chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist via Pfizer (MRF# 2016537371) refers to an over 65 year old female patient. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (dose, route and frequency were not reported)  to protect against pneumococcal pneumonia. On an unknown date the patient felt sick for a couple days and had feeling of achiness. The outcome of the events was unknown. The reporter did not provide the causality between the PNEUMOVAX 23 and the events. This is one of the two reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1612USA013567.
(L) shoulder site became red, hot, swollen, hard w/definable edges the night of the injection; improved after a few days, but never resolved completely. On 1/6/2021, became increasingly itchy, w/increased swelling, redness, heat.
No adverse event; Dose administered after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) in an 18-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 042H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Jun-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 09-Jun-2023,  after starting , the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry).    No concomitant medication was reported.  No treatment information was reported.
Same day post vax, the pt developed fever of 105. Treated at home with Tylenol. Taken to physician on 7/20/00 and dx with viral illness. Developed rash after 5 days. Fever lasted for approximately 5 days. Physician was notified and dx as roseola.
Attendee received first dose Pfizer vaccine at 12:07 pm in the left arm.  Lot# FA7485. Attendee was directed to observation area.   At 12:16 voiced complaints of nausea, feeling cold and shivering.  Attendee's skin was cold and clammy.  Attendee's respirations were not tachypneic or dyspneic. Attendee assisted to the cot to lie down. Sips of water given. HR:  60   BP:  100/60   RR:      O2Sat%:  99      12:25 - Attendee stated he felt better, no longer nauseous but still visibly shaking.   HR:  80   BP:  98/62   RR:   20   O2Sat%:  99  12:30  Still shivering.   12:35  EMS was on site for a different attendee and so they came to evaluate and take over care of the attendee.   2:45  EMS had him standing and attempting to walk a bit.  Still visibly shaky, developed nausea again.  Another ambulance was called to transport the attendee.  12:55  Taken to emergency room by ambulance.
reported minor pain and slight tiredness; reported minor pain and slight tiredness; This is a spontaneous report from a non-contactable consumer (patient).  This patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 01Feb2021 at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. The patient reported that overnight (Feb2021) he/she experienced minor pain and slight tiredness, however the tiredness could have been related to a late night due to snowstorm. Both the events were considered as non-serious. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
04NOV94 felt like had sore throat; also very hoarse cont to be hoarse; feels like has small blisters inside nose very high;
is a fever a normal side effect within 24 hours of administration?; This case was received via regulatory authority (Reference number: US-irms-MOD21-127285 ) on 06-Aug-2021 and was forwarded to Moderna on 06-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (is a fever a normal side effect within 24 hours of administration?) in a male patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (is a fever a normal side effect within 24 hours of administration?). At the time of the report, PYREXIA (is a fever a normal side effect within 24 hours of administration?) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by reporter. Treatment medication not reported.
PT INDICATED SEVERE COLD CHILLS/FEVER WEAKNESS, NAUSEA OVERNIGHT THROUGH THE FOLLOWING DAY.
A report has been received from a Pharmacist concerning a 62 year old, male subject, who has been receiving nasal FLUMIST. FLUMIST started on 05-SEP-2013. It was reported that the pharmacist inadvertently gave a 62 year old FLUMIST on 05-SEP-2013. FLUMIST was discontinued on 05-SEP-2013. The outcome of the event of 62 year old patient received FLUMIST is unknown. The report was considered to be non-serious.
administered with the vaccine which has been stored in the refrigerator for more than 30 days; administered with the vaccine which has been stored in the refrigerator for more than 30 days; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with the vaccine which has been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (administered with the vaccine which has been stored in the refrigerator for more than 30 days) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with the vaccine which has been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (administered with the vaccine which has been stored in the refrigerator for more than 30 days). On 22-Jul-2021, EXPIRED PRODUCT ADMINISTERED (administered with the vaccine which has been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (administered with the vaccine which has been stored in the refrigerator for more than 30 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported  No treatment information was provided   This case was linked to MOD-2021-265450 (Patient Link).
Worsening of joint pain & temp, around 100, dizziness & near-fainting, increase in heart rate, facial flushing, headache, muscle spasms in neck & back -on-going. No treatment (stiff back & legs).
Under his armpit it was swelled up and a little lumpy; Under his armpit it was swelled up and a little lumpy; He noticed that under his armpit it was swelled up and a little lumpy/ he thinks it was his lymph nodes; Some discoloration, like a bruise in his arm where the shot was administered; Some discoloration, like a bruise in his arm where the shot was administered; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (Formulation: Solution for injection; Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 30Aug2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Caller stated he received his first dose of the Pfizer Covid 19 vaccine on 30Aug, and he is scheduled to receive his second dose next Monday. When he received his first shot, he noticed that under his armpit it was swelled up and a little lumpy, it only lasted 48 hours. He stated he thinks it was his lymph nodes. He also noticed some discoloration, like a bruise in his arm where the shot was administered, the pharmacist told him to put an ice pack since it felt swollen. Since it was swollen, the pharmacist said to put an ice pack on it. The outcome of the events under his armpit it was swelled up and a little lumpy was recovered and outcome for other events was recovered.  This lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.
bruising at site of injection, swelling from site of injection right deltoid to elbow in a line, itching with no rash. no pain anywhere reported by patient
Had DTaP/HIB on 06/20/02. Mother reported swelling and redness 06/22/02 seen in ED-no studies done. Dx-local reaction vs. cellulitis. Given Keflex and told to do soaks. Given Benadryl and Tylenol by ED staff. Seen 06/24/02, normal exam.
Following the third dose of Lymerix, the pt experienced arthralgia. As of 5/24/01, the outcome of the event was unknown.
no immunity conferred from series of 3 hepatitis B vaccinations from 1/23/03 - 7/22/03.
This is one case out of a cumulative total of 18 cases received during the surveillance period from 01 January 2010 to 03 May 2011. Enter Incident ID# 504963. Initial report received on 03 May 2011 from the Investigator participating in the above-mentioned post-marketing observation surveillance study under the reference number M5A16. A case of pertussis disease in a male subject (initials not collected), who was approximately 35 months of age, was identified by the investigator based on review of data from the system. The subject's vaccine history included one dose of DAPTACEL; lot number C3082AA received on 03 July 2009, one dose of PENTACEL, lot number C3174AA received on 08 October 2008, two dose of DAPTACEL, lot number C2956BA received on 08 August 2008 and lot number C2953AA received on 30 May 2008 (routes and sites of administration not reported). The subject developed cold-like symptoms on an unspecified date, and on 07 March 2011, approximately 20 months after the last dose, developed a cough. On 09 March 2011, the subject developed a paroxysmal cough with no whoop and no posttussive vomiting. The subject also experienced sleep disturbance. Laboratory testing included positive PCR on 07 April 2011. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 07 April 2011 for five days. The subject was not hospitalized. At the time of final contact on 28 April 2011, the subject's cough was still persisting. The duration of the cough was reported at that time as 52 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Felt like my ears were clogged within 15 minutes.; I felt a sensation like something was stuck in my throat when I swallowed.; and my right ear has some ear pain and I still have a slight sensation in my throat.; This is a spontaneous report received from a non-contactable reporter (Consumer or other non-HCP). The reporter is the patient.  A 45-year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 01May2021 09:15 (Lot number: Ew0167) at the age of 45 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "pitted fruit such as cherries" (unspecified if ongoing).  Concomitant medication included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; VITAMIN D [VITAMIN D NOS]; ZINC. Past drug history included: Penicillin, reaction(s): "Known allergies: penicillin". The following information was reported: EAR DISCOMFORT (non-serious) with onset 01May2021 10:00, outcome "unknown", described as "Felt like my ears were clogged within 15 minutes."; OROPHARYNGEAL DISCOMFORT (non-serious) with onset 01May2021 10:00, outcome "unknown", described as "I felt a sensation like something was stuck in my throat when I swallowed."; EAR PAIN (non-serious) with onset 01May2021 10:00, outcome "unknown", described as "and my right ear has some ear pain and I still have a slight sensation in my throat.". Therapeutic measures were not taken as a result of ear discomfort, oropharyngeal discomfort, ear pain. The patient felt like his ears were clogged within 15 minutes. He waited at the hospital for a total of 30 minutes and headed home. About 15 minutes after leaving the hospital the patient felt a sensation like something was stuck in my throat when he swallowed. About 2.5 hours since the injection and right ear has some ear pain and he still have a slight sensation in my throat. The throat sensation is not really an itchy one, it feels more like something is in there.  No follow-up attempts are possible. No further information is expected.
Pt was sitting on edge of  exam table. After approximately 5 minutes after getting covid vaccine pt fell backwards on to her  back  on to exam table  and lost consciousness momentarily.  Pt opened her eyes after a few seconds and  appeared drowsy. After a minute or 2 pt became more alert. Pt stayed laying on exam table for about 15 minutes. Doctor was informed and assessed pt. Nurse got water for pt to drink.  After  approximately 15 minutes pt stood up. Pt  was balanced, no c/o dizziness.
COVID 19; COVID 19; Vaccine brand other=moderna/ Vaccine dose number=5,4; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Mar2021 as dose 1, single (Lot number: EP6955), in left arm, on 13Apr2021 as dose 2, single (Lot number: EP6955), in left arm and on 13Oct2021 as dose 3 (booster), single (Lot number: GF6389), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 27May2022 as dose 4 (booster), single (Lot number: OSNM21A), in left arm and on 04Nov2022 as dose 5 (booster), single (Lot number: 017H22A Walf), in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Erythromycin, reaction(s): "known allergies erythromycin". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 27May2022, outcome "unknown", described as "Vaccine brand other=moderna/ Vaccine dose number=5,4"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19 (PAXLOVID Treatment).
no adverse effect reported; Six month old patient received PNEUMOVAX 23; This spontaneous report as received from a medical assistant regarding a 6 month old patient. Information on the patient's pertinent medical history, other concurrent conditions, drug allergies or reaction and concomitant medication were not reported. On 06-AUG-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, frequency, route of administration, batch/lot # and expiration date were not provided) for prophylaxis (product administered to patient of inappropriate age). No adverse effect reported. No product quality compliant (PQC).
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 24Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing); "High BP" (unspecified if ongoing); "MDD" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "cancer in remission" (unspecified if ongoing), notes: no active treatment, have been NED for 8 years. The patient's concomitant medications were not reported. Vaccination history included: bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Anatomical location: Arm Left), administration date: 15Nov2022, for Covid-19 immunization; bnt162b2 (DOSE 4 (BOOSTER), SINGLE, Anatomical location: Arm Left), administration date: 15Mar2023, for COVID-19 immunization; bnt162b2;bnt162b2 omi ba.4-5 (DOSE 5 (BOOSTER), SINGLE, Anatomical location: Arm Left), administration date: 17Jun2023, for COVID-19 immunization; Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunisation; Bnt162b2 (DOSE 2, SINGLE, Anatomical location: Arm Left), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 26Oct2023 to 30Oct2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300356717 Same patient, different product, different dose/event;
This was an off-label use of Moderna and writer was advised by CDC to complete a VAERS report. Dose one was given on 3/24/21 and a VAERS report was completed. CDC recommended to administer Dose 2 on time and report to VAERS as off-label use.
Child was given 0.2ml dose of undiluted Pfizer 5-12 vaccine/  Parent was contacted 1/26/2022 and reported child had fever, chills, achiness, and site pain.  No other reactions up to the date/time contacted.
h/a that started evening of 7SEP93; has not subsided when agency was notified on 24SEP93 110PM; 28SEP93 pt seen by MD;
c/o dizziness-vomited x 1;c/o h/a had depressed LOC;seen by MD pt states still feels bad but going about nl activities;
First Vaccine given on 3/1/2021. Intramuscular in left arm. Moderna. Lot: 041L20A. Pharmacy.
Rash/Pimple like on fact and neck. This is in follow-up to report (s) previously submitted on 11/14/2006. Initial and follow-up information has been received from a health professional concerning a 23 year old female with no known allergies who on 11-OCT-2006 at 9:00 was vaccinated with a second dose of GARDASIL (lot # 653978/0955P), intramusculary in the deltoid. Concomitant therapy included ORTHO TRI-CYCLEN. On 12-OCT-2006 at 9:00 AM the patient experienced 'face/neck rash, pimple like stinging.' It was also received from the FDA through the Freedom of Information Act. There is no additional information. Additional information has been requested.
First two COVID-19 vaccinations were Pfizer - patient complained that left arm was "lame" from the elbow down.  They could not lift their arm and it "felt swollen" and heavy.
rash at the injection site, rash that looked like a little bump on the right side of the arm; headache; fatigue; soreness; swelling at the injection site; itching at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash at the injection site, rash that looked like a little bump on the right side of the arm), HEADACHE (headache), FATIGUE (fatigue), VACCINATION SITE PAIN (soreness) and VACCINATION SITE SWELLING (swelling at the injection site) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A, Unknown and Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lung cancer (Patient is a cancer survivor with a past medical history of stage 4 lung cancer (only left side of lung was involved) and vocal cord damage) in 2013. Concurrent medical conditions included Arthritis. Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Allergy, ALPRAZOLAM (XANAX) for Breathing arrested, PREDNISONE for Breathing difficult, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for COPD, ONDANSETRON (ZOFRAN ZYDIS) for Nausea, OXYGEN, GUAIFENESIN (MUCINEX), MONTELUKAST SODIUM (SINGULAIR), APIXABAN (ELIQUIS), ACETYLSALICYLIC ACID (BAYER ASPIRIN REGIMEN), PARACETAMOL (TYLENOL ARTHRITIS), ERGOCALCIFEROL (VITAMIN D2) and OXYCODONE for an unknown indication.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, received third 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 SITE RASH (rash at the injection site, rash that looked like a little bump on the right side of the arm), HEADACHE (headache), FATIGUE (fatigue), VACCINATION SITE PAIN (soreness), VACCINATION SITE SWELLING (swelling at the injection site) and VACCINATION SITE PRURITUS (itching at the injection site). At the time of the report, VACCINATION SITE RASH (rash at the injection site, rash that looked like a little bump on the right side of the arm), HEADACHE (headache), FATIGUE (fatigue), VACCINATION SITE PAIN (soreness), VACCINATION SITE SWELLING (swelling at the injection site) and VACCINATION SITE PRURITUS (itching at the injection site) outcome was unknown.            Concomitant medication also includes Antibiotics taken once daily to clear out the lungs and prevent pneumonia, Fentanyl with Saline for unknown indication . Patient says she applied Cortaid on injection site and the rash went away   This case was linked to MOD-2021-294272 (Patient Link).
Pt says that shortly after his shot, he started smelling gasoline - like odor. He stopped by the pharmacy 11/2/14 and says that he still feels like he is smelling gasoline.
Dizziness, loss of appetite, fatigue, rash at injection site, ringing in ears, fever, stomach ache.
Chills, body aches, nausea, fatigue, arm pain. Lasted 36 hours.
Information has been received from a consumer concerning her 75 year old mother with a history of shingles who on 10-MAY-2007 was vaccinated SC with a dose of Zostavax (Oka/Merck).  Concomitant therapy included SYNTHROID, ZOVIRAX, VALTREX and "2 blood pressure pills."  Subsequently the patient has had two outbreaks of shingles on 18-JUN-2007 and 04-JUL-2007.  Unspecified medical attention was sought.  There were no lab studies performed.  At the time of the report the patient had not recovered.  There was no product quality complaint involved.  No further information was provided.  Additional information has been requested.
Severe Hair loss (alopecia) around temples (around ear area, mainly in front) and some hair loss around hair line and crown. Has happened the last 3 years in October-November after administration of the Influenza vaccine (first vaccine in 2006). Noticeable loss each year starting approximately 30 days after administration of vaccines.