chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hives started on left cheek; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Dec2021 14:45 (Lot number: 330368D) at the age of 47 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergic to Vscan dye" (unspecified if ongoing); "Gerd" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "hiatal hernia" (unspecified if ongoing); "Chronic sinusitis" (unspecified if ongoing); "torn meniscus" (unspecified if ongoing). Concomitant medication(s) included: PANTOPRAZOLE. Past drug history included: Omeprazole, reaction(s): "Drug Allergy"; Tamiflu, reaction(s): "Drug Allergy". The following information was reported: URTICARIA (non-serious) with onset 30Dec2021 21:15, outcome "recovering", described as "hives started on left cheek". The event "hives started on left cheek" was evaluated at the physician office visit. Therapeutic measures were taken as a result of urticaria.  No follow-up attempts are possible. No further information is expected.
Not serious, but the fact that it didn't happen until eight days after the vaccination seemed unusual. Sore arm at the site, redness, some swelling and itching and a rash  Faded after about three days.
Patient received 2 vaccines.  She received flu shot and first COVID-19 vaccine. She had mentioned that she had a history of fainting with previous vaccines but patient said it had been awhile. Patient was also claustrophobic, but did not mention that prior to getting her vaccine. After the vaccinations (both), she was fine and talking, she jumped up to get out of the immunizing room, she made it to the outer seating and then slumped down in the seat. She did not appear to lose complete consciousness but was not completely alert either. She was not responding well but eyes were open. Pt turned pale and had a brief bluish tint to lips. We could not safely move patient to the floor. Patient was sweating . BP was checked and found to be low and was checked again about 5 minutes later given patient was talking again. Color returned to her cheeks and we continued to monitor.
Stomach pain; It was almost like diarrhea; Sore muscle pain; Redness in injection site on Left arm; This is a spontaneous report received from a non-contactable consumer (patient).  A 56-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 13Apr2021 (Batch/Lot Number: ER8729) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. A couple hours after first shot the patient had rather sore muscle pain and redness in injection site on Left arm on 13Apr2021 (Tuesday and Thursday). On 14Apr2021 (Wednesday) the patient also had some stomach pain (and it wasn't), it was almost like diarrhea not quite. The patient recovered from the event diarrhea on 16Apr2021 while outcome of the events muscle pain, vaccination site erythema, stomach pain was unknown.  No follow up attempts needed. No further information expected.
patient states after she got her second dose she had tenderness and soreness at the site of inject she also experienced tenderness, swelling, rash, and redness in her left armpit. she also had fever 103 and nausea. she ended up going to the hospital and the ER doctor told her she has cellulitis.
Suspected vaccination failure; mimicked the flu; Body pain; Adverse drug reaction; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 66-year-old male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   Previously administered products included Shingrix (had 1st dose, 1.5 to 2 years ago, refer case US2019231576). Concurrent medical conditions included epilepsy (had epilepsy) and aneurysm cerebral (had brain aneurysm).   On an unknown date, the patient received Influenza vaccine Quadrivalent 2019-2020 season at an unknown dose. On an unknown date, less than 3 weeks after receiving Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced vaccination failure (serious criteria GSK medically significant), flu symptoms, general body pain and adverse drug reaction. On an unknown date, the outcome of the vaccination failure, flu symptoms, general body pain and adverse drug reaction were unknown.   It was unknown if the reporter considered the vaccination failure, flu symptoms, general body pain and adverse drug reaction to be related to Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. After receiving flu vaccine, the patient had complete body aches which mimicked the flu.  After days, other symptoms started but he did not elaborate on what those symptoms were. Several days after vaccination, the patient had adverse events The reporter did not conset to follow up. This case was considered as a suspected vaccination failure case since details regarding complete immunization schedule for influenza and the lab test confirmation for influenza were unknown.
PATIENT CALLED STATING HER ARM WAS RED, WARM,  AND SWOLLEN  AROUND THE INJECTION SITE. I ADVISED HER TO KEEP AN EYE ON IT AND USE ICE TO HELP REDUCE THE SWELLING. SHE DID NOT REPORT ANY DRAINAGE.
It was reported that a male pt received a Fluzone SV '00-'01 vaccination 25 Oct 2000. Reportedly that same day the patient complained of soreness and numbness with elevation of arm at injection site. Further information is requested.
9 days after his first shot he took a massive stroke despite having no prior record of high blood pressure or anything.. he is still alive and paralyzed on his left side with his speech being very poor and it drastically fast tracked his alziemers diagnoses
Information regarding Prevnar was received from an investigator regarding a 16 month old female participant in the Prevnar Post-Marketing Safety Surveillance Trial, "Post-Marketing Evaluation of Prevnar Pneumococcal 7-Valent Conjugate vaccine: Safety of Prevnar Administered Concurrently with Routine Infant Vaccinations at 2, 4, 6, and 12 to 15 Months of Age," who died as a result of SIDS-like syndrome. The child received the third dose on 5/20/02, at 6 months of age. On 4/10/03, the pt experienced SIDS-like syndrome. The reporter indicated that the "coroner's report (pending paperwork) states the cause of death is not explainable due to findings; too old for SIDS." No additional info was available at the time of this report. Both the investigator and the medical monitor assessed the SIDS as "not related" to the study vaccine. No additional info was available at the date of this report. Follow Up: On 10APR2003, at approximatley 1530 hours to 1545 hours, the child was found unresponsive by a day care worker. The 911 system was activated and the paramedics responded. The child was taken to an emergency room; efforts to resuscitate her failed. At 1642, she was pronounced dead. The coronoer's reported cause of death was "not explainable due to findings; too old for SIDS." On 11Apr2003, at approximately 1530 hours to 1545 hours, the child was found unresponsive by a day care worker. The 911 system was activated and the paramedics responded. The child was taken to an emergency room; efforts to resuscitate her failed. At 1642, she was pronounced dead. The coroner's reported cause of death was "not explainable due to findings; too old for SIDS." On 11APR2003, an autopsy was performed; the results revealed a clinical hisotry of listlessness and tirednes. The autopsy anatomical diagnoses included "cerebral flattening, pulmonary edema and congestion, no congenital anomalies, and a healing fracture of right clavicle." The coroner's autopsy reported cause of death was reported as "anatomic and toxicologic findings insufficient to explain death in a child with a healing fracture of right clavicle." The investigator indicated that the cause of death was "SIDS-like syndrome."
Dizzy, emotional and not knowing why, confusion, being very uneasy. Pain in (L) arm/erythema.
After receiving vaccine patient had clonic movements and unresponsiveness lasting about 1 minute. Recovered with. Episode occurred after 2nd vaccine (Varivax).
Pt presented with complaint of mild nausea. Pt denied CP, SOB. Full assessment performed and V/S obtained. Pt denied any significant PMH. Pt denied the possibility of pregnancy. Pt stated that she felt as though it may have been an anxiety reaction. Pt did not vomit while with Observation Staff. Pt rested in observation area x10 mins. At conclusion of time, pt noted relief of symptoms. Pt stated that she did not want to go to the hospital. Pt informed of risks of refusing, up to and including death. Pt accepted risks and stated she would follow-up with his PCP. Pt signed AMA and released without incident. Pt transported home by mother who accompanied her to appointment
had night sweat in the middle of night; shaking where she is like drenched she wake up in the middle of night; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 81 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 04Oct2021 (Lot number: 301558A) at the age of 81 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE) (Batch/Lot number: unknown) as unk unk, single; denosumab (PROLIA) (Batch/Lot number: unknown). The patient's relevant medical history was not reported. Concomitant medication(s) included: METOPROLOL; BISOPROLOL; AMLODIPINE; HYDROCHLOROTHIAZIDE; VITAMIN D [VITAMIN D NOS]; ZOLOFT; FLECAINIDE; XARELTO. Vaccination history included: Bnt162b2 (First dose), for Covid-19 immunization; Bnt162b2 (Second dose), for Covid-19 immunization. The following information was reported: NIGHT SWEATS (non-serious) with onset 04Oct2021, outcome "not recovered", described as "had night sweat in the middle of night"; TREMOR (non-serious) with onset 04Oct2021, outcome "not recovered", described as "shaking where she is like drenched she wake up in the middle of night". The events "had night sweat in the middle of night" and "shaking where she is like drenched she wake up in the middle of night" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. The action taken for denosumab was unknown. Therapeutic measures were not taken as a result of night sweats, tremor.  No follow-up attempts are possible. No further information is expected.
On day 8, I awoke with itching and when I looked at my arm, there was a circular red rashy area around shot site.
Body aches and sore at injection site night of second injection.  Morning after, fever at 101.4, body aches, extreme fatigue. By afternoon, temp had dropped to 100.3.  Still very tired, aches diminishing.  Slept poorly that night. Temperature normal on second day, still a little tired. Back to "normal" on third day.
This spontaneous prospective pregnancy report as received from a pharmacist referring to a 14 year old female patient. On an unknown date the patient was vaccinated with the first dose of GARDASIL, lot#, dose, frequency and route unknown. The patient was 13 weeks pregnant at the time that she received her first dose of GARDASIL. The Last Menstrual Period (LMP) and Estimated date of delivery (EDD) was not known. The pregnancy outcome was outcome pending. No adverse effect was reported. Additional information has been requested.
has a stomach virus; his arm was a little sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient. A male patient received bnt162b2 (BNT162B2), administration date 07Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single), for COVID-19 Immunization.  The following information was reported: GASTROENTERITIS VIRAL (non-serious) with onset 08Apr2021, outcome "not recovered", described as "has a stomach virus"; PAIN IN EXTREMITY (non-serious) with onset Apr2021, outcome "unknown", described as "his arm was a little sore".  Additional information: The patient stated that he had the second dose of the Pfizer COVID-19 Vaccine on Wednesday, 07Apr2021 and had no issue with the COVID-19 vaccine. The patient sold stated that he did not have any issue with the COVID-19 Vaccine, except his arm was a little sore on an unknown date in Apr2021. The patient stated that he had a stomach virus this morning (09Apr2021), and last night (08Apr2021). The patient stated wants to know if he could take Imodium AD. The patient said he did not want to take the Imodium AD if the Imodium AD was going to be in conflict with the COVID-19 Vaccine. The patient advised he would be transferred to Pfizer Medical Information for further assistance with his question and was referred to HCP. The patient declined to answer any additional questions. He stated his grandbabies, and his wife, all had the stomach virus, and they had not had the COVID-19 Vaccine. He said he went to his doctor last night, and his doctor told him there was a stomach virus in the area, and his stomach virus was not caused by the COVID-19 Vaccine. He said what he was calling about was just related to the stomach virus. He said he was feeling better and wanted to make sure the Imodium AD was not in conflict with the COVID-19 Vaccine. The case was assessed as non-serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I received the Pfizer Bivalent booster on 9/15/2022. On 11/26/2022, I developed a severe headache and had a feeling of general malaise all over. I had a low-grade fever, also, so I took a home antigen test, which quickly yielded a positive result. I had body aches, and my joints were especially painful. By the time the morning of 11/27/2022 came, I couldn't even use my hands, because they were both stiff; I have arthritis in my hands, and the COVID-19 seemed to exacerbate it. My doctor prescribed me PAXLOVID. I began taking PAXLOVID at about 4 PM on 11/27/2022. By the time 11/28/2022 rolled around, I felt significantly better. The symptoms weren't all gone, but I was able to move my hands, and my body aches subsided. I still had a headache, though it was less severe than before. I also still had extreme fatigue. I continued to get better every day afterwards. By 11/30/2022, which was the last day to take the PAXLOVID, I felt much better. The headache had subsided, but I still had residual fatigue. When I took another home antigen test on 12/1/2022, I still had a positive result. When 12/3/2022 came, I felt better, but I got sick later that evening. I had a headache, a runny nose, a low-grade fever, and a slight cough. However, I didn't have any body aches. It felt more like a cold than anything. I tested again that evening and got a very positive result. I tested every 2 days afterwards, and I tested positive each time. I finally got a negative result when I tested again on 12/13/2022. At the time of this writing, I feel fine and like I'm back to normal. I don't even have any residual fatigue now.
Patient received the vaccination on Monday 5/4/2009.  Mother called office on 5/5/09 and stated that child's Right arm where he had received his Dtap vaccination was red and swollen.  RN asked mother if she has put ice on his arm at all and mother stated no.  Advised mother to put ice child's arm for 15 minutes every four hours while awake and to contact office back on 5/6/09 if swellling and redness do not subside.  Mother brought child to clinic on 5/6/09.  Child's right arm was swollen 2 times the size of left, and red.  Redness of arm was approximately 5 to 6 inches in diameter (mother had drawn an ink line around the redness). Mother stated that she did not have a physician, advised her to take him to a physician to be seen in order to rule out any problems.  Mother called office on 5/7/09 and stated that she had taken child to Hospital and he was diagnosed with cellulitus, and given PO antibiotics.  Physician in office on 5/7/09, mother brought child to office for appointment.  Dr. assessed child's arm  Dr. stated that due to the decrease in swelling as reported by mother and the decrease in redness as seen by the redness being far inside the ink line that mother had drawn one day before that this was not likely to be cellulitus, most likely a reaction to the Dtap.
Vertigo/dizzines with associated nausea and vomiting beginning on day 5.  It is not as severe on day 8 but still there.
Sudden  pain started in the evening of January 26th from only the right shoulder to the elbow. It was so painful, she was crying. No pain from the vaccine when it was administered on January 6th or any other time. She believes it was from the shot, and not any thing else
Sudden onset severe 10/10 pain at injection site and underarm which woke me up in the middle of the night associated with severe chills. Slight improvement minutes after taking advil and sleeping on the other side. Pain gets worse with movement.
Information has been received from a 31 year old female consumer with a history of a right shoulder condition and a cyst on her stomach cord who in October 2007, was vaccinated with a dose of Pneumovax 23 while she was hospitalized for double pneumonia. Concomitant therapy included influenza virus vaccine (unspecified) administered on the same day, hormonal contraceptives (unspecified), estrogens (unspecified), trazodone hydrochloride (TRAZADONE) and rizatriptan benzoate (MAXALT). On 04-DEC-2007 around 4:00 pm, the patient went to her physician's office and received another dose of Pneumovax 23. On 05-DEC-2007 around 5:30 am, the patient woke up and her arm was swollen. Then later on that day around 1:30 pm she started to get a fever that went up to 103.2, chills, her skin hurt, her swollen arm got worse, and her body ached all over and she had red blotches on her arm as well. Later that night, the patient went to the hospital and was admitted for about three days. It was reported that the chills, fever, body aches and her hurting skin went away, but her arm is still a little bit swollen and it hurts when she touches it. No product quality complaint was involved. No further information is available.
bSymptom: Dizziness Comment: +/- accompanied pt. nausea, memory loss (short term), fever-intermittent fevers as high as 103, fatigue>60days, Lymphadenopathy, anterior cervical chain-intermittent swelling of nodes in neck, under the arms, groin, etc; sometimes tender, Pain-sharp localized stabbing pain, shooting: intermittent in arms,legs, neck, etc., Abdominal Pain-intermittent, also c/o bloating and diarrhea, fasciculation, Joint pain, multiple joints, muscle pain, cognitive deficiency, tremors, diarrhea, intermittent-see clinical summary for details.
FUSSY - NO FEVER.  EYES ROLLED BACK, CORE STIFFENED, STOPPED BREATHING, FOAMING AT THE MOUTH, HEAD SHOOK. 911 EMERGENCY WAS CALLED.  SHE WAS TREATED FOR A SEIZURE.
Patient started experiencing chest pain, headache about 2 minutes after vaccine. He reported throat tightness, dizziness and difficulty breathing. Epi pen administered at 1405. Patient had nausea after epinepherine. No swelling or rash noted. EMS arived at 1415 and he was transported to the emergency department.
High fever, greater than 103F, axillary. Gave Tylenol and Advil with temp remaining elevated next day when grandparent placed call to vaccine administrator. Advised to have child seen by PCP.
I have a deep venue clot in my left palpate vein 12/17/2021; EKG test was abnormal; Treadmill test was abnormal; I had swelling in my legs 12/13; worst swelling in both legs 12/14; I gained 5 pounds from my swelling; starting a blood thinner today (name of blood thinner medication Eliquis) 12/20/2021.
Within one week after injection -  (L) facial numbness, chest heaviness, coughing, felt crummy, foggy thinking, all lasting 4 weeks - sxs improved briefly in 1st 10-14 days after IV Solu Medrol txs x 2 but then worsened again.
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient's healthcare provider recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 04-SEP-2012, a healthcare provider administered ZOSTAVAX, (lot# and route unknown) to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. On or about 01-FEB-2017, the patient was treated by a physician provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive 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; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
The dose was expired; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 32-year-old male patient who received HAV (Havrix) (batch number H4H53, expiry date 30-JAN-2023) for prophylaxis.   On 24-APR-2023, the patient received Havrix. On 24-APR-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: The dose was expired). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 24-APR-2023 and 26-APR-2023 The nurse reported that a patient was vaccinated with Havrix. The dose was expired on January 30th 2023 and the nurse asked how to proceed?. The Vaccine Administration Facility is the same as Primary Reporter. The reporter did not consented to follow up. This case was found to be duplicate of US2023060925 and all the future correspondence would be added in case US2023AMR060812 which stands as case of record for this patient and the case US2023060925 would be deleted.
Information has been received from a health professional via a Pharmacist concerning a patient who on an unspecified date was vaccinated with Pneumovax 23 (lot# unknown). Subsequently the patient experienced an unspecified reaction and was hospitalized. Medical attention was sought. No other information was available. At the time of reporting it was unknown if the patient had recovered. The unspecified reaction required hospitalization. This is one of two reports from the same source. Additional information has been requested.