chrisvoncsefalvay/vaers-outcomes huggingface dataset:
redness; swelling; COVID arm; rash on my upper left arm; Nausea; headache; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness), SWELLING (swelling), VACCINATION SITE REACTION (COVID arm), VACCINATION SITE RASH (rash on my upper left arm) and NAUSEA (Nausea) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced NAUSEA (Nausea) and HEADACHE (headache). On an unknown date, the patient experienced ERYTHEMA (redness), SWELLING (swelling), VACCINATION SITE REACTION (COVID arm) and VACCINATION SITE RASH (rash on my upper left arm). At the time of the report, ERYTHEMA (redness), SWELLING (swelling), VACCINATION SITE REACTION (COVID arm), NAUSEA (Nausea) and HEADACHE (headache) outcome was unknown and VACCINATION SITE RASH (rash on my upper left arm) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported  Patient took antihistamines and used a cortisone cream as treatment.
lightheadedness, confusion feeling out of body. Numbness in my fingers, my feet, my lips and tongue. It comes and goes mostly when I eat food, then I feel numbness. It is a very scary.
Flu-like symptoms.  Severe fever, chills, body aches, nausea.
Red, sore, knot, warm to touch, pain with pressure, itchy, some pain with elevation of arm; treated with heating pad x30 min 3x/day and Aleve OTC & red spot on chest near armpit that lasted 4 days. Currently still recovering multiple knotty areas still present.
HEADACHE; This spontaneous case report was received from a consumer (PVX2019-665) on 15-Mar-2019. It described a 68-year-old elderly female consumer who had headache following the intake of Vivotif for travel.  The consumer occasionally has headache from caffeine.   It was reported that the consumer took the first dose of Vivotif on 20-Feb-2019 and the last dose on 26-Feb-2019. On 21-Feb-2019, she experienced headache which persists for the whole day in an irregular manner. She had a headache on the left side of her head and it was worse in evenings and nights when she had to sleep. She stated that the pain would move around the top, side, back and bottom of the neck. She further stated that it had not completely gone away, but she was getting better.  The consumer's treatment medications included ibuprofen, Tylenol (paracetamol), and Aspirin (acetylsalicylic acid) which she was taking alternatively for headache.  The action taken with Vivotif with respect to the event headache was dosage maintained.  The clinical outcome of the event headache was resolving.  Company's Comment: In this case, it was reported that a 68-year-old elderly female consumer who had headache following the intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, headache is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that a 68-year-old elderly female consumer who had headache following the intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, headache is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible.
After my 2nd dose I had a bad headache the day after. Now I have noticed that I get similar headaches more often, maybe once every 4-6 weeks that are severe enough that I need to take ibprophin and at times am sensitive to light. My period has also been irregular as it used to come on the dot every 28 days and now it varies more. It's hard to discern whether this is related to the vaccine or whether it is related to the parathyroidectomy I had in Dec 2019, or related to stress because I work in a hospital during the pandemic.
Injection site pain; This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had minor achiness in the injected arm, after 1st dose of Shingrix. The achiness in the injected arm went away quickly, with no othe issues. For tolerance to the 2nd dose of Shingrix refer case US2019AMR069899, reported by the same reporter.
Pt complains of fatigue, which evolved to right knee joint pain (pt suffers from arthritis/back pain already), dizziness, drooling, and face drooping. Everything has resolved per patient except right knee pain. He was advised by his dr to discontinue diclofenac, which he began the same day as receiving the vaccine. Dr did not seem concerned it was vaccine related; patient believes it is.
Patient began having swelling pain, bruising, and redness to right arm 3 days after TDAP given.  Bruising occurred July 6.  No fever.  Went to MD prescribed SEPTIA for 10 days.
Information has been received from a nurse and refers to multiple unspecified patients of unknown ages and genders. There was no information about patients' concurrent conditions, medical history or concomitant medications. On multiple unknown dates, the patients were vaccinated with doses of improperly stored VARIVAX lot # N012618 and expiration date of 21-APR-2019, (route of administration and anatomical location were not reported) for prophylaxis, reconstituted with properly stored sterile diluent (lot # unknown). The vaccine was stored in an unspecified temperature range and time frame. Previous temperature excursion was reported as unspecified. No adverse effects were reported. Digital data logger was involved. This is one of several reports from the same source. Sender's Comments: US-009507513-1709USA007318.
VACCINE WAS KEPT IN THE  FREEZER AFTER DELIVERY AND  THAWED OVERNIGHT AND KEPT IN  THE FRIDGE TILL VACCINATION; POOR QUALITY DRUG ADMINISTERED; This spontaneous report received from a pharmacist concerned a 63 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821288, expiry: UNKNOWN) dose was not reported, administered on 30-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-MAY-2021, the subject experienced the vaccine was kept in the freezer after delivery and thawed overnight and kept in the fridge till vaccination. On 30-MAY-2021, the subject experienced poor quality drug administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the the vaccine was kept in the freezer after delivery and thawed overnight and kept in the fridge till vaccination and poor quality drug administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210605028, 20210605010, 20210605120, 20210604703 and 20210605009.
Vaccine taken on 5/6/99, 5/8/99, 5/10/99, 5/12/99. Patient had abdominal pains on 5/7/99 and 5/8/99, mild and fleeting. on 5/14/99, woke with severe bloating and abdominal pain about 45 minutes. Resolved after 2 tabs.
Pt went to ER with complaints of chest pain on 2/16/14 - shot given on 2/14/14.
Shot administered on 3/4/2021 at 10am.  Woke up with chills and cold sweats at 3:30 am on 3/5/21.  Spend 3/5/21 on couch or in bed, fever spiked at 100.5 around noon.  Symptoms disappeared around 4pm.  Fatigued day 3 on 3/6/21.  All better by Day 4 - 3/7/21
Initial report received from nurse on 16 Dec 2009: The patient, a 3-year old girl, received one dose of FLUVIRIN (batch no. 1008142P) on 14 Dec 2009. No adverse effect was reported.
About 1992, have been experiencing some type of itching that comes and goes.  Sometimes lasting weeks.
SMALL HIVE AT AREA OF INJECTION ALONG WITH BRUISE AT INJECTION SITE NEXT DAY
PT EXPERIENCED INCREASE IN HEART RATE, DIZZINESS, NAUSEA, CHEST PRESSURE.  BP 148/104 HR 107 SO2 100% RESOLVED WITHIN 10 MINUTES.  GIVEN BREAKFAST BAR AND ICEWATER
Days 1 & 2 (as expected): Soreness, headache, fatigue. Days 10 to current: At injection site, itchiness, swelling, hard knot, hot, redness.
Headache, Myalgia, Arthralgia, Fever, chills, tired Narrative:
Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperatures and administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had administered dose of GARDASIL on 15-JUL-2013 (lot # H010915, Expiration Date: 13-FEB-2015). This is one of the report from the same source, linked reports. Additional information is not expected.
Student received flu vaccination at 9:07 am. At approximately 9:17 am, she fell off of the bench, eyes rolled back, face and mouth pale, non-responsive, shallow breathing and incontinent urine. Staff called student's parent, medical director and 911. At 9:20 am, student became responsive, sitting up, alert and oriented, still pale. At 9:24 am, color improved, RR stable. At 9:30 am, student transported by  Rescue EMT.
Vaccine was administered on the upper left arm. Onset symptoms following the injection included inability to raise left arm without pain in shoulder join and have continued for over 30 days (today is December 1st) and pain continues. My shoulder is not properly functioning as it did prior to injection.
Already had a small rash on my face when I got the vaccine, within 2 days I started having itchy body rashes on my face, jaw and arms. Haven't seen Dermatologist yet, but believe it's Eczema.
Admitted to Medical Center with syncopal event that occurred at home. Cause of syncope unclear at discharge
Out of know where on 1-13-21 awoke at 3:00 AM with severe anxiety which has continued to date, 1-31-21 but not as severe.  Unable to sleep, no matter what medication given.   At beginning had high blood pressure which is unusual for me and heart palpitations.  Had two trips to the ER , 1-13-21  9:00 PM, released  and  1-15-21 10:00  PM and admitted, kept for one day.   Heart palpitations decreased within the first week and blood pressure came down to normal.    Unable to sleep, after being given Hydroxyzine Hydrochloride-25mg and later Alprazolam-.5 mg.   Tried taking herbs before taking Alprazolam due to the addiction factor.  Took Kava , Deep Sleep and CBD.  Took Alprazolam after herbs didn't seem to help but it made me feel bad and didn't help with the sleep so went to over the counter sleep aid.
pt received vaccine. waited at pharmacy for 15 min. then went shopping. she returned to pharmacy with complaint of shortness of breath about 25 min after receiving vaccine. i sat her down and as i was talking to her about how she was feeling and  she began to have convulsions. i laid her on ground and made sure she had an airway and pulse . pt was unresponsive for  approx. 5 min. she regained consciousness and ems took over and took her to er
Got "covid arm", arm was itchy, red, and swollen/raised at the injection site. Probably at least 2-3" in size. This subsided after ~24-48hr.
Throat itching; Injection site redness; This is a spontaneous report from a non-contactable pharmacist. A 48-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via intramuscular route of administration in the left arm on 13Apr2021 (at the age of 48-years-old) as a single dose for COVID-19 immunisation.  Medical history and concomitant medications were not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On an unknown date in 2021, the patient experienced throat itching and injection site redness and was resolved by BENADRYL po. Therapeutic measures were taken as a result of the events and included treatment with diphenhydramine hydrochloride (BENADRYL). The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the event throat itching and injection site redness was resolved on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
Information has been received from a physician concerning an approximately 19 week old male patient who on 24-AUG-2010, was vaccinated PO with the second dose of ROTATEQ (Lot# not reported) and then sometime after the vaccination the patient experienced severe diarrhea and was advise to take PEDIALYTE. Then on 31-AUG-2010, the patient went to see the physician since the patient was still having diarrhea. The physician reported that a bacterial report was done on the patient's stool and the test was negative. The physician reported that he believed the patient went to the emergency room after being seen on 31-AUG-2010 but he still had not received the emergency room report. The physician did not know if the patient was admitted. At the time of the report, the patient's outcome was unknown. Follow-up information was received from a physician who reported that the now 6 month old male patient with no pre-existing allergies, no birth defects, no medical conditions, no illness at time of vaccination and no adverse events following prior vaccination on 24-AUG-2010, was vaccinated PO with the second dose of ROTATEQ (Lot# not reported) in the morning. On the same day, the patient was vaccinated IM in the left thigh with the second dose of PENTACEL (Lot# C3656AA) and IM in the right thigh with the second dose of PREVNAR (Lot# E69592) in the morning. It was reported that on 24-AUG-2010 in the afternoon, the patient developed diarrhea after immunization. The patient had a stool analysis performed and there were no Salmonella, no Shigella and there was no Campylobacter. There was no vomiting or fever. "Acting and feeding". The patient was taken to hospital to the emergency room on 02-SEP-2010 and was given intravenous fluids, but no medicines. On 14-SEP-2010, the formula was change to PROSOBEE. On 15-SEP-2010, the diarrhea stopped. No further information is available.
Pt. returned to pharmacy on 9/29/11 with sign of red swollen area about 3 inches in diameter at injection site. Taking ibuprofen and feeling better.
Pt. received immuniz. Fri AM 12/9; approx 48 hours later had prolonged crying/inconsolable, went to ER & dx'd w/ Intussusception. Had surgery, recovered and went home 3-4 days later.
muscle in upper left arm hurting; This is a spontaneous report from a contactable consumer or other non health care professional (patient). An 85-year-old male patient received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EM9810, Expiration Date: 30Jun2021), via an unspecified route of administration in left arm on 04Feb2021 08:30-08:45 (at the age of 85-year-old) as a single dose for COVID-19 immunisation in hospital. The patient's medical history and family medical history was reported as none. The initial assessment was reported as none. History of all previous immunization with the Pfizer vaccine considered as suspect or patient age at first and subsequent immunizations if dates of birth or immunizations were not available was reported as none. Concomitant medications were not reported. Additional vaccines administered on same date of the Pfizer Suspect was reported as none. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient stated that the muscle was hurting but has calmed down on 04Feb2021 17:00-18:00. This has bothered the patient on the vaccination day. Patient wanted to know if he can take a muscle relaxer pill. Patient clarified that it was for the Virus 19 shot. The event did not result in Emergency Room or Physician Office. The patient underwent lab tests and procedures which included blood test, the day before he got the shot when he went to the doctor and came up good. The patient has tried to move it around as much as he can as a treatment for the event. The outcome of event was reported as resolving.  Follow-up attempts are completed. No further information is expected.
5 day post vaccine, I woke up in the AM and my arm was 'asleep.' It was very numb and tingling. I thought I had slept on it wrong. I disregarded then the next day, I had a large (size of softball) red area below the injection site. I also was experiencing serious tingling and numbness in that arm. Called employee health but went to my PCP.
Patient received ROTATEQ and PCV13 when pt began holding his breath for a few seconds and began breathing. Pt then was given HIB when he held breath again and stopped breathing. Pt face turned red and body was stiff when vigorous stimulus was applied and began breathing again. Code Blue was called prior to stimulus and doctors assessed pt when pt was transported to hospital.
7 days after receiving Varicella shot pt broke out with several small poxs on arms back, and torso 75-100 covered rp.
enlarged and painful lymphoma; took both shots in Oct and has been week since; enlarged spleen; pain in legs and head; pain in legs and head; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the parent.  A 19 year-old male patient received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) as dose 2, single and administration date Oct2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ASTHENIA (non-serious), outcome "unknown", described as "took both shots in Oct and has been week since"; the patient had been to doctor 4 times with SPLENOMEGALY (non-serious), outcome "unknown", described as "enlarged spleen", LYMPHOMA (medically significant), outcome "unknown", described as "enlarged and painful lymphoma", HEADACHE (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "pain in legs and head". The events "enlarged and painful lymphoma", "took both shots in oct and has been week since", "enlarged spleen", "pain in legs and head" and "pain in legs and head" were evaluated at the physician office visit. The doctor had no idea how to help him.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Pt complained of abdominal discomfort on 4/17/01 at approx. 15:00. This morning at approx 04:30, child began vomiting and continued to vomit and feel nauseous this morning at 10:00.
Received smallpox vaccination-had rash down her arm. Received vaccine at 10am, rash started about 2pm on 2/19/03, 4 hrs later. Saw doctor at about 2:30pm (rash, hives and itching on chest and back). Pt is fine.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On 27-JUN-2018, the patient inadvertently received an expired dose of ROTATEQ vial, orally, lot # M041768, expiry date 25-JUN-2018, for prophylaxis. No adverse effects were reported.
4 y.o female bib father presents to the clinic  c/o a rash on upper L back x 10 days and L upper arm x 1 days. Father describes the the rashes are tiny, red, crusty vesicles. Thought that they may have been a vaccine reaction. However, a new crop of vesicles appeared on L mid bicep yesterday so he decided to bring her in for further medical evaluation. Pt denies of fever, pain, and itch. Patient received 2nd dose of varicella 12 days ago per pt's chart. Pt is otherwise well. Denies f/c/ns, n/v, cough, extremity swelling, SOB, CP. No other concerns.
This spontaneous report was received from a healthcare worker and refers to a 4 months old patient of unknown gender. The patient's concurrent conditions, past medical history were not reported. On 08-DEC-2015, the patient was vaccinated with an improperly stored ROTATEQ (lot # K014826, expiry date 28-MAY-2016, dose, strength, vaccination site, dose number unspecified). Concomitant medications were not provided. No adverse effects were reported. Product quality complaint (PQC) was not reported. On 26-JAN-2016, a phone call was placed to the physician. The physician was unavailable at the time of call. The phone call was transferred to the Certified Medical Assistant (CMA). The C.M.A. was unable to place specific lot numbers for each of the reported vaccines that experienced a temperature excursion; M-M-R II, ROTATEQ and VAQTA, with the information already supplied for patient identifiers, date of birth and date of vaccination, at this time. The C.M.A. will need to review the records. This is one of the several reports received from the same reporter. Additional information has been requested.
Diagnosed with PMR; other vaccine same date product= Flu; other vaccine same date product= Flu; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 at 12:15 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 73 years for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 14Oct2022 as unk, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed but manufacturer unknown), for COVID-19 Immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 14Oct2022, outcome "unknown" and all described as "other vaccine same date product= Flu"; POLYMYALGIA RHEUMATICA (medically significant) with onset 31Oct2022 at 06:15, outcome "not recovered", described as "Diagnosed with PMR". Therapeutic measures were taken as a result of polymyalgia rheumatica.  Additional information: There were no known allergies.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Dose administered >12 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017f21a) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture). On 07-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter. No treatment was reported by the reporter.