chrisvoncsefalvay/vaers-outcomes huggingface dataset:
during pregnancy patient received Adacel vaccine/No AE; Initial information received on 08-Nov-2019 regarding an unsolicited valid non-serious case from a consumer/non-hcp.  This case involves female patient of an unknown age who received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (batch number, expiry date, dose, route and site of administration were unknown) on an unspecified date, while she was pregnant.  Data regarding this pregnancy were received prospectively.   The date of last menstrual period was not reported.  The estimated due date was not reported.  The medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was the case of vaccine exposure during pregnancy. The patient was pregnant when she received vaccine.  It was unknown whether patient experienced any adverse reaction after the injection.  Pregnancy outcome was unknown at the time of report.  Information on the batch number was requested.
pt recv vax 12SEP95 & awoke 16SEP95 w/severe itching, erythema-firmness lt arm shoulder-elbow
Information has been received from a physician concerning a patient who on an unknown date, was vaccinated with ZOSTAVAX (Oka/Merck) SQ (lot # not reported).  Subsequently the patient developed a shingles-type rash multiple times after receiving the vaccine.  Unspecified medical attention was sought.  Additional information has been requested.
no known varicella exposure;rash x 3d 10-20 micropapules w/central scabbing on exam
7.5CM WIDE CIRCUMFERENTIAL ERYTHEMA AND SWELLING EXTENDING 3/4 AROUND UPPER ARM WITH INJECTION SITE CENTRALLY LOCATED WITHIN REACTION SITE.
Resident received first dose of Pfizer on 5/3/21. Second dose of Pfizer due on 5/24/21. Moderna administered on 5/24/21 instead of Pfizer. No adverse effects noted.
Rash / rash presents as large (about 3 by 4 cm) red areas of skin on arms, shoulder and torso; slight headache; feeling warm to the touch; This case was reported by a consumer and described the occurrence of red rash in a 62-year-old male patient who received Herpes zoster (Shingrix) (batch number 5554L, expiry date 8th April 2022) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   On 28th October 2020, the patient received Shingrix and Influenza vaccine Quadrivalent 2020-2021 season. In October 2020, 30 hrs after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season and an unknown time after starting Aspirin, the patient experienced red rash, headache and skin warm. The patient was treated with acetylsalicylic acid (Aspirin) and hydrocortisone (Cortisone Topical Cream). On an unknown date, the outcome of the red rash, headache and skin warm were not recovered/not resolved.   It was unknown if the reporter considered the red rash, headache and skin warm to be related to Shingrix and Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were reported as follows: This case was reported by patient for himself. About 30 hours after receiving vaccine, the patient experienced slight headache and rash, rash presents as large (about 3 by 4 cm) red areas of skin on arms, shoulder and torso, feeling warm to the touch, no itching or pain. The events were still persisting at about 50 hours after injection. The patient was unresponsive to topical cortisone and headache responsive to aspirin (975 mg). The patient did not seek any other medical assistance so far. The patient's spouse received vaccination from same lot and experienced no adverse events.
After shot, pain/soreness at injection site lasting up to 1 week after shot. Same night around 11:00pm vaccine symptoms include: fever/chills, headache, diarrhea lasting up to 10hrs. Reduced with aspirin. 9-13 days later increase in nightly symptoms including: Headache, stomach pains (upper stomach) Rashes/hive like bumps itching on body spreading to different parts each night ( 3-17-21, rash/swelling on both feet including white bumps that mostly went away with Benadryl (Diphenhydramine) and aspirin), ( 3-18-21, Rash spread to throat and face over night, numbness in upper lip mostly went away with Benadryl (Diphenhydramine) and aspirin), (3-18-21 rash moved to lower back left side, itchiness and sore throat.
Patient received the Moderna Covid 19 vaccine after temperature excursion; Patient received the Moderna Covid 19 vaccine after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna Covid 19 vaccine after temperature excursion) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In April 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the Moderna Covid 19 vaccine after temperature excursion). On 26-May-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna Covid 19 vaccine after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna Covid 19 vaccine after temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that there had been temperature excursions with the freezer that was happened for weeks since April 2022. Storage condition at the time of the excursion were frozen.  It was reported that Lot numbers: 065K21A and Lot numbers 045L21A had undergone temperature excursion and maximum and minimum temperatures reached were 30 Fahrenheit Degrees and minus 18.9 Fahrenheit Degrees respectively.  It was reported that the vaccines suffered 2 temperature excursions since April, both lasted less than 1 minute and date the vials moved from freezer to refrigerator was unknown, they were now stored in frozen condition and no vaccine state change was observed.  No treatment medications were reported.   This case was linked to MOD-2022-591989 (Patient Link).
Adult Hep A given instead of pediatric dose of Hep A, mother of patient contacted, informed of valid dose but at increased risks for local adverse reaction. No reaction noted at time of administration.
BODY ACHE; MILD FEVER; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. 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: Unknown, expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. 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 an unspecified date, the subject experienced body ache, and mild fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, and mild fever. This report was non-serious.
Received second dose on a Thursday.  No immediate reactions to first or second dose other than very slight soreness at site of injection. On Saturday morning, however, following second dose, experienced moderate dizziness upon rising--had to hold on to furniture to maintain balance.  Dizziness gradually subsided and was completely gone after 20-25 minutes.  Additional note: several years ago experienced one episode of extreme benign postural vertigo, but experience after second dose of vaccine was milder and shorter in duration.
Soreness; little body ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness) and MYALGIA (little body ache) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced MYALGIA (little body ache). On an unknown date, the patient experienced PAIN (Soreness). At the time of the report, PAIN (Soreness) and MYALGIA (little body ache) outcome was unknown. Not Provided          Treatment details not provided. concomitant details not provided.
Information has been received from a physician assistant concerning unspecified patients. The patients' concomitant medications, pertinent medical history, and drug reactions and allergies have not been provided. On unspecified dates these patients were administered improperly stored GARDASIL 9 (lot # L038503, expired date 18-DEC-2017) (dose and frequency were unknown). The GARDASIL 9 was stored at 46.8 F for 4 hours and 30 minutes. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Sudden onset of malaise shaken chills, fatigue, oliguria, Creatinine to 8, albumiuria, pitting edema of legs. Treatment: hospitalization, hemodialysis, prednisone starting at 60 mg daily, tapering by 10mg  daily dose every 7 days. Phosphorous binding, bicarbonate tablets, renal diet, heparin 5000 subculture bid + sequential TEDs for VTE prophylaxis.
Fully vaccinated patient admitting through ED for COVID who subsequently died from COVID.  Provider discharge note "65 YO male with AML requiring BMT and subsequent GVHD admitted with hypoxia due to covid pneumonia.  Patient developed respiratory failure with hypoxia requiring HFNC and BiPAP support.  Eventually transitioned to comfort care with progression of disease despite aggressive treatment.  Patient passed today comfortably with family at bedside at 856AM."
Excessive saliva - so much so that I "spit" when I talk (occasionally); Pains in hands; Pain in shoulder, pain in joints; Aching; Soar muscles; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03Apr2021 at 12:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included bariatric surgery in 2018, penicillin allergy and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included levothyroxine sodium (SYNTHROID) for unknown indication on unknown date and unknown if ongoing. The patient previously took omeprazole (PRILOSEC) and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Apr2021, the patient experienced excessive salivation, so much so that she spat when she talked occasionally. The patient also had pains in hands and shoulders, aching, sore muscles, pain in joints. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events excessive saliva, so much so that she spat when she talked occasionally; pains in hands and shoulders, aching, sore muscles, pain in joints was unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
started shaking chills late evening 1/7 (did not take temp). In morning 1/8 leg weakness, generalized weakness/fatigue
flu; Initial information was received on 14-Dec-2020regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.  This case involves a patient (age and gender unspecified) who had flu (Influenza ), when received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was flu (Influenza ), (unknown latency, non-serious event) following the administration of INFLUENZA VACCINE. The patient get the flu whenever he/she get the flu shot.  No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case.
No other AE; received a dose of VARIVAX that was expired; This spontaneous report was received from a medical assistant, referring to a patient of an unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported.  On 03-DEC-2020, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # r030604 has been verified to be a valid lot number, expiration date 23-OCT-2020 (dose reported as 1 dose, route of administration and injection site were not specified) for prophylaxis. No additional adverse effect was reported.
Information has been received from a female pharmacist who on approximately 27-JUL-2007 was vaccinated with the first dose of ZOSTAVAX (No lot number given) in the left arm. On approximately 01-AUG-2007 the patient developed injection site discoloration, itching and swelling. No medical attention was sought. Subsequently the patient was recovering. There was no product quality complaint. Additional information has been requested.
Pt called 7/30/07 c/o fatigue, swollen area under armpit Instructed to apply ice if no better call
Redness, swelling, & pain at the injection site, neck pain, bouncing heart rate.
I do not know the exact time as I wasn't watching the clock. However right after the injection I felt heat radiate from my left shoulder up, it felt like the injection was right on the shoulder rather than about 1-2 inches down from where I felt the heat and slight pain. I also had a bad taste in my mouth, similar to metallic taste that lasted a very long time however no time frame. Little by little I felt more itching and rash symptoms which really progressed on my drive home between 5-6 pm. Along with the rash were some bumps. I itched inside out. I also had digestive issues which caused pain and itchiness when going to the bathroom including rash. Also loss of focus as mentioned in another email in which I went home halfway through the following day.
light sensitivity; didn't feel great; flu like symptoms; she turned hot then cold then hot again; arm started "itching beyond itching"; injection site became a lump the size of her hand; headaches; fatigued; arm was warm; arm was red; Arm swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (arm was warm), PHOTOPHOBIA (light sensitivity), MALAISE (didn't feel great), INFLUENZA LIKE ILLNESS (flu like symptoms) and BODY TEMPERATURE FLUCTUATION (she turned hot then cold then hot again) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0301-20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy, Immune thrombocytopenic purpura, Asthma, Diabetes and Psoriatic arthritis. Concomitant products included METOPROLOL TARTRATE (METOPROLOL - 1 A PHARMA), QUINAPRIL, METFORMIN HCL, PIOGLITAZONE, HYDROCHLOROTHIAZIDE, GLIPIZIDE, CANAGLIFLOZIN, ATORVASTATIN, EXENATIDE and SECUKINUMAB (COSENTYX) 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 14-Feb-2021, the patient experienced VACCINATION SITE WARMTH (arm was warm), VACCINATION SITE SWELLING (Arm swollen) and VACCINATION SITE ERYTHEMA (arm was red). On 23-Feb-2021, the patient experienced PHOTOPHOBIA (light sensitivity), MALAISE (didn't feel great), INFLUENZA LIKE ILLNESS (flu like symptoms), BODY TEMPERATURE FLUCTUATION (she turned hot then cold then hot again), VACCINATION SITE PRURITUS (arm started "itching beyond itching"), VACCINATION SITE INDURATION (injection site became a lump the size of her hand), HEADACHE (headaches) and FATIGUE (fatigued). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, VACCINATION SITE WARMTH (arm was warm), PHOTOPHOBIA (light sensitivity), MALAISE (didn't feel great), INFLUENZA LIKE ILLNESS (flu like symptoms), BODY TEMPERATURE FLUCTUATION (she turned hot then cold then hot again), VACCINATION SITE PRURITUS (arm started "itching beyond itching"), VACCINATION SITE INDURATION (injection site became a lump the size of her hand), VACCINATION SITE SWELLING (Arm swollen), VACCINATION SITE ERYTHEMA (arm was red), HEADACHE (headaches) and FATIGUE (fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Hives over entire body, lip, eye, throat, face, neck swelling, heavy chest.
ON 4/16/21 @ 6:28 PM, PHARMacist completing this  FoRM IMMUNIZED patient with MODERNA Vaccine. At 6:32 pm, patient Complained oF FeeLing OF Swelling OF Lips. At 6:33 p.m. patient Received 25 mg po DipHenhyDRamine LiQuid. OBserved x; 40 Minutes, At Which time patient claimed to Be Feelin Well. I RECOMMENDED THAT SHE aRRaNge FOR TRANSPORTATION HOMe. Additional information: ADViseD tHAt ADMINIStRAted DiPHeNhyDRamine Could Likely Cause Drowsiness ADVised to Follow-up with pharmacist ON Duty THe Following Day (4-17-21) with ANy Concerns OR Questions-
THE UNDILUTED PEDIATRIC DOSE WAS GIVEN TO THE PATIENT. WE CALLED MANUFACTURER AND WERE INFORMED THAT THE GIVEN DOSE WAS EQUIVALENT TO AN ADULT DOSE. PATIENT DID NOT REPORT ANY ADVERSE EFFECTS.
Sever pain and stiffness in shoulders and hips every morning. Eases during the day with medication and movement.
Extreme soreness in arm that night but especially next day Headache/ borderline migraine next day and continuing for about a week and a half (so far) Mild body aches/ malaise the day after Fatigue next day and for next week and a half (so far) afterwards
Hard to stay awake/Feeling drowsy; Wasn't able to sleep last night; Body aching; Huge headache; Arm aching; This spontaneous case was reported by an other health care professional and describes the occurrence of MYALGIA (Body aching), SOMNOLENCE (Hard to stay awake/Feeling drowsy), INSOMNIA (Wasn't able to sleep last night), HEADACHE (Huge headache) and VACCINATION SITE PAIN (Arm aching) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2021, the patient experienced MYALGIA (Body aching), SOMNOLENCE (Hard to stay awake/Feeling drowsy), INSOMNIA (Wasn't able to sleep last night), HEADACHE (Huge headache) and VACCINATION SITE PAIN (Arm aching). At the time of the report, MYALGIA (Body aching), SOMNOLENCE (Hard to stay awake/Feeling drowsy), INSOMNIA (Wasn't able to sleep last night), HEADACHE (Huge headache) and VACCINATION SITE PAIN (Arm aching) outcome was unknown.        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.   No concomitant medications were mentioned. No treatment details were reported.
Large baseball size swelling at injection site, hot to touch, chills, headache, dizziness
4 1/2 hrs after vaccines, patient started screaming during a feed.  Then she started to "bear down" while mouth "locked shut", then she slumped over.  Alternated between these two states for 20 min.  When paramedics arrived, pt. looked OK.  Next day (6/17 PM) had similar activity and was taken to the ER.  Neurology admitted her to hospital - had normal head CT, brain MRI, EEG.  That day, developed vomiting and loose stools.  Was discharged from hospital on 6/20 after vomiting resolved.  Is now doing well.
Severe dizziness Headache  Pea size red spot near injection site, flat no oozing Diminished appetite
Awoke on 12/7/00 with fever of 102.5F. Did not respond to Tylenol. Temperature continued to increased up to 104.3F with OTC thermometer. Took her to the ER and they could not find anything wrong and was told it was a "virus" and was placed on antibiotics. Had a generalized red, raised rash and was lethargic. By 22:30, feeling better. Temperature 102.4F which responded to Motrin on 12/8/00. No longer had elevated temperature. "Back to normal" but still had rash.
Mild itching around eyes, nose, mouth, chin - no rash, redness or swelling.   Took Benadryl 25 mg. approx 8:30 p.m. Approx 10 p.m. headache mostly in the back of my head.  Could not sleep, felt chilled although never a fever at any time.  A few hours later began having aching back of neck, top of shoulders, down my back, hips, thighs, shine and my knees were throbbing.   I took (2) 750 mg. of Tylenol (as I already take Celebrex 200 mg. b.i.d.)  I finally fell asleep after 4 a.m. and slept for several hours.   I took 750 mg. Tylenol once the next morning.  No more aching but just felt tired.   I seemed to be mostly recovered by mid afternoon on Aug 31st. NO redness, swelling, rash at the injection site.  Mildly sore as expected.   NO PROBLEM with my 1st injection.
Information has been received from a healthcare professional concerning an 11 year old female who "in the summer of 2007" was vaccinated with the first dose of GARDASIL. Per the reporter, the patient has bot been sleeping at night since vaccination with GARDASIL. The patient sought unspecified medical attention. No lot number was provided and no further information was available. Follow-up information (11-JAN-2008): "It was originally reported that the patient received her first dose of GARDASIL a few weeks ago, but this information is incorrect. She actually received the dose in the summer of 2007." No additional information was given. Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/14/2008. Follow-up information (20-FEB-2008). A member of the office staff has reported that the patient is not a patient of the physician. They do not have any information concerning this patient; therefore they do not want any further correspondence. Memo received from physician's office on 26-FEB-2008 stating that they have no additional information available. Additional information is not expected.