chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient presented on 2/16 with SOB and cough over past 3 weeks. Patient treated with antibiotics, steroids and nebulizers.Patient improved and discharged 2/24 with plan for outpatient biologic treatment for eosinophilic asthma. Per EAU, hospitalizations are to be reported irrespective of attribution to the vaccine. .
Pt developed fever, rash on 10/23 - 11 days following the administration of MMRV vaccine. Rash cw measles like illness, public health contacted and pt was indeed positive for measles by PCR urine and throat swab. This lasted approx. 48 hours and pt resumed normal activities.
Redness, pain, burning from shot site all the way down the arm. Lasted 5 days. Itching also.
Bruising of entire arm and felt to the heal of my foot. Nausea. Extremely tired. Headache. Body aches. Internal tremor. Stiffness. Lasted 24 hours and still have a weird numbness throughout my body. And tiredness and mild headaches.
This spontaneous report as received from a registered nurse refers to a 4 months old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 10-NOV-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M025192, expiry date: 21-MAR-2019 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706: US-009507513-1610USA008140.
hoarse voice goes in and out; pains in chest; shortness of breath; Migraines more often; High fever; Muscle aching; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHONIA ( hoarse voice goes in and out), CHEST PAIN (pains in chest), DYSPNOEA (shortness of breath), MIGRAINE (Migraines more often) and PYREXIA (High fever) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No relevant medical history reported).   On 06-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced PYREXIA (High fever) and MYALGIA (Muscle aching). On an unknown date, the patient experienced DYSPHONIA ( hoarse voice goes in and out), CHEST PAIN (pains in chest), DYSPNOEA (shortness of breath) and MIGRAINE (Migraines more often). On 07-Apr-2021, PYREXIA (High fever) and MYALGIA (Muscle aching) had resolved. At the time of the report, DYSPHONIA ( hoarse voice goes in and out), CHEST PAIN (pains in chest), DYSPNOEA (shortness of breath) and MIGRAINE (Migraines more often) outcome was unknown.            Concomitant medications were not provided. Treatment for the events was not provided.  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.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Follow Up received- Email Address of reporter updated. On 03-Jul-2021: Follow Up received- 4 new events added.; 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 report as received from a nurse refers to a 19 months 19 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Bladder/UTI infection, diarrhea, muscle spasms, fever, headache
Fussy, vomited x 2 4-16-07, low grade fever saw MD for well baby checkup 2 days later and everything OK, states MD thought "a normal reaction to immunization".
Pt recvd Pneumococcal vax on 10MAY90; Later that day exp fever of 104.6F, chills, pale sking, sweats; Seen in an ER tx APAP, Vibramycin, & Codeine; Lab eval w/in normal limits; Pt recovered;
At the time of the injections (morning of 4/3), before I even left the person giving the injection, I could feel the vaccine moving down my left arm. While sitting for 15 minutes for observation I did not have a reaction. However, on my 90 min drive home, the left side of my face and neck felt tingly like the very end of when Novocain from a dentist's office is wearing off. That lasted for a few  hours. Then, I was fine until the evening of  4/6 when I started to feel very tired. By 4/7 I felt like I had the flu with absolutely no energy and my throat was so sore I could barely swallow. On 4/8, I was having heart issues including racing and irregularity that lasted that morning.  From 4/9-through today (4/13), I have very low energy, feel achy like the flu, and have lots of post nasal drip and stuffiness which is causing a cough.
I did not have an adverse reaction to a vaccine. I have had 4 shots. I tested positive for COVID-19 on 5/30/2022. I had mild URI symptoms, and started Paxlovid the same day. The infection cleared and I was negative on 6/5/2022. In several days, I developed rebound symptoms: runny nose and mild cough. I tested positive on 6/9/2022. The infection ran its course. I tested negative on 6/13/2022. These were all home tests - no PCR's.
Arm soreness Joint pain shoulder pain stiff neck involuntary sleep leg cramps  taking Tylenol, trying to stay hydrated, making doctor apt.
received vaccine on 29Oct2021 with an expiration date of 11Oct2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received vaccine on 29Oct2021 with an expiration date of 11Oct2021) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (received vaccine on 29Oct2021 with an expiration date of 11Oct2021). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received vaccine on 29Oct2021 with an expiration date of 11Oct2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Per the recommendations of our local health jurisdiction, we are reporting this as an adverse event as the booster was given after the FDA  unauthorized  the use of  monovalent vaccines as booster doses for individuals 12 years of age and older.
Blown pupil; This case was reported by a nurse via sales rep and described the occurrence of dilated pupils in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced dilated pupils. On an unknown date, the outcome of the dilated pupils was unknown.   It was unknown if the reporter considered the dilated pupils to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the patient experienced blown pupil after receiving the first dose and was advised not to take second dose. The reporter denied for further follow up. Note: GSK receipt date was conservatively kept as 8 March 2022, clarification already raised.
Onset itching approximately 24 hrs. Then developed swelling and redness L arm induration 20x22mm, erythema 30x36mm.
Information has been received from a consumer concerning her 75 year old sister with osteoarthritis, polymyalgia and no drug reactions or allergies who on 15-SEP-2010, was vaccinated with a dose of ZOSTAVAX (Merck) (Lot# not reported). The consumer stated that on 18-SEP-2010 "3 days later from vaccination", her sister developed a few bumps around the waist. She went to see a physician at urgent care. The physician at urgent care informed her sister that it was not shingles, the bumps were hives. No lab diagnostics were performed. The consumer stated that the physician prescribed her sister ZYRTEC. On 06-OCT-2010, the physician stated that the patient's hives had resolved on an unspecified date, but on 05-OCT-2010, the patient noticed one hive on her back at waist level. She also mentioned that the hives she had experienced had been itchy. At the time of the report, the patient's outcome was unknown. Follow up information has been received from the consumer and a physician and a physician assistant via a medical record. It was reported that the patient with arthritis, controlled high blood pressure, mild asthma, oesophageal stricture and eggplant allergy, who did not use tobacco, drunk less than 1 drink per day and did not use illicit drugs, on 15-SEP-2010 at approximately 11:00 was vaccinated with a dose of ZOSTAVAX (Merck). The patient had no illness at the time of vaccination. Concomitant therapy included CELEBREX stopped about the same time as the vaccination, pantoprazole, losartan potassium, spironolactone, atenolol, "dirioran" and PROAIR. The patient reported that three days after vaccine, on 18-SEP-2010, the patient developed hives around waist, front and back, about 12 in all, itchy, this lasted about a week. Four days after vaccine, the patient developed a rash on hip and back; mild itchy which lasted about 1 week. The patient had occasional mild hive, 1 week, for six weeks after vaccine. The patient went away within 2 days. The patient visited an urgent care center. The physical exam was within normal limits except for skin inspection and palpitation which revealed faint maculopapular diffuse rash on back and respiratory symptoms such as short of breath. The physician reported that the patient had a non severe possible allergic reaction for 7 days which was itching. No laboratory diagnostics studies were performed. The patient was prescribed with fluids, ZYRTEC 10 mg daily for itch, hydrocortisone cream as needed and hydroxyzine 10 mg every 8 hours PRN for itch if other medication not effective. It was reported that the patient recovered from hive on 28-OCT-2010 (as well as unknown). This is one of several reports received from the same source. No further information is available.
ON DAY  8 AFTER RECEIVING THE SHOT I EXPERIENCED A RASH, SORENESS, SWELLING AND HOT TO THE TOUCH AROUND INJECTION SITE
low grade fever; myalgia; joint pain; This is a spontaneous report from a contactable Nurse in response to HCP letter sent. A 49-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection, Batch/Lot Number: E219899), intramuscular, administered in Deltoid Left on 21Dec2020 11:00 as Single dose for covid-19 immunisation at Workplace clinic. Medical history included colitis ulcerative from 15Jul1996 to an unknown date (mild symptoms). The patient's concomitant medications were not reported. On an unspecified date, the patient experienced low grade fever, myalgia and joint pain. The action taken in response to the events for BNT162B2 was not applicable. The causality assessment from reporting person and reporting was unrelated. The outcome of events was recovered.
Redness, tenderness & pain at site. Pt seen at office 2/29/12. Pt prescribed BENADRYL PRN.
Onset of migraine visual aura and nausea.  Migraine headache did not occur  while the patient was under our observation.  Patient  thinks the aura may have been triggered by bright lights in observation room.  No medications given.
SYMPTOMS STARTED THE EVENING OF THE VACCINE CHILL, FEVER, INJECTION SITE IS RED AND SWOLLEN, LACK OF ENERGY, LOSS OF APPETITE AND BODY ACHES.
Information has been received from a mother concerning her 20 year old son with no past medical history and no known drug allergies who in "May and fall of 2000" was vaccinated with a first and second dose of hepatitis A virus vaccine inactivated.  It was reported that the patient was vaccinated from recalled lots.  On 09/05/2002 the patient donated blood and was told that his ALT was elevated at 500.  The patient was negative for hepatitis B and C, however his AST, LDH, GGT were elevated.  The lab work was repeated the week of 09/16/2002 with results pending.  The mother reported that her son had contracted hepatitis A.  The patient sought medical attention.  It was reported on 09/27/2002 that the patient started on amoxicillin "last week" and the patient was scheduled to have a liver ultrasound on 09/28/2002.  Additional information has been requested.
Patient had his second Covid vaccine 3/25 at covid vaccination site.  Initially had redness at injection site (patient thinks as hives) immediately after administration, but subsided within 15 minutes on its own. Patient reports he really started having symptoms 72 hours after vaccination, including: Dizzy spells, sore throat comes and goes, headache comes and goes, occasional chest tightness.   Patient states he did also have these symptoms with the 1st dose as well. Patient is still able to eat and drink fine. Taking Tylenol during the day, and Benadryl before bed for some relief.  Patient is monitoring at home, drinking lots of water and will seek care if symptoms to not dissipate or worsen in any way.  No shortness of breath, difficulty swallowing or breathing, rashes, etc at this time.
arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm pain). At the time of the report, PAIN IN EXTREMITY (arm pain) outcome was unknown.            No concomitant medications information was reported. No treatment medications were provided.
Patient reported to the pharmacy on 10/19/17 that she was feeling numbness and significant pain in her arm at the injection site and had trouble moving her arm. She was asked when the pain started and she reported it started on 9/24/17 after receiving the vaccination and steadily got worse of the next 3 weeks. Patient did not report sooner because she felt it would go away. She also reported a knot forming at the injection site that may or may not have gone away.
After 1st Dose 2/24/2021, six days later arm swelled around injection site and was itchy, painful, hot and red for about 12 days; then symptoms eased and went away.. After 2nd Dose on 3/24/2021 I got tinnitus in right ear (site of prior shingles outbreak).  Saw ENT and got MRI to rule out any tumors.  Symptoms have eased.
This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 21-OCT-2012 12:39, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Fingers began to swell and crack; Palms and plantar surface of his feet started drying out and cracking; Fingers began to swell and crack, Palms and plantar surface of his feet started drying out and cracking; This is a spontaneous report from a contactable other health professional (patient). A 48-year-old male patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, administered in arm right on 08Jan2021 at 08:00 AM at 48 years (Lot Number: ELO142) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history was none. Patient did not experience COVID-19 prior to vaccination. There were no concomitant medications. Patient did not receive other vaccines in four weeks. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) (Batch/Lot No: EK5730), in arm right, on 19Dec2020 at 08:00 AM at 48 years for COVID-19 immunisation. The patient experienced fingers began to swell and crack (medically significant) on 15Jan2021 at 06:00 AM with outcome of not recovered, palms and plantar surface of his feet started drying out and cracking (medically significant) on 15Jan2021 at 06:00 AM with outcome of not recovered. The events required emergency room visit and physician office visit. Therapeutic measures were taken as a result of the events and included treatment with steroids topical/injection. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 24Sep2021.; Sender's Comments: Considering a temporal relationship, a possible contributory role of suspect product BNT162B2 to the reported events Peripheral swelling, dry skin , skin fissures cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate
p/vax pt broke out in hives on both legs & body;MD tx w/DPH w/good response to medication;
tingling sensation in the lips just days after, the type when you are going  to get a cold sore. I took my medication. if i didn't take it almost every day for over 2 weeks I would get the sensation back. then in July I got the worst cold sore in my history. lasting now over 2 weeks. it because infected and very large. new bumps are starting in my inner lips and i have to medicate with valclovir .
Client received immunizations and walked outside with father and younger brother to car.  Father realized that he forgot to turn his paperwork in to immunization clerical office and turned to go back into Health Department and at this time, client became light-headed and fell down.  Received minor abrasion to left side of upper cheek - no bleeding noted.  Father states client did not lose consciousness.  Client taken to Immunization waiting room to sit down until lightheadedness subsided which took approximately 10 minutes.  Client left Health Department with his father and brother.
fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 28Apr2021 as dose 2, single (Lot number: EW0171) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing); "familial heterozygous hypocholesteremia", start date: 2015 (unspecified if ongoing); "Chronic migraine", start date: 2014 (unspecified if ongoing); "foot surgery", start date: 2021 (unspecified if ongoing). Concomitant medication(s) included: CLIMARA PRO; ESTRADIOL / NORETHINDRONE ACETATE. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EW0151), administration date: 07Apr2021, for COVID-19 immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown".  Additional information: The patient never had COVID plus test or diagnosis. The patient also felt fatigue after her second Pfizer dose but did not have the feeling in her chest. There was no product complaint associated with the case.  No follow-up attempts are possible. No further information is expected.
Palpitations PT STATED "HEART RACING" AMB TO RM WITH STRETCHER.
0945 pulled into medical site @ clinic .  States she received vaccine @ 9:25 an  waited 15 minutes after receiving the vaccine & was cleared to leave. After she left the site she started feeling hot, c/o itchy rash on left side of neck, and feeling hot and shaky.  EMS on site to evaluate patient.  9:47 gave Benadryl 25 mgm PO  10:10 symptoms resolved.  Doctor notified.  Patient instructed to take Benadryl 25 mgm when she gets home and to notify her PCP regarding additional f/u.  Patient left site @ 1020.
pt recvd vax; c/o of soreness in lt arm, bruising & redness from elbow to shoulder; painful to touch & move; resolved by apap &  cold compress;
did not feel 100% on 12/25 but had tested negative for covid; This is a spontaneous report from a contactable reporter (consumer or other non hcp).  A 24-year-old female patient (not pregnant) received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), administration date an unknown date in 2021 (Lot number: unknown) as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Chronic pain" (unspecified if ongoing), notes: some chronic pain from injuries and some being still diagnosed for reason,; "Abdominal pain" (unspecified if ongoing), notes: some abnormal pain associated with reproductive tract as well (not sure if that diagnosed); "Multiple injuries" (unspecified if ongoing), notes: some chronic pain from injuries and some being still diagnosed for reason and "Reproductive tract disorder NOS" (unspecified if ongoing), notes: some abnormal pain associated with reproductive tract as well (not sure if that diagnosed). It was unsure whether the patient received any medications in two weeks of vaccination. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; MANUFACTURER UNKNOWN, Lot number: Unknown Route of administration: Unspecified), for COVID-19 immunisation.  The following information was reported: MALAISE (non-serious) with onset 25Dec2021, outcome "unknown", described as "did not feel 100% on 12/25 but had tested negative for covid". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was unsure whether the patient had any known allergies. It was unknown whether, the patient receive any other vaccines within four weeks prior to the COVID vaccine. It was reported that the patient was vaccinated (probably fully by at least Jul2021 as the patient had to work in person so she probably was able to receive it earlier than some others) as of this summer, but the reporter was not sure the amount of doses had currently received or which vaccine or exact dates. Since the vaccination, the patient had been tested for COVID-19 and the result was negative.  The lot number for BNT162b2 was not provided and will be requested during follow-up.