chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever; she is tired; does not want to eat anything; This is a spontaneous report from a contactable consumer. This Consumer reported for a female Patient (Daughter) that: A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection Batch/Lot number was not reported) via an unspecified route of administration on 18May2021 as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. patient previously received first of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as single for COVID-19 immunisation. After received the second vaccine yesterday the patient experienced constantly running fever which is very high like 102.5, 102.9 she is tired, The patient's mother really do not know what to do with her because she does not want to eat anything on 19May2021. The patient underwent lab tests and procedures which included body temperature: 102.5 fahrenheit 102.5 and body temperature: 102.9 fahrenheit on 19May2021 102.9. She need somebody to tell her what was wrong with her kid she has a 102.9 fever. The outcome of events was unknown.  No follow-up attempts are completed; information about lot/batch number cannot be obtained.
have two autoimmune diseases; caught the flu and been very ill; Initial information received on 26-Dec-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves an unknown age and gender patient who have two autoimmune diseases and caught the flu and been very ill after receiving Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s)were not provided. Family history : mother with 4th stage COPD   On an unknown date, the patient received a unknown dose of suspect Influenza Vaccine produced by unknown manufacturer (lot number, strength, formulation, expiry date was not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed two autoimmune diseases (autoimmune disorder) (unknown latency) following the administration of Influenza Vaccine. This event was assessed as medically significant.  On an unknown date the patient developed a non-serious event "caught the flu and been very ill" (influenza) (unknown latency) following the administration of Influenza Vaccine.  It is unknown if there were lab data/results available.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for both the events.  At time of reporting, the outcome was Unknown for both the events.; Sender's Comments: Sanofi Company Comment dated 26-Dec-2022: This case involves an unknown age and gender patient who have two autoimmune diseases after receiving Influenza Vaccine. Furthermore, information regarding condition at the time of vaccination, medical history,  concomitants, lab data excluding other predisposing etiologies, intervention (if any), corrective treatment/medical management, would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Left leg started swelling about 3 hours after vaccine. Developed fever 8 hours after vaccine  to 102 degrees Fahrenheit at home 101.5 in ER. No erythema at site. Taken to ER where work up negative. Seen in office 12/2 minimal swelling, no erythema, no fever.
Pt began c/o itching 45 min. after receiving flu vaccine.  B/P 90/60,  HR 82, R 18.  No other symptoms noted.  Scratching arms, legs, and neck.
Narrative:  77yo male patient died of colon cancer with mets to the liver on 7/11/2021. Pt had received covid vaccines on 3/4/21 & 4/1/21. This death is not related to covid vaccines.
Hurt during administration. Felt dizzy waited 20 minutes. Went home still felt light headed, chills, fever and headache eventually developed. Took ADVIL. Next couple of days was fatigued, chills, stuffy nose, fever, cough with phlegm until Friday. Weekend felt fatigued/tired. Today feeling better. Has never had problems with flu or any vaccine before.
Swollen left leg because of DTAP.  Upper left leg warm to touch.  Erythematous.
Clinic Team Leader had mother check both childrens' forms to make sure information was correct.  Mom signed  forms and stated information was correct. Patient's birthdate was wrong.  I gave the Pfizer 6mos to <4years instead of the Pfizer 5-11.  Patient is 5 years old.  As soon as I noticed the error, I immediately told Mom.  Mom asked what could happen.  I stated the Pfizer dose would probably not be strong enough.  She stated that it was 'no big deal.'
10/13 evening injection site RUA sore slight redness, has headache, feels hot. 10/14 generalized body aches, fatigue, notices injection site larger inflammation. 10/15 develops fever 102.1-oral, shaking chills, RUA inflammation has spread 4.5x5 inches, warm and tender to touch. Assessed by NP, advised cool compress, elevate area, Tylenol 2 tab po q4h. Marked border of inflammation. If border spreads by tomorrow am, begin rx for Keflex 500mg qid #28. NP cell # provided to call if questions.
Exactly an hour after recieving the shot, I started horribly itching from head to toe and had a red rash. I took 2 zyrtec. The allergy meds helped but once they wore off I would start itching. Two days after the shot my face got really puffy especially around the eyes. For six days I took 2 Zyrtec in the morning and 1 benadryl at night. After 6 days of the allergy meds I finally was back to normal.
.25mg Moderna for a 1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (.25mg Moderna for a 1st dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (.25mg Moderna for a 1st dose). At the time of the report, INCORRECT DOSE ADMINISTERED (.25mg Moderna for a 1st dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications or treatment details were reported.
Tubersol was given in the right forearm. Then Hepatitis B was given IM in the left deltoid. The patient was complaining of nausea immediately. Approximately 40 seconds later nonresponsive. Epi pen was given. The patient did respond to questions approximately 15 seconds after epi given. Sent to the ER. Appeared to be a seizure.
Case previously recorded as MA2009-3968. Initial case report received from a nurse, via Novartis Medical Communications, on 06 NOV 2009. A 7 month-old male patient was vaccinated with 0.5 ml of S-OIV FLUVIRIN (batch no. 102044P1) i.m. on 06 NOV 2009, an off-label indication. No adverse event was reported. MedCom reference no.: NA09-007775.
Swelling of tongue; Swelling of lips; Swelling of eyes; Trouble swallowing; Itching on my body and scalp; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (Swelling of tongue), LIP SWELLING (Swelling of lips), EYE SWELLING (Swelling of eyes), DYSPHAGIA (Trouble swallowing) and PRURITUS (Itching on my body and scalp) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWOLLEN TONGUE (Swelling of tongue), LIP SWELLING (Swelling of lips), EYE SWELLING (Swelling of eyes), DYSPHAGIA (Trouble swallowing) and PRURITUS (Itching on my body and scalp). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 1 dosage form. At the time of the report, SWOLLEN TONGUE (Swelling of tongue), LIP SWELLING (Swelling of lips), EYE SWELLING (Swelling of eyes), DYSPHAGIA (Trouble swallowing) and PRURITUS (Itching on my body and scalp) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Had two Covid p.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  It was reported that 12 days later the patient began having symptoms and the patient realized later that were of covid.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: NNI
Approximately 6-7 hours after injection, I experienced mild facial swelling and redness.  No pain or other rashes.  No respiratory effects.  No medications were taken to treat the symptoms, and they had subsided by morning.  Moderate arm pain near injection site started around 2-3am, and has continued throughout the next day.
headache immediately after vaccination lasting approx. 15 minutes; sore throat upon awakening in AM, fatigue during the day after vaccination, low grade fever and chills; excessive post nasal drip, runny nose in following days up to the present, excessive phlegm/mucus, chest ache, excessive fatigue, dry red itchy eyes, muscle aches; worsening sore throat; chest ache, sleeplessness, exhaustion, low-grade fever and chills at present 4/27/2010 2:44 AM...
has a running nose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Lot number: FF2593) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacture by- Unknown, Dose No- 1), for COVID-19 Immunization; Covid-19 vaccine (Manufacture by- Unknown, Dose No- 2), for COVID-19 Immunization. The following information was reported: RHINORRHOEA (non-serious), outcome "unknown", described as "has a running nose". Therapeutic measures were taken as a result of rhinorrhoea.  Additional information: Caller said her husband took all 3 shots and had running nose. She said his nose runs like a sieve and runs constantly. She doesn't want to speak for him. He has to take a decongestant. Unable to obtain full details. Caller declined to complete report. He was taking a decongestant twice a day since his nose was running. Husband's nose started running after hers and husband has had all three shots.   No follow-up attempts are possible. No further information is expected.
Patient stated that she had an allergic reaction to fist dose of Pfizer Vaccine, Patient stated that she has hives all over her body. Patient states that reaction started of 06/27 and has gotten worse, she visited her doctor. Patient was prescribed cream and steroid for relief and neither has worked.
Hives throughout entire body, swelling in throat and tongue, itching, feverm warm to touch, pain.
Pain, swelling, redness, w/in 10 min, nausea, fatigue and fever at night.
WEIGHT LOSS; HEADACHE; PAIN AT INJECTION SITE; FATIGUE; NAUSEA; LACK OF APPETITE; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's past medical history included brain aneurysm. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid, and calcium carbonate.  On 06-APR-2021, the subject experienced lack of appetite. On 06-APR-2021, the subject experienced headache. On 06-APR-2021, the subject experienced pain at injection site. On 06-APR-2021, the subject experienced fatigue. On 06-APR-2021, the subject experienced nausea. On 12-APR-2021, the subject experienced weight loss. Laboratory data included: Weight (NR: not provided) lost 4 pounds. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from weight loss on 13-APR-2021, and headache on 12-APR-2021, was recovering from fatigue, nausea, and lack of appetite, and had not recovered from pain at injection site. This report was non-serious.
admitted on 11/22 for COVID PNA and was admitted to the hospital on 12/2 for increasing oxygen requirements. PMHx of atrial flutter, hypothyroidism, DM2, Follicular Lymphoma receiving monoclonal antibody therapy, chronic GERD, BPH. He was treated with Remdesivir, Dexamethasone, and Baricitinib. Baricitinib had to be discontinued early secondary to lymphopenia. As oxygen requirements declined, the patient was transferred to the stepdown unit. While in the stepdown unit, the patient had an increase in his oxygen demands again. For this reason he was transferred back to the medical ICU. Patient remains on HFNC. Patient found to have RLL segmental artery acute PE and moderate left pneumothorax.  Pigtail chest tube was placed 12/4.  However, on 12/5 patient had increasing oxygen requirements and increased work of breathing.  CXR showed re-accumulation of pneumothorax due to the chest tube being kinked.  Placed a new chest tube and patient required intubation 12/5. 12/6 chest tube was removed without residual pneumothorax. Patient has slowly continued to deoxygenate with maximum vent settings, VC 500TV 100%FiO2 Rate 24. Patient's spouse, was called about futilities of Full Code status and she decided that it was in the patient's best interest to make her husband DNAR. 12/7, the patient continued to decline, with O2 saturation <70% on maximal vent settings. On 12/07/2021 at 11:07 CST the patient was pronounced dead with wife bedside. Cause of death: acute hypoxic respiratory failure 2/2 COVID pneumonia and immunocompromised state.
PT WAS SITTING IN POST-VACCINATION AREA. HE COMPLAINED THAT HE IS VERY NAUSEATED. HE VOMITTED AND FELT BETTER. HE STATES THAT HE ATE RIGHT BEFORE GETTING THE VACCINE.
9OCT91 pt recvd flu vax; 15OCT91 vomiting, high fever seen by MD initial labs showed elevated liver function tests which resolved by 22OCT91;
Narrative: 67 yo male developed hypotension after his 1st and only dose of Jansen Covid -19 vaccine. Hypotension resolved after oral fluid ingestion.
Soreness at the injection site/arm; Soreness at the injection site/arm; I am currently breastfeeding at time of vaccination; I am currently breastfeeding at time of vaccination; This is a spontaneous report from a contactable consumer (patient). This consumer reported information for both mother and baby. This is the maternal report. This consumer (mother) reported for herself that: a 37-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: Ek9231), via an unspecified route of administration in Left arm on 08Jan2021 11:15 at single dose for COVID-19 immunization. Medical history included ongoing breast feeding. There were no Known allergies. Concomitant medication included escitalopram oxalate (LEXAPRO), ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS). There were no other vaccines received in four weeks. The patient did not have covid-19 prior vaccination and did not have covid-19 tested post vaccination. The patient was currently breastfeeding at time of vaccination and would continue to do so. The patient experienced soreness at the injection site/arm starting a couple hours after administration on 08Jan2021 13:15 and lasting 1 day. The patient did not receive any treatment for events soreness at the injection site/arm. The outcome of events soreness at the injection site/arm was Recovered in Jan2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021022052 Same reporter/drug, different patient/event (baby/mother case)
Erythema, itching, and warmth over injection site. Approximately size of a quarter. Treated with Motrin, ice, and Benadryl.
I had a very bad sore throat and low-grade fever. I tested positive for COVID-19 on 03/05/2023. I was prescribed PAXLOVID by my primary care provider. Since taking the treatment, I'm doing pretty fine.
27jun89 pt vax hepta B w/in several days pt developed muscle weakness, joint pain & GB sx /w inability to stand.pt treated w/ diflunisal(MSD) and electromyogram was performed. unable to work one week.still experience weakness of upper back.
2nd booster. Everything was fine day of (Thurs morning). Saturday night around 9pm I looked at my arm & noticed there was a large red spot near the injection site (bigger than a golf ball). It is NOT raised, itchy, or painful, but feels warm to the touch. I called the pharmacy to report it at  10:20am today (Sun) and was told to report it to this site. I was not asked or told to go back in. They said if it 'lasts longer than 2 weeks' I should get it checked.
Information has been received from a medical assistant concerning a 15 year old female who in approximately March 2008 and in October 2008, was vaccinated with first and second doses GARDASIL (dose, route and lot number not provided). The medical assistant reported that on 13-FEB-2009 the patient had surgery for ovarian cysts. The reporter stated that the patient was hospitalized (name, address and phone number of hospital unspecified) but did not specify how long the patient was in the hospital. The reporter considered ovarian cysts as an other important medical event. Additional information has been requested.
Developed a hoarse voice around noon time; developed fever around 6:00 PM which got progressively worse 102.5 to 103.5 Tylenol/Ibuprofen did not significantly help fever; brought it down only 0.4 degrees. Parents took child to ER. Were told that child either has the flu or could be reaction to vaccine. Child still running fever Monday 11/16/09 at 3:30 pm (101 -102.5).
Headache, NauseaVomiting, fever, chills, headache, N/V, bone aches, fatigue, SOB, injection site pain Narrative:  Patient had COVID and recovered in March. Hx of asthma Was fine until vaccination on Monday. Reports experiencing all of the same side effects as when he had COVID: fever (101 F) nausea/ vomiting bone aches, chills, fatigue, chest tightness/SOB persistent headache injection site pain
Metallic taste in her mouth; Slight numbness feeling on her tongue; Slight arm pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 53 year-old female patient received bnt162b2 (BNT162B2), administration date 21May2021 12:50 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization, reaction(s): "Arm didn't hurt like it did after the first one". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset May2021, outcome "unknown", described as "Slight arm pain"; DYSGEUSIA (non-serious) with onset 21May2021 13:25, outcome "recovering", described as "Metallic taste in her mouth"; HYPOAESTHESIA ORAL (non-serious) with onset 21May2021, outcome "recovering", described as "Slight numbness feeling on her tongue".  Additional information: The patient received second dose of vaccine 2 hours ago that afternoon. She felt fine and her arm didn't hurt like it did after the first one. She stated that then she got a strong metallic taste on her tongue about 35 minutes after the shot. Her tongue felt a little numb. Her whole tongue had a metallic taste and then it faded and 30 minutes later she could taste it on the tip of her tongue and it was very slightly numb on her tongue. She wanted to make sure that this was a normal side effect.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient complained of rash, redness, pain and warmth RA. Advised to apply ice to area and OTC for pain or discomfort. Return if worsens.
pt vax hepta B.  pt devel. nausea, achiness & temp of 100.9 F.
24 hours after Pfizer booster injection, developed overall body urticaria. Symptoms continued and subsequently developed swelling in jowls, lips and redness to lower legs and swelling of legs and ankles.
The individual starts to show signs of anaphylaxis reaction some minutes after vaccination by the nurse. Said"I am not feeling good." Upon assessment, the individual is leaning his head backwards, unable to read how many fingers I held up; complained "can't see"; slow in responding. The individuals appears to be losing consciousness; eyes closed. Color of face pale. HR: 47; Pusle Ox 95%. RR:16. BP 112/64.  Epipen 1 dose administered L leg IM.  911 was called. Continue to monitor and check vital signs. BP 143/75, HR: 54 and pulse ox: 94%. At 0850:EMS arrived. VS remain stable. HR: 62; Pulse Ox 94%.  The individual starts to open up his eyes and responding. Parents at his side. He is taken to the ER. Followed up with the patient's parent, mom and is stable and doing better.
Symptoms started as ringing in left ear .  The symptoms increased over 10-14 days with addition of dizziness and hearing loss in the left ear.
3 small lumps under her chin; This spontaneous case was reported by a physician and describes the occurrence of SKIN MASS (3 small lumps under her chin) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. EYT721824) for COVID-19 vaccination.     The patient's past medical history included Cancer (Needs to get a control mammogram before April.) in 2003. Concurrent medical conditions included Diabetes, Heart disorder and Overweight (little overweight.).    On 03-Mar-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 SKIN MASS (3 small lumps under her chin). At the time of the report, SKIN MASS (3 small lumps under her chin) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided. Treatment information included "hydrating lotion for diabetics dry skin relief" on the affected area.