affected pancreas and cause him to bleed) in a male patient of an unknown age 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 information was reported.    On 11-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PANCREATITIS (inflamed pancreas) (seriousness criterion medically significant), HAEMORRHAGE (severe vomiting that affected pancreas and cause him to bleed) (seriousness criterion medically significant), RETCHING (dry heaves), OROPHARYNGEAL PAIN (throat very sore from vomiting), FEEDING DISORDER (had not eaten in 4-5 days and was on liquid diet) and VOMITING (severe vomiting). At the time of the report, PANCREATITIS (inflamed pancreas), HAEMORRHAGE (severe vomiting that affected pancreas and cause him to bleed), RETCHING (dry heaves), OROPHARYNGEAL PAIN (throat very sore from vomiting), FEEDING DISORDER (had not eaten in 4-5 days and was on liquid diet) and VOMITING (severe vomiting) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the patient had gone to hospital twice and now he has to see a specialist. The patient received first dose of vaccine sometime in Apr-2021. No treatment and concomitant medications were reported.  Action taken with mRNA-1273 in response to the event was Not Applicable   Company Comment:  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. However, very limited information on the event Pancreatitis and hemorrhage has been provided at this time. No further information is expected.   This case was linked to US-MODERNATX, INC.-MOD, US-MODERNATX, INC.-MOD.; 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. However, very limited information on the event Pancreatitis and hemorrhage has been provided at this time. No further information is expected.
Redness and swelling of injection site. BENADRYL and anti inflammatories given.
This spontaneous report was received form a physician via company representative, concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 07-DEC-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot number L024129; expiration date 21-JAN-2017) "10 PK 0.5 ml SD-PFS LLok w tip" (route of administration and anatomical location were not reported). On an unspecified dates, the PNEUMOVAX 23 had one temperature excursion of 24 hours. The lowest recorded temperature was 34 F (1.111111111). No adverse effects reported and no product quality complaint was involved. The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type of excursion were reported as "Refrigerator(R)". This is one of several cases from the same reporter. Additional information has been requested.
Fever of 102 within 12 hours of vaccine. Moderate to severe body aches and dizziness. Symptoms lasted 48 hours. No treatment applied. Full recovery.
Pt recvd vax 10Am fed & fell asleep @ usual naptime, w/in 30 mins of vax vomited x 1 approx 2 hrs later fell back to sleep; seen by MD very lethargic & dazed;
Mother reports entire upper arm swollen and red with itching. On PE: Red swollen area to lateral deltoid with warmth and mildly tender from x 4.
My son had sharp chest pain, difficulty breathing & lost consciousness briefly.; My son had sharp chest pain, difficulty breathing & lost consciousness briefly.; My son had sharp chest pain, difficulty breathing & lost consciousness briefly.; This is a spontaneous report from contactable consumer (parent). A 13-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 20May2021 13:30 (Lot Number: EW0179, at age of 13 years old) as single dose for COVID-19 immunisation. Medical history included asthma. Concomitant medications included cetirizine hydrochloride (ZYRTEC ALLERGY); montelukast sodium (SINGULAIR). The patient previously took azithromycin and experienced allergy. The patient experienced had sharp chest pain, difficulty breathing & lost consciousness briefly on 23May2021 11:30. The event result in Doctor or other healthcare professional office/clinic visit. Events were reported as non-serious. The patient received treatment for events and visit pediatrician & EKG. Had been referred to a cardiologist. The outcome of events was recovered in May2021.  Further information has been requested.
A non-serious report of administration of expired FLUMIST has been received from a nurse concerning a four-year-old female.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.  Neither medical history nor concomitant medications were provided.  The patient received FLUMIST on 17-Mar-2008.  The FLUMIST had expired on 10-Mar-2008.  The reporter stated that she received 100 doses of FLUMIST from the Vaccines for Children Program on 22-Feb-2008 and the vaccine expired on 10-Mar-2008.  The clinic did not realize the expiration date on the product and continued to give it from 11-Mar-2008 to 17-Mar-2008 to 26 patients.  No adverse events were reported.  The event has resolved.  It was not reported whether or not FLUMIST was re-administered.  The reporter provided no causality assessment for the event.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.  This case is linked to following 25 other cases reported from the same reporter: MEDI-0006660; MEDI-0006661; MEDI-0006662; MEDI-0006663; MEDI-0006664; MEDI-0006665; MEDI-0006666; MEDI-0006667; MEDI-0006668; MEDI-0006669; MEDI-0006670; MEDI-0006671; MEDI-0006672; MEDI-0006673; MEDI-0006674; MEDI-0006675; MEDI-0006676; MEDI-0006677; MEDI-0006678; MEDI-0006679; MEDI-0006680; MEDI-0006681; MEDI-0006682; MEDI-0006683; MEDI-0006659.