chrisvoncsefalvay/vaers-outcomes huggingface dataset:
human leukocyte antigen (HLA) sensitization subsequent to vaccination;  This literature marketed report has been received from authors of the literature article entitled as stated above and refers to an unspecified pediatric patient waiting for kidney transplant. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) (formulation, strength, dose, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date after vaccination, the patient's anti-HLA antibody test was positive; the patient experienced human leukocyte antigen (HLA) sensitization subsequent to vaccination. The outcome of the event was unknown. The authors considered the event to be related to suspect vaccine.  This is one of five reports derived from the same literature article.  A copy of the published article is attached as further documentation of the patient's experience.; Sender's Comments:  US-009507513-2209USA010290: US-009507513-2209USA010293: US-009507513-2209USA010291: US-009507513-2209USA010292:
Information has been received from a physician concerning a 12 month old female who on 25Jul05 was vaccinated with a 0.5ml SC dose of varicella virus vaccine live (lot 1029). On 10Aug05 the pt presented with hives on her arms, legs and trunk. The pt was treated with over the counter diphenhydramine hydrochloride (Benadryl). At the time of the report the pt had not recovered. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Follow up information from a physician indicated that the pt was unable to be located Additional information is not expected.
Exhaustion-slept a lot; Exhaustion-slept a lot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Mar2021 13:00 (Lot number: EN6078) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Chronic low back pain", start date: Dec1979 (ongoing), notes: Pertinent Details: surgeries 1982, 1986,1988, 1989 Ongoing; "Hypertension", start date: 1990 (ongoing), notes: Ongoing, Pertinent Details: Oral treatment since 1990; "Hemorrhagic stroke", start date: 01Jun2015 (ongoing), notes: Ongoing, Long term symptoms-legs, June 2015-interventional radiology left occipital AVM; "osteoarthritis", start date: 1975 (ongoing), notes: Ongoing,Pertinent Details: chronic pain can be severe; "endometrial cancer", start date: 2015 (ongoing), notes: Ongoing,Pertinent Details: radial hysterectomy the chemo on radiation; "several drug allergies" (unspecified if ongoing), notes: Myself - several drug allergies. Family history included: "breast cancer" (unspecified if ongoing), notes: mother's side- breast cancer in 3 women. Concomitant medication(s) included: MELOXICAM taken for arthritis (ongoing); LEVETIRACETAM taken for seizure (ongoing); VERAPAMIL taken for hypertension (ongoing); HYDROCHOROTHIAZIDE taken for hypertension (ongoing); ACETAMINOPHEN taken for pain (ongoing); ATORVASTATIN CALCIUM taken for hyperlipidaemia (ongoing); K-TAB taken for hypokalaemia (ongoing). Vaccination history included: Bnt162b2 (1st dose, Lot number : EN6201,intramuscular, left upper arm), administration date: 20Feb2021, for COVID-19 immunization; Bnt162b2 (1st dose, Lot number : EN6201), for covid-19 immunization, reaction(s): "flu -like aches", "sore throat", "Fever low grade -990"; Bnt162b2 (1st dose,Lot number : EN6201), for covid-19 immunization, reaction(s): "congestion". The following information was reported: FATIGUE (non-serious), SLEEP DISORDER (non-serious) all with onset 14Mar2021, outcome "recovered" (14Apr2021) and all described as "Exhaustion-slept a lot". Therapeutic measures were not taken as a result of fatigue, sleep disorder. Additional information: The patient did not received any prior vaccinations.  No follow-up attempts are possible. No further information is expected.
Muscle aches and joint aches (elbows, wrist, knees, fingers and jaw). Swelling and tenderness of lymph nodes especally underarm and neck.
Right side red and hot with in hours of vaccine, looked better the next day. Then developed a large knot within 48 hours of vaccinations. Had a fever 14 hours status post vaccination, which was 101.3 (axillary actual) at it's maximum.
10 minutes after the shots where administered to the patient, patient's mom notified one of the medical  assistants that the patient was developing a rash around the shot site on her right leg. I went to look at Pt's right leg and the area around the shot site looked red and swollen. I notified Dr and he instructed me to give her 1 teaspoon of Children's BENADRYL. Pt waited 20 minutes post BENADRYL, the swelling in her right leg went down but the area was still red. Mom will continue to give BENADRYL at home.
pt recv vax 15OCT96 & 20DEC96 pt noticed a decrease in hearing;24DEC96 pt was seen by MD & informed that there was a 95% decrease in hearing in the right ear & 20% decrease in hearing in the lt ear;poss of an inner ear infect;mild stuffines
pt recvd vax;w/in 24 hrs,devel rxn at DTAP site consisting of erythema, induration, swelling & hot to touch approx 10mm in diam;tx w/ ice;as of 29apr rxn persisted w/ skin "sloughing";not seen by MD;rptr assumes rxn resolved;no f/u from mom
rashes around both eyes, mostly under eyes/non itchy rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rashes around both eyes, mostly under eyes/non itchy rash) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     Concomitant products included BETAHISTINE HYDROCHLORIDE (VERTEX [BETAHISTINE HYDROCHLORIDE]) for Allergy.    On 27-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, the patient experienced RASH (rashes around both eyes, mostly under eyes/non itchy rash). At the time of the report, RASH (rashes around both eyes, mostly under eyes/non itchy rash) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information does not provided. The action taken with the drug was not applicable. Upon in internal review on 04-Aug-2021, the age was corrected to 22 years   This case was linked to MOD-2021-073782 (E2B Linked Report).; Sender's Comments:  MOD-2021-073782:First  dose case
Information has been received from a certified medical assistant concerning a patient who on an unknown date was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine. Subsequently, the patient experienced arm pain, redness at the injection site and warmth at the injection site. It is unknown if medical attention was sought. At the time of this report, the patient's outcome was unknown. This is one of 4 reports from the same source. Additional information has been requested.
12 Hours after receiving the vaccine, I developed a fever, headache, and general malaise.  It continues all night and into the morning.  The fever is being controlled by aspirin (650 mg every 6 hours)
patient accidentally received the Dtap instead of the Tdap vaccine; 11 years old received infanrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old female patient who received DTPa (Infanrix) (batch number 9R2D7, expiry date 23-MAY-2025) for prophylaxis.   On 19-JUN-2023, the patient received Infanrix. On 19-JUN-2023, an unknown time after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: patient accidentally received the Dtap instead of the Tdap vaccine) and inappropriate age at vaccine administration (Verbatim: 11 years old received infanrix). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were 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: 05-JUL-2023 A registered medical assistant called and reported that a patient accidentally received the Dtap instead of the Tdap vaccine which led to wrong vaccine administered. The reporter wished to know if any information was available. The provided information about vaccine, event and patient agreed to receive follow up. The vaccine administration facility is the same as primary reporter. 11 years old received Infanrix which led to inappropriate age at vaccine administered. The reporter consented to follow up.
Vagal nerve response-racing heart, cold clammy skin, shivering, profuse sweating, almost simultaneous bowel movement and vomiting, nausea.
This nurse was at an offsite for employee COVID vaccines. Patient came in for her 2nd Moderna shot. Denies any reaction from first dose. Denies feeling sick at time of injection. Vaccine administered to left Deltoid. Patient waited 15 minutes and then returned to work. At 10:00 am, the Bowater nurse received a call that the patient has been vomiting since she received the injection. Patient was brought to the nurse clinic at Bowater. BP 111/76, HR 106, respirations 18, BP 111/76. Patient states she feels nauseated and very week. Patient stated she feels like it is hard to breath. Bowater had a Nurse Practitioner on staff. NP examined patient and stated her Uvula was swollen. NP stated lung were clear. NP immediately applied O2 @ 2 liters, administered Benadryl 50 mg IM to right deltoid, started IV and hang NS gravity, and administered Dexamethasone. Patient remained alert the entire time. No shortness of breath noted. Bowater has their own EMT's on staff and they were ordered to take her to Hospital ER.  Husband was called for patient. Husband reported after patient received all this treatment that she had vomited 3 days prior and that she had not eaten in 3 days prior to her vaccine and has not felt good. Since NP diagnosed this episode as Anaphylactic, this nurse felt it should be reported.
1st dose of Moderna vaccine administered on 1/29/2021. 2nd dose of Moderna vaccine administered on 2/27/2021. Patient developed an infusion reaction on 3/11/2021 with vedolizumab - severe low back pain that began within minutes of infusion and stopped with discontinuation, and then occurred again when infusion was re-trialed within minutes. Patient has been on this infusion for > 1 year without any similar symptoms. It is unclear if development of this infusion reaction is related to the recent vaccination with the Moderna COVID19 vaccine.
Itchiness; Rash; Swelling; redness 3-6inches; was warm to touch; Tenderiness; Small pink redness; This spontaneous case was reported by a consumer and describes the occurrence of   in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Cortisone and Advil
On day 13 post smallpox vax, developed malaise, fatigue, lightheadedness with mild sore throat and occasional cough; myalgias, no lymphadenopathy. Had had local pruritis and local rash at vac site day 7. Reported to clinic day 20 for symptoms that started day 13 and persisted. No F/C/N/V/D; mild congestion. Has been running 70 miles/week for competition; signs/symptoms may be due to overtraining, better with rest.
dizzy; weak; feeling terrible; at injection site hurts/injection site pain is in her right upper arm; muscle pain; fever; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Dec2022 as dose 5 (booster), single (Lot number: GJ6739) at the age of 74 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: PRAVASTATIN. Vaccination history included: BNT162b2 (1st dose Pfizer COVID-19 Vaccine:, Date Received: 26Jan2021, Lot number: unknown, Route of Administration: Intramuscular), administration date: 26Jan2021, when the patient was 72-year-old, for Covid-19 immunization; BNT162b2 (2nd dose Pfizer COVID-19 Vaccine:, Date Received: 17Feb2021, Lot number: EN6201, Route of Administration: Intramuscular), administration date: 17Feb2021, when the patient was 72-year-old, for Covid-19 immunization; BNT162b2 (3rd dose Pfizer COVID-19 Vaccine:, Date Received: 13Oct2021, Lot number: 30155ISA, Route of Administration: Intramuscular), administration date: 13Oct2021, when the patient was 73-year-old, for Covid-19 immunization; BNT162b2 (4th dose Pfizer COVID-19 Vaccine:, Date Received: 22Apr2022, Lot number: FM9992, Route of Administration: Intramuscular), administration date: 22Apr2022, when the patient was 73-year-old, for Covid-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 20Dec2022, outcome "not recovered", described as "at injection site hurts/injection site pain is in her right upper arm"; DIZZINESS (non-serious) with onset 20Dec2022, outcome "not recovered", described as "dizzy"; MALAISE (non-serious) with onset 20Dec2022, outcome "not recovered", described as "feeling terrible"; PYREXIA (non-serious) with onset 20Dec2022, outcome "not recovered", described as "fever"; MYALGIA (non-serious) with onset 20Dec2022, outcome "not recovered", described as "muscle pain"; ASTHENIA (non-serious) with onset 20Dec2022, outcome "not recovered", described as "weak". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Other conditions was noted as no. Vaccination facility type was noted as clinic. Patient was calling about third Booster Bivalent COVID-19 Vaccine. She had the booster yesterday (19Dec2022) and today (20Dec2022) when she woke up, she was feeling terrible and have not had that reaction to her previous Pfizer vaccines. She was dizzy, weak, at injection site hurts, muscle pain, and fever. These started on 20Dec2022 (today) when she woke up. These symptoms were still ongoing and were about the same. Patient clarified the injection site pain is in her right upper arm. Adverse events require visit to emergency room and physician's office were noted as no. Investigations was noted as no.
Patient was 17 y/o at the time she received her first dose of the Moderna vaccine.
Administration error: second dose was given as half of a dose instead of full dose; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Administration error: second dose was given as half of a dose instead of full dose) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Administration error: second dose was given as half of a dose instead of full dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Administration error: second dose was given as half of a dose instead of full dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Administration error: second dose was given as half of a dose instead of full dose). No concomitant medications were reported.  The HCP (health care professional) stated the patient received a first full dose of Moderna COVID-19 Vaccine. The HCP stated that the patient would be informed about this for them to call back and report an event to Moderna. It was unknown if the patient experienced any symptoms after getting any of the vaccines.  No treatment medications were reported.
Numbness of face and lip; Face tingling; Felt sensitive to light; Nauseous; Really bad headache, left side of face; Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness of face and lip) and PARAESTHESIA (Face tingling) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hysterectomy. Concurrent medical conditions included Shellfish allergy, Egg allergy, Food allergy (dairy) and Food allergy (different food when she was a child). Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 20-Apr-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness). On 20-Apr-2021 at 12:00 PM, the patient experienced HEADACHE (Really bad headache, left side of face). On 21-Apr-2021, the patient experienced HYPOAESTHESIA (Numbness of face and lip) (seriousness criterion medically significant), PARAESTHESIA (Face tingling) (seriousness criterion medically significant), PHOTOPHOBIA (Felt sensitive to light) and NAUSEA (Nauseous). At the time of the report, HYPOAESTHESIA (Numbness of face and lip), PARAESTHESIA (Face tingling), PAIN IN EXTREMITY (Arm soreness), PHOTOPHOBIA (Felt sensitive to light), HEADACHE (Really bad headache, left side of face) and NAUSEA (Nauseous) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included ibuprofen.  Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship with the product use cannot be excluded.  Headache and nausea are consistent with the known safety profile of the product.; Sender's Comments: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship with the product use cannot be excluded.  Headache and nausea are consistent with the known safety profile of the product.
shortly after receiving pfizer booster pt c/o feeling like "asthma" coming on. Has hx of asthma. Lungs remained clear with good air movement, no wheezing noted, SaO2 96%. A few min later felt some mild itching to face, neck, torso and arms. No hives or rash noted. Dr called. Advised Benadryl 50mg IM which was given at 1335. Itching subsided, observed for an hr and again evaluated by Dr and OK for discharge. Lungs clear, SaO2 97% and VS normal on discharge.
2/13/2023 Early I noticed symptoms a bad runny nose. Participant tested with an at Home COVID-19 Test, positive.  Televisit with doctor who proscribed Paxlovid and advised to treat symptomatically.  Symptom improved the next day.  Fatigue lingered until about day 3 when participant felt much better.
Client reports for appointment of second dose of Engerix B. Prior to vaccination, she states that right after (minutes), she began experienced numb and swollen lips and tongue. She says she took PO Benadryl every 4 hours for 24 hours and that decreased the swelling some but did not resolve completely for about 48 hours.
With autoimmune issues - I was unaware that getting this shot would throw my body into a severe flare up.   by 8 pm on the day of the shot - continuing for 3 days - I had an extreme PSA flare up in which my joints all swelled, could barely move, terrible pain widespread throughout my body.  Had I known that people with automimmune diseases may end up with a severe flare due to the vacccination - I would have opted to NOT get the vaccine.  It is my understanding that the test groups did not include people with the autoimmune diseases.   In addition to the severe autoimmune flare up - since that has resolved, I have had an upper respiratiory cold - runny nose, sneezing, now coughing and congestion every since.  So once past the 3 days of flare, I have had now 6 days of cold type symptoms that nothing seems to help - no over the counter cold or sinus medicines are helping at all.
allergies; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (Pfizer COVID 19 Vaccine, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 07Apr2021 as dose 1, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included cetirizine hydrochloride (ZYRTEC ALLERGY) and montelukast sodium taken for an unspecified indication for an unspecified date. The patient stated on call after the first dose of the vaccine she was scheduled on April 28 for the second dose. However, caller was experiencing allergies and taking allergy medicine like Zyrtec and Montelukast sodium 10 mg. Caller wants to know if it would effect the vaccine since she had allergies and was taking medication. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
bad headache; Hives in left side on neck; This is a spontaneous report from a contactable consumer (Patient). A 50-years-old non-pregnant female patient received BNT162B2 (COMIRNATY; Formulation: Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration, administered in Arm Left on 08Feb2021 11:15 (at the age of 50-years-old) as dose 1, single for COVID-19 immunization. Patient was not pregnant. Medical history was reported as none. No other vaccine was given in four weeks. No known allergies were reported. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 09Feb2021 07:00 the patient experienced bad headache and hives in left side on neck. The patient did not receive any treatment for the events. The outcome of the events was recovered on unspecified date in 2021.  Information on the Lot/Batch number has been requested.  Follow-up (11MAY2021): Follow-up attempts completed. No further information expected.