chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Got shingles shot, got shingles/Suspected vaccination failure; Shingles; Covid; Pain; This serious case was reported by a consumer via media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine and COVID 19 VACCINE. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got shingles shot, got shingles/Suspected vaccination failure) (serious criteria medically significant), shingles (Verbatim: Shingles), covid-19 (Verbatim: Covid) and pain (Verbatim: Pain). The patient was treated with salonpas (nos) (Salonpas). The outcome of the vaccination failure and covid-19 were not reported and the outcome of the shingles was not recovered/not resolved and the outcome of the pain was recovering/resolving.   The reporter considered the vaccination failure, shingles, covid-19 and pain to be possibly related to Shingles vaccine.     The company considered the vaccination failure, shingles, covid-19 and pain to be possibly related to Shingles vaccine.   Additional Information: Receipt Date: 05-MAR-2023 This case was reported by a patient via media. The reporter reported that his/her relative received Covid 19 vaccine and Shingles vaccine. The reporter stated that dollars were wasted on Shingles vaccine. The patient experienced shingles than a year later Covid. The patient received Salonpas patches for pain. He was surprised to find that it had helped him. The reporter think that the event might have been related to the Product/Device. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Since administering vaccination 04/24/2018, pt has been experiencing soreness in muscle. Denies any fever, redness, warmth at injection site, or bruising.
After receiving the fourth dose of Pfizer I started having brain fog, fatigue, chills and the next day I had all over body, joint, and muscle pain. I had Costochondritis, and I was given methocarbamol for the prior doses so I just used these medications to treat the pain. This event lasted for 2.5 days in total.
patient has been exposed to COVID-19 infection before getting their third dose; he was exposed to Covid before their 3rd dose of the vaccine; This is a spontaneous report from a Pfizer-sponsored program  Support. A contactable consumer reported for a male patient.   A male patient of an unspecified age received second dose of bnt162b2 (COMIRNATY, Solution injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. Medical history included that patient is immunocompromised. The patient's concomitant medications were not reported. Patient previously received first dose of bnt162b2 (COMIRNATY, Solution injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. Caller is calling in behalf of a consumer, who received the third dose of the Pfizer (Comirnaty) vaccine. Caller states that a patient has been exposed to COVID-19 infection before getting their third dose. Caller is asking if an immunocompromised patient who have contracted COVID-19 before the third dose could be treated with monoclonal antibodies or not. Caller is asking if how long will the patient receive another monoclonal antibody after the vaccination. Caller noted that he knew that immunocompromised patients should defer vaccination if they received antibody therapy 90 days before vaccination.  The patient underwent lab test includes Covid-19 test with result positive on an unspecified date. The outcome of the event was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Developed cough, throat/chest tightness, itchy eyes 2-4 hours after administration of flu vaccine. Sent for treatment to urgent care facility. On dicharge placed on Benadryl, pain medication. Had CT scan with contrast and it was 0 for pulmonary embolism.
Indication: Treatment of COVID-19; Indication: Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 83 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Oct2021 12:45 (Lot number: EW017) as dose 3 (booster), single, administered in arm left, administration date 09Feb2021 16:00 (Lot number: EM9809) as dose 2, single and administered in arm left, administration date 19Jan2021 12:30 (Lot number: EL3249) as dose 1, single for covid-19 immunisation. Relevant medical history included: "bronchiectasis" (unspecified if ongoing), notes: Other medical history: bronchiectasis. Concomitant medication(s) included: LUTEIN, start date: Jan2020, stop date: Feb2022; VITAMIN D3, start date: Jan2020, stop date: Feb2022; CALCIUM 600 + D, start date: Jan2020, stop date: Jan2020. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2022, outcome "unknown" and all described as "Indication: Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Pentacel dose given after expiration with no reported adverse event; Initial information received on 02-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 months old male patient who reported pentacel dose given after expiration with no reported adverse event while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and ROTAVIRUS VACCINE LIVE ORAL 1V (ROTARIX) for Prophylactic vaccination.  On 02-Sep-2022, the patient received a  0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (1X) (lot UJ544AB; expiry date: 07-Aug-2022) via intramuscular route in the left thigh for prophylactic vaccination.  On 02-SEP-2022 the patient reported pentacel dose given after expiration with no reported adverse event (expired product administered) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (expired product administered).  At time of reporting, the outcome was Unknown for the event expired product administered.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
After receiving shingrix, she started experiencing chills, aches, and inflammation on her arm. she finally called & stopped by the pharmacy, and the RPH sent her to a clinic to further exam the site of vaccination. It was swollen and red & warm
I had a 2 inch round red itchy rash at injection site for 4 days after injection. It went away and then returned after one week. It is currently red, itchy and swollen again.
Itches started; arm pain,feeling achy; Went upto 103 at one point; hands are freezing; started feeling crappy; body hurts; Chills; Back pain; Knee pain / Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain), PERIPHERAL COLDNESS (hands are freezing), PRURITUS (Itches started), PAIN IN EXTREMITY (arm pain,feeling achy) and MALAISE (started feeling crappy) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included PSEUDOEPHEDRINE HYDROCHLORIDE (SUDAFED 12 HOUR), BUSPIRONE, PANTOPRAZOLE, FLUOXETINE, FLUOXETINE, ATOMOXETINE, CETIRIZINE and ALUMINIUM HYDROXIDE, DICYCLOVERINE HYDROCHLORIDE, MAGNESIUM OXIDUM LEVE (DICYCLOMINE CO) for an unknown indication.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, the patient experienced BACK PAIN (Back pain) and ARTHRALGIA (Knee pain / Joint pain). On 14-May-2021, the patient experienced PERIPHERAL COLDNESS (hands are freezing), MALAISE (started feeling crappy), MYALGIA (body hurts) and CHILLS (Chills). On an unknown date, the patient experienced PRURITUS (Itches started), PAIN IN EXTREMITY (arm pain,feeling achy) and PYREXIA (Went upto 103 at one point). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, BACK PAIN (Back pain), PERIPHERAL COLDNESS (hands are freezing), PAIN IN EXTREMITY (arm pain,feeling achy), MALAISE (started feeling crappy), MYALGIA (body hurts), CHILLS (Chills) and ARTHRALGIA (Knee pain / Joint pain) outcome was unknown and PRURITUS (Itches started) and PYREXIA (Went upto 103 at one point) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-221176 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Follow-up information received on 14-JUN-2021 contains non-significant information.
Allergic reaction; Face and throat became swollen; Face and throat became swollen; Unable to swallow normally; Swollen fingers; Voice has been affected; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Allergic reaction), SWELLING FACE (Face and throat became swollen), PHARYNGEAL SWELLING (Face and throat became swollen), DYSPHAGIA (Unable to swallow normally) and PERIPHERAL SWELLING (Swollen fingers) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced HYPERSENSITIVITY (Allergic reaction), SWELLING FACE (Face and throat became swollen), PHARYNGEAL SWELLING (Face and throat became swollen), DYSPHAGIA (Unable to swallow normally), PERIPHERAL SWELLING (Swollen fingers) and DYSPHONIA (Voice has been affected). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, HYPERSENSITIVITY (Allergic reaction), SWELLING FACE (Face and throat became swollen), PHARYNGEAL SWELLING (Face and throat became swollen), DYSPHAGIA (Unable to swallow normally), PERIPHERAL SWELLING (Swollen fingers) and DYSPHONIA (Voice has been affected) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications was not provided. Treatment for the events included diphenhydramine hydrochloride which helped ease the symptoms and the symptoms started to resolve in approximately four to five days.
small papular rash @ site of inject w/swelling, pain fever & intense itching x 2 wks; macular rash on abdo below navel lasting x 3 days; no fever, swelling, or pruritis exp;
appear blood clot in my lungs; This is a spontaneous report from a contactable consumer (patient herself). A 29-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 14May2021 (Batch/Lot Number: EW0172) (at the age of 29-years-old) as second dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to vaccination, patient was not diagnosed with COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was previously administered with first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: ER8731) on 23Apr2021 (at the age of 29-years-old) in the left arm for COVID-19 immunisation. On 15May2021, patient reported appearance of blood clot in her lungs. The event resulted in Emergency room/department or urgent care. The patient was given Eliquis as treatment for the event. The event was assessed as non-serious. Outcome of event was unknown. Since the vaccination, patient has been tested for COVID-19.
Pain everywhere overnight. Mild shivering. Pain to touch. Didn't get much sleep. Took tylenol. Pain calmed down in about1-2 hours. Still aching when I got up at 9:10 a.m. Headache, pain in neck, shoulders, arms, hands, feet, toes, knees. Joints hurt as well as all muscles when touched.
Patient reports flu like symptoms, felt very cold and myalgia. Next day she self treated and went to work and had to leave. Patient reports night sweats, severe fatigue. Patient says the night sweats is the reason she is calling.
This spontaneous as received from a 81 year old male physician with no drug reactions or allergies reporting on himself. The patient's medical history included bilateral hip replacement, retinal surgery and Guillain-Barre syndrome in 1999. On 09-JUL-2010, the patient was vaccinated with a dose of ZOSTAVAX (Lot # not reported). Concomitant therapies included FLOMAX and LUMIGAN. The physician reported that on approximately 18-FEB-2013, "three weeks ago", he developed shingles. The physician reported that he had a rash on the mid-back dermatome. He reported that there was no blistering, he had a little bit of sensory change, but not painful. The physician reported that the diagnosis of shingles was confirmed by his physician. There were no Lab diagnosis or studies performed. The patient did not receive treatment for the adverse event. The outcome of shingles was unknown. Additional information has been requested.
her arm was sore but no other adverse reactions until Saturday, Feburary 6th 2021 she had stroke between 4 and 6pm.  She died within 6 to 7 hours later.
Swelling arm; Sleepy / sleepy since March; Arm hurts; Rash broken out / rash broke out on my arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling arm), SOMNOLENCE (Sleepy / sleepy since March), MYALGIA (Arm hurts) and RASH (Rash broken out / rash broke out on my arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Swelling arm), SOMNOLENCE (Sleepy / sleepy since March), MYALGIA (Arm hurts) and RASH (Rash broken out / rash broke out on my arm). At the time of the report, PERIPHERAL SWELLING (Swelling arm), SOMNOLENCE (Sleepy / sleepy since March), MYALGIA (Arm hurts) and RASH (Rash broken out / rash broke out on my arm) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The concomitant information was not provided.  The treatment information was not provided.       Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Non significant follow up appended On 10-Jun-2021: Non-significant follow-up
Patient developed left arm swelling/swelling of fingers of left hand about 14 hours post injection. Shortly after receiving injection, patient developed itching of both arms. She reported HA, swelling, warmth at injection site, fever.
About 5 hours after injection had chills for several hours during the night.  During the night developed pain in the injection site.  Had not felt pain upon going to bed.  Upon waking in the morning (about 15-16 hours after vaccination) felt nauseous, had headache, fatigue, and pain in the injection site.
I still experimented stomach problems; diarrhea; stomachache; Stomach pain with cramp; full of gasses; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (I still experimented stomach problems), DIARRHOEA (diarrhea), ABDOMINAL PAIN UPPER (stomachache), ABDOMINAL PAIN (Stomach pain with cramp) and FLATULENCE (full of gasses) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     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 DISCOMFORT (I still experimented stomach problems), DIARRHOEA (diarrhea), ABDOMINAL PAIN UPPER (stomachache), ABDOMINAL PAIN (Stomach pain with cramp) and FLATULENCE (full of gasses). At the time of the report, ABDOMINAL DISCOMFORT (I still experimented stomach problems), DIARRHOEA (diarrhea), ABDOMINAL PAIN UPPER (stomachache), ABDOMINAL PAIN (Stomach pain with cramp) and FLATULENCE (full of gasses) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Fever (38.1C); Muscle pain in the lower body; Fatigue; Headache; Sensitive skin; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0165) via an unspecified route of administration in the right arm on 29Apr2021 at 16:45 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ERE733) via an unspecified route of administration in the left arm on 08Apr2021 at 16:45 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. On 30Apr2021, the patient experienced fever (38.1C), muscle pain in the lower body, fatigue, headache and sensitive skin. On the same day, the patient underwent body temperature test and the result was 38.1 centigrade. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever (38.1C), muscle pain in the lower body, fatigue, headache and sensitive skin were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
left shoulder - sore at first. One day later could not lift left arm at all. Very painful. Got some better - use hot and cold on it. Has recurred twice after shot that was given 2 weeks ago. still in pain.
Rapid heartbeat at bedtime (highly unusual).  Next morning, fainted with seizure lasting 2 minutes at 7:00 AM.
right side under arm (arm pit) and down from there very sore and hurts; right side under arm (arm pit) and down from there very sore and hurts; hurts to lift arm or move it; very uncomfortable; feels tight towards the front breast; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 28Apr2021 08:00 (Lot number: EW0161) at the age of 60 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Allergy" (unspecified if ongoing), notes: unspecified known allergy to medication, food or other products; "Blood pressure high" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1; Lot number: ER8729; Administration time: 08:30), administration date: 07Apr2021, when the patient was 60 years old, for COVID-19 immunisation. The following information was reported: AXILLARY PAIN (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 29Apr2021 17:00, outcome "not recovered" and all described as "right side under arm (arm pit) and down from there very sore and hurts"; PAIN (non-serious) with onset 29Apr2021 17:00, outcome "not recovered", described as "hurts to lift arm or move it"; DISCOMFORT (non-serious) with onset 29Apr2021 17:00, outcome "not recovered", described as "very uncomfortable"; CHEST DISCOMFORT (non-serious) with onset 29Apr2021 17:00, outcome "not recovered", described as "feels tight towards the front breast". Therapeutic measures were taken as a result of axillary pain, pain in extremity, pain, feeling abnormal, breast pain. Additional information: The patient took unspecified medications in two weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.On 29Apr2021 at 17:00, the patient experienced right side under arm (arm pit) and down from there very sore, and hurts. Felt swollen but was not. It hurt to lift arm or move it. Very uncomfortable. Felt tight towards the front breast. Therapeutic measures were taken as a result of the events and included acetaminophen (TYLENOL); acetaminophen worked just for a while for right side under arm (arm pit) and down from there very sore and hurts, hurts to lift arm or move it.No follow-up attempts are possible. No further information is expected.
3 hours after injection joint pain started, transient lasting 1-2 hours, migratory 1st neck left neck and shoulder, then lumbar back and SI joint bilaterally.  Then Achilles Tendon pain Left then Right.  Mild, lasting 2 days.   7 days later Left Axillary Lymphadenopathy with tenderness began and lasted for 12 days.  Intermittent SI joint pain recurs mild and brief.
Information has been received from a pharmacist concerning her 12 year old daughter with no pertinent medical history or allergies who on 21-JUL-2008 was vaccinated intramuscularly with 0.5 ml first dose of GARDASIL in her left upper arm.  There was no concomitant medication.  A few minutes after vaccination, the patient experienced faint.  No laboratory diagnostics studies were performed.  The patient recovered while in the office.  Since returning home from the office, the patient had complained of malaise and tingling of the left arm "from shoulder to fingertips".  There was no problem with movement of the arm.  At the time of report, the patient's malaise and tingling of the left arm persisted.  Additional information has been requested.
Pt c/o light-headedness and dizziness 15 mins after receiving vaccine. She denied any past medical history. She noted that she last ate at 10:30am today. She was assessed and monitored by NP, EMT and paramedic. BP - 127/88, HR - 93, O2 sat 97% on RA.