chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt devel fever as high as 104.6  & a non localized varicella like rash w/10-15vesicles on trunk, neck, face 9-10 days p/vax;
Information has been received from a health professional concerning a 16 year old female who on approximately 18-MAR-2008 was vaccinated with GARDASIL (lot# not reported). Concomitant therapy included VARIVAX, for the treatment of prophylaxis (duration and dose not reported) and VAQTA, for the treatment of prophylaxis (duration and dose not reported). Other concomitant therapy included MENACTRA. On approximately 18-MAR-2008 the patient fainted shortly after the vaccinations. Subsequently, the patient completely recovered from fainting before leaving the office. Additional information has been requested. 02/18/2010 Information and follow up has been received from a health professional concerning a 13 year old female with a history of congenital nystamia who on 12-MAR-2008 was vaccinated intramuscularly in the right arm with her first does of GARDASIL (lot# 659182/1757U). Concomitant therapy included the second dose of VARIVAX (duration and dose not reported) subcutaneously in the left arm (lot# 659941/1791U). Other concomitant therapy included the first dose of HAVRIX intramuscularly in the right arm (lot# AHAVB256AA) and the first dose of MENACTRA intramuscularly in the left arm (lot# U2550AA). She experienced a mild headache and was prescribed Motrin. At the time of vaccinations the patient had Otitis media.  Additional information has been requested.
C/o ring finger and pinky finger stiffness that comes and goes. Has not been to Doctor.
Pt received Td vaccine on 11/2/05 in left deltoid-Developed pain and swelling in left upper extrem. The pain worsened. Had a cardiac work up that was negative in March 2006. RTC 7/19/06 to see me.  Exam showed atrophy of left deltoid and muscle, same residual pain and swelling, CK was elevated at 492. Patient ultimately saw a neurologist who diagnosed post vaccination bronchial pleuritis.
A physician reported that a 3 month old infant received the second dose of Rota Shield on 6/29/99 and within 24 hours developed generalized urticaria. The urticaria resolved within 36 hours. Follow up information received from the physician on 9/9/99 indicated that the urticaria was treated with oral Atarax. The infant remained recovered. The initial report indicated that the infant had received several vaccines within 4 weeks of the second dose of Rota Shield, but the dates of administration were unknown. On follow-up the physician indicated that no vaccines were given within 4 weeks of the second dose of Rota Shield.
21SEP91 "migraine h/a"; 22SEP91 fever 106; 23SEP91 rash to face, forehead & cheek & fever 101; 23SEP91 saw MD;
Swollen hot red welt 5.5 cm across injection site. Itching. Lasted for 2 days.
Shortness of breath and heart palpitations. Diagnosed with pulmonary embolism.
Pt received all listed vaccines & approx 10 mins later started with hives & lead to facial swelling. Pt was placed on continuous SaO2 reading @ 98-100% without resp distress noted. Vomited x 1 episode. Pt was given 1 tsp Children's BENADRYL liquid PO at 3:45pm then was given EPIPEN Jr x 1 in Lt thigh IM @ 3:58pm. Pt obs'd until 4:30pm and released to parents in stable condition with b/s to call "911" for.
Friday evening I was tired and slept a lot. When I woke up on saturday I had pain in my muscles and neck and in my shoulders. I was not hungry and I had a fever(101.2). I slept until 1pm and I started getting nauseous. I never got up off the couch saturday. Pain in left arm/shoulder blade went away around 5pm Saturday. I still had a slight fever and headache saturday evening. Sunday I felt better but I still had a slight fever and headache but felt generally much better. Monday I had no fever no headache, and a little aching in my right arm at the injection site.
The night of the injection, patient started itching in the creases of each arm, bumps appeared. The scratching led to rash/eczema flare up. Patient used triamcinolone cream and shea butter to decrease the itching. Patient is still experiencing itching/redness from the day of the immunization.
Immediate headache following vaccine, able to work throughout day.  Upon the next morning headache, extreme fatigue and diarrhea caused me to call off work for the 1st time in years.
PATIENT STATES DX WITH CELLULITIS POST INJECTION, RECOVERING WELL WITH ANTIBIOTICS
Pain in left arm was so strong that I could not roll over to get out of of bed. All other joints and areas in which I have minor aches and pains were very sore.   Mind somewhat clouded.  Modest temperature, 101. Chills.  Like a bad flu, but more pain and less congestion. Strong but not splitting headache. Not like a migraine--not at all as bad.  Very minor nose congestion and sore throat.  Symptoms all ended by 36 hours after 2nd shot
Felt that both legs and hands were numb almost like paralysis; Tingling on right leg; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 28Aug2021 (Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient in 2021 felt that her both legs and hands were numb almost she had like paralysis. She went to the hospital and they checked her out. The patient was checked, and she did not have anything like that. She was watched for a while now and she was feeling ok with no issues but a little bit tingling on the right leg. The patient was wondering if this was the side effect of the vaccine shot and the reporter did not know. The outcome of numbness of extremities was recovered in 2021 and outcome of tingling was not recovered.  The lot number for BNT162B2 was not provided and will be requested during follow up.
This spontaneous report as received from a medical assistant refers to a male patient of approximately 5 years old. The patient was vaccinated with dose 1 VARIVAX (merck) on 20-OCT-2008. The second dose of VARIVAX (merck) was administered on 23-JUL-2012. Lot number for the second dose was reported as H012132 (lot in validation), exp 25-JUN-2014. No other co-suspects were reported. As concomitant medication, 'inhalers' were reported. On an unknown date the patient experienced rash that looks like chickenpox. The patient had not been seen by a physician yet at the time of reporting and the medical assistant requested 'VZVIP packet' for analysis. No treatment was given for the event. The outcome of rash that looks like chickenpox is unknown. The relatedness for rash that looks like chickenpox is unknown for VARIVAX (Merck). Additional information has been requested.
ADMINISTRATION OF AN EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 24 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: 21-SEP-2021) dose was not reported, administered on 27-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-SEP-2021, the patient experienced administration of an expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of an expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210958425, 20210958525, 20210958716, 20210958371, 20210958806, 20210958977, 20210958518 and 20210958348.
9 hours after receiving the vaccine I experienced joint pain, muscle pain, headache, fever and chills. Symptoms resolved after 36  hours.
None Just a little sore arm or achy with the previous Pfizer COVID vaccines; None Just a little sore arm or achy with the previous Pfizer COVID vaccines; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 75-year-old female patient received BNT162b2 (BNT162B2), on 05Mar2021 as dose 1, single (Lot number: EN6205), in right arm and on 25Mar2021 as dose 2, single (Lot number: ER8733) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obese" (unspecified if ongoing), notes: Obese and has type 2 diabetes diagnosed 2 years ago.; "Type 2 diabetes" (unspecified if ongoing), notes: Obese and has type 2 diabetes diagnosed 2 years ago.; "Hayfever" (unspecified if ongoing), notes: Hayfever and Seasonal allergies diagnosed years ago.; "Seasonal allergies" (unspecified if ongoing), notes: Hayfever and Seasonal allergies diagnosed years ago.; "Compromised immune status" (unspecified if ongoing), notes: Compromised immune status-10 years ago. There were no concomitant medications. Past drug history included: Prednisone, notes: She is immunosuppressed because she is on daily doses of Prednisone. The following information was reported: PAIN IN EXTREMITY (non-serious), PAIN (non-serious), outcome "unknown" and all described as "None Just a little sore arm or achy with the previous Pfizer COVID vaccines".  Additional information: Obese and has type 2 diabetes diagnosed 2 years ago. Hayfever and Seasonal allergies diagnosed years ago. Compromised immune status-10 years ago. She is immunosuppressed because she is on daily doses of Prednisone. This was before taking the Pfizer COVID vaccines.   Follow-up attempts are completed. No further information is expected.
Doesn't feel very good; Fever; Very, very, very tired; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Doesn't feel very good), PYREXIA (Fever) and FATIGUE (Very, very, very tired) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 05-Apr-2021, the patient experienced MALAISE (Doesn't feel very good), PYREXIA (Fever) and FATIGUE (Very, very, very tired). At the time of the report, MALAISE (Doesn't feel very good), PYREXIA (Fever) and FATIGUE (Very, very, very tired) outcome was unknown.            No relevant concomitant medications were reported. Treatment medicine include Cold Tylenol.   This case was linked to MOD21-070121, US-MODERNATX, INC.-MOD-2021-069011 (E2B Linked Report).; Sender's Comments:
Received the vaccine being pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 17-Feb-2021 and the estimated date of delivery was 24-Nov-2021. On 13-Aug-2021, the patient experienced EXPOSURE DURING PREGNANCY. The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the twenty-fifth week of the pregnancy. On 13-Aug-2021, EXPOSURE DURING PREGNANCY (Received the vaccine being pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter. This is a case of product exposure during pregnancy with no associated AEs for this 25-year-old female. Further information has been requested.
Enclosed letter. Solid body hives (mouth, head, feet, hands). On October 19, 2012 I took the shingles shot. I was fine until the next day. When I got up I had hives my faces was swollen and my body same. I called pharmacy he said take BENADRYL. (I did that for 3 days) I was fine for about 3 weeks). I swelled up with hives worse than before Saturday November 10, 2012 4:30 A.M. I went to emergency room in hospital. Told me to take BENADRYL gave it to me there. I had to wait to make sure it took effect. Took it until following Monday. Went to dr on Monday November 12, 2012. He put me on prednisone and hydroxyzine. I took it for 2 days and went back to him again as I wasn't a lot better. He upped the amount of both the prescriptions. I took them for about 10 days. This did help me. This is now, Dec. 4th 2012. I still get swelling in my face (eyes) some still come & go in my mouth Carrying an Epipen prescribed by my doctor. Went to allergy doctor on Nov 29th 2012. Did 100 patch test that all came negative she said reaction was proof from the shingles shot. I was fine prior to all of this. Going for more testing in January.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Apr2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 03May2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 27Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 47 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative; Positive, notes: Test type: Antigen Test. Therapeutic measures were taken as a result of covid-19, drug ineffective.Brand: Paxlovid.treatment start date:14May2022. treatment stop date:18May2022.Recurrence of Covid symptoms (stuffy nose only), positive antigen test after 3 days of negative testing.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200781722 Same patient, different product and event
High fever, will alternately return to normal, then spike 102; Headache; Pain in lower right abdomen was so severe they thought they were experiencing appendicitis; Fatigue; Chills; Sweats; Pain at the injection site; 1st dose Oct/2021 and 2nd dose 08/Jul/2022; General feeling of malaise, confined to bed from Monday through Thursday; Lose of appetite shortly after symptoms began and only being able to consume small amounts of cereal; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 54-year-old male patient who received Herpes zoster (Shingrix) (batch number KJ937, expiry date unknown) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received in October of 2021 refer case US2022AMR107457).   On 8th July 2022, the patient received the 2nd dose of Shingrix. On 8th July 2022, immediately after receiving Shingrix, the patient experienced injection site pain and drug dose administration interval too long. On 11th July 2022, the patient experienced fever, headache, lower abdominal pain, fatigue, chills and sweating. In July 2022, the patient experienced malaise and appetite lost. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain, fever, headache, lower abdominal pain, fatigue, chills, sweating, malaise and appetite lost were not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the injection site pain, fever, headache, lower abdominal pain, fatigue, chills, sweating, malaise and appetite lost to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR107457   Additional Information: GSK Receipt Date: 15-Jul-2022 Reporter's comment:  The patient received Shingrix vaccine in left arm.  The patient immediately experienced pain at the injection site after second dose.  The patient felt fine over the weekend, with just a general feeling of malaise.  The patient experienced chills, sweats, high fever, headache, pain in lower right abdomen, and fatigue after second dose, which started on Monday, 11 July 2022.  The patient confined to bed from Monday through Thursday, 14 July 2022.  The patient experienced loss of appetite shortly after symptoms began and only was able to consume small amounts of cereal.  The patient had pain in lower abdomen which was so severe they thought they had experienced appendicitis.  The patient had fever which would alternately return to normal, then spike to 102.  The patient had all symptoms which had improved, but are still present.  The consent to follow up was given. Additional Supportive Information: The patient received first dose of Shingrix in October of 2021 and second dose on 8th July 2022, which led to lengthening of the vaccine schedule.; Sender's Comments:  US-GSK-US2022AMR107457:Same reporter
Patient had COVID-19 exposure and reported having a very bad cold with cough on 4/12/21 to his primary care physician. He was tested and found to be COVID-19 positive at that time. He presented to emergency department on 4/19/21 with worsening shortness of breath. He was admitted to hospital for further management of infection.  Patient admitted from 4/19/21 to 4/24/21 and discharged to a skill nursing facility for further care.
Administered first dose of COVID19 vaccine at 1:29pm on 1/4/21. At approximately 11:00pm resident exhibited acute respiratory decompensation with very limited air entry and hypoxemia. Patient received Benadryl, steroids, epinephrine, and Duoneb without improvement. Resident was referred to the emergency room and found to be COVID positive. No fever or rash were reported.
Pt recvd 2 Hep vax 3rd vax recvd on 13JUN91 & pt was a non-responder; & recvd a 4th & 5th  doses given 31JUL91 & 17SEP91 & pt was a non-responder p/doses 4 & 5;
Dermatomyositis rash flare up/ facial skin inflamed, bright red, and swollen; rash on her face; Dermatomyositis rash flare up/ facial skin inflamed, bright red, and swollen; rash on her face; headache; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL9265, expiration date: May2021) via unspecified route of administration in the left arm on 16Feb2021 14:00 at single dose for COVID-19 immunization. Medical history included dermatomyositis since 1993 and sinus problems (sinus disorder). Concomitant medications included immunoglobulin human normal (GAMUNEX) and methotrexate 2.5 mg tablets, both for dermatomyositis; and diphenhydramine hydrochloride (BENADRYL 50 mg) IV as premedication. It was reported that every 2 weeks, a nurse comes to her home and gives her a Gamunex 85gram infusion. She clarified she use 4-Gamunex 20gram vials, and 1 Gamunex 5gram vial to make up her Gamunex 85gram infusion. Product information: Gamunex 5gram Vial (uses 1 vial) (NDC Number: 13533-800-20, Lot Number: B36JE00393, Expiration Date: 20Jul2023) and Gamunex 20gram Vial (uses 4 vials) (NDC Number: 13533-800-24, Lot Number: B8GLE00933, Expiration Date: Aug2023). Reported she takes Methotrexate 2.5mg tablets three times a week. She stated she gets pre-medicated every 2 weeks with IV Benadryl prior to her Gamunex 85gram infusion. She provided the IV Benadryl 50mg product vial information as: (NDC Number: 0641-0376-21, Lot Number: 080010, Expiration Date: Aug2022). The patient previously took budesonide 3 mg capsule (taper dose) from 18Nov2020 to 13Feb2021 for microscopic colitis. On 16Feb2021, on the first day after vaccination, patient had a mild headache. The patient woke up on Saturday morning, 20Feb2021, with her facial skin inflamed, bright red, and swollen. She had a rash on her face as she could feel the unevenness of her facial skin when she placed her hand on her face. Patient reported that she called her neurologist to inform her of the adverse reaction, and her neurologist told her to report the reaction to manufacturer. She said what she experienced on Saturday (20Feb2021) was a Dermatomyositis rash flare up, which for her is very rare. She said she normally doesn't have any skin involvement when she has a Dermatomyositis flare. As a treatment, she said she took generic diphenhydramine 25 mg on 20Feb2021 (lot number: Lot Number: P112026, Expiration Date: Sep2020); and took 2 more since then (She said she takes 1 Diphenhydramine 25mg at a time); and her facial redness is down, but she still has a rash, and her face is a little bit swollen. Her facial skin was still elevated a little bit. Her facial swelling has improved quite a bit from Saturday (20Feb2021), stated she does not have any swelling around her eyes now. She said her facial skin is not as red as it was on Saturday. Outcome of the event headache was recovered on unspecified date in Feb2021; while dermatomyositis rash flare up was recovering.
Patient felt faint & "tingly" with some mild anxiety post-administration. No true syncope. BP 114/68 sitting, 112/64; no orthostatic hypotension. Remained in an upright position. c/o suborbital ocular twitch x 20 seconds which was observed by this writer. Visual onset of mild swelling L upper cheekbone. Treated with cold pack to area, Benadryl 25mg IM PRN to RD, decrease in environmental stimuli, reassurance, and direct observation x 15 mins. Interventions effective; no further swelling, no s/sx anaphylaxis, anxiety & other symptoms relieved. Client observed with steady gait "I'm better"
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 61-year-old male patient received BNT162b2 (BNT162B2), on 30Mar2021 at 14:15 as dose 1, single (Lot number: ER8737), in left arm, on 20Apr2021 at 14:45 as dose 2, single (Lot number: EW0162), in left arm, on 19Oct2021 at 15:30 as dose 3 (booster), single (Lot number: FF8841), in left arm and on 27May2022 at 11:15 as dose 4 (booster), single (Lot number: FX9893) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: TRIAMTERENE AND HYDROCHLOROTHIAZID; AMLODIPINE BESYLATE; LISINOPRIL. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Covid-19 treatment as Paxlovid was started on 09Aug2022 till 13Aug2022.