chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This non-serious initial spontaneous case, was received from other health professional (nurse) on 03-Oct-2017, concerning a 61-year-old adult female patient. The patient had no relevant medical history. On 03-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, batch number: 195124 (as reported), expiry date: Apr-2018, route of administration and anatomical location: not reported). On the same day (in night) (as reported), the patient experienced injection site redness, swelling, hardness, pain, which were hot to the touch. It was reported that, the patient felt redness and hotness of arm. O9-Oct-2017, the patient recovered from the events. The reporter assessed the report as non-serious. Follow  up received from reporter (nurse) on 25-Oct-2017: The outcome of the events was changed from not recovered to recovered on 09-Oct-2017. Amended narrative accordingly. Significant case correction received with IRD 03-Oct-2017: The event coding was corrected from 'injection site lump' to 'injection site induration for the event verbatim 'injection site as [red], swollen,] hard[, painful and hot to the touch]'. Labelling and causality of the event 'injection site induration' was updated accordingly. Listedness of the event 'injection site swelling' was corrected from listed to unlisted in CORE flu vaccine cell subunit NVD. Significant case correction received with IRD 03-Oct-2017: The event coding of the verbatim 'injection site as [red,] swollen,] hard [,painful and hot to the touch]' was corrected from 'injection site lump' to 'injection site induration' and labeling was corrected accordingly. The listedness of the event 'injection site swelling' was corrected.
feels anxious; severe diarrhea; fever; tightness in his thighs and hip; Initial information received on 12-Dec-2022 regarding an unsolicited valid serious case from a pharmacist.  This case involves a 23 years old male patient who had severe diarrhea, fever, tightness in his thighs and hip and feels anxious after receiving vaccine diphtheria-2/tetanus/5 AC pertussis vaccine [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On 08-Dec-2022, the patient received a booster dose 1 at dosage 0.5 mL of suspect diphtheria-2/tetanus/5 AC pertussis vaccine, Suspension for injection Once (strength, lot number, expiry date: not reported) via intramuscular route in the left arm for immunisation.  On 10-Dec-2022 the patient had severe diarrhea (diarrhoea), fever (pyrexia), tightness in his thighs and hip (muscle tightness) (Latency: 2 days) following the administration of diphtheria-2/tetanus/5 AC pertussis vaccine. On 12-Dec-2022 the patient feels anxious (anxiety) (Latency: 4 days) following the administration of diphtheria-2/tetanus/5 AC pertussis vaccine.   It was reported "as her son got the shot Thursday morning and starting on Saturday, he experienced severe diarrhea, fever, and tightness in his thighs and hip. She says that the tightness died down by a lot yesterday but patient feels anxious today".  No lab data was reported.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events.   Seriousness criteria: Medically significant events severe diarrhea, fever,  feels anxious, and tightness in his thighs and hip.  The outcome was Recovering / Resolving for the event severe diarrhea,  fever,  feels anxious and Recovered / Resolved on an unknown date for the event tightness in his thighs and hip.; Sender's Comments: Sanofi company comment Follow up dated 14-Dec-2022:  This case involves a 23 years old male patient who experienced severe diarrhea, fever, feels anxious, and tightness in his thighs and hip after receiving diphtheria-2/tetanus/5 AC pertussis vaccine. Furthermore, information regarding condition at the time of vaccination, role of medical history, concomitant medications and vaccination history excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Difficulties swallowing; Product Complaint; Hives; This case was reported by a nurse via call center representative and described the occurrence of hives in a 22-year-old male patient who received HBV (Engerix B adult) (batch number 9AX5P, expiry date 23rd November 2023) for prophylaxis. This case was associated with a product complaint.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concurrent medical conditions included type i diabetes mellitus.   On 23rd November 2021, the patient received the 2nd dose of Engerix B adult (intramuscular) and Engerix B Pre-Filled Syringe Device. In November 2021, less than a day after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced hives. On an unknown date, the patient experienced swallowing difficult and pharmaceutical product complaint. The patient was treated with prednisone. On an unknown date, the outcome of the hives was not recovered/not resolved and the outcome of the swallowing difficult and pharmaceutical product complaint were unknown.   The reporter considered the hives to be related to Engerix B adult and Engerix B Pre-Filled Syringe Device. It was unknown if the reporter considered the swallowing difficult to be related to Engerix B adult and Engerix B Pre-Filled Syringe Device.This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received Engerix-B dose and within 12 hours of vaccination, he developed hives all over his face, neck, chest and back.  The patient saw his primary physician and was prescribed prednisone. The hives resolved but return every evening.  Less than 3 weeks after vaccination, the patient also experienced difficulties swallowing. The action taken with Engerix B adult was no change. The reporter believed the hives were related to this lot number.  The reporter reported that neither she nor anyone else had previously reported this complaint to GlaxoSmithKline.  The reporter was uncomfortable using this lot number for any additional patients. The reporter stated that the Engerix-B box had 2 syringes used from it and 8 syringes remained. There was no obvious visual defect noted to the box or syringes. The reporter ordered additional Engerix-B and received four more boxes of this same suspect lot number.  The reporter would retain the vaccine in question until GlaxoSmithKline contacts her.  The reporter consented to follow up. The case had been linked to US2021252035, reported by the same reporter. Note: There was discrepancy regarding the event difficult swallowing, during clarification it was not clear which patient had this event only guess was made through the notes that the male patient had, therefore conservatively difficult swallowing was coded in both cases.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021252035:Same reporter. Pt 1/2.
Reported feeling faint and nauseated during observation period.  Placed on cart in trendelenberg
Possible Sun sensitivity increased.  Sun burned 2 times this year. This last one today was only in the sun for a combined 30 minutes.
planned ileostomy tomorrow in the setting of neurogenic bowel and multiple sclerosis. COVID is pending.
Case number PHHY2014US022024 is an initial spontaneous report from the nurse received on 29 Oct 2014. This report refers to a 70-year-old male patient. He was vaccinated with FLUVIRIN (batch number: 1411401) intramuscularly at a dose of 0.5 ml on 19 Oct 2014. On the same date, after vaccination he experienced muscle pain in the arm that received the FLUVIRIN injection. He also experienced soreness, discomfort and limited motion in the left arm. The final outcome of the events was unknown. The seriousness and causality of the events were not reported.
Required hour after vaccination, patient had a fever of 103.5 and she was treated with Ibuprofen and Tylenol. She had difficulty talking (slurred speech, described by her mom that she sounded like she was intoxicated, nausea, chills fatigue, cough, sore throat, runny nose, dizziness, headache, joint pain and neck stiffness. After 24 hrs her fever came down. She was brought to the ER and prescribed Ibuprofen and Tylenol, with adjusted dosage. No antibiotics were given. She suffered a total of 5 days. As of 01/04/2010 she still has a reduced appetite but is otherwise doing well.
Large (9 cm round) area of redness, warmth and tenderness. No better with BENADRYL/TYLENOL. Cool compress.
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 63-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 63 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 17Feb2021 as dose 1, single (Lot number: EN6201), in left arm, on 10Mar2021 as dose 2, single (Lot number: EN6203), in left arm, on 09Nov2021 as dose 3 (booster), single (Lot number: FG3527), in left arm and on 10Apr2022 as dose 4 (booster), single (Lot number: EJ4939), in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing); "allergy induced asthma" (unspecified if ongoing); "post menopausal vaginal atrophy" (unspecified if ongoing), notes: post menopausal vaginal atrophy; "visual migraines" (unspecified if ongoing); "migraine headaches" (unspecified if ongoing); "high eye pressures" (unspecified if ongoing), notes: high eye pressures. Concomitant medication(s) included: LUMIGAN, start date: May2013; ALLERGAN, start date: May2013; ESTRADIOL, start date: May2013. Past drug history included: Ampicillin, reaction(s): "known allergies: ampicillin", notes: known allergies: ampicillin; Ceclor, reaction(s): "known allergies:ceclor", notes: known allergies:ceclor; Keflex, reaction(s): "known allergies:keflex", notes: known allergies:keflex; Tetracycline, reaction(s): "known allergies:tetracycline", notes: known allergies:tetracycline; Erythromycin, reaction(s): "known allergies:erythromycin", notes: known allergies:erythromycin. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  The patient started anti-viral treatment with Paxlovid on26Dec2022 to 30Dec2022 for the treatment of COVID-19. Other medication in 2weeks product: Estrace tabs.
This spontaneous report was received from a nurse practitioner refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with the first dose of VARIVAX, dose, route and frequency unknown. On 13-MAY-2013, the patient was vaccinated with improperly stored VARIVAX dose 2, lot#: 0610AE. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
This is a spontaneous report from a contactable nurse communicated to a Pfizer sales representative. This nurse reported similar events for 4 patients. This is the fourth of four reports. A patient of unspecified age, ethnicity and gender, started to receive PREVNAR 13 (Lot #: S43277, Expiration date: Sep2018,NDC number: 0005197101), via an unspecified route of administration on an unspecified date at single dose for routine immunization. The patient's medical history and concomitant medications were not reported. The patient called into the office about experienced redness, swelling and a hard knot at the injection site lasting for several days, on an unspecified date (reported as within the last 2 weeks). The nurse reported administering the product with possible quality issue to the patient.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017400561 similar report from same reporter
I received dose 1 of Pfizer COVID-19 vaccine on Feb 24.  The initial symptoms starting Feb 25 were somnolence, mild muscle stiffness and dizziness that lasted approx 5-6 days but gradually resolved.  Approx 3 days after the shot I developed chills, which took approx 2 weeks to resolve.  As for neurologic symptoms, approx 6 days after the shot, I experienced a worsening of my peripheral neuropathy that is still ongoing >2 weeks since dose 1 (normally very mild at baseline and mostly limited to the feet).  This exacerbation manifested primarily as stockings/gloves sensation to the mid-calves and elbows/mid-upper arms. I have also experienced some tingling in hand/feet and a notable cold sensation in the feet (worst in the toes- when I step into hot water in the shower, the feet/toes become quite painful and a transient blotchy redness appears on the feet).  The stockings/gloves sensation and foot coldness persist though approx 50% better than when it started.  No muscle weakness or myalgias accompany these symptoms.  I am concerned about receiving my 2nd dose on March 26 given the ongoing presence of symptoms from the first.  I have scheduled an appt to discuss with my Rheumatologist. My Neurologist is unsure I should receive 2nd dose.
From initial information received on 10/6/04 from a registered nurse regarding an adverse event occurring in the USA, it was reported that a 24 year old male patient received TD ADS ADULT vaccination, lot number U1347AA, administered in the right forearm, and a TUBERSOL 5 TU skin test, lot number C1602AA, administered ID in the right forearm on 10/4/04. Two days later on 10/6/04, the patient developed redness, warmth to the touch, induration the size of a nickel and slight itching. The TD ADS ADULT was inadvertently administered ID. It is unknown if the patient recovered from these events.
pt stated after she got the vaccine her arm was sore and she became lethargic.  She becomes lightheaded and dizzy when trying to do normal activities.  The dizziness was intermittent .  She became concerned so spoke to the pharmacist about it.  They told her to contact her PCP.  She had a televisit with PCP and was told it was safe to take second dose.  She received her 2nd dose on 5/18/22 which is the same lot number. After 2nd dose she developed these same symptoms immediately except they were back to back continuously.   She had to go to the ER where they ran test but could not find anything.  She was given motion sickness medicine and to FU w/ PCP.   She states it feels like vertigo and she is still experiencing these symptoms at this time.   Patient does not wish to disclose her medical records w/ CDC.
Severe splitting headache for 3 days Flushing for 2 days Burning feeling at the injection site right after injection for 2 days Moderate Pain at the injection site for 5 days Muscle weakness and aches, mild for 2 days Difficulty with concentration   Feeling tired for a few weeks
Immediately, post vax, pt had a brief episode of shaking. Has continued to have them about 3 times a day. Neurologist dx'd benign myoclonus of infancy. Pt had never had this before shot on 9/15/00. He developed hives on 9/16/00 on right leg, hip, chest, neck, face and left leg.
Day 1 - paresthesias hands and feet. Day 2 - weakness left. Day 4 - shallow breathing, continued leg weakness, shortness of breath, fatigue, tremors, burning sensation in arms and legs - unable to ambulate secondary weakness, labile BP - elevated blood pressure with orthostatic hypotension, burning chest/back indigestion - Physical therapy. Placed on blood pressure meds and and reflex.   12/8/09 and 12/9/09 Discharge summary and hospital records received for dates of service 10/27/09 to 10/30/09.  Dx:  Paresthesias of the extremities with hypertension.  Presented with increased weakness of left foot. Tingling of hands and feet, SOB, HA.  Burning of upper arm across face.  Increased heart rate and blood pressure with flushing.  Paresthesias with subjective dyspnea, fatigue.  Feeling of shaking chills with no fever.  IVIg initiated.  GBS eventually ruled out.    12/21/09:  Hospital records received for dates of service 11/3/09 to 11/5/09.  Dx:  Dysautonomia features.  Uncontrolled HTN.  Cannot R/O Conversion D/O.  Multi systematic and symptomatic condition without evidence of objective evidence of neurologic disorder. Presents with hx of dysthesia, involuntary motor movements and spells that evolved after seasonal flu shot and H1N1 injections.  C/o feeling cold, clammy, weak in lower extremities, rapidly migrating numbness and burning sensation from both extremities up toward torso, shoulders and back.  Low grade fever and hot flashes as well as uncontrolled blood pressure.
Severe stomach ache, diarrhea, headache,dizziness,coldness, and loss of consciousness.  After passing out I fell and hurt my face and pump my head.  For a few hours I was dizzy.  The rest of the day I was tired,but all symptoms were gone. The site were the vaccine was administered got swollen and red. Today look fine.  Did not call my doctor because I started feeling better and I don't seem to have any adverse damage.
Patient had developed a sever case of shingles.  She has had them before but never this bad.  It appears on the same side (left) as she got the shot in.  It has even affected her eye.  Now she is hesitant to get the second shot next Saturday and likely will not be able to due to this illness.  If she takes it it will probably be at the end of the maximum allowable time, which is 60 days I believe.    Have researched this on line and there do appear to be some related cases of shingles associated with COVID 19 and the vaccine
Feeling of warmth; A weird taste in her mouth; Swollen injection site; vaccination site pain; Redness in the injection site that spread and looked like when you fell and the upper layer of your skin scrapes off; Arm feels itchy; A spontaneous report was received from a nurse who was a 51-year-old, female patient who received Moderna's COVID-19 Vaccine, and who experienced a weird taste in her mouth, feeling of warmth, pain, swollen injection site and redness in the injection site that spread and looked like when you fell and the upper layer of your skin scrapes off, arm started to feel itchy and the injection site turned into a bump.  The patient's medical history was not provided.  Concomitant product use was not provided by the reporter  On 30-Dec-2020, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (LOT# 034K20A) intramuscularly for prophylaxis of COVID-19 infection.   Patient received the Moderna vaccine on 30-Dec-2020.  Initially, she experienced a weird taste in her mouth and a feeling of warmth.  She also reported pain, swelling and redness at the injections.  She stated that the redness spread and looked like when you fall and the upper layer of skin gets scraped off.  On 02-Jan-2021, she reported that her arm started to feel itchy and the injection site turned into a bump.  She was concerned since her side effects still persisted a week after injection. Treatment for the events included paracetamol.   Action  taken with mRNA-1273 in response to the events was not provided.  The outcome of the events, a weird taste in her mouth, feeling of warmth, pain, swollen injection site and redness in the injection site that spread and looked like when you fell and the upper layer of your skin scrapes off, arm started to feel itchy and the injection site turned into a bump, was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Information has been received from a physician concerning a 12 month old male who on 5/20/2005 was vaccinated with a dose of varicella virus vaccine live (lot 648935/0829P). On 5/28/2005 the patients mother called the office to report that he developed a varicella rash at the site of vaccination. It was noted that he has since recovered from the rash. No other information was provided. The patients brother WAES0506USA02820 had pox marks following vaccination with varicella virus vaccine live. Additional information has been requested.
I started about 5-7 days after my booster having intense full body itching and I would scratch and I would get raised large red welts. I reached out to both my primary Doctor and dermatologist, They recommended Alegra. It still there, I have bruises on my legs from scratching and I will see my dermatologist soon. I have tried all different creams , nothing has worked.
Within a couple hours after injection began experiencing atril fibrillation, sent Kardia EKG to my cardiologist via patient portal  and he confirmed atril fibrilation;  Today, 9/22 have converted to sinus rhythm.  Dr, office
Headache developed that afternoon.  Since then he has been having intermittent headaches.  Was not prone to headaches in the past.
Between 26Jul2021 - 13Aug2021 fainting, chest pains for couple weeks and shortness of breathe and dizziness - dose 2 - in march2021.  Saw doctor 16 Aug2021.
Patient came to the pharmacy to receive his first COVID-19 vaccine.  The patient was very nervous about vaccines.  He was ok during the vaccine.  Shortly afterwards ,he said he was light-headed.  I immediately advised the patient to sit on the ground (he was sitting in a chair).  He was able to sit on the ground and was in the process of laying down when he lost consciousness.  He regained consciousness very shortly after.  We contacted emergency services and management.  Emergency services checked the patient out and he was able to walk out on his own.
Vaccine at 6:00 PM Thursday, 3/4/21, symptoms started Friday afternoon  3/5/21 (About 20 hours after vaccine) my cheeks and eyelids became slightly red and felt irritated and felt like a bad sunburn..  Woke up on Saturday 3/6/21 at 8:00AM and the left side of my face and eye was swollen and red rash covered most of cheeks on both sides and well an the entire eyelids on both eyes as well as my far head.  Was very painful and felt like a bad burn. Went to Urgent Care and was prescribed over the counter products and said rash is most likely a related  to Covid Vaccine and to report it to VAERS.  As of 6:45 PM on 3/7/21 as I am filling this out my face is still the same as it was Saturday still red in the same places and still sore.
Swelling and Redness in left arm beginning the evening after immunization and continuing for 4 days. No additional treatment sought, reaction resolved on its own.
I haven't been able to walk nor stand without very sharp pain in my left lower side.I Been experiencing really bad spasms whenever i stand or sit down.
PATIENT WAS SCHEDULED FOR MODERNA 2ND DOSE BUT GOT PFIZER INSTEAD