chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from the manufacturer pregnancy registry from a nurse practitioner concerning a 32 year old female with a history of 2 spontaneous abortions who on 9/11/03 was vaccinated with a dose of varicella virus vaccine live (lot number not known). Concomitant therapy that day included a dose of MMR. There were no other concomitant medications. At the time of vaccination, the patient was 4 weeks pregnant, but did not show it. The patient had been monitored during pregnancy, and presented to the office on 10/28/03 at 10.6 weeks gestation. At that time, the fetus had no cardiac activity. The patient is scheduled for a D&C. It is unknown if laboratory data was performed. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested. Follow up on 11/17/2003: "Follow up information indicated that on 10/15/2003 the patient had an ultrasound that showed + cardiac activity.  At that time, the EDD was 05/20/2004.  On 10/28/2003, 10 weeks and 6 days from her LMP, the patient had a spontaneous abortion (also identified by the reporter as "fetal death/stillbirth").  Two 2 stillbirths or miscarriages occurred in previous pregnancies at 6-8 weeks gestation.  It is unknown if the patient was tested for varicella antibodies before vaccination.  It is unknown if there was a local reaction at the vaccination site.  It is unknown if there was varicella symptoms post vaccination.  It is unknown if there was herpes zoster symptoms post vaccination.  No further information is expected."
This spontaneous report as received from Registered Nurse refers to a 13 month old patient. On 04-SEP-2013 the patient was inadvertently vaccinated with two dose of the same lot PEDVAXHIB (lot # H017031, expiration date 16-JAN-2015, 0.5 ml, intramuscularly) in the same leg. The administering nurse had mistaken the second dose of PEDVAXHIB for an unspecified Hepatitis A vaccine (manufacturer unknown)(lot # not reported). The patient had no had any adverse effects. It was unspecified whether the patient sought for medical attention. Additional information has been requested.
Pt exp h/a, tired, 6x7.5cm erythema/induration lt upper arm, & also local pain, no fever;
Tested COVID-19 positive, resulted in hospital admission. Symptoms included cough, shortness of breath, nausea or vomiting, and fatigue.
pt recv vax; hurting all over; had sz; taken to er by amb; also had rash over entire body; pt cont to have sz; verbal report from MD: sz not caused by DTP;
TALKED MYSELF OUT OF THROWING UP; NAUSEA THAT CREEPS UP WITHOUT WARNING; ON AND OFF HEADACHE RIGHT BEHIND EYES; ITCHING FOR NO REASON THAT BECAME MORE INTENSE TO TORSO AND BACK; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and other pre-existing medical conditions included patient did not seek medical attention. patient had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821288 expiry: UNKNOWN) dose was not reported, administered on 16-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-JUN-2021, the subject experienced itching for no reason that became more intense to torso and back. On 18-JUN-2021, the subject experienced on and off headache right behind eyes. On 19-JUN-2021, the subject experienced talked myself out of throwing up. On 19-JUN-2021, the subject experienced nausea that creeps up without warning. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from on and off headache right behind eyes, itching for no reason that became more intense to torso and back, nausea that creeps up without warning, and talked myself out of throwing up. This report was non-serious.
828a- covid injection left arm 836a- itchiness at site of injection in left arm 839a-hives at site of injection left arm physician notified 840a-benadryl 50 mg PO liquid given, zyrtec 10 mg given po 852a-symptoms resolving, pt feeling fine, no difficulty breathing or swallowing, no further increase in hives
Since receiving the Pfizer vaccine, I noticed about a few weeks later, I began experiencing "hot flashes".    The hot flashes I experienced during menopause stopped several years ago.   It happens about once a week or more,  and lasts for ten minutes or so.  I get hot all over and begin sweating.   I typically never sweat even at high exercise levels.    Since the side effect has not stopped, I concluded that it must be a side effect of the Covid vaccination.     I have had no treatment for this nor did I ever have treatment during menopause.   I just put up with it. It has not subsided.  I just feel it is important enough to report.   Other people I know have the same side effect, all women.
pt exp pain from shoulder down into upper arm & side of neck & back of neck;cont to move down arm across back to finger tips persisting x 3 wk;rx edurmicin hydrocodone;numbness in fingers, palm;
I couldn't lift up my arm; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (I couldn't lift up my arm) and VACCINATION SITE PAIN (Vaccination site pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     Concurrent medical conditions included Ambidexterity. Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced LIMB DISCOMFORT (I couldn't lift up my arm) and VACCINATION SITE PAIN (Vaccination site pain). The patient was treated with IBUPROFEN for Injection site pain, at a dose of 300 mg. At the time of the report, LIMB DISCOMFORT (I couldn't lift up my arm) and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle Soreness) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy (Ceftin), Drug allergy (Neomycin) and Allergy to grains (grains). On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced MYALGIA (Muscle Soreness). At the time of the report, MYALGIA (Muscle Soreness) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not provided by reporter. Patient weight was reported as 180. Treatment medications were not provided by reporter. This case was linked to MOD-2021-386869 (Patient Link).
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On 19-JUL-2016, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # M001200, dose, route of administration and expiration date was not reported). This is one of several reports received from the same source. Additional information has been requested.
Hx ADHD, had seizure, lasting 3-4 min. Hx of myoclonic epilepsy. Usually takes KEPPRA 1000mg BID, RITALIN 20mg, clonazepam PRN. Seen at ER, observed. Sent home.
At the end of July, I was experiencing tingling in my hands and feet and some numbness.  I was diagnosed with a B12 deficiency and began receiving B12 shots weekly.  I got my first COVID vaccine on 8/16/21.  Around the first or second week of September, I started feeling different when I walked.  My feet became heavy, and I couldn't run anymore when I was playing tennis with my husband.  Then , around September 11, I noticed that I could not manage stairs without holding on to a rail, and even then, I felt most of my upper body was pulling me up.  I was also experiencing extreme dizziness, especially as I closed my eyes in the shower.  I would have to hold on to something so that I wouldn't fall over. September 12, I felt ill and dizzy at church and a nice lady drove me and my boys home.  From then on, I decided not to drive until we figured out what was going on in my body.  I had a Pap smear with my Dr. on September 13 and I told her that something else must be going on besides B12 deficiency as I was having trouble walking.  She tested my reflexes and found I didn't have any in my knees or feet.  She then referred me to a Neurologist.  I was finally able to get an appointment on September 23.  Nurse Practitioner, Neurological, saw I had no reflexes and was having trouble walking, but that I still had strength in my legs.  She asked Dr. to come and check on me.  He then wanted me to do Nerve tests, shock and needle.  After that he sent me to the ER for more tests (blood tests, spinal tap, MRI and CT scan) and they found I had high levels of protein in my spinal fluid. This confirmed Dr.'s diagnosis that I had either Guillain Barre or CIDP. They began Immune Globulin Infusions (I believe I received 5 bottles worth over the three days in the ER), along with blood thinner shots in my stomach and magnesium IVs.  My breathing became a concern and so I was moved to the Progress care unit and they continued to monitor my breathing every 4 or so hours.  I continued treatment and was released to go home the afternoon of September 26.  I didn't see a huge improvement in the hospital, but have noticed more strength as the weeks have gone on.  The Neurologist was very pleased with my progress at my last visit.  I  will have another visit with my Neurologist in about 3 months.
16 y.o. female who received the Pfizer-BioNtech COVID-19 Vaccine, mRNA, BNT162b2 (PF) 30 mcg/0.3 mL IM Susp, Lot EW0158 on 4/23/2021.The patient experienced the following reaction(s) during the immediate of observation: Tinglings, blurry vision, diaphoretic. Patient was treated/managed as follows: Pt brought to treatment area to lay down on mat with legs elevated. VS: 4:15 pm BP: 100/80 R: 18 HR: 58 O2: 98% Pt reports feeling much better after laying down.  4:30 VS: BP: 105/78 HR:60 O2: 99% Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance. Pt escorted to car with mom by nurse.
shots worse than desease itself, kicked my behind; This case was reported by a consumer via interactive digital media and described the occurrence of feeling abnormal in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of feeling abnormal (received 1st dose on an unknown date, refer link case US2022AMR050261).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feeling abnormal. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the feeling abnormal was recovered/resolved.   The reporter considered the feeling abnormal to be possibly related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR050261  Additional details were provided as follows: The patient self reported this case. The age at vaccination was not reported. The patient thought his/her Shingles shots were worse than the disease itself. The patient stated that it kicked him/her behind for days. The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR050261:Same patient, different dose
Was given vaccines and patient immediately became pale and non responsive. Given O2, BP 70/50, was given Benadryl 50 mg IM and Epi. Patient had seizure like activity was transported by ambulance to local ER.
Morning of April 4th: Nauseous, Fever (100 F), High Blood Sugars -Took 2 Tylenol pills - Felt better early afternoon   Late Afternoon April 4th: Dizzy, Nauseous, Light Headed, Collapsed and was unconscious for 2ish minutes - Called 911 -> Medics ran heart and bp tests which were all normal and did not consent to go to hospital  Evening April 4th: Chills, Fever spiked to 100F, Nauseous,  Light headed -Took 2 Tylenol pills - Did not take Ciprofloxacin evening dose   Morning April 5th: Fever hovering around 100F, more color in face and up and moving around  -Reported incident to doctor & pharmacist where Ciprofloxacin came from  - Pharmacist contact information
pt recvd vax; w/in 24 hrs pt devel abdominal pain; joint pain; diarrhea & headache;
Patient reported L facial drooping and ear pain within 24-48 hours after receiving the Shingrix vaccine. He went to the ER thinking he was having a stroke. This was ruled out and he was subsequently diagnosed with Bell's palsy. As of 8/14/20 he had largely recovered but still has some L sided mouth drooping.
Diziness, Sweating, Visual disturbance,  Heavy arm, Pale, Hearing disturbance (hearing voices), Nauseated
slow processing; body ache; can't focus all day; still not feel by myself; I sleep the next day, same flue symptoms; chills; headache; Myalgia; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (I sleep the next day, same flue symptoms), DISTURBANCE IN ATTENTION (can't focus all day), FEELING ABNORMAL (still not feel by myself), BRADYKINESIA (slow processing) and PAIN (body ache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0021321A and 011M203) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported.On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (I sleep the next day, same flue symptoms), CHILLS (chills), HEADACHE (headache) and MYALGIA (Myalgia). On 17-Mar-2021, the patient experienced DISTURBANCE IN ATTENTION (can't focus all day) and FEELING ABNORMAL (still not feel by myself). On an unknown date, the patient experienced BRADYKINESIA (slow processing) and PAIN (body ache). The patient was treated with IBUPROFEN for No adverse event, at a dose of 200 mg. At the time of the report, INFLUENZA LIKE ILLNESS (I sleep the next day, same flue symptoms), HEADACHE (headache) and MYALGIA (Myalgia) was resolving, DISTURBANCE IN ATTENTION (can't focus all day), FEELING ABNORMAL (still not feel by myself), BRADYKINESIA (slow processing) and PAIN (body ache) outcome was unknown and CHILLS (chills) had not resolved. No concomitant and treatment medication were reported. The patient sleep the next day, same flu symptoms, chills, headache, body ache. On Tuesday had the chills but, started to get better. On Wednesday mind head could not focus all day, never experience that. On Wednesday's night, Thursday and today, forgetting things could not  focus, slow processing, hard time to decision making. The patient work but, still not feel by myself. The patient said work part time on Wednesday and full time on Thursday and Friday, It was hard but, could not concentrate. This case was linked to MOD-2021-386023 (Patient Link).
Fever the whole month; diagnosed with inflammation on the thyroid gland S.thyroiditis; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of THYROIDITIS (diagnosed with inflammation on the thyroid gland S.thyroiditis) and PYREXIA (Fever the whole month) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced THYROIDITIS (diagnosed with inflammation on the thyroid gland S.thyroiditis). On an unknown date, the patient experienced PYREXIA (Fever the whole month). The patient was treated with PREDNISONE from 05-Mar-2021 to 15-Mar-2021 for Thyroiditis, at a dose of 20 mg once a day. At the time of the report, THYROIDITIS (diagnosed with inflammation on the thyroid gland S.thyroiditis) outcome was unknown and PYREXIA (Fever the whole month) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Feb-2021, Blood thyroid stimulating hormone (0.5-3.74):. On 20-Feb-2021, Red blood cell sedimentation rate increased: elevated (abnormal) elevated. On 03-Mar-2021, Blood thyroid stimulating hormone (0.5-3.74): 0.011 (Low) TSH (0.011). On 03-Mar-2021, Thyroxine: free t4 : 1.85 milligram per decilitre (Inconclusive) Free T4 : 1.85 mg/dl. On 04-Mar-2021, Red blood cell sedimentation rate increased:. On 04-Mar-2021, Ultrasound thyroid: inconclusive (Inconclusive) Inconclusive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided.
She also complained of all the COVID signs and symptoms; She also complained of all the COVID signs and symptoms; left cervical, axillary, clavicular and periscapular lymphadenopathy; left arm and shoulder pain; left arm and shoulder pain; This is a spontaneous report from a contactable physician. An adult female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection, lot number was unknown, intramuscular in the left arm on 28Dec2020 at a single dose for COVID-19 immunization. Medical history included covid-19 from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient is not pregnant. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that after receiving the Pfizer COVID-19 vaccine in the left deltoid, the patient experienced left cervical, axillary, clavicular and periscapular lymphadenopathy in Dec2020 with outcome of not recovered. She also complained of left arm and shoulder pain and all the COVID signs and symptoms in Dec2020 with outcome of not recovered. The onset was within a day of immunization. She has a history of COVID-19, she had Covid prior vaccination. It was unknown if the patient tested for Covid post vaccination. The onset date of the events was reported as Dec2020. The events was reported as non-serious and it was unknown if the patient received treatment for the events.  Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the suspected LOE, COVID 19 and other reported events due to temporal relationship.  Of note, it is reported that the patient had a history of COVID-19, and she was diagnosed with  COVID 19 infection prior to the  vaccination.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics , counteractive treatment measures and concomitant medications.   This case will be reassessed once additional information is available.  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.
Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomiting) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced VOMITING (Vomiting). At the time of the report, VOMITING (Vomiting) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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.`   Reporter did not allow further contact
No adverse event. Person was accidentally given 1ml dose. Monitored for 15 minutes without issues.
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown ages and genders. No information regarding the patients' medical history, concomitant medications, concurrent conditions and drug reactions or allergies was provided. On 02-JAN-2017, the patients were vaccinated with improperly stored doses of ROTATEQ orally (dose, was not reported; lot # M007125, expiration date: 06-OCT-2017 and lot # M007298, expiration date 19-NOV-2017). The vaccine underwent a temperature excursion of 24 degrees Celsius for 56 minutes , which was detected by a digital data logger. No previous temperature excursions were reported. No product quality complaint (PQC) was involved. No adverse events were reported. This is one of the several reports received from the same reporter. Additional information is not expected as there was no consent for further contact.; Sender's Comments: US-009507513-1701USA012094:
Dose 1: a - muscular pain in shot location 2 days following administration of vaccine. Dose 2:    a - muscular pain in shot location 2 days following administration of vaccine. b - Flu like symptoms for three days following vaccine - mild fever, body aches, muscles soreness in legs.         c - Small fiber peripheral neuropathy in feet - has gradually advance to arms, legs and trunk of body.
Pt developed a 4cm localized redness, swelling and itching to vaccine site. Treated with Benadryl and Motrin.
Back hurts, Temp 101, neck & body aches.  Headache - symptoms started about 10 AM.
Information was received from a medical assistant who stated that multiple temperature excursions involving ROTATEQ took place from 20-FEB-2014 through 06-MAR-2014. Improperly stored vaccines of ROTATEQ (lot # J009725, expiration date 04-MAR-2014) were administered to unspecified patients on unspecified dates (dosages not provided). No adverse effects reported. Additional information has been requested.
Symptoms started about 1-2 minutes after injection. Dizzy, sweating, passed out while sitting in chair. Pt placed head between legs, cool pack applied to back of neck and cold water to drink given. Informed Dr. lasted for 5 minutes.