chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shortly p/vax c/o diff swallowing, chest tightness, thickness of tongue, dry mouth;BP 80/60, P92 regular pt has hx HTN, DPH given & pt put in lying position;p/5min BP 130/82, feeling better, some light headedness;P88 regular;5min later BP 1
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2022 at 18:00 as dose 5 (booster), single (Lot number: GH9693) at the age of 60 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (21Dec2022) Positive, notes: Tested positive again on 21Dec2022. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Product: COVID 19 Treatment, Paxlovid, Treatment start date: 08Dec2022, Treatment stop date: 13Dec2022. Rebound case of Covid. Tested positive again on 21Dec2022.
24 hours after the 4th Rabies vaccine was administered, the patient developed pain in his feet and knees. This then developed into swelling of feet, knees, and elbows within 24hrs.  Large red "dots" developed on lower extremities. Difficulty walking.  Family brought patient to ED. Pedi MD diagnoses patient with HSP (Henoch-Schonlein Purpura).
Came to employee health 6 hours after vaccination and stated that she was experiencing throat tightness and felt that her face was swollen.  States has been sneezing every few minutes since vaccination and that face is burning. States she is short of breath. Appears to be very anxious.  B/P is 150/70 with Pulse of 76. Evaluated and given Claritin.  At 1315 B/P is 135/80 with pulse of 80.  Pulse oximetry is 98% saturation.  At 1330 B/P is 120/78, pulse is 74, RR is 26.  O2 Sat is 97%.  Discharged and will F/U.  Will take Claritin Qd through weekend.
145PM pt recvd vax & upon rising from chair p/shot pt c/o feeling dizzy & that arm felt heavy; 205PM MD gave adrenalin; BP 148/90 a/inject; heat rate 110 3 mins p/inject; BP 140/88 @ 214PM;
Pt reported pain on injection, then 3 hours later, had swelling on the deltoid about the size of an egg and hot, took an ibuprofen, 2 hours later, swelling expanded down to elbow and covered most of the upper arm, the next morning swelling was past the elbow so went to ER and received cephalexin 500mg qid, swelling started to diminish the 2 nights after starting the antibiotic (approx 5-6 doses abx), 2 days after that the swelling was completely gone; patient had received Fluvirin in the same arm 5 days prior.
Noticed bloody urine in toilet at approximately 3PM, 4PM, and 9PM on Friday 1/29/2021.  Awoke Saturday morning to severe abdominal pain and extreme bloody urine.
Pt revd vax flu-like sx as of 15SEP92 sx had resolved;
Patient felt shortness of breath after Prevnar 13 was administered; This is a spontaneous report from a contactable nurse via Pfizer Sales Representative. A male patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date (Batch/Lot Number: DL2860; Expiration Date: Nov2022) as single dose for immunisation.  The patient's medical history was not reported. The concomitant medications included Hep A, Hep B and Flu vaccines at the same day with Prevnar 13. Patient felt shortness of breath after Prevnar 13 was administered. Event took place after use of product. The outcome of event was unknown.  No follow-up attempts are possible. No further information is expected.
This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (would fall down when I walk), FATIGUE (Very tired) and VOMITING (Threw up twice) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033B21A and 027C21A) for COVID-19 vaccination.  No Medical History information was reported. On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Jun-2021, the patient experienced GAIT DISTURBANCE (would fall down when I walk). 02-Jun-2021, the patient experienced FATIGUE (Very tired) and VOMITING (Threw up twice). At the time of the report, GAIT DISTURBANCE (would fall down when I walk), FATIGUE (Very tired) and VOMITING (Threw up twice) outcome was unknown. Patient stated she did not experience these side effects after the 1st dose. The action taken with mRNA-1273(Moderna COVID-19 Vaccine) was not applicable. Concomitant medications were not provided. Treatment information was not provided.
Asthma Reaction; Dizzy; Lighted headed; Difficulty breathing; A spontaneous report was received from a consumer who is a 29-year-old male patient that received Moderna's COVID-19 vaccine (mRNA-1273) and experienced dizziness, light headed, asthma reaction (asthmatic crisis) and difficulty breathing.  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included pantoprazole 40 mg.  On 28-Dec-2020, approximately three hours prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 28-Dec-2020, the patient developed dizziness, became light headed, experienced an asthmatic reaction and difficulty breathing. The events were treated with a dose of albuterol. The patient was transported to the Emergency Room but additional information was not provided.   Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events, dizziness, light headed, asthma reaction and difficulty breathing was unknown.; Reporter'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.
2 SEIZURES IN SAME DAY, LOSS OF APPETITE,HEADACHE,I ASKED DR IF THIS HAD ANYTHIG TO DO WITH HER SHOTS. HOSPTALIZED ON 6/11/08 FOR 8 DAYS BRAIN SURGERY BIOPSY ON 6/12/08. STEROIDS AND ANTI SEIZURE MEDICINE GIVEN. RELEASED WITH JUST SEIZURE MEDICINE. MY DAUGHTER DID NOT GET BETTER. SLEPT ALL DAY.NO APPETITE,RE-ADMITTED AFTER 2 WEEKS. I MENTIONED AGAIN IF HIS HAD ANYHING TO DUE WITH VACCINE. SHE WAS TESTED AND THEN DIAGNOSED THAT THIS WAS DUE TO VACCINE. DIAGNOSIS IS ADEM. SHE WAS GIVEN HIT DOSES OF STEROIDS FOR 3 DAYS. RELEASED AND SENT HOME WITH TAPERED DOSES OF STEROIDS. STILL ON KEPPRA AND ZANAC. MULTPLE MRI'S TAKEN. TIME COURSE: VACCINE GIVEN 5/28/08 AND SHE IS STILL RECOVERY AS OF THIS DAY.  9/26/08 Reviewed hospital medical records of 8/25-9/04/2008. FINAL DX: brain mass, cerebritis, HTN, antiseizure meds, transient hyponatremia probably secondary to SIADH. Records reveal patient experienced lethargy, irritability, HA, anorexia & right arm numbness & tingling which had recurred w/steroid taper.  Admitted to ICU & tx w/high dose steroids & IVIG.  ONcology, Neuro, Neurosurgery & intensivist consults done. Improved & d/c to home with mass biopsy for T cell clonality pending.    9/2/08 Reviewed hospital medical records of 6/11-6/17/2008. FINAL DX: Seizure, left cerebral mass, cerebritis, HA, s/p incisional biopsy left cerebral mass Records reveal patient experienced seizure activity at summer camp of unresponsive, jerking movements of RUE & drooling lasting approx 2 min.  Had c/o of HA for 6 wks prior.  Neurology, neurosurgery, ID consults done.  Started anti-seizure & steroids meds.  Taken to OR for craniotomy & biopsy.  No further seizure activity while hospitalized but did have slight right sided weakness at d/c to home w/neuro, neurosurg & ID f/u as outpatient.  Readmitted 7/24-7/28/2008. FINAL DX: Headache, encephalitis. Records reveal patient experienced HA, reduced oral intake, neck pain & lethargy x 2 days.  Tx w/steroids.  Progressed well & d/c to home on tapering steroids to be f/u by ID.  8/22/08 Reviewed PCP office records.   FINAL DX: cerebritis vs viral encephalitis Records reveal patient was in good health on day of vaccination.  Returned to clinic 6/30/08 post hospitalization.  Had neurology & neurosurgery appts set.
SORE ARM; This spontaneous report received from a patient concerned a 76 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1802068 expiry: UNKNOWN) dose was not reported, administered on 05-MAR-2021 at left Arm for prophylactic vaccination. No concomitant medications were reported. On 05-MAR-2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore arm. This report was non-serious.
general discomfort; 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 DISCOMFORT (general discomfort) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DISCOMFORT (general discomfort). At the time of the report, DISCOMFORT (general discomfort) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication/lab results were reported. Treatment information not provided.
Pt felt light headed and sweaty 1 minute after vaccination. She notified her vaccinator, who instructed her to lay on the floor. Pt reports that she felt better as soon as she got down to the floor. She was brought back for observation. Pt was offered wheelchair on way out but refused. VSs normal.  1418: HR: 78 RR: 12 BP: 117/82 SPO2: 97 on RA 1424: HR: 84 RR: 12 BP: 124/86 SPO2: 100 on RA Pt released at 1425.
RASH. 8 days after each shot. Rash after second shot was severe. Not at injection site. On both forearms, hands, and onto triceps. Palms, bottoms of feet, face, ears, and at the end, throat. Progressed for 8 days, then began to fade. (It is still detectable now, but nothing is inflamed.) Rash presented as either flat blotches or raised firm bumps.  All became red and inflamed. Some bumps formed a head, some popped, which became scabs. Very very itchy. Only alleviated by ice packs.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a adult patient who received FLULAVAL QUADRIVALENT 2018-2019 season (batch number 4MA57, expiry date 11th June 2019) for prophylaxis. This case was associated with a product complaint. On 11th October 2018, the patient received FLULAVAL QUADRIVALENT 2018-2019 season. On 11th October 2018, immediately after receiving FLULAVAL QUADRIVALENT 2018-2019 season, the patient experienced injection site pain. On an unknown date, the patient experienced pharmaceutical product complaint and syringe issue. On an unknown date, the outcome of the injection site pain, pharmaceutical product complaint and syringe issue were unknown. It was unknown if the reporter considered the injection site pain to be related to FLULAVAL QUADRIVALENT 2018-2019 season. Additional details were provided as follows: This case was reported by the pharmacist for her colleague. The age at vaccination was not reported. The patient noted the unusual amount of air in syringe, as well as, experienced pain during the vaccination and could feel the vaccine being injected. The reporter did not provide more information about colleague at the time of reporting. This case has been linked with the case US2018185671 and US2018GSK197109, reported by same reporter.
I noticed that I started swelling -  my hands and my feet especially; my Provider noticed it - she noticed my face was really swollen (I work at the office of my provider). It happened a week after the vaccine - she put me on Lasix to help with the swelling and my joints had pain. It flared up my joint pain from Fibromyalgia. Two weeks after that I started losing a lot of hair - it was more handfuls then I had ever lost before. It lasted up through when I got the second shot. The Lasix brought the swelling down in my face but it didn't bring it down in my legs.  Fibromyalgia symptoms and swelling and still a little hair loss (although hair loss was slowing down)was happening at time of second vaccine.
within 30 minutes of receiving the flulaval started having urticaria no hives no SOB.  given 50 mg benadryl IM and within 15 minutes urticaria reduced to minor areas. given 50 mg benadryl QID for 3 days with f/u in 24 hours from time vaccine given. pt was observed for over 1 hour. PT states the last two flu vaccinations resulted in hives or urticaria, was seen by provider and treated with benadryl, but was not told he was allergic. last flu vaccine was flu mist and the only vaccination at the time.  was given anthrax, small pox, typhoid, hep b and a without any urticaria. pt is able to each chicken without urticaria.
I felt fine after my booster (10:30AM). At 6:15PM, I noticed that the skin on my left hand (my injection arm) looked noticeably blue from the wrist down through my fingers, while my right hand looked totally fine and normal. After moving my hand around for a few minutes, the blueness was just in my fingers (no longer up to my wrist), but my fingers stayed with a blue/purple tint to them for the rest of the night. I have a photo of it. The next morning, when I woke up, the tint was very slight blue (still only in my left hand), but by 8:00AM, it was entirely back to normal. I went to my PCP around 9:30-10AM the next day anyway just to be safe. The Physicians Assistant saw me and said he didn't see anything to be concerned about, all my vitals were normal and my blood oxygen was 98 in my left hand and 99 in my right.  He had no explanation for the blue fingers in one hand.    Other than this, my side effects were normal and similar to my second vaccine - sore arm, swollen lymph nodes, feeling slow and a little achey, low-grade fever (99.9). I was entirely better by the second day mid-day, except for the swollen lymph nodes in my left armpit, which are still swollen (fourth day after). This year after my regular flu shot, my lymph nodes in my left armpit (same arm as the flu vaccine given) were also quite swollen for a few weeks.
Follow up information received from the pediatrician on 03-JUN-2003 provided additional vaccination details, including vaccination dates and vaccines given within four weeks, patient date of birth, concomitant medications, illness at the time of vaccination, event onset date and recovery status. A pediatrician reported that a six month old female received her third dose of Prevnar on 22-APR-2003. The infant had bronchitis that was improving at the time of vaccination. Concomitant medications included Pulmicort (budesonide) and Xopenex (levalbuterol). Vaccines administered within 4 weeks of Prevnar included the infant's third doses of Tripedia (Aventis) and IPOL (Aventis ) on 14-APR-2003. On 26-APR-2003, the infant developed an injection site reaction on her thigh at the site of Prevnar administration characterized by a "knot". The knot resolved 4 days post vaccination; however, a rash at the Prevnar injection site then appeared. She was treated iwth Benadryl (dephenhyddramine). She recovered. The infant developed a generalized, erythematous, maular-papular rash following receipt of her second doses of Prevnar, Tripedia (Aventis), IPOL (Aventis and Comvax (Merck) accines at 4 months of age  (se MCN HQWYE036305MAY03). The physician indicat4ed that there were "no problems" following receipt of the infant's first doses. Informatin regarding this event has been forwarded to Aventis.
Reported by patient 4 days following administration that they had been sick, that they reaction to them and had been ill in bed for 3 day. Patient reports that they never want this type of vaccine again. Nausea Vomiting and Influenza-like illness.
all got the flu that year; Initial information received on 19-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves Adult female patient who got the flu that year after receiving Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient who got the flu that year (influenza) received an unknown dose of suspect Influenza vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for Influenza with unknown form, strength, frequency, route, expiry date.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (all got the flu that year).  Outcome: Unknown.
Delayed hypersensitivity reaction at injection site.  Onset 8 days post-injection.  Area approx. 5" long 3" wide.  Well-demarcated oval area of slight erythema and very mild swelling.  Principal symptom is pruritus.  Slightly tender to touch but no pain unless it is pressed on.  No systemic adverse reactions experienced.   Today, day 9 post-injection reaction is similar to date of onset but no worse.  I am just applying some topical cortisone and benadryl creams to reduce the itching.  I thought I should submit this so you would have this in your data base. I have not experienced this type of reaction to any other vaccine I have received in the past but it is similar to the type of reaction I develop a few days after being stung by a bee. I anticipate a full recovery and look forward to getting my second dose of the vaccine despite this  localized adverse allergic reaction.
Anaphylactic reaction; A spontaneous report was received from a healthcare professional concerning a 24-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Anaphylactic reaction.  The patient's medical history included allergy to milk. No concomitant medications were reported.  On 12 Jan 2021, 5  10 minutes prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in an unknown arm for prophylaxis of COVID-19 infection. The patient experienced chest tightness and tachycardia symptoms following which she was transported via gurney to the observation area. The patient looked sleepy and had trouble arousing her. The blood pressure was at 140/80 mmHg, heart rate was in the 90s to 100s heartbeats per minute. The patient's breath sound decreased bilaterally. It was also noted that her throat felt uncomfortable. The reporter stated that anaphylaxis reaction was suspected due to the rapid decline in status. Following an increasing heart rate and complaints of chest discomfort the patient was treated with a dose one of epinephrine pen. It was noted after a minute or two the patient's chest felt better. Her blood pressure was stable at 140/80's mmHg, the heart rate initially increased to 110 and then back down to 100 about 5 minutes after the first dose. At about 8 minutes from dose one of epinephrine pen, the patient's heart rate increased to 160 and developed additional symptoms of chest tightness again so a second dose of Epinephrine pen was administered. The patient was somnolent but protecting airway. Oxygen was added 2 liters after second dose of epinephrine pen. The patient's oxygen saturation dropped right around second dose of epinephrine pen to 94% but about 2-3 minutes later it was back at 98%. The paramedics arrived 5 minutes after second dose of epinephrine pen and care was transferred to them. The patient was transported in a stable condition.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome for the Anaphylactic reaction was unknown.; Reporter's Comments: This case concerns a 24 year old, female patient, who experienced serious unexpected event of Anaphylactic reaction. The event occurred 1 day (5-10 min) after mRNA-1273 (Lot# Unknown). Treatment included EpiPen (2 doses). Very limited information regarding this event has been provided at this time. Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Additional information has been requested.
Never received dose 2 and 3; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 57-year-old male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 19th September 2021, batch number 75C72 and expiry date 13th June 2022).   On an unknown date, the patient did not receive the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-APR-2022 Reporter's comment: The pharmacist reported that a patient never received second and third dose of Twinrix.  The reporter consent to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd and 3rd dose of Twinrix, which led to incomplete course of vaccination.
This spontaneous report as received from a medical assistant refers to a unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date in 2015, since 26-FEB-2015, the patients were vaccinated with improperly stored RECOMBIVAXH B oral (dose, lot number and expiration date were not reported). No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Jan 28. 2nd dose vaccine, sore arm at injection site. Slight fever at night. Jan 29. Still sore arm, temp 99.7F Jan 30. 8pm rashes all over the body and scalp. Fever 100.7F. Tylenol and Benadryl taken.  Jan 31 went to urgent care. Possible rashes due to covid vaccine. Methylprednisolone prescribed. HEart rate 115-130s Feb 1 still with rashes temp 99.1 heart rate 100-120s
L.A. - pain lifting arm. I had this shot on 10 Oct 2016 and I still notice left arm doesn't function like it should.