chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I have been having like vivid dreams every night; This is a spontaneous report from a contactable consumer (patient) reported that: An unspecified age and gender patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730; Formulation: solution for injection: expiration date: unknown), dose 1 via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE and second dose via an unspecified route of administration on an unspecified date (Batch/Lot Number: EW0161) as 2ND DOSE, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Consumer stated, "I was just wondering I got the Pfizer Covid 19 vaccine. I got two doses and I have been having like vivid dreams every night on an unspecified date''.  The patient did not know like if other people were reporting that and was just wondering like know if other people were reporting it.  Patient was enquiring that was said like it eventually goes away or was it continue for a long period of time. The patient glad to report what side effect the patient having but the main concern was to know do they have like other people that reported it and if so like did it eventually go away. Also enquiring about was their experience that it went away after a month or two, or does it keep continuing. The patient just wanting to get some information because right now patient having strange dreams, they were not like before and some of them were very scary. The outcome of the event was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
is having difficulty sleeping at night due to being jittery; being jittery; he is feeling a lot of fatigue; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included COVID-19 VACCINE.   On 29th May 2021, the patient received the 1st dose of Shingrix. On 29th May 2021, less than a day after receiving Shingrix, the patient experienced fatigue. On an unknown date, the patient experienced difficulty sleeping and jitteriness. On an unknown date, the outcome of the fatigue, difficulty sleeping and jitteriness were not recovered/not resolved.   It was unknown if the reporter considered the fatigue, difficulty sleeping and jitteriness to be related to Shingrix.  Additional details were provided as follows: The reporter was patient's wife. The age at vaccination was not reported. The patient had taken first COVID 19 shot two months ago. The patient received first dose of Shingrix three days ago felt lot of fatigue on same day and also had difficulty in sleeping at night due to being jittery. The reporter did not consented to follow up. This case has been linked with case US2021117068 by same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021117064:same reporter
This spontaneous report was received from a physician and from a support services director and refers to a patient of unknown age and gender. No information regarding the patient's medical history and concurrent conditions was provided. On 10-JUN-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 injection (lot # J011042, expiry date: 04-MAR-2015; exact dose and route of administration were not reported). There were no concomitant therapies reported. On an unknown date, the dose of the vaccine was exposed to the temperature excursion lasting 840 hours with the lowest recorded temperature of 20 degrees Fahrenheit (-6.66 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. this is one of several reports received from the same reporter. Additional information has been requested.
pt broke out in rash, hives, w/nausea & fever p/inj; also malaise, h/a, wheezing & diff breathing;
w/in 5min post vax pt slumped then had a tonic sz w/arms & legs shivering, eyes rolled up;no clonic movement;became conscious w/in 1-2min
Vaccine recipient became nauseas and light headed approximately 30 minutes after vaccine.  Recipient also had started menses which was very heavy, also she said she saw the needle and she shouldn't have looked.
PAPULAR LESIONS, SOME HAVE CLEAR LIQUID, SOME SCABBED OVER.  CALAMINE LOTION, CHILDRENS TYLENOL,
Migraine; Nausea; joint pain/specifically in a joint that had a previous injury (not all joints).; This is a spontaneous report from a contactable consumer, the patient A 29-years-old non-pregnant female patient  received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL3247), via an unspecified route of administration in the left arm on 16Feb2021 at 13:15 (at the age of 29-years-old) as a single dose, for COVID-19 immunisation.  Medical history included Osteoarthritis of the knee due to an injury,  Known allergies to cats.   No  concomitant medications.  Historical Vaccination includes BNT162B2 Dose 1,  lot number=EL3247, administration date=26Jan2021 at 13:15  in the left arm for COVID 19 immunization. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 17Feb2021 at 03:00, The patient experienced Migraine, nausea, and joint pain specifically in a joint that had a previous injury (not all joints). No treatment was given for the events. The clinical outcome of the events migraine, nausea and  joint pain was recovering. :
Swelling in right arm below vaccination site began evening 02/25/2021 and worsened to entire upper right arm
I had surgery 3 years prior for nerve issues in my spine after the vaccine I started having weakness in my arm and tremors so I made an appointment for doctor and this continued for about 5 months.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 15-JUL-2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 23-AUG-2016, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as herpes zoster. The patient was prescribed VALTREX and lidocaine for management of her painful symptoms and chronic pain. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Patient arm was wiped with an alcohol swab. Needle was injected, taken out, and reinjected immediately. No re-sanitization with an alcohol swab occurred before the reinjection.  Patient did not have any complaints or pain immediately after the incident.
father called to report a knot where shot was given;Brought pt in approx 2x2cm knot;no redness/heat;under skin;instructed to see PMD since was so large & unresolved post 2wk;
Child will not walk on leg, falling down, crying, holding the leg where injection was given. Was seen in clinic 10-24-18. Limping, bloodwork ran, and x-rays of hip and knee. 10-29-18 fever and still limping. Ultrasound on left leg. More bloodwork. All negative.
Injection given too high up on arm; This case was reported by a consumer via call center representative and described the occurrence of vaccine administered at inappropriate site in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th January 2023, the patient received the 1st dose of Shingrix. On 9th January 2023, unknown after receiving Shingrix, the patient experienced vaccine administered at inappropriate site. On an unknown date, the outcome of the vaccine administered at inappropriate site was unknown.   Additional Information: GSK receipt date: 12-Jan-2023 Reporter's comment: The reporter consented to follow-up. Additional supportive information: The Shingrix injection was given too high up on the patient's right arm, which led to vaccine administered at inappropriate site.
13 year old identical twin boy who started having chest pain approximately 24 hours after 2nd dose of covid vaccine.  Chest pain was persistent and within 48 hours he developed shortness of breath so mom brought him to ED.  Found to have elevated troponin and EKG with some ST segment elevation and was admitted for acute myocarditis.
Patient went to the hospital for an infusion treatment after being diagnosed with COVID-19.  Medical personnel admitted patient to the hospital on 08/30/2021.
Pt c/o sore throat & swelling at injection site, as well as fever, cough, phlegm, itchiness of ears, eyes & throat. All symptoms lasted approximately x 2 days. Pt did not treat the symptoms, went away on its own.
Patient received second dose of Pfizer vaccine.  Vaccine expiration time 0930 on 5/12/2021. Patient received vaccine on 5/12/2021 at 0938. MD made aware.  No harm to patient or adverse reactions.
24 hours after vaccine I was short of breath, 105 fever, and it felt like coronavirus all over again. I was sick for 24 hours and then it was just gone.  I also had diarrhea, racing heart, dizziness. I had a funky x-ray and my lungs were going white and I passed a PFT on June 26 and my doctor was baffled. That's the main reason I reported -- the tests were part of the recover clinic protocol. My lung disease (ILD) got worse since I got the vaccine as well.
Unknown vaccine information. The patient was vaccinated through a local vaccination clinic - 10/3/2019. He came into the walk-in clinic today 10/4/2019 with a large localized reaction. Erythema with slight edema to the upper left arm 12cm x 10cm. No systemic symptoms.
very loud extreme ringing in his ears, it was so bad he could hardly hear people talking or the television; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Mar2021 (Lot number: EN6208) at the age of 67 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Psoriasis" (ongoing), notes: Verbatim: Psoriasis, Diagnosed at least 5 years ago.; "Arthritis" (unspecified if ongoing), notes: Verbatim: Arthritis, Diagnosed at least 5 years ago. Concomitant medication(s) included: COSENTYX taken for arthritis, psoriasis (ongoing). Vaccination history included: Bnt162b2 (Dose number:01, Batch/lot number :EN6201 , Dosage text :Unknown Dose; Left Arm, Protection against Covid), administration date: 18Feb2021, for covid-19 Immunization, reaction(s): "arm was very sore right where her got the shot". The following information was reported: TINNITUS (non-serious) with onset 16Mar2021, outcome "recovered" (30Mar2021), described as "very loud extreme ringing in his ears, it was so bad he could hardly hear people talking or the television". Therapeutic measures were not taken as a result of tinnitus.  Additional information: arm was very sore right where her got the shot: (From: 18Feb2021 To: 20Feb2021) (Recovered/Resolved). Additional Information for Concomitant Products Cosentyx: 2 injections once a month; each 150mg. Started last Summer. Caller states he is calling about the Pfizer Covid Vaccine. Caller states he just had a side effect from it that he doesn't see listed as one that he wanted to report. Caller states with his first shot, his arm was very sore right where her got the shot. Caller states after his second shot, his arm was not sore at all. Caller states he had a very loud extreme ringing in his ears, it was so bad he could hardly hear people talking or the television. Caller states the really bad ringing lasted 24 hours then each day it continuously got less and less, but it lasted for 2 weeks. Concomitant Medications: States he keeps reading Cosentyx lowers the immune system and the Covid vaccines may not be as effective as in other people but on advice of Dermatologist, Rheumatologist and PCP, they all encouraged him to get the shot. States he gave himself 2 shots on 26Feb2021, so 8 days after the vaccine. In March his second shot was on 16Mar2021, and he gave himself his shots on 23MAR2021. States he was trying to get as much distance between them as he could. Time the Vaccination Was Given: States both vaccines were given Mid Day. Additional Vaccines Administered on Same Date of the Pfizer Suspect: None. Time of Onset (24-hour clock): Sore Arm: An hour or two after received it. Ringing in his ears: Six Hours after Shot; started slightly and then worsened for 24 hours and then less extreme for 2 weeks. AE did not require a visit to Emergency Room, Physician Office. Family Medical History Relevant to AE was none.  No follow-up attempts are possible. No further information is expected.
No additional AE information provided; the patient was administered an improperly stored dose of PNEUMOVAX23; This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age and gender. Patient's concurrent conditions, medical history and concomitant therapies were not reported.    On 29-AUG-2019, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (route and dosage schedule were not reported) lot # S004548, exp date: 12-AUG-2020 for prophylaxis. No adverse event reported.    The temperature excursion was of 47.3 degrees Fahrenheit, for 20 minutes. No previous temperature excursion reported. A data logger was used.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress: ; manufacturercity: ; manufacturerstate: ; manufacturercountry: ; devicelotnumber: S004548; expirationdate: 12-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2005USA000302:
This spontaneous report was received from a licensed vocational nurse refers to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not provided. On an unknown date, the patients were vaccinated with doses of PROQUAD (route, lot numbers and expiration dates were not provided). On an unknown date, there was incorrect product storage as multiple unspecified patients had received PROQUAD that were improperly stored. No adverse event were reported. It was unknown if the patients sought medical attention. At the time of the report, the patients' status was unknown. Additional information has been requested.
No additional AE/no PQCs.; Nurse reported PROQUAD was administered after TE; see TE case 02487539. See full details below. No additional AE/no PQCs.    ?    Names of vaccines involved PROQUAD X007537 09/08/2024        ?    Temperature 8.1°F        ?    Time frame 3 hour; This spontaneous report was received from Other Health Professional and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient started therapy with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 1 dose, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On 18-SEP-2023, nurse reported PROQUAD was administered after TE; see TE case 02487539 (Temperature 8.1°F for 3 hours). See full details below. No additional AE/no PQCs.  Lot Number X007537 is not valid for V221.
It felt like bumble bee or wasp bit and tingling; Rash on her right upper arm; Mild site injection soreness/ Injection site tender to the touch; Red rash on her upper right arm; Injection site was a little swollen; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PARAESTHESIA (It felt like bumble bee or wasp bit and tingling), RASH (Rash on her right upper arm), VACCINATION SITE PAIN (Mild site injection soreness/ Injection site tender to the touch), VACCINATION SITE ERYTHEMA (Red rash on her upper right arm) and VACCINATION SITE SWELLING (Injection site was a little swollen) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced INJECTION SITE PARAESTHESIA (It felt like bumble bee or wasp bit and tingling), RASH (Rash on her right upper arm), VACCINATION SITE PAIN (Mild site injection soreness/ Injection site tender to the touch), VACCINATION SITE ERYTHEMA (Red rash on her upper right arm) and VACCINATION SITE SWELLING (Injection site was a little swollen). At the time of the report, INJECTION SITE PARAESTHESIA (It felt like bumble bee or wasp bit and tingling), RASH (Rash on her right upper arm), VACCINATION SITE PAIN (Mild site injection soreness/ Injection site tender to the touch), VACCINATION SITE ERYTHEMA (Red rash on her upper right arm) and VACCINATION SITE SWELLING (Injection site was a little swollen) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication details were not reported by the reporter. Treatment included compress.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This spontaneous case was initial received on 07-Dec-2015. The case report was received from a Health Professional and concerns an 17 years old male patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug (s), timing and conditions surrounding the onset of reaction (s)/event (s): The patient received AFLURIA for indication protection against seasonal influenza on 18-Nov-2014 -18-Nov-2014, Batch no: not provided, Route of administration: Intramuscular, Dose: 0.5 ml. AFLURIA was stored correctly. Additional suspect drug (s): No additional drugs suspected. Reaction (s)/event (s) and outcome: On an unknown date, after starting/ treatment with AFLURIA the patient experienced Localized swelling in deltoid (non serious, outcome: Recovered/Resolved). For relevant test results see appropriate report section.
Itchy Throat, Shortness of breath, dizzy- occured approx. 10 mins after vaccination. Symptoms remained the same throughout encounter until the arrival of EMS. 0.3mg IM Epi 50 mg Diphenhydramine Called EMS.
pt recv vax SEP95&devel a hard lump @ the inj site;hx of sz disorder&a thyroid problem;takes Dilantin,Phenobarb,synthroid;
The day after the vaccine I had an intermittent  intense burning, tingling sensation on my lower left leg  lasting for three days.  I used hydrocortisone 10% cream to relieve the burning.  It resolved without further incident.
no adverse effects reported; the patient received one dose  of improperly stored MMR II; This spontaneous report has been received from a registered nurse concerning to a patient of unknown age and gender.  The patient's concurrent conditions, medical history, past drug reactions or allergies and concomitant medications were not reported.  On 15-AUG-2019, the patient received one dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (Albumin status of rHA (recombinant human albumin) (M-M-R II)  (route of administration and anatomical location were not reported) (lot#: R031681, expiration date: 01-NOV-2020) reconstituted with properly stored sterile diluent (lot#: N029636, expiration date: 29-MAR-2020) for prophylaxis. The total temperature was above 47 degrees Fahrenheit (48.1 degrees Fahrenheit) for a total time frame of 7 hours. There were no previous temperature excursions. The call was due to a data logger. No adverse effects reported.
Left arm sore  directly after injection at 730am, around 9am right upper arm started to itch.  Around lunch time started getting a headache, by the time work was over around 5pm arm was becoming more sore and itching became more intense.  Went home took ibuprofen around  6pm for headache, checked injection site and discovered it was red and swollen, looked at inside of upper right arm and noticed about 4 or 5 red bumps (hives). Went to bed around 9pm  Woke up Tuesday 2/2 felt nauseous both right and left arm itching found red bumps on left arm including one on top of my injection site, headache becoming a little more intense, called Dr?s office and spoke to on call RN and directed to take an antihistamine.  Took 2 Benadryl and headed to work, while at work started to get chills, body aches and when the Benadryl wore off intense itching. Came home and took 2 more Benadryl around 545pm not able eat not hungry, took 2 more Benadryl at 930pm and went to bed. Today  2/3 felt better itching not as bad, headache gone but still feeling tired, still have hives but they have not spread.
had devel high fever 2hr p/vax 2PM observed to be fussy, crying constantly;sx persisted throughout the noc had devel vomiting x5;was brought to hosp 6MAY97 5:30;to MD office 0900 still t103.2 & lethargic;adm to hosp
10-14-15 2 hrs after immunization of Hep AB, numbness of (R) thumb. Painful if cold weather. Referred to dr. 10/14. Sometimes tip of (R) Thumb aches "like a toothache" all day. Continued to be numb some days.
First night says had "heart pain" in left chest.  Sore on hand got infected first week and worse second week.  Has had continued fatigue, and asthma symptoms since got vaccine on 7/9/21.  Still disabled.
pt recvd vax; 31jul95 exp fever; 3rd day of fever, pt exp T 104.6;pt sibling vaccinated same day & exp papular lesions;
Tired; Feeling funny; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL and FATIGUE in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included AFib.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced FEELING ABNORMAL. On 07-Apr-2021, the patient experienced FATIGUE. The patient was treated with METOPROLOL ongoing since an unknown date at a dose of UNK. On 08-Apr-2021, FEELING ABNORMAL and FATIGUE had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Apr-2021, Heart rate: 128 beats per minute (High). On 08-Apr-2021, Heart rate: normal per minute (normal).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.       Concomitant medications included heart medications.
LEFT THIGH SWOLLEN AND RED FOR SEVERAL HOURS AFTER IMMUNIZATIONS. PT ALSO HAD LOW GRADE FEVER FOR THE FIRST 3-4 HOURS.