chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pneumonia; Information has been received regarding a case in litigation concerning a female patient (pt) of unknown age. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant medications were not provided.  In or around 29-JAN-2015, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) as routine health maintenance/prevention of shingles (dose, vaccine schedule, route of administration, site of administration, lot number and expiration date were not provided).  On an unspecified date (reported as shortly after zoster vaccine live (ZOSTAVAX) vaccination), the patient suffered and was diagnosed with pneumonia. It was reported that the pt's symptoms resulted in physical limitations, mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt had severe and permanent injuries; further, as a tragic consequence of Company's wrongful conduct, the pt suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Company conduct, the pt had suffered and incurred damages, including medical expenses, the loss of accumulation and other economic and non-economic damages. At the time of the report, the pt had not recovered from pneumonia.  The event pneumonia was considered as related to zoster vaccine live (ZOSTAVAX).  Upon internal review, pneumonia was considered as disabling and medically significant event.
patient received booster dose of Moderna COVID-19 vaccine from a pediatric vial (6Y-11Y) instead of bivalent booster vial; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient received booster dose of Moderna COVID-19 vaccine from a pediatric vial (6Y-11Y) instead of bivalent booster vial) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     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 WRONG PRODUCT ADMINISTERED (patient received booster dose of Moderna COVID-19 vaccine from a pediatric vial (6Y-11Y) instead of bivalent booster vial) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (patient received booster dose of Moderna COVID-19 vaccine from a pediatric vial (6Y-11Y) instead of bivalent booster vial) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (patient received booster dose of Moderna COVID-19 vaccine from a pediatric vial (6Y-11Y) instead of bivalent booster vial).    This case contains information for the sixth patient out of the 6 adult patients as described by reporter.  No concomitant medications were reported.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-660841, US-MODERNATX, INC.-MOD-2022-660860, US-MODERNATX, INC.-MOD-2022-661292, US-MODERNATX, INC.-MOD-2022-661298, US-MODERNATX, INC.-MOD-2022-661299 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 17-Oct-2022: Live follow up contains significant information that included updated IRD of initial version to 17-OCT-2022 as per narrative. On 17-Oct-2022: Live follow up contains non-significant information; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-660841:same reporter US-MODERNATX, INC.-MOD-2022-660860:same reporter US-MODERNATX, INC.-MOD-2022-661292:same reporter US-MODERNATX, INC.-MOD-2022-661298:same reporter US-MODERNATX, INC.-MOD-2022-661299:same reporter
PATIENT REPORTS BLURRED VISION LASTING 1 HOUR APPROX. 2 HOURS AFTER INJECTION. INJECTION SITE SORENESS ON 12/16/20 AND CONTINUES TO PERSIST; NO SIGNS OF CELLULITIS.  GENERALIZED MALAISE STARTED 12/19/20 AT 1000.
swollen, painful, warm area lt deltoid 4 1/2 x 4 1/2cm;DPH given
This was second dose/booster. Both times: for 24+ hours afterwards, muscle aches, fatigue, inappetance. Sore arm at injection site. Second dose: arm was red, swollen, hot, itchy. All side effects worse with second dose. Muscle aches, etc. lasting more like 48 hours.
Swelling, redness, warmth of right upper arm + shoulder began eve 7/8/09. Decreased but persistent am 7/9/09.
Initial report was received from a health care professional on 17 August 2012. A 37-year-old male patient had received a dose one intramuscular injection of ADACEL, Sanofi Pasteur Ltd. (lot number and site not reported) on 28 June 2012. On 07 July 2012, the patient was seen in the emergency room (ER) with a petechial rash. A complete blood count (CBC) was done and the patient's platelet count was 2. On the day of vaccination, the patient's platelet count was normal at 186. The patient was hospitalized from 07 July 2012 to 12 July 2012 and treated with high doses of steroids and intravenous immunoglobulin (IVIG). The patient had a bone marrow analysis post hospitalization which indicated low cellularity. The patient improved but was still being treated. The patient had no illness at the time of vaccination and had a past medical history of high cholesterol. Outcome was reported as recovered. Documents held by sender: None.
Exhaustion, headache, chills, fever, unsettled stomach lasted 1 & 1/2 days
I got the 2nd vaccination for Pfizer-BioNTech Covid-19 Vaccine EUA and after i have a Fever, chill, headache, nauseos and muscle pain where injection is and chest.
Doses administered past the published expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry date) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry date). On 12-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 12-OCT-2021 at 08 am, the vaccine was removed from the freezer.  No concomitant medications were reported.  No treatment information was reported.
Tested positive for COVID-19 after 1st Dose; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19 after 1st Dose) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19 after 1st Dose). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19 after 1st Dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Patient developed rash within 24 hours of receiving Pentacel Vaccine. Provider noted small erythematous papules to her legs, arms and back of her neck. Provider prescribed Cetirizine.
p/vax pt devel neck & back pain; no treatment given; condition of pt  ongoing
This is a serious spontaneous case, initially received from other health professional on 25-Feb-2019, concerning a male neonate patient. The patient's mother was 21-year-old mother with obstetrical history of one previous pregnancy reported with a full-term live birth. The mother's historical condition included bacterical vaginosis (from 09-Jul-2018 to 16-Jul-2018), chlamydial infection (from 15-Jul-2018 to 04-Oct-2018) and anemia (16-Jul-2018 to 10-Sep-2018). The mother's current condition included nausea and constipation (since 05-Jul-2018). The concomitant medications included Metrogel for bacterical vaginosis, ferrous sulfate for anemia, prenatal vitamins (minerals NOS, vitamins NOS) for pregnancy, promethazine for nausea, azithromycin for chlamydia and Colace for constipation. The mother's last menstrual period (LMP) date was 15-March-2018. On 04-Oct-2018, at gestational age of 31-weeks and 5 days, the foetus was exposed to FLUCELVAX QIVc (influenza vaccine, subunit influenza virus vaccine polyvalent, cell-culture-derived, route of administration: transplacental, batch number: 252664, dose, anatomical location and expiry date: not reported) (explicitly coded as foetal exposure during pregnancy) for an unknown indication. On 18-Oct-2018, 08-Nov-2018 and on 16-Nov-2018 mother's ultrasound test was performed, and no major congenital malformation was noted. 1 month and 26 days after vaccination, the mother delivered a male neonate at 37.6 weeks gestation, vaginally. At the time of delivery, no pregnancy complications were reported. The neonate's birth weight was 2066 grams (coded as low birth weight), head circumference was 33 cm and body length was 47 cm. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 9 (at one minute and five minutes) and there was no data for 10 minutes. There was no major congenital malformation noted. The outcome of the events was unknown. The mother's estimated delivery date (EDD) was reported as 06-Dec-2018 and corrected EDD was reported as 17-Dec-2018. This case is linked to (201902219), the corresponding maternal pregnancy report.; Reporter's Comments: A male neonate patient delivered at 37.6 weeks gestation experienced low birth weight, 1 month and 26 days after administration of Flucelvax QIVc to mother (coded to fetal exposure during pregnancy). Despite the plausible temporal relationship, there is no evidence for a biological mechanism that could cause the event and underlying risk factors (bacterial vaginosis, chlamydial infection, nausea and anemia) and co-administered drugs (metrogel, ferrous sulfate, promethazine and azithromycin) to mother are risk factors for the reported event. Therefore, the event of low birth weight was assessed as not related to the suspect vaccine. The event of fetal exposure during pregnancy was assessed as not related considering the intended use of the vaccine during pregnancy.The company assessed the event 'low birth weight' as serious (medically significant).
I woke in the middle of the night, around 4am Feb. 5, with chills, a splitting headache, nausea, stomach pain, and body aches. It lasted the night, and then I took ibuprofen 200mg in the morning and throughout the day it got better, but around 3pm, it started to come back, so I took another 200mg ibuprofen. I also didn?t eat anything for fear I would throw it up. Later that evening, it got worse and I became extremely fatigued. I was able to eat some soup and crackers. I took another ibuprofen and couldn?t go to sleep until 4am. The next morning I felt better, with only residual side effects. My left arm was also extremely sore and tender from the time of administration until Feb. 6.
high pitched screaming for several hours 2 days p/vax;difficult to console;no fever;
Patient received vaccinations on 5/7/08.  Mom states that patient was crying and was inconsolable for 3-4 hours after administration.
This spontaneous report as received from a nurse practitioner refers to a 7 weeks old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 14-JAN-2015, the patient was vaccinated with the dose of PEDVAXHIB lot # K008874 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion. No information on patient's concomitant medication was provided. This is one of several reports from the same reporter. Additional information has been requested.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 51-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Oct-2021 at 11:05 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 14-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 14-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.
Red, swollen area. Approx. quarter size on Left lat. thigh at sight of injection.
Client rec'd immunization on Tuesday morning, 04-29-08 and felt fine until later that evening when she developed a "severe" headache, temp 101.5, left arm soreness beyond the normal--hard to lift her left arm, small amount of redness at left arm injection site and she is sleeping more than normal.  Mom is "pushing fluids" and giving Advil as directed.  Symptoms are alleviated with the Advil, but return as Advil wears off.  Symptoms were worse today than yesterday, but, again, are alleviated with Advil.  Client is able to keep appointments today and was talking on the phone to me without difficulty.
Pt was unresponsive, weak, limp, eyes dilated, jerky, jittery, trembling, fever, vomiting, earache, crying, sleepless, diarrhea, dehydrated, allergic reaction, hives,rash, and absent response, no eye contact.
experiencing symptoms of COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of   in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment was reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
(April 17) An abscess started on my buttocks. (April 21) Urgent Care lanced & cleaned the area, started on antibiotics. (April 22) Urgent Care lanced & cleaned the wound, added a second antibiotic and pain medicine. (April 24) Urgent Care sent me to the Emergency Room where I was admitted.  They gave me IV antibiotics and pain medicines.  (April 26) A surgeon deep cleaned the abscess.  (April 27) I was discharged from the hospital with antibiotics and pain medicines. I have home health aides every other day to clean the abscess.
very puffy and swollen face around eyes. Left eye mostly affected. Red and dry skin  around eyes.  Very irritated and painful. Healing, but still evident today.
her back ached; she started feeling achy all over and had a lot of pain; She can barely lift her right arm when the shot was administered in the left arm.; Her hips and joints all over her body are aching./having really bad joint pain; it was bad she could hardly walk she was having a difficult time walking on her walker; This is a spontaneous report from a non-contactable consumer or other non hcp. A 92-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch Number/Lot Number: Not reported), via an unspecified route of administration, administered in Arm Left on 04Feb2021 as dose 1, single for COVID-19 immunisation. Medical history included hip surgery from an unknown start and stop dates. The patient's concomitant medications were not reported. The patient experienced she started feeling achy all over and had a lot of pain, she can barely lift her right arm when the shot was administered in the left arm, her hips and joints all over her body are aching/having really bad joint pain on 09Feb2021, her back ached on an unspecified date and it was bad she could hardly walk she was having a difficult time walking on her walker on Feb2021. Patient had really bad joint pain. Patient got the shot in her left arm but it was her right arm she was having the joint pain in. Patient couldnt lift up it was so sore in the joint she could not use but one way and otherwise she couldn't use it at all. Her shoulder was really bad and she kind of ached all over in her joints and her back ached. The outcome of the events were reported as unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Erythemic hands (bilateral); enlarged veins; numbness, tingling, and swelling in hands and feet; pain in finger joints; fatigue; severe intractable headache since January with double vision and dizziness.
patient received only the liquid CWY component of Menveo; patient received only the liquid CWY component of Menveo; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA957A, expiry date 30-SEP-2024) for prophylaxis.   On 29-AUG-2023, the patient received Menveo. On 29-AUG-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: patient received only the liquid CWY component of Menveo) and inappropriate dose of vaccine administered (Verbatim: patient received only the liquid CWY component of Menveo).  The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 30-AUG-2023 Nurse reported that a patient received only the liquid CWY component of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow-up via email. This case was 1 of 3 cases, reported by same reporter.; Sender's Comments:  US-GSK-US2023118668:same reporter US-GSK-US2023118682:Same reporter US-GSK-US2023118684:Same reporter
Developed an itchy rash on right side of my abdomen that circled around to the back.  I thought it was poison ivy at first but the pain was unusual so I went to the doctor and was diagnosed with Shingles.
c/o dizziness, hives after 3 days of receiving influenza vaccine. The patient cont. to c/o of hives sporadically appearing/disappearing on arms, torso, neck and behind knees. c/o pruritis. The size of Hives range from size of a pencil eraser to golf ball size.
Severe lymphadenopathy bilateral axillary; Bilateral arms swelling; Chest swelling; This is a spontaneous report from a contactable nurse. A 56-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the left arm  on 04Jan2021 at 16:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19.The patient did not receive any medication within two weeks prior to the COVID-19 vaccine. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. On 16Jan2021 at 7:00, the patient experienced severe lymphadenopathy bilateral axillary, bilateral arms swelling and chest swelling. The events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events severe lymphadenopathy bilateral axillary, bilateral arms swelling and chest swelling was resolving at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a Certified Medical Assistant (C.M.A.) regarding an unspecified number of patients of unknown ages and genders. The patients medical history or concurrent conditions were not provided. On an unspecified dates, the patients have been administered with a dose of RECOMBIVAX HB (dose, route, frequency, lot numbers and expiration dates were not provided), which have been exposed to temperatures outside of the recommended range. No adverse effect has been reported. This is one of several reports from the same source (MARRS #1507USA014064, 1507USA014065, 1507USA014066, 1507USA014067 and 1507USA013244). Additional information has been requested.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive; (May2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 05May2022 to 10May2022. Clinical course: No other medications were received in two weeks. It was reported that there was full return of symptoms and positive rapid antigen testing after testing negative day after completion of treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
No adverse effect, will monitor. The patient was given  Quadracel  5 months earlier, she is 3 years old and 7 months.
Mother noticed hives appearing on right thigh the morning after vaccinations.  The hives spread to groin, trunk, and face.  She brought her daughter to the pediatrician that morning.
That evening had aches, headache. Woke up next AM w/face puffy - urticaria. Terrible itching on face and lesions everywhere. Friday (2 days post-shot) increased facial swelling and neck also w/urticaria.
first two shots were fine. no unusual side effects. shots were administered at a grocery store pharamcy. After Booster shot severe headache, nausea. Continued Tinnitus for almost 2 weeks at this point with no sign of it getting better.
C/o redness & itchy with some bumps under skin near insertion site. 1-17-2011 given KEFLEX 500 mg TID x 7. Pt stopped after 3 doses reaction to med. 1-24-11 - feeling better.
Major local RX- severe pain with induration of 35mm. erythema 15 mm with streaking and adenopathy, No NODES palpable 0 temp. nausea
Red hot painful hard area at injection site. Right leg weakness, myalgias, malaise, chills.