chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SORENESS AT INJECTION SITE; GENERAL DISCOMFORT; CHILLS; SEVERE BODY ACHES; FATIGUE; HEADACHE; FEVER; SORENESS; This spontaneous report received from a patient concerned a 33 year old male. The patient's weight was 180 pounds, and height was 182 centimeters. The patient's past medical history included mild rash. The patient experienced drug allergy when treated with ampicillin for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 08-APR-2021 12:38 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-APR-2021 19:30, the subject experienced soreness. On 08-APR-2021 19:30, the subject experienced fever. On 08-APR-2021 22:30, the subject experienced severe body aches. On 08-APR-2021 22:30, the subject experienced chills. On 08-APR-2021 22:30, the subject experienced fatigue. On 08-APR-2021 22:30, the subject experienced headache. On 09-APR-2021, the subject experienced general discomfort. On 11-APR-2021, the subject experienced soreness at injection site. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 09-APR-2021 20:00, had not recovered from severe body aches, and the outcome of soreness at injection site, fever, chills, fatigue, general discomfort and soreness was not reported. This report was non-serious.
Information has been received from registered nurse (R.N.), for GARDASIL, a Pregnancy Registry Product, concerning a 24 year old female patient with no reported allergies who on 07-AUG-2007 was vaccinated IM with the first 0.5ml dose of GARDASIL and second dose on 05-APR-2010. There was no concomitant medication. In March 2009, the patient underwent a laparoscopic surgery. At the end of March 2010, the patient experienced miscarriage and was hospitalized for a specific length of time (location unknown). The patient sought unspecified medical attention and was recovering. The patient required hospitalization and the reporter considered the event was serious. Follow-up information was received on 31-AUG-2010 from the nurse who reported that the patient on 10-AUG-2007 received the first dose of GARDASIL (IM, 0.5 mL), Lot number 657737/0522U. There were no concomitant vaccinations administered at that time. On 06-APR-2010, the patient had a Pregnancy Test prior to the administration of the second dose of GARDASIL. The Pregnancy Test was negative. On 06-APR-2010, the patient received the second dose of GARDASIL (IM, 0.5 mL), lot number 663559/1178Y. There were no concomitant vaccinations administered at that time. The patient reported that on 28-APR-2010, she had another Pregnancy Test and the result was positive. At the end of May 2010, the patient had a miscarriage. She was 8 to 10 weeks pregnant at the time of the miscarriage. On 26-AUG-2010, the patient returned to the Health Department Clinic and received the third dose of GARDASIL  (IM, 0.5 mL), lot number 666121/0597Z. There were no concomitant vaccinations administered at that time. The patient stated that she had not seen her family physician after she had the miscarriage. The patient reported that she was having regular periods and was doing fine. The patient was restarted on Birth Control pills. The patient's next Health Department appointment was scheduled for 07-APR-2011. Upon internal review, laparoscopic surgery was considered to be an other important medical event. Additional information has been requested.
Consistent numbing discomfort that develops into pain daily.  Affected area is from the elbow to the shoulder.  Feels as if there is inflammation in the center area of the arm.  Responds to ibuprofen or rest/sleep bur reoccurs in the same cycle daily.
Wave of what felt like was an adrenaline rush and then chest tightness. When getting up to stand felt as if I was going to fall down.  Nurse there took HR & BP. HR was about 110. BP was normal range. Self resolved within 15 min.
Tightness in her left arm, left upper chest, neck, left leg, and face onset immediately after receiving the COVID vaccine. She also felt "flushed" in her face and was told that she had a rash to her neck. At the time, she also had a slight headache which has since resolved and she felt lightheaded.    Patient was administered: diphenhydramine 25mg iv, famotidine 20mg iv, methylprednisolone 125mg iv
Hellucinogenic visions of monsters and violent events; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), via an unspecified route of administration on 05Jan2021 at 14:30 on Right arm at single dose for COVID-19 immunization in hospital. The patient medical history included Hypertension, Hypothyroid. Prior to vaccination, patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine sodium (LEVOXYL); Olmesartan; aluminium hydroxide gel, dried, magnesium carbonate (PEPCID); bifidobacterium bifidum, bifidobacterium lactis, bifidobacterium longum, lactobacillus acidophilus, lactobacillus rhamnosus (PROBIOTIC); ascorbic acid, biotin, folic acid, iodine, pantothenic acid, pyridoxine hydrochloride, retinol, vitamin b12 nos, vitamin d nos, vitamin e nos, zinc (CENTRUM MULTIGUMMIES). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took and had known allergies with bacitracin zinc;neomycin sulfate;polymyxin b sulfate (NEOSPORIN) and bacitracin zinc;neomycin sulfate;polymyxin b sulfate (POLYSPORIN). The patient experienced hellucinogenic visions of monsters and violent events on 06Jan2021 at 02:00 AM. Since the vaccination, patient had not been tested for COVID-19. No treatment was received for the event. The outcome of the event was recovering. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.
Erythematous, warm 5.5 cm x 6.5 cm oval at vaccine site that is tender. Subjective fever.
Rash & UrticariaPruritus Narrative:  Employee was self-treating with Benadryl and Zyrtec and has since followed up with primary care provider.
Information has been received from a registered nurse concerning a 11 year old female with no pertinent medical history and no drug reactions/allergies who on 21-AUG-2009 was vaccinated with a 0.5 ml dose of GARDASIL (Lot # 660612/0229X) IM. Concomitant therapies were not reported. The registered nurse reported that the patient had not yet started her menses, and on 21-AUG-2009, the patient experienced vaginal bleeding. The patient sought medical attention, phone call. At the time of the reporting, the patient had not recovered. Additional information has been requested.
Vaccines given 4/27/10 PM.  Approx 28 hours (evening 4/28/10) later mom noticed purplish red discoloration with a lot of swelling to site and warmth.  Pt complained of pain and itching at site.  4/29/10 14:00 swelling remains yet decreased by 1/2 the size remains warm to touch and pink in color.  Dr. recommended cold and warm compresses and MOTRIN per mom.  4/30/10 spoke with mom swelling continues to decrease.  Much better.
extremely itchy; Had a very sore left arm for about 3 days; the site was very red, hot, & swollen; the site was very red, hot, & swollen; the site was very red, hot, & swollen; This is a spontaneous report from a contactable consumer (patient). A 44-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Lot Number: AA16607), dose 2 via an unspecified route of administration, administered in left arm on 04Oct2021 15:00 (at the age of 44-year-old) as dose 2, single for COVID-19 immunization. The patient previously received the first dose of bnt162b2 (COMIRNATY, Lot number: FF2587) administered in left arm on 11Sep2021 13:30 (at the age of 44-year-old) as dose 1, single for COVID-19 immunization and had a very sore left arm for about 3 days. Medical history included penicillin allergy, fibromyalgia, high blood pressure, GERD, depression, anxiety, painful periods. Concomitant medications included gabapentin, duloxetine, zolpidem tartrate (AMBIEN), topiramate, and bupropion hydrochloride (WELLBUTRIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 05Oct2021 18:00, the patient experienced extremely itchy, had a very sore left arm for about 3 days, and the site was very red, hot, & swollen. Course of events: The patient had a very sore left arm for about 3 days after dose 1 & 2. After dose 2, about 3 hours after the injection, the site was very red, hot, & swollen. It was bigger than the size of a half dollar. It became extremely itchy, she tried hydrocortisone cream but that didn't help. It continued to stay like that the rest of the night. At bedtime, she washed the injection site with soap & took one benadryl pill. Woke up in the morning & no more problems except arm still being sore. Therapeutic measure was taken as a result of extremely itchy and the site was very red, hot, & swollen. The patient received no treatment for the event very sore left arm. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from sore left arm on 08Oct2021 and from the remaining events on unspecified date in Oct2021.  Follow-up attempts are completed. No further information is expected.
This case was reported by a consumer and described the occurrence of respiratory syncytial virus in a 4-month-old male subject who was vaccinated with Diphtheria tetanus acellular pertussis (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included asthma and milk allergy. On 1 March 2010 at 15:15 and 5 May 2010 at 11:30 the subject received 2nd dose and 3rd dose of Diphtheria tetanus acellular pertussis (unknown, unknown thigh) respectively. On 5 March 2010, 4 days after 2nd dose vaccination with Diphtheria tetanus acellular pertussis, the subject experienced funny cough, wheezing, crackle, tight breathing, and fever of 102. The subject was taken to the physician's office where he was diagnosed with possible respiratory syncytial virus or possible pneumonia. The subject was prescribed an Antibiotic, PULMICORT and Albuterol. The fever resolved on 05 March 2010; wheezing, crackles, tightness in breathing, cough, possible respiratory syncytial virus or possible pneumonia resolved on an unspecified date in April 2010. On 10 May 2010, 5 days after 3rd dose vaccination with Diphtheria tetanus acellular pertussis, the subject experienced wheezing, crackles, tightness in breathing and cough. The patient was placed on asthma related medications. On 18 June 2010 the subject developed a fever of 100 so he was taken to the physician's office where he was diagnosed and treated for possible bronchitis. The wheezing, crackles, tightness in breathing, cough and possible bronchitis resolved by the end of June 2010. This case was assessed as medically serious by GSK.
Information has been received from a Nurse Practitioner (N.P.) concerning a 23 year old female who on 03-NOV-2009 was vaccinated with the second dose of GARDASIL (lot number was not available). Concomitant therapy included VALTREX and unspecified birth control medicine. On 03-NOV-2009 the patient developed a rash with no itch and her tongue started peeling a few hours after receiving her second dose of vaccine. The patient sought medical attention by visiting the nurse practitioner. The patient had recovered after stopping therapy. Additional information has been requested.
pt recvd Hep B vax in 1987 &  22JAN92 revealed neg titer for anti-HBs & anti-HBC on 18MAR92 pt recvd 3 more dose of vax & exp difficulty lifting forearms, muscular aching, quivering spasms in arm muscles, local reaction in both arms;
Swelling, redness, and increased pain to injection site. Then started to have increased itching to bilateral arms and face Seen at medical facility and prescribed medrol dose pack.
Pt reports diaphoresis associated with leg "heaviness" and arm "heaviness". Denies SOB, hives or urticaria. Vitals: BP 145/83 P92 R16 T 36.5 P.O. 100%. Given BENADRYL 50 mg PO at 0100. Recheck at 0115 with no change in symptoms. Recheck at 0200 continues to deny SOB, hives or urticaria.
Information has been received from a physician concerning a 25 year old female who on 03-APR-2008 was vaccinated with the first dose of GARDASIL well tolerated. On 03-JUN-2008, the patient was vaccinated with the second dose of GARDASIL well tolerate. On 09-SEP-2008 the patient was vaccinated with the third dose of GARDASIL. Approximately 6 to 8 hours after the third dose the patient developed chills, aches and felt warm but never really took her temperature. The patient was advised how to self-medicate for the chills and aches and there had been no other adverse events reported. Additional information has been requested.
first dose of Shingrix on 3/30/2019 / experienced a slight rash on her back; every time / gets a rash / gets nervous; This case was reported by a consumer via call center representative and described the occurrence of rash in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included lymph node excision, breast operation (knot removed in 1999 and 1989) and rash. Previously administered products included Zostavax (received on an  unknown date). Concurrent medical conditions included herpes virus infection and breast cancer. Concomitant products included valaciclovir (Valacyclovir).   On 30th March 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced rash and nervous. On an unknown date, the outcome of the rash was recovered/resolved and the outcome of the nervous was unknown.   It was unknown if the reporter considered the rash and nervous to be related to Shingrix.  Additional details were provided as follow: The case was reported by the patient. The patient experienced slight rash, few days after receiving 1st dose. The rash was resolved after months. The patient stated that, every time she got a rash, she gor nervous because she had history of rashes. The patient waited for a year to get 2nd dose, for tolerance refer case US2021AMR080144.  The reporter consented to follow up; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR080144:same reporter
Sore arm after. Soreness has continued for over 2 weeks. It is sore to the touch and also to lift arm up. She has tried to massage arm and also warm compress.
Experienced rash that expanded down the upper arm, then started to recede on 12/12.
arm swelled from shoulder to wrist-red, hot;ice & ibuprofen given took approx 5 days for swelling to decrease;
Patient states that 4-5 days after receiving his zoster and flu shots, he is experiencing leg tendon aching and pain in extremities. Reported 9 days after shot.  He had also received a zoster vaccine of the same brand and manufacturer previously in March of the same year.
Jan 9 after getting the vaccine I had shortness of breath, chest tightness. My doctor said it was bronchial spasms. On the 25 of Jan 2021 by blood pressure was 158/107 and sustained at that high currently. Tingling in the hands, arms and feet. Headaches,tightness and pressure in the chest and short of breath, nausea and overall malaise.
1.  10/13/2021:  felt exhausted, later knees & upper legs painful upon walking, rising from sitting. 2.  11/03/2021:  using arms painful upon reaching, dressing, etc.; Tylenol had no effect 3.  I could not go for walks or do normal chores for 2.5 months 4.  Have had Osteo/psoriatic arthritis for many years without these issues; previously maintained a 3200sq.ft. home, gardened on 2 acres, marketed our CT home for sale and downsized to a 750sq.ft. apartment 5.  11/16/2021: Rheumatologist prescribed methotrexate (6x2.5mg once/week) without effect; pain improved around Christmas 6.  Incidentally, noticed one adverse report had a lot number only different by next to last digit,  a "B" instead of my "8" - typo.
Site: Pain at Injection Site-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypertension-Severe
Palm size redness that's hot, lightly tender to the touch, swollen,  and larger in size on the 2nd day.  Marked the outside of the redness to see if there is change.  Heat pack and Aleve.
New and worsened muscle and joint pain. Treatment with Naprosyn sodium.  It is not improving
Approximately 30 patients received a 0.25ml booster dose of the bivalent Moderna Covid-19 vaccine instead of the 0.5ml booster dose/that all patients are over the age of 65; No Adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Approximately 30 patients received a 0.25ml booster dose of the bivalent Moderna Covid-19 vaccine instead of the 0.5ml booster dose/that all patients are over the age of 65) and NO ADVERSE EVENT (No Adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (Approximately 30 patients received a 0.25ml booster dose of the bivalent Moderna Covid-19 vaccine instead of the 0.5ml booster dose/that all patients are over the age of 65) and NO ADVERSE EVENT (No Adverse event). At the time of the report, UNDERDOSE (Approximately 30 patients received a 0.25ml booster dose of the bivalent Moderna Covid-19 vaccine instead of the 0.5ml booster dose/that all patients are over the age of 65) was resolving and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Approximately 30 patients received a 0.25ml booster dose of the bivalent Moderna Covid-19 vaccine instead of the 0.5ml booster dose/that all patients are over the age of 65).    No information about previous COVID-19 vaccination doses. Approximately 30 patients received a 0.25ml booster dose of the bivalent Moderna Covid-19 vaccine instead of the 0.5ml booster dose. All patients are over the age of 65. Concomitant medication not reported.  Treatment medication not reported.
vomiting, passed out, extended (3-days) pain, headache, lethargic and bedridden   Could not continue clinic visit.
Right arm swelling from shoulder to wrist, warm to touch, very swollen after receiving PNEUMOVAX 23 on 6/3/17 at Pharmacy.
Information has been received from a pharmacist via a company representative referring to a diabetic patient of unknown age and gender. The patient's drug reactions/allergies and concomitant medication were unknown. On an unspecified date when the diabetic patient was 55 years old, the patient received a dose of PNEUMOVAX23 (lot #, expiration date, dose and route were not reported). On an unspecified date in April 2016 (reported as 3 months ago), the patient developed pneumonia. The outcome of the event was unknown. Causality was not provided. Upon internal review, pneumonia was considered to be medically significant. Additional information has been requested.
deathly ill; tested positive for COVID/the Pfizer didn't work; tested positive for COVID; pneumonia; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (patient's ex-wife). A 78-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single, dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient received the first and second Pfizer vaccine and was deathly ill and tested positive for COVID. The reporter wanted him to have Johnson and Johnson booster shot because the Pfizer didn't work. The patient got the covid vaccine and ended up getting covid. The reporter reported he probably won't make it. He had pneumonia. He was on an antibiotic for pneumonia and also on oxygen. If he passes away there will be a real problem. The patient underwent lab tests and procedures which included COVID-19: positive on an unspecified date.  The outcome of the events was unknown.  Information about lot/batch number was requested.
Shingles on my face/eye, treated with valtrex, lasted 1.5 weeks
diagnosed this morning with shingles; pain is mild; dry skin in a circle 6 inches below the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (diagnosed this morning with shingles), DRY SKIN (dry skin in a circle 6 inches below the injection site) and PAIN (pain is mild) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included Ulcerative colitis (had to have a large bowel removal due to that.), COVID-19 in November 2020 and Immune system disorder (NOS) (Immune health issues). Concomitant products included LOPERAMIDE HYDROCHLORIDE (LOMOTIL [LOPERAMIDE HYDROCHLORIDE]), FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) and ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL]) for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced DRY SKIN (dry skin in a circle 6 inches below the injection site). On 17-Feb-2021, the patient experienced HERPES ZOSTER (diagnosed this morning with shingles) and PAIN (pain is mild). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALTREX) at an unspecified dose and frequency and GABAPENTIN at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (diagnosed this morning with shingles) and PAIN (pain is mild) outcome was unknown and DRY SKIN (dry skin in a circle 6 inches below the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications reported also included Nasotine for drug use for unknown indication.
About ten days after the vaccine I started to have intense cramping and I lost a blood clot. My belly was tightening up and I started to feel downward pressure. I also had back pain. I was checked out at the hospital, and they did not find anything wrong.  I was 23 weeks pregnant at the time. I have not had any more cramping. I am also breast feeding my toddler and she was cranky and out of sorts after each dose of the vaccine. She was really irritable and she was running a low grade fever. My daughter is 22 months old.   Pregnancy-second
Skin has raised in a thick, red, itchy ring, about 5 inches in diameter
t105, generalized seizure lasting 10mins; poss erythema multiforme on 4th day;
Patient had FLULAVAL QUADRIVALENT administered and within 24 hours, dermatologic manifestations appeared: round/regular border, red, raised, scaly, and itchy (form of dermatitis).
Patient received pediatric formulation of vaccine for ages 5-11 when patient was 12 years old. No adverse events reported after receiving pediatric formulation.