chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported in a literature article and described the occurrence of iridocyclitis in a subject who received Meningococcal ACWY-CRM vaccine. On an unknown date, 1 day after receiving Meningococcal ACWY-CRM vaccine, the subject developed iridocyclitis. Serious criteria included GSK medically significant. The outcome of iridocyclitis was unknown. The investigator considered the iridocyclitis to be unlikely related to Meningococcal ACWY-CRM vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of iridocyclitis (uveitis) in a patient aged between 11-and-21 year of unspecified gender who was vaccinated with MENVEO (GlaxoSmithKline). The patient was a part of a self-controlled postlicensure safety that evaluated the safety profile of quadrivalent meningococcal conjugate vaccine in a large cohort aged 11 to 21 years. The patient belonged to the risk window. [In this study, the risk window was 1-42 days: time period in which it was hypothesized that the risk of events might be affected by vaccination-following index vaccination (first dose of vaccination)]. No information on patient's medical history or family history or concurrent condition or concomitant medication was provided. On an unspecified date between 30 September 2011 and 30 June 2013, the patient received MENVEO (administration route and site unknown; dosages unknown; batch number not provided) at a participating medical centre. On an unspecified date, between 1 and 42 days post index vaccination, the patient developed iridocyclitis (uveitis) which was found to be parasitic. Treatment was unknown. The outcome of the event was not reported. The authors considered the event of iridocyclitis (uveitis) to be highly unlikely related to MENVEO. The authors concluded that "This observational study was not intended to provide conclusive evidence of causality. Rather, it detected potential temporal associations between MenACWY-CRM vaccination and adverse events. With nearly 50 000 individuals vaccinated with MenACWY-CRM included in this study, we observed a temporal association between occurrence of Bell's palsy and receipt of MenACWY-CRM concomitantly with other vaccines. The association needs further investigation because it could be due to chance, concomitant vaccination, or underlying medical history predisposing to Bell's palsy". This is 1 of the 8 valid cases reported in the same literature article.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 15-JAN-2015 the patient was received improperly stored VARIVAX (Merck) (lot # reported as R/R ON 6/15, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
I started feeling flush, exp chills and my husband took me to the ER. I was hospitalized, started IV for dehydration.
SOB, hives pt given Epi x 3; 3 different ER visits; also given Decadron, Pred, SOlu Medrol, DPH;
She mentioned that she is unable to go back to the facility for her 2nd dose due to an issue with hearing.; She mentioned that she is unable to go back to the facility for her 2nd dose due to an issue with hearing.; This is a spontaneous report from a contactable consumer or other non hcp from a Pfizer.  A female patient of an unspecified age received bnt162b2 (BNT162B2,Formulation:Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 17Apr2021 as Dose 1, Single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated that she was unable to go back to the facility for her second dose due to an issue with hearing on an unspecified date in 2021. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Narrative: Patient with acute severe hepatocellular and cholestatic liver injury. Liver biopsy suggestive of autoimmune hepatitis pattern. Patient with no known medical comorbidities prior to vaccination. No autoimmune disease history and previously healthy.
hip started to hurt again last night/hip soreness; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (hip started to hurt again last night/hip soreness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 021B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced ARTHRALGIA (hip started to hurt again last night/hip soreness). At the time of the report, ARTHRALGIA (hip started to hurt again last night/hip soreness) outcome was unknown.            No concomitant medication was provided. No treatment medication was provided. The patient would like to take Advil Dual Action to relieve the hip soreness. The patient reported that the hip soreness was totally unassociated with getting the vaccine and the patient had no symptoms following the first dose of the vaccine. The patient moved a few months ago and overused the hip with bending and lifting.
No redness at injection site, but the flabby part of the arm was red(about palm size). Pt said that her arm was sore but that the redness was getting better.
Severe nerve and joint pain. Pain still persisting. Pt reports got sick shortly after and sickness lasted weeks.
I noticed a be be pellet sized nodule on my collar bone on 3/28/21 around 9 PM.  My lymph nodes around my shoulder and arm pit were tender and slightly swollen.  This is not excruciating pain just noticeable.  It is on the left arm where shot was given.  I did not seek medical attention as I read it might be a side effect symptom from the COVID shot.  I don?t have a fever or any other problems.  The soreness in the lymph nodes has subsided, but the pellet sized nodule is still around my collar bone.
Felt like the room was spinning; Very nauseous; Throwing up; Headache; Chills; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Felt like the room was spinning), NAUSEA (Very nauseous), VOMITING (Throwing up), HEADACHE (Headache) and CHILLS (Chills) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VERTIGO (Felt like the room was spinning), NAUSEA (Very nauseous), VOMITING (Throwing up), HEADACHE (Headache) and CHILLS (Chills). At the time of the report, VERTIGO (Felt like the room was spinning), NAUSEA (Very nauseous), VOMITING (Throwing up), HEADACHE (Headache) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient post receiving their first dose of vaccine experienced very nauseous, headache, throwing up and chills. Reportedly, the patient felt like the room was spinning for about 2 days   No Concomitant product use was reported. No treatment information was provided.
pt states that 24 hrs p/vax awake w/c/o nausea, vomiting 203x; denies fever, loose Bm or inject site tenderness; pt admits to anxiety & heavy alcohol sonsumpton on the nite a/; sx self limiting;
Swelling, pain and redness at right arm continued on for less than 2 weeks. Swelling of cervical lymphnodes, fever and muscle aches. Symptom onset day of injection also with ear aches, throat pain, dry cough and chest pain related to coughing.
Patient reported the usual soreness and pain after getting injection.  The pain had increased over the last week and moved to other parts of her arm...toward the hand and toward the neck on the same side as well.  She describes it as an achiness through arm that has radiated.
10/28 in the evening, my throat became sore and was very red by the pharynx.  Accompanied by headaches.    Took acetaminophen 500 mg and ibuprophen 400mg as well as Ricola cough drops.  Slight soreness at sight of vaccination, but not serious.  Did not sleep well, only three hours. 10/29 in the evening (around 9:30pm) developed fever (101F) and nausea.  Vomited for several hours until stomach was empty.  Took Ondansetron HCL 4mg at about 2am.  About 3am vomiting stopped.  Took acetaminophen 500mg.  Fever disappeared and was able to sleep until 8am.  Feel much better and able to eat a small, bland breakfast (oatmeal).  No headaches or nausea.  Still difficult to sleep.
Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium, Additional Details: pt was observed scratching by pharmacist, when queried she showed her fore arms were covered with red rash. pt was immediately given an epipen shot and 911 called , EMTs escorted pt to ambulance for vitals, We called pt in evening at 3.50pm, pt said she was completely fine, rash was almost gone,she said EMTs called ER MD and MD said patient was ok to be released.There were no breathing issues.and was observed for a 20 min interval in store again. Pt said she was calling her PCP on monday to f/u
Initial misuse report received from a healthcare professional on 01 April 2013. A patient was administered an expired dose of MENACTRA. No information was provided regarding the patient. No adverse event was reported. List of documents held by sender: none.
This is a spontaneous case, initially received from pharmacist on 29-Oct-2018, concerning a 55-year-old, adult, male patient. The patient had no relevant medical history and concomitant medications. On 29-Oct-2018, the patient (less than 65 years) was administered FLUAD (TIV) dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, expiry date: 30-Jun-2019 and batch number: 250804) (explicitly coded as inappropriate age at vaccine administration). At the time of the report, no adverse events were reported. The reporter assessed this case as non-serious.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 1:56 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 1:56 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 50.49 years.  No concomitant medications were reported.  On 03-Apr-2021, at 09:00 AM, vial underwent excursion with temperature of 34. This vial was moved to fridge on 30-Mar-2021 and beyond use date for the vial was reported as 29-Apr-2021. Product moved to clinic on 03-Apr-2021. 20 vials were sent to clinic. Condition of vaccine prior to administration was not frozen.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
Redness, swelling, itching, pain and tenderness and slight bruising at and around injection site on second day after vaccination lasting about five days;about two weeks later, runny nose and sneezing plus about three weeks later, numerous small red, itchy splotches.  These latter effects have lasted about two weeks--the splotches remain after about four days.
resident had vomiting and fever start on 10/11/23 through 10/13/23.
Low grade fever, sever body ache, chest highness and congestion, headache, some SOB. Inflammation and  on injection site left arm  and warm to touch. the injection site pain extended to left shoulder, loft jaw and left upper back.
shortness of breath/ she is gasping for air.; This is a spontaneous report from contactable Physician. A 69-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on 16Aug2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On unspecified date of Aug2021, the patient experienced shortness of breath. Reporter stated that patient had been having shortness of breath when talking. She had been fine when going up and down stairs and when walking. But when talking it's like she is gasping for air. The event was assessed as non-serious. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Pt given injection at 1015. Did well with injection initially but asked father to pick him shortly after. Started sweating, got pale, asked for something to drink. Remained very pale for about 20 minutes. Did not lose consciousness. Pulse 108, respirations 20, O2 Sats 98% RA. Stated he had a tummy ache. Retched once. Given apple juice 8oz. Stated he was feeling better around 1100. Color returned to patient.
This case was reported by a nurse and described the occurrence of inappropriate age at vaccine administration in a 16-month old unk patient who received KINRIX. On an unknown date, the patient received KINRIX at an unknown dose. On an unknown date, an unknown time after receiving KINRIX, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.
Flu like symptoms; extradose; This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a 67-year-old male patient who received Herpes zoster (Shingrix) (batch number 2YN4S, expiry date 9th July 2021) for prophylaxis.   On 11th April 2019, the patient received the 3rd dose of Shingrix. On 11th April 2019, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were reported as follows: The pharmacist reported that, the patient received a 3rd dose of Shingrix, which led to extra dose administered.   Follow up information received from pharmacist on 24th July 2019: The patient's demographic details were updated. The patient received 3 doses of Shingrix in deltoid muscle.  Prior 2 doses were in August 2018 and November 2018, in checking the patient profile it was missed. The patient received the 3rd dose of Shingrix via intramuscularly .5 ml.  On an unknown date, less than 3 months after, the patient experienced flu like symptoms that could resulted. The outcome of the flu like symptoms was unknown.  It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix. The VAERS details were updated. This case was a medication error with harm
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 61-year-old male patient who received SHINGRIX for prophylaxis. On 17th February 2018, the patient received the 1st dose of SHINGRIX. On 18th February 2018, 1 days after receiving SHINGRIX, the patient experienced influenza-like symptoms and shivering. On 19th February 2018, the outcome of the shivering was recovered/resolved. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. The reporter considered the influenza-like symptoms and shivering to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine in left arm. The patient stated that he received his SHINGRIX dose in February 2018 and the next day he experienced flu-like symptoms and shivering. The patient stated that these symptoms resolved after 1 day. The patient was not comfortable in providing address and had denied permission to contact their physician.
Left deltoid cellulitis of 4" x 4". Red, warm to touch, tender to touch, itching at red area.
received  2nd booster vaccination at 0900, reported feeling "fuzzy headed" approx  0915, denied any previous reactions to vaccination, reported no recent illnesses but was observed to have a cough but reported no recent illnesses or underlying medical issues, patient became pale,  diaphoretic, nausea, and episodes of responding only to verbal stimuli,  vitals were taken with bp 162/100, O2 97%, pulse 62,  proceeded to c/o head and arm feeling fuzzy and right arm pain also, EMS was called and patient was transported to local hospital
100F fever from 2pm - 6pm. 98F at bedtime. Normal temperature in the morn upon awaking at 6:30am.
Pt began experiencing nausea and felt as though she was going to pass out. She experienced slight light headache and dizziness. Symptoms began apprx. 2 hours after vaccination and lasted about one hour.
1 of 2 pts vaxed from the same vial exp an inject site react which included erythema (size of a grapefruit) & a knot (size of a goose egge); react appeared to be a sterile abscess; required ER/MD visit;
Soreness in upper left arm (injection site) which became noticeable about 11 hours after injection; The discomfort was minor; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 25Feb2021 at 12:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received flu vaccine (MANUFACTURER UNKNOWN) via an unspecified route of administration in the upper left arm for an unknown indication from an unknown date. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 25Feb2021 at 23:00, the patient experienced soreness in upper left arm (injection site) which became noticeable about 11 hours after injection. The discomfort was minor. However, he usually had not been this reaction to other shots (i.e. flu vaccine) was given in the same location. The patient was a Pfizer employee and received the shot at his normal work location. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events soreness in upper left arm (injection site) which became noticeable about 11 hours after injection and the discomfort was minor was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
3/14/03, 6pm - intense dizziness lasting 5-10 seconds followed by elevated BP ~210/110.  BP remainded elevated (170/102) x 3 days.  Saw MD on 3/17/03 - BP meds increased.
I have had very mild peripheral neuropathy due to  a benign spinal cord tumor that was removed  4 years ago.   A few days after my 2nd Pfizer shot, my neuropathy greatly increased with tinge and burning in my legs for about a month after the shot.  The neuropathy is improving but is still worse than before the shot.
2 Hemorrhages - Left Eye; Swollen Lymph Nodes - Left Side of Body; Arm Pain - Near Injection Site; A spontaneous report , was received from a  health care professional, concerning a 65-year-old female patient, , who was administered Moderna's COVID-19 vaccine (mRNA-1273) and experienced 2 hemorrhages - left eye/eye hemorrhage , swollen Lymph Nodes - Left Side of Body/lymphadenopathy and arm pain - Near Injection Site/injection site pain.  The patient's medical history and concomitant history was not provided by the reporter , no lab data was reported .    on 04 MAR 2021 the patient received the first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in left arm for prophylaxis of COVID-19 infection.  On 13 MAR 2021, the patient experienced  2 Hemorrhages - Left Eye , Swollen Lymph Nodes - Left Side of Body, Arm Pain - Near Injection Site. The treatment included were acetaminophen and ibuprofen.  The Action taken with the first dose of mRNA-1273 in response to the event was not reported.   The  outcome of the events, 2 hemorrhages - left eye/eye hemorrhage , swollen lymph nodes - left side of body/lymphadenopathy and arm pain - near Injection Site/injection site pain  were considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
I had a sore arm after receiving the vaccine for about two days. I have allergies so I have a runny nose and itchy eyes. I tested positive for COVID-19 on 01/19/2023. I contacted my doctor and got prescription of 5-day regiment, and I tolerated it without any issues. As of today, I do not have any lingering symptoms and feel back to normal.
Hearing loss right ear. Rash with acyclovir 200mg oral capsules for 10 days.