chrisvoncsefalvay/vaers-outcomes huggingface dataset:
weak; headache; chills; fever; broke out with sweats a couple times; cough; not eating; got diagnosed with COVID-19; got diagnosed with COVID-19; This is a spontaneous report from a Pfizer sponsored program received from a contactable consumer (Patient). A 63-year-old female patient received first dose of BNT162B2 (BNT162B2) intramuscular, administered in Arm Left on 18Mar2021 (Batch/Lot Number: EN6206) as 1ST DOSE, SINGLE for covid-19 immunization. Medical history included diabetes and blood pressure from unknown date and unknown if ongoing. Concomitant medications includes; metformin (METFORMIN) taken for diabetes mellitus, lisinopril (LISINOPRIL) taken for blood pressure, acetylsalicylic acid (ASPIRIN 81), atorvastatin (ATORVASTATIN), amlodipine (AMLODIPINE) taken for an unspecified indication from 19Apr2021, vitamin d3 (VITAMIN D3)  and zinc (ZINC). The patient got diagnosed with covid-19 on 31Mar2021, weak, headache, chills, fever, broke out with sweats a couple times, cough and not eating all on unspecified dates. Reporter states she is fine. She was weak from not eating. She was weak for a week after the fourteen days. Once she started eating back on a regular basis she was fine. She doesn't have lasting effects. She doesn't remember exact days, she started feeling a little more strength around the 16apr2021 or 17apr2021. She was gaining her strength back. She wasn't feeling bad or anything. She is not a doctor or a nurse but when Covid came out she got her and her daughters on a vitamin regimen. She is adamant about taking it everyday and feels that it helped her. She was weak, had headache and chills. She didn't have breathing trouble. She had a little fever and little chills. The headache was off and on. She also broke out with sweats a couple times. The shirt would wet with sweat when she woke up. She states she had a little cough, but not a lot. At first caller states that she took Mucinex pills but then clarified that she couldn't take it because the pills were too big. Caller clarified it was not brand name Mucinex. It was pharmacy brand. She does not have a problem swallowing pills. States she lives in two bedroom apartment. She was really weak. She would be very tired when walking from bedroom to the kitchen. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 31Mar2021. Outcome of the event Covid-19 was recovered. Outcome of all the other events was unknown.  Information about lot/batch number was available. Additional information has been requested.
left sided lung pain; "spent the day in bed"; This case was reported by a consumer via call center representative and described the occurrence of pulmonary pain in a 89-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th March 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 17th March 2020, 1 days after receiving Shingrix, the patient experienced pulmonary pain and bedridden. On an unknown date, the outcome of the pulmonary pain was unknown and the outcome of the bedridden was recovered/resolved.   It was unknown if the reporter considered the pulmonary pain and bedridden to be related to Shingrix.  Additional details were received as follows: The reporter mother received dose 2 of Shingrix. He states that on 17 th March 2020, she started to have left sided lung pain, on 18th March 2020 right sided lung pain, and on 19th March 2020, lung pain on both sides. She describes the pain as, spasm that goes from the back down to the lungs. The reporter did not consented to follow up.  The reporter has no vaccine information for this case, does not consent to follow up. This case was linked with case US2020049311, reported by the same reporter.
On August 18, 2021, my adult son (who lives with me) tested positive for Covid-19.  I was tested later that day, and my results were negative.  On  August 20, 2021, which was five and a half months after my second dose, I started getting Covid-19 symptoms. These included fever, chills, headaches, body aches, brain fog, and congestion.   On August 21, 2021, I tested positive for Covid-19.
Patient received DtaP and Hib on right thigh, IPV and Prevnar on left thigh.  In less than 10 minutes right foot/leg had red/purple splotches, redness spread to both legs.  Medical doctor notified, BENADRYL given, observed for greater than 30 minutes, improved.
Received a vaccine that underwent a temperature excursion; No adverse event; Received a vaccine that underwent a temperature excursion; This spontaneous case was reported by a medical assistant and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Received a vaccine that underwent a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Received a vaccine that underwent a temperature excursion) and NO ADVERSE EVENT (No adverse event) in a 3-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Aug-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Received a vaccine that underwent a temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Received a vaccine that underwent a temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Received a vaccine that underwent a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Received a vaccine that underwent a temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Received a vaccine that underwent a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Received a vaccine that underwent a temperature excursion).    The patient had a weight of 29 (unit not specified).  No concomitant medication was reported by reporter.  Patient got 1st dose on LQ (unspecified).  Some vaccines were stored in the freezer and other vials in the refrigerator. The excursion occurred on 7-Aug-2022 and was picked up by state review of the temperature data logger 2 weeks later after the excursion. Total 38 patients received this.  1 refrigerated vial was with lot number AS1412B and expiration date 10-Feb-2023. Maximum or minimum temperatures reached was 14 degrees Celsius for 3hr 5min. Vial was moved from refrigerator on 8-Aug-2022. Those were administered or discarded. Proposed desired used by date was 18-Aug-2022.  There were no reported side effects.  No treatment medication was reported by reporter.
This case was reported by a nurse via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 11-year-old male patient who received MENVEO (batch number A15125, expiry date May 2017). On 11th August 2016, the patient received MENVEO. On 11th August 2016, immediately after receiving MENVEO, the patient experienced nausea and headache. On 12th August 2016, the patient experienced extensive swelling of vaccinated limb, injection site erythema and injection site warmth. On an unknown date, the outcome of the extensive swelling of vaccinated limb, nausea, headache, injection site erythema and injection site warmth were unknown. the reporter considered the extensive swelling of vaccinated limb, nausea, headache and injection site warmth to be probably related to MENVEO. It was unknown if the reporter considered the injection site erythema to be related to MENVEO. Additional details were provided as follows: This case was not previously reported to anyone. the patient felt nauseated and had headache immediately after receiving MENVEO vaccine in left deltoid. He was given some juice and asked to lie down. the next morning, he developed a 6 by 7 inch red area that was swollen and hot to the touch.
Ringing in my left ear and a hallow sound... this has been happening on short intervals over the past 2 days
-  Sick with fever/chills for three days - Very heavy off-cycle period with sever cramping day after vaccination and then no period for 3 months.  -  Period came back 4 months later
Unconsolable fits lasting for 15-45 minutes (multiple episodes through out the day and night),  shrill screaming multiple times throughout day and night. Decreased sleeping through day and night. Symptoms lasted 7 days, started within an hour of getting vaccinations.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Mar2021 at 14:30 as dose 1, single (Batch/Lot number: unknown), in left arm, on 30Mar2021 at 10:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 13Oct2021 as dose 3 (booster), single (Lot number: EE3590) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroid" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "Hormone replacements" (unspecified if ongoing); "known allergies :Penicillin" (unspecified if ongoing). Concomitant medication(s) included: ARMOUR THYROID, start date: 01Jan2010, stop date: 03Nov2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Duplicate prevnar 13....Doctor's office called 10/2/19 informing us they gave pt prevnar 13 back on 1/6/16 (before pt was 65 years old). When pt was in pharmacy in August, she was getting something else and we screened for prevnar due to age and she said yes (had no memory of it) and we administered it in August 2019..insurance company paid for it as well.
Generalized malaise, unbroken erythemic lesions on face, neck, body and extremities; over the course of 2 weeks.
Information has been received from an office manager concerning a 17 year old female who was vaccinated with the third dose of GARDASIL. The patient then tested positive for HPV. The patient went to her obstetrician and tested positive for HPV. The office was concerned that the vaccine caused the patient to test positive for HPV. No further information is available.
20 hour after the second injection my tinnitus increased approximately 50%  muscle pain in legs increased, burning in feet started, terrible fatigue and an irregular heartbeat started
16 vesicular lesions on trunk/scalp/face, dx'd as breakthrough varicella
Vaccine given at 0800 am. While waiting the 15 minute period post-vaccination, I began to experience nausea and chest became very hot. Both symptoms seemed to have faded before I left the monitoring area. Proceeded to drive home (20 minute drive) and nausea returned, as well as increasing pressure and pain in chest. I decided to turn around and go back to the urgent care clinic. Arrived back at clinic by 0900am. Pressure in chest had receded but there was still some aching/occasional sharp chest pains and nausea. Clinic referred me to the ED for further workup. Most symptoms had stopped by 1000am when I went to the ED.
High fever (102.5), chills, all over body aches, nausea, headache
Large red area noted at site of vaccine within 1 minute of SC vaccine. Ice applied, Benadryl given.
Grand mal seizures. 1st - 16 hours after vaccination. 2nd - 24 hours after vaccination. Anticonvulsant drugs given.
p/vax exp acute lower back & leg pain;onset occurred p/20min;to ER, able to walk w/ one assist; within one hour paralyzed from waist down; tests reveal healthy, normal person w/ no apparent cause. Annual FU: transverse myelitis at T8/9 level. Paralysis is permanent.
extreme fatigue; Weakness; muscle aches; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 53-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 23Mar2021 08:30 (Batch/Lot number: unknown) at the age of 53 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Blood pressure high" (unspecified if ongoing); "Sjogren's syndrome" (unspecified if ongoing); "Levaquin Allergy" (unspecified if ongoing). Concomitant medication included: ATENOLOL. The following information was reported: FATIGUE (non-serious) with onset 23Mar2021 18:30, outcome "recovering", described as "extreme fatigue"; ASTHENIA (non-serious) with onset 23Mar2021 18:30, outcome "recovering", described as "Weakness"; MYALGIA (non-serious) with onset 23Mar2021 18:30, outcome "recovering", described as "muscle aches". Therapeutic measures were not taken as a result of fatigue, asthenia, myalgia.  Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced extreme fatigue, weakness and muscle aches after 10 hours of vaccination on 23Mar2021. Adverse events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
VOMITING; CHILLS; FEVER 103 AND 100.5 F; NAUSEA; HEADACHE; WEAKNESS; This spontaneous report received from a patient concerned a female of unspecified age. 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: Unknown) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 15-MAR-2021, the subject experienced vomiting. On 15-MAR-2021, the subject experienced chills. On 15-MAR-2021, the subject experienced fever 103 and 100.5 f. On 15-MAR-2021, the subject experienced nausea. On 15-MAR-2021, the subject experienced headache. On 15-MAR-2021, the subject experienced weakness. Laboratory data included: Body temperature (NR: not provided) 103 F, 100.5 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever 103 and 100.5 f, vomiting, chills, nausea, headache and weakness was not reported. This report was non-serious.
Patient presented today (10/29/11) after receiving her flu shot (10/17/11) with shoulder pain. Patient reported not being able to raise her arm above her head. Patient is going to start naproxen and follow up with PCP.
Headache and aches at the sinus area; Diagnosed positive of COVID-19; Diarrhea; 100°F fever; Nausea; Chills; This spontaneous case was reported by a consumer and describes the occurrence of SINUS HEADACHE (Headache and aches at the sinus area), COVID-19 (Diagnosed positive of COVID-19), DIARRHOEA (Diarrhea), PYREXIA (100°F fever) and NAUSEA (Nausea) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced SINUS HEADACHE (Headache and aches at the sinus area), COVID-19 (Diagnosed positive of COVID-19), DIARRHOEA (Diarrhea), PYREXIA (100°F fever), NAUSEA (Nausea) and CHILLS (Chills). At the time of the report, SINUS HEADACHE (Headache and aches at the sinus area), COVID-19 (Diagnosed positive of COVID-19), DIARRHOEA (Diarrhea), PYREXIA (100°F fever), NAUSEA (Nausea) and CHILLS (Chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. No treatment was reported.
tested positive for COVID with home test; tested positive for COVID with home test; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), on 17May2022 as dose 4 (booster), single (Lot number: PJ4991) at the age of 73 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 29Jan2021 as dose 1, single (Lot number: 007M20A), on 26Feb2021 as dose 2, single (Lot number: 004M20A) and on 11Nov2021 as dose 3 (booster), single (Lot number: 939903) for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "heart attack" (unspecified if ongoing); "kidney stone all resolved." (unspecified if ongoing), notes: Other medical history: Kidney stone all resolved. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for COVID with home test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Fever of 102; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 102) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced PYREXIA (Fever of 102). At the time of the report, PYREXIA (Fever of 102) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided
I had chills and a slight fever from about 1:00PM until 4:00PM on 04/01/2021. I was also very tired.  These symptoms lasted only those few hours and then I seemed to feel better. This was my second dose. First dose was on 03/03/2021.. No side effects from that one except slight discomfort in injection site.
Rash progressively spreading from face to trunk to legs over the time period of about 5 minutes.
Patient became very weak and sleepy about a week after the vaccine.  By the following saturday, he couldn't even stay awake enough to eat.  His blood pessure was very low and he had a fever , so I called paremedics, and they took him to the hosp.  After many tests, they found blood in the urine, and his blood platelets had dropped to 121.( Now he had blood work done in June of 2020 and his platelets were 225.)  After a few days, his platelets began to creep back up, and are now around 165, back to normal range. He is currently at a rehad facility for physical therapy to regain strength.
the consumer is due their third dose on 30Sep2019/no AE; Initial information received on 30-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 71 years old patient who was due for third dose of vaccine RABIES (HDC) VACCINE [IMOVAX RABIES] on 30-Sep-2019;  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was of actual medication error due to Incomplete course of vaccination.  It was unknown whether vaccine was given or not later.  Information on the batch number was requested.   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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.  List of documents held by sender: none. .
24-48 hours after receiving the pneumovax 23 vaccine, I started experiencing lightheadedness, pac's and pvc's, nausea, tingling from my head to my toes. I was taken to the er by ambulance on Dec 1st. I followed up with cardiologist on Dec 3rd.
Developed a few spots on hands and arms on 10-26-07. On 10-27-07 developed spots on legs, arms, buttocks, groin, lips, went to ER and they recovered he f/u with family doctor. Had tenderness at injection site for several days following injection. Dx by doctor on 10/29/07 with Erythema Multiforme
twitching of fingers, core, leg toe foot random  going  to call dr on monday has labs for tuesday and appt for thursday  Completed follow up call on 4/16/2021 at 10:22am: Pt reported a couple of day from rcvding her 1st dose on 4/3/2021, she also experienced fatigue (legs felt weak) and nausea. Pt reported that the twitching has subsided and occurring less frequent than first reported. On 4/15/2021, she reported that her right toe still twitches a little, and this morning 4/16/2021 her left thumb twitched again. Pt reported that she spoke with her MD Thursday 4/15/2021, per MD this could have been a reaction from the vaccine. Pt also reported trouble sleeping since rcvding the vaccine, prior to the vaccine she reported no trouble with sleeping. Pt mentioned the insomnia to her MD; MD thinks this may be due to the possiblity of pt experiencing peri-menopause but pt reports she does not have any peri-menopause symptoms except having low progesterone.   ***NOTE*** Recommend  pt to keep an eye on her symptoms, and if symptoms persist and does not get better to communicate info to MD.
The female overnight pharmacist who administered the vaccine did so in the wrong location.  She injected too high on the arm, in the shoulder capsule, not in the deltoid.  I felt a sharp pain during injection, and almost immediately, experienced pain in the arm.  Within about 10 minutes, I had severe pain in the left arm, radiating from the shoulder all the way down to the elbow, and had numbness in the arm as well.  Within a few hours, the pain worsened and I could not move my arm without severe pain.  I took ibuprofen and iced the arm over the next few days without much relief.  I had severe pain upon any movement for about 5 days, and now, some 19 days later, still have pain when I try to lift my arm over my head.  There is no pain upon rest, but any movement of my arm causes pain, while much less severe than the first few days post-administration.
Monday, 9/6: symptom onset. Persistent headache, fatigue, low-grade fever (1.5 degrees higher than normal). Tues: Persistent headache, fatigue, low-grade fever (1.5 degrees higher than normal). Sinus pressure affecting ears (new). Wed: Persistent headache, fatigue. Diarrhea (new).  Thurs: Persistent headache, fatigue.  Loss of appetite, taste and smell (new). Fri-Sun: Persistent headache, fatigue, loss of appetite, taste and smell. Monday, 9/13: Loss of taste and smell.
PATIENT SAID ABOUT 6 HOURS AFTER BEING VACCINATED SHE STARTED HAVING RACING HEART, DIFFICULTY BREATHING, WHEEZING AND A BARKING COUGH.  THESE SYMPTOMS LASTED ABOUT 1 TO 1&1/2 HOURS.  SHE SAID SHE IS DOING FINE HOW.