chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain in arm; Tiredness; This is a Spontaneous report from a contactable consumer (patient).  A 49-year-old female patient received  bnt162b2 (PFIZER BIONTECH COVID19 VACCINE, Lot#:Ew0187), via an unspecified route of administration in arm left on 04Jun2021 12:30 at age of 49-year-old as dose 1, single for COVID-19 immunisation. The patient had no known allergies. Prior to vaccination, the patient was diagnosed as COVID-19. The patient was not preganant at time of the vaccination. Other vaccine in four weeks and other medications in two weeks were none. On 05Jun2021, the patient experienced pain in arm,tiredness and swallowed though. The events did not resulted in emergency room visit or physician office visit. Therapeutic measures were not taken as a result of adverse events. Since the vaccination, the patient had not been tested for COVID-19. In 2021, the outcome of adverse events pain in arm,tiredness and swallowed though was resolved.   No follow-up attempts are needed. No further information is expected.
pt c/o extreme fatigue & h/a;usually works out & is currently unable to lift the usual;muscles seem to tire out very quickly;
pt irritable 1st-2nd day; on 3rd day cried from 6-10PM; constantly;
Information has been received from a nurse practitioner concerning 2 patients at the practice who were vaccinated with a dose of GARDASIL on unspecified dates. Subsequently, they experienced extended loss of consciousness after getting GARDASIL vaccine. This is one of several reports received from the same source. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.  This is in follow-up to report (s) previously submitted on 2/13/2009. Follow up information received from the nurse practitioner stated that one of the female patients was vaccinated with another vaccine at the same time of the GARDASIL vaccine. The patient was not hospitalized and the events were not considered as disabling or life threatening. The patient recovered on an unspecified date. This is one of several reports received from the same sources. Additional information had been requested.
delayed cutaneous hypersensitivity reaction Narrative: Onset 7 days post vaccination. and duration was 4 days. Around injection site the skin was red, warm, and itchy and the area was round with a diameter of approximately 3 inches. Area responded well to ice and topical hydrocortisone.
I had hives on head 4 days later. Took Benadryl and went away. Hives on right calf (leg) taking Benadryl , hives still present today 3/30/2021
Immediate pain down right arm, significant pain and loss of use of 3rd and 4th digits on right hand, flu like symptoms. Extremely loose bowel movements since injection. I have seen my GP several times and had a neurological exam.
No other AE information given at this time; HCP calling to report patient was given PNEUMOV AX 23 that was recalled; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions or allergies were not provided.  On 19-OCT-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) which was recalled at a dose of 0.5 milliliter as prophylaxis (concentration, number of administered dose, route and anatomical location of administration; lot # S036495, expiration date reported 13-SEP-2021) (recalled product administered). No adverse events were reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); devicelotnumber: S036495; expirationdate: 13-SEP-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Pneumonia vaccine administered afternoon of 10/12/04. Patient awoke at 3am 10/13/04 "gasping for air" and noticed small rash 3in. below inj site. Woke in A.M. with palm-sized erythema & hardness in same area. Took Zyrtec at that time. Presented to me at ~11A.M. 10/13/04 in no apparent respiratory distress. I told her to go to doctor asap for follow-up. Per pt: Bullseye at shot site 4 hrs later, 8 hrs after shot generalized rash on arm with swelling. Took Benadryl PO saw her allergist 10/13/04 who advised no additional medication-use ice to site of Pneumovax. Some progression of swelling rash thru 10/14. Better on 10/16/04, continues with brusing on arm, pain almost gone
I developed hives on my skin. I went to allergist he said it was mild and it would be okay to get second dose. By the fifth day the hives have gotten bigger and itchy. Today I?m on my 12 day and I still have the hives. They are all over but they are slowly improving. I have pumps on my arms, stomach, back, neck, and thighs . I thought by now they would al have disappeared. I?ve been taking cizalla for the days. Some days my skin is really itchy I but calamine lotion for relief.
Unusually Pain radiating in mid section on one side of body. Was sent to a center by provider on Jun 1 and XRAY, EKG, and blood work results were negative. Was Contacted on Sat PM by center with instructions to go to ER. ER performed Blood work, EKG, and CT. Tests proved negative.  Patient was released and sent home- pain medication administered. Two-three days later, patient returned to Primary and while in primary care were sent to ER due severe pain. Contrast CT, Ultrasound, Kept for 4 days- given pain medication. Primary physician indicated illness was result of vaccine.
Miscarriage 11/13/09 Medical records received for date 10/16/09. Annual GYN exam WNL pt. desire pregnancy G1P1. 12/3/09 Medical records received for date 11/6/09.  DX: miscarriage. Pt called OB offices to state pt is 7 weeks pregnant and began bleeding x1 day ago. Bleeding now increased. Pt. states received H1N1 vax x1 day ago, sx. began shortly after vax.
Patient felt light headed, clammy, thought he was going to pass out, loss of color and blacked out for a few seconds. Called 911 to ensure patient was ok.  EMS arrived and cleared patient because he refused to be transported to the hospital.
had no energy; could barely crawl up the stairs; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (had no energy) and GAIT INABILITY (could barely crawl up the stairs) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (had no energy) and GAIT INABILITY (could barely crawl up the stairs). At the time of the report, ASTHENIA (had no energy) and GAIT INABILITY (could barely crawl up the stairs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
The patient is a 6 month old, dependent who was referred to the agency, Immunization Healthcare Brand (IHB) by Dr for vaccine causality assessment of a rash following receipt of her 4 month vaccinations. According to the infant's mother the patient received her 2 month old vaccinations (PEDIARIX, PEDVAXHIB, PREVNAR 13 and ROTARIX) on 10/9/14 without adverse event. The infant received her 4 month vaccinations (PEDIARIX-left thigh, PEDVAXHIB -right thigh, PREVNAR 13-right thigh, and ROTARIX) on 12/17/14 at 1100. On 12/18/14 at 0400 the infant was noted to have a fever (103.0). The mother called the Nurse Advice Line (NAL) and treated the infant with a dose of TYLENOL. Later that evening (at 1800) the mother noted that the infant had "little red bumps/blotches" at each vaccination site and that the site was red and "felt warm". Over the next 12-96 hours the rash began to spread upward to the groin and downward toward the knee bilaterally. The mother took the infant to a ER on 12/20/14 and was told that the child was having an allergic reaction-no treatment was prescribed. Over the next week the rash slowly resolved. The infant was slightly fussy but continued to eat normally-without vomiting or diarrhea, sleep without difficulty, wet the normal amount of diapers and was consolable. On 2/25/15 the mother brought the patient to Clinic for her 6 month old check-up: her vaccinations were deferred due to "urticaria following 4 month vaccines".
Redness and swelling at injection site arthralgia multiple sites including left 3rd finger - PIP joint.
fever over 101 for 5 consecutive days; This is a spontaneous report from a contactable Other Health Care Professional (Patient). An adult male patient (Age: 50, Unit: Unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot Number: el9263), dose 2 via an unspecified route of administration, administered in Arm Left on 30Jan2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number=ek9231), dose 1 via intramuscular administration in Left arm on 09Jan2021 at 08:00 AM for COVID-19 immunisation. The patient did not receive other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced fever over 101 for 5 consecutive days on 01Mar2021 at 09:00. The AE resulted in Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures on post vaccination which included body temperature: over 101 on 01Mar2021, sars-cov-2 test: negative on 02Mar2021, sars-cov-2 test: negative on 04Mar2021. Therapeutic measures were taken as a result of the event included fever reducer. The outcome of event was recovering.
Information has been received from a physician concerning an adult pt who was vaccinated with hep A virus vaccine inactivated. The physician reported that the pt was previously vaccinated with hep A virus vaccine inactivated (Havrix) for their first hep A dose and then received hep A virus vaccine inactivated for their second dose. Subsequently the pt experienced injection site pain. The physician reported that the pt sought unspecified medical attention. Additional information is expected.
Fever; Chills; Aches in joints; Aches in kidney; Aches in bladder area; Headaches; Nausea; Diarrhea; Burning in nail beds of big toes; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 21May2021 at 09:30 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. The patients' medical history was reported as none, the patient reported that she was healthy and was not on medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of the vaccination. The patient previously took FLAGYL and and codeine and experienced a drug allergy. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 21May2021 at 10:15, with in an hour, the patient experienced fever, chills, aches in joints and kidneys and bladder area, headaches, nausea, diarrhea and burning in nail beds of big toes. "All side effects lasted 4 days except the toes." Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events fever, chills, aches in joints and kidneys and bladder area, headaches, nausea, diarrhea was resolved on 25May2021. The clinical outcome of the event burning in nail beds of big toes was resolved on an unknown date in 2021.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Skin rash, involving a large pink annular scaly patch followed by smaller spots scattered over the trunk Got COVID-19  within 4 weeks of the vaccination.  The rash started about 10 weeks after the vaccination. Rx triamcinolone 0.1% cream
Patient was  nauseous (dry heaves), feverish , shaky, and right arm was super sore. Patient still felt lousy the next morning , but by 2:30pm on 8/25/2019 patient was feeling better and symptons were resolving.
Guillain Barre syndrome; Syncopal episode; Acute inflammatory demyelinating polyneuropathy (AIDP); GASTROPARESIS; Insomnia; Poor short-term memory; Spinal stenosis in cervical region; polyneuropathy; Numbness; weakness; Chest pain; Lower extremity pain/bilateral leg pain; Malignant tumor of breast; Lightheadedness; Muscle weakness; Fatigue; This case was reported by a lawyer and described the occurrence of demyelinating polyneuropathy in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, an unknown time after receiving Shingrix, the patient experienced demyelinating polyneuropathy (serious criteria GSK medically significant) and guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the demyelinating polyneuropathy and guillain barre syndrome were unknown.   It was unknown if the reporter considered the demyelinating polyneuropathy and guillain barre syndrome to be related to Shingrix.  The initial information received on 10 December 2020, via medical records. As per records, she was alcohol user for 2 to 4 times a month. As per records, she had history of orthostatic hypotension, gastroparesis, retention of urine, unspecified. As per records, he had concurrent 28 April 2019, of spinal stenosis in cervical region, Microscopic colitis, Essential hypertension, dyslipidemia and hypothyroidism. As per records, the female patient received shingles vaccine in 2012. As per records, on 12 September 2019, she had Shingrix (PF) 0.5 ml intramuscular suspension. On 25 November 2019, she had Cobalamin deficiency, muscle weakness, lightheadedness, fatigue, acute inflammatory demyelinating polyneuropathy, In October 2019, she was hospitalized. On 06 January 2020, she was hospitalized for Guillen Barre and chronic diarrhea. On 07 January 2019, breast cancer screening. As per records dated 30 April 2020, she had malignant neoplasm of nipple and areola, left female breast. She also had dyslipidemia, acute inflammatory demyelinating polyneuropathy, cobalamin deficiency. As per records dated 13 February 2020, she had adult hypothyroidism, bilateral renal artery stenosis, Chest pain, chronic pain of lower extremity, dyspnea on exertion, lipedemia, lower extremity pain, syncope, Guilliain-barre syndrome onset date 21 November 2019. As per records, she had gotten the shingles vaccination in September 2019, and developed symptoms of bilateral leg pain and then had a syncopal episode. She was then admitted to the hospital. As per records dated 21 September 2020, she had Guillain-Barre syndrome a year ago. She was hospitalized and in rehab for an extensive amount of time. It thought that might have occurred after her shingles vaccine.
pt recv vax 26JUN95 & 29APR96 devel a rash w/approx 20 lesions on trunk, head & extremity;30APR96 pt devel fever, which resolved by 01MAY96;dx w/varicella;
This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (very itchy), LYMPHADENOPATHY (swelling in her armpit) and VACCINATION SITE ERYTHEMA (arm very red) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. Concurrent medical conditions included Diabetes and Blood pressure. Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) and CLONAZEPAM for an unknown indication. On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (very itchy), LYMPHADENOPATHY (swelling in her armpit) and VACCINATION SITE ERYTHEMA (arm very red). At the time of the report, PRURITUS (very itchy), LYMPHADENOPATHY (swelling in her armpit) and VACCINATION SITE ERYTHEMA (arm very red) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitantly patient was taking steroids, blood pressure medications and diabetes medications. No treatment related information has been reported.
11/08/2022 I received my Covid-19 vaccine. I was fine most of the day with flu like symptoms the days after. The fatigue from the flu went away however I still felt an underlying feeling of fatigue that is gradually getting worse. On 12/15/2022 I started to notice hair loss. After reaching out to my doctor there was no diagnosis.
pt recv vax 3AUG95 & 9MAY97 pt devel a fever;10MAY97 pt devel less than 50 lesions which lasted 1 wk;pt recovered;
Patient informed me prior to receiving vaccine that he gets nervous about shots and does not want to see the needle. After I administered the vaccine the patient was fine he started to feel nauseous and had to use the bathroom. Upon returning patient was given some watered and allowed to breath without his mask on. After sitting the 15 minute observation period patient was fine. He was just anxious and nervous. His father was with him. Patient was fine upon leaving the pharmacy.
pt recv vax;par observed unusual movement, sort of quivering,lasted about 5 sec;father report resp arrest;did CPR on pt for about 1 min & pt began breathing on his own;was cyanotic per PAR;in er;MD not sure if was sz;
First day after vaccine given, large, but local area of redness and swelling, hot-to-touch and painful to any pressure. No systemic reactions. Second day, minimal swelling, decreased area of very faint redness (2" x 2"), no longer hot-to-touch and less pressure-sensitive. 3rd VARIVAX dose in 6 MOS, because employee did not provide RECs of previous boosters.
This spontaneous report was received from a Registered Nurse referring to a 15 year old patient of unknown gender. On 08-AUG-2017, the 15 year-old patient was inadvertently vaccinated with a dose of PROQUAD, for prophylaxis (strength, route, lot # and expiration date were not reported). Concomitant therapies included sterile diluent. On 08-AUG-2017, 1 day after onset of therapy the patient experienced drug administered to patient of inappropriate age. On an unknown date the patient experienced no adverse event.
Swollen and red at the site of the injection. Erythema and slight induration over lateral deltoid; Marked margins, warm to the touch, no break in the skin. Pain rated as 7/10 when arm is moved. Movement make pain worse.
fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st December 2019, the patient received the 1st dose of Shingrix. On 22nd December 2019, 1 days after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The patient developed a fever the following day.  The fever went up to 102 degree F and only lasted a day. The reporter did not consent to follow up.
About two days following the injection I noticed a red area below the site.  The area was sensitive to touch  and felt like it ws burning.  The size of the site was about 1/2" by 1 1/2" with irregular edges. This red area lasted for about a week. I also had some discomfort around a nerve trunk area.  This lasted only for about an hour.
Dizzy; Little headache; I was little tired; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9267), via an unspecified route, administered in left arm (upper left arm like the shoulder area) on 24Feb2021 (at the age of 58 years) as Dose 2, Single for Covid-19 immunization. There were no medical history and concomitant medications reported. On 27Feb2021, the patient experienced dizzy, little headache, and was little tired. Patient got second vaccine (later clarified as COVID 19 Vaccine) on Wednesday which was the 24Feb2021 and felt great. Everything went great, and patient was little tired. But yesterday she started getting very dizzy and was dizzy today. Reporter stated, she mean she didn't have fever, no chills, her arm really wasn't sore, it's just all that it's dizzy, and like a little headache. So, the patient wasn't really sure if that was normal. She got her card, and she would have to put her glasses on as she could not see very well. Reporter added, "she just took a Motrin and Benadryl today (clarified as treatment)". No investigation assessment was reported. The patient received Motrin and Benadryl as a treatment medication for resulted events. The outcome of dizzy was not recovered and the outcome of other events was unknown.  Follow-up attempts completed. No further information expected.
ADACEL C4712AA Exp. 3/22/17. 1 week after injection pt states arm was itchy, red, swollen, arm erythematous, Nontender -> 2/16/15 ice and ALEVE as needed.
Patient states that his left eye swelled after the vaccination and lasted a few days, and resolved on it's own. He went to his primary care doctor for a regular check-up and she did not advise him anything at that time because it had already resolved, she informed him to continue his regular medications as prescribed. I called the patient to remind him of his second vaccination and that's when he informed me about the eye swelling. Will not give second dose until advised and safe to do so.
Case number PHEH2012US024700 is an initial spontaneous report received from a consumer who was also a nurse on 13 Dec 2012. This report refers to a 53-years-old female patient. She experienced tinnitus with cephalosporins, penicillin and streptomycin. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly on 17 Nov 2008. On the same day, she had a huge lump on her arm. It was reported that she was disabled for a month after the vaccine and was diagnosed with mitochondrial myopathy in 2010. The outcome of the event was not reported. No further information was provided.
Patient was vaccinated on 10-29-09 with LAIV H1N1 intranasal. On 10/31/09 he began having a rash on his arms, from shoulders to elbows. On 11/2/09, the rash progressed to the face (cheeks, around eyes). Recommended he see a health care provider.