chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report and medical records were received 11 February 2011 from a health care professional. A newborn male infant had received a first dose transplacental administration of MENACTRA, lot number U3088AA and a first dose transplacental administration of VARIVAX (manufacturer Merck, lot number 1411Y) on 17 September 2010 and 139 days later, he experienced respiratory distress and hypovolemia following premature delivery that same day. Maternal drug exposures during pregnancy consisted of Prenatal vitamins and Cromolyn Sodium (start dates 21 September 2010), TYLENOL (for headache and aches/pains), TUMS (for heartburn), Ferrous sulfate 325 mg PO qd (for mild anemia), Insulin and LEVEMIR (for gestational diabetes) and unspecified antibiotics (for UTI, start date 02 December 2010). Maternal medical history consisted of eczema, premenstrual dysphoric disorder, headaches, occasional aches and pains, heartburn, UTI (diagnosed 02 December 2010), mild anemia, gestational diabetes, upper respiratory illness (four days prior to 31 January 2011), preterm labor, hypokalemia, and magnesium toxicity. Additional drug exposures received by the mother during labor and delivery consisted of LISPRO, Promethazine, magnesium sulfate, Sodium Chloride 0.9%, Dextrose 5% lactated Ringers, ampicillin, terbutaline, K+ supplement, Procardia, betamethasone and pitocin. The mother was a non-smoker, non-drinker, who had not used illicit drugs. On 03 February 2011, five hours after rupture of membranes, the patient, a live premature male infant, was delivered vaginally at 30+4 weeks gestation; apgar scores were 8 and 9 at one and five minutes respectively. He weighed 1560 grams, length was 43 cms and he had no congenital anomalies. Upon delivery, he was alert, active, pale pink, with a heart rate >100 with minimal retractions. He received blowby for five minutes and was admitted to NICU for observation and prematurity. Initially, he had good air exchange with saturations 100% on room air, but upon admission, he had respiratory distress evidenced by tight breath sounds with air exchange slightly decreased. Physical examination noted respiratory distress +, minimal retractions + bilateral equal air entry. The patient was also noted to be hypovolemic evidenced by poor perfusion with capillary refill of approximately 5 seconds and VBG with -3 base deficit. He received bCPAP 5cm and support as indicated and a chest x-ray was ordered (results not reported). Physical examination also noted facial and neck bruising with edema on the right side of his neck. GBS was unknown and Ampicillin and Gentamycin were started (for at least 48 hours) for septic workup. Blood culture was ordered (results not reported). UVC placement was performed. He was NPO with stock amino acid solution with urine output and weight to be monitored. Additional medications received consisted of Erythromycin ophthalmic, 1 application to both eyes beginning 03 February 2011. The patient's  outcome was not reported. The mother case has been captured in case number 2010-05327. Documents held by sender: Medical records.
woke to severe heartburn; very tired; weak; aching targeted lower back and knees; aches were getting more severe and over entire body/achy; had headache; aching in shoulders and neck; woke up hot; sweating; aching in shoulder joints/aching targeted lower back and knees; woke to chills; shaking; This is a spontaneous report from a contactable consumer (patient).  A 39-year-old female patient (age at vaccination: 39-year-old) received bnt162b2 (BNT162B2, lot EN 5318), via an unspecified route of administration inf left arm on 19Feb2021 16:45 as dose 2, single for Covid-19 immunisation. Medical history included high blood pressure, drug allergies to Amoxicillin, Lisinopril, Veropamil and Depo Provera, allergy to latex. She had her dose 1 of BNT162B2 (lot EN5318) on 29Jan2021 17:30 via unknown route in left arm. Concomitant medication included hydrochlorothiazide, triamterene (TRIAMTERENE & HCTZ) taken for an unspecified indication, start and stop date were not reported. The patient experienced woke to chills and shaking on 20Feb2021 03:00, aching in shoulder joints/aching knees on Feb2021 03:30, woke up hot and sweating on 20Feb2021 05:00, had aching in shoulders on 20Feb2021 06:30, headache on 20Feb2021 06:30, achy/aches were getting more severe and over entire body on 20Feb2021 07:20, aching targeted lower back on 20Feb2021 19:00. The patient took Ibuprofen. She also reported that on 21Feb2021, she felt very tired too ibuprofen routinely and had to continue taking lots of naps and was also weak (not treatment). On 21Feb2021 12:48 she woke to severe heartburn and took tums and pepto bismol over next 2 hours. The outcome of headache was recovered on 21Feb2021; for heartburn was recovered on unspecified date; for fatigue and weak was unknown; for other events was recovering.  No follow-up attempts are needed. No further information is expected.
Migraine headache, joint aches, dizziness - started at 6 PM on 10/25 and continued into 10/27. Site of injection became swollen, red and itchy. Treatment consisted of antihistamines, anti-inflammatory, ice.
Patient left building and started to walk to car and turned around with c/o "lump in throat.  She c/o tightening in throat and hard to swallow.  She was taken to EMS, 50 mg IM was given and symptoms subsided in about one hour with her going home with husband 90 minutes after start of symptoms.  O2 sat 100% , BP at start was 170/80, hr-100, and at departure was 120/78, HR-80.
Area of redness, edema and warmth approx 8cm x 5cm noted to LUE over deltoid muscle, 2 areas consistent with needle insertion sites visible over L upper arm.
Patient developed chest pain and left arm pain the day following the vaccination. Presented to the emergency center with continued symptoms and labs were performed.
3 hours after vaccine was given she got welts and a red raised rash on her neck, arms, chest, and back. Her face was flushed and she felt like she had heart palpitations.
This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. This pharmacist reported similar events for two patients. This is the second of two reports. A patient of unspecified age, ethnicity and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had local redness and swelling at injection site 2 days post dose of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein). The events took place after the use of the product. The outcome of the events was unknown. No follow up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017428821 same reporter/vaccine/event, different patient.
On 3/14/01, left deltoid 5cm X 5cm redness, itchy but not hard. Treated with Benadryl and ice 3 X 1 day.
Right after receiving the vaccine she feels light headache and sweaty, transported in wheelchair to medic area and in observation for 30 minutes. BP and pulse stable. 9:52am went home on her own.
Approximately 33 hours after immunizations infant was inconsolable for 7 hours (8pm-3AM) Patient did not have fever. Patient did not  receive Tylenol at time of her inconsolability.
irregular area about 2" x 3" of tiny pale prickly papules at the area of injection. No other sx
Information was received from a lawyer regarding a case in litigation regarding an 11 year old female with history of a twisted and necrotic ovary with surgery (January 2011). It was reported that the patient followed her physician's advice and on 30-MAR-2011 was vaccinated with her first dose of GARDASIL, (Lot number 667866/1437Z, expiration 25-FEB-2013). On 08-AUG-2011, the patient was vaccinated with her second dose of GARDASIL, (Lot number 667194/1271Z expiration 11-DEC-2012). On 12-DEC-2011, the patient was vaccinated with her third dose of GARDASIL, (Lot number 670049/1261AA, expiration 11-NOV-2013). It was reported that on 30-MAR-2011, almost immediately after the first injection, the patient began to experience stomach pain, bloating, feeling full, nauseated and bladder infection-like symptoms. After the completion of the three vaccinations, the symptoms worsened, and she began to suffer additional symptoms of insomnia, night sweats, day sweats, and chills. On an unknown date, she developed headaches, fatigue, fever, light sensitivity, blurred vision, personality changes, back pain itchiness, dizziness, chest pains and racing heart, spasms in her limbs, tingling and numbness in the hand and feet, confusion, and other mental abnormalities, all of which were reported to be caused by GARDASIL. The patient was told for over three years by her physician that her symptoms she experienced were post-operative symptoms. The patient's symptoms worsened and medical advice from another physician on 20-NOV-2014, reported that the patient "is vaccine injured". The patient's mother found medical literature regarding a finding of contamination of GARDASIL in nine different countries, and unfortunately, one of the listed GARDASIL contaminated lots was GARDASIL Lot # 1437Z, which is the lot number of the patient's first injection of GARDASIL on 30-MAR-2011. The patient's conditions were reported directly and proximately caused by the GARDASIL and are permanent. The conditions the patient has experienced has continued for over five years and are presumed to be permanent. Stomach pain, bloating/feeling full, nauseated and bladder infection-like symptoms, insomnia, night sweats, day sweats, chills, headaches, fatigue, fever, light sensitivity, blurred vision, personality changes, back pain itchiness, dizziness, chest pain and racing heart, spasms in her limbs, tingling and numbness in the hand and feet, confusion, and other mental abnormalities are considered disabling. Upon internal review, mental abnormalities was determined to be important medical event. Additional information has been requested.
@ 5mins post inj a pale, red rash noted @ inj site;MD prescribed DPH x 24hrs;19OCT95 arm is hard, red, warm to touch, size of palm of mom's hand;some redness below elbow;dx possible cellulitis;tx w/Lorabid, DPH
disrupt your periods, missed my last 2 periods; had a lot a couple weird side affects; certain foods and drinks taste like chemicals or smell like s; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION IRREGULAR (disrupt your periods, missed my last 2 periods), VACCINATION COMPLICATION (had a lot a couple weird side affects) and DYSGEUSIA (certain foods and drinks taste like chemicals or smell like s) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MENSTRUATION IRREGULAR (disrupt your periods, missed my last 2 periods), VACCINATION COMPLICATION (had a lot a couple weird side affects) and DYSGEUSIA (certain foods and drinks taste like chemicals or smell like s). At the time of the report, MENSTRUATION IRREGULAR (disrupt your periods, missed my last 2 periods), VACCINATION COMPLICATION (had a lot a couple weird side affects) and DYSGEUSIA (certain foods and drinks taste like chemicals or smell like s) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported.
patient was tested routinely for surgery, has shortness of breath thought to be cardiac origin, however current chest xray shows worsening of aeration and patchy groundglass opacities on 12/10. patient is afebrile, w t max 99.7 on 12/10.
She also had a sore arm; Headache; body aches; Sore throat; Sore arm - Swollen and red; Sore arm - Swollen and red; Tiredness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Pharmacist). The reporter is the patient.  A 75 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Sep2021 12:00 (Batch/Lot number: unknown) at the age of 75 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "allergies- rag weed seasonal allergies spring and fall." (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, single, Anatomical location:  Right arm), when the patient was 75 years old, for COVID-19 Immunization; Bnt162b2 (Dose: 2, single, Anatomical location:  Right arm), administration date: Mar2021, when the patient was 75 years old, for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 30Sep2021, outcome "recovered" (30Sep2021), described as "Headache"; PAIN (non-serious) with onset 30Sep2021, outcome "recovered" (30Sep2021), described as "body aches"; OROPHARYNGEAL PAIN (non-serious) with onset 30Sep2021, outcome "recovered" (30Sep2021), described as "Sore throat"; PAIN IN EXTREMITY (non-serious) with onset 30Sep2021 23:00, outcome "unknown", described as "She also had a sore arm"; PERIPHERAL SWELLING (non-serious), ERYTHEMA (non-serious) all with onset 2021, outcome "unknown" and all described as "Sore arm - Swollen and red"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "Tiredness".  Additional information: The patient was vaccinated at Pharmacy or Drug store. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not had any additional vaccines administered on same date of the Pfizer suspect. These events did not required the initiation of new medication/other treatment/procedure. Patient wanted to report side effects to the COVID booster she had yesterday 30Sep2021 at 12 o'clock. She has received the two previous COVID shots as well. After the booster about 3 hours later, she developed a headache, body aches, and a sore throat. They are gone today. The side effects probably lasted 11-12 hours. She was okay this morning. She also had a sore arm, but she expected that. Her sore arm probably started at 11pm last night. The second dose she knew was the middle of Mar2021. Somewhere around the 15th. She had the same side effects with the second dose of the COVID vaccine. Those lasted two days though. She doesn't know the date of her first vaccine. She did get the first and second doses in her right arm. No relevant lab test or specific relevant tests for thromboembolic events with thrombocytopenia was reported. These events did not resulted in emergency room/physician office visit. The patient did not received treatment for the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pain, / in the arm (site of injection); swollen / in the arm (site of injection); redness in the arm (site of injection); general discomfort.; This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced injection site pain, injection site swelling, injection site erythema and general discomfort. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site erythema and general discomfort were unknown.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema and general discomfort to be related to Bexsero.  Additional details were reported as follows: The age at vaccination was not reported. Nurse informed that after the vaccination of patient with Bexsero, the patient experienced pain, swollen, redness in the arm (site of injection) and general discomfort. The reporter consented to follow up. This case is 1 of the 13 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR209822:same reporter US-GLAXOSMITHKLINE-US2020AMR210161:same reporter US-GLAXOSMITHKLINE-US2020AMR210162:same reporter US-GLAXOSMITHKLINE-US2020AMR210163:same reporter US-GLAXOSMITHKLINE-US2020AMR210164:same reporter US-GLAXOSMITHKLINE-US2020AMR210165:same reporter US-GLAXOSMITHKLINE-US2020AMR210160:same reporter US-GLAXOSMITHKLINE-US2020AMR210159:same reporter US-GLAXOSMITHKLINE-US2020AMR210166:same reporter US-GLAXOSMITHKLINE-US2020AMR210157:same reporter US-GLAXOSMITHKLINE-US2020AMR210156:same reporter US-GLAXOSMITHKLINE-US2020AMR210158:same reporter
My left arm developed a circular rash slightly below the injection sight. The itching was particularly bothersome the first night (1/21) so I used a cold compress just prior to retiring for the night. The next day I took one diphenhydramine 3 separate times and also used a topical anti-itch cream (diphenhydramine hydrochloride 2%+zinc acetate 0.1%). The reaction has since gradually subsided to where I no longer need either medication. Yesterday (1/24) I only used the topical cream and only once. As of now the redness is very faint.
Patient returned to the pharmacy approximately 30 mins after vaccination stating they felt odd and faint. Pt was observed and given water and snack, pt had elevated BP with reading of 150/90 and HR 90. No signs of injection site reaction. Pt was still talking in the seated position and stating they felt odd and lightheaded. Pt was observed for approximately 15 mins before being walked to car where she chose to wait further with spouse.
Injection site swollen,4? Diameter, red..itchy..mildly painful,warm to the touch..some discomfort down arm to elbow 10 days later and no better
An extreme fever that hit 103 and lasted for about 24 hours after my vaccine. I had full body muscle pains for about 2 days and strange pains in the left side of my body, and left femoral artery felt clogged for several days after vaccine. Even 2 weeks after the vaccine I am breaking into sweats very easily
Since receiving first dose of vaccine,  I have been noticing loss of taste especially at rear part of my tounge. It feels like if my tounge was soar or numb. When I eat something, it tastes like fade. I can smell things normally and various corona tests done after vaccination also resulted negative.
Site of injection became red, hot, swollen,itchy, very sore lasted 5 days.  Also, headaches, which lasted 7 days. Main concern was extremely  elevated blood pressure.   Visited Doctor, who said symptoms would subside, which they have.
Breakthrough case admission after 2 vaccines Pfizer 4/29/21 lot# Ew0165;  Pfizer 5/20/21 lot# Ew0186
Information has been received from a certified medical assistant concerning a 14 year old female pt with no allergies and no pertinent medical history, who on 03jan06 was vaccinated with 10 micrograms of hep B virus vaccine rHBsAg (yeast). There was no concomitant medication. On 03Jan06, reported as today, shortly after the pt received the vaccine, she began to twitch and shake. There were no laboratory studies performed. The adverse events did not improve and the pt's outcome is not recovered. There was no product quality complaint reported. The pt sought unspecified medical attention. Additional information has been requested.
Underage client given first dose of Moderna vaccine which has not been cleared for use in clients under the age of 18 years old. No treatment required at time of vaccination.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's medical history and current conditions were not reported. On 24-MAR-2015, the patient was vaccinated with an improperly stored dose of (Merck) VARIVAX (dose, frequency, route of administration, lot# and expiration date were not reported). No adverse effect was reported. Product quality complain (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Pfizer vaccine administration dates- 01/03/2021 and 01/23/2021, COVID-19 Booster 10/01/2021. COVID-19 positive on 10/18/2021. Medical history per friends included daily alcohol consumption, which had recently been reduced to 3-4 times per week. After receiving the booster vaccine, dec?d became ill with a fever for reported 3-4 days in bed.
Patient was administered his second dose of COVID-19 Pfizer BioNTech for ages 5-11 years (NDC: 59267-1055-04) on 10/07/2022, and the Lot number (FL2757)used expired on 9/30/2022.
Patient came in the day after receiving the vaccination. Her left arm was swollen and red and hot to the touch around the injection site.
Not a clear focus; Headache; No energy; This spontaneous case was reported by a consumer and describes the occurrence of DISTURBANCE IN ATTENTION (Not a clear focus), HEADACHE (Headache) and FATIGUE (No energy) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced DISTURBANCE IN ATTENTION (Not a clear focus), HEADACHE (Headache) and FATIGUE (No energy). At the time of the report, DISTURBANCE IN ATTENTION (Not a clear focus), HEADACHE (Headache) and FATIGUE (No energy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
10-11-19 Quad given left thigh 4:36 Pm 10-13-19 Discoloration/red rash like a bruise at vaccine site and a hard round mass appreciated under the skin at vaccine site.  10-14-19 Purplish blotchy rash on upper left thigh that itched. This purplish rash spread to both legs. Rash was treated with application of ice. 10-15-19 Evaluated by Peds 10x13.5 cm eryth, warm with scattered 1 cm eryth circular macules back of legs, firm mass at injection site.
12 DOSES ADMINISTERED TO 12 PATIENTS THAT DID NOT ADHERE TO STORAGE CONDITIONS OUTLINED IN THE PRODUCT FACT SHEET; DOSES EXPOSED 18 TIMES TO A MIN TEMPERATURE OF 32.2F FOR A CUMULATIVE PERIOD OF 28 HOURS AND 49 MINUTES; This spontaneous report received from a health care professional concerned multiple patients. 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: 1822811 expiry: 20-MAR-2022) dose was not reported, administered on 25-OCT-2021 for prophylactic vaccination. No concomitant medications were reported.  On OCT-2021, the patient experienced doses exposed 18 times to a min temperature of 32.2f for a cumulative period of 28 hours and 49 minutes. On 25-OCT-2021, the patient experienced 12 doses administered to 12 subjects that did not adhere to storage conditions outlined in the product fact sheet. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the doses exposed 18 times to a min temperature of 32.2f for a cumulative period of 28 hours and 49 minutes and 12 doses administered to 12 patients that did not adhere to storage conditions outlined in the product fact sheet was not reported. This report was non-serious.