chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician, via company representative, and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On  27-JAN-2016, the patient was vaccinated with an improperly stored PNEUMOVAX 23 10 PK, lot # L002310, expiration date 08-JUL-2016, at a dose of 0.5 ml (route and anatomical location of administration were unspecified). The vaccine underwent a total temperature excursion, of 24 hours. The highest recorded temperature was 47 Fahrenheit degrees (8.333333333 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effects were reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Systemic: reported by staff patient expired under suspicious circumstnces after receiving vaccine. Patient was on hospice, reported not expected to pass this soon; symptoms lasted 0 days
24 hours post vax, the pt developed hives on her neck, stomach, and thighs. Treated with Benadryl.
Headache sore arm, axillary lymphadenopathy, chills, fever, muscle aches, achy joints, that began Thursday night and have resolved over the next 4-5 days; today the injection site is still a bit sore to touch and axillary lymph nodes still mildly sore.  Narrative:  sore arm, axillary lymphadenopathy, chills, fever, muscle aches, achy joints, that began Thursday night and have resolved over the next 4-5 days; today the injection site is still a bit sore to touch and axillary lymph nodes still mildly sore
devel red swollen arm approx 6 hrs p/inject; 4 days of nausea & anorexia;
His arm bothered him; Chills; Fever; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old male patient received BNT162b2 (BNT162B2), on 19Mar2021 as dose 2, single (Lot number: ER8727) at the age of 78 years, in right arm for covid-19 immunisation. The patient's family history included: "Glaucoma" (ongoing). Concomitant medication(s) included: LATANOPROST taken for glaucoma (ongoing). Vaccination history included: BNT162b2 (Dose 1, single, Lot: EN6202, Expiry Date: Unknown, Site: Unknown, by injection), administration date: 26Feb2021, when the patient was 78-year-old, for COVID-19 immunization, reaction(s): "Arm bothered", "Chills", "Fever"; Flu vaccine (usually gets a bad reaction from the flu shot and has not had it in years), for immunisation, reaction(s): "Bad reaction", "Was very achy", "Would run a 102 fever". The following information was reported: CHILLS (non-serious) with onset 2021, outcome "unknown"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "Fever"; LIMB DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "His arm bothered him".  Additional Information: Patient had no prior vaccination within 4 weeks. On the first shot his arm bothered him and had chills and a fever. The second shot was the same, but a little more severe.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201277494 same patient/reporter/events, different dose;
Tested positive for COVID 19.; Tested positive for COVID 19.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 5 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Nov2021 (Batch/Lot number: unknown) at the age of 5 years as dose 2 (tris), single and administered in arm left (Batch/Lot number: unknown) as dose 1 (tris), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included FLU taken for immunisation. The following information was reported DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 24Dec2021, outcome recovering. The patient underwent the following laboratory tests and procedures sars-cov-2 test (24Dec2021) positive, Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.  Prior to vaccination, the patient was not diagnosed with COVID-19, Since the vaccination, the patient has been tested for COVID-19. The patient did not receive any other medications the patient received within 2 weeks of vaccination. Device Date 29Dec2021.
Initial information received on 08-Jan-2019 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a four years old patient who was received 0.5 ml dose  of QUADRACEL (batch number, expiry date not reported) via subcutaneous instead of intramuscularly. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to Inappropriate route of vaccination. It was not reported that the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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. List of documents held by sender: none.
not reported any adverse reaction; HBP calling to report adverse event for expired administration of PROQUAD.; This spontaneous report was received from health business partner (HBP) (Office Manager) and referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies and historical therapies were not reported.  On 17-AUG-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 0.5 ml / two dose series, lot #W002785, expiration date: 24-JUL-2023, administered for prophylaxis (strength, anatomical site of administration, and route of administration were not provided) (expired vaccine used). The HBP stated the patient involved had not reported any adverse reaction (no adverse event) related to the administration of the expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) vaccine or otherwise.
full blown auto immune flare/ a great big flare; mild headache; temperature of 102 degrees; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3247), via an unspecified route of administration on 21Jan2021 (at age of 66 years old) at single dose for COVID-19 immunization. The patient's medical history included autoimmune diseases (She had a host of autoimmune diseases. Her body was one big inflammatory responses). Concomitant medications were not reported. The had reactions and was concerned about getting the second dose. She had a host of autoimmune diseases. Her body was one big inflammatory responses. Her doctor figured she would feel it. She started with a mild headache. On the 7th day she was slammed. Her doctor said it was pretty unusual after this long. She had a temperature of 102 degrees. It was like having a full blown auto immune flare that lasted for two days and went away. She was left with a great big flare. She was not able to provide full details as she had an appointment that she had to pay out of pocket for. She was not concerned about the reaction that takes a day or 2 to get over. She was having hell from her usual responses. She was afraid in six months she would be crippled. The outcome of events was unknown. She was due to receive the second dose on Tuesday.
Jerking motions bilateral hands and arms and had lasting approximately 5 seconds but was repeated 6-10 times over 1 1/2 hours, 2 days after immunizations.
patient reports that her menses has been very regular since she had a child at age 35 years.  reports that her menses have been every 28 days with no lapses since that time.  reports that her menses was due 4-5 days after she received her second dose of COVID vaccine but that it did not arrive.  states she also skipped her menses the next month, but it resumed June 16.  reports no other symptoms with this occurrence
Pt states took prophylactic Benadryl prior to vaccine dose 1 reaction 9AM received IM injection @ let deltoid sat in waiting area 9:10 states "tongue feels weird" to Pharmacist. Pharmacist administered Pepcid 40 mg PO.  Tongue continued to feel "tingly" generalized itching, anxious 0925-Taken to ED via wheelchair by LPN and pharamcist
The following morning pt noted to be pale, decreased responsiveness, lethargic, then noted to have several seizures over proceeding few hours. Hospitalized for several days with trial of medications to control seizures.
Papilledema-no increased ICP on LD headaches-persistent beginning day after vaccines given, evaluated by neurology later felt to be Drusen on reevaluation.
Extreme body aches started 01/20/21 at 06:00am as well as headache and fever. This has continued to today 01/21/21 with body aches, fever, congested nose.  Taken IBU and Tylenol with little relief
Janssen COVID-19 Vaccine EUA About 8 hours after the vaccine, I developed a fever and chills. Then when I went to bed at 9:30 pm I had extreme thirst. I tried falling asleep but my fever got worse, chills worsened, I developed body aches, and I got a massive headache. I ended up not being able to get any sleep at all during the entire night because I was in so much pain. I felt tightness in my chest, stomach pains, super sore joints, and my body aches and headache kept getting worse and worse. When I got up to go use the bathroom I could barely walk because I felt so weak and was super dizzy. Later into the night my legs felt like pins and needles as if they were starting to go numb. I still have a fever, body aches, and a headache.
Diarrhea & Nausea Vomiting Narrative: chills, upset stomach and diarrhea
Cellulitis at vaccination site- about the size of "palm of hand".  Hot but not fluctuant, indurated.  Not present on day 7 but appeared suddenly on day 8 post vaccination.  Local erythema and pustule also present. Treated by personal physician with Cipro.
Administered GARDASIL 9 in right arm and then flu vaccine in left arm. Patient then passed out.
painful sore lump with redness/rash on the 7th day The redness rash got bigger for 3 days and the pain was bad enough I could not raise my arm I felt fatigued and mentally unable to focus for 4 days after the 7th day.
Warm to touch and sore beginning at almost immediately.  Swelling of area (and body chills) by 24 hour post vaccine. At 48 hours: pink raised rash present; very warm and sensitive  to touch. By 72 hours: rash has turned redder and is warmer to touch. It has also grown larger and is more swollen. Also now sensitive into the armpit; limited motion.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021 at 1:55 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Nov-2021 at 1:55 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient age was reported as 65.47 years. No concomitant medications were reported. Patient received booster dose. The vial underwent temperature excursion on 03-Nov-2021 with temperature 35 degrees Fahrenheit and the vial was initially moved to the fridge on 05-Oct-2021. Vial was moved to clinic on 03-Nov-2021 and proposed beyond use date was 05-Nov-2021. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. No treatment information was provided.
Patient was undergoing predeployment processing on 07 Feb 05. The Smallpox vaccination was administered following a urine HcG test. On 28 Feb 2005, the patient notified me that she had a positive home pregnancy test.
Extreme chills, fever, fatigue, headache, cold sweats, diarrhea, dizziness, swelling and pain in lymph node in underarm in left arm.
chills wash over off and on; nauseous; feel sick and it goes away but comes back off and on; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of CHILLS (chills wash over off and on), NAUSEA (nauseous) and MALAISE (feel sick and it goes away but comes back off and on) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 21-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced CHILLS (chills wash over off and on), NAUSEA (nauseous) and MALAISE (feel sick and it goes away but comes back off and on).            Reporter did not allow further contact
Initial report received on 04/Aug/2006 from a healthcare professional. An 18-year-old female patient with no current illness had received a first intramuscular dose of Menactra, lot number U2117AA, in the left deltoid, on 01/Aug/2006. Twenty four hours post-immunization, the patient's left deltoid was red, warm, and indurated at the injection site that required medical evaluation. Per the reporter, there was a questionable diagnosis of cellulitis, but no cultures were performed. Treatment received was not reported. The reporter stated that a 27g 1/2 inch needle was used to administer the intramuscular injection. The recovery status of the patient was reported as not recovered. A corrective version was created for the sole purpose of amending the event of cellulitis to injection site cellulitis, and making the events of left deltoid red at the injection site, left deltoid warm at the injection site, and left deltoid indurated at the injection site as co-manifestations of the injection site cellulitis. No new medical information was received.
small stroke; TIA; blood clot; completely blind; went blind in his right eye; weakness in his left arm; headaches; Fatigue; was sleeping 12-14 hours; did not feel right/kept telling everyone how bad he felt; dragged left leg; not able to raise his legs; This is a spontaneous report from a contactable consumer (patient).   A 63-year-old male patient (height:173 cm, weight: 74.84 kg) in perfect health received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. ER8737) at 0.3 mL, single dose, in the left arm, on 07Apr2021, for COVID-19 immunisation. Relevant medical history included stent placement on an unspecified date (had just had stents put in before getting COVID-19 shots). The patient previously, on 16Mar2021, received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EN6268) at single dose, in the left arm, for COVID-19 immunisation. The patient did not experience any adverse reaction after the first dose. No problems with vaccines in the past. No further details provided. The patient received concomitant medications (unspecified). On an unspecified date, in 2021, the patient had small stroke/ transient ischaemic attack (TIA), blood clot, experienced blindness (he went blind in his right eye for about 30-40 minutes, completely blind), weakness in his left arm, headache, fatigue (became very fatigued), he was sleepy (was sleeping 12-14 hours), he was feeling bad (did not feel right/kept telling everyone how bad he felt), leg dragging (he dragged left leg) and he was not able to raise his legs. The patient went to emergency room and they said it was a small stroke or TIA. It was reported that it was a blood clot that went through his head and that was where the blindness came from. A lot of blood work were performed at the hospital (unspecified result). Clinical outcome of the adverse event blood clot was unknown, while clinical outcome of the other events was recovering at time of this report.   Follow-up attempts are completed. No further information is expected.
PROQUAD was administered after a temperature excursion; This spontaneous report was received from a medical assistant 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 25-AUG-2021, the patient started therapy with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, lot #U028184, expiration date: 08-MAR-2023, administered for prophylaxis (strength, and route of administration were not provided). The vaccine was exposed to temperature of -14 Celsius for 7 hours. No previous temperature excursion was reported. No PQC was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513- 2204USA006070:
Positive COVID-19 test; Fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Positive COVID-19 test) and PYREXIA (Fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Positive COVID-19 test) and PYREXIA (Fever). The patient was treated with REMDESIVIR at an unspecified dose and frequency and CONVALESCENT PLASMA COVID-19 for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (Positive COVID-19 test) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: unknown (Positive) COVID-19 positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Jan2021 at 15:00 as dose 1, single (Lot number: EL1283), on 04Feb2021 at 10:00 as dose 2, single (Lot number: EL9265) and on 25Oct2021 at 14:00 as dose 3 (booster), single (Lot number: EW0186) at the age of 54 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 20May2022 at 11:00 as dose 4 (booster), single (Lot number: 004M21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High BP" (unspecified if ongoing). Concomitant medication(s) included: VERAPAMIL; DYAZIDE; VITAMIN D3; IMMUNITY WITH BETA GLUCAN; BABY ASPIRIN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Jun2022) Negative, notes: Tested negative on Binax now home test on 27Jun; (29Jun2022) Positive, notes: 29Jun started feeling symptoms returning. Took another Binax test, positive; (30Jun2022) Positive, notes: 30Jun positive Binax test with full symptoms again. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Anti viral details: COVID 19 Treatment with Brand Pfizer Paxlovid, treatment start date from 19Jun2022 till treatment stop date 23Jun2022 with Lot number: 300691085301.  No follow-up attempts are possible. No further information is expected.
"Right side of underarm is swollen and feels squishy," per patient after receiving Tdap - doctor advised parent to monitor and if it didn't go away, ultrasound would be needed.
feeling okay 26 Feb 2021; very sick 24 Feb 2021; chills 24 Feb 2021; headaches 24 Feb 2021; fever 102.2F 24 Feb 2021; fever 99.1F at 11am 25 Feb 2021; fever 101F at 4pm 25 Feb 2021; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Feb-2021 and was forwarded to Moderna on 27-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF RELAXATION (feeling okay 26 Feb 2021), ILLNESS (very sick 24 Feb 2021), CHILLS (chills 24 Feb 2021), HEADACHE (headaches 24 Feb 2021) and PYREXIA (fever 102.2F 24 Feb 2021) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING OF RELAXATION (feeling okay 26 Feb 2021), ILLNESS (very sick 24 Feb 2021), CHILLS (chills 24 Feb 2021), HEADACHE (headaches 24 Feb 2021), PYREXIA (fever 102.2F 24 Feb 2021), PYREXIA (fever 99.1F at 11am 25 Feb 2021) and PYREXIA (fever 101F at 4pm 25 Feb 2021). At the time of the report, FEELING OF RELAXATION (feeling okay 26 Feb 2021), ILLNESS (very sick 24 Feb 2021), CHILLS (chills 24 Feb 2021), HEADACHE (headaches 24 Feb 2021), PYREXIA (fever 102.2F 24 Feb 2021), PYREXIA (fever 99.1F at 11am 25 Feb 2021) and PYREXIA (fever 101F at 4pm 25 Feb 2021) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact