chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received second dose 2.5 weeks after first; fever; tired; slept a lot; This is a spontaneous report from a non-contactable consumer via a sales representative. A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date, as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 vaccine, on an unspecified date for COVID-19 immunization. On an unspecified date, the patient experienced received second dose 2.5 weeks after first, fever, tired, and slept a lot. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Initial report received from a RN on 02May06. A 5 yr old female pt with an allergy to walnuts developed left arm swelling large area, redness and sore to touch five days after receiving the injection of the fourth dose of Daptacel, lot number C2431AA (expiry date 14Jan08) and IPOL, lot Y0824-2 (expiry date 15Sep07) on 26Apr06. Both vaccines were administered into the left deltoid. Route of admin was not reported. The pt received in concomitant the injection of MMR, lot 0751F, in the right deltoid.  Per reporter a 5/8", 25 gauge needle was used, however it was not specified for which vaccine. Per the reporter the pt had no illness at the time of vaccination and was not seen by a physician for this event. At the time of this report the pt had not recovered. Same reporter in cases 200601016 and 200601017.
I experienced COVID-19 after my vaccine. I had PAXLOVID. I caught Covid on a trip I took. I went to urgent care three times to get chest x-ray because my oxygen level were so low. I felt very ill. I also fainted and passed out. The third time I went to the ER is because I needed albuterol which helped me a lot. This is the sickness I ever been in my life and I am still not very well.
Pt recvd 2 doses of Engerix-B & 12-14 hrs p/2nd dose had fever, aches, chills, h/a, local tenderness; tx APAP; sx lasted 24 hrs;
Long lasting burning pain; Fever; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Long lasting burning pain) and PYREXIA (Fever) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BURNING SENSATION (Long lasting burning pain) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form and IBUPROFEN (ADVIL 12 HOUR) for Adverse event, at a dose of UNK dosage form. At the time of the report, BURNING SENSATION (Long lasting burning pain) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound scan: unknown An ultrasound test was done in the emergency room to rule out clotting..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Ultrasound done to rule out clotting Treatment given as Tylenol and advil
Excruciating pain in right knee; This is a spontaneous report from a contactable physician (neighbor). The contactable physician reported similar events for three patients (this is the third of three reports). This case is non-serious. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced excruciating pain in right knee on an unspecified date with outcome of 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-202101030082 Same reporter/drug, similar event, different patient;US-PFIZER INC-202101032200 Same reporter/drug, similar event, different patient
Information has been received from a medical assistant concerning a 76 year old female who in approximately 2002, "about 5 years ago", exact date was not known and who was vaccinated, intramuscularly with the first dose of PNEUMOVAX.  On 01-NOV-2007, the patient was vaccinated, intramuscularly with the second dose of PNEUMOVAX, (Lot # 658673/0990U or 658451/0963U).  On 02-NOV-2007, the next day, the patient developed erythema and swelling at the injection site area.  The lot number for the first dose was unknown and the lot number for the second dose was #658673/0990U or #658451/0963U.  The medical assistant requested a lot check for Lot # 658451/0963U and Lot #658673/0990U.  No further information was available.  The medical assistant reported that there were 3 other patients that had injection site reactions after the administration of PNEUMOVAX, (WAES # 0711USA01127).  A standard lot check investigation was performed.  All in-process quality checks for the lot number in question were satisfactory.  The lot met the requirements of the research center and was released.  Additional information has been requested.
After I received the 8/20/21 vaccine, I had a normal menstruation cycle from 8/23-8/25.  Since then, I did not have a regular period in September or October.  I did have severe abdominal cramping on 10/30.   On 11/05/21, I threw up due to unrelated heartburn and a side effect of the puking was a severe nosebleed.   I have never had a nosebleed before that day.
During the shipping of vaccine to immunization clinic on 20 JUL 2010 temperature was recorded at 1.3 degrees C for 6 hrs 5 min. Vaccine was administered to individual on 26 July 2010. Clinic reports no adverse event noted.
The pt said she received the vaccination in the afternoon (3:21 pm) and felt fine for the remainder of the day. Beginning the next day, she reported that the injection site was red, raised, warm, and painful. It continued to get worse. She was instructed to see a physician.
ADMINISTERED EXPIRED PRODUCT; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: 21-JUN-2021) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced administered expired product. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered expired product was not reported. This report was non-serious.
States shot felt weird going in to arm.  Felt "thick".  Ears began to ring and felt light headed 1625 BP 104/? O2 sat unable to obtain due to cold periphery 1630 BP 118/? O2 sat 97% cold periphery  1640 BP 137/86 HR 76 O2 sat 98% RR 16 lungs clear 1645 BP 127/75 HR 70 O2 sat 100% RR 16 1650 BP 130/79 HR 70 O2 sat 100% RR 18 lungs clear After 40 minutes stated felt better provided snack bar, apple and water was able to leave area at a baseline level.
pt recv vax 22MAR96 & 29MAR96 pt exp erythema multiforme & fever;there were no tests, hosp or other problems;
COVID-arm lasting for a week; tightness in her chest (lasted 3 days); Throat ticklish; Cough; Felt like asthma attack; Slight Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (tightness in her chest (lasted 3 days)), THROAT IRRITATION (Throat ticklish), COUGH (Cough), ASTHMA (Felt like asthma attack) and HEADACHE (Slight Headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A12A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anaphylactic reaction. Concurrent medical conditions included Type II diabetes mellitus, Asthma and Drug allergy. Concomitant products included IRBESARTAN (AVAPRO), BUDESONIDE (RHINOCORT ALLERGY), CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), EPINEPHRINE (EPIPEN), AMLODIPINE BESILATE, ATENOLOL (AMORIL AT), SODIUM CHLORIDE (SALINE SPRAY), ADENOSINE (TRICOR [ADENOSINE]), PARACETAMOL (TYLENOL), SALBUTAMOL SULFATE (INHALERIN) and LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) 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 17-Mar-2021, the patient experienced CHEST DISCOMFORT (tightness in her chest (lasted 3 days)), THROAT IRRITATION (Throat ticklish), COUGH (Cough), ASTHMA (Felt like asthma attack), HEADACHE (Slight Headache) and FATIGUE (Fatigue). On 27-Mar-2021, the patient experienced VACCINATION SITE REACTION (COVID-arm lasting for a week). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. On 20-Mar-2021, CHEST DISCOMFORT (tightness in her chest (lasted 3 days)) had resolved. On 07-Apr-2021, VACCINATION SITE REACTION (COVID-arm lasting for a week) had resolved. At the time of the report, THROAT IRRITATION (Throat ticklish), COUGH (Cough), ASTHMA (Felt like asthma attack), HEADACHE (Slight Headache) and FATIGUE (Fatigue) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient did not seek medical attention but reported treating events with Asthma inhaler and Tylenol.
1- Within minutes noticed a very slight effect on perception. Fogginess. Never mentionned to staff 2- Drove home feeling good but very slight headache. Has continued. 3- The PROBLEM started several hours later. Severe ringing...Tinnitus. 4- Never stops even when I wake up in the middle of night, first thing in the morning and at night. 5- Nothing helps, called my PCP the day after injection.  6- PCP assistant called back next day. Suggested I call an ENT. 7- Called my insurance UHC Advantage to speak with nurse. Gave me a list of ENTs 8- PCP instructions were to give it a day or two to see if the ringing would stop.  9- Tinnitus is very significant and is causing me much distress...Max Words!
Narrative: Patient reported throat swelling and itching 4 hours following 1st dose of pfizer covid vaccine. Patient did not seek medical care nor did they take any medication to manage these symptoms and this feeling passed. No other issues reported.
pt slept most of PM p/shot woke up 930PM eyes wide & staring @ ceiling fan started gasping for breath & jerky motions; lasted for a few minutes; restless all noc; t101 ax in AM; 12MAR93 would not walk or stand;
Vaccine caused bad swelling in arm and knot in muscle. Affected joints, shoulder, knees, back. Took one month to recover.
Information has been received from a registered nurse concerning a 31 day old male patient with no pertinent medical history and no drug reactions/allergies who on 11-AUG-2010, was accidentally vaccinated IM in the thigh with a first pediatric dose of VAQTA (Lot#: not reported) instead of hepatitis B virus vaccine. There was no concomitant medication and no lab diagnostics studies were performed. The registered nurse stated that the patient was in the office for 10 -15 minutes and no adverse effect was noted in that time period. Additional information has been requested.
Pt received first dose Pfizer 6/7/21. Pt received second dose Pfizer 6/22/21, 8 days earlier than due. No known adverse event occurred. Minimum interval between doses reviewed with registration staff and immunizers.
Renal failure; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer. A patient of unspecified age and gender received bnt162b2, 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. The patient's medical history and concomitant medications were not reported. The patient previously received 1st dose of BNT162B2 on an unspecified date for COVID-19 immunization. The patient experienced renal failure on 18Mar2021 with outcome of unknown. The patient was hospitalized for renal failure from 18Mar2021 to an unknown date.  Information on the lot/batch number has been requested.
Patient received vaccine, checked out and pulled into observation area for required wait period.  RN supervising observation noticed patient's husband get out of vehicle and at that time, he waved RN over.  Patient's spouse stated that she her voice sounded funny,  she was experiencing SOB and at that time he decided to administer EpiPen that they brought with them (patient has history of anaphylaxis).  RN had access to EpiPen but husband was already in process of administering Epi (he was trained and comfortable with process per his report).  Patient was trying to pull pants down to expose thigh and RN advised medication to be administered through pants.  Patient began feeling symptoms subside, other clinical staff responded and administerd 50mg Diphenhydramine.  Patient refused treatment in ED because had follow up scheduled at allergist immediately following vaccination.
the patient had the second dose of Pfizer vaccine  and broke into hives 3 days; This is a spontaneous report from a non-contactable pharmacist. A 32-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history not reported. The patient's concomitant medications were not reported. It was reported that the patient had the second dose of Pfizer vaccine and broke into hives 3 days after vaccine. The outcome of event was unknown.
Classic zosteriform rash, painful, unilateral, along T6-T7 dermatome, started within 3 days of receipt of ZOSTAVAX & Influenza vaccine.
Patient had immunizations on 08/16/05. He received his Dtap in left deltoid. Mom noticed left arm larger than right on 08/18/05 in pm bath. Arm swollen, slightly reddened, warm to touch. no difficulty with mobility. Patient denies any pain. Child has been "cranky". Mom reports he's afebrile.
Woke up from sleep wheezing, tachycardic, feeling like heart was pounding out of chest. Facial swelling. Used Xopenex inhaler. Wheezing subsided, but heart symptoms last approx 4 hours. Facial swelling continued until midday on 10/23/2009.
03/14/2008 ileocolic intussusception reduced by air contrast enema at Hospital. Admitted for observation and discharged home the following day.  4/23/2008 MR received for DOS 3/14-15/2008 with D/C DX: Intussusception.  Infant presented to ER with somnolence/unresponsiveness following an episode of vomiting milk.  Pt also had a spastic/shaking episode with bloody emesis and bloody/mucusy stool.  PE (+) for lethargy and bloody stool in diaper. IS reduced by Air contrast Barium enema and d/c home next day.
Passing out multiple times; Heart stopping for 11seconds; Lightheaded; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 63-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 24Apr2021 01:15 as UNKNOWN, SINGLE DOSE for covid-19 immunization. The patient past medical history included high blood pressure, borderline diabetes, penicillin allergy and sulfa allergy. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID. On an unspecified date in Apr2021, the patient experienced lightheaded and passing out multiple times and heart stopping for 11seconds and visited emergency room. Patient was hospitalized for 3 days. Eventually needing a pacemaker. Reported seriousness criteria: Life threatening and Hospitalization. The patient was not diagnosed with COVID-19 prior to vaccination and tested for Covid-19. The patient lab test includes sars-cov-2 test: negative on 27May2021. The outcome of the events was unknown.  Information on the batch/lot number has been requested.
5:00 PM-SOB, Hard to breath, Phlegm cough-->ceased at 6:30 PM. 7:00 PM-Stiff neck, bilateral arms, continuously increased; Pain into back and legs. 9:00 PM-Blood shot, puffy eyes.
@ approx 1040PM, pt recvd DTP/OPV & approx 5 mins later started to stiffen, while still on mom's lap, & eyes rolled back w/few jerks of arms; pts head hit the edge of the desk when put on floor PHN called for other PHN to call 911;
Initial information received on 06-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 2 months old patient (gender not reported), who was vaccinated with a 0.5 ml dose of PENTACEL (Batch number:C5466AB) (expiry date and dose in series not reported) via intramuscular route in the right leg. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DTAP for Immunisation; HEPATITIS B VACCINE for Immunisation; and PREVENAR 13 and ROTATEQ for Immunisation on an unknown date. It was a case of actual medication error due to inappropriate reconstitution technique because the nurse gave mixed the Hib portion sterile water and administered it with that. It was unknown if any adverse event was occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none
This spontaneous report has been received from a pharmacy student referring to a 15 year old female patient. The patient did not have pertinent medical history, drug reactions, allergies, concurrent conditions and concomitant therapies. On an unknown date, the patient was vaccinated with the first and second dose of GARDASIL (strength, route of administration, frequency, lot#, and expiration date were unknown by the reporter) for prophylaxis. On 16-JAN-2017, the patient was vaccinated with a third dose of GARDASIL (strength, route of administration, frequency, lot#, and expiration date were unknown by the reporter) for prophylaxis. On 16-JAN-2017, reported as "immediately after the third dose", the patient experienced in the vaccinated left arm and fingers pain and tingling for a month. The pain did not resolve and became worse. Therefore on an unknown date a nuclear magnetic resonance imaging (MRI) was performed  and "showed inflammation". The pharmacy student also reported that the "pain spiked to 10 out of 10" and the patient could not use her arm, the reporter suspected that the patient could have osteomyelitis. The patient went to the emergency room on an unspecified date and then on 19-FEB-2017 the patient was hospitalized in a local hospital for control the pain, the patient's treatment included TYLENOL, TORADOL and morphine. At the time of reporting the outcome of pain and tingling in her arm was not recovered and the outcome of osteomyelitis and inflammation was unknown. The reporter stated that the osteomyelitis, pain and tingling in the patient's arm cause disability. The relatedness between the events and GARDASIL was not reported. Upon internal review osteomyelitis was considered to be a medically significant event. Additional information has been requested.
Report 2001015040-1 described swelling at the injection site in a five year old male who received Infanrix. This report was received from an office manager and has been verified by a licensed vocational nurse. The vaccinee is a "well child." Concomitant medications were not specified. The vaccinee had no illness at the time of vaccination. On 06/11/2001, the vaccinee received his fifth 0.5cc IM dose of Infanrix, his fourth SC 0.5cc dose of IPV, and his second SC 0.5cc dose of MMR vaccine. On 06/12/2001, the vaccinee experienced a localized site reaction consisting of redness, slight swelling and warm to touch. Cold pack was applied to deltoid. Ibuprofen 1 1/2 teaspoon every six hours as needed was prescribed. The redness and swelling subsided after 2-3 days with no compromising effects afterwards. Infanrix was discontinued. The reporter stated that the adverse events could not be associated with medical history, other drug, lack of efficacy, or erroneous administration. The reporter stated that the adverse events were mild in intensity and were related to Infanrix. As of 08/15/2001, the adverse events had resolved.
Patient experienced vasovagal symptoms, blacked out, excessive sweating, difficulty swallowing/drinking, difficulty keeping head up. Symptoms occurred within a few minutes of the vaccine injection. Patient stated similar symptoms when they drew blood previously. Patient started feeling better after a couple a minutes sitting down.
1.5 inch in diameter induration at injection site.  Injection site warm to touch and painful.
Diarrhea; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and NAUSEA (Nausea) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced DIARRHOEA (Diarrhea) and NAUSEA (Nausea). At the time of the report, DIARRHOEA (Diarrhea) and NAUSEA (Nausea) outcome was unknown.            No treatment information was provided.  No concomitant medication was provided.   This case was linked to MOD-2021-018805 (Patient Link).
discomfort in the arm of the injection; mild headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (discomfort in the arm of the injection) and HEADACHE (mild headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     The patient's past medical history included Palpitations, Swollen ankles (Left ankle got swollen) and Vein pain (Veins hurt).    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced VACCINATION SITE DISCOMFORT (discomfort in the arm of the injection) and HEADACHE (mild headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE DISCOMFORT (discomfort in the arm of the injection) and HEADACHE (mild headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.   This case was linked to MOD-2021-098190 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: Follow up information was received and the reporter information, event outcome were updated.
Pt developed vomiting and diarrhea the day after the shots.  diarrhea persisted, and pt became dehydrated, needing hospitalization for hypoalbuminemia; pt needed TPN for a few days