chrisvoncsefalvay/vaers-outcomes huggingface dataset:
has them after she got the shots/suspected vaccination failure; has them; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 19-Oct-2022 Reporter's comment: The case was received from the consumer via interactive digital media. The patient (reporter's sister) had them after she got the shots. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Initial unsolicited report received from consumer via Pfizer on 09 Feb 2017. Manufacturer report number: 2016554702. This case was linked with 2017SA025687 and 2017SA025717 (same reporter). This case involves a male patient who was vaccinated with first dose of MENINGOCOCCAL VACCINE (Vaccine against meningitis) and first dose of PNEUMOCOCCAL VACCINE (batch number, expiry date, dose and site of administration was not reported) on an unspecified date (few month ago). The patient's medical history and concomitant medications were not reported. On an unspecified date, post vaccination, the patient had asthma. On an unspecified date, the patient was hospitalized. Lab data and corrective treatment was not reported. Outcome of the event was not reported. List of documents held by sender: none. Sender's Comments: Poorly document case of child who was vaccinated against meningitis and pneumococcal and had asthma. Additional information regarding time to onset, details regarding the asthma and hospitalization, medical history is needed to further assess the case. Based on available information the role of vaccine cannot be assessed.
Sharp pain in the kidneys; Sharp pain in the gut; Fever; Chills; Arm Pain and legs; This spontaneous case was reported by a consumer and describes the occurrence of RENAL PAIN (Sharp pain in the kidneys), GASTROINTESTINAL PAIN (Sharp pain in the gut), PAIN IN EXTREMITY (Arm Pain and legs), PYREXIA (Fever) and CHILLS (Chills) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025597407089) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm Pain and legs). On 22-Apr-2021, the patient experienced RENAL PAIN (Sharp pain in the kidneys), GASTROINTESTINAL PAIN (Sharp pain in the gut), PYREXIA (Fever) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, RENAL PAIN (Sharp pain in the kidneys), GASTROINTESTINAL PAIN (Sharp pain in the gut), PAIN IN EXTREMITY (Arm Pain and legs), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported that they received their first dose of the Moderna Covid-19 vaccine and had arm pain. On 22-Apr-2021, the patient had fever and chills and felt sharp pain in the kidneys, gut and legs.  The patient second dose was scheduled for 19-May-2021.  No Concomitant product use was reported.  Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. However, no information is available regarding medical history/medications that could be confounders/co-suspects for some of the events.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Non significant Follow-up received email address added.; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. However, no information is available regarding medical history/medications that could be confounders/co-suspects for some of the events.
Pediatric patient was in office for his 12 yr physical, guardian requested for him to get his covid booster vaccine. I drew up the Pfizer 12+ yr old 0.3ml dose and placed on the counter, at the same time another nurse RN was drawing up Pfizer 5-11age group 0.2ml. I accidentally grabbed one of the 5-11 yr old covid vaccines and administered that to my patient 12 yr old. I was informed by RN that I grabbed the wrong covid dose as the one I drew up was still on the counter. I informed my provider that I was working with and called the guardian of my pt. to make aware. No harm or injury noted as this is the same dose he had previously been administered for his initial 2 doses.
BLURRED VISION; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch number. No concomitant medications were reported. On an unspecified date, the subject experienced blurred vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blurred vision was not reported. This report was non-serious.
I95.9 HYPOTENSION 5/4/2021 PANCYTOPENIA DUE TO ANTINEOPLASTIC CHEMOTHERAPY I95.9 HYPOTENSION 5/4/2021 ATHEROSCLEROSIS OF AORTA I95.9 HYPOTENSION 5/4/2021 ATHEROSCLEROSIS OF AORTA I95.9 HYPOTENSION 5/4/2021 ATHEROSCLEROSIS OF AORTA I95.9 HYPOTENSION 5/4/2021 ATHEROSCLEROSIS OF AORTA
fever 100.5F, malaise, myalgia, headache, and rigors x 2 days. responded well to acetaminophen and ibuprofen
FEELING OF SWELLING IN THE HEAD; HEADACHE; LITTLE BIT OF FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020, and batch number: 1805020 expiry: UNKNOWN) .5 ml, administered on 06-MAR-2021 11:30 to Right Deltoid for prophylactic vaccination. No concomitant medications were reported.  On 07-MAR-2021 01:00, the subject experienced feeling of swelling in the head. On 07-MAR-2021 01:00, the subject experienced headache. On 07-MAR-2021 01:00, the subject experienced little bit of fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from little bit of fever on MAR-2021, and had not recovered from headache, and feeling of swelling in the head. This report was non-serious.
This spontaneous report was received from a registered nurse concerning an unknown number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. In approximately 2016 (reported as "may have occurred between 05-AUG-2016 and 20-SEP-2016"), the patients were vaccinated with RECOMBIVAX HB injection, lot # M010671, expiration date 02-JUN-2018, (dosage number, route and anatomical location of administration were unknown), which were improperly stored. The temperature of excursion was 11.3 C and the time frame was 965 hours 19 minutes cumulative since 05-AUG-2016. The temperature excursion was detected by a digital data logger. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
TDAP administered, then MCV - 4 given & second after this injection Pt. stated "I'm dizzy".  Pt be came weak & pale.  Checked blood pressure & was low 60/00 & I couldn't hear it.  911 called & we lowered pt. to floor lying down & ambulance arrived 10-15 min later.  Pt. stayed weak, pale & dizzy & was brought to ER by ambulance.
right after the shot I started breaking out with shingles and very tired  this year have flu shot, shingles shot and pneumonia shot after second shot of moderna shot broke out with shingles
breathing this hot, scratchy air into my throat; no appetite; couldn't lift her arm; Fatigue; chills; Headache; Fever; This spontaneous case was reported by a patient and describes the occurrence of RESPIRATION ABNORMAL (breathing this hot, scratchy air into my throat), DECREASED APPETITE (no appetite), MOBILITY DECREASED (couldn't lift her arm), FATIGUE (Fatigue) and CHILLS (chills) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Panic attack, Airways obstruction, Chills, Fever, Headache, Pain, Appetite absent, Fatigue and Arm spasticity.    On 15-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 RESPIRATION ABNORMAL (breathing this hot, scratchy air into my throat), DECREASED APPETITE (no appetite), MOBILITY DECREASED (couldn't lift her arm), FATIGUE (Fatigue), CHILLS (chills), HEADACHE (Headache) and PYREXIA (Fever). At the time of the report, RESPIRATION ABNORMAL (breathing this hot, scratchy air into my throat), DECREASED APPETITE (no appetite), MOBILITY DECREASED (couldn't lift her arm), FATIGUE (Fatigue), CHILLS (chills), HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatments reported included use of unspecified antihistamines.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
After receiving second dose of vaccine, patient had a seizure within 5 minutes or so. Pharmacist placed patient on the floor on her side. After a minute or so, patient was conscious and was able to state her name and basic information. She did not remember seizing and has no history of seizures.
24 y/o male receives multiple vaccinations including primary SMALLPOX, AVA #1, TYPHOID, and TWINRIX vaccines and developed skin rash approximately 2 days later. Rash has been recurrent and chronic over the years but controlled only with the chronic and daily use of ALLEGRA and ZYRTEC antihistamine therapy.
This was the second Shingrix injection. In progression symptoms/side effects Wednesday night through night until Friday morning (36 plus hours) Fatigue, slight nausea, chills, cold feet then combined with sweating, slight fever ( baseline at doctors office that day 97.7) progressed from 98.7 to top of 99. 4 (11/12-8:00am), mild headache like with the flu, gradually dissipated throughout day as I looked after 5 and 6 year old grandkids but fatigue continued until Friday morning. It should be noted that I had no reaction to the first injection 2 months ago.
Headache; fever; Sweaty; This is a spontaneous report from a contactable consumer (Mother). A 25 years old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number was not reported, Expiry date: Unknown) via an unspecified route of administration on an unspecified date (at the age of 25 years old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 Immunisation on an unspecified date. Consumer states after her second dose her daughter had a headache and she took tylenol. The next morning, she woke up sweaty so caller states she probably had a fever. Mentions her daughter was on vacation. Consumer was not sure if she had a fever since she took Tylenol. She didn't have anything special. Patient received treatment for the events fever and headache. Outcome of the events was unknown. No Follow-up attempts are needed. Information about lot/batch number cannot be Obtained.
Expired Vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021 at 4:09 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitants and treatment drugs were provided.
Blood pressure went from normal reading to 160/95 was placed on blood pressure medicine to lower blood pressure.. 6 month later blood pressure returned to normal discontinued medication.. during this 6 month period experience rapid heart beat and chest pain as well as an out of breath feeling
It appeared patient was having a cardiac event and was rushed by ambulance to the nearest hospital. 11 months later, she is still symptomatic with no definite diagnosis. Her energy level is depleted. She can not attend a full week of school. She does not go out with friends because she knows she can't keep up with them. She fluctuates between constipation and diarrhea. Frequent headaches. Hands tingle, go numb and change colors.
within 15 minutes she said a bit dizzy  I didn't think it was an anaphylactic reaction  I told her to follow up in ER if it got worse
soreness at injection site; sore body; chills/sweats; chills/sweats; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Dec2022 at 12:00 as dose 4 (booster), single (Lot number: GJ6742) at the age of 43 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "covid" (unspecified if ongoing), notes: If covid prior vaccination: Yes. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: CHILLS (non-serious), HYPERHIDROSIS (non-serious) all with onset 13Dec2022 at 21:00, outcome "unknown" and all described as "chills/sweats"; MYALGIA (non-serious) with onset 13Dec2022 at 21:00, outcome "unknown", described as "sore body"; INJECTION SITE PAIN (non-serious) with onset 13Dec2022 at 21:00, outcome "unknown", described as "soreness at injection site". Therapeutic measures were not taken as a result of injection site pain, myalgia, chills, hyperhidrosis.
No additional AE reported; Caller is a HCP calling to report a TE for PNEUMOVAX 23; This spontaneous report has been received from a nurse, referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, previous drug reactions, or allergies were not provided.  On 14-MAR-2022, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot number U021995 has been verified to be a valid lot number, expiration date 13-JAN-2023) (strength, dose, frequency, and vaccination scheme were not provided) (product storage error) administered for prophylaxis.   The pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was stored at a temperature of 0 degree Celsius (C) for a time frame of 24 hours. There was a previous temperature excursion.   No additional adverse events were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA007094: US-009507513-2206USA006587: US-009507513-2206USA006674: US-009507513-2206USA006670: US-009507513-2206USA006770: US-009507513-2206USA006731: US-009507513-2206USA007090: US-009507513-2206USA007068: US-009507513-2206USA006981: US-009507513-2206USA007045: US-009507513-2206USA006852: US-009507513-2206USA007070: US-009507513-2206USA006952: US-009507513-2206USA007059:
This spontaneous report was received from a registered nurse and refers to a 12 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 11-AUG-2017, the patient was vaccinated with an improperly stored VARIVAX at a dose of 0.5 (units not specified) from lot # N000683 with expiry date: 06-JAN-2019 (dose number, route, anatomical location and site of administration were not reported) for prophylaxis. Concomitant medications included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA004945.
Patient states that got nausea, vomiting, fever, sore arm, redness at injection site and muscle cramps in thighs that started about 5 hours after vaccination.  Pateint attempted to go to ER but could not be seen with out a Covid test so patient was able  to speak with her doctor on 11/9/20. After speaking with patient on 11/12/20 she states that most adverse reactions have gone away except for some redness still in her arm
Patient state she note her heart racing a couple hours after receiving the vacine today.   she went to neighbor's house where a nurse lives and got blood pressure and hr rates taken. state these readings :    127/92  hr=152  ,  then 122/103    hr=83,   then 102/90    hr = 83 ,  94/68  hr= 148
Information had been received on 02-MAR-2017 from a medical assistant who reported that a patient (age and gender not reported) received an expired dose of VAQTA (lot# L042039, expiration 14-JAN-2017) 1.0 ml, once, intramuscular on 28-FEB-2017. A physician continued the call and reported that the patient had no adverse effects. Reason for escalation: expired product was not on post expiry memo. No further information was provided. Additional information has been requested.
Information has been received from a registered nurse concerning a 17 year old female patient with overweight and no drug reactions/allergies who was vaccinated with the first dose of GARDASIL (lot#657006/0188U) on 01-NOV-2007, the second dose (lot#658488/0930U) on 27-DEC-2007 and the third dose (lot#661531/1311X) on 19-AUG-2009. Concomitant therapy included CLARITIN. On 20-AUG-2009, a blood work was done and showed a protein s deficiency. The patient has been referred to a hematologist. At the time of the report, the patient did not recover. Follow-up information has been received from the physician concerning the patient who on 19-AUG-2009 received the third dose of GARDASIL (lot#661531/1311X) intramuscularly in the left arm and the first dose of DAPTACEL (Sanofi, lot#C2865AA) intramuscularly in the right arm. There was no illness at time of vaccination. It was reported that pre-existing allergies, birth defects and medical conditions had not yet been diagnosed. The patient was diagnosed with protein s deficiency on 20-AUG-2009 and she had a strong family history of this disease. It was reported that the patient had reported no adverse events since receiving GARDASIL and did not require emergency room/doctor visit. On 20-AUG-2009, a protein S free AG test was performed and the result was 13%, the CBC/routine hematology test showed normal. On 14-SEP-2009, the blood studies showed: PROTIME: 13.2sec, INR 1.0, PTT 25.4sec, protein C 115%, ANTITHROMBIN III 113%, lupus anticoagulant negative; lipoprotein a <5mg/dl; anti-cardiolipin IgG 4GPL/ml, anti-cardiolipin IgM 7MPL/ml; the factor V Leiden mutation (G1691A, Arg506Gln) analysis and prothrombin G20210A mutation analysis showed normal. At the time of the report, the patient's outcome was unknown. Additional information is not expected.
Headache, Fever, chills, HA and temp resolved 12/31 Narrative:
This case was reported by a consumer and described the occurrence of injection site pain in a 63-year-old male patient who received SHINGRIX. Previously administered products included Shingles Vaccine with an associated reaction of no adverse event (some years ago). On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema, injection site discoloration, injection site warmth and bedridden. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site discoloration, injection site warmth and bedridden were unknown. It was unknown if the reporter considered the injection site pain, injection site pain, injection site erythema, injection site discoloration, injection site warmth and bedridden to be related to SHINGRIX. Additional details were provided as follows: The reporter was the patient. The patient received SHINGRIX vaccine on right arm. The patient wanted to report the worst reaction he had ever experienced, after receiving a SHINGRIX vaccine (reported as Shingret vaccine). Neither his physician nor his pharmacist warned him of the possible adverse reaction to the vaccine. The patient was given the SHINGRIX vaccine on a Friday afternoon, and he found himself confined to bed for 3 full days and 2 partial days. The patient reported that, to the touch on the place on his right arm where the vaccine was given, within 1 hour the patient noticed a red or black mark on his arm the size of a softball. It started to elevate his skin and was warm to the touch. No matter how he tried to position himself, it ached constantly. Again, he wanted to state that this injection was the worst he had ever experienced. If he had known that he would have been in pain for the amount of time described, he would not have taken the vaccine. The patient's conclusion was that it was not tested enough and that the FDA and GSK rushed it to market. The patient was requesting the information that he should have been given with large warning labels describing the side effects. And the worst part was that he had to go back and get a second injection of SHINGRIX. The patient wanted to know the research on the reaction to the second injection.
Minor localized reaction(swelling) to Inluenza and pneumococcal in L deltoid diagnosed after physician evaluation