chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm was sore; Four months since first dose; Tenderness behind the knee; SVT behind the knee; Superficial venous thrombosis was aggravated; Leg swelling; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Tenderness behind the knee), THROMBOPHLEBITIS SUPERFICIAL (SVT behind the knee), CONDITION AGGRAVATED (Superficial venous thrombosis was aggravated), PERIPHERAL SWELLING (Leg swelling) and PAIN IN EXTREMITY (Arm was sore) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Superficial thrombosis of veins.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 15-Feb-2021, the patient experienced PERIPHERAL SWELLING (Leg swelling). On 17-Feb-2021, the patient experienced TENDERNESS (Tenderness behind the knee) and THROMBOPHLEBITIS SUPERFICIAL (SVT behind the knee). 17-Feb-2021, the patient experienced CONDITION AGGRAVATED (Superficial venous thrombosis was aggravated). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm was sore) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Four months since first dose). On 20-Feb-2021, PERIPHERAL SWELLING (Leg swelling) had resolved. At the time of the report, TENDERNESS (Tenderness behind the knee), THROMBOPHLEBITIS SUPERFICIAL (SVT behind the knee) and CONDITION AGGRAVATED (Superficial venous thrombosis was aggravated) outcome was unknown and PAIN IN EXTREMITY (Arm was sore) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Four months since first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment medication was reported. The patient reported that she thinks the superficial venous thrombosis was aggravated after receiving her first dose.       Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Reporter contact details were updated, patient demographic details were updated, vaccine facility details were updated and new events were added.
11/30 - within 2 hours of injection  - start of shortness of breadth, left side chest pain intermittent, body aches then progressive development of following other symptoms. After 24 hours developed rigors for about 8 hours. Within 24 hours diaphoresis (drenched pillows), sinus congestion, excessive mucus production, harsh cough, non-productive cough, a-febrile, brain fog, vision distortion, headache, swallowing difficulty, gastro-intestinal disturbances,  diarrhea, vomiting, abdominal aches/cramping, right hip pain, right knee pain, general joint pains, nearly all of these symptoms have been continuing since. Lack of libido. Body aches slowly subsided after 30 days.
pt recv vax 23SEP96 & 24hr p/vax pt devel itching rash;pt was seen by MD 26SEP96;@ that time the rash was on abd;pt was seen by MD on 1OCT96;pt could not sleep @ noc d/t itching;tx depo medrol, zantac & atarax;
This case was reported by a physician via call center representative and described the occurrence of shingles in a 73-year-old male patient who received SHINGRIX for prophylaxis. On 3rd May 2018, the patient received the 1st dose of SHINGRIX. On 9th July 2018, 67 days after receiving SHINGRIX, the patient experienced shingles, painful rash and itchy rash. On an unknown date, the patient experienced post herpetic neuralgia. On an unknown date, the outcome of the shingles, post herpetic neuralgia, painful rash and itchy rash were not recovered/not resolved. It was unknown if the reporter considered the shingles, post herpetic neuralgia, painful rash and itchy rash to be related to SHINGRIX. Additional details were provided as follows: The field-based GlaxoSmithKline sales representative, heard this case from a physician and nurse at a practice. The patient developed rash on midsection of body and was seen at an urgent care on 16th July 2018 and was diagnosed with shingles. On 29th August 2018, the patient was seen in the reporters office and still itching and pain with the rash and it was suspected that, the patient might have post herpetic neuralgia as well. Less than a year after receiving SHINGRIX, the patient experienced post herpetic neuralgia.
Patient came into the emergency department on 1/8/21 with an acute ischemic stroke with complete occlusion of her left MCA. She had acute and complete flaccid paresis of her right face, arm, and leg, complete aphasia, and neglect of the right side of her body. NIHSS of 27. Onset of deficit was between 6:30pm-7:10pm. She recieved her 1st COVID-19 vaccine dose that morning at 10:31am.
SEVERE FLU LIKE SIDE EFFECTS; JOINT PAIN; HEADACHE; HIGH FEVER; 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 not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. As per procedure no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced severe flu like side effects, joint pain, headache, and high fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe flu like side effects, joint pain, headache, and high fever. This report was non-serious.
Severe menstrual cramping. Treated with 800mg Naproxen and rest. Pain lasted two hours.
This case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a 94-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2021-2022 season) (batch number ZD3NZ, expiry date 30th June 2022) for prophylaxis.  Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis. On 1st December 2021, the patient received FluLaval Quadrivalent 2021-2022 season (intravenous) and Flulaval Tetra Pre-Filled Syringe Device. On 1st December 2021, unknown after receiving FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route 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 details were provided as follows: The patient received  FluLaval Quadrivalent via Intravenous route, which led to intramuscular formulation administered by other route. The reporter consented to follow up.
3- 4 minutes after injection I had tingling in my lips and a strange numb sort of feeling in my face, and then some "rubbery" weakness in my arms and legs. Treated in an ambulance at vaccine site with IV Benadryl, had some skin tingling, also given IV solumedrol and observed for almost 2 hours with no other symptoms. I was also hypertensive, probably due to anxiety.
headaches, some strong ones; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of HEADACHE (headaches, some strong ones) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ATORVASTATIN CALCIUM, EZETIMIBE (STATIN EZ) for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headaches, some strong ones). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at a dose of UNK dosage form. At the time of the report, HEADACHE (headaches, some strong ones) had not resolved.        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.
My tongue went numb, my left arm went numb, my throat tightened up, my blood pressure and heart rate went way up, I had a hard time swallowing, dry mouth, tight chest
Patient did not inform us that they had already received 2 previous doses. When we checked in vaccine registry, it did not indicate any previous doses administered. Upon rejection from insurance, we were made aware by the insurance that another pharmacy had administered 1 previous dose, but not recorded it in the vaccine registry. Therefore, patient received 3 total doses of Shingrix.
Constant ringing and buzzing in ears.  Also some loud sounds.  Also right eye and side of face feeling numb. Never had this before.
RASH, ITCH, NO PAIN ON HIS WAIST AND THIGH. LOOKS SIMILAR TO SHINGLES BUT NO BLISTERS.
Child complained of itchiness, especially around the neck. Thurs-Sun -- just applied lotion (Aveeno baby lotion) after showering in the evening. On Monday morning (6/27) around 8AM, child complained of extreme itchiness and asked for me to take pictures. Her neck/check area was very red as well as the back of the neck up to the hairline. I applied 2.5% hydrocortisone ointment after this time.  Child also complained of a headache on Sunday afternoon (probably around 2PM through 5PM or so).
Info regarding Prevnar injection was received from a healthcare professional regarding a 2 month old pt who experienced diffused redness from head to toe, cherry red in color and blotchiness on face and scalp. The pt received a dose on an unspecified date. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose. Concomitant medications were not reported. Event Details: The pt experienced diffuse redness from head to toe, cherry red in color two to three minutes after the administration of the Prevnar vaccine. The redness started to fade away within five minutes. However, the baby was still blotchy on face and scalp (rash Macular) for an unknown period of time. No additional info was available at the time of this report.
Patient traveled to another country on 12/1/11.  Following day, began bleeding from his nose and coughing up blood.  Found to have low platelets and profound coagulopathy.  Subsequently has developed respiratory failure and acute renal failure requiring peritoneal dialysis.  No infectious or other etiology identified to date.
Employee reports rash to torso running up to neck / chin, severe genralized body aches, fever, chills, headach.  Was unable to function due to reaction for 24hours.  Said all resolved. Did not seek treatment.  Adivsed by Emp Health to not receive 2nd vaccine unless consults with MD for clearance.
powder vials unmatched adjuvant diluents; Adjuvant only administered; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional Information: GSK Receipt Date: 28-Jun-2022 Reporter's Comments: The pharmacist reported that they found in their stock three Shingrix powder vials unmatched with adjuvant diluents. The patient might had received the diluent only. The reporter gave consent to follow up. Additional supportive Information: The patient might had received the diluent only which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This is one of 3 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR099690:Same reporter, Patient 2 US-GLAXOSMITHKLINE-US2022099168:Same Reporter, Patient 1
Patient reported achy all over for 2 days, extreme soreness/redness and a knot at site for 6 days.  Symptoms now reported as resolved
Aches; Sore arm; Chills; Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Aches), EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy), MYALGIA (Sore arm) and CHILLS (Chills) in a 36-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 022M20A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (No complications and live, full-term birth.) on 28-Feb-2018. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 27-May-2020 and the estimated date of delivery was 03-Mar-2021. On 16-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On 13-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Aches), MYALGIA (Sore arm) and CHILLS (Chills). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-third week of the pregnancy. The delivery occurred  on 28-Feb-2018, which was reported as Full-term. For neonate 1, The outcome was reported as Delivered NOS. Live, full-term birth. The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 13-Feb-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. At the time of the report, PAIN IN EXTREMITY (Aches), MYALGIA (Sore arm) and CHILLS (Chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Glucose tolerance test: normal (normal) normal. On an unknown date, Ultrasound scan: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-018518 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Feb-2021: Internal review conducted on 23-Jul-2021 resulted in updates to pregnancy information.
UNABLE TO URINATE; CONSTIPATION; LOW GRADE FEVER; This spontaneous report received from a patient 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, intramuscular, batch number was not reported) dose was not reported, administered on 14-MAR-2021 19:30 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. patient had compliant of low grade fever, unable to urinate, and constipated after receiving the Janssen Covid-19 vaccine on 3/14/21 @ 7:30pm The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the low grade fever, constipation and unable to urinate was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20210329454  -COVID-19 VACCINE AD26.COV2.S-unable to urinate. This event is considered unassessable. The event 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.
FEELING WEAK; This spontaneous report received from a patient concerned a 68 year old male. 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) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date in AUG-2021, patient felt good but was hospitalized for feeling week. Patient mentioned that hospitalization was after receiving vaccine and it was due to being out in the sun. The number of days hospitalized was unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of feeling weak was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210915360-Covid-19 vaccine ad26.cov2.s-Feeling weak. This event(s) is labeled per RSI and is therefore considered potentially related.
Had MMR #2 8/2/16. Developed welt of site with redness, induration peeling 8/2/16. Today 8/4/16 had headache, photophobia, increased redness and blisters at site and pain and swelling of L knee and ankle, improving with ibuprofen, TYLENOL. Much improved.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 68-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (Received on an unknown date). On 17th December 2018, the patient received the 1st dose of SHINGRIX. On 17th December 2018, several hours after receiving SHINGRIX, the patient experienced pain in arm, feeling unwell, feels awful, influenza like illness, headache and numbness in hand. On an unknown date, the outcome of the pain in arm, feeling unwell and feels awful were not recovered/not resolved and the outcome of the influenza like illness, headache and numbness in hand were unknown. It was unknown if the reporter considered the pain in arm, feeling unwell, feels awful, influenza like illness, headache and numbness in hand to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm at afternoon 2:00- 2:30 hours and by the evening she started feeling awful. It was felt like she had flu and arm became very painful. She did not have fever but did have a headache. Her wrist and hand felt little numb. Batch number was not provided. The reporter denied permission for follow up.
Sick; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A male patient received BNT162b2 (BNT162B2 NOS), 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: ILLNESS (non-serious), outcome "unknown", described as "Sick".  Additional information: Caller was medical assistant called regarding the Comirnaty Covid-19 Vaccine that was administered to his family and then his brother died, and he also mentioned (Name withheld) died as well after the vaccination; also, his uncle and other family members were sick as well. Caller was the only one who didn't receive the vaccination. Customer and/or medical inquiry was not forwarded or referred.  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-PV202300031634 same reporter/drug, different patient/event.;US-PFIZER INC-PV202300031636 same reporter/drug, different patient/event.;US-PFIZER INC-PV202300031963 same reporter/drug, different patient/event.;
I had a headache, discomfort in arm and rash started the same day as vaccination. Two courses of one week prednisone for rash and swelling in feet. Symptoms better when taking prednisone but when I stop it is terrible. Went to the ER due to left foot swollen: ultrasound, CT scan head nothing. Advised to try support panty hose for relief but no relief. All test done by primary doctor are good.
Weak in the knees / knees gave out; Knees ache; would never get the second dose; Sore all over; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of lower extremities weakness of in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, several hours after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced lower extremities weakness of (Verbatim: Weak in the knees / knees gave out), knee pain (Verbatim: Knees ache), general body pain (Verbatim: Sore all over) and incomplete course of vaccination (Verbatim: would never get the second dose). The outcome of the lower extremities weakness of and knee pain were not reported and the outcome of the general body pain was resolved (duration 2 weeks) and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the lower extremities weakness of, knee pain and general body pain to be related to Shingles vaccine.     It was unknown if the company considered the lower extremities weakness of, knee pain and general body pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by a patient via interactive digital media. The reporter reported that the patient received first dose received and never receive the second dose. The patient stated that after received Shingles vaccine within a few hours he or she experienced his or her knees gave out and now his or her knee aches all the time. The patient regret of getting the vaccine. The patient stated that he or she received Shingles vaccine and he or she would not recommend to anyone to receive the vaccine and it made him or her weak in the knees and sore all over for 2 weeks. Follow-up would not possible as no contact details were available. Till the time of reporting, the patient did not receive the 2nd dose of Shingles vaccine, which led to incomplete course of vaccination.
Sore arm with mild pain after getting SHINGRIX that lasted for 24 hours. General minor muscle pain, a mild headache, mild shivering, slight nausea w/ loss of appetite.
pharmacist accidently administered MODERNA COVID 19 vaccine to patient 16 years old.
muscle and joint pain, body aches, fever 101.6 F, severe chills, sore arm at injection site