chrisvoncsefalvay/vaers-outcomes huggingface dataset:
There are 5 published case reports on patients developing sarcoidosis in close time proximity to COVID-19 mRNA vaccination; This is a literature report.  A patient (no qualifiers provided) received bnt162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SARCOIDOSIS (medically significant), outcome "unknown", described as "There are 5 published case reports on patients developing sarcoidosis in close time proximity to COVID-19 mRNA vaccination".  DISCUSSION: The current patient qualified for the diagnosis of clinical cardiac sarcoidosis via the 2014 HRS criteria, and while myocarditis was in the differential, the patient presented uniquely from the typical COVID19 vaccine-induced myocarditis patient. Sustained VT is not a frequently reported feature of COVID19 vaccine induced myocarditis; amongst 139 adolescents diagnosed with vaccine induced myocarditis, zero patients developed sustained VT, and non-sustained VT was rare (5%). To date, there are 5 published case reports on patients developing sarcoidosis in close time proximity to COVID-19 mRNA vaccination.; Sender's Comments: Based on the available information in the case, an association between the reported events SARCOIDOSIS and The suspected drug cannot be ruled out.  The impact of this report on the benefit/risk profile of the Pfizer product 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.,Linked Report(s) : US-PFIZER INC-PV202300165539 Same Article/drug/event and different patient;US-PFIZER INC-PV202300165539 same article/drug/event and different patient;US-PFIZER INC-202300319518 same article/drug/event and different patient;
Pt became blotchy and itchy. Had itchiness in the mouth. No difficulty breathing or shortness of breath.
While waiting for record completion after four shots were administered, Patient experienced lightheadedness and lost his balance. Patient landed in a seated position.
Itching on both hand and legs and red color; Itching on both hand and legs and red color; This is a spontaneous report received from a contactable consumer (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Mar2021 (Batch/Lot Number: ER8730, at the age of 46-year-old) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced itching on both hand and legs and red color on 19Apr2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant. The outcome of the events was unknown.  No Follow-up attempts are needed. No further information is expected.
After giving HPV9 in (R) deltoid pt appeared to have stiffened up her arms/flexed then started groaning, foaming at the mouth and then went limp/eyes were staring at first then started to roll towards back of head.
This solicited report has been received from a 76 year old male patient enrolled in a study conducted by MSW Research. The patient's concurrent condition, historical conditions and concomitant medications were not reported. On an unknown date the patient was vaccinated with PNEUMOVAX23. On an unknown date the patient reported that he had a reaction to pneumonia vaccine many years ago and do not know whether he should get another one. So he wanted to ask doctor. The outcome of the event was unknown. Action taken with the study therapy was unknown. The causality between the event and PNEUMOVAX23 was not reported. Additional information is not expected as the reporter did not consent for further follow up.
Information has been received from a nurse practitioner concerning 7 patients between 1 and 4 years old ("males and females") who on unspecified dates "between March and April 2010", were vaccinated with a dose of MMR II (Lot # 664659/0838Y) into the left thigh. The nurse reported that the patients had reactions at the injection site. Most patients had a hard red and raised bump and several had blisters around the site as well. At the time of this report, the patients had recovered on unspecified dates. The patients sought unspecified medical attention. This is one of several reports received from the same source. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. All telephone attempts to obtain to follow up information have been unsuccessful. Additional information has been requested.
DOSE GIVEN TO EARLY.   NO KNOWN SIGNS, SYMPTOMS ADVERSE REACTIONS
Chest pain starting on second day after vaccination that progressively worsened over a week. Blood test, ekg, and future echo cardiogram is scheduled. Currently being prescribed  ibuprofen 400mg every 8 hours and colchicine once a day
Arm pain, soreness at injection site, 1/19/11 - 1/31/11 symptoms started 1/19/11 continued few days, resolved for a few days then returned. Pt's example: unable to take off sweater with vaccinated arm without hurting bad.
c/o rash on legs, grass & back w/itching approx 3-4hr p/inj;swelling noted in hands;saw MD 4NOV97 & given med for itching & swelling;no better returned to MD 5NOV & given pred;
Fever, muscle pain, lethargy for 4-5 days after the second dose in the series. No symptoms after the first dose.
Patient has a history of being very anxious with needles (needing sedatives before shots in the past). After the injection, patient had symptoms of light-headedness, tingling sensation at the hands, and tunnel vision. Symptoms resolved rapidly after I had the patient place their head between their knees. I observed the patient with my colleague Pharmacist for 30 minutes and made sure she was able to walk without any symptoms.
About 30 minutes after injection I suddenly felt a rush of heat throughout my body; felt dizzy, weak and a bit nauseated; felt dizzy, weak and a bit nauseated; felt dizzy, weak and a bit nauseated; tired/ fatigue; have some minor injection site pain; This is a spontaneous report from a contactable nurse reporting for herself.  A 42-years-old non-pregnant female patient the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE): lot number: EJ1675,  intramuscular, in the left arm on 18Dec2020 at 13:15 (at the age of 42 years-old) as a single dose for COVID-19 immunization.  The patient received the vaccine at a hospital. Medical history included an allergy to cilantro. Concomitant medication included colecalciferol (VITAMIN D), zinc (ZINC) intermittently, and paracetamol (TYLENOL) once, all within 2 weeks of vaccination.  The patient previously took amitriptyline and experienced swelling of eyelid and palmar erythema.  The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Dec2020, the patient experienced a rush of heat throughout her body, felt dizzy, weak and a bit nauseated and minor injection site pain. The clinical course as follows: At 13:45, about 30 minutes after injection she suddenly felt a rush of heat throughout her body, felt dizzy, weak, nauseated.  This lasted about 30 minutes and then the warm feeling went away.  She still felt a little dizzy, weak, nauseated and very tired. The dizziness lasted about 1.5 hours and the weakness, fatigue and mild nausea lasted about 6 hours. She reported that It felt as though she had taken diphenhydramine (BENADRYL). She stated that had she not been working (RN in an Emergency Department), she just would have taken a nap and it would have been ok.  Having to work through it was not pleasant she said.  She never had a fever during this but had some minor injection site pain.  She reported that she never experienced an immune response to any vaccine (has had 6 in a day before and was fine). The patient was not hospitalized for the events. The patient was treated with 600 mg of naproxen sodium. The clinical outcome for the events of a rush of heat throughout her body, felt dizzy, weak and a bit nauseated and minor injection site pain, was recovered on an unspecified date in Dec2020. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Swollen lymph nodes in the armpit; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 04Mar2022 11:45 (Lot number: FF2589) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number: 2, Brand : Pfizer/BioNTech,, Lot_number: EL3247,, Route of administration: Intramuscular,, Administration time: 09:30 AM, Location: Left arm), administration date: 22Mar2021, for Covid-19 Immunization; Bnt162b2 (Dose number: 1, Brand : Pfizer/BioNTech,, Lot_number: EL3247,, Route of administration: Intramuscular, Administration time: 09:30 AM, Location: Left arm), administration date: 01Mar2021, for Covid-19 Immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 05Mar2022 09:00, outcome "not recovered", described as "Swollen lymph nodes in the armpit". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional Information: No covid prior vaccination and not tested for covid post vaccination. No other vaccines in four weeks.  No follow-up attempts are possible. No further information is expected.
Narrative:  Patient is a 58 yo male with PMH of CAD, HOLD, and HTN who received first COVID-19 vaccine (Moderna) on 3/9/21. Patient received second dose on 4/6/21. On chart review, patient c/o dizziness, fever of 100.4 F, body aches, and numbness/tingling in fingers and left arm pain. Patient noted to receive both injections in left deltoid. Patient spoke to nurse on 4/15/21 via telephone c/o left arm pain x1 month, worsened after second dose of COVID-19 vaccine. Pain score 8/10 relieved with ibuprofen 800mg down to score of 5/10. Patient noted to have MI ~10 years ago. No follow-up with PCP as patient denied. Patient was instructed to present to ED if symptoms worsen.
On 8/25/17 at 0955 pt was in supine position and IM HPV9 was given, pt c/o dizziness 5 minutes after izz given (pt still in supine position), pt knees bent, stayed in this position x 20 minutes, BP prior to exit 137/81-pulse 66-O2 Sat 100% on RA.
Case previously recorded as MA2009-5168. Initial case report received from a physician via agency, on 19 NOV 2009. The patient 3-year-old male was vaccinated inadvertently with S-OIV FLUVIRIN (batch no. 102124P1) once i.m on 13 NOV 2009. No adverse event was reported. Agency reference no.:NA09-008308.
Syncope; Fall; Head injury; Hyperhidrosis;   This regulatory authority case was reported by an other health care professional and describes the occurrence of SYNCOPE (Syncope) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced SYNCOPE (Syncope) (seriousness criterion medically significant), FALL (Fall), HEAD INJURY (Head injury) and HYPERHIDROSIS (Hyperhidrosis). At the time of the report, SYNCOPE (Syncope), FALL (Fall), HEAD INJURY (Head injury) and HYPERHIDROSIS (Hyperhidrosis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, Vital signs measurement: consistent with fainting episode (abnormal) Vital signs consistent with fainting episode and stabilized within fifteen minutes..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication use was reported.   Treatment information was not reported.   On 17Mar02021, it was noted by the reporter that the patient was observed kneeling by a chair as diaphoretic immediately post vaccine. The reporter asked the patient if he would lie down  to be assessed.  The patient then fainted and fell to the floor, hitting the back of his head on the floor. The code team was called for immediate assistance. The patient's head and neck were supported. The patient's vital signs were consistent  with fainting episode  and stabilized within fifteen minutes.  The patient was transferred by EMS to  the hospital for evaluation of head injury.   It was noted by the reporter that the initial assessment showed no immediate neurological deficits and no  superficial  bleeding at head impact location on the patient. Further clinical course is unknown/not reported at this time.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
The symptoms started with a runny nose that was constant and clear. I started taking Mucinex. A day later, the I also developed a dry sore throat. The next day, I developed a severe headache and a cough. On day three, I tested positive for COVID-19. I reported it to my doctor via MyChart. She scheduled a telehealth appointment. I received a prescription to Paxlovid due to my high-risk status. I was told to stop taking Atorvastatin while on Paxlovid. I began taking the Paxlovid about 5 days after my symptoms started. I took three in the morning and three at night for five days. My symptoms improved almost immediately. By the second day, the symptoms were going away totally. I experienced a nasty metallic taste in my mouth for the full five days. On day 7 or 8 after testing positive for COVID-19, I tested negative. COVID-19 also effected my taste and energy levels and that has lingered.
This spontaneous report was received from an office manager regarding unspecified number of patients of unknown age and gender. There was no information on pertinent medical history and drug reaction or allergies. The reporter reported that an unknown date in 2014 an unspecified number of patients was vaccinated with RECOMBIVAX HB (strength, dose, frequency, product lot#, expiry date not reported) that was improperly stored since 09-MAY-2014. This was not supported. No adverse effects reported. There was no product quality complaint involved. The outcome of the events was unknown. This is one of the several reports from the same reporter. Additional information has been requested.
Patient came to the pharmacy today 08/08/18 informing us that she had a adverse reaction from the  shingrix vaccine -rash, itchy,swollen arm,  lasted more that one week and left a large knot on her right arm
I had two shots in one sitting one was Pneumococcal Polysaccharide Vaccine. The other was the seasonal flu vaccine for 2017 but I don't know the particular name of it. After about 5 hours, I had severe pain in my left arm at the site of the two injections. It was a throbbing aching pain. This prevented me from sleeping so I took 250mm Ibuprofen. During the night, I experienced chills and fever and disturbed sleep. By morning I felt better however my arm is still sore to the touch at the injection site though I no longer have the throbbing aching pain.
Information has been received from a physician concerning a female patient with no known drug allergies and no previous medical history who on an unspecified date was vaccinated at another physicians office with her first dose of GARDASIL (lot #unknown, site and route not reported). There was no concomitant medication. The patient reported to the physician that 3.5 post vaccination, she "felt lightheaded for 5 minutes, experienced dizziness, could not see, and everything turned black for a few seconds. Five minutes after the 1st lightheaded spell went away, it happened again and lasted for 5 minutes." The patient did not seek medical attention. It was reported that on an unspecified date the patient was considered to have recovered from the events. The physician reported that the patient plans to continue further doses of the vaccination. No additional information was reported. Upon internal review, vision loss was considered to be an other important medical event. Additional information has been requested.
Varivax given on 2/11/02; 17 days later, on 2/28/02, developed a rash with lesions mostly 1-2mm (max 3mm) red, slightly raised and non-pruritic with initially 20 (max 40, 3 days later) on scalp, hip, groin, supra-pubic and chest. Felt to be generalized reaction to varivax vaccine. Had 2nd dose of varivax and had no reaction.
This spontaneous case, initially received from a pharmacist on 15-Oct-2018, (initial and follow-up 1 combinedly processed) concerns a 33-year-old, adult male patient. On an unspecified date, FLUCELVAX QIVc was stored at a maximum temperature of 56 F for 8 hours following a power outage (explicitly coded as incorrect product storage). On 14-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252668 and expiry date: 30-Jun-2019) which was stored inappropriately (explicitly coded as drug administration error). At the time of this report, no adverse event was reported. The reporter assessed the case as non-serious. This case 201804546 was cross-linked with the original case 201804533 due to the same reporter.
Was inadvertently given doses of Moderna Covid19 vaccine 18 days apart; A spontaneous report was received from a physician concerning a 61-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and was inadvertently given doses of Moderna COVID-19 vaccine 18 days apart.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 09 Jan 2021, the patient received her first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 27 Jan 2021, the patient received her second of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection and was inadvertently given doses of the Moderna COVID-19 vaccine 18 days apart.   No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The event, was inadvertently given doses of Moderna COVID-19 vaccine 18 days apart, was resolved on 27 Jan 2021.; Reporter's Comments: This case concerns a 61 year old female patient who received her second of two planned doses of mRNA-1273 (Lot #s: uknown) intramuscularly for prophylaxis of COVID-19 infection and was inadvertently given doses of the Moderna COVID-19 vaccine 18 days apart. There were no reported adverse events reported after the vaccine was administered in the case of inappropriate schedule of product administration.
This spontaneous report as received from a public health nurse and refers to a currently 6 month old female patient. There was no information about patient's concurrent conditions, medical history or concomitant medications. Two instances of a temperature excursion took place. The first excursion occurred on an unspecified date in March 2018. Following which, it was reported that approval was provided from the manufacturer for the effected vaccinations to be administered. On 08-MAY-2018, the patient, at an approximate age of 5 months, was vaccinated with improperly stored ROTATEQ orally, lot # N012757 with expiration date of 27-JAN-219 for prophylaxis. Dosing details were not reported. The first temperature excursion occurred in a range at or above 32 Fahrenheit (°F) degrees to 35°F for 19 hours and 30 minutes. The second excursion occurred on 15-MAY-2018; the details of which were not reported. Following the second temperature excursion, there have been no doses of the vaccination ROTATEQ administered. No adverse effects were reported. A previous temperature excursion was reported to have occurred on an unknown date in a range at or above 32°F to 35°F for 4 hours. A digital data logger was involved. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1803USA011860: US-009507513-1806USA004705:
no adverse event; Monovalent doses administered after the BUD to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (no adverse event) in a 55-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Feb-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 18-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients).    Patient ID was mentioned as 4961178. No concomitant medications was reported. It was reported that it was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported that 77 Monovalent doses administered after the BUD to patients 12 and up. Breakdown of doses is as follows- 37 doses from Lot 059H21, 26 doses from Lot 065K21A, and 12 doses from Lot 058A22-2A.  Treatment information was not provided.   This case was linked to MOD-2022-690803 (Patient Link).
First Pfizer shot on 02/01. Flu like symptoms for 3 days. Followed by overall fatigue. The. 10 days after shot ear symptoms began.  Complete hearing loss in right ear. Began as 3 days of tinnitus. Then complete hearing loss. Put on steroid blast (60mg of Prednisone) by my primary.  Refered to ENT. ENT ran hearing test and concluded that the hearing loss was complete. 12 days of complete hearing loss. Then repeated hearing test. Slight improvement. ENT delivered shot of steroids directly into my right ear. Hearing test repeated 10 days later. Slight improvement again. Now currently about 90% of hearing had returned to my right ear.
Pain, redness and swelling at injection site.  I feel bad and a little nauseous.
immediately patient reported pain at arm, within 4 minutes patient had nausea/vomiting and lightheadedness
Right arm soreness, sweating, itching, visual & auditory hallucinations, tremors, paranoid, tachycardia, neuropathy of right side then left side, vomiting & diarrhea.