chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the patient began to deteriorate (unspecified) shortly after, and the deterioration was eventually diagnosed as Lupus; Initial information was received on 07-May-2021 regarding an unsolicited valid serious case received from a consumer (patient's mother).  This case involves a 15 year-old male patient who began to deteriorate (unspecified) and the deterioration was eventually diagnosed as lupus (systemic lupus erythematosus), after receiving MENINGOCOCCAL VACCINE.  The patient's medical history, past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.   On an unknown date in 2011, the patient received [once] dose of suspect MENINGOCOCCAL VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient began to deteriorate (unspecified) which was eventually diagnosed as lupus (systemic lupus erythematosus) (unknown latency-reported as shortly after) following the administration of MENINGOCOCCAL VACCINE. This event was assessed as medically significant.  Caller stated that patient had life time AE [adverse event] from vaccination. It was a vaccine injury program and she was not aware of the program and she missed the benefits due to statute of limitations. Caller wanted to know if Sanofi offered in compensation. She stated it was a federal program. She asked for information regarding program Sanofi may have for injury. Caller seeking compensation after her son was diagnosed with Lupus after getting a MCV4 vaccine. The caller has been instructed to send a letter but the caller needs to verify the manufacturer of the vaccine in question due to all she had MCV4 vaccine. During the call the caller verbalized that she cannot use legal action due not having time.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At time of reporting, patient had not recovered from the event.  It was reported that the providers did not believe the MCV4 vaccine was the cause of the Lupus; that about 10-years later she found out that vaccines had a link to causing Lupus. That this year she went to a conference that said a vaccine could be a cause Lupus and she did not know the manufacturer of the MCV4 vaccine.  There will be no information available on the batch number for this case.; Sender's Comments: This case involves a 15 year-old male patient who experienced systemic lupus erythematosus after vaccination with MENINGOCOCCAL VACCINE (unknown manufacturer). The time to onset was unknown. Further information regarding medical history, concurrent condition during vaccination, previous vaccination and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Syncope, Nausea, Vomiting, diaphoretic Blood Pressure - 90/62 @ 11:30 am Blood Pressure - 104/66 @ 11:50am Blood Pressure - 93/63 @ 12:30 pm
vertigo, fingers became edematous, hyperventilated, fainted then seen in ER; t101;
She woke up when had some rash on her legs and the doctor told her it's psoriasis; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), in Apr2021 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: PSORIASIS (non-serious) with onset 2021, outcome "unknown", described as "She woke up when had some rash on her legs and the doctor told her it's psoriasis".  Additional information: it was reported that the caller mentioned she had a booster shot last April of the Pfizer Covid-19 vaccine. She woke up when had some rash on her legs and the doctor told her it was psoriasis.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201210271 same reporter/patient/AE; different dose number;
This is a spontaneous report from a contactable pharmacist. An 80-year-old female patient started to receive PREVNAR 13 (NDC: 00005197102), intramuscular on 10Oct2017 at single dose for pneumonia.  The medical history and concomitant medications were not reported. On 10Oct2017, the patient received the pneumococcal 13-valent conjugate vaccine for pneumonia. In Oct2017, the patient experienced redness/her arm was redder than he had seen and in a larger area and swelling. The events were further described as: the redness was almost to her elbow and covered most of her arm. It was also swollen, but it was mostly the redness. Therapeutic measures were taken in response to the events, redness/her arm was redder than he had seen and in a larger area and swelling. She called her doctor's office and they said to treat it with diphenhydramine (BENADRYL) and ice. The clinical outcome of the events, redness/her arm was redder than he had seen and in a larger area, swelling, and drug use for unapproved indication, was unknown.
Temperature of 104.1F, lethargic, tachypnea and tachycardia per mother.  A follow up report received 8/27/2002 adds: Child seen in both ER and Dr's office - Tylenol for fever control. No more pertussis.
13 days following vaccination (Moderna booster) onset of chronic hives and dermatographia (skin writing). Ongoing as of this date.
11 yo female child presented to clinic with mother. Child received Tdap, meningococcal, and HPV9 vaccine. MOP reported child was starting to feel bad later on that day. (+) nausea, headache, chills, feverish, stomach pain. MOP reported local reaction  on her left arm (+) erythema, inflammation progressing to size of hand, hot to touch. MOP treated with anti inflammatory last night with no relief.
Numbness and tingling in the middle, ring, and small fingers of the right hand.  First seen Saturday morning after vaccine administered.  No pain reported.  Has not changed.  Reported to the pharmacy 10/14/20 (Wednesday)
Malaise. General feelings of depression. Feelings lasted about two days and dissipated of their own accord.
the injection site is red and developed a bruise; her sister feels, chills, "weak feelin,"; the injection site is red and developed a bruise; her sister feels, chills, "weak feelin,"; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (the injection site is red and developed a bruise), ASTHENIA (her sister feels, chills, "weak feelin,"), VACCINATION SITE ERYTHEMA (the injection site is red and developed a bruise) and CHILLS (her sister feels, chills, "weak feelin,") in a 74-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (When first COVID came out (before received any covid vaccines)).    On 25-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE BRUISING (the injection site is red and developed a bruise), ASTHENIA (her sister feels, chills, "weak feelin,"), VACCINATION SITE ERYTHEMA (the injection site is red and developed a bruise) and CHILLS (her sister feels, chills, "weak feelin,"). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE BRUISING (the injection site is red and developed a bruise), ASTHENIA (her sister feels, chills, "weak feelin,"), VACCINATION SITE ERYTHEMA (the injection site is red and developed a bruise) and CHILLS (her sister feels, chills, "weak feelin,") outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Reporter had no reactions with any of the Moderna doses, but reporter's sister (patient) always had a problem whether the patient received Moderna doses and the patient experienced a reaction with it. It has been reported that bruising was bigger than a half dollar for patient and which started from the injection site and went to the elbow and bruising was red and hot. Further bruising went a bit past the elbow, but was not as red. The patient felt like she had covid again.
This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of INFECTION (infection), VACCINATION SITE WARMTH (warm at injection site), RASH (rash), VACCINATION SITE PRURITUS (itching, itching, itching at injection site) and VACCINATION SITE SWELLING (swollen at injection site) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included GABAPENTIN, ROSUVASTATIN, METOPROLOL, VENLAFAXINE, LOSARTAN, DICLOFENAC SODIUM and RANOLAZINE for an unknown indication.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced INFECTION (infection), VACCINATION SITE WARMTH (warm at injection site), RASH (rash), VACCINATION SITE PRURITUS (itching, itching, itching at injection site), VACCINATION SITE SWELLING (swollen at injection site) and VACCINATION SITE ERYTHEMA (red at injection site). On 07-Mar-2021, RASH (rash) outcome was unknown. At the time of the report, INFECTION (infection), VACCINATION SITE WARMTH (warm at injection site), VACCINATION SITE PRURITUS (itching, itching, itching at injection site), VACCINATION SITE SWELLING (swollen at injection site) and VACCINATION SITE ERYTHEMA (red at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment given for infection at the site of injection was antibiotics which the patient ahs not started taking yet.
Expired vaccine was given to the patient; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine was given to the patient) and NO ADVERSE EVENT (no adverse event) in an adult female patient who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine was given to the patient) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine was given to the patient) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine was given to the patient).    No concomitant medications was reported.  It was reported that the 6 doses monovalent vaccines vial size of 5ml was initially stored in refrigerator on 16-Feb-2023 and was administered to patients on 24-Feb-2023, 28-Feb-2023, 01-Mar-2023 and 06-Mar-2023. The vial did not undergone any temperature excursions.  No treatment medications was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-715780, US-MODERNATX, INC.-MOD-2023-715730, US-MODERNATX, INC.-MOD-2023-715792, US-MODERNATX, INC.-MOD-2023-715804, US-MODERNATX, INC.-MOD-2023-715806 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-715730: US-MODERNATX, INC.-MOD-2023-715780: US-MODERNATX, INC.-MOD-2023-715792: US-MODERNATX, INC.-MOD-2023-715804: US-MODERNATX, INC.-MOD-2023-715806:
Patient received the COVID vaccine booster on 5/12/22 and presented to the ED on 5/16/22 with back pain (likely unrelated to vaccine).
Can't remember anything; Crippling anxiety; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for Covid-19 immunization. The following information was reported: AMNESIA (non-serious), outcome "recovered", described as "can't remember anything"; ANXIETY (non-serious), outcome "recovered", described as "crippling anxiety".  Additional information: Patient has been a hairstylist for years and had exactly liked that feeling. Patient messed the 3 hair colours that she had never done in most 20 years of colouring hair and she couldn't remembered anything. She got crippling anxiety, she said she got her second shot and then on day 4 after her second shot all the symptoms gone away then she got better.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
doses administered after excursion; No adverse event; received vaccine from vaccine that underwent a temperature excursion in the Freezer; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (received vaccine from vaccine that underwent a temperature excursion in the Freezer), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) in a 60-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.  On 19-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 19-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (received vaccine from vaccine that underwent a temperature excursion in the Freezer). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (received vaccine from vaccine that underwent a temperature excursion in the Freezer), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (received vaccine from vaccine that underwent a temperature excursion in the Freezer) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion).    No Concomitant medications were provided.  Patient did not reported any adverse event.  No treatment medications were provided.
horrible pain (whole arm, shoulder, neck); This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Jan-2021 and was forwarded to Moderna on 15-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (horrible pain (whole arm, shoulder, neck)) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Injury (Patient reported a previous injury on her right side.).    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 15-Jan-2021, the patient experienced PAIN IN EXTREMITY (horrible pain (whole arm, shoulder, neck)). At the time of the report, PAIN IN EXTREMITY (horrible pain (whole arm, shoulder, neck)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The Treatment information included muscle relaxer that was prescribed for a previous injury on right side. No relevant concomitant medications were provided.; 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.
was hospitalized for Guillain Barre Syndrome; numbness in her feet; This case was reported by a consumer via call center representative and described the occurrence of guillain barre syndrome in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 1st December 2019, 6 days after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria hospitalization and GSK medically significant). On an unknown date, the patient experienced numbness in feet. On an unknown date, the outcome of the guillain barre syndrome and numbness in feet were not recovered/not resolved.   It was unknown if the reporter considered the guillain barre syndrome and numbness in feet to be related to Shingrix.  Additional details wee reported as follows: The case was reported by the patient's spouse. The patient received dose of Shingrix at the end of November 2019 and 6 days later, she was hospitalized for Guillain Barre syndrome. The patient was hospitalized and was in rehabilitation for 7 months and that had not resolved. The patient had ongoing numbness in her feet. The lot number and expiration date were unknown at the time of reporting. The reporter consented to follow up.
This spontaneous report as received from a medical assistant (also reported as healthcare worker) refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with doses of M-M-R II HSA, lot number for Vaccines for Children (VFC) Vaccines J004204, expiration date 12-APR-2015 (dose and route were not reported) that had a temperature excursion. Patients were also vaccinated with improperly stored Tetanus-Diphtheria vaccine (TD). No adverse effects were reported. The reporter was unable to provide any patient information or dates of vaccination. This is one of several reports received from the same reporter. Additional information has been requested.
throat started hurting; terrible headache; fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 21 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Aug2021 (Lot number: FC3182) at the age of 21 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: OROPHARYNGEAL PAIN (non-serious) with onset 24Aug2021, outcome "recovering", described as "throat started hurting"; HEADACHE (non-serious) with onset 24Aug2021, outcome "recovered" (25Aug2021), described as "terrible headache"; PYREXIA (non-serious) with onset 24Aug2021, outcome "not recovered", described as "fever". Therapeutic measures were taken as a result of oropharyngeal pain, headache. Additional Information:The patient had not received any other vaccines within 4 weeks prior to the COVID vaccinePatient recently got the first dose of the Pfizer vaccine on Friday. Patient clarified as the covid 19 vaccination. Patient had vaccination on Friday and thought after 2 to 3 days it would be over with. Patient went to work on Monday and worked overnight. At 1 o'clock her throat started hurting. Patient got off at 5 and once patient came home went to the store to get Nyquil thought it was a regular sore throat. woke up around 10 or 11 in the morning and patient had a terrible headache. It felt like someone had been banging her against her head and her throat felt ten times worse.  No follow-up attempts are possible. No further information is expected.
A few minutes after receiving the vaccine (approx. 2-3 mins), I felt dizzy and drank some water.  Usual arm soreness at injection site. I was monitored for 15 minutes without progression of dizziness so I left to go home. Upon getting home at approximately 1 hour later, I felt a mild headache. Symptoms resolved upon taking 650mg acetaminophen.  I went to bed around midnight and woke up at 530am to get ready for work. Arm soreness at injection site was more painful than the day prior as expected, but I also had developed a mild cough. The cough progressed mildly throughout the day. Feel lethargic and weak, as if a mild fever might be coming on soon. Took acetaminophen 650mg.  It is currently still less than 24 hours since receiving the vaccine. Will update further through the week as necessary.
Information has been received from a physician concerning a female who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (lot 3 657143/0380U). Subsequently, the patient developed erythema at the injection site within one day. The erythema was described as swollen, painful and warm from the injection site to the elbow. The pain and swelling prevented the patient from her arm. Unspecified medical attention was sought. At the time of the report, the outcome was unknown. The physician requested a lot check. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for the Biologics Evaluation and Research and was released. Additional information has been requested.
She got the vaccine on 2/26/21 and had no issues other than the sore arm, and then on 3/13/21 at the site of the injection on the right arm had blotches, raised very little. They were hot to the touch and itchy. She did not take anything for it. Did call her doctor to see if it should be reported, and they told her to report the incident and if it got worse to come in.
RT arm pain, erythema, blotches (Cellulitis like within 48 hours of receiving vaccine)
Rash on face within minutes of injection and resolved within 20 minutes. Given BENADRYL during the last few minutes of reaction.
A pharmacist gave the flu shot too high on the arm and patient complained of arm soreness and pain for over 3 weeks. Patient went to her doctor and was put on prednisone. She said it is hard to move her arm but it is getting better now.
The patient is a 46-year-old man who had Pneumovax vaccine here on June 17.  Within 1 or 2 days, he developed localized redness and irritation that has been gradually enlarging.  He had a tetanus in the other arm with no problem. 6/20/09 prescribed dicloxacillin 500 q.i.d. to take on an empty stomach for 8 days.  6/21/09 pt stated "it is less red and feels better"
Fever, terrible body soreness, extreme fatigue, fever that naproxen or ibuprofen don't break
Arm pain at injection site and fatigue night one. Severe arm "burning" pain day 2. Chills temperature 99.6 ache on entire left side, severe. Numbness and tingling left fingers and toes. Interferes with activity such as making dinner.
At 24 hours: extreme muscle aches and pain. Constant as well as  shooting pains. Nausea, no appetite. Fatigue. Pain was extreme. Following morning (36 plus hours post vaccine) noticed large red area surrounding vaccine site