chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Persisting itches; Persisting redness; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Persisting itches) and INJECTION SITE ERYTHEMA (Persisting redness ) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced INJECTION SITE PRURITUS (Persisting itches) and INJECTION SITE ERYTHEMA (Persisting redness ). At the time of the report, INJECTION SITE PRURITUS (Persisting itches) and INJECTION SITE ERYTHEMA (Persisting redness ) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Initial unsolicited report received from a consumer on 01 May 2015. A female patient (age at the time of event unspecified), whose concomitant medications were not reported, had received a dose of H1N1 flu shot (batch number, expiry date, dose and dose number, route and site of administration were not reported) on an unspecified date in 2010. The patient had medical history of asthma. On an unspecified date, after vaccination, the patient got paralyzed, and three months after vaccination, patient had coma for about three weeks. Patient also had an autoimmune disease called Acute Disseminated Encephalomyelitis (ADEM) with lesions on her brain and spinal cord, although doctors told that condition was a result of flu shot, but federal health officials said that's tough to prove. It was also reported that, five year later at the age of twenty two, patient was wheelchair-bound and can barely move the left side of her body. Laboratory investigations and corrective treatments were not reported. At the time of reporting, outcome of event for coma was recovered and unknown for Acute Disseminated Encephalomyelitis and paralyzed. Documents held by sender: none.
Patient says he began having difficulty breathing and a fever of 102F about 24 hours after vaccine was given.
while nursing, pulled off, turned head & began screaming;lt eye rolled back, arms & legs were shaking;very fussy & difficult to console;head cocked to rt;underwent full septic workup w/antibiotics administered;resolved late that evening
vertigo spells; over all "crappy feeling"; dizziness; nauseous; headache; rash all over face and chest; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo spells), FEELING ABNORMAL (over all "crappy feeling"), DIZZINESS (dizziness), RASH (rash all over face and chest) and NAUSEA (nauseous) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced RASH (rash all over face and chest). On 22-Mar-2021, the patient experienced VERTIGO (vertigo spells), FEELING ABNORMAL (over all "crappy feeling"), DIZZINESS (dizziness), NAUSEA (nauseous) and HEADACHE (headache). On 20-Mar-2021, RASH (rash all over face and chest) had resolved. At the time of the report, VERTIGO (vertigo spells), FEELING ABNORMAL (over all "crappy feeling"), DIZZINESS (dizziness), NAUSEA (nauseous) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
A mother reported that her 6 year old son received an injection of DTP and subsequently, developed seizures. No further information was available as of the date of this report. Seizures are considered "Medically Important".
NO ADVERSE EVENT; baby had mistakenly received the hep a vaccine instead of a hep b vaccine; baby had mistakenly received the hep a vaccine instead of a hep b vaccine; This spontaneous report as received from a physician refers to a 7.5 months old patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided.     On 02-APR-2021 the baby had mistakenly received the hepatitis a vaccine, inactivated (VAQTA) lot # T018227 expiration date not reported, but upon internal validation established as 11-DEC-2021, instead of a hepatitis b vaccine (recombinant)(manufacturer unknown).    No adverse events were reported and nd the physician stated that "the baby was fine."
On 2/27/2018 she received the SHINGRIX vaccine in the left upper arm. The patient states that shortly thereafter, she did develop some discomfort in the arm. On 2/28, the patient states that she experienced joint pains in association with her nails and hair also hurting. She had no fevers or chills and no difficulty breathing. Then, on 3/1/2018 she states that the arthralgias resolved but she developed redness in the left upper arm. The tenderness does persist in the form of burning. She has had no fevers or chills and complains of no numbness or tingling in the lower extremities or hands currently.
Patient was inadvertently given an expired dose of Twinrix on 09Jan2023; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 57-year-old female patient who received HAB (Twinrix) (batch number P9LT9, expiry date 1st January 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th January 2023, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 9th January 2023, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was 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: 09-JAN-2023 Reporter's Comments: The patient was inadvertently given an expired dose of Twinrix. No further details provided. The reporter consented to follow up. Additional supportive information: The patient received Twinrix beyond the expiration date, which led to expired vaccine used.
Redness, swelling, joint pain, diarrhea, dizzy, palpitations
pt recv vax;felt warm to touch;T 104;attempted to give apap & child began sz;to hosp & tx in er;rectal supp for fever;mom reports pt had exceeded 99F since incident
(R) leg pain x 3 days. (R) arm movement which was considered unusual.
tired the day after receiving her second Moderna COVID-19 vaccine; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (tired the day after receiving her second Moderna COVID-19 vaccine) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. RA182 and 20G20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal. Concomitant products included PARACETAMOL (TYLENOL [PARACETAMOL]), URSODEOXYCHOLIC ACID (URSODIOL) and (MESALAMINE) for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (tired the day after receiving her second Moderna COVID-19 vaccine). At the time of the report, FATIGUE (tired the day after receiving her second Moderna COVID-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication also included blood pressure medication. No treatment details were reported.   This case was linked to MOD-2021-396732 (Patient Link).
Patient states he woke up the day following the vaccination with hives on his faces and both forearms. Face and arms were red and itching.  Patient reports taking Benadryl 50 mg by mouth for two days and using hydrocortisone cream on skin which was ineffective.  Patient reports symptoms resolved by day five after vaccination.  Patient denies seeking medical attention after event and reports skin sensitivity to sweat and sun after hives resolved.
Trouble breathing; Nauseated; Heart Palpitations; Hot, felt flush; A spontaneous report was received from a nurse concerning a 61 year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events, hot, felt flushed, heart palpitations, nauseated and trouble breathing.   The patient's medical history, as provided by the reporter, included myocardial infarction. Concomitant medications reported included sertraline hydrochloride.    On 30 Dec 2020, approximately 20 minutes prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 30 Dec 2020, the patient was walked to the waiting room to wait 15-20 minutes following vaccination. At 3:50 pm the patient began to feel hot and flushed. The patient started having heart palpitations and felt nauseated. The patient was assisted by a nurse and approximately 20 minutes later, patient reported feeling better. The patient was instructed to wait another 30 minutes before leaving the clinic. At 4:30 pm, the patient stated that she was not feeling well, reporting heart palpitations, flushing and trouble breathing. Patient was taken to the hospital via emergency medical services at 4:43pm. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events,  hot, felt flushed, heart palpitations, nauseated, and trouble breathing, was unknown..; Reporter's Comments: This case concerns a 61 year old, female patient, with medical history of Myocardial Infarction, who experienced a serious, unexpected events of hot flush, heart palpitations, nausea and trouble breathing.  The event occurred 20 minutes after administration of the first dose of mRNA-1273 (Lot number: 011J20A). Very limited information regarding this event has been provided at this time.  Based on temporal association between the use of mRNA-1273 and the onset of the event, a causal relationship cannot be excluded.
Cold chills, Body aches, fever 100.5, nausea  all last 24 hrs but still nausea  and a headache now.
Headache, Myalgia, Arthralgia, NauseaVomiting, Fever, fatigue Narrative:  Dose 1: pt reported chills,  nausea,fatigue,headache,joint pain post vacc done 1/4/2021.
No additional AEs reported; GARDASIL 9 was administered following a temperature excursion; This spontaneous report was received from an office manager referring to a 12-year-old male patient.  The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 02-DEC-2022, the patient was vaccinated with one dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) pre-filled syringe injection, administered as prophylaxis (there were five possible lot # of the vaccine administered: lot #1775811, expiration date: 07-DEC-2023; lot #1775827, expiration date: 27-JUN-2024; lot #W009829, expiration date: 19-OCT-2024; lot #U032681, expiration date: 26-OCT-2023; and lot #1780876, expiration date: 09-NOV-2023; however, it was not specified which one was received by the patient) (strength, dose, route of administration, anatomical location, and vaccination scheme were not provided). It was reported that the vaccines suffered from three temperature excursions with a total of 25 minutes (on 09-SEP-2022 for 8 minutes; on 16-SEP-2022 for 5 minutes; and on 03-JAN-2023 for 12 minutes). The excursions were not noted until it was noticed that an employee mistakenly cleaned the data logger more than once a day (product storage error). There were no additional adverse events (AEs) reported in the patient (no adverse event).  This is one of several reports received from the same reporter.
CDC reports: 5 mo infant received DTP/OPV on 25JAN90 and died 3FEB90.
The evening of the day after vaccination my stomach was upset, then had a large amount of green diarrhea, chills.  That  night and the next day I slept most of the time and had chills,  It's now the 3rd day and I'm feeling a bit better but still very tired and sleeping a lot.
Injection on 10/14/22, , 10/17/22 noted swollen left axillary node, 10/21/22 left posterior upper arm unusually sore, 11/06/22 identified tip of left pinky odd sensation was actually numbness, 11/16/22 entire  left pinky fingertip numb, approx a week later tip of left index finger numb., Prednisone taper 12/4/22. Symptoms less severe and more intermittent. Usually opted out of flu vaccine due to adverse event in 2007. Hospital Chief of Staff removed my exemption. Needed to get the vaccine within two weeks to keep hospital privileges.
When our facility received the Covid - 19 vaccine, I spoke and was told that the exp. date for the vaccine was 9 months from the. date on the box. Which made the exp. date 5/31/22. On 5/20/22 Contacted me stating that we have given exp. vaccines to patients and that the exp. date was 10 weeks from the date the vaccine was received which would have been 5/2/22. Thus we unknowingly gave exp vaccine to patient.   Patient tolerated vaccine well, no adverse effects have been reported.
PENTACEL given-24 hours after large wheal hive at injection site. Within 12 hours-multiple hives covering entire body.
Information has been received from a consumer refers to his daughter, a 4 year old female patient. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with her first dose of PROQUAD (Merck) (lot#, expiration date, strength, dose were unknown and on 05-APR-2016 received her second dose of PROQUAD (Merck)) (lot#, expiration date, strength, dose were unknown) both intramuscularly. The patient's concomitant medication was not reported. On 05-APR-2016 (reported as "a couple hours") after receiving the second dose of PROQUAD (Merck), the patient developed a fever and "a couple hours after that she broke out in hives and a rash". The reporter stated that "the rash got worse yesterday to the point where three quarters of her body was covered. The rash was on her neck, face and most of her back, belly and legs". The reporter stated he gave the patient BENADRYL as treatment (unspecified date). The reporter stated on 07-APR-2016, he took his daughter to the emergency room due to her reaction. The patient was given DECADRON while at the emergency room and had a "strep test" performed which came back as "negative". The patient daughter was not admitted to the hospital and went home later in the day. The outcome of pyrexia and rash generalised was reported as not recovered/not resolved. The causality between the events and PROQUAD (Merck) was not reported. Additional information has been requested.
Initially no response, around March severe headaches, six times lost feeling in hands/arm/jaw (both right and left on different instances, one side at a time), sent for MRV, diagnosed as having CVST (cerebral venous sinus thrombosis), admitted to hospital with 4 large clots, put on heparin, kept for 3 days, released with LMW heparin shots for 3 weeks, changed to pradaxa today, will test by MRV in 4 months to determine if can stop treatment.  Long list of other blood test to determine cause, none came back with any reason for the disease.  Could have still caught Virus and had asymptomatic case which led to CVST?
Client had date of birth incorrect by the time of vaccination on 12/10/21. Client received Pediatric dose instead of the adult dose, as the client was 12 at the time of vaccination. Error reported today 1/11/22 as mother came back for second dose and requested change of DOB, and error was noticed on site.
Sore left upper arm, numbness in face all around nasal cavity, felt like  a Novocaine shot.  felt like face was swollen but  I don't notice any swelling.  Throat felt tight I wasn't able to swallow water earlier I had to spit it out, later I was able to drink small amounts of water.  At about noon or so I was able to drink without any issues.    My neck feels a bit stiff, my ears hurt a bit.  I took one benadryl at about 11;00am
few min p/vax pt became pale, ashen looking on face-pt referred to ER-EPI given;
Incorrect dose (0.25 mL) administered. Booster for dose for NDC in stock should have been 0.5 mL. No adverse reactions reported by the patient.
At the onset of menses, the volume of bleeding was approximately twice to triple that of which I have experienced previously across my history of menstrual cycles with the exception of immediate postpartum bleeding. I also observed substantially heavier and larger clots than I typically see at the time of my period. I track my fertility including temperature and cervical mucus observations. In the intervening days between the adminstration of the Pfizer shot and the onset of my period of August 10th, I also observed oddities in my pattern of temperatures .
I experienced two separate adverse reactions.   First adverse reaction occurred on 2/11/21 at 5:00 am (after receiving my second shot of the Moderna Covid-19 vaccine).  I experienced tachycardia with an approximate heart rate of 175 bp for approximately 30 minutes.  I was able to lower my heart rate down with 25 mg of quick release metoprolol.   Second adverse reaction started on 2/21/21.  I developed shingles on my lower left side.  It appears the shingles originated from my L1 dermatome.  At the current time 2/10/21 I am still recovering from my shingles.
JOINTS HURTING MORE THAN NORMAL; This spontaneous report received from a patient concerned a 38 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included joints hurting.The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 vaccination. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) 160 mg, frequency was not reported, from 11-MAY-2021 for hidradenitis suppurativa. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 11-MAY-2021, the subject experienced joints hurting more than normal. The action taken with covid-19 vaccine was not applicable; and dose of adalimumab was not changed. The outcome of joints hurting more than normal was not reported. This report was non-serious.
Severe chills and shivering; Total body aches; Fatigue; Unable to get comfortable; Headache; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the right arm on 07Apr2021 at 11:30 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. Concomitant medications included sertraline hydrochloride (ZOLOFT) and levocetirizine dihydrochloride (XYZAL) from an unknown date, for unknown indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the right arm on 17Mar2021 at 15:30 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 02:30, the patient experienced severe chills and shivering, total body aches, fatigue, unable to get comfortable and headache. Therapeutic measures were taken as a result of the events severe chills and shivering, total body aches, fatigue, unable to get comfortable and headache and included treatment with Tylenol. The clinical outcome of the events severe chills and shivering, total body aches, fatigue, unable to get comfortable and headache were not resolved at the time of report.   No follow-up attempts are needed. No further information is expected.
ACUTE HYPOXIC RESPIRATORY FAILURE IN SETTING OF COVID-19 PNEUMONIA
Client received COVID vaccine @ 3:45pm.  Client in observation area, reported having "cold sweats" to EMT staff @ 3:55pm.  EMT staff provided client with water, attempted to assist client to zero-gravity chair.  Client became unresponsive @3:58pm.  Client became responsive @4:01pm, transferred over to cot with assistance, with legs raised.  Client able to speak, denies shortness of breath, reports "anxiety with injections and anything going in to my body".  Vital signs @ 4:06pm, BP 102/58, P 87, RR 12, O2 sat 97%.  Client continued with observation, provided with water.  Vital signs @ 4:14, BP 104/60, Pulse 82, RR 12.  Client reports he feels much beter, able to sit up in chair.  Client advised to follow up with primary care, client reports he will call parents for ride home.  Client left observation area @ 4:30pm, walking with steady gait.
Myalgia, Arthralgia, fatigue Narrative:  2/3 11:00 Myalgia, arthralgia, fatigue;  will follow up with PCP if necessary.
Initial and follow up nformation has been received from a registered nurse concerning an 81 year old female patient who on 10/15/04 was vaccinated into the left deltoid with a dose of pneumococcal 23v polysaccharide vaccine (lot # 647655/0869N). On 10/16/04 the patient felt soreness around the injection site. Later in the day she noticed a swelling and redness around the injection site (about 4 inches in diameter). The soreness continued and it began to itch as well. The patient went to the emergency room and was treated with prednisone 10mg twice a day until the swelling and redness went down. She was also instructed to take diphenhydramine hydrochloride and to use an ice pack on the area. On 10/18/04 the patient told the nurse that the swelling, soreness and redness had subsided. It was noted that the patient was recovering. According to the nurse as of 10/27/04 the patient's symptoms had subsided and treatment with diphenhydramine hydrochloride and prednisone was discontinued. The reporter considered the patient's experiences to be other important medical events (OMIC). Additional information has been requested. Follow up 03/03/05: Patient has recovered from the adverse event.
Approx 48 hrs after vaccine (6 inch x 8 inch), red, warm, indurated area, surrounding injection site - tender to touch.
Pfizer-BioNTech COVID-19 Vaccine  Slight headache on the morning of 12/22/2020, and feeling exhausted. These two symptoms persisted during the day but did not get worse.  In the early morning of 12/23/2020, the headache was worse, I had chills and my fever was 102.1. I was very dizzy at the time when getting up. I took Tylenol and ibuprofen, alternating, to help with the headache and fever. On 12/24/2020, I still have a slight fever of 100.4 but symptoms are getting better.