chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received on 29 July 2010 from a health care professional. This is the third report from this reporter involving the same lot number of DT ADS PED USP and this patient experienced a similar event as the previous cluster of two patients which are captured in cases 2010-03423 and 2010-03424. A 2-year-old male patient, with no known allergies, no medical history, and no adverse events following prior vaccinations, received a third right thigh intramuscular injection of DT ADS PED USP (lot number U2630AA) on 12 July 2010. The following day, on 13 July 2010, the patient had redness noted at the injection site and between thigh was also swollen and warm to touch; he was irritable and "clingy". According to the patient's parent, he may have slight fever. On 14 July 2010, the patient was evaluated by his physician and at that time, his entire right thigh was red, swollen, warm to touch and his lower back was also warm and reddened. Corrective treatment included an unspecified homeopathic remedy. At the time of the report, the reporter had not had any further reports from the patient's parents and assumed that everything resolved. However, the outcome was entered as unknown on the VAERS form. Follow-up information was received on 07 September 2010 from a healthcare professional. The reporter noted that the reddened area on the lower back was 2 and 1/2 inches. Treatment therapy included a homeopathic remedy of LEDUM "200 C" intramuscular injection with a start date of 14 July 2010 and stop date of 15 July 2010. The patient had recovered from the adverse events on an unknown date. Documents held by sender: None.
Fever; chills; stomach upset; tired; This is a spontaneous report from a contactable consumer. An adult female patient (unknown if pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not reported), via an unspecified route of administration on 27Mar2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown whether the patient received any medication within two weeks of vaccination. It was unknown if any other vaccines received within four weeks prior to the COVID-vaccine. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: unknown) via an unspecified route of administration on an unknown date at single dose for COVID-19 immunisation. On 28Mar2021, the patient experienced fever and chills 2 days, stomach upset next 24 hours, tired for additional days. The events did not result 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. It was unknown whether the patient received any treatment for the reported events. The clinical outcome of fever and chills was recovered on 30Mar2021, stomach upset was recovered on 29Mar2021 and tiredness was recovered in 2021. This report was reported as non-serious by reporter.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021 at 11:02 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 29-Apr-2021 at 11:02 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 25.68.  No concomitant medications were reported.  Batch number 007C21A underwent temperature excursion on with temperature 33 degrees Fahrenheit at 10AM. These vials were moved to fridge on 19-Apr-2021, moved to clinic on 29-Apr-2021 and beyond use date was reported as 19-May-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Day 1/2 - Headache, Pain at injection site/slight arm sweeping, tiredness Day 2 - nausea, tiredness, dizziness, shortness of breath, feeling hot/flushed, fainted (led to a 911 call / ED visit)
Tenderness to palpation site 2 wks after administration. Small area of erythema and firmness at injection site. No evidence of infection. "Dizziness" starting 1 week after injection.
Patient reported having swelling, pain, redness, and a red line on inside of upper arm on the left arm. She reported it to the pharmacist on 10/25/17. Said the swelling and pain had decreased since the day before.  Patient said her eye doctor doesn't want her to take antihistamines so she did not. Patient said she took some TYLENOL for the pain. I recommended monitoring and if the swelling and redness do not clear to go to the doctor and they can prescribe something for it.
I have extra soft stool (diarrhea) for 5 days. Taking Kaopectate 3-4 times a day has not seemed to help.
Shortness of Breath after running; Lightheadedness; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA EXERTIONAL (Shortness of Breath after running), DIZZINESS (Lightheadedness) and FATIGUE (Fatigue) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIZZINESS (Lightheadedness). 25-Feb-2021, the patient experienced FATIGUE (Fatigue). On 04-Mar-2021, the patient experienced DYSPNOEA EXERTIONAL (Shortness of Breath after running). At the time of the report, DYSPNOEA EXERTIONAL (Shortness of Breath after running) and DIZZINESS (Lightheadedness) outcome was unknown and FATIGUE (Fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant and treatment information not provided.  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.   This case was linked toMOD-2021-100844 (E2B Linked Report).; 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 MOD-2021-100844:Case for secnd dose
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) 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 (No reported medical history).    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 HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
COMA; GANGRENE ON HANDS AND FEET; YELLOW WELTS AROUND EYES; BODY WAS WILTING OUT; BLEEDING LUNGS; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer who reported that he heard of a friend's cousin, a 6 decade old male (52-54 years old) of unspecified race and ethnicity. 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 not reported, batch number: Unknown, expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date on MAY-2021, after vaccination the patient was diagnosed with Covid-19 (suspected covid-19 infection) and had suspected clinical vaccination failure. He was hospitalized (date unspecified). On an unspecified date on AUG-2021, the patient's lungs were bleeding and had been doing worse. On an unspecified date, the patient was unconscious and in a coma and also had gangrene on hands and feet which needs to be amputated and his body was wilting out. The patient had yellow welts all around eyes. Reporter was not clear on if these afflictions were induced by the vaccine or from being infected with the coronavirus after vaccination. Number of days hospitalized was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and bleeding lungs, and the outcome of coma, gangrene on hands and feet, yellow welts around eyes, suspected clinical vaccination failure, and body was wilting out was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210841428-COVID-19 VACCINE AD26.COV2.S.- Coma, Bleeding lungs, Gangrene on hands and feet, Suspected clinical vaccine failure, Suspected covid-19 infection, Yellow welts around eyes, Body was wilting out. This events is considered unassessable. The events has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
The injection site is painful, itchy and red. The red spot is about 2 inches wide. It is a little warm to the touch. The pain/itchiness started at about 7am on 5/5/21 and has gotten slightly worse.  It is being treated with Cortizone-10 for the itchiness, as needed.
Initial report received on 18 May 2012 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in an 11-month-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance electronic database. The subject had received 3 doses of PENTACEL; lot number C3754AA received on 30 June 2011, lot number C3867AA received on 19 September 2011 and lot number C3892BA received on 18 November 2011 (routes and sites of administration not reported). The subject developed cold-like symptoms on 11 April 2012, approximately 4 months after the last dose. On 18 April 2012, the subject developed a cough and then a paroxysmal cough with whoop started on 22 April 2012. The subject also experienced posttussive vomiting, sleep disturbance and apnea. Laboratory testing included positive PCR on 28 April 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 28 April 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 14 May 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 26 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Family called in on very hectic day wanting to get child with bone marrow transplant revaccinated.  They were on their way home from doctor. Receptionist made appt. Father gave form with very small print and stated said her baby shots needed to be repeated and doctor stated their was a combination but he was not sure what was in it. My mind went to baby. Reviewed manf inserts and realized that Pediarix nor Pentacel should be given due to age.  However I failed to remember Td should be given after age 7.  Tripedia and Prevnar was given in error.
No additional AE reported; Customer called for a temperature excursion and reported PROQUAD that had undergone temperature excursion was administered to patients before calling. No additional AE reported. No PQC reported. No patient demographics was provided. No further i; This spontaneous report was received from a medical assistant referring to a unknown number of patients of unknown age and gender. The patients' medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On an unknown date, the patients were vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) lot number W019628, expiration date 19-DEC-2023 (dose and route of administration) for prophylaxis (product storage error). No adverse event was reported.  No information about the temperature excursion was provided.  Follow up information has been received on 10-MAR-2023.  Varicella virus vaccine live (Oka/Merck) (VARIVAX) (Lot numberW018828 expiration date 14-JUN-2024), and  Lot number W006412 expiration date 23-FEB-2024) (dose and route of administration) for prophylaxis (product storage error), and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) lot number W019627, expiration date 19-DEC-2023)  (product storage error).    This is a non-valid case due to the lack of patient identifiers.  Follow up information has been received from an other healthcare professional on 18-APR-2023. The reporter specified the patient's information. Therefore, this valid case was split from original case 2303USA002114. This spontaneous report was regarding a 4 years old male patient. The patient's pertinent medical history, concomitant therapies and drug allergy or reactions were not reported. On 10-DEC-2022. the vaccine measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) (lot number W019628, expiration date 19-DEC-2023) underwent temperature excursion for 1 hour. The digital data logger was involved in recording excursion details. On 21-DEC-2022, the patient was vaccinated with the improperly stored vaccine measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) (lot number W019628, expiration date 19-DEC-2023, strength and dose were not reported) intramuscularly (IM) at right thigh for prophylaxis at private doctor's office/hospital.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2303USA002114: US-009507513-2304USA007837:
This case was reported by a consumer via call center representative and described the occurrence of injection site reaction in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site reaction, erythema, swelling and pruritus. On an unknown date, the outcome of the injection site reaction, erythema, swelling and pruritus were unknown. It was unknown if the reporter considered the injection site reaction, erythema, swelling and pruritus to be related to SHINGRIX. Additional details were provided as follows: The reporter was the patient's wife. The age at vaccination was not reported. The reporter did not consent to follow up. This case has been linked to the case US2019032527, reported by the same reporter.
Today I have a headache/she has a slight headache; This is a spontaneous report from a contactable consumer (patient). A female of unspecified age received a first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Lot number: EL9265, Expiry Date: Unknown), via an unspecified route of administration on 07Feb2021 as a, single dose for covid-19 immunization. The patient's medical History included seasonal allergies and sinuses form an unspecified date. Patient's concomitant medications were not reported. In Feb2021 on unspecified date. The patient reported that, she got the vaccine yesterday and she has a slight headache. She wants to know if can take Tylenol. she is not sure if the headache is from the vaccine or her sinuses; she has sinus issues from time to time. Patient also reported that, she has seasonal allergies which may be causing the headache. The outcome of the event was not recovered.  Follow-up attempts completed. No further information expected.
Nausea.  Vomiting.  Migraine.  Hot, but had constant cold chills Body aches, head to toe.  Extremely tired.  Super sore on injection site and about 4 inches surrounding.
Injected Arm Red, Turned Hard and Access Swelling. Dizziness, Headache -Lasted 4 Days. Itching.
A non-serious spontaneous report of fever and extreme headache has been received from a mother/consumer concerning a 19-year-old female, subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. On 24-Dec-2009, the patient received H1N1, Intranasal for an unknown indication. On 24-Dec-2009, 12 hours after vaccination the patient experienced fever and severe headache. The outcome of the reported events was unknown.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 25-APR-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion two times. The total cumulative excursion time of the first time was 136 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 40 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Shot on 1/9/21 at 10:10 am. Body aches 1/9/21 from 12:30-2:30pm. Relieved with naproxen 500mg and sleep.
Patient was fussy in the afternoon following vaccination. Seen in office to recheck; mild swelling in thigh that had Pediarix/HIB. Plan to space out next vaccines.
Within 12 hours, fever chills and body ache. After those passed in a day and a half, deep muscle soreness set in left side. Pain was felt in armpit, chest, left breast, left shoulder and neck. Swollen lymph nodes on the left side that lasted two weeks from the date of the second shot.
Fatigue; headache; muscle pain; injection site pain; feeling unwell; swollen lymph nodes; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Oct2021 (Lot number: 32030BD) at the age of 31 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; ESCITALOPRAM. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL0140, Location of vaccine: Arm Left), administration date: 06Jan2021, when the patient was 31 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3302, Location of Vaccine: Arm Left), administration date: 27Jan2021, when the patient was 31 years old, for COVID-19 Immunization. The following information was reported: FATIGUE (non-serious) with onset 22Oct2021, outcome "recovering", described as "Fatigue"; HEADACHE (non-serious) with onset 22Oct2021, outcome "recovering", described as "headache"; MYALGIA (non-serious) with onset 22Oct2021, outcome "recovering", described as "muscle pain"; VACCINATION SITE PAIN (non-serious) with onset 22Oct2021, outcome "recovering", described as "injection site pain"; MALAISE (non-serious) with onset 22Oct2021, outcome "recovering", described as "feeling unwell"; LYMPHADENOPATHY (non-serious) with onset 22Oct2021, outcome "recovering", described as "swollen lymph nodes". Therapeutic measures were not taken as a result of fatigue, headache, myalgia, vaccination site pain, malaise, lymphadenopathy.  Additional Information: The patient had no known allergies. The patient did not received any other vaccines within 4 weeks prior to the covid 19 vaccine. The patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.  No follow-up attempts are possible. No further information is expected.
Pt recvd 3 doses Hep B vax 8NOV88, 8DEC88, 10MAY89 & on 10AUG89, exp fatigue; JAN91 devel h/a & blackouts; APR91, exp muscle spasms & pain in arms, loss of balance, ringing in ears, hearing loss, bladder spasm, loss of memory, diff breathin
Painful Shoulder; Hot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Painful Shoulder) and DRY SKIN (Hot) 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 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced PAIN IN EXTREMITY (Painful Shoulder) and DRY SKIN (Hot). At the time of the report, PAIN IN EXTREMITY (Painful Shoulder) and DRY SKIN (Hot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.   Reporter did not allow further contact
With the intention of screening for tuberculosis, 0.1ml of IPV was injected intradermally into patient's forearm instead of 0.1ml of tubersol. Client notified as soon as error was discovered (within 10 minutes of receiving), as was program manager.