chrisvoncsefalvay/vaers-outcomes huggingface dataset:
doses apart, two years eight months; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received two years eight months ago).   On 23rd August 2022, the patient received the 2nd dose of Shingrix. On 23rd August 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.       Additional Information: GSK Receipt Date: 24-AUG-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The patient put off getting the second dose but received a second dose a day before reporting.  The doses were so far apart two years eight months so patient wanted to know he/she need to get another shot. The follow-up could not be possible as no contact details were available. Additional Supportive Information: The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of the vaccine schedule.
Vaccinated at age of 16; A Spontaneous report was received from a physician concerning a 16-year old patient, who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not reported. Concomitant Medications were not listed.  On 12 Mar 2021, prior to the onset of events the patient received first dose of their two planned doses of mRNA-1273 (Batch N0: unknown) intramuscularly for prophylaxis of covid 19 infection.  The patient was received the first dose of Moderna COVID-19 vaccine at age of 16.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of event was recovered or resolved on 12 Mar 2021.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (16 year old) for mRNA-1273 (lot number unknown) with no associated AEs reported.
Migraine; Body aches; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine) and MYALGIA (Body aches) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MIGRAINE (Migraine) and MYALGIA (Body aches). At the time of the report, MIGRAINE (Migraine) and MYALGIA (Body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
This spontaneous report was received from a medical assistant and refers to a 18 year old patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 03-AUG-2018, the patient inadvertently received adult dose (1 ml) of VAQTA instead of pediatric dose (0.5 ml) lot # N032753, expiration date 23-MAR-2019, intramuscularly for prophylaxis. No adverse effects were reported.
Escalation in number and frequency of migraines, intermittent tinnitus/nerve/joint pain, blurred vision, chest pain, dizzy spells, weakness and fatigue, brain fog, inability to concentrate. Symptoms have continued to worsen in the four and half months since second dose was administered. Patient was given several weeks off of work to recouperate and tested on a trial of Ivermectin and Fluvoxamine starting in late August. Initially responded well but symptoms returned after a couple weeks. Blood results came back normal with no inflammation markers. Patient stopped taking trial medications and advised to take high dose Vitamin C. Treatment ongoing.
I did not dilute the Pfizer Covid-19 pediatric vaccine aged 5-11 years before the dose was administered.
Extreme high blood sugar over 400  never previously seen  Headache  mild  rest Sore shoulder  local  minor  rest
Patient seen on 07/05/2022 and vaccinated without incident.  VS:  BP 116/84   P 74   T 98.2F.  No concerns. Parent requested to space out Immunizations needed. Parent/Pt presented for another set of Immunizations on 07/12/22 and Parent commented of noting some redness on Pt's Left deltoid two days before but has since resolved. Denies ever noting any SOB, pain or fever on Pt.  Parent decided to wait another week for f/u Immunizations.
3/27/2023   in the morning symptoms were bruises on multiple parts of the body hands legs feet, arms and calves, initial diagnosis was pregnozone was causing bruising, referred to oncologist, 3/28/2023 resulted from blood work that was done.  Blood work confirmed I had very low plalates.  3/31/2023 had appointment with oncologist  admitted to hospital 4-3-2023.
This spontaneous report was received from a physician concerning a female patient of unknown age. Patient's historical condition and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with dose number two, 1 month after the first dose and dose number 3 was given 2 months after number one (series completed in two months) of GARDASIL (strength, dose Lot No and expire date were unspecified). There was no concomitant medication described. No adverse event was informed. There was not a product quality complain involved. Additional information has been requested.
vision loss; Shingles; other zoster-related conditions.; This spontaneous report as received from a lawyer and the patient (pt) regarding a case in litigation, refers to a pt of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. In 2015, the pt was vaccinated with a dose of zoster vaccine live(ZOSTAVAX) for the longterm prevention of shingles and zoster-related conditions. Subsequent to pt's vaccination, the pt was treated by healthcare providers for shingles, vision loss and other zoster-related conditions. As a direct and proximate result of the use of zoster vaccine live(ZOSTAVAX), the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.  Upon internal review vision loss was considered as medically significant.
Breakthrough case admission after 2 vaccines Pfizer 4/14/21 lot# Ew0164;  Pfizer 5/5/21 lot# Ew0179
Felt extremely tired and nauseous. That only lasted about 2 hrs. Had intense pain and lots of swelling at injection site. Red circle with bruise around injection site about 4 inches in diameter and protruded about 1 1/2 inches for 3 days then red and itchy.
Patient is a 66 year old female patient of, PA-C with a past medical history of hypertension, hyperlipidemia, depression, GERD, NPH, prior TBI, frequent falls, physical deconditioning, non-ambulatory status, sarcoidosis of lung who presented to ED 4/8/2023 due to fever, dizziness, weakness.  Positive for COVID-19 in ED.  She has been placed in observation for further workup/management.  Course thus far is remarkable for:   Covid-19 Virus Infection Date of onset of symptoms:  Per ED documentation: "there were no family members that were tested, however, they did have flulike symptoms last week" as reported 4/8/23; patient is poor historian Symptoms present on admission: Fever, weakness, cough Date of covid positive test: 4/8/2023 Vaccination status: vaccinated Imaging: CXR non-acute Oxygen requirements on admission: Room air Current oxygen requirements: Room air Medical therapy: not indicated Consultants following: None Anticipated special isolation end date: S/p supportive IV fluids; now with adequate PO intake Out of isolation on 4-19-2023 Discharging patient to nursing home today in very stable condition Out of isolation Normal pressure hydrocephalus Generalized weakness Gait instability Impaired cognition Recently seen by Dr Neurosurgery on 4/3/2023 Per his documentation: "MRI brain shows enlarged ventricle system with Evans Ratio of 0.42" Noted patient's extremely de-conditioned state Recommended ongoing PT; did NOT recommend drain trial PT/OT/CM consults completed Planning for after 4-19 -2023 when out of isolation   Constipation, resolved Bowel regimen adjusted to PRN    Hypertension Continue home lisinopril, atenolol, amlodipine Hold for SBP<100   Hyperlipidemia Continue home statin   Depression Continue home Zoloft   Urinary incontinence Continue home Detrol   Chronic pain  Continue home PRN tramadol- controlled
Pt states experienced weakness and pain in right arm. Unable to raise arm overhead. She also developed pneumonia after the shot, for which she was treated as with levofloxacin, not hospitalized. Still feels weakness and discomfort in right arm as of report date. Saw MD for PNA.
Shingles to dermatomes L2, L3 to left leg beginning 3 days after administration of Gardasil (L leg), Menactra (R leg)
Eryth mac- papular spots thigh 3-4, arms 3-4, face with vesicular appearance to nose/forehead
Initial report received from a lay press reporter on 14 January 2011.  A patient (sex and age not provided) received 3 years ago (date not provided) an injection (route and site not provided) of MENACTRA, lot number not reported.  In September 2010, the patient was first diagnosed with acute pneumonia, not meningitis.  But after the pneumonia patient was released from the hospital, blood tests revealed the presence of Neisseria meningitidis serotype Y.  The patient had received the meningitis vaccine three years before becoming infected.  The outcome was not reported.  This case has the same reporter as case 2011- 00232.  Documents held by sender: None.
Patient started to feel dizziness. Placed patient on monitoring. Given water, crackers. Continued to monitor her for 30 minutes. Patient prone to seizures
Patient had pain at the injection site and in her shoulder.  She said she could not lift her arm.
Pt recvd shot 5SEP91 & was basically OK until 1AM on  8SEP91 had fever, rash & shrill cry & couldn't be settled; Seen in ER & sent home; Taken to MD & admitted to Hosp;
Extreme vertigo with neausa.  Currently day 5 still very dizzy when waking up and standing or laying down. No fever No issues prior to this.
This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sickness and stuff like you are supposed to after 2nd shot) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21-2A and 038A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced ILLNESS (Sickness and stuff like you are supposed to after 2nd shot). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency. At the time of the report, ILLNESS (Sickness and stuff like you are supposed to after 2nd shot) outcome was unknown.            Treatment details included jergens ultra healing lotion.  Action taken with the mRNA-1273 in response to the event is not applicable.
One huge red bump on upper arm; Itchy arm; Aches; Low grade fever; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of NODULE (One huge red bump on upper arm), PRURITUS (Itchy arm), PAIN (Aches), PYREXIA (Low grade fever) and CHILLS (Chills) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) and IPRATROPIUM BROMIDE, SALBUTAMOL SULFATE (COMBIVENT RESPIMAT) for Bronchial dilator level NOS, OXYGEN for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Feb-2021, the patient experienced NODULE (One huge red bump on upper arm), PRURITUS (Itchy arm), PAIN (Aches), PYREXIA (Low grade fever), CHILLS (Chills) and HEADACHE (Headache). On 10-Feb-2021, NODULE (One huge red bump on upper arm), PRURITUS (Itchy arm), PAIN (Aches) and HEADACHE (Headache) had resolved. On 26-Feb-2021, PYREXIA (Low grade fever) and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treatment to the events not reported.
10:30 a.m. Td booster given in left deltoid. Child immediately said, "I feel weird" eyes rolled up. Arm feeling heat? child laid down - eyes open. No response x 30 sec approx. BP normal - monitored for 1 hr.
injection site turned black and blue; high raised rash a few days later; fever; glands under her left arm are "quite miserable"; swollen glands under both arms; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE DISCOLOURATION (injection site turned black and blue), VACCINATION SITE RASH (high raised rash a few days later), PYREXIA (fever), LYMPHADENOPATHY (glands under her left arm are "quite miserable") and LYMPHADENOPATHY (swollen glands under both arms) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-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 INJECTION SITE DISCOLOURATION (injection site turned black and blue), VACCINATION SITE RASH (high raised rash a few days later), PYREXIA (fever), LYMPHADENOPATHY (glands under her left arm are "quite miserable") and LYMPHADENOPATHY (swollen glands under both arms). At the time of the report, INJECTION SITE DISCOLOURATION (injection site turned black and blue), VACCINATION SITE RASH (high raised rash a few days later), PYREXIA (fever), LYMPHADENOPATHY (glands under her left arm are "quite miserable") and LYMPHADENOPATHY (swollen glands under both arms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and concomitant medicines were not included   This case was linked to MOD-2021-081357 (Patient Link).
Presented to clinic 8/21 with swelling from Left shoulder to elbow, diffuse erythema, no tenderness. No treatment was indicated.
Patient received Pfizer booster 15 hours after first puncture. Spoke with PFIZER rep, no harm to patient, no need to revaccinate.
mom states approx 30-45 mins p/leaving office pt w/loud, high pitched scream-duration 3 1/2 hrs no temp as mom had premedicated w/APAP;
I got my vaccination at 9:00 a.m. and at 6:00 p.m. my muscle started feeling like they were going to collapse and they were very sore and I laid down I felt like I had been beaten and the feeling didn't go away and it was obvious to me since nothing else had happened that it was from the covid vaccination and then experience this feeling for about 36 hours it finally eased up and I also experienced malaise my head felt heavy and diarrhea and I did not feel like eating, then it just went away after about 48 hours and I'm just left with feeling like I'm getting over a cold or flu.
Approximately 1 hr after administration of vaccine (Japanese encephalitis) 10 minutes prior to symptoms Twinrix, Typhoid VI, Rabies vaccines were administered. client became pale, clammy, flushed. C/O tightness of chest and throat closing up. Liquid Benadryl 2 Tsp. administered. 911 called.
Blood clots,  heart attack,  died, cpr 5 times  survived  Blood is very thick  blood thinners unable to thin
Caller states her psoriasis has worsened ever since her first dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 67 year-old female patient received bnt162b2 (COMIRNATY), administration date 18Feb2021 (Lot number: EL9269) at the age of 66 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "plaque psoriasis" (ongoing), notes: since she was 16 years old. There were no concomitant medications. The following information was reported: PSORIASIS (non-serious) with onset Feb2021, outcome "unknown", described as "Caller states her psoriasis has worsened ever since her first dose".  Additional information: The patient had the primary series of the Pfizer BioNTech Covid-19 Vaccine and then got a booster dose in Nov2021. Her psoriasis had worsened ever since her first dose and continues to worsen after her booster dose. She had psoriasis since she was 16 years old, but it was now much worse, very itchy, and she was experiencing gigantic spots on places she never had before, all up and down her legs, crawling up her arms, and four patches on her breasts. She did not take anything for her psoriasis, and she might be prescribed something from her dermatologist to treat it now that it had gotten so bad. Her primary care physician had instructed her not to get any more doses of Comirnaty. She reported that the extent of the psoriasis was itches so bad and it was hideous looking. There were no other products or investigation assessment.  No follow-up attempts are possible. No further information is expected.
Woke at 4 am, headache, dizzy.  Went to the bathroom.  Went back to bed, woke again at 7:30 went downstairs, felt tired and dizzy.  Asked husband to come with me back upstairs because I felt more dizzy.  Legs became weak and by the time I got to the second floor, my legs gave out and I could not break my fall with my arms, as I felt I had no control over my body from the neck down.  My husband was behind me and broke my fall by lowering me to the floor.  I was conscious, but felt a strange sensation in my upper neck.  After about 30 seconds, feeling was returning and I felt I had to use the toilet.  Not realizing it, I had already soiled myself.  Cleaned up and went back to bed until 10:00 am.  Woke feeling groggy, but much better.  Speech slightly difficult.
Intense chest pain for three days, 14 days of moderate chest pain, fatigue and breathlessness. Symptoms gradually improved.
Approx 15 minutes after immunizations were given-child's face became red and developed hives-resolved quickly.
Resident was to receive Pfizer Bivalent Vaccine and was inadvertantly given Pfizer Monovalent.
Per clients mother, child awoke yesterday 08/23/2005 with left arm swelling, redness and tenderness. Today child has 9 x 11cm induration in left upper arm and about 2cm erythema beyond swelling. Mother states area improved today.
Patient woke up with only minor fever at 2:00 AM 07/10/2010, then woke up at 5:00 AM with a phlegmy cough. By Sunday 07/11/2010 the cough was much deeper. Tuesday 07/13/2010 he was diagnosed with pneumonia.
no additional AEs; patients received doses of VARIVAX vaccine on 8/9/22 while improperly stored outside recommended storage temperature range; This spontaneous report has been received from a registered nurse regarding a 5 years-old patient of unknown gender. The patient's concomitant medications, pertinent medical history, and drug reactions/ allergies were not reported.  On 03-AUG-2022, varicella virus vaccine live (oka/merck) (VARIVAX) was exposed to -14 Fahrenheit (F) up to 46 F (14F) for 4 hours (h) 15 minutes (min). On 09-AUG-2022, the vaccine was exposed to 14 F up to 46 F (45F) for 4 h 45 min. On the same day, the patient was vaccinated with one dose of a stored outside the recommended storage temperature range of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, subcutaneously, on the left deltoid at a dose of 0.5 milliliters (ml), once (lot number: W011626, which was verified to be valid, with an expiration date: 06-APR-2024; strength was not reported) (product storage error). The reporter called for an evaluation of vaccine temperature stability. There was no additional adverse event (AE) reported, and no further information was provided.  This is one of several reports from the same reporter.
On 4/19/01 at 2:00pm following a nap the mom noticed a red, hard, hot area on the left upper lateral thigh, approximately the size of a "golf ball". Applied warm compresses and soaked in a warm tub. On 4/20/01 in the AM the hard, reddened and hot to the touch area is progressively getting larger measuring 5 1/2 x 4 inches on pt's left thigh.
This spontaneous report received from a consumer, concerned a female of unspecified age. Medical history, weight, height, concomitant medications and concurrent conditions not reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch/lot number: not reported) dose, start therapy date: not reported, for immunization. Unable to perform follow-up to request batch/lot numbers. On an unspecified date, patient experienced severe headaches. The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The patient has not recovered from severe headaches.
Case number PHEH2012US018854 is an initial spontaneous report received from a medical assistant on 18 Sep 2012: This report refers to an adolescent female patient. Her medical history included gluten allergy. She was vaccinated with MENVEO (batch number: A11042) intramuscularly on 13 Sep 2012. After vaccination she experienced fever, nausea and hives. This reaction was similar to the reaction that she experienced after consuming gluten. Outcome was reported as condition unchanged as on 18 Sep 2012. No further information about seriousness and causality was available.
Patient received the vaccine on 4/5/21. On 4/17, he was at work when he started experiencing pain in his shoulder. Not sure it is related to vaccine since he had not had pain up until that point.
Breakthrough COVID-19 case 05/03/2022. Janssen vaccine given as part of the mix and match booster trial in July 2021.
Pt recvd Engerix-B on AUG91, OCT91, FEB91 & reported as being a nonresponder;