chrisvoncsefalvay/vaers-outcomes huggingface dataset:
aches; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aches) and PYREXIA (fever) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Nov-2021, the patient experienced PAIN (aches) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, PAIN (aches) and PYREXIA (fever) had not resolved.            High blood pressure medication was given as concomitant.  Company comment: This spontaneous case concerns a 37 year old female with no reported medical history , who experienced non -serious unexpected event of pain and expected event of pyrexia which occurred the day after the vaccination with the 3rd dose of mRNA-1273 vaccine ( Moderna Covid 19 Vaccine ) . The re-challenge for this case is not applicable since the events were reported as not resolved and the events also occurred after the 3rd dose and no additional doses will be given. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 24-Nov-2021: Follow-up received: Non-significant.; Sender's Comments: This spontaneous case concerns a 37 year old female with no reported medical history , who experienced non -serious unexpected event of pain and expected event of pyrexia which occurred the day after the vaccination with the 3rd dose of mRNA-1273 vaccine ( Moderna Covid 19 Vaccine ) . The re-challenge for this case is not applicable since the events were reported as not resolved and the events also occurred after the 3rd dose and no additional doses will be given. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's pertinent medical history and concurrent condition were not reported. On 13-AUG-2015, the patient was vaccinated with improperly stored dose of PROQUAD (Merck) (lot # K021548, expiration date 06-MAY-2016, dose, frequency and route were unkonwn). No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was involved. This is one of several reports from the same reporter. Additional information has been requested.
Shortly after second Shingrix dose I began to develop numbness in toes and feet, fingers and hands.
Client received flu vaccine on 10/5/09. 2-3 hours after vaccine - developed hives from shoulder to ankles very itchy, went to ER. Given shot of BENADRYL. PREDNISONE oral and 2 EPIPEN
presents with shortness of breath and diagnosed with COVID-19 pneumonia. Originally diagnosed in 08/19/21. Dexamethasone. Ruled out superimposed pneumonia and stopped the empiric Ceftriaxone and azithromycin.  Acute hypoxemic respiratory failure.  Albuterol, Spiriva, QVAR, supplemental oxygen, RT. Discharged once stable on steroids and inhalers.
Infant was found unresponsive in crib at home.  Parents brought child to emergency room. Follow up: COD is SIDS per ME's office. Copy of final autopsy report is awaiting the ME's signature. ER Report received on 11/22/2004 states pt experienced respiratory arrest.  Autopsy Report received on 12/01/2004 states SIDS.
Weakness, nausea, headache, extreme coughing, runny nose, sore throat. Everything started a month after the vaccine.
By April 1st his coughing started to get worse but there was no fever. He saw a doctor because he was wheezing, and he was put on a antibiotic and steroid liquid and a nebulizer. We were instructed to continue treatment three times a day. His coughing improved but a few days later his coughing got worse again. The doctor gave him a steroid injection, a new antibiotic, and new nebulizer. At this point they called it asthmatic bronchitis. He still had no fever. Then from there he got better. We continued the nebulizer treatments and antibiotics. We finished out the prescribed treatments. We were cleared on April 7th. We finished the antibiotic April 14th, and he has been good ever since.
3/29/2021- received vaccine around 12:15pm  Within 3 hours, I was extremely "hyper"  My husband noticed that my entire left arm (which received the shot) was a different color than my entire right arm.  I did not sleep at all Monday night. 3/30/2021- felt fine until about 1:00pm when I noticed body aches.  It worsened from then until bedtime.  My hands, feet, and back hurt the worst.  I asked my husband to rub my back, and he gasped when I lifted my shirt.  My entire midback area was covered in a bright red, raised rash with blisters. I took Benadryl and applied betamethasone prescription cream (which I use for poison ivy or bug bites).  My hands also itched, so I used the cream on my hands as well. I was sweating profusely but freezing.  Took my temperature several times but it was never over 98.  I could not sleep well, awake for an hour, asleep for 5 minutes off and on all night. 3/31/2021- I notified my primary care physician of the allergic reaction via the patient portal.  His reply was to take Benadryl, which I was already doing every couple hours.  The itchy back rash remained and more blisters formed.  By the time I finished working, the redness was gone but the blisters remained.  Itching stopped.  Body aches were lessening. 4/1/2021- Rash completely gone, itching completely gone.  Feeling lethargic (possibly due to lack of sleep, but maybe from the vaccine).  One large blister (size of a quarter) and several smaller blisters remain. 4/2/2021- as of now, my left arm is still a bit sore when I raise it over my head.  Main concern is the huge blister that is still on my back.
Pfizer Bivalent administered 15 days after initial Pfizer primary series.  Patient should have received 2nd dose of primary series 21 days after receiving the first dose
tingling sensation; she fell down and could not get up; She stated that she is able to use her left hand but it is very painful.; pain in the joints, ankle, knee, hands; numbness; This is a spontaneous report from a contactable consumer (patient). A 91-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Mar2021 (Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced tingling sensation, she stated that she is able to use her left hand but it is very painful, she fell down and could not get up, pain in the joints, ankle, knee, hands, numbness. On 10Mar2021 morning she has been having symptoms, like stoke (that is what she calls it she said) she fell down and could not get up, pain in the joints, ankle, knee, hands. Pain the hands got worse and have numbness, can't pick up things, numbness moves to the hand and fingers. Caller wanted to know can she safely take the second dose. The following morning (on 10Mar2021) she woke to a tingling sensation in her left ankle/foot that progressed to her leg and eventually into her left hand. She stated that it feels as if these regions of the left side of her body have fallen asleep and are waking up but the sensation is continuous. She stated that she is able to use her left hand but it is very painful. She wants to know if she will ever recover from these symptoms and what her recourse is. She has since canceled her appointment to receive her second dose of the vaccine. The outcome of the events was not recovered.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
arm pain/arm is sore where she got the shot; shivering; body aches; headache; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported), via an unspecified route of administration on the arm on 29Dec2020 at 15:20 at single dose for COVID-19 immunization.  Medical history included thyroid issue, low blood pressure from an unknown date and unknown if ongoing, surgery for an ovarian cyst in 1999 (She had surgery for an ovarian cyst 21 years ago), cyst on her tailbone removed in 2016 (had cyst on her tailbone removed 5 times. The first removal was in 2016. It was removed twice in 2017 and then twice in 2018). Concomitant medication included levothyroxine sodium (SYNTHROID) for thyroid issue. The patient got the vaccine on Monday (29Dec2020) and waited the 15 minutes then felt okay. Then on Tuesday (30Dec2020) she developed/woke up with arm pain and shivering, body aches and mild headache. She woke up with arm pain, shivering, body aches, and headache. The patient states it is very mild. She is sitting there shivering and has body aches. No joint pain. Her arm is sore where she got the shot. When you feel pain, you automatically have a headache. Side effects started this morning around 9:30AM or 9:45AM. She felt nothing when she was in the bed. When she went into living room for breakfast she felt shivering. She called her friend that got the injection yesterday too and her friend feels ok and gave her the number to call. Therapeutic measures were taken as a result of the events which included treatment with Tylenol. The patient was recovering from the events.   Information about lot/batch number has been requested.
Onset of COVID symptoms 11/8, tested positive for COVID 11/10/21.  admitted from the floor earlier today for acute hypoxic respiratory failure secondary to Covid PNA. Patient was initially a transfer from a hospital on 11/13. Admitted after he needed NIPPV.  Intubated 11/17 and paralyzed and proned 11/17.  Deceased 11/28/21.
This case was reported by a consumer and described the occurrence of nasal congestion in a 65-year-old male patient who received FLUARIX. In November 2015, the patient received FLUARIX. On an unknown date, less than a month after receiving FLUARIX, the patient experienced nasal congestion, flu and sickness. On an unknown date, the outcome of the nasal congestion, flu and sickness were unknown. It was unknown if the reporter considered the nasal congestion, flu and sickness to be related to FLUARIX. Additional details were as follows: This case was linked to a case US2016GSK028216 for which upon the receipt of follow up information the present case for the suspect vaccine was created. The patient received follow up and he planned to return form but preferred no contact to his treating physician. The patient reported being sick after vaccination with the Flu while on VENTOLIN HFA (see linked case). The patient also reported congestion during the sickness. Sickness or flu occurred about 2 weeks after receiving the Flu vaccine. The patient attributed this flu vaccine to a lack of effect or coverage of the 2015-2016 influenza shot he received. The patient felt as though the shot was not formulated to cover the correct strains. The patient was unable to provide manufacturer or brand name of the flu shot. The patient declined to provide further details for follow up safety report.
According to patient on 1/6/21 around 400 PM,, one week post 1st  dose Moderna injection, right arm injection site started to itch.  On the morning of 1/7/2021, patient noted site was red, warm and tender to touch.  Reported to RN and MD and observed  erythema approximately 1 " circle around injection site, warm to touch with slight swelling. Itching somewhat subsided.
The patient did not have an adverse event from this vaccine. He should have received the first dose of the Pfizer Covid 19 vaccine series. This would have been his first dose. We were doing both vaccines in the clinic and the nurse gave him the Bivalent as his first dose in error.  We wanted to report this event.   Thank you
I had internal bleeding from ulcers in my stomach and small intestine and I had Afib. May 15th - I went to ER - I went to Hospital. I was transferred from there because they didn't have a GI doctor on staff - to Hospital.. I received blood transfusions 8 units of blood. Was put on several medications.  Medications - I was put on Amiodaron and Dojoxin (that was stopped so I'm not taking it now - I didn't need it anymore); put on Ferrous Sulfate; Pantoprazole;  - those were the new ones I was put on. Have almost recovered.
Patient experienced red hot face, hives at injection sites and on chest and shoulder.   She went to urgent care and states she was treated with benadryl injection, cortisone shot and given rx for oral prednisone and loratidine.  She went to work the next morning but is stating that she is feeling flushed. She is going to contact her PCP now.
pt had temp of 104 that wouldn't come down;mom took pt to ER;crying uncontrollably, unable to be comforted;
Experienced Shortness of Breath about 3 minutes after the vaccine was admistered.  BP 168/80 - O2 sats 99.  STated feeling better and slight notice of breathing.  Shortly thereafter HR 34-40 briefly and not feeling right. EMS called.  HR quickly returned to baseline in the 80s.  BP 173/80.  Patient has a history of HTN and did not take BP meds that Am.  Given a lighter surgical mask as patient's mask felt "thicker than normal".  EMS arrived, vitals were stable.  Patient was feeling better, no more SOB.  Patient cleared and released.
pt recv vax 21JUL95 & pt exp 12-15 lesions in different stages, some still vesicular;JUN96 pt exp a low grade fever; no further details were provided;
About 16 hours after PNEUMOVAX vaccine was given, pt had total muscle weakness, no strength for both legs, went to ER at hospital. After about 12 hours they released him. His heart rate was 148; 17,000 was his blood count after 24 hours he was a little better. Still 60 days later and after a regiment of physical therapy, pt still has major muscle weakness, more so on the right leg, pt used to walk with a cane. He now can only walk with a walker. Pt was given this PNEUMOVAX vaccine 4 times in 7 years. The last one which has more disabled him was given 6 months after the previous one. Overdose.  - 7/27/04, 8/16/05, 10/26/10, 5/13/11.
Chills/rigors; wheezing; shortness of breath; cough; myalgias; local vaccination site swelling as well as tenderness and colorimetric changes (looked like a POPeye arm with yellow/green tingling hanging down in a large tear drop); local vaccination site swelling as well as tenderness and colorimetric changes (looked like a POPeye arm with yellow/green tingling hanging down in a large tear drop); local vaccination site swelling as well as tenderness and colorimetric changes (looked like a POPeye arm with yellow/green tingling hanging down in a large tear drop); local vaccination site swelling as well as tenderness and colorimetric changes (looked like a POPeye arm with yellow/green tingling hanging down in a large tear drop); This is a spontaneous report from a contactable physician (patient). A 66-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3283), via an unspecified route of administration on 20Jan2021 at a single dose on Right deltoid for COVID-19 immunization. Medical history included Chronic lymphocytic leukemia with 65% of cells lymph's, low WBC count (13500) otherwise; DM2, A1C usually close to 6.1; HTN. Unspecified concomitant medication taken. The patient previously took nickel and experienced allergies. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9331), intramuscular on 31Dec2020 12:15 PM at a single dose on left arm for COVID-19 immunization. The patient experienced chills, rigors, wheezing, shortness of breath, local vaccination site swelling as well as tenderness and colorimetric changes (looked like a POPeye arm with yellow/green tingling hanging down in a large tear drop), cough, myalgias on 20Jan2021 23:30. Therapeutic measures were taken as a result of the events which included Benadryl, Aleve, Nebulizer treatment, change in local temperature to help stop rigors. The outcome of the events was recovering. No other vaccine in four weeks. The patient was not pregnant. Not diagnosed with COVID prior vaccination. Not COVID tested post vaccination.
This consumer spontaneous report (initial receipt 23-Apr-2014) concerns a female patient). On an unspecified date, the patient received unspecified influenza virus vaccine (manufacturer and batch number not provided) and unspecified DTAP (manufacturer and batch number not provided). On an unspecified date, the patient was hospitalised for low blood sugar. The outcome was reported as unknown.
Pt reported that almost immediately after receiving the shot, he felt a warm/burning sensation, that did not go away. By 10pm when the pt went to try to sleep for the night, the pain in his arm was intense to the point that he was unable to move it, and he also started feeling a headache (pt reports that he doesn't normally get headaches). At midnight he was unable to sleep and took 2 ANACIN. At 9AM the next morning, pt took 2 TYLENOL. At 3pm he reported a fever of 100.1 F and he also experienced a slight amount of nausea, not to the point that he felt like vomiting, but rather just a queasiness feeling. By the time I spoke with pt 3 days later, the pt report that he was feeling no nausea, no fever, and while his arm still ached, it was no longer the unbearable pain, but now a level he could tolerate.
Information has been received from a physician concerning a 19 year old female with unspecified drug reactions/allergies and medical history who was vaccinated IM with a first 0.5 ml dose of GARDASIL (route and lot number not reported). The physician stated that "after getting vaccinated with her first dose of GARDASIL. It was unspecified if the laboratory tests were performed. Therapy was discontinued "after the adverse event occurred". At the time of the report the outcome of the patient was unspecified. The patient sought unspecified medical attention. Follow up information has been received from a physician concerning a 19 year old female with no medical history reported and no known drug allergies and no illness at the time of vaccination who on 14-MAY-2009, at 02:34p.m., was vaccinated into the left deltoid with first dose of GARDASIL (route not reported, lot number 659054/0315Y). There was no concomitant medication. On 16-MAY-2009 the patient experienced on and off chills, vomiting for one week, fever for three days and hot and cold sweats. No laboratory testing was done. Subsequently, the patient recovered from on and off chills, "nauseated", vomiting, fever, and hot and cold sweats. No further information is available.
Miscarriage; she received first moderna vaccine while pregnant; Nausea; Headache; Vomiting; This spontaneous retrospective pregnancy case was reported by a patient and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 23-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (she received first moderna vaccine while pregnant), NAUSEA (Nausea), HEADACHE (Headache) and VOMITING (Vomiting). On 15-May-2021, the patient experienced ABORTION SPONTANEOUS (Miscarriage) (seriousness criterion medically significant). The delivery occurred  on 15-May-2021. For neonate 1, The outcome was reported as Spontaneous Abortion NOS. On 23-Mar-2021, EXPOSURE DURING PREGNANCY (she received first moderna vaccine while pregnant) had resolved. At the time of the report, ABORTION SPONTANEOUS (Miscarriage), NAUSEA (Nausea), HEADACHE (Headache) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  In about a period of two weeks, the ultrasound indicated that the baby's heart beat was non-existent and on 15 May 2021, the patient had a spontaneous miscarriage.  Date of last menstrual period and estimated due date were not provided.  No treatment was given.  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.   This case was linked to MOD-2021-226308 (Parent-Child Link).   See case MOD-2021-226308 for details regarding the child case.; Sender's Comments: 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.
Patient described a redness on his arm that appeared about 10 days after the vaccination.  Resolved after a couple of days without any issues.
Td (Tetanus diphtheria) booster dose given intradermally - dispensed & mislabeled as tuberculin (TUBERSOL) by pharmacist. Pt developed painful, indurated, erythematous, edematous skin rx x 3 days.
Soreness at injection site about 6 hours after injection. Extreme fatigue, thought I couldn't drive home from work. Around 9 hours after injection unimaginable joint and bone pain. Every single bone hurt so bad I cried for hours on end and even percocets did not subdue the pain. The following day, day 3 now, I felt sick to my stomach and short of breath. Aches went away though. Next day 4 just felt winded with little exercise . Day 5 fine. One lingering effect is pain in my left armpit by breast. Will have my doctor check it out in June.