chrisvoncsefalvay/vaers-outcomes huggingface dataset:
51 year male presented to vaccine clinic, scheduled for a Moderna booster. Reconciled past immunization records on databases, pt had received 1st  dose (1/05/21) and 2nd dose (01/28/21) of Moderna and indicated to proceed with administration of 3rd dose. Pt received 0.5cc of Moderna on 10/21/21 @ 14:57, double the recommended volume of 0.25cc for booster. Pt did not have any allergic reaction or adverse event during 15 min monitoring period nor upon leaving.    Moderna Lot #11F21A, exp 1/19/2021
Severe nausea 4-6 hours, fever (101.1), chills, body aches, and headache 24 hours.
Immunized on 8/9/2019 (Friday).  Very fatigued over the weekend and spent most of the day in bed.  8/12/2019 c/o legs feeling shaky, unsteady gait, fear of falling, "jitteriness in the legs."  .  Symptoms progressed through the week.  Fear of falling increased especially with going down steps or walking down incline.  The 3rd week after immunization, symptoms became worse and contacted family doctor.  Physician exam on 9/3/2019 - c/o sweaty several times/day, heart beating funny but relieved with Valsalva, gait more unsteady.  Today (9/9/2019) unsteady gait continues, reflexes - ok, no foot drop, no falls, denies muscle weakness, most unsteady when going from sitting to standing position, fear of falling continues - especially with downward incline.
I received the shot on my left side. I have under arm soarness and swelling. I experienced symptoms of a cold w/o a temp and extreme tiredness.
Has rash 1 month post flu shot.  Localized to silver dollar size around site of injection.
Narrative: 8/20/21 patient states: I got the Moderna Covid shots back in March/April. After the first shot I had pain that went away after some time but I then developed long lasting side effect like nerve damage pain burning itching in  my right arm from my shoulder to my hand. 11/14/21: per patient -Parsonage Turner Syndrome Brachial Neuritis This is concerning my chronic shoulder pain and arm nerve damage since getting the COVID shot#1 in my right arm. I am doing the Occupation Therapy appointments 11/17/2 per provider: ordered Nerve condition test and an RT shoulder Xray done on that arm Patient states he is still chronically having pain 7 months after vaccination
The next day it was hard for me to sleep. I had a high fever and my arm was sore at the site of injections.
Received the 1st dose of COVID vaccine, felt well when she left, but developed a lot of fatigue and was in bed by 7 pm, very unusual for her. She woke up next day and had some swelling on her forehead and generalized itching.  She took an Allegra and facial swelling resolved.  No perioral swelling or lesions. No erythema.  Then had 3 episodes of vomiting.  Still feels nauseated.  She contacted her PCP, who advised being seen.  Pt uses Singulair at night, Allegra or Zyrtec in morning if she is itchy.  Pt denies cough, shortness of breath, abdominal pain, diarrhea, skin irritation.  For Nausea and vomiting, intractability of vomiting not specified, unspecified vomiting type- ondansetron ODT (ZOFRAN ODT) 4 mg oral tablet,disintegrating; Dissolve 1 tablet on tongue and swallow every eight hours as needed for nausea/vomiting.  Dispense: 15 tablet; Refill: 0.  Pt appears well. No facial swelling.  History consistent with allergic reaction to COVID vaccine.  No evidence of anaphylaxis.Pt to self-report to Occ Health and agency.  I also left message at Occ Health.  Zofran ordered prn nausea.   Pt has an Epipen.  She lives with her husband, who can also monitor her. To ED if she develops fwelling, shortness of breath, cough, wheezing, persistent vomiting, or otherwise worsens.
Tdap and VARIVAX injection site became sore and warm on evening she received injection. Today Tdap site (L) deltoid red (55mm) VARIVAX site back of (L) arm red (44mm). Both areas warm and painful to touch. Arm sore with lifting. 8/28/13 sites have cleared - no redness /pain. Small bump at Tdap site per client.
Dermatographia, hives. Starts in hands and scalp, spreads to entire rest of body. No closing of throat or shortness of breath, only intense itching and can draw on skin.
extensive macular, erythematous, lacy rash all over body including palms & soles;low grade fever x48hr;tx DPH/calamine lotion;APAP;
pt recvd vax 250PM 26OCT95 & 7PM-730PM severe back & joint pain, h/a, chills, fever;1145PM stiff neck, backache;27OCT95 red rash, (disappeared in 24hrs), palms of hands red, skin felt like sandpaper, t104 w/chills, severe nausea;
A pharmacist reported that a male received an injection of Flu Shield '00-'01 in 11/00 and subsequently, has experienced irritation of his eyes when using contact lens solution containing thimerosal. The reporter indicated that the pt had no previous history of sensitivity to thimerosal. No further information was available at the date of this report.
leg weakness. On Arpil 11,2021 I fell, hit the rght side of my body against a tree and landed on the ground.  Had a hard time breathing when I fell.   I went to ER on 4/12 . no fracture on ribs, left tiny avulsion fracture on foot.  Seen primary care provider on 4/20 was sent to ER due to increase shortness of breath. Was put in  hospital observation 24 hours  and had a stress stress test, echo and labs .  have been to ER twice for same issue. I have had 2 complete pulmonary function tests- negative., CT High Resolution, CT PE protocol, numerous  labs, chest xray.   I have seen Pulmonologist, Rheumatologist and my primary care provider  ,  I have leg weakness, fatigue, lack of energy, shortness of breath walking more than 50 feet, increase blood pressure, my Lupus has flared up,  lack of vocal cord usage, muscle weakness and nausea..   Since seeing my primary care provider I have been put on other medications,  Coreg, Losartan, Zofran, Clonidine.
Narrative:  COVID infection after completion of COVID vaccine series: 06/01/2021 Covid vaccine dose (J&J) 07/13/2021 Pt reported onset of cough, diarrhea, HA, myalgia, and rhinitis. Pt later stated that sone also COVID and "gave it to him." 07/15/2021 COVID positive per nasopharyngeal swab 07/17/2021 Pt report BP 187/103 during video visit. Advised to go to ED for further assessment. 07/17/2021 Per ED note, no further tx req'd and pt discharged home 07/19/2021 Pt reported experiencing nausea, but this could also be from chemo 07/20/2021 Pt reported improvement of cough, onset of fatigue 07/21/2021 Pt reported continued improvement of sx 07/22/2021 Clinical resolution of COVID infection
HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 16-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of headache was not reported. This report was non-serious.
Immediate hematoma at injection site, normal injection soreness, no itching, no redness. 10 minutes later felt dizziness and light headedness but it only lasted 5 minutes. 20 minutes later pt still has a small bleb at injection site.
Patient came in today, 8/27, complaining that his right hand was feeling numb from the mid-forearm to the finger tips of the arm that was not vaccinated. Said that the symptoms started about 3 hours after his vaccine was administered and it has not gotten better.  He said it felt like it tingled to the touch, but did not hurt, he was having a hard time keeping his wrist upright when holding his arm parallel to the counter.  He could move his fingers but felt like it was limited movement.  He was able to touch each finger tip to his thumb.
cold; severe headache; he headache was severe to the point it would hurt to open her eyes.; vomiting; She had an arm pain; Her whole body was aching; chills; joint pain; tired; She didnt have an appetite to eat; She had a bad and wet cough and mucus in her cough; voice has changed; This is a spontaneous report from a contactable consumer. This consumer reported for a 32-year-old female patient (granddaughter) received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: FA7484 and expiry date were not reported), via an unspecified route of administration, in Arm Right, on 23Jul2021 at 12:15 PM (age at vaccination: 32 years), as dose 1, single dose for COVID-19 immunization at pharmacy/drug store. Vaccine was administered at private facility. The patient's medical history was none. Concomitant medications were not reported. The patient was taking Pfizer Covid 19 vaccine to prevent the Covid 19 virus. The reporter was calling on behalf of her granddaughter. She received the first dose on 23Jul2021. The same night she experienced severe side effect such as severe headache. The headache was severe to the point it would hurt to open her eyes. The next day she was vomiting. She had an arm pain. Her whole body was aching. She had chills, joint pain and felt tired. The reporter told her she had some liquids but she didn't have an appetite to eat. She developed a cold on 24Jul2021. She had a bad and wet cough and mucus in her cough on an unspecified date in Jul2021. She wanted to know if the second dose was recommended. The second dose was scheduled for 13Aug2021. She was feeling better now. She was afraid as she heard some people report death and heart problems post vaccination. The reporter stated her granddaughter did not take any medication and she was healthy. The patient's voice has changed on an unspecified date in Jul2021. The patient did not take any medications, she was fine before the vaccine. She didn't have things go wrong with her. The patient was an energetic and hyper person. Overall, she reported her symptoms have improved. The adverse events did not require a visit to emergency room and physician office. Outcome of the event voice has changed was unknown and for all other events, it was recovering.  Follow-up attempts are completed. No further information is expected.
RASH / HIVES TO NECK, CHEST, AND FACE; SLIGHT HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient experienced drug allergy when treated with erythromycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and batch number: 1805020 expiry: 25-MAY-2021) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced rash/ hives to neck, chest, and face. On 10-MAR-2021, the subject experienced slight headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slight headache, and was recovering from rash/hives to neck, chest, and face. This report was non-serious.
Quadracel vaccine was givent to a 4 month old, no adverse event; Initial information was received on 13-May-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case is linked to cases 2020SA126031 (same reporter).  This case involves a four month old patient who was administered DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (inappropriate age at vaccine administration).  Medical history, concomitant medication, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On 11-May-2020, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot number and expiry date not reported) via intramuscular route in left thigh for prophylactic vaccination.  It was a case of an actual medication error due to product administered to patient of inappropriate age.  The patient received Quadracel in fourth month. No other vaccines were given on that day. This was the third DTaP and first Ipol.  At the time of report, no adverse event was reported.  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 2001/83/EC and Module VI of the Good Pharmacovigilance 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.  There will be no information available on lot number for this case.
Patient complained to clinic staff of itching approximately 25 minutes  post vaccine administration. Vaccine administered around 1245.  BP  and pulse assessed by nursing staff 132/80 pulse 90 SpO2 94% on room air. Patient skin is red and blotchy. Relates throat is scratchy and begins to cough. 1307 pm 911 called. 0.3mg Epinephrine administered IM to right thigh. Client relates relieve and improved breathing. 1312 BP assessed 122/78, pulse 96, SpO2 96% on room air. Patient is talking feely and is no longer coughing.  Client transferred per self to private exam room. 1316 noted patient lips are slightly swollen and she is clearing throat and occasional cough. When asked if she is having a increased symptoms patient reported yes. 1316 0.3mg Epinephrine IM administered to left thigh. Ambulance arrived 1317. Patient related improved symptoms. Report provided to EMS along with symptom history. Client taken by ambulance to hospital.
PAC; Shortness of breath; Sore arm; Chills; Nausea; Vomiting; Fever / fever went to 103.6; Sweating; Extreme Headache; fatigue; complete body ache; illness; Third dose was administered; Third dose was administered; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received the third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 08Oct2021 13:00 (Batch/Lot Number: FF2590) (at the age of 62 years old) as dose 3 (booster), single dose for Covid-19 immunisation. Medical history included hypothyroidism and fibromyalgia. The patient had no known allergies. The patient was not pregnant at the time of vaccination. The patient did not have Covid-19 prior to vaccination. The first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was administered on 09Mar2021 at 09:15am (Batch/Lot No: Pfizer EN6199) (at the age of 61 years old) in left arm, second dose on 25Mar2021 at 10:15am (Batch/Lot No: Pfizer ER8732) (at the age of 61 years old) in left arm, both for Covid-19 immunisation. Concomitant medication included unspecified prescription medication. Third dose was administered on 08Oct2021 at 13:00. The following day, 09Oct2021 at 10:00, the patient experienced shortness of breath, sore arm, chills, nausea, vomiting, fever/fever went to 103.6, sweating, PAC's (premature atrial contraction), extreme headache, fatigue, complete body ache, and illness. They lasted for 6 days (as reported), fever going lower and lower. Patient had two ER visits and visit with her own personal internist doctor. Treatment received: Tylenol and potassium. The events resulted in emergency room visit and physician office visit. The patient underwent lab tests and procedures which included body temperature: 103.6 on 09Oct2021 at 10:00; Cat Scan, Blood Work, and X-ray in Oct2021 with unknown results; Covid-19 PCR/Nasal swab: negative on 10Oct2021. Outcome of the events was recovering.
Patient felt swelling on her bottom lip and her throat so we gave her 25mg of Benadryl and 50mg of Tylenol and monitored her blood pressure which was normal
- Itching legs - Dizziness - Throat started to feel thick (I notified the EMS workers at the observation area) - Hives on right upper torso (was given one dose of Benedryl) -Hives spread to left upper torso (another dose of Benedryl) -Blood pressure was 160/100 - to the best of my memory and my heart rate was elevated) -Rapid heart rate - Symptoms did not decrease (was given an Epi Pen injection - left leg) (transported to ER by ambulance) - EKG performed - Steroid given - Bloodwork done - (the only medicine given as a result was Potassium as my level was low) - I was observed until 7:00 to see if I showed any symptoms after the Epi Pen wore off. - Released with a prescription for Prednisone
muscle pain; fatigue; going downhill with her health; Her arm was sore with the covid vaccine; She's out of work and has been feeling so lousy/Feel horrible; 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 61-year-old female patient received BNT162b2 (COMIRNATY), on 18Mar2021 as dose 1, single (Lot number: ER2613), on 08Apr2021 as dose 2, single (Lot number: EW0153) and on 07Jan2022 as dose 3 (booster), single (Lot number: FJ6369) at the age of 61 years for COVID-19 immunization. The patient's relevant medical history included: "Fibromyalgia" (unspecified if ongoing), notes: Comments: Fibromyalgia Diagnosed for 32 years; "Rheumatoid arthritis" (unspecified if ongoing), notes: Rheumatoid arthritis Diagnosed at least 3 years ago or longer.; "compromised immune system" (unspecified if ongoing), notes: she has a compromised immune system. The patient took concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Jan2022, outcome "not recovered", described as "Her arm was sore with the covid vaccine"; FEELING ABNORMAL (non-serious) with onset Jan2022, outcome "not recovered", described as "She's out of work and has been feeling so lousy/Feel horrible"; FATIGUE (non-serious) with onset Jan2022, outcome "not recovered"; GENERAL PHYSICAL HEALTH DETERIORATION (non-serious) with onset Jan2022, outcome "not recovered", described as "going downhill with her health"; MYALGIA (non-serious) with onset Jan2022, outcome "not recovered", described as "muscle pain". The events "muscle pain", "fatigue" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient had not prior vaccinations (within 4 weeks) to the first administration date of the suspect vaccine. Patient family medical history relevant to AE(s) was none. Caller stated that she received her first booster dose of the Pfizer-Biontech COVID-19 vaccine on 07Jan2022. And ever since she has experienced muscle pain and fatigue. She wanted to know if these were common side effects due to the vaccine. Patient had the COVID booster shot; she has a compromised immune system. Ever since then, she has been going downhill with her health. She has been out of work for 3.5 weeks now. Symptoms were all in her muscles and she's fatigued. She felt like she can't function from the fatigue. She enquired that, this is a side effect, has this happened before? What should she do? Her muscles were in so much pain. She was out of work and has been feeling so lousy. She has not been doing much. Felt horrible.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) on or about 21-OCT-2011 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 08-SEP-2015, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster. The patient was prescribed unspecified pain medication for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Had a mild headache and felt like I had a cold coming on for 2 days.  After that I felt flushed but had no fever.  I also felt fuzzy like you do with the flu, and have had a lot of nausea, and excessive belching.  I also still have a small rash at the injection sight.  Last night I had some blisters appear on the inside of my lower lip. I feel a little better today but not completely back to normal.
2 days p/vax pt exp stiffness, pain & swelling in all joints;got progressively worse on days 3 & 4;used med to relieve sx;minor stiffness & pain lingers in some joints;
Moderna COVID19 Vaccine is approved for pts age 18 or over. Pt was screened improperly and was given the vaccine 2 months prior to turning 18. Pt received vaccine under mother's guidance and consent. No adverse reaction reported.
Within 10 minutes horrible headache and tasted metallic taste.  In an hour my face and tongue was numb. The headache got more and more extreme The next morning people at work noticed I was slurring my words. Felt like crap full body aches and extremely tired. Went to the hospital and it was determined I have bells palsy.  Still have headache and facial paralysis
Received vaccine approx. 4:30pm and by 7pm the pt developed fever of 103 deg. F. which elevated to 104 deg. F over that evening. Tylenol/Motrin given. Ran low-grade fever 100-101 for two days after.
Date of 1st COVID vaccine: 11/13/21.  Patient began experiencing concerns of progressive weakness following 1st COVID vaccine.  Symptoms worsened after 2nd COVID vaccine.  Date of 2nd COVID vaccine 12/11/21.  Patient presented to  emergency room on 12/14/21 with complaints of bilateral leg weakness, episode of falling, and gait difficulty x 2 weeks.  Pain worsened and spread to bilateral arms and neck 1 week ago.  3 days prior to admission he had loss of bladder sensation and trouble with bowel movements. He was admitted with concern for Guillain Barre Syndrome.
AFTER FLU SHOT, PATIENT FELT TIRED,WEAK. IT WAS GETTING WORSE, HE DID NOT HAVE ENERGY TO HOLD THINGS. HE WAITED FOR 3-4 DAYS THEN SAW DOCTOR, INFORMED BY MD THAT HE GOT GBS. NOW HE IS RECOVERING.
about 20 minutes post-injection, nose & cheeks became red & swollen; voice became raspy, difficulty breathing, called PMD.  took 25 mg Benadryl & within 20 minutes symptoms resolved; 3:30 pm symptoms returned - took another Benadryl (25 mg) & again symptoms resolved.  10 am on 11/7/07 - symptoms did not return; feels fine.  has had flu vaccine each year before.  10/01/2007, received PPV23 @ PMD; injection site reaction:  swelling, redness, soreness, itching; resolved over 4 days - Benadryl; in 1995 had reaction to flu vaccine (below)
still feel deathly ill; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On 21-SEP-2023, the patient received RSV vaccine. In SEP-2023, an unknown time after receiving RSV vaccine, the patient experienced feeling unwell (Verbatim: still feel deathly ill).  The outcome of the feeling unwell was not resolved.   It was unknown if the reporter considered the feeling unwell to be related to RSV vaccine.     It was unknown if the company considered the feeling unwell to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 22-SEP-2023 The patient self-reported this case via interactive digital media. The patient got his/her RSV vaccine yesterday (from reporting date) and still feel deathly ill. The patient asked how long it would last.