chrisvoncsefalvay/vaers-outcomes huggingface dataset:
dose 1 in 01-Feb-2022, dose 2 in 22-Feb-2022; COVID; Bladder infection; Sinus infection; Aches; Neck issue; Neck issue during the time of the COVID vaccine; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 21K-163-4186728-00 (Company).  A 79-year-old female patient received BNT162b2 (BNT162B2), on 01Feb2021 as dose 1, single (Batch/Lot number: unknown) at the age of 79 years and on 22Feb2021 as dose 2, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), first regimen (Lot number: 1139174) at 40 mg (40 mg, (citrate free, 1 in 2 wk)) and second regimen (Lot number: 1155993) at 40 mg (40 mg, (citrate free, 1 in 2 wk)), all subcutaneous. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCULOSKELETAL DISORDER (non-serious) with onset Feb2021, outcome "unknown", described as "Neck issue"; VACCINATION COMPLICATION (non-serious) with onset Feb2021, outcome "unknown", described as "Neck issue during the time of the COVID vaccine"; COVID-19 (medically significant), outcome "recovered", described as "COVID"; VACCINATION FAILURE (medically significant), outcome "recovered", described as "dose 1 in 01-Feb-2022, dose 2 in 22-Feb-2022"; CYSTITIS (non-serious), outcome "unknown", described as "Bladder infection"; SINUSITIS (non-serious), outcome "recovering", described as "Sinus infection"; PAIN (non-serious), outcome "unknown", described as "Aches". The action taken for adalimumab was dosage permanently withdrawn.  The reporter's assessment of the causal relationship of "covid", "dose 1 in 01-feb-2022, dose 2 in 22-feb-2022", "bladder infection", "sinus infection" and "aches" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The reporter considered "neck issue" and "neck issue during the time of the covid vaccine" related to BNT162b2. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded.
29F no PMH had COVID-19 almost 1 year ago. On 2/2 received 1st shot of COVID-19 vaccine.  Since then with mild headache, body aches, chill. On the morning of 2/3, with prolonged standin, felt weak, abdominal pain, pre-syncopal, grabbed a co-worker and then syncopized. Caught and did not sustain injuries. Rapid response called and she was brought here.
She was hospitalized many times for this only after MMR vaccine. I'm fuzzy on a lot of info. I wanted to make sure it was reported since I was never told about vaers until recently. This happened a while back but lasted until she was a pre teen. She would swell up for no reason and wasn't able to breathe. Official diagnosis of parotitis.
Patient hospitalized for COVID treatment after vaccination  and admitted on 07/17/21 1st dose Moderna vaccine 02/24/21 and 2nd dose 03/22/21
Information has been received from a registered nurse concerning an outbreak of chickenpox in a child, between the ages of kindergarten to 4th grade, who had been vaccinated subcutaneously with a first dose of 0.5 mL of varicella virus vaccine live (Oka/Merck). Subsequently, the child developed chickenpox. The child may have 50 lesions or more. Additional information is not expected. This one of several reports received from the same source.
Arm soreness; Feels like she ran a race; Felt much more tired than usual; This spontaneous case was reported by an other and describes the occurrence of PAIN IN EXTREMITY (Arm soreness), FEELING ABNORMAL (Feels like she ran a race) and FATIGUE (Felt much more tired than usual) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm soreness), FEELING ABNORMAL (Feels like she ran a race) and FATIGUE (Felt much more tired than usual). At the time of the report, PAIN IN EXTREMITY (Arm soreness), FEELING ABNORMAL (Feels like she ran a race) and FATIGUE (Felt much more tired than usual) outcome was unknown.            Concomitant medications were not reported. Treatment information in response to the events was not provided.
107 patients received the expired vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (107 patients received the expired vaccine) in a 42-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Aug-2021 at 9:38 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 19-Aug-2021 at 9:38 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (107 patients received the expired vaccine). On 19-Aug-2021 at 9:38 AM, EXPIRED PRODUCT ADMINISTERED (107 patients received the expired vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided. List of concomitant medication were not given.
Patient became pale, nauseous, blurred vision and lowered blood pressure. Ambulance called and patient was ok and sent home with parents. Next morning at 1030 Am patient was called and was fine.
Small hardened lump at injection site, raised wheal 2.5 inch diameter, redness and soreness.
Hives covering entire body. Now lasting 4 days. Went to ER tonight as Benadryl would not work. Prescribed prednisone.
He has pain; really sleepy; lot of fatigue in his legs and joints/he is tired; had chills; some nausea but no vomiting; This spontaneous case was reported by a patient and describes the occurrence of PAIN (He has pain), SOMNOLENCE (really sleepy), FATIGUE (lot of fatigue in his legs and joints/he is tired), CHILLS (had chills) and NAUSEA (some nausea but no vomiting) in an adult male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3032472) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (He has pain), SOMNOLENCE (really sleepy), FATIGUE (lot of fatigue in his legs and joints/he is tired), CHILLS (had chills) and NAUSEA (some nausea but no vomiting). At the time of the report, PAIN (He has pain), SOMNOLENCE (really sleepy), FATIGUE (lot of fatigue in his legs and joints/he is tired), CHILLS (had chills) and NAUSEA (some nausea but no vomiting) had not resolved.            Patient did not provide any information about previous COVID-19 vaccination doses.  No concomitant medications were provided.  Patient wanted the turn around time for the side effects of the Moderna vaccine. He has a lot of fatigue in his legs and joints. He has pain, he was tired. He wanted to know how long the side effects last, or it depend on the individual. He had some nausea but no vomiting. He had chills. He wanted to know when people report side effects how long it usually last. The side effects he was still having that he was really sleepy and fatigue.   No treatment information was provided
Facial drooping occurred on 1/3/2021, patient sent to ER and returned with diagnosis of Bels Palsy on 1/4/2021
progressive generalized weakness including of cranial nerves diagnosed as acute demyelinating encephalomyelitis (ADEM)
Got 2nd dose vaccine at 7:20 am at 5:30 pm I developed chills, went to bed around 8:30 due to not feeling well. I woke up at 10 pm sweeting and body aches. All through the night I was hot then cold. I developed a temperature of 100.8. Had no appetite in the morning. At 7:30 am I started to feel better. Had head ache through out the day Thursday.
Low grade fever, migraine head ache, chills, body aches for two days after my second shot.; body aches for two days after my second shot; migraine; headache; chills; This is a spontaneous report from a non-contactable consumer (patient). A 45-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 12Apr2021 at 09:00 AM (Batch/Lot Number: ER8734) as DOSE 2, SINGLE (at the age of 45-years-old) for COVID-19 immunisation. The patient's medical history included Under active thyroid from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine 25 mcg tablet, vitamin D3 50 mcg. The patient had no known Allergies. The patient's historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 22Mar2021 at 09:00 AM (Batch/Lot Number: EP7534) as DOSE 1, SINGLE (at the age of 45-years-old) for COVID-19 immunisation. On 13Apr2021 at 03:00 hours, the patient experienced low grade fever, migraine headache, chills, body aches for two days after the second shot. The patient underwent lab tests and procedures which included body temperature: low grade fever on 13Apr2021. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The events were non serious and did not result in death/Life threatening/Caused/prolonged hospitalization/Disabling/Incapacitating/Congenital anomaly/birth defect. The patient received no treatment for the adverse events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient had recovered from the adverse events on 15Apr2021.  No follow-up attempts are possible. No further information is expected.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 78-year-old female patient who received SHINGRIX. The patient's past medical history included neoplasm malignant (20 years ago). Previously administered products included SHINGRIX with an associated reaction of pain in extremity (received the 1st dose in 2017 about 2.5 months before the date of reporting, refer case US2018GSK072987). Concurrent medical conditions included lymphedema (in left arm). On 18th April 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 18th April 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm, mobility decreased, fatigue, headache, fever, shivering, nausea and appetite absent. On 19th April 2018, the patient experienced inability to work and feeling bad. On an unknown date, the outcome of the pain in arm, mobility decreased, fatigue, headache, fever, shivering and nausea were recovering/resolving and the outcome of the inability to work, feeling bad and appetite absent were unknown. The reporter considered the pain in arm, fatigue, headache, fever, shivering and nausea to be related to SHINGRIX. It was unknown if the reporter considered the mobility decreased, inability to work, feeling bad and appetite absent to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient's concomitant medications included cocoa supplement and multivitamins. At 12:00 hours, the patient received SHINGRIX on right arm. After vaccination, the patient came home and her arm was immediately hurting and it got worse and worse over the day until she could barely lift her arm. The patient became very fatigued, to the point that she could barely move. She experienced splitting headache, fever, chills, nausea and shivering. One day after receiving the SHINGRIX vaccine (on the day of reporting), the patient had to take off work because she felt so bad. The patient felt a bit better and was going to try some tea and scrambled eggs. The patient had not eaten in 24 hours.
Vaccinated: 10AM Reaction: 10:01AM Pt experienced dizziness and light headedness after receiving her Pfizer booster. PT noted also to be clammy and pale. PT taken to hospital to lay down and was given juice and crackers. PT later reported she briefly lost her hearing until she sat in wheelchair to be taken to hospital and her hearing came back. Patient noted to have significant history of dizziness with needlesticks. Father says she gets this from him.  Vitals: 109/48, 65, 14 -> @10:31: 108/72, 56, 14, O2 100% Pt reported feeling better after laying down and after sitting up and eating crackers and juice. Her adverse symptoms resolved and she left facility ambulating independently with steady gate, accompanied by her parents, and in NAD at 10:34AM. Patient educated to stay well hydrated before and after needlestick injections in future and to have future needlestick injections given at facility where she can receive injection while laying down, i.e. doctor's office, vaccine center.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative from social media concerned a 23 year old of unspecified sex of unknown race and ethnicity. 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 and expiry: Unknown) dose was not reported, 1 total, administered on JUN-2021 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.  Patient was vaccinated on JUN-2021 (two months ago) but on 09-AUG-2021, the patient was found covid-19 positive. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On an unspecified date, the patient experienced suspected clinical vaccination failure and was having cough and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was associated with product quality complaint 90000189066. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210820072- covid-19 vaccine ad26.cov2.s - Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically:SPECIAL SITUATIONS
I waited in the area for about 30 minutes. Was reported to me that I was white as a sheet, went back to work around 10:30 am I started getting itchy.  First under my arm where the shot was administered, then within 15 minutes head to toe. I was itchy for about 45-50 minutes when I started not feeling good. Lightheaded, Dizzy, nauseous., hard to swallow, Throat sore, headache, hard to take a deep breath.  I went to my boss and we went over the  clinic where my blood pressure was elevated and they called 911.
There was no adverse reaction. (mother) was informed of the situation. Mother stated, "Pt is doing fine".
Day 1: feverish at injection site Day 2: soreness/knot at injection site Day 3: body aches, chills Day 4: fever, severe chills, nasal congestion Day 5: low grade fever, lethargic (report made on day 5)
Patient received the vaccine and was sitting for 15min for the observation period. Patient started fainting around 10 minutes after receiving the shot. The EMTs arrived, his vitals were running normal and was taken to the nearest hospital.
On 5/8/21 I was dizzy and my blood pressure was consistently around 200/100 for several hours. I went to the ED and was diagnosed with essential hypertension.
This case was reported by a consumer and described the occurrence of blood cholesterol increased in a male patient who received SHINGRIX. On 25th April 2018, the patient received the 1st dose of SHINGRIX. On 25th April 2018, less than a day after receiving SHINGRIX, the patient experienced blood cholesterol increased. On an unknown date, the outcome of the blood cholesterol increased was unknown. It was unknown if the reporter considered the blood cholesterol increased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had 1st dose of SHINGRIX yesterday morning and had blood work drawn by another provider that afternoon, his cholesterol levels were a little elevated compared to his prior lipid test done 6 months prior. The patient noticed that the SHINGRIX vaccine contains cholesterol and was curious as to the impact that cholesterol would have on blood test.
EMS assessed; took vital signs. Client given oxygen via nasal Canula. Client was given recommendation to be picked up by family or friend; client stated someone is waiting for  her outside. EMS walked client to friend in car.
Still got the flu; Still got the flu; Initial information received on 03-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves Adult and unknown gender patient who still got the flu after receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect influenza vaccine produced by unknown manufacturer (dose, strength, frequency, formulation, route, batch number, expiry date: unknown) in unknown administration site for Flu (influenza)  On an unknown date the patient diagnosed with non-serious events still got the flu (influenza), (drug ineffective) (unknown latency) following the administration of influenza vaccine.  No lab data was reported.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event  At time of reporting, the outcome was Unknown for both the events
PATIENT WAS TO RECEIVE COVID 19 BOOSTER BIVELENT AND WAS ACCIDENTALLY GIVEN THE REGULAR COVID 19 VACCINATION DOSE NO ADVERSE REACTION
My arthritis in my hips has started up again.  My hips have been aching every night since the shot. They have been like this in the past but havnt been bothering me like this for quite some time. The pain will go away with pain meds, but I don't want to over use my oxicodone and the motrin starts to mess with my stomach after several days.  This isn't life or death, I just thought it would be good data.
This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history and concurrent condition were not provided. Between 13-SEP-2017 to 08-NOV-2017, the patient was vaccinated with an improperly stored dose of PROQUAD (therapy type rHA) second dose, lot number N014759 and expiration date 08-NOV-2018 (frequency, route of administration were not provided) for prophylaxis; which was reconstituted with a properly stored of sterile diluent (manufacturer unknown). No adverse effects reported. The vaccine was stored at a temperature of 15° Fahrenheit to 46° Fahrenheit, time frame of 11 hours and 30 minutes with a previous temperature excursion that was reported as after the first excursion, but not after current excursion, the past excursion was of 15° Fahrenheit to 46° Fahrenheit with a time frame of 1 hour and 15 minutes. Digital Data logger was involved. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1711USA009475:
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions were not reported. On an unknown date in 2013 the patient was vaccinated with a dose of ZOSTAVAX (dose volume, frequency, lot number, expiry date were not reported). At the time of vaccination, the patient took concomitant medication ZOVIRAX, 800mg daily. The reporter asked if the patient should receive another dose of ZOSTAVAX. The pharmacist's colleague, also the pharmacist, stated that the patient did not experience any adverse effects. Additional information is not expected.
PT STATES THAT HE FEELS CHEST PAIN AFTER HE EATS HIS DINNER.
Headache, Myalgia, Arthralgia, NauseaVomiting, FATIGUE Narrative:
noticed that a Menveo Vaccine expired 30/SEP/2023 but was administered today; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 13-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number amva725z, expiry date 30-SEP-2023) for prophylaxis.   On 17-OCT-2023, the patient received Menveo. On 17-OCT-2023, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: noticed that a Menveo Vaccine expired 30/SEP/2023 but was administered today). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 17-OCT-2023 The reporter was a nurse at a healthcare facility that was going thru paperwork at the time of reporting and noticed that a Menveo vaccine expired but was administered at the time of reporting, which led to expired vaccine used. The reporter consented to follow up.
Initial report was received on 13 November 2012 from a healthcare professional. This case was originally part of a cluster of approximately 17 patients (six elderly patients, two adolescent patients and approximately nine unidentified patients), who tested PCR positive for influenza A/H3N2. The two adolescent patients were captured in case number 2012-05659 and the ten unidentified patients (previously reported as nine patients) were captured in case numbers 2012-05660, 2012-06067, 2012-06068, 2012-06069, 2012-06070, 2012-06071, 2012-06072, 2012-06073. In addition this case was previously part of the six elderly patient's case 2012-05658. The other elderly patient cases have been captured in case numbers 2012-10691, 2012-10692, 2012-10693 and 2012-10694. An 92 year-old female patient had received on 11 October 2011 a dose of FLUZONE, lot number UH454AC (route and site of administration not reported). The patient participated in an influenza surveillance program. The patient's approximate treatment date and "collection date" was 24 January 2012. According to the reporter, the type of influenza was flu A and the subtype of influenza was H3N2. Treatments were not reported. No further information was available at the time of the report. The patient's outcome was recovered (date not reported). Documents held by sender: none.
After second dose I immediately felt lightheaded, later that evening I began to feel nauseous. Dizziness and nausea have continued for the past week and a half. I'm unsteady on my feet and having difficulty eating normally. I have not seen a doctor since I assumed this was a vaccine side effect.
Bleeding gums, bloating, extreme fatigue, joint pain (particularly in feet and ankles), headaches, dizziness. Most symptoms have resolved themselves as of 6/8/2021.
9/9/06-onset numbness fingers and toes. Seen in our clinic on 9/11 and 9/14/06. Patient's father reports diagnosis of Guillain-Barre Syndrome. Diagnosis by private Medical Doctor in Atlanta. Father did not know date of diagnosis. DX Guillain-Barre.  PMH viral syndrome 8/16/06, HX mononucleosis note for DOS 9/11/06-C/O numbness in feet for 2 days numbness moving to fingertips. Seen several time in past 3 months for throat closing, headaches, chest pain and trouble breathing, nothing has seemed to make the problem better. Pain on lower sides in organs and lower back on sides .