chrisvoncsefalvay/vaers-outcomes huggingface dataset:
MISSED THE SECOND DOSE; A spontaneous case report was received from a caregiver on 17-Jun-2019 for four consumers.  Based on the information obtained from the caregiver, four individual case safety reports PVX201906-000505 (PVX2019-1565; 14-year-old male consumer), PVX201906-000506 (PVX2019-1566, 10-year-old female consumer), PVX201906-000507 (PVX2019-1567; 13-year-old female consumer), and PVX201906-000508 (PVX2019-1568; 16-year-old female consumer) were created and cross-linked in the database.  This case describes a 13-year-old adolescent male consumer who "missed the second dose", while being on oral Vivotif (one capsule every other day) (lot number: 3003277) for typhoid prophylaxis.  Case report: The consumer took the first dose of Vivotif on 14-Jun-2019 and missed to take the second dose which was due on 16-Jun-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "missed the second dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed the second dose" was considered as not applicable. US-PaxVax Berna GmbH-PVX201906-000505:
Information has been received from a registered nurse referring to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates, these patients were vaccinated with improperly stored doses of MMR II (lot # L012479, expiration date 10-APR-2017; lot# L019989, expiration date 01-JUN-2017; dose and route were not reported; temperature: 52 F, time frame: 2 hours). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
itchy, red, scaley rash appeared on on entire area of wrist of left arm (vaccination arm) the evening after recieving vaccine. Patient covered area with cortisone cream and took zyrtec 10mg. It appears to be decreasing in redness every day and get less itchy every day with cortisone use
Hard time catching her breath; Very rapid heart beat; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Hard time catching her breath) and HEART RATE INCREASED (Very rapid heart beat) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Tachycardia.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jun-2021, the patient experienced DYSPNOEA (Hard time catching her breath) (seriousness criterion hospitalization). 12-Jun-2021, the patient experienced HEART RATE INCREASED (Very rapid heart beat) (seriousness criterion hospitalization). At the time of the report, DYSPNOEA (Hard time catching her breath) and HEART RATE INCREASED (Very rapid heart beat) outcome was unknown.            No concomitant medication provided. No treatment information mentioned.  The patient received her first dose of Moderna Covid-19 vaccine around three weeks prior from her  second dose. The patient went to the emergency room where some test were performed and everything was normal.  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.; 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.
Pt waiting his 15 minutes, cam to the counter asking for a water because patient was filling light headed. Patient fainted, with seconds patient was awake and knew where he was. he was clammy and  in the face. Gave patient a water, he immediately felt better.
This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender who on 25-JUN-2015 the patient was vaccinated with a dose of GARDASIL (lot # K006960)(route and dose were not provided) that was exposed to temperatures outside of the recommended range during 63 hours excursion. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
4 hrs p/vax pt exp runny nose, scratchey throat & devel joint pain 21DEC, t99.4 this AM otherwise not aware of inc temp;
September 28: Presented with pain, redness, and swelling at injection site; body aches started that afternoon; slight fever (99.4); shortness of breath (used rescue inhaler once at work and later on that evening) September 29: Presented with pain, redness, and swelling at injection site; body aches; slight fever (99.6) that resolved by that afternoon; increased shortness of breath (used rescue inhaler multiple times that day at least 5 times); that evening difficulty speaking at times (straining to get words out/neck muscles started to contract when speaking)  September 30: Presented with pain, redness, and swelling at injection site; body aches; no fever; increased shortness of breath; continue difficulty speaking September 30: Went to urgent care and was seen at 7:45 am  due to increased shortness of breath and was prescribed Flovent HFA 110 mcg  October 1-2: Continued symptoms as day prior October 3: Increased shortness of breath and difficulty speaking; only redness at injection site October 4: Returned to urgent care around 4pm due to shortness of breath and difficulty speaking; given triamcinolone acetonide injection and prescribed prednisone 50 mg  and instructed to continue with Flovent October 5: shortness of breath is improving
Redness/swelling at immunization site, fever, chills, body aches, syncope, nausea
Warm, tender, red rash on left arm. Started 2" down from injection site and about 5" long and 3" wide.
15 min post vaccine patient (6 y.o) reported feeling dizzy, double vision. No diff. breathing, No itching, No hives Vitals all WNL
Fever, less energetic. About 5 days later developed acute onset of GTC seizures leading to coverage with multiple AEDs without response. Incubated. Met criteria for FIRES.
client received additional dose of Moderna after having received Janssen and then a 1st dose of Moderna
I have lost strength; have pain radiating from my right leg nonstop. It also goes completely straight not bending; have pain radiating from my right leg nonstop. It also goes completely straight not bending; I lose complete strength in it causing me to fall over.; booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 24Aug2021 (Lot number: ew0198) at the age of 24 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: Pollen" (unspecified if ongoing); "Known allergies: sutures" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Adderall, reaction(s): "Known allergies: Adderall"; Ritalin, reaction(s): "Known allergies: Ritalin". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ew0186, Location of injection: Arm Right), administration date: 28May2021, when the patient was 24 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ew0164, Location of injection: Arm Right), administration date: 24Apr2021, when the patient was 24 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (disability) with onset 24Aug2021, outcome "unknown", described as "booster"; ASTHENIA (disability) with onset 25Aug2021, outcome "unknown", described as "I have lost strength"; PAIN (disability), LIMB DISCOMFORT (disability) all with onset 25Aug2021, outcome "unknown" and all described as "have pain radiating from my right leg nonstop. It also goes completely straight not bending"; FALL (disability) with onset 25Aug2021, outcome "unknown", described as "I lose complete strength in it causing me to fall over.". The events "booster", "i have lost strength", "have pain radiating from my right leg nonstop. it also goes completely straight not bending", "have pain radiating from my right leg nonstop. it also goes completely straight not bending" and "i lose complete strength in it causing me to fall over." were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of immunisation, asthenia, pain, limb discomfort, fall and included treatment with medications (tried) and in physical therapy. Clinical course: There was no other vaccine in four weeks. Patient did not have covid tested post vaccination.
Arm extremely sore, malaise and fatigue, muscle aches -  X2 days
shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or about 27-MAR-2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose, dose number and route not specified) for long-term prevention of shingles and zoster-related conditions.  On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare provider for shingles. As a direct and proximate result of patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future.  The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
very strong cold; had a lot of cough; nose is congested; This is a spontaneous report from a contactable consumer. A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), dose 1 via an unspecified route of administration on 07May2021 (Lot number: unknown) as single dose for covid-19 immunisation. The patients medical history and concomitant medications were not reported. The patient felt more or less, she was due to get the second dose of Pfizer's COVID-19 vaccine on Friday 28May, but she had a cold, a strong cold, a very strong cold on an unspecified date. That day she couldn't go out, she had not received the vaccine, she was having a lot of cough and her nose was congested, she had asked question as could she get vaccinated with these symptoms. The outcome of the events was unknown.  Information about lot/batch number has been requested.
shoulder was quite sore; discomfort; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shoulder soreness in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Co-suspect products included influenza vaccine (Flu Vaccine (Name Unknown)) for prophylaxis.   In SEP-2023, the patient received RSV vaccine. On an unknown date, the patient started Flu Vaccine (Name Unknown). In SEP-2023, less than a week after receiving RSV vaccine, the patient experienced shoulder soreness (Verbatim: shoulder was quite sore) and discomfort (Verbatim: discomfort). The outcome of the shoulder soreness was resolving and the outcome of the discomfort was not resolved.   It was unknown if the reporter considered the shoulder soreness and discomfort to be related to RSV vaccine.     It was unknown if the company considered the shoulder soreness and discomfort to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 23-SEP-2023 The case was received from the patient via interactive digital media. The patient got RSV vaccination this week (reporting week) when he/she went to the pharmacy to get flu shot.  The patient stated the second night shoulder was quite sore. It seems to be getting better. The patient thought any discomfort would go away by the fifth day. It was unknown if the reporter considered the shoulder soreness and discomfort to be related to FLU vaccine.  The follow-up could not be possible as no contact details were available.
There is a large red circle around the injection site. The circle is about 3 inches in diameter as of 0700 hours, 6 May 2021. It is painful, itchy, hot to the touch, the pain extends past the red circle and keeps getting bigger. Full sharp pains throughout the entire body but not body aches. Other symptoms include dizziness, nauseousness, fatigue, and tiredness.
This case was reported by a healthcare professional and described the occurrence of injection arm reddened in a 83-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medications included Vit B12 shot given in the right arm at the same time as vaccination. On 18 October 2010 at 15:00 the subject received a dose of FLULAVAL (.5 cc, unknown route, left arm). On 19 October 2010, 1 day after vaccination with FLULAVAL, the subject experienced injection arm reddened to her elbow and warmness to touch at injection site. At the time of reporting the event of injection arm reddened was resolved and the outcome of the warmness to touch at injection site was unspecified. The healthcare professional considered the events were probably related to vaccination with FLULAVAL. Follow-up information was received on 23 November 2010. It was reported that the events began one day following administration of FLULAVAL on 19 October 2010. The events resolved by 26 October 2010. In the reporter's opinion, the events were probably related to treatment with FLULAVAL.
Patient develops rash on bilateral lower extremities and was seen at Dr.'s primary care office and prescribed hydroxyzine and prednisone.
Progressive fatigue with fall, decreased oral intake, AKI  supportive treatment, fluids, not COVID directed.
He has double vision; Weakness; Tiredness; Headache; He had problem with lymph nodes; doesn't feel good; This is a spontaneous report from a contactable consumer (patient's wife). An 86-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6207), via an unspecified route of administration administered in left shoulder on an unspecified date (at the age of 86-year-old) at SINGLE DOSE for COVID-19 immunisation. Medical history included blood pressure abnormal and blood cholesterol abnormal. Concomitant medication included lisinopril taken for blood pressure. On an unspecified date, the patient experienced he has double vision, weakness, tiredness, headache, and he had problem with lymph nodes. The reporter further stated, "Now I realize that was Wednesday, now this Wednesday afternoon it will be a week do these symptoms last these long normally I am calling because I mean he is not ready for the hospital or anything like that but he just doesn't feel good." The reporter also mentioned that the patient has no fever. The patient was afraid to get the second shot. They are scheduled for the second dose of vaccine on 06Apr2021. There was no treatment received for all events. The patient was recovering from all events.
Feeling really bad with flu-like symptoms; Felt like glands were swollen; Tenderness in throat; Tenderness in neck; Very painful when the vaccine was going into arm; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 9th September 2019, immediately after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the patient experienced influenza-like symptoms, swollen glands, throat discomfort and neck pain. On an unknown date, the outcome of the injection site pain, influenza-like symptoms, swollen glands, throat discomfort and neck pain were recovering/resolving.   It was unknown if the reporter considered the injection site pain, influenza-like symptoms, swollen glands, throat discomfort and neck pain to be related to Shingrix.  Additional details were received as follows: The patient stated that after vaccination She described that it was very painful when the vaccine was going into her arm. The patient said she experienced 72 hours of feeling really bad with flu-like symptoms.   The patient felt like her glands were swollen and had tenderness in her throat and neck. These symptoms started to taper after three days, however, she did not feel back to normal until approximately 10 days later. This case has been linked to US2019AMR204588, reported by the same reporter.
After 1st vaccine on 1st day I had migraine; After 1st vaccine on 1st day I had migraine; This is a spontaneous report received from contactable reporter (other healthcare professional). The reporter is the patient.  A 64 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 24Mar2021 13:30 (Lot number: ER8733) at the age of 64 years as dose 1, single for covid-19 immunization. Relevant medical history included: "Brown- Sequard ( cervical myelopathy)" (unspecified if ongoing); "CVID" (unspecified if ongoing); "Migraine" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "CRPS" (unspecified if ongoing); "IC" (unspecified if ongoing); "Allergies:Cipro, Macrobid, Supra, Tetracycline" (unspecified if ongoing); "Allergies:Reglan" (unspecified if ongoing); "Flu Vaccine" (unspecified if ongoing); "Allergies:Sulfa" (unspecified if ongoing); "Allergies:IVIG" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; CYTOMEL; NEURONTIN; LYRICA; MET 500. The following information was reported: MIGRAINE (non-serious), DISEASE RECURRENCE (non-serious) all with onset 24Mar2021, outcome "unknown" and all described as "After 1st vaccine on 1st day I had migraine". Therapeutic measures were not taken as a result of migraine, disease recurrence.  Additional information: The patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.  No follow-up attempts are possible. No further information is expected.
No other AE occurred; An expired dose was administered to a patient; This spontaneous report has been received from a registered nurse, concerning a patient of unknown age and gender.  The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On 24-OCT-2022, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 1 dose (lot number 1742417 has been verified to be valid for rotavirus vaccine, live, oral, pentavalent (ROTATEQ), expiration date reported and validated as 14-OCT-2022) administered orally as prophylaxis (exact dose was not provided) (Expired product administered).  No other adverse event (AE) occurred and the vaccine did not experience any temperature excursions.
Pt was feeling light headed/dizzy 10 min after receiving vaccine. Patient was laid in supine position and BP was monitored Q5 min for 30 min. W/I patient's normal reported range. She did not lose consciousness and did not fall. After 30 min, patient sat up and felt much better. Sat an additional 15 min and felt fine and declined further treatment.
Got extremely cold day after.  On Saturday 4/3 I woke up and mouth was numb.  As morning went on I went to Urgent care and they diagnosed me as having Bell's Palsy.  Followed up with my personal doctor and she said it was from the Covid shot
Extreme Uncontrollable Itching all over body; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Extreme Uncontrollable Itching all over body) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: MORPHINE (The patient has similar reaction (itching) to the morphine in the past). Concomitant products included CLONAZEPAM, ZOLPIDEM, AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL), ATORVASTATIN CALCIUM (LIPITOR), MONTELUKAST SODIUM (SINGULAIR), DOXEPIN, ESCITALOPRAM OXALATE (LEXAPRO), TOPIRAMATE and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced PRURITUS (Extreme Uncontrollable Itching all over body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itching, at an unspecified dose and frequency. On 28-Mar-2021, PRURITUS (Extreme Uncontrollable Itching all over body) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Muscle Relaxant was used as concomitant medication
Patient had painful, large, red swollen left arm and flu like symptoms with fever ( 101 degrees F at one point) for 3 weeks. Afterwards, pt made full recovery.
Patient stated he almost fainted and felt dizzy. After sitting for 20 minutes and drinking some water under supervision he felt better.  Called 2 hours after event and 4 hours after event, and patient stated he felt fine.
This spontaneous report as received via a company representative from a physician refers to a patient of unknown age and gender with no reported medical history. On an unknown date the patient (at age of 1 year) was vaccinated with VAQTA, dose 1, 25 U/0.5 ml (route unknown). On an unknown date the patient (now at age of 15 months) was vaccinated with VAQTA dose 2, 25 U/0.5 ml (route unknown). No other suspect therapy or concomitant medication was reported. On an unknown date the patient experienced received first dose of VAQTA at the one year of age and the second dose at the 15 month of age (medication error). No adverse effect was reported. Additional information has been requested.
UrticariaPruritus Fatigue, Sore and tender at injection site, Left axilla tenderness Narrative:    Other Relevant History:
Arthralgia, Fever, Diarrhea, chills, low grade fever Narrative:
her sister got COVID several times, and her niece, nephew, etc; her sister got COVID several times, and her niece, nephew, etc; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "her sister got COVID several times, and her niece, nephew, etc".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.