chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 22-year-old female patient (gravida 4, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 046A21A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy on 19-Jul-2017 and Spontaneous abortion (Patient had 3 previous pregnancies and had 2 spontaneous abortion). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 10-Feb-2021 and the estimated date of delivery was 16-Oct-2021. On 06-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  third week of the pregnancy.  On 06-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Pregnancy test: positive (Positive) Positive.
Vaginal bleeding; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration on 05Jan2021 at 05:00 at a single dose for COVID-19 immunization.  Medical history included skin auto-immune disease and auto-immune hypothyroidism.  The patient's concomitant medications were not reported.  The patient received the vaccine on 05Jan2021 at 05:00. The next day at 6:30 AM (06Jan2021), the patient started having vaginal bleeding that has not subsided yet and still going strong. The patient had seen a lot of specialist. She went to the ER twice and had CT scan, 3 biopsies taken, internal sonogram, had blood tests and urinalysis done, all with unknown results. The doctor told her if it doesn't stop in a couple of weeks, the patient will undergo a general anesthesia to further analyze the situation. The physician did not have information on vaccination for people with auto-immune issue. The patient had not yet recovered from the event vaginal bleeding.   Information about lot/batch number has been requested.
Information has been received from a consumer concerning his 10 year old daughter who on 04-OCT-1998 was vaccinated with th first dose of VARIVAX (Merck) via intramuscular administration on her left upper arm. On 04-APR-2008 the patient developed an injection site reaction, one day after she was vaccinated with the second dose of VARIVAX (Merck) intramuscularly. The patient developed redness, swelling, itching and soreness at the injection site of the left upper arm. The size of the reaction increased and the patient was examined in the physician's office later that day. At that time, the diagnosis was "a reaction to the vaccine". No treatment was prescribed. On 05-APR-2008, the area of redness had increased in size and the patient was evaluated in the emergency room (but not admitted to the hospital). The evaluation revealed a 11 times 13cm area of redness. Blood studies were normal except for an elevated C-reactive protein. The patient was diagnosed with a bacterial infection at the injection site and was prescribed oral KEFLEX. On 07-APR-2008, the symptoms are improving. No further information is available.
The injection site:  Tender Large red spot splotchy Hot to touch Swollen Hard Itchy Other: Fever of 100.1 Chills  Tenderness and swelling in left arm pit Pain in joints painful to lift arm
pt had allergic react to DTP/OPV given in the office w/marked facial swelling distorting facial features & extensive hives;
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 12-MAR-2015, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot number not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 05-JAN-2016, the patient was treated for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
COVID infection following COVID vaccine series 12/23/20 COVID vaccine dose #1 01/13/21 COVID vaccine dose #2 09/02/21 COVID vaccine dose #3 10/18/21 pre-op COVID testing positive 10/19/21 seen in ED only due to concomitant workup for lung mass, discharged home with no interventions 10/21/21 Remained asymptomatic 11/08/21 COVID test negative
This spontaneous report was received from a physician via company representatives referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 30-OCT-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 0.5 mL (Vls 10 SDV) (Lot # K007822, expiration date 15-AUG-2015) single dose, route and anatomical location were not provided. There was no concomitant medication provided. No adverse effects were reported. On an unknown date, the PNEUMOVAX had a temperature excursion for 720 hours, the lowest recorded temperature was 20F (-6.667 Celsius). The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". There was no product quality complaint involved. This is one of several cases received from the same reporter. Additional information has been requested.
Sore arm for a little bit; This is a spontaneous report from a contactable consumer (patient). This female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on an unspecified date for COVID-19 immunization. Medical history and concomitant medication were not reported. Patient received the Pfizer BioNTech covid vaccine and had no other reaction than a sore arm for a little bit. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
That Saturday when I started coughing up stuff I went that following Sunday to get a Covid test to rule it out. That came back negative. That following Wednesday I did a telehealth call with my doctor thinking I needed to get on antibiotics to clear it up. It didn't seem to do anything. On 12/31/2021 I went to an urgent care because I was coughing up stuff. They said my lungs were fine and they did a Covid test which was negative. They said it might just take time to clear up on its own they diagnosed it as acute bronchitis. It lasted up through the middle of February.
~6 hours post-injection, left deltoid muscles started to feel sore and hardened; the worst ~12 hours post, and mostly resolved 48 hours post. ~48 hours post, I started to have a sore throat and minor dry cough. In the evening of the same day, I started to develop a feeling like a low-grade fever throughout my body and had difficulty sleeping. Did not measure body temperature though. ~72 hours post, today, sore throat recovered a little and had phlegm, and I started to feel minor headaches on the top of my head and became very sensitive to the temperature drops, like wind and cold water. The feeling of fever mostly spread from the thighs and pelvis. Felt weak and soft.
Started getting a sore throat and felt fatigued. Took a home COVID-19 test and it was positive. Was prescribed PAXLOVID. Took another COVID-19 test 10 days later and it was negative. Started coughing a lot again, took another COVID-19 test and it was positive. Started feeling better a few days later and tested negative for COVID-19.
This spontaneous report was received from a registered nurse referring to a 4 month old patient, of an unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 18-MAR-2019, the patient was inadvertently vaccinated with the second expired dose of ROTATEQ orally, lot # N030364, expiration date on 06-MAR-2019 (strength was not provided) for prophylaxis, however no adverse effects reported.
patient fainted  after the covid  vaccine . He was unresponsive for 1 minute and better after . EMT service provided to patient and was good and walked with the EMT for further observation .
Previously received Pentacel but what about Pediarix?  We have a little one who received Pediarix at 2 & 4 months but when he came in for his 6 month well child check, he was given Vaxelis.No additional information available from this first contact; This spontaneous non -serious safety report, with reference number 2023SA244561 (Inquiry number), was received by the partner on 08-AUG-2023 and forwarded to agency on 10-AUG-2023, from a health professional.  The causal relationship between Vaxelis and the reported event " Previously received Pentacel but what about Pediarix? We have a little one who received Pediarix at 2 & 4 months but when he came in for his 6 months well child check, he was given Vaxelis. No additional information available from this first contact" was assessed as not applicable due to the nature of the event.  Further information is expected.   Significant follow-up information was received by agency on 06-SEP-2023, from a HCP. The case is maintained as non-serious.  The causal relationship between Vaxelis and the reported event " Previously received Pentacel but what about Pediarix? We have a little one who received Pediarix at 2 & 4 months but when he came in for his 6 months well child check, he was given Vaxelis. No additional information available from this first contact" was assessed as not applicable due to the nature of the event.  No further information is expected.  NI is not working, added State under vaccine facility information and Reporter State.
A purchasing agent reported that a 64 year old female received an injection of Tetanus and Diphtheria Toxoids Adsorbed, Purogenated and subsequently developed an injection site reaction. The patient was seen in the ER and recovered. This is 1 of 2 patients from this facility who developed an injection site reaction following receipt of Tetanus and Diphtheria Toxoids lot # 470-531.
Headache about 1 hr at shot, stomach ache around 5PM. Vomit and diarrhea started at 2:00AM still present at time chills.
Pt. states a neighbor noticed she had raised red rash on arms and face at approximately 3:30PM on 11/06/2009. Denies any other symptoms. Pt took Benadryl 25mg capx1and put benadryl cream on rash. Rash subsided by 9:45 PM
FATIGUE FOR 1 DAY; 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, route of admin not reported, batch number: Unknown) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced fatigue for 1 day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue for 1 day. This report was non-serious.
Developed 6 days after vaccine RUQ abd pain that woke her from sleep.  Seen later that day by PCP in another facility and had labs done: t..bili 1.6, GGT 472, alb 4.2, alkaline phos 257 (upper nl 150), AST 276 (upper normal 33),  ALT 512 (upper normal 33) HepB surf ag - non-reactive, hep B core Igm - non-reactive,  IgA non-reactive,  hepC non-reactive CBC wbc-9.8 rbc 5.26 hgb 17.1  hct 49.7, MCV 94.6 MCH 32.5,  MCHC 34.3, plt 229 mpv 10.3 RDW 14.2 Lipids - Tot-218, TRG-138, HDL - 65 LDL-125 non-HDL 153paLiver US (2.12.2021) - liver diffusely coarsened and increased in echogenicity  that can be seen in fatty infiltration or other diffuse hepatocellular process. This limits the sensitivities for the detection of hepatic masses. Cholecystectomy. dilatation of th ecommon duct due to postcholecystectomy state.
Patient stated that two weeks after vaccination she noticed these white splashes like someone had threw hot water on her. Patient stated that she has these patches all over her body and the spots are turning light and it seems that she is loosing color petition.
I had a health physical on 11/30/2020.  I had lab work on 2/01/2021.   My Creatinine  readings  both times were in  the normal range of 1.  After having the Moderna injection on 2/11t2021, I had flu like symptoms  on 2/12/2021.  On 2/13/2021 I assumed  my daily activities.   On Sunday  the. 14th of February  around 6PM, I became very weak.  I could  only get out of bed to use the restroom.   I was to weak to do my normal  activities.  I was bed ridden for the next 11days.  On 2/22/2021, I went to Medical  Practice.  They treated me and sent me home.  On the 25th of February at or around 5PM, I went to Hospital.   My Creatinine number was 9 and they admitted  me.  Eventually  i was diagnosed  with Kidney Failure.
Swollen lymph nods in armpits and neck. Severe headache, body aches, shaking, joint pain, chest pain, difficulty walking, dizziness, fainting. Headache got better after ER visit but came back once meds wore off. She still has all of these symptoms.
allergic reaction to shrimp; This spontaneous case was reported by a patient and describes the occurrence of FOOD ALLERGY (allergic reaction to shrimp) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: flu shot. Past adverse reactions to the above products included No adverse event with flu shot.    On 14-Jan-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 FOOD ALLERGY (allergic reaction to shrimp). At the time of the report, FOOD ALLERGY (allergic reaction to shrimp) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication was reported.  The patient received bivalent booster on 08-Dec-2022 and was taking Amoxicillin to prevent infections since 07-Dec-2022 because of a teeth surgery.  No treatment information was provided.
One of my family members had no medical history she took the vaccine now she's dead.; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified as dose number unknown, single for COVID-19 immunisation. The patient medical history was reported as none. The concomitant medications were not reported. The reporter stated that so many side effects had not been listed on the Pfizer website. Many people experience death, stroke and other problems. Reporter stated that one of the reporter's family members had no medical history she took the vaccine now she's dead on an unspecified date. Reporter stated to have seen so many people dying after receiving the vaccine. People who had no medical history get sick after the vaccine. The patient died on an unspecified date. It was not reported if an autopsy was performed.  Follow-up attempts are completed. No further information is expected. Batch/lot number not available for BNT162B2.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101253587 same reporter/product, different patient / event.; Reported Cause(s) of Death: One of my family members had no medical history she took the vaccine now she's dead.
Start with cough, 11/07/2014 went to emergency facility, diagnose bronchitis gave me Prednsone, Claritin and albuterol. Cough continue after treatment went to a generalist diagnosed sinusitis. Give me some nasal decongestant, antibiotics, send to take a head xray an refer me to a OTORHINOLARYNGO SPECIALIST HE CHECK ME gave me Alegra and Singulair. Feel a little better but the cough still prevailed until today 12/04/2014.
Presents from memory care center with SOB, loss of appetite, & AMS;  dx with COVID 3 days PTA at same ED & DC'd at that time. Admit for COVID & AKI. Tx: zinc, dexamethasone, vit D, remdesivir. DC back to memory care center.
Swollen knee/puffiness on the inner left knee joint; Mild localized arm soreness at injection; puffy and swollen feet; pain caused patient to wake at night; right and left knee pain in inner meniscus/felt pain in both inner knees, tendor spot at meniscus on right knee; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (puffy and swollen feet), JOINT SWELLING (Swollen knee/puffiness on the inner left knee joint), INSOMNIA (pain caused patient to wake at night), ARTHRALGIA (right and left knee pain in inner meniscus/felt pain in both inner knees, tendor spot at meniscus on right knee) and VACCINATION SITE PAIN (Mild localized arm soreness at injection) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     The patient's past medical history included Meniscus tear in 2011. Concurrent medical conditions included Penicillin allergy. Concomitant products included OSTEO BI-FLEX GOLD WITH VITAMIN D for an unknown indication.    On 14-Apr-2021 at 1:00 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced PERIPHERAL SWELLING (puffy and swollen feet), INSOMNIA (pain caused patient to wake at night) and ARTHRALGIA (right and left knee pain in inner meniscus/felt pain in both inner knees, tendor spot at meniscus on right knee). On an unknown date, the patient experienced JOINT SWELLING (Swollen knee/puffiness on the inner left knee joint) and VACCINATION SITE PAIN (Mild localized arm soreness at injection). The patient was treated with NAPROXEN SODIUM (ALEVE) for Adverse event, at a dose of UNK, bid. At the time of the report, PERIPHERAL SWELLING (puffy and swollen feet), INSOMNIA (pain caused patient to wake at night) and ARTHRALGIA (right and left knee pain in inner meniscus/felt pain in both inner knees, tendor spot at meniscus on right knee) had not resolved and JOINT SWELLING (Swollen knee/puffiness on the inner left knee joint) and VACCINATION SITE PAIN (Mild localized arm soreness at injection) had resolved.            This case was linked to MOD-2021-219132 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Jun-2021: Reporter details, patient demographics, relevant history conditions, product details and events were updated.
flaring up psoriasis, a fairly localized reaction, primarily on the groin area; This spontaneous case was reported by a physician and describes the occurrence of PSORIASIS (flaring up psoriasis, a fairly localized reaction, primarily on the groin area) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ADALIMUMAB (HUMIRA), LEVOTHYROXINE and SILDENAFIL CITRATE (VIAGRA) for an unknown indication.    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 PSORIASIS (flaring up psoriasis, a fairly localized reaction, primarily on the groin area). At the time of the report, PSORIASIS (flaring up psoriasis, a fairly localized reaction, primarily on the groin area) 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.   No treatment medication was provided
On 10/11/00 PM, child was fussy, decreased appetite, lethargy and temperature of 99F (rectal). Father called 7 days later, regarding sluggishness and cramps. Seen in ER; weight loss of 4 oz., temperature 98F. PE by MD-WNL. Possible gastritis.
unknowingly were all exposed to the covid virus and tested positive; This is a spontaneous report from a contactable consumer reporting same the same event under the same suspect product for 3 patients (this is for the reporter's husband). This is one of 3 reports. A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 27Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation, age at vaccination was unknown at a pharmacy. The patient medical history included unknowingly exposed to the covid virus and tested positive on an unspecified date. The patient's concomitant medications were not reported. The patient was unknowingly exposed to the COVID virus on an unspecified date and tested positive with symptom of fever on 09Mar2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 09Mar2021 Positive. Reporter asked if they should receive the second vaccine or start again. They were told after 90 days, they had to start over again. The patient received the antibody infusion for the virus from reporter's mother in law on the 24th. Outcome of the event was unknown.  Information about Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : PFIZER INC-2021354303 same reporter, suspect drug, same adverse event; different patient.;PFIZER INC-2021357177 same reporter, suspect drug, same adverse event; different patient.
At injection site as of today 1 week 1 day after my first shot I have a mass the size of a baseball on my arm that itches and is hot. It has tripled on size today alone.
Within 24 hours headache that lasted > 48hrs. On Friday: nausea, diarrhea (severe), muscle aches, chills, fatigue, runny nose.  On Saturday I woke with myself and my sheets soaked in sweat and dizziness.
Severe body aches debilitating recipient, chills, fever and soreness all around the morning after vaccination. Unable to move regularly, needs assistance, and cannot work properly