chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Lump at injection site; Redness at injection site; Rash at injection site; Soreness in her arm after the injection; This spontaneous case was reported by a consumer and describes the occurrence of   in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator No treatment medications provided by the reporter.
Right deltoid given Varivax -redness and stiffness measured 4 X 3 1/4 Left forearm given PPD -reaction measured 4 3/4 x 3 1/4-itchy pain and big blisters in center Pt was given Ceftin x 8days & diprolene Lotion BID
Was called to patient observation area, pt slide out of chair to floor stated she felt light headed and was going to pass out. Pt commented that she was fasting.  Vital signs obtained, pt was hypotensive BP 65/52 P 63, R 16 pusle ox 98% RA.  Pt was transported by wheelchair to a private observation room and was seen by Dr. who encouraged pt to drink fluids and eat some crackers.  Pt was observed for another 30 min, vital signs at discharge BP 97/63 P 71  R18 pulse oximetry 100%.  Pt stated that she was no longer light headed.
MD believes that the bursa was hit during vaccination.  The patient has been complaining for several weeks of severe pain.  She now is attending physical therapy.  If that does not improve after 2 weeks, then the doctor wants an MRI to see if the rotator cuff was damaged.  Doctor is afraid that she will end up with a frozen shoulder.
2 weeks after Flu shot I had, fever, stomach pain, joint ache and found out I had shingles. Took Prednisone and corticosteroids prescription. After 2 1/2 months still have burning pain on left body.
Abdominal pain; Groin pain; Tingling in left forearm, thumb; Don't feel normal anymore/feels like someone has crushed the bones in the tops of feet; Bothered to walk; Motor dysfunction NOS; Extremely fatigued; Arthritic pain in tops of feet; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Oct-2021 and was forwarded to Moderna on 04-Oct-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (Abdominal pain), GROIN PAIN (Groin pain), PARAESTHESIA (Tingling in left forearm, thumb), FEELING ABNORMAL (Don't feel normal anymore/feels like someone has crushed the bones in the tops of feet) and GAIT DISTURBANCE (Bothered to walk) in a female 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN (Abdominal pain), GROIN PAIN (Groin pain), PARAESTHESIA (Tingling in left forearm, thumb), FEELING ABNORMAL (Don't feel normal anymore/feels like someone has crushed the bones in the tops of feet), GAIT DISTURBANCE (Bothered to walk), MOTOR DYSFUNCTION (Motor dysfunction NOS), FATIGUE (Extremely fatigued) and ARTHRALGIA (Arthritic pain in tops of feet). At the time of the report, ABDOMINAL PAIN (Abdominal pain), GROIN PAIN (Groin pain), PARAESTHESIA (Tingling in left forearm, thumb), FEELING ABNORMAL (Don't feel normal anymore/feels like someone has crushed the bones in the tops of feet), GAIT DISTURBANCE (Bothered to walk), MOTOR DYSFUNCTION (Motor dysfunction NOS), FATIGUE (Extremely fatigued) and ARTHRALGIA (Arthritic pain in tops of feet) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment details were reported.   This case was linked to MOD-2021-266628 (Patient Link).
Swollen arm; Fever; Chills; Swollen lymph nodes (neck and back of head); Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm), PYREXIA (Fever), CHILLS (Chills), LYMPHADENOPATHY (Swollen lymph nodes (neck and back of head)) and MYALGIA (Body aches) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm), PYREXIA (Fever), CHILLS (Chills), LYMPHADENOPATHY (Swollen lymph nodes (neck and back of head)) and MYALGIA (Body aches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 27-Jan-2021, PERIPHERAL SWELLING (Swollen arm), PYREXIA (Fever), CHILLS (Chills) and LYMPHADENOPATHY (Swollen lymph nodes (neck and back of head)) had resolved. On 28-Jan-2021, MYALGIA (Body aches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jan-2021, Body temperature: 100.5 (Inconclusive) 100.5.         No relevant concomitant medications were reported. Action taken with mRNA-1273 in response to the events was not applicable.
The patient was given the wrong Moderna vaccine due to package similarity, wording discrepancies, and staff not knowing which color was what.
Client received one vaccine Vaqta IM Left deltoid, felt nauseated immediately after vaccine was given, (9:10 AM BP 50/0 radial pulse undetectable, able to hear, 9:15 AM BP 88/0, 9:20 AM BP 102/52, transferred to a reclining chair with legs elevated, legs and arms felt like cement. 911 called and EMS arrived and Blood glucose: 116.  Refused to go to hospital. 10:00 AM head elevated and able to drink juice, eat a banana and crackers. Client said right side of throat hurt while drinking juice.  10:15AM arms and legs felt cold. Husband arrived 10:10 AM and 10:30 AM client able to sit up, stand, walk, left walking with husband to go home.
hives disappeared after he took Pfizer Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient. A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Unknown Manufacturer), for COVID-19 immunization; Bnt162b2 (Dose 2, before he is taking Zyrtec and Allegra for his hives), for COVID-19 immunization, reaction(s): "he experience turbel case of hives" The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "hives disappeared after he took Pfizer Booster". Additional Information: Verbatim and Event Description Describe the adverse experience (AE)/beneficial effect/at risk including all pertinent information: Caller (name withheld), Consumer mentioned he had something important to report, he took Pfizer injection and on the second dose he experience turbel case of hives and suffered 6 months but after he took Pfizer Booster his hives disappeared. It helps him to clear his skin and stop itching, before he is taking Zyrtec and Allegra for his hives. Caller wants to report it so if others have the same disease they can use it as a suggestion. No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Almost immediately after injection left arm began to hurt, tingling in left arm and hand. Continued for several hours and for the next few days, still slight tingling off and on to this date, but not quite as adverse as first few days.
COVID-19; High temperature; sinus congestion; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (COVID-19), PYREXIA (High temperature) and SINUS CONGESTION (sinus congestion) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 07f121A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Patient did not have any drug allergy.  The patient's past medical history included Overweight (BMI 28). Concurrent medical conditions included Asthma and Allergy. Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.   On 10-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (Oral) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (COVID-19), PYREXIA (High temperature) and SINUS CONGESTION (sinus congestion). At the time of the report, COVID-19 (COVID-19) was resolving and PYREXIA (High temperature) and SINUS CONGESTION (sinus congestion) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: up to 103 (High) up to 103.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment.  It was reported that seven days after completing paxlovid symptoms returned on 28-May-2022, temperature was up to 103, sinus congestion. The event did not require hospitalization. Patient was required to quarantine again and miss additional days of work. COMPANY COMMENT: This is an spontaneous case concerning a 34-year-old female patient with medical history of Overweight,  (BMI 28), Asthma and Allergy, Concomitant products included PARACETAMOL (TYLENOL), PAXLOVID) (oral) from 17-May-2022 to 21-May-2022 for COVID-19 treatment who experienced the unexpected event of COVID-19 (AESI), PYREXIA and SINUS CONGESTION unknown days after 3rd dose of  mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: COMPANY COMMENT: This is an spontaneous case concerning a 34-year-old female patient with medical history of Overweight,  (BMI 28), Asthma and Allergy, Concomitant products included PARACETAMOL (TYLENOL), PAXLOVID) (oral) from 17-May-2022 to 21-May-2022 for COVID-19 treatment who experienced the unexpected event of COVID-19 (AESI), PYREXIA and SINUS CONGESTION unknown days after 3rd dose of  mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
administered expired dose pregnant female patient; administered expired dose of FluLaval QIV; This non-serious prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 35-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number CA52L, expiry date 30-JUN-2023) for prophylaxis.   Concurrent medical conditions included pregnancy.   On 25-SEP-2023, the patient received FluLaval Quadrivalent 2022-2023 season. On 25-SEP-2023, an unknown time after receiving FluLaval Quadrivalent 2022-2023 season, the patient experienced expired vaccine used (Verbatim: administered expired dose of FluLaval QIV). On an unknown date, the patient experienced exposure during pregnancy (Verbatim: administered expired dose pregnant female patient).  The outcome of the expired vaccine used and exposure during pregnancy were unknown.   Pregnancy exposure: Pregnancy Exposure (FluLaval Quadrivalent 2022-2023 season): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2023131803   Additional Information: GSK Receipt Date: 25-SEP-2023 The Obstetrics and Gynecology Office Supervisor reported to a Medical Assistant that expired dose of FluLaval QIV was administered to pregnant female patient which led to expired vaccine used and exposure during pregnancy. The reporter consented to follow up. The vaccine administration facility is the same as primary reporter. The reporter gave permission for follow up. This case is linked with US2023131803, same reporter.; Sender's Comments:  US-GSK-US2023131803:Same reporter, different patient
COVID-19; This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine ad26. cov2. s (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) 1 total, dose, start therapy date were not reported for prophylactic vaccination. On an unspecified date the patient had Covid-19 (Dose number in series 1). The outcome of Covid-19 was not reported. The patient received booster dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date the patient had Covid-19 (Dose number in series 2) and patient further stated that the patient did not believe the shots were ready to be used. It was reported "I have had COVID twice with all the shots. I don't believe the shots are ready to be used". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 was not reported. This report was non-serious. This report was associated with product quality complaint: 90000217340. The suspected product quality complaint has been confirmed to be voided (this report indicates medical adverse events for the patient, there was no product quality issue described in the information reported.) based on the PQC evaluation/investigation performed. This case, involving the same patient is linked to 20220231689.
Pt called call center on 4/28/21 . Pt got his 1st dose Pfizer vaccine on 4/25/21 at site. Pt states he has chest pain when breathing and some trouble breathing this morning and body ache. Advised pt to go to ED immediately and pt verbalized understanding to go to ED for evaluation.
tiredness, cold like symptoms, headache, fever blisters developed on upper lip and under nostrils
06/29/22 presents to hospital for "fall". PMHx of "HTN, high hypothyroidism, cerebral aneurysm, and GERD".
Information has been received from a 31 year old female nurse practitioner with chronic asthma and latex allergy who on 10/24/06 was vaccinated with a dose of Pneumococcal 23v polysaccharide vaccine (lot 651318/1006P) (0.5ml), IM. Concomitant therapy that day included influenza virus vaccine (unspecified), at a different site. Subsequently, about two hours post vaccination, the pt developed local reactions at the injection site. The reactions included erythema, induration and cellulitis. She stated that she was also short of breath and required additional asthma medication. At the time of the report, the pt was recovering. The reporter considered her experience to be an other medical event (OMIC). Additional information has been requested.
Patient developed superficial venous thrombosis on palmar aspect of left middle finger. This was noticed today and patient was very upset and anxious, requesting an urgent review. This is highly unusual and patient has now been referred to see a vascular surgeon, for further assessment and treatment
Symptoms: headache, fever, sore throat, arm soreness, 3/30/2021 vomiting x2 Treatment: Tylenol 1000mg Outcome: Symptoms continued following Tylenol.
Rash, welts and hives lasted 5 days. Soreness in eye and forehead.
I have had the shot and still got shingles 3 times/Suspected vaccination failure; still got shingles 3 times; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I have had the shot and still got shingles 3 times/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still got shingles 3 times).The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 08-MAR-2023 This case was reported by a patient via interactive digital media. The patient had the shingles shot and still got shingles three times. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Left shoulder became increasingly painful.  By morning of 10/16, my left shoulder was immobilized, excruciating pain, could not move/lift left arm.  Pain radiates into back scapula/shoulder.
The patient said her arm is still sore after 5 days and she cannot lift it. She has been taking Tylenol to relieve pain.
woke up @ 130PM 9OCT98 walked to bathroom then collapsed on floor came to moments later arm swollen-shoulder to elbow, warm, bright red did not call 911 or MD no problems since;
I was having a scratchy throat and a runny nose, and I did take a COVID-19 Home Test and it was negative. I had been in another city for an event over the weekend and heard people at the event had been testing positive. I went and got a PCR test, and it was positive. I had a very bad stuffy nose, and I was congested. When I did go on they put me on Paxlovid and that did help at first and I got better but after being off of that for a few days and that is when the sinus issues got way worse. It was similar to a bad sinus infection, but I was COVID positive.
Vaccine administered at 1816. Patient walked to the observation area and while in the observation area, got up to use the restroom.  Patient exited the restroom and said she needed assistance.  She indicated to the observation nurse that "this ain't good" or "this ain't right".  Patient reported seeing spots and having chest pain.  The time was approximately 1830.  She was assisted to the floor.  Help was summoned and 911 called at approximately 1834. Upon being lowered to the floor patient was breathing, she was not cyanotic, her eyes were open and she was not responsive.  The patient had a pulse.  Sometime after 1830, but before 1835, the patient was observed to have seizure like activity as bilateral
Admitted for COVID pna. Fully vaccinated. Diagnosed PTA, condition declined at home. Treated with steroids, O2, zinc, doxy. Improved and was discharged home on oral steroids and 2L O2.
left side of body felt like it fell asleep it was numb, left side was in pain from jaw down, whole left side felt like it was  not connected  to her body
Redness at injection site, leg was sore, temperature was 100.1, red rash/ bumps all over face and body
After patient had the shot did not want to wait 10 minutes but decided to go shopping. After leaving the pharmacy became lightheaded and fell. Had a cut on back of his head. Did vomit a little but did not want to us to call 911.
Patient reported lightheadedness, numbness of both cheeks and lips. Lightheadedness resolved after oral hydration.
the patient was sent into kidney failure; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RENAL FAILURE (medically significant), outcome "unknown", described as "the patient was sent into kidney failure". Clinical course: Patient details were not disclosed and description of event was reported as, wouldn't disclose except for stating that the patient was sent into kidney failure. Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
1 hour after the vaccine, patient became disconnected.  His speech was unintelligible and words didn't make sense to the situation.  His behavior was erratic and beyond wild for his age.  In the morning after the vaccine patient had a tonic clonic seizure that led into a nonconvulsive seizure. this lasted approximately 4-5 minutes
Patient presented to doctor's office and reported: "Started with left upper arm pain, erythema, and swelling. The next day she had a fever. Two days later, the erythema resolved but the shoulder began to throb with a sharp stabbing pains when she would move her arm. Now having significant neck muscle tenderness. The pain is now making her nauseous because it is down to her fingers. She has not been able to use that arm due to the pain. She has been icing it on and off, which does help to reduce the swelling. Denies any current fever. Reports pain 5/10." She called clinic again on 6/10/2021, note states: "She states she was told to call back if symptoms did not go away, and she is still experiencing 6-10/10 throbbing/aching/sharp pains from shoulder to wrist on left side. States the swelling and redness have gone down and the Flexeril/Tylenol/Ibuprofen help some, but the pain is still excruciating. Ultrasound on 6/17/21 should no evidence of blood clot. She declines appointment." She was treated for left shoulder impingement syndrome on 7/22/2021 .
This spontaneous report was received from a Licensed Practical Nurse referring to a 74 year old male patient. The patient's concurrent conditions and medical history were not reported. On 03-NOV-2016, the patient received a dose of GARDASIL 9 lot # M009116; expiration date 13-JUN-2018 (dose, route and anatomical location were not reported) in error (interchange of vaccine products). The patient was indicated to receive PNEUMOVAX 23. The nurse did not know why the error occurred. No adverse effects have been reported. No additional information was provided. Product Quality Complained was not involved. Additional information has been requested.
Patient developed a local reaction at injection site on 10/10/23. Presented with red, swollen  and warm area about the size of a quarter. She also stated some other red spots were popping up along her chest and she was developing some chest congestion. Advised patient to take Benadryl and seek urgent medical attention if condition worsened or any symptoms of breathing difficulty arose.