chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had anxiety reactions after receiving their Moderna Covid- 19 vaccinations; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (had anxiety reactions after receiving their Moderna Covid- 19 vaccinations) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANXIETY (had anxiety reactions after receiving their Moderna Covid- 19 vaccinations). At the time of the report, ANXIETY (had anxiety reactions after receiving their Moderna Covid- 19 vaccinations) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication were reported.  Reportedly no other adverse events were reported.  No treatment medication were reported.   This case was linked to MOD-2022-546513, MOD-2022-546517 (Patient Link).
Pulmonary embolism; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PULMONARY EMBOLISM (medically significant), outcome "unknown". The physician said he wasn't sure if it was caused by the vaccine, but he wondered. He said did not affect his belief in or usage of the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported event of PULMONARY EMBOLISM due to temporal relationship.  Case will be re-assessed upon the additional information provided. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
PAIN MID TO RIGHT BREAST; SHORTNESS OF BREATH; TIGHT CHEST; DRENCHED BED SHEETS UPON  WAKING; PULSE 134 TO 143 WHILE SLEEPING; PRESSURE IN EYES; SHOOTING PAIN LEFT ARM TO HIP; VOMITING; SORE ARM; FATIGUE; NAUSEA; HEADACHE; FEVER; BODY ACHE; 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: 108-5022, and batch number: 108-5022 expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for in left arm prophylactic vaccination. No concomitant medications were reported. On MAR-2021, Laboratory data included: Pulse rate (NR: not provided) 134-143 bpm. On 14-MAR-2021, the subject experienced drenched bed sheets upon waking. On 14-MAR-2021, the subject experienced pulse 134 to 143 while sleeping. On 14-MAR-2021, the subject experienced pressure in eyes. On 14-MAR-2021, the subject experienced shooting pain left arm to hip. On 14-MAR-2021, the subject experienced vomiting. On 14-MAR-2021, the subject experienced sore arm. On 14-MAR-2021, the subject experienced fatigue. On 14-MAR-2021, the subject experienced nausea. On 14-MAR-2021, the subject experienced headache. On 14-MAR-2021, the subject experienced fever. On 14-MAR-2021, the subject experienced body ache. On 18-MAR-2021, the subject experienced shortness of breath. On 18-MAR-2021, the subject experienced tight chest. On 19-MAR-2021, the subject experienced pain mid to right breast. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from drenched bed sheets upon waking, pulse 134 to 143 while sleeping, pressure in eyes, shooting pain left arm to hip, vomiting, sore arm, fatigue, nausea, headache, fever, and body ache on MAR-2021, was recovering from tight chest, and shortness of breath, and had not recovered from pain mid to right breast. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Edema in L thigh, no redness, no warmth. Benadryl Eliper per wt.
This is a spontaneous report from a contactable consumer or other non hcp. A 56-years-old female patient received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: FA7485), dose 1 via an unspecified route of administration, administered in Arm Left on 03Aug2021 10:00(age at vaccination: 56 Years) as DOSE 1, SINGLE for covid-19 immunisation. Patient didn't received other vaccines within 4 weeks prior to vaccination. Medical history included familial Mediterranean fever from an unknown date and unknown if ongoing, inflammation from an unknown date and unknown if ongoing. Concomitant medications included cortisone (CORTISONE) taken for an unspecified indication, start and stop date were not reported; ibuprofen (IBUPROFEN) taken for inflammation, start and stop date were not reported. The patient experienced injection site pain on Aug2021, feeling something like a mild tingling in her left eye about an hour after vaccination on Aug2021, eye was watering, burning, tearing, and she was experiencing pain and double vision on Aug2021, eye was watering, burning, tearing, and she was experiencing pain and double vision on 03Aug2021, blurriness on Aug2021, she has still felt "poking" on Aug2021 with outcome of not recovered. Therapeutic measures were taken as a result of eye was watering, burning, tearing, and she was experiencing pain and double vision, eye was watering, burning, tearing, and she was experiencing pain and double vision, blurriness. The outcome of the events vaccination site pain, lacrimation increased, eye irritation, diplopia, vision blurred, feeling abnormal was recovered, the outcome of the event feeling abnormal, eye pain was not recovered, the outcome of the event paraesthesia was unknown. No follow-up attempts are needed. No further information is expected.
Two days after the 2nd dose, the patient presents the following symptoms: 75% oxigenation, 35% Puls, 153 sugar, HBP 64/44 and vomiting.
Drowsiness; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Drowsiness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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 SOMNOLENCE (Drowsiness). At the time of the report, SOMNOLENCE (Drowsiness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
This report describes the occurrence of mercury poisoning in a male child of unspecified age who was vaccinated with hepatitis B vaccine recombinant (Engerix B) for prophylaxis. This report was received as part of litigation proceedings and has not been verified by a physician or other healthcare professional. The subject's medical history, concurrent conditions, and concurrent medications were not reported. The subject received an injection of Engerix-B on 12/31/92, 1/29/93, 9/30/93, and 1/23/97. He also received injections of diphtheria and tetanus toxoids and pertussis vaccine, Haemophilus influenzae type B vaccine, combination diphtheria and tetanus toxoids and pertussis vaccine/Haemophilus influenzae type B conjugate vaccine, and influenza virus vaccine. The subject's attorney alleged that as a result of the mercury in the Thimerosal-containing vaccinations that the subject received he now suffers and in the future will continue to suffer, from the toxic neurological effects of mercury poisoning. The attorney further alleged that the subject has developed severe neurodevelopmental disorders with associated high mercury exposure levels as a result of the vaccinations he received, and has suffered serious permanent injury. Onset and treatment of the events were not specified. The mercury poisoning in this report, with resultant neurodevelopmental disorders, is considered medically serious.
Client fainted for 2-3 seconds and then vomited x 3 after receiving 3rd and 4th vaccines.
Severe chills beginning approximately 10 hours after injection, lasting about two hours until tylenol was taken.
Moderna COVID-19 Vaccine EUA  Fever, chills, headache, sore throat, nausea, injection site pain, body aches, fatigue
This spontaneous report as received from an Immunization Program refers to a patient of unknown age. On an unknown date the patient was vaccinated with a dose of improperly stored PNEUMOVAX23 (lot # J006921, expiration date: 09-AUG-2014) (dose and route not reported). Additional information is not expected.
rash on arms and neck, then flank, back and abdomen. Continued to spread and worsen. Puritic  60 Day follow up states "Unable to contact- no response"
Pt recvd MMR vax on 18OCT91 & 30OCT91 devel a generalized red rash over face & trunk, pain in eyes & a fever; Pt seen by MD for sx; later recovered; no further details were provided;
5 Days after second Moderna shot, I developed intermittent stinging at the top of two toes on my left foot and at the same time stinging and itching on my face.  Red, itches splotches/patches developed on the left side of my neck and traveled up the left side of my face, across the top of the face and eyelids, town the right side, and now have spread to the right side of my neck.
Pt complaining of increased itchiness on arms, trunk of body, palms of both hands and neck. Nurse assessed and reported student began with symptoms on 4/5/00. Has not applied any topical cream to rash areas. Has rash, red raised areas, fine; rash decreasing.
Initially myalgias, progressed to fever to 104, photophobia, headache, neck stiffness, ear pain, nasal congestion, nausea, whole body rash- took one week for recovery.
dose was given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose was given after expiration date) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose was given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose was given after expiration date) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment information was provided.  No adverse event was reported. The vial had not undergone any temperature excursion issue. The vial was initially placed in the refrigerator on 03-Nov-2021. Many doses administered from expired lots were caused due to confusion with the expiration date printed in the label.
She has measles like bumps it started below injection area didn't notice till she got home on both arms and legs and hands.  She still has them and they are itchy and red.
patient said he felt fatigued, had muscle weakness and diarrhea for 3 days
The first time I got the vaccine I had monoclonal antibodies and I had COVID really bad I might be dead without them; The first time I got the vaccine I had monoclonal antibodies and I had COVID really bad I might be dead without them; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 71-year-old female patient received BNT162b2 (BNT162B2), on 06Dec2020 as dose 1, single (Lot number: EW0173) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "The first time I got the vaccine I had monoclonal antibodies and I had COVID really bad I might be dead without them".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300130070 same reporter/patient/product, different dose/event.;US-PFIZER INC-202300130069 same reporter/patient/product, different dose/event.;US-PFIZER INC-202300130071 same reporter/patient/product, different dose/event.;
Following day - I had pain on my feet and during the day I had the pain from my bottom of feet to my head. Then around 2:00 I was having chills. And then around 6 pm, chills worsened and I had   a headache and a high fever - 103. Around 8 pm it was getting worse - the pain, the body aches, chills and headaches and I called my dr and she told me to take Ibuprofen and I took it at 8:40 and by 9:40 my chills were going away and my fever going down and by 10 pm  I just had a headache and had pain in my body - the pain in each was less and I was feeling very tired. The next day, I woke up fine. I woke up with body pain but it wasn't bad. I had a low fever but nothing else. And then by Wednesday, 3 days after, I started developing a rash. The rash was on my arm and on my belly and on both legs. I went to see my Primary Care Dr - as it  (the rash) was getting worse. She gave me Steroid cream. Two weeks after that it was getting much worse - I was not sleeping at night. It was itchy and it was too much. Went back to my doctor and she did a biopsy on my arm on February 24th. I went back to my Primary care doctor - she thought maybe it was a false positive and I did it again and it was positive again. I went to Endocrinologist - and she said that it is Hashimoto's Disease. No treatment yet. I will have follow up with her this month for her to check my thyroid levels again.  I still have the rash but it is less. I am getting rid of the rash, it's just a slow process.
diarrhea; vomiting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 03Dec2021 (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 (Previous dose product: COVID 19, Previous dose brand: Pfizer, Previous dose number: 1), for Covid-19 Immunization.  The following information was reported: DIARRHOEA (non-serious) with onset 04Dec2021, outcome "unknown", described as "diarrhea"; VOMITING (non-serious) with onset 04Dec2021, outcome "unknown", described as "vomiting". Therapeutic measures were not taken as a result of diarrhoea, vomiting.  Additional information: The patient had no covid prior vaccination. The patient had not been tested for covid post vaccination.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
15 minutes after immunization patient fainted in waiting room. She had been ambulating in exam room without difficulty and ambulated to waiting room by herself. Last meal greater than 12 hours prior to immunization. Complained of back pain as she fell back against the wall and slid to floor - Vitals checked.  Ice applied, juice grape and crackers given. Patient monitored x1 hr discharged to home with step mom.
This spontaneous report was received from a health professional refers to a female patient of unknown age. Patient's pertinent medical history was reported as asthma. Patient had an unspecified reaction on sulfa drug. Patient was administered with the first dose of GARDASIL (Lot # K009811, expiration date: 19-JUN-2016) on 04-NOV-2014 and with the second dose (Lot # K023435, expiration date: 05-NOV-2016) on 06-JAN-2015. Concomitant therapies included VENTOLIN. On 27-FEB-2015 patient sought medical attention at the office of healthcare provider for rechecking of a pre-existing diagnosis of asthma which had not changed or worsened since the administration of GARDASIL. At the office visit on 27-FEB-2015 patient's mother stated that since an unspecified date the patient experienced floating outside of her body while lying in the bed at an unspecified frequency after the administration of GARDASIL. No treatment was given for the adverse event. No lab diagnostic studies were performed. Outcome of the adverse event was unknown. Causality assessment was not provided. Additional information has been requested.
Vaccine expired 06/30/23. administered 10/24/23 @ 0915
Rt delt. slightly red./ swollen. - 10/30/09.  Febrile started 10/29/09 6 PM.  Conglomerate with symptoms of flu.
No adverse reaction. Reporting due to the vaccine administration error. Patient should have been given Tdap not Dtap.
~9 days of vaginal spotting (in between menses), and several mild nosebleeds.
Skin discoloration at injection site; Skin hot to the touch at injection site; extreme restlessness; Severe pain radiating into the left underarm; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 28-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: E19266), via an unspecified route of administration in left arm on 20Feb2021 at 15:30 as a single dose for COVID-19 immunisation. The patient's medical history included PCOS (polycystic ovarian syndrome) and known allergies: Citrus. Concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9269) on 28Jan2021 at 16:45 as a single dose in left arm for COVID-19 immunisation. Patient did not receive other vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination. The patient did not underwent COVID test post vaccination. The patient experienced skin discoloration at injection site, skin hot to the touch at injection site, extreme restlessness, severe pain radiating into the left underarm on 20Feb2021 at 16:30. No treatment medications was received for the adverse events. The outcome of the events was recovering.
Initial report received from the consumer (patient) on 15 Jul 2010: This polymedicated patient had medical history of diabetes mellitus and was bitten by a dog at index finger on 08 Oct 2009. The patient was vaccinated with RABIPUR (batch unknown). 1 ml. intramuscular 08 Oct 2009, 11 Oct 2009, 15 Oct 2009, 22 Oct 2009 and 05 Nov 2009. On 16 Nov 2009, the patient was hospitalized because he presented with cough, leucopenia and WBC (white blood cell) decreased at 2.1x10^9/L (reference range and unit was not provided). The patient received treatment with granulocyte colony-stimulating factor and was requested to leave hospital on 26 Nov 2009. From 30 Nov 2009 to 31 Dec 2009, the patient was hospitalized again for cough, expectoration and fatigue. The patient was diagnosed with PTB (pulmonary tuberculosis) during hospitalization. WBC decreased value showed at 1x10^9/L (01 Dec 2009) and 3.8x10^9/L (28 Dec 2009). The patient complained that vaccination lead to his leucopenia and his HCP stated that no evidence revealed that the patient's disease was caused by vaccination, but he did not agree. The outcome of the patient was reported as recovered.
"COVID Arm":  Soreness at the injection site and surrounding area with a large itchy and red and white inflamed circle with three circles and bullseye.  It lasted for about 4 days.  I used Benadryl and ice packs to relieve itchiness and redness; and ibuprofen for inflammation and soreness.   I noticed today that it finally feels "normal."  There is still a large red circle but it's faded, similar to a long-lasting bruise; but red not yellow.
tingling in tongue & then having bad taste in mouth; not swelling in lips or tongue; scratchy throat
Hive all over their body. I administered anti allergens and the symptoms went away after about 30 min.
Mother reports child woke up around 0530 this am.  She brought child to bed with her.  Soon after she felt child was shaking and when looking at him noted his eyes were rolled back, had tonic-clonic activity of all four extremities, was unresponsive, making clicking/gurgling sound, and his face was rigid.  Reports this activity lasted anywhere from 1-2 minutes.  Afterwards child fell asleep until she woke him up to bring to ED.  Reports initially in ED seemed tired, but otherwise acting per usual.  On exam by peds team states he seems back to baseline (~ 5 hours after event).  No tongue biting; reports she noted wet diaper after event but unsure if it was present from overnight.  No color change of lips/extremities during the event.  No recent trauma.  No recent fevers.  Of note, child did receive immunizations yesterday to include: MMRV, DTap, Hep B, IPV, pneumococcal.
Patient received both vaccinations and walked away from the pharmacy. She returned about 2 or 3 minutes later stating she didn't feel well. She said her face felt funny. The pharmacist had the patient sit down and right after sitting down the patient started yelling and screaming and breathing quickly as though she was in a lot of pain. She kept saying her back her back. Because the situation did not seem to be resolving after about a min or so 911 was called. By the time the paramedics arrived the pain had subsided and the patient was able to talk. She said she first got this weird feeling over her face and then her back started to spasm and the spasm wouldn't stop. Everything checked out ok with the paramedics but they did recommend she go to the hospital to get evaluated b/c they did not know if this is something that would reoccur. The patient agreed.
PT was warm and was given tylenol @ 415PM; @11PM PT was limp and could not be aroused; PT began crying and vomiting a/ambulance arrived; temp @ ER was 104; PT was given suppositories at ER; PT given tylenol @ 230PM 30AUG91;
all joints hurt, right arm swollen from elbow down to fingers, tingle sensation in lower right arm and fingers
Redness, swelling pain in deltoid swelling in hand US to rule out DVT is negative
Case previously recorded as MA2009-4176. Initial case report received from a registered nurse via MedCom, on 12 NOV 2009. A 2-year-old female patient was accidentally vaccinated with S-OIV FLUVIRIN (batch no. 11041P1) i.m. on 11 NOV 2009. No adverse effect was reported. MedCom reference no.:NA09-008056.
Mom states pt had episode of "increased salavation thur mouth and nose, tongue rolled back of mouth couldn't breathe. Mom moved tongue with her finger. Pt had two more episodes within 3 hrs called EMS on arrival pt ok. Pt not seen by MD. She called her MD, and was told to have Benadryl on hand for next shots.
Cognitive distortion, loss of balance, muscle tension, muscle tremors, fever, chest diaphragm spasms and fatigue... Face swelling.  This lasted for a few hours, when I woke up at 10am, I still had tremors, but no other symptoms.