chrisvoncsefalvay/vaers-outcomes huggingface dataset:
"extreme pain at injection site"; hallucinations; inappropriate schedule of vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of hallucination in a 86-year-old female patient who received Herpes zoster (Shingrix) (batch number PF454, expiry date 26th November 2022) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 29th November 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 29th November 2019, less than a day after receiving Shingrix and 38 days after receiving Shingrix, the patient experienced injection site pain (serious criteria hospitalization) and drug dose administration interval too short. In December 2019, the patient experienced hallucination (serious criteria GSK medically significant). On an unknown date, the outcome of the hallucination was not recovered/not resolved and the outcome of the injection site pain and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the hallucination and injection site pain to be related to Shingrix.  Additional details were provided as follows: On 22nd October 2019, the patient received 1st dose of Shingrix. The patient received dose of Shingrix in the right arm. The health care professional reported that, less than recommended 2 months schedule from 1st dose of Shingrix, the patient received 2nd dose earlier, which led to shortening of vaccination schedule. The patient's daughter called to report that, within hours after vaccination, the patient had extreme arm pain at the injection site. Less than a day after vaccination, the patient had injection site pain. The reporter stated that, called on the day of reporting to check on the patient and the patient's daughter reported that, the patient was admitte in the hospital on 29th November 2019 and was now hallucinating. Less than a week after vaccination, the patient had hallucination. The reporter consented to follow up.
His voice started go; His voice completely went out, You can barely understand him; This is a spontaneous report from a contactable consumer (patient's wife). A 63-years-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: ER8729, Expiry date: Unknown) via an unspecified route of administration on 21Jul2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced his voice started go, his voice completely went out, you can barely understand him. Patient went to walk-in clinic and they gave him a 'z-pack' (not clarified). The patient underwent lab tests and procedures which included weight: about 209 lbs on an unspecified date. It was reported that patient didn't receive any treatment for the events. The outcome of the event was unknown.
No adverse event, patient due for DTaP and Quadracel was given by mistake. Patient received DTaP and Polio instead of just DTaP. Polio was not due at the time of service.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Information regarding medical history and concurrent conditions were not provided. On 12-APR-2016, the patient was inadvertently vaccinated with a dose of PNEUMOVAX 23 which had lot # of K020215, that had expired on 23-MAR-2016 dose, (dosage number, route of administration were not provided); although no adverse events were reported. Additional information has been requested.
Narrative:  COVID infection after completion of COVID vaccines series: 03/02/2021 COVID vaccine dose #1 03/30/2021 COVID vaccine dose #2 07/09/2021 Pt reported onset of fatigue, HA, and nausea/upset stomach. Stated that had close contact with COVID positive case (grandchildren) 07/15/2021 Pt requested to be tested due to still feeling poorly 07/16/2021 COVID positive per facility nasopharyngeal swab 07/17/2021 Pt reported improvement of symptoms 07/18/2021 Pt reported continuation of fatigue 07/19/2021 Pt reported feels "100%" 07/19/2021 Clinical resolution of COVID infection per CDC guidelines
Description AV: One day after receiving the vaccine, I experienced a day of fever, chills, muscle aches. This is not my typical response to vaccinations I have received in the past. These symptoms lasted for about 48 hours. I slept and took TYLENOL for the symptoms. I also drank hot tea for my symptoms. I completely recovered from my symptoms within 48 hours.
fever 102 +, painful left upper arm, chills;; pt cant move arm at all
This spontaneous case, initially received on 19-Sep-2016, was reported by a non health professional and concerns a female patient. Weight: not provided; Height: not provided. The patient's medical history is unknown. Administration of company suspect drug(s): On an unknown date, the patient received Influenza Virus Vaccine (INN). Dose regimen: Not reported, Route of administration: Unknown. Batch number: Not reported. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date following vaccination, the patient reacted badly to high dose flu vaccine (outcome: recovered / resolved). The reporter considered the event non-serious.
Information has been received from a registered nurse concerning a preschool aged male who was vaccinated when he was younger with a first dose of measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live.  Subsequently, the patient developed a seizure one week post vaccination.  It was unknown if the child was treated or hospitalized at the time.  Unspecified medical attention was sought.  There was no product quality complaint involved.  Upon internal review seizure was considered to be another important medical event.  Additional information has been requested.
Lipschutz ulcers - pain 2 days after booster, major ulcers 3 days after booster; originally sent home with Clobetasol and Lidocaine. Required high dose prednisone to resolve and Oxy for excruciating pain.
patient fainted 5 minutes after receiving pfizer vaccine. became alert after 30 seconds. school nurse attended to patient and checked vitals - bp was low and final bp returned to levels within range after 30 minutes. mother took patient homE
Information has been received from an 82 year old female consumer with a history of shingles (February and April) who on 08-MAY-2007 was vaccinated with a single dose of Zostavax (Oka/Merck).  Concomitant therapy included calcium (unspecified) and vitamins (unspecified).  In "early June 2007" the patient developed an echoing in her ear and a headache in her forehead.  Unspecified medical attention was sought.  A hearing test was performed results not reported.  At the time of this report the patient had not recovered.  No further information was provided.  There was no product quality complaint involved.  Additional information has been requested.
rash on arm; 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 VACCINATION SITE RASH (rash on arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (rash on arm). At the time of the report, VACCINATION SITE RASH (rash on arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Red and swollen arm. Pain. Headache. Fatigue. Arm felt warm.
Injection site pain; tiredness; muscle pain; chills; joint pain; injection site swelling; injection site redness; feeling unwell; severe allergic reaction; rash; itching; hives; swelling in the face; loss of taste; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 58-years-old male patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8736), via an unspecified route of administration, administered in Arm Left on 23Apr2021 09:30 (Age at vaccination: 58-years-old) as dose 1, single for covid-19 immunization. (Vaccination facility: Other). Medical history was reported as none. There were no concomitant medications. Patient did not receive other vaccine in four weeks. Patient did not receive Other medications in two weeks. Patient was not diagnosed with covid prior to vaccination. On 25Apr2021 patient experienced Injection site pain, tiredness, muscle pain, chills, joint pain, injection site swelling, injection site redness, feeling unwell, severe allergic reaction of rash itching hives, swelling in the face, loss of taste. Patient was no tested for covid post vaccination. patient did not receive any treatment for the events. The outcome for the events was reported as resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
numbness and tingling in hands and feet; lungs felt heavy; night sweats; gastrointestinal issues; rash on face and neck; fatigued; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (numbness and tingling in hands and feet), RESPIRATION ABNORMAL (lungs felt heavy), NIGHT SWEATS (night sweats), GASTRIC DISORDER (gastrointestinal issues) and RASH (rash on face and neck) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included FISH OIL and VITAMIN D NOS for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced PARAESTHESIA (numbness and tingling in hands and feet), RESPIRATION ABNORMAL (lungs felt heavy), NIGHT SWEATS (night sweats), GASTRIC DISORDER (gastrointestinal issues), RASH (rash on face and neck) and FATIGUE (fatigued). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 04-Mar-2021, GASTRIC DISORDER (gastrointestinal issues) had resolved. On 05-Mar-2021, RESPIRATION ABNORMAL (lungs felt heavy) had resolved. On 06-Mar-2021, PARAESTHESIA (numbness and tingling in hands and feet), RASH (rash on face and neck) and FATIGUE (fatigued) had resolved. On 08-Mar-2021, NIGHT SWEATS (night sweats) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Upon internal review on 21-May-2021, the age was corrected to unknown.
Flu Mist had an expiration date of 12/26/22, vaccine was given on 12/28/22
Immediately after receiving the shot at 10am, I felt flushed and had pain at injection site. this lasted for an hour or so and slowly faded into a dull aching in my arm and general fatigue throughout my body over the course of the next 8 hrs. I attempted to go for a walk after work about 6pm and noticed I was having irregular heartbeat with some rapid heart rate . I stopped walking because of these symptoms and drove home. I continued to feel tired with periodic rapid heart rate until bedtime. I got into bed about 10:15pm and by 10:30 pm I began a full onslaught of symptoms: I was flushed, fever of 102 F, I was sweating and shaking uncontrollably with chills and constant teeth chattering. I sweat through 2 frozen ice packs, had extreme dizziness when sitting up, weakness in arms and hands and legs. I could not take myself to toilet, needed assistance with transferring, toileting and drinking a glass of water. My neck and temples were throbbing in the veins causing a tremendous headache. I could not sleep  but was afraid to take any medication for how it might react . My husband assisted me in getting water every 30 mins or so. The chills/shaking lasted until about 4 am. At 630am I had to get up for work, so I took OTC ibuprofen which did help my headache. My fever dropped down to 99 F as well by mid day on 10/15. Over the last three days I continue to hover about 1 degree above regular body temperature and still feel very fatigued with a headache that only subsides with routine dosing of ibuprofen. Most concerning, I am continuing to have cycles of irregular heart beat with rapid heart beat and the sensation of a "skipped beat".
Normal short term reaction; swelling at site, tired feeling 3-4 days. Approx. 30 days later experienced significant swelling in both legs and feet.  I have never had edema prior to this date. Edema has persisted since. Dr. testing has ruled out heart(imaging test), kidney(test) or other organ issue. Blood work returned positive/high RNP Antibodies. Dr has indicated symptoms of lupus and has referred me to a  specialist. Dr. has started diuretics once per day as I gained 20 pounds in 4 week period. Swelling has reduced in legs but feet remain swollen. Now I'm feeling pain in my body OTC no relief. Very good health prior vaccine
Patient was irritable and more tired than usual for the remainder of the day after receiving six month vaccinations,  Infantile Spasms first recorded on 11/10/2018 at 9:35am. Episodes/Clusters of spasms increased in frequency and intensity until finally diagnosed with EEG on 12/07/2018.  Developmental  skills were also lost between receiving vaccines on 11/05/2018 and diagnosis of Infantile Spasms on 12/07/2018(child stopped rolling, stopped babbling, stopped smiling and laughing, and became less alert)
Approximately 4 hours after receiving vaccine, dizziness, headache, nausea with vomiting . Temperature 100.9 degrees F. No medical treatment, symptoms continue for approximately 32.
Administration error: Pt received 0.25 mL of Moderna but is under age 18. Should have received Pfizer booster. So far pt has not had an adverse reaction.
Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 80 year old female pt. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 05-NOV-2007, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, route, dosage schedule, lot number and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the pt experienced herpes zoster and she was treated by a healthcare provider. The outcome of herpes zoster was not specified, and the reporter considered this event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Pt was seen in the ED for tongue swelling, chest and stomach pains, diaphoresis, acid reflux. These sx started 2 minutes after getting the vaccine. Pt was given benadryl on site, he was stable by the time he got to the ED for triage and was not given epinephrine. BP was stable, did not drop below 112/84. He was triaged but not admitted. Had f/u appt w me today. Pt was vaccinated at  Events Center
Approx 6:30 PM, felt swelling in arm and hardness in arm. Soreness in shoulder blade area. Could not lift arm without pain.
Initially day two there was swelling and pain at injection site which subsided in two days.  On day 10, after a workout, arm swelled - hard knot at site, unable to determine redness as there is dark tatoo in the area.  Burning and very hot - applied ice packs and this lasted two days.  Extremely uncomfortable.  Still has small not but bearable.
Information has been received from a physician concerning a 17 year old female with sulfonamide allergy who on 04-APR-2007 was vaccinated IM with the first dose of Gardasil. Concomitant therapy included allergy medicines. On 04-APR-2007 the patient was vaccinated and two hours later broke out in a rash. The rash looked like the type of rash from a sulfa allergy rather than hives. The physician gave the patient Benadryl and the patient recovered on 08-APR-2007. Medical attention was sought. Additional information has been requested.
patient complained of pain in arm and loss of motion post vaccine.  went to the emergency department and was told the vaccine was given too high in the arm and into the periosteum
adverse side effect; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (adverse side effect) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (adverse side effect). At the time of the report, VACCINATION COMPLICATION (adverse side effect) outcome was unknown.            No concomitant medication was reported by the reporter. No treatment was reported by the reporter.
After receiving the vaccination, he felt something falling off of the injection site, which he thought was probably blood. He has a history of aversion to needles. He also has a history of feeling lightheaded with intramuscular injections. He felt lightheaded 1 minute after receiving the injection. He did not syncopize and he denied any other symptoms. He requested to lay supine, and initially laid supine on the floor of the areba. He was taken to a private section of the area and continue to lay supine, and after 30 minutes, his lightheadedness resolved.
Approximately 5 minutes after receiving vaccine, while sitting in waiting room, patient experienced a syncopal event with shaking of his body.  This lasted <1 minute but did result in falling out of his chair and hitting his head on the floor.  He was back to baseline upon waking up.   He had a contusion on his forehead.  He was given a cool rag, sucrose and water to consume.  Patient was examined and was back to baseline mentation with no adverse effects other than the contusion of forehead and mild head pain.  However, MOC insisted on taking him for further evaluation to the local emergency department.
approximately 3 months after I received the 2nd Moderna  vaccine my hair began to fall out in clumps.  It was think hair and now is thin.  I continue to loose about 3 clumps a day.
Induction of alopecia areata after COVID-19 vaccination/patchy hair loss started on the bitemporal and occipital scalp the day following her first dose of the BNT162b2 vaccine; This is a literature report for the following literature source:   A 57-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (batch/lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "type 1 diabetes" (ongoing); "psoriasis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ALOPECIA AREATA (medically significant), outcome "recovering", described as "Induction of alopecia areata after COVID-19 vaccination/patchy hair loss started on the bitemporal and occipital scalp the day following her first dose of the BNT162b2 vaccine". The events "induction of alopecia areata after covid-19 vaccination/patchy hair loss started on the bitemporal and occipital scalp the day following her first dose of the bnt162b2 vaccine" required physician office visit. The patient underwent the following laboratory tests and procedures: trichoscopic image: yellow dots, black dots, notes: vellus hairs, and thin arborizing vessels are observed in a single alopecia patch. Therapeutic measures were taken as a result of alopecia areata. The patches progressed to 50% scalp involvement despite initial treatment of systemic triamcinolone 40 mg/ml injections. 95% of regrowth was observed within eight months of initial visit with mini-pulse systemic dexamethasone, Clobetasol solution, and oral minoxidil.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events "ALOPECIA AREATA " and the suspect drug cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
A non-serious spontaneous report of crying and runny nose has been received from a health professional concerning children of unknown ages, subsequent to FLUMIST. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. No relevant medical history has been reported for these patients. Concomitant medication included injectable vaccines. On an unknown date, the patients received FLUMIST. After the administration of FLUMIST, the patients received unknown injectable vaccines and began crying, consequently they developed runny nose. The outcome of the events was unknown.
At 1 am, my son presented with headache, dizziness, lightheadedness, shaking, ringing in ears, shortness of breath, and pallor.  Vasovagal  symptoms and near syncopal episode.  Was able to get him to the floor to avoid a fall.  Vomited several times.  Severe vasovagal symptoms began to resolve within one hour.  Didn?t check heart rate during initial near syncopal episode but was tachycardic after initial stabilization.  Headache and fatigue persisted and is still lingering today.
Dizziness, loss of appetite, generalized discomfort, and weakness started 1 week (on 5/30/22) after COVID-19 booster #2 (4th dose) on 5/23/22. Dizziness got worse prior to emergency room visit on 6/19/22, treated with normal saline IV 2 liters, magnesium sulfate 2 grams IV, and Tylenol 650 mg. Patient?s daughter had telephone appointment for ER follow-up on 6/22/22 with me and had requested that I report this adverse event, since patient also had prolonged dizziness after COVID-19 vaccine dose #2 on 4/4/2021 that started 6 days after COVID-19 vaccine and required hospitalization on 4/18/4/19/2021. Dizziness had resolved temporarily in June 2021,  but then dizziness returned on July 2021 to December 2021. Patient did vestibular rehab via physical therapy and massage therapy of neck/upper back, which led to resolution of dizziness and patient doing well between December 2021 to May 2022. Patient also had dizziness for 2 days after COVID-19 vaccine dose #1 on 3/14.  Patient did NOT have symptoms after COVID-19 booster #1 (dose 3) on 12/20/2021. Patient had Pfizer-BioNTech for all 4 doses of COVID-19 vaccines.
Well demarcated erythematous, itchy,  4cm by 4 cm, no warmth, no tenderness, no swelling.
rash lasted 5 days, no fever, no antipyretics given;MD dx;no complications & no meds given by MD;less than 50
At the site of injection was red, swelling and painful. After using ice pack and taking TYLENOL. It got better. Spoke to patient and she is doing fine.