chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a patient and a nurse practitioner via pregnancy questionnaire for GARDASIL, a Pregnancy Registry product, concerning herself, a 20 year old female patient smoker, with no allergies or drug reactions, a history of 0 pregnancies and 0 live births and no pertinent medical history who on 03-AUG-2011 was vaccinated by a nurse practitioner with 0.5 mL of the second dose (also reported by the patient that was the first dose) of GARDASIL (Lot# 668229/1569Z, expiration date not reported). There was no concomitant medication. It was reported that after the dose was administered on 03-AUG-2011, the office did a blood test and it was determined she was pregnant. The date of her last menstrual period was 26-JUN-2011. On 22-SEP-2011 she went to an unspecified emergency room with spotting and bleeding, an ultrasound was scheduled for 23-SEP-2011. On the way to the ultrasound test she miscarriage. It was determined that she was 10 weeks pregnant (also reported by the patient as 14 weeks pregnant). It was reported that there was unknown if the products of conception were examined. The patient had not yet had the first pregnant visit, the first visit was scheduled 28-SEP-2011. The patient sought medical attention. At the time of reporting the patient was recovering. Upon internal review, miscarriage was determined to be an other important medical event. Additional information has been requested.
Mild fever; fatigue; This is a spontaneous report from a contactable consumer. A 59-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03Apr2021 at 18:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included none. The patient did not have a history of allergies to medications, food, or other products. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 13Mar2021 at 18:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Apr2021 at 15:00 the patient experienced mild fever and fatigue after second dose. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events mild fever and fatigue was recovered on an unknown date in 2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
On the clinic day, the vaccine was transported out from the pharmacy to the facility without a digital data logger. The packing used for transport was a refrigerated packaging tote to maintain a temperature of 36 F-46 F. However, that is not approved by State for COVID-19 vaccine transportation. The total time (from when vaccine left the pharmacy to the clinic completion) was less than 6 hours. There were no adverse events.
"sore arm"; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY ("sore arm") in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     Concurrent medical conditions included Herniated disc (herniated disc in neck). Concomitant products included GABAPENTIN and PARACETAMOL (TYLENOL) for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY ("sore arm"). At the time of the report, PAIN IN EXTREMITY ("sore arm") outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medications included a steroid (unspecified). No treatment drugs are not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-075089 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-075089:Link to Dose 2 case
joint pain in left hip; This is a spontaneous report from a contactable consumer (patient) received via COVID-19 Vaccine Adverse Event Reporting System. An 86-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number unknown), via an unspecified route of administration, administered in the left arm on 04Mar2021, at 14:00 (at the age of 86 years old) as dose 1, single for COVID-19 immunisation. Medical history included known allergies: crab, spinal stenosis, arthritis, and high blood pressure. The patient was not pregnant. Concomitant medications included quinapril, amlodipine, and tramadol. She did not receive any other vaccines within four weeks prior to the COVID vaccine. On 06Mar2021, at 16:00, the patient experienced joint pain in left hip. The patient was not diagnosed with COVID-19 prior to vaccination and she has not been tested for COVID-19 since the vaccination. No therapeutic measures were taken as a result of the event. The patient was recovering from joint pain in left hip.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Muscle tightening, fatigue, aches and pains, weakness, back pains.
patient had received first dose of Pfizer COVID-19 vaccine at another location and came to get her 2nd dose of COVID-19 vaccine and was mistakenly given MODERNA COVID-19 vaccine dose.
Severe itching, redness, swelling at injection sight.  Parasthesia left arm. 4/15/99 Neurology Appt 16 Jun 99 Optic Neuritis 11 Aug 99 Optic Neuritis 3 Feb 00 Diagosis of Multiple Sclerosis with confirmed lesions on MRI 3 Feb 00
Per Dr: "Skin over face, abdomen, chest areas now of confluent slightly raised, erythematous, large macules with central, flat, slightly dusky/violaceous clearing. No vesicles. No crusts. Palms and soles have no rash." No fever
Pt did not develop "protective titers" p/3 injections of Engerix-B; "plan to revaccinate" pt; Reporter states the non-protective titers can be possibly disabling and/or life threatening "if person contracts Hepatitis";
Pain, swollen - at injection site - no redness. Applied ice. Swollen subsided 24 hrs. later. Has taken prior flu vaccine with similar reaction last year. Informed to have MD provide vaccine in the future.
TUMOR GROWING ON THE TRIGEMINAL NERVE; REACTED TO VACCINE; MISERABLE; LOST A LOT OF WEIGHT; NUMBNESS ON ONE SIDE OF FACE; This spontaneous report received from a consumer via social media via a company representative concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. Patient went from a perfectly healthy active person to a miserable man. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced tumor growing on the trigeminal nerve, reacted to vaccine, miserable, lost a lot of weight, and numbness on one side of face. The reporter stated that, "My husband reacted to the Johnson and Johnson vaccine when we first received it. A few months later he woke up with numbness on one side of his face. Not a stroke he has a tumor growing on the trigeminal nerve. He went from a perfectly healthy active person to a miserable man. He has lost a lot of weight. We now need to find a neurosurgeon to see what treatment is available". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tumor growing on the trigeminal nerve, and the outcome of reacted to vaccine, numbness on one side of face, lost a lot of weight and miserable was not reported.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220224199-Covid-19 vaccine ad26.cov2.s-Tumor growing on the trigeminal nerve. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
tested positive for covid-19 days after the first dose of moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for covid-19 days after the first dose of moderna vaccine) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037k20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure, Dyslipidemia and Depression.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for covid-19 days after the first dose of moderna vaccine). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for covid-19 days after the first dose of moderna vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jan-2021, SARS-CoV-2 test positive: positive (Positive) POSITIVE.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included taking blood pressure medication, cholesterol medication and antidepressant medication.  Treatment for the events not reported.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: TCR; Sender's Comments: Based on reporter's causality  the event SARS-COV-2 TEST POSITIVE  is assessed as unlikely related to mRNA-1273.
Donor felt light headed and warm apprx. immediately 10 seconds after receiving Tetanus injection. Ice packs and shock position. Recovering less than fifteen minutes.
Client had vaccine around 5:55pm and was instructed to wait in the lobby for 30 minutes after vaccine to monitor for reaction. Around 6:30 pm she went out to her car and came back into the clinic stating that she had pressure in her chest and a lump in her throat. 911 was called and client when to the emergency room where it was determined that she had an allergic reaction to the vaccine. We have called client to follow up but she has not returned our voicemail.
fever, sore throat, spitting up phlegm, cough. starting 1/20/22
Can not stop itching , head and back of hair line just will not go away, also top of feet and turn beet red. Inside of arms with hives that get little red bumps. face and neck and chest  turn beet red for no apparent reason face gets hives too.
bruise at the injection site; blotchy redness around the bruise; like a rash in different areas of her shoulder; rash a little itchy; bruise getting greener/bruise still kind of purple; headache; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (bruise at the injection site), RASH MACULAR (blotchy redness around the bruise), RASH (like a rash in different areas of her shoulder), RASH PRURITIC (rash a little itchy) and SKIN DISCOLOURATION (bruise getting greener/bruise still kind of purple) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included PANTOPRAZOLE for Heartburn, HYDROCODONE for Osteoporosis, DILTIAZEM and ACYCLOVIR [ACICLOVIR] for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CONTUSION (bruise at the injection site), RASH MACULAR (blotchy redness around the bruise), RASH (like a rash in different areas of her shoulder), RASH PRURITIC (rash a little itchy), SKIN DISCOLOURATION (bruise getting greener/bruise still kind of purple) and HEADACHE (headache). The patient was treated with ACETAMINOPHEN for Headache, at an unspecified dose and frequency. At the time of the report, CONTUSION (bruise at the injection site), RASH MACULAR (blotchy redness around the bruise), RASH (like a rash in different areas of her shoulder), RASH PRURITIC (rash a little itchy), SKIN DISCOLOURATION (bruise getting greener/bruise still kind of purple) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Face is swollen/face was puffy; complaining of pain in her throat glands/Glands under throat are painful; sleeping a lot; didn't really eat much; Very Lethargic; vomited once or twice/Vomiting; This is a spontaneous report from a contactable consumer. This consumer (patient's mother) reported for her daughter (patient). A 13-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 13-years-old via an unspecified route of administration on 15May2021 15:30 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. Medical history included ongoing reaction to bread. Concomitant medication included an unspecified anxiety medication. It was reported the patient received the first dose of the Pfizer COVID-19 vaccine on 15May2021, and the next day, 16May2021, she was sleeping a lot and vomited once or twice, didn't really eat much. This morning, 18May2021, she vomited and noticed face was puffy and complaining of pain in her throat glands, they will be taking her to her HCP this afternoon. Shee mentioned that she has had a reaction to bread, possible gluten intolerance, maybe yeast, and was asking if is there is yeast in the production of the vaccine. She got the vaccine on Saturday at 1530. It was further reported that for the first day or two she was very lethargic and vomiting on 15May2021. States they thought it was just a normal reaction. The reporter stated that today her daughter isn't in school again because she is vomiting, her face is swollen, and her glands under her throat hurt. States she is going to the doctor this afternoon. The patient did not recover from vomiting, was recovering from very lethargic while the outcome of the other events was unknown.  Information on the lot/batch number has been requested.
Arm pain; Headache; Back neck and joint pain; Back neck and joint pain; Back neck and joint pain; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 38-years-old female non pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0172) via an unspecified route of administration in right arm on 30Apr2021 at 13:15 (at the age of 38 years old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient was not a pregnant at the time of vaccination. Historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0151) via an unspecified route of administration in right arm on 09Apr2021 at 13:15 as dose 1, single for COVID-19 immunization and experienced arm pain after dose 1 from 6-30 hours afterward and missed period (was scheduled to get 4/23-4/25). Facility where the most recent COVID-19 vaccine was administered was hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination reported as birth control. Prior to vaccination patient was not diagnosed with COVID-19 and. Since the vaccination, patient has not been tested for COVID-19. The patient experienced arm pain, headache, Back neck and joint pain from 3-33 hours after 2nd dose on an unspecified date in 2021. The clinical outcome of all events was unknown.  Device Date: 02May2021  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Noticeable tinnitus within 2 to 3 days of booster shot (shot #3).
Red hot deltoid 180 degrees around.  Not circumferential;  Tender to palp.  Started 24 hrs after shot given Tdap.
Pt was fainted for 30 sec after receiving Pfizer vaccine . He regained his consciousness very quickly and said " I am ok". He was sweat a little bit.  Cold compressed applied to his face, neck and wrists.  His vital signs are stable: Temp 97.8 F  98.6F ; BP 148/98 HR 98: BP 138/90 HR 90; BP 126/75 HR 78.  After 15 min, the patient felt  good and sat on chair for 20 min then go home with his mother.
p/vax pt became sick c/ cramps c/violent vomiting; continued throughout night into next day; went to ER; IV fluids& meds to stop vomiting; 8/26 rt leg went numb from 2'' below knee to big toe-front of leg only
I came home from vacation on 04/21 and I had runny nose, fever, chills, tachycardia, shortness of breath on minimal activity and a cough. All of that lasted for around a week and a half. I took an at home COVID-19 test that day and it was positive. I was able to treat my symptoms with Mucinex and Tylenol and did not require medical attention. When I thought I was feeling better, the tachycardia never really went away and actually began to get worse with activity. I also began having headaches. At that point I went to my doctor who ordered some lab work. That all lasted about a week and I developed an uncontrollable head tremor with muscle tremors and pain in my arms and legs which all lasted around two weeks. I had multiple tests done and all results so far have come back normal with the exception of an elevated D-dimer. I am still waiting on results from wearing a heart monitor for two weeks. When I received the results of the D-dimer they advised that I go to the emergency room for a chest CT. I also visited the emergency room when I was experiencing chest pressure and tachycardia and headaches. They did blood work which all came back normal and I was released.
After my 30 minute observation period, I left the facility. Shortly after leaving the Campus, I felt my lips begin to tingle and noticed my face was hot and turning red. As I was pulling over to the side of the road to pull medication from my purse, my symptoms increased and my tongue began to swell.  I took two Benadryl gel-caps and waited to see if my symptoms would calm or if I would need my epi pen . The Benadryl calmed the response and I continued home. This was approximately 40 minutes after my vaccination. When I have an anaphylactic reaction to pork, tuna, or shell fish, the reaction time is typically much closer to the event, but the reaction sequence is similar.
The pain in  my arm post vaccination on 5.6.21 never fully went away.  It got better for a couple weeks but still noticed it.  Around the beginning of June, the pain in my arm, at the vaccination site, started to intensify.  I kept an eye on it for a couple weeks, thinking it'd get better but it didn't, it just got worse.  On Tuesday, June 15th the pain really intensified.  To the point that by Thursday, June 17th I was unable to move my arm.  Because the pain was so bad I went to Urgent Care where they thought I was having muscle spasms.  I knew something wasn't right so I contacted my doctor that afternoon who then sent me for blood work.  He ran a D-dimer test which came back elevated on Friday June 18th.  From there I went to the ER so they could run a doppler scan on my left arm.  The pain was so bad they were only able to do half the test but quickly saw that I have a blood clot in one of the veins.  The ER doctor put me on Eliquis and now here I am.
24 hours-36 hours after injection, developed redness, blisters and pain at inj. site and up into shoulder. Pain, redness and rash (blisters) are still present 72 hr. later with redness 50 x 100mm and rash area 30 x 50mm. Seen by physician - Rx'd with Acyclovir.
She got her vaccine, the first day she was feeling tired which was expected. She went to bed, felt very cold, believes she had a fever, did not record it as she could not get herself to walk or get a thermometer. The next day she was sleeping the whole day, sleeping and waking up, get up for about a half an hour and fall back to sleep and could not move at all and wiped out. The next day she started having some pain in her muscles, body aches were really, really bad. From there she was so tired from that point on, and her body never really recovered. She has a lot of pains in her body out of no where or if she does anything she is not able to do her normal daily things that she does as she gets so easily. This did not happen before receiving the vaccine. She saw her PCP several times where she did extensive blood work and did not find anything. She went to a rheumatologist where he diagnosed her with fibromyalgia, which she never had problems before, and does not know if the vaccine caused it. She has had back pain since then and feels that her nerves are move sensitive to pain now. She has never had back pain like this before the vaccine. She now has a different life than it was before, and does not remember what a normal life is. She cannot clean her house now without limping on one leg, and has joint and bone pain that was not there prior to the vaccine. After her vaccine she started loosing her words, which is strange to her. She has had a lot of brain fog, and not able to go back to her normal sharpness that she had. This was very shocking and has made a difference in her life as she cannot find the words that she wants to say.
she got violently ill; This is a spontaneous report from a Pfizer-sponsored program. A contactable Certified Pharmacy Technician (CPhT) and a 62-year-old female consumer (patient) reported that patent started to receive palbociclib (IBRANCE, tablet) oral on 26May2021 at 15 mg for malignant neoplasm of unspecified site of right female breast and BNT162B2 on an unknown date, as single dose, for COVID-19 immunisation. Relevant medical history and concomitant medication were not provided. On an unknown date, patient reports, will not be taking medication until after 03Jul2021 and may lower her dosage due to she got violently ill when she got her Covid shot and was taking the Ibrance medication so she was going to hold off on medication. The outcome of the event was unknown.   No follow-up attempts are possible. No further information is expected.
Hospitalized 12/27/21-1/5/22 Abd pain, weakness, decreased appetite, hypoxia, PNA, dyspnea, cough, body aches, low grade fever,  UTI, sepsis