chrisvoncsefalvay/vaers-outcomes huggingface dataset:
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported.   This case was linked to MOD-2021-395985 (Patient Link).
she felt very tired a day after; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021335230.  A 75 year-old female patient received bnt162b2 (BNT162B2), administration date 16Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 17Mar2021, outcome "recovered" (18Mar2021), described as "she felt very tired a day after".  Additional information: Is the Reporter a Healthcare Professional (HCP): UNKNOWN, Occupation/Specialty: UNKNOWN, Is the Reporter's contact information available to you or a sub-contracted party: UNKNOWN, Is the reporter the prescribing HCP: UNKNOWN. Verbatim and event description: The caller (Name) said that she received the 1st dose on 16Mar2021, and she felt very tired a day after. She is also scheduled for surgery a day before the 2nd dose schedule and she will miss the appointment. Upon callback, caller stated she wanted state that she would not be able to make the appointment. consumer stated when she got the Pfizer shot, "she was fine the rest of the day, and the next morning, all day long, the 2nd day, felt like a dog. She was just very tired and the next day she was fine. It was not like she was going through COVID at all. Her husband had no reaction. Her relative was very tired the next day after receiving her shot." Caller wanting to confirm if 6 weeks out to receive the 2nd dose is ok. Medical information: were any unaddressed medical questions referred to medical information: No.  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-2021335230 Same reporter/drug/event, different patient.
2 month old baby was administered Kinrix; Received kinrix first dose in DTAP AND IPV series; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-month-old female patient who received DTPa-IPV (Kinrix) (batch number 5AY2J, expiry date 10-JUN-2024) for prophylaxis.   On 20-SEP-2023, the patient received Kinrix. On 20-SEP-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 2 month old baby was administered Kinrix) and inappropriate schedule of vaccine administered (Verbatim: Received kinrix first dose in DTAP AND IPV series).  The outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 25-SEP-2023 The reporter was a medical assistant. The reporter reported that the 2 month old baby patient was administered Kinrix vacine.  The reporter stated that it was supposed to be the first dose in DTAP AND IPV series, which led to Inappropriate schedule of vaccine administered. The patient received Kinirix who was younger than the indicated age which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Migraines increased on day after 2nd dose.  More abortive meds required on 4/16
Slightly nauseous, lightheaded, tired in the early evening.  Overnight, violent chills, fever of 101, body aches, headache.  Took ibuprofen, felt better in the morning.    Also, significant pain at injection site at time of vaccination, but it subsided after several minutes. Only minor lingering soreness.
Information has been received from a registered nurse concerning a 25 year old female with no known allergies and no pertinent medical history who on 23-AUG-2007 was vaccinated intramuscularly in the left deltoid with a second dose of Gardasil.  There was no concomitant medication.  The patient stated that when she got back to her office after the second injection she became "very, very dizzy" and had to sit down and wait till it passed.  Patient had something to eat and the feeling passed.  The patient recovered on 23-AUG-2007.  Additional information has been requested. Follow-up received 04/16/2008. No further information is expected.
Severe rash starting 8 days after injection.  Rash on hands, fingers, feet, toes, legs, arms and on torso
Information has been received from a male consumer with dry skin who in January 2008, "about a month ago", was vaccinated with a dose of Zostavax (Oka/Merck).  Concomitant therapy included CARDURA, "Azacol" (therapy unspecified) and LUNESTA.  A couple of days ago the patient experienced rash on lower chest and upper stomach.  It looks like a bunch of little dots.  It's hardly itching and feels a little warm.  The patient has been putting cortisone cream on it.  The patient's rash on lower chest and upper stomach persisted.  No product quality complaint.  Additional information is not expected.
Tested positive for Covid; Stuffy nose; Fatigue; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Tested positive for Covid), NASAL CONGESTION (Stuffy nose) and FATIGUE (Fatigue) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Nose congestion since 08-Jan-2021.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2021, the patient experienced FATIGUE (Fatigue). On 08-Jan-2021, the patient experienced NASAL CONGESTION (Stuffy nose). On 12-Jan-2021, the patient experienced COVID-19 (Tested positive for Covid). On 07-Jan-2021, FATIGUE (Fatigue) had resolved. At the time of the report, COVID-19 (Tested positive for Covid) and NASAL CONGESTION (Stuffy nose) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2021, SARS-CoV-2 test: positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the events of  fatigue, COVID-19 and nasal congestion are assessed as unlikely related.; Sender's Comments: Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the events of  fatigue, COVID-19 and nasal congestion are assessed as unlikely related.
I got the arm sore as little lump or whatever and inability to lift my arm; I got the arm sore as little lump or whatever and inability to lift my arm; it's like rash it's like not rash, all red like a good circle around the Infusion; like very itchy; chills; Headache; fatigue; fever 100.8; but the problem my now is the Injection site I did not feel then my am burn that could have been alcohol; This is a spontaneous report from a contactable consumer (patient) reported for herself.   A 55-year-old female patient received of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route of administration on 21Apr2021 (lot number: EW0170) (age at vaccination 55-year-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history included hypertension from 20 years back, auto immune disease, Covid in December and was very ill for about 8 weeks when she was available to get the vaccine. The patient concomitant medications included metoprolol, lisinopril for blood pressure high and Vitamins. The patient had, the problem in the injection site did not feel then my am burn that could have been alcohol, chills, headache, which is reminiscent of actual virus then, had fatigue and in the night had a fever 100.8 on 22Apr2021 and then got the arm sore as little lump or whatever and inability to lift my arm within next day or two which was told have Wednesday, Thursday night, the soreness has been gone like nothing going to be wrong whatever and now like it's one more thing, It's like how it's like rash it's like not rash, all red like a good circle around the Infusion, I do not know it's like very itchy now and it hurts and it's itchy. The patient took Tylenol as this was becoming unbearable like it was Itchy and hurts, do not want to scratch them. The patient lab tests included SarS-Cov-2 test was positive like in December 3 and body temperature was found to be 100.8 on 22Apr2021. The outcome of the events was reported as unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Had DTaP 05/27/2003, today on 06/06/2003, mother reporting "knot" in right thigh where DTaP was administered.  States size slightly under "nickel size".  No redness or other swelling.  Did run a temperature of 100.5F night after shot and last night.  Infant moving limbs normally and is in no apparent distress.
Patient given incorrect vaccine for age--17 y.o. given first dose Moderna on 3/27/21.   Given second dose Moderna on 4/24/21 as per CDC guidance.  No AE.
side effects experienced (if any): none; 1999 and 2002; This spontaneous report has been received from a lawyer via Plaintiff Fact Sheet (FS), from a physician via medical records (MR) and from registered pharmacist via immunization records (IR), from a case in litigation for zoster vaccine live (ZOSTAVAX) (# 1803USA001102), concerning currently an 81-year-old female patient, whose age at a time of the pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) was at least 61-year-old. Her medical history included disability: neck injury (for 1 year, from 1986 tp 1987). Historical vaccines included influenza ("flu") vaccine administered annually (since 1996). Concurrent conditions included cigarettes: 1 pack daily (since 1953), alcohol use: less than 5 drinks a month (since 1958), primary care physician treatment (unspecified, since 1996), and chronic obstructive pulmonary disease (COPD). Concomitant therapies included fluticasone propionate (+) salmeterol xinafoate (ADVAIR) for COPD.  On an unknown date in 1999, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (provided as "pneumonia" vaccine (dose, lot #, expiration date, route of administration and anatomical location were not provided) for prophylaxis. On an unspecified date in 2002, she received another dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (product use issue) (in MR there was reported pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX), however it could not be confirmed when the patient was administered that vaccine. In immunization records (IR) there was information included numbers provided as "J013211", "5-16", however it was not specified if it pertained to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX): nothing indicated that this vaccine was administered according to this document). Side effects after pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) were reported as none (no adverse event).  All available medical records will be provided upon request.  This is one of 2 linked reports regarding the same patient (cross referenced with the case # 1803USA001102).; Sender's Comments:  US-009507513-1803USA001102:
(L) deltoid 5cm swollen, red slight discomfort (R) deltoid 2 cm swollen slight redness no discomfort
10/31/08 - developed rash around neck, chest, upper torso. Warm feeling on skin -went to ER on 11-1-08 AM of 11-1-08.
Chest pain and pressure; Chest pain and pressure; Unable to gasp air and hard time breathing; This is a spontaneous report from a contactable consumer, the patient.  A 43-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown), via an unspecified route of administration in the left arm on 22Feb2021 at 14:00 (at the age of 43-years-old) as a single dose for COVID-19 immunization. Medical history included rheumatoid arthritis. The patient had no known allergies. Concomitant medication included methotrexate from an unknown date at an unknown dose, for an unknown indication. Prior to the vaccination the patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162B2 (Lot number unknown) on 03Feb2021 at 15:00  (at the age of 43-years-old) via an unspecified route of administration in the left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  On 23Feb2021 at 04:00 the patient experienced chest pain and pressure, the patient was unable to gasp air and hard time breathing. The events were reported as non-serious.  The patient did not receive treatment for the events. The clinical outcome of the events chest pain and pressure and unable to gasp air and hard time breathing was recovering.  It was also reported that since the vaccination, the patient has not been tested for COVID-19.  The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.
no adverse event---administration error only. Patient needed to be 16 to receive vaccine and was only 15 yrs old at the time of first dose administration.
On 5/3/09 Mother noticed L arm red @ injection site. 5/4/09 blisters on L upper arm with redness + tenderness at the base. Mom called child's Dr + he had, Motrin + anti itch cream. Blisters became crusts, then scabs.
Information has been received from a physician concerning a 22 year old female who was vaccinated with the second 0.5 ml dose of GARDASIL (lot# 1423X) 2 months ago (approximately December 2008).  On 12-FEB-2009 the patient experienced a seizure.  The patient was sent to the emergency room.  Upon internal review, seizure was determined to be an other important medical event.  Additional information has been requested.  3/9/09 Received GYN medical records of 10/08-2/12/2009 along w/note that no lot #s are available. FINAL DX: Records reveal patient experienced condyloma & had cryo tx 11/20/08, 12/8/08, 12/18/08, 1/8/09, 1/22/09, 2/12/09.  HPV #1 given LA on 12/8/08, HPV #2 given 2/12/09 LA.  On 2/12 had syncopal episode then tonic-clonic seizure x approx 1 min w/eyes deviation upwards, groaning but no loss of sphincter control.  Sent to ER for observation & w/u.  3/16/09 Received ER medical records of 2/12/2008. FINAL DX: seizure activity likely secondary to vasovagal syncope Records reveal patient experienced witnessed seizure in GYN office s/p HPV shot.  Episode preceded by dizzness, ringing in ears & then blacked out.  When came too had dizziness, confusion & nausea.
6-inch mass of swollen red; 6-inch mass of swollen red; 6-inch mass of swollen red; nauseous; extremely gassy; heart burn; A spontaneous report was received from a other healthcare professional concerning a 55 year old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced COVID arm (6-inch mass of swollen red)/limb mass peripheral swelling erythema, heart burn/dyspepsia, extremely gassy/flatulence and nausea.  The patient's medical history was not provided by the reporter.The relevant concomitant medications use were not reported.  On 12 Jan 2021, about 2-3 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) through unknown route for prophylaxis of COVID-19 infection.   On 14  Dec 2020,about 2-3 days after vaccination the patient experienced  COVID arm (6-inch mass of swollen red), extremely gassy,  heart burn and nauseous. No treatment information was provided. Lab details were not provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, COVID arm (6-inch mass of swollen red), extremely gassy,  heart burn and nauseous were considered unknown.
Discharge Provider: MD Primary Care Provider: MD Admission Date: 9/21/2022 Discharge Date: 09/22/2022 Presenting Problem: Acute on chronic combined systolic (congestive) and diastolic (congestive) heart failure (HCC)  HOSPITAL COURSE: 69 y.o. male with past and current medical history of EF 20%, coronary artery disease, hypertension, dyslipidemia, asthma; he presents with shortness of breath and found to be COVID-19 positive on presentation to the hospital on 9/21/22.    Labs found sCR 1.41. CXR negative for congestion or signs of COVID pneumonia. Patient was felt to be dry on exam, diuretics were held. Home farxiga and entresto were held, AKI resolved the next day back to normal. He was maintained on hydralazine and isordil in stead.    Infectious disease was consulted and recommended transition to 5 day course of Paxlovid. Medication was reviewed with the pharmacy and medication was in stock for pt to receive on discharge. Prior to discharge patient ambulated around his room and maintained oxygen saturations above 95% on room air.    He was instructed to take his INR with his home INR checker daily while on Paxlovid due to possible interactions with his coumadin. Patient is aware of this and agrees to continue coordination with anticoagulation clinic, on day of discharge his INR was within goal at 2.3 (goal 2-3).    Patient will follow up in HF clinic after completing 5 day course of Paxlovid and get follow up BMP on day of appointment as well. He was instructed to contact HF clinic if sx do not improve on this regimen.      Orders will be placed for patient to schedule an outpatient RHC once he has fully recovered for ongoing evaluation of failure to thrive. He has an upcoming 11/2022 pancreatic imaging study scheduled as well with GI outpatient.
symptomatic w viral symptoms, followed by abdominal symptoms and GI bleed admitted on 5/10/22
Widespread rash over back with red bumpy circles of many sizes, up to 12+ cm
Had moderate fatigue/malaise and mild progressive respiratory shortness of breath within 2 weeks of the first vaccine, then progressed to severe after the 2nd vaccine and was hospitalized on 4/9/2021 with acute pneumonitis for 2 days with steroid treatment and Oxygen, discharged 4/11/21.
Vasovagal syncope in shower morning of 6/6 - no prior such sx. HPV vaccine given at 13:30 6/5 #1.
Received flu vaccine on 9/26/23. Came to Ortho clinic on 10/12/2023 c/o intermittent right should pain.  She had previously gone to urgent care where an x-ray was done.  No findings of needle breaking off.  Prescribed steroids and PT per Ortho.
PATIENT WOULD NOT PUT ANY WEIGHT ONTO LEFT LEG SINCE INJECTION. SEEN BY DR ON 10-05-2009, SEEN BY ANOTHER DR ON THE 10-14-09. SINCE 10-15-09 SHE PUT WEIGHT ON LEFT LEG.
Her parents contracted COVID-19 badly; her parents contracted COVID-19 badly; This is a spontaneous report from a Pfizer sponsored program COVAX Support via a contactable consumer. This consumer reported similar events for two patients (her parents). This is the second of two reports. A male patient (reporter's father) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as singe dose, dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included hospitalized for 5-10 days in mid Feb2021. The patient had to receive antibiotics as well as plasma during treatment process. The patient's concomitant medications were not reported. The reporter stated the patient was, as of about 3 weeks ago, fully vaccinated with the Pfizer vaccine. She (reporter) was trying to be cautious since her parents contracted COVID-19 badly. The outcome of the event was unknown.  The lot number for the vaccine bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021887349 same reporter/drug/AE, different patient
extreme pain in her arm  and legs/ arm hurt to touch; flue like symptoms; night sweat; extreme pain in her joints; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (extreme pain in her arm  and legs/ arm hurt to touch), INFLUENZA LIKE ILLNESS (flue like symptoms), NIGHT SWEATS (night sweat) and ARTHRALGIA (extreme pain in her joints) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced PAIN IN EXTREMITY (extreme pain in her arm  and legs/ arm hurt to touch), INFLUENZA LIKE ILLNESS (flue like symptoms), NIGHT SWEATS (night sweat) and ARTHRALGIA (extreme pain in her joints). At the time of the report, PAIN IN EXTREMITY (extreme pain in her arm  and legs/ arm hurt to touch), INFLUENZA LIKE ILLNESS (flue like symptoms), NIGHT SWEATS (night sweat) and ARTHRALGIA (extreme pain in her joints) outcome was unknown.            No relevant Concomitant medications were reported. Treatment details was not reported by the reporter.
Fever, chills, muscle ache, and headache began at 3:30 am the next day (17 hours after). Muscle ache persists as of May 13, 8:30 pm (58 hours after). Fever, chills, and muscle ache mostly resolved as of 6:00 am on May 13.
(R) side of face is weak, pain in jaw. Weakness in (R) eye and (R) side of mouth. Dx: Bell's palsy.