chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is currently 16 years of age and received moderna vaccine as first dose, patient monitored fr 15 minutes, no issue or concern after vaccine was given .
Red blotches all over body in different location. Itchy all over body. No problem at site of injections.
"caught covid"; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 ("caught covid") in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history 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 COVID-19 ("caught covid"). At the time of the report, COVID-19 ("caught covid") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
This case was reported by a pharmacist via call center representative and described the occurrence of abdominal pain in a 50-year-old male patient who received SHINGRIX (batch number LL552, expiry date 20th May 2021) for prophylaxis. On 12th March 2019, the patient received SHINGRIX (intramuscular). On 12th March 2019, less than a day after receiving SHINGRIX, the patient experienced abdominal pain and testicular pain. On an unknown date, the outcome of the abdominal pain and testicular pain were unknown. It was unknown if the reporter considered the abdominal pain and testicular pain to be related to SHINGRIX. Additional information were provided as follows: The patient began to experience severe abdominal pain as well as testicular pain. The batch number was changed from ii552 to LL552, as per sales data sheet.
About 5 days after vaccination injection site was very red, itchy and skin was hot..Went to primary care Doctor a few days later and was diagnosed as having an infection.  was placed on an antibiotic for 7 days.  Rash improved greatly and hotness of skin dissipated.  I still have some redness and a measles like rash today (24 Feb21).  I am concerned about getting 2 nd shot on 2 March 21.
itchy red and inflamed skin at injection site, chills, body aches, headache and fatigue
Pt had Covid Shot on Wednesday.  Developed period on Thursday and had severe bleeding.  Went to the ER, and was found to be tachycardic.   Received IV DDAVP for Von Willingbrand Disease.  Physician unsure if reaction to COVID Vaccine, but requested report be made to VAERS.  ECG shows patient to have Sinus Tachycardia, with moderate ST depression.
Was sick for 24 hours; Had to lay down; She was miserable the whole night; She wasn't feeling good by 2000; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Caller mentioned that her daughter had a reaction to the Covid-19 Vaccine. On an unspecified date her daughter got the vaccine and was sick for 24 hours then it was done. The caller read so much online, and her daughters symptoms were pretty right on. They said that younger people would get a robust reaction. She was not feeling good by 2000 and had to lay down. She was miserable the whole night and it lasted for 24 hours. The caller did not think she needs to do a report on her. It was straightforward. She had a reaction that was one and done like a miracle. She felt better after 24 to 30 hours. The outcome of the events illness, malaise, dizziness, feeling abnormal was recovered on an unspecified date.  Information on lot /batch number has been requested.
Initial report received from nurse on 13 Oct 2010: This patient received FLUVIRIN 2010-2011 (batch number 1116925P) 0.5 intramuscularly in right deltoid on 13 Oct 2010. Ten minutes after vaccination the patient reported numbness at injection site that radiated to the jaw and cheek on right side of face. The outcome was reported as ongoing. No other information was reported. Follow-up report received from the nurse on 21 Oct 2010: This patient with a vaccination history of Hepatitis B vaccine and FLUZONE in 2007, and FLUVIRIN in 2009 was administered FLUVIRIN vaccine in the right deltoid on 13 Oct 2010 in the morning. The vaccine was well tolerated in the past. However after about 03 hours the patient reported numbness in right deltoid radiating to the right scapula and upto right face which started around 10 min after receiving vaccine. The patient was sent to a medical center for follow up. Later on the same day in the evening the patient was hospitalised. The patient was discharged from the hospital on 18 Oct 2010 with a discharge diagnosis of transient ischaemic attack (TIA). Final outcome of the patient was reported as recovered.
tongue swelling that patient felt was onset of anaphylaxis, began about 5 minutes after vaccine was given, pt was given one dose of EpiPen and went to ER where they received IV steroids, benadryl, pepcid and observed for 45 minutes. Upon discharge they were prescribed a 5 day course of prednisone
This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (Patient who is not immunocompromised received full 3rd dose) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. No Medical History information was reported. On 20-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Sep-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL OVERDOSE (Patient who is not immunocompromised received full 3rd dose). At the time of the report, ACCIDENTAL OVERDOSE (Patient who is not immunocompromised received full 3rd dose) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. Pharmacist stated that the patient who received the primary doses in Jan-2021 and Feb-2021 from another store received a third full dose. When the patient came for the third dose, patient told the pharmacist that the patient was immunocompromised, however when pharmacist called the patient asking for the fourth dose, patient said he was not immunocompromised, but the patient takes care of wife who is immunocompromised. Information of first and second doses were unknown. No treatment medications were reported.
Initial information received on 11-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 2 months old male patient who received only the diluent of vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR and ROTATEQ. On 11-Mar-2019, the patient received only a diluent (DTAP/IPV liquid) of a suspect PENTACEL Lot # UJ108AA, Expiration Date: 24-Jul-2020, PENTACEL Box Lot # UJ062AAA, Expiration Date: 24-Jul-2020, HIB: Lot # UJ062AA, Expiration Date: 24-Jul-2020) via intramuscular route in left leg. This would have been the first PENTACEL for the patient. It was a case of actual medication error due to inappropriate reconstitution technique. It was unknown if any adverse event occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
I had a lot of pain initially at the site, which subsided after a few days. A week later, the pain returned-- much worse than at first. I started running a fever, and I pain shooting up and down my arm. The doctor diagnosed me with a soft tissue infection and gave me an antibiotic.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The pharmacist noted that the patient was inadvertently vaccinated subcutaneously with an expired dose of VARIVAX (Merck) (1188Z exp 09-OCT-2012) on 19-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. No treatment information was reported. The pharmacist did not known if this was the first or second dose of VARIVAX (Merck) that this patient had received. No adverse effect was reported. Additional information has been requested.
My wife, who is in perfect health, has had inflammatory lymph nodes under both arms since the first vaccine in January resulting in a biopsy, benign for malignancy. Starting in mid July she started to develop symptoms of shortness of breath when normally able to run 6 miles a day. She saw cardiology on September 23 and found to have 3rd degree heart block and now is s/p a permanent pacemaker on 9/28/21. So since January and the vaccines this perfectly healthy woman still has inflammatory nodes under both axillas and now has a permanent pacemaker of no known etiology. All tests and labs were normal except for new conduction abnormality
bloody nose last night; This is a spontaneous report from a contactable consumer (parent).   A 18-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) via an unspecified route of administration on 15Apr2021 as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Consumer reported that his son received his first dose of the Pfizer-Biontech Covid19 vaccine, yesterday on 15Apr2021. He had a bloody nose last night, that has since resolved. On an unspecified date, the patient had bloody nose. Consumer wanted to know if that was a commonly reported AE, and if they needed to be concerned. The outcome of the event was resolved on an unspecified date.  The response provided to reporter as: Reviewed fact sheet for "blood", "bleeding", and "nose" with no results [LAB-1457-7.0; Revised: 06April2021].  Answered as per guidance in "VR-Consumer Inquiry Management (Off-Label or No Info) (v15.0)".  Referred back to HCP, caller indicated they had already contacted HCP.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
2/7: By 7:00 pm, I had fever which rose to 102+ before midnight.  2/8: Low-grade fever, flu-like feeling, "heavy head", lethargic  2/9-2/10: Pretty much back to normal with the addition of an injection site "hot spot"- raised, rashy and feverish 2/11: Began feeling general malaise in the afternoon. Low grade fever, pain behind collarbone on both sides. By 7pm, severe chills.  2/12: Called PCP and advised of symptoms. Went and got a Covid19 PCR test just in case. Negative 2/13-2/15: Still had low-grade fever (usually around 100*) which often didn't present until 2pm and then stayed until bedtime. Glands became swollen, bad night sweats. Pain behind collarbone worse when sneezing, coughing, yawning, burping, etc. Additional information for Item 18: Almost like a "catch" rather than constant pain. 2/16: Went to local medical center for drive-thru rapid Covid 19 and flu test. Both came back negative as did the PCR Covid test they also ran.  2/17-2/20: Symptoms pretty much the same....no fever in the am and thought I was finally getting better, then it would spike again around 1:00-2:00. Never over 101*. On the morning of 2/21, the "catch" around the collarbone had moved down to the bottom of my ribcage.  2/22: Contacted PCP again and made appointment for bloodwork, chest x-ray, and further tests. "Sick and tired of feeling sick and tired!"
Information has been received from a physician concerning a female with a history of attention deficit disorder who was vaccinated with all three doses of Gardasil.  Concomitant therapy included ADDERALL TABLETS.  Subsequently the patient experienced alot of pain at the injection site for all three doses.  The patient sought unspecified medical attention in the physician's office.  Subsequently, the patient recovered from the injection site pain.  No further information is available.  Additional information has been requested.
Since I have gotten the vaccine I have developed severe psoriatic arthritis and rheumatoid arthritis in mainly my hands. I can barely use my hands. The pain and swelling has been excruciating. I also have  trigger thumb on my right thumb . I am scheduled to see a rheumatologist soon. I am scheduled to get x-rays of my hips and spine.
By about 18 hrs (@ 10:00AM on 8/14/21) after 2nd dose of my Pfizer Covid vaccine, the headache started and then by 21 hrs (@ 1:00 PM on 8/14/21) vomiting began.  Felt better after vomiting but still had a headache. Then by 31hrs (@11:00PM on 8/14/21) vomiting began again, but felt some relief immediately after.  After first event, (2) 500mg Acetaminophen (@1:30 on 8/14/21) tablets were taken and then (@10:00AM on 8/15/21) because headache was still present. Then, (@ 7:00AM on 8/16/21) due to persistent headache.
C/O hive/rash, itchiness, stated had itchiness with first dose of Moderna Vital signs taken all WNL, stayed for 30 minutes and discharged to home
After my father received the second COVID vaccination he started complaining of headaches.   He had lung cancer, but he was in good condition.   Within weeks his health deteriorated and when we bought him for a scan the beginning of March he had two small brain bleeds.   The cancer had spread to the brain and he had a mass.    They put a shunt in on March 18th because they said he had fluid, and this was the only treatment.   Ten days later he was back in the hospital and after a week we had to take him home on hospice.   I think the vaccine could of escalated his cancer this rapidly.  Especially because he had two brain bleeds.
24 hours after the second covid 19 vaccine which was given 9/5/21, I started bleeding very heavily with large clots and pain. Contacted my OB/GYN office and couldn't get in to be seen right away so I went to the ER 9/8/21.
chills; body aches; headache; This is a spontaneous report from a contactable consumer.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history was and  concomitant medications were not reported. The patient experienced chills, body aches and headache 15 hours after receiving 2nd dose of BNT162B2. Outcome of the events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from a female consumer who was vaccinated SC with a 0.5 ml dose of ZOSTAVAX on 22-JUN-2012. On 23-JUN-2012 the patient experienced atypical herpes zoster after receiving ZOSTAVAX. The patient had been nauseous and fatigued, but attributed those reactions to the acyclovir (strength and manufacture unspecified) medication her physician put her on after discovering the atypical herpes zoster. It was unknown if the patient sought medical attention. At the time of report, the patient was not recovered. Additional information is not expected.
BODY ACHES; HAD A VERY STRONG IMMUNE RESPONSE; CHILLS; 103 DEG FEVER FOR MORE THAN 8 HOURS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included: covid, and sniffles. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAR-2021 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 body aches, had a very strong immune response, chills, and 103 deg fever for more than 8 hours. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103 degree. The action taken with covid-19 vaccine was not applicable. The outcome of the body aches, chills, 103 deg fever for more than 8 hours and had a very strong immune response was not reported. This report was non-serious.
(Tuesday) First night I had a fever and chills that lasted all day on the 2nd day (Wednesday). Ibuprofen has not helped. Thursday fever spiked again. Friday. Mild fever.  Saturday fever  of 101.8.   Saturday night into Sunday morning fever of 102.5 with chills. Ibuprofen has not helped. My arm was sore Tuesday night and Wednesday but that is better.
polymyalgia rheumatica; had muscle problems; arm irritation; arm tenderness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 75-year-old female patient received bnt162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Lot number: EN6205) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "lupus" (ongoing), notes: was in 30s when started; "Hashimoto's" (ongoing); "Fibromyalgia" (ongoing); "Sjogren's" (ongoing); "Shrunk form back surgery" (unspecified if ongoing); "Shrunk form back surgery" (unspecified if ongoing). The patient's family history included: "Rheumatoid arthritis" (ongoing), notes: was in her late 30s. Caller's aunt had rheumatoid arthritis. There were no concomitant medications. The following information was reported: LIMB DISCOMFORT (non-serious) with onset Mar2021, outcome "unknown", described as "arm irritation"; PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "not recovered", described as "arm tenderness"; MUSCLE DISCOMFORT (non-serious) with onset Mar2021, outcome "unknown", described as "had muscle problems"; POLYMYALGIA RHEUMATICA (medically significant) with onset Mar2021, outcome "not recovered". Clinical course included patient had the usual arm irritation, was very mild, with 1st dose on 02Mar2021. The vaccine triggered another autoimmune disease in body, PMR, polymyalgia rheumatica, as of Mar2021. Patient had muscle problems. Patient had tenderness, got progressively worse.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300337361 same patient/vaccine, different doses/event.;
No Adverse Reaction. Patient was given a 5-11 yr covid vaccine dose. We were wondering if she needed additional dosing since she is 12 Yr. No further dosing was given.
patient presented with blisters on both ankles 48 hours post vaccine, they later became infected. her podiatrist feels they are and adverse reaction to the vaccine.
Received Prevnar vaccine on 5/8/00. Approximately 4-5 hours post vax, pt developed multiple papules on extremities, chest, abdomen, back. No fever was noted and no other symptoms were experienced.
Rash at site after injection given. Fever noted 7-9 days later with rash. (Thus was his first time receiving MMR and varicella vaccines). Mom also gave peanut soup but he has had this before without incident.
VIVOTIF OPENED UP IN HER MOUTH AS SHE TOOK IT; This spontaneous case (PVX2019-1185) was received from a consumer on 13-May-2019. It describes a 62-year-old adult female consumer whose "Vivotif opened up in her mouth as she took it". The consumer was receiving oral Vivotif capsule for an unknown indication.  Case report: The consumer took the first dose of Vivotif on 07-May-2019. On 11-May-2019, when she took the third dose, the capsule opened in her mouth. She took the dose and afterwards, she drank a ton of water.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "Vivotif opened up in her mouth as she took it" was considered as not applicable. ; Sender's Comments: Company's Comment: The causality of the event "Vivotif opened up in her mouth as she took it" was considered as not applicable.
THIRD BOOSTER SHOT Normal, chills, achy - has lasted off since then, extremely tired, lack of energy, headaches  Rare - swollen lymph nodes in NECK, more so on the Left side (shot in the right arm); tender to touch and movement.   10 days later still very little energy, still achy
patient has developed a demyelinating disorder 1.5 months after vaccination, she was previously health. She has demyelinating lesions in her brain and spinal cord.
The morning following the injection, the pt called home from school complaining her side was tender and swollen, nausea, vomiting and headache. The pt was takent to the MD and he placed her on an anti-inflammatory (Celebrex). Pt continues to have a tender and swollen spleen and liver.
I am scheduled to get my second dose on 8SEP2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I am scheduled to get my second dose on 8SEP2021) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jul-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I am scheduled to get my second dose on 8SEP2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I am scheduled to get my second dose on 8SEP2021) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was mentioned. No treatment medication was mentioned.
Acid reflux, gas/bloating, pelvic pain, stomach pain and headache since first dose, daily, not resolved. Menstrual period is also 9 days late, never irregular and not pregnant.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OcT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share with Merck. Follow-up information has been received from the registered nurse who provided patients details. This report refers to a 2 years old child patient of unknown gender. On 16-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported, lot # J016188, expiration date 02-OCT-2016) that was improperly stored. No adverse effects were reported. This is the one of several reports received from the same reporter. Additional information is not expected.
Pt recvd vax & tired & hallucinating, t102, tired, hot & cold chills, achy, malaise, h/a; loss of appetite, photophoiba, not thinking straight 1 wk from vax;
Muscle aches, nausea, low platelet count, emergency room visit with a black stool. Gall stone, hair loss from prednisone.