chrisvoncsefalvay/vaers-outcomes huggingface dataset:
FLARE UP; Headache; Fatigue; JOINT PAIN WHEN WEATHER CHANGES; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (FLARE UP), HEADACHE (Headache), FATIGUE (Fatigue) and ARTHRALGIA (JOINT PAIN WHEN WEATHER CHANGES) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Plaque psoriasis and Psoriatic arthritis.    Concurrent medical conditions included Plaque psoriasis and Psoriatic arthritis.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced CONDITION AGGRAVATED (FLARE UP), HEADACHE (Headache), FATIGUE (Fatigue) and ARTHRALGIA (JOINT PAIN WHEN WEATHER CHANGES). At the time of the report, CONDITION AGGRAVATED (FLARE UP) had not resolved and HEADACHE (Headache), FATIGUE (Fatigue) and ARTHRALGIA (JOINT PAIN WHEN WEATHER CHANGES) outcome was unknown.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial  No concomitant and treatment information was provided.  The reporter's causality with Humira (adalimumab) for the event condition aggravated was a reasonable possibility, for the events headache and fatigue was no reasonable possibility and for arthralgia was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Patient is a 65-year-old female with a past medical history of allergies to multiple products including but not limited to perfumes and seafood, experiencing and adverse reaction to COVID-19 vaccine within first five (5) minutes and treated with Benadryl PO (25mgs). Outcome resolved favorably with assistance of Paramedic on-site. Team Leader (RN) completed the report at vaccination site.
?Covid Arm?. Red slightly painful lump At injection site that started day after injection and lasted for about 3 days.  Then 7 days after injection an itchy red rash developed at the injection site.
Pt. returned c/o itching and swelling to face. No c/o SOB. ER called and pt sent immediately to ER for evaluation.
3:45 pm T 97.8 P-86 R-12 PO2 92-96% BP 139/99. C/O intermittent nausea, dizziness, shortness of breath. PO2 drops to 85% for 5-10 sec then returns to 98-100% c/o nausea, dizziness, shortness of breath when PO2 decreases to 90%. Transported to Emergency Room by ambulance at 5:15 pm.
3 pts recvd 3 doses of Engerix-B & have not responded; Reporter indicated that they were checking for core antibody not surface antibody;
Pt. c/o waking up with burning, itching, and swelling to the extremitiy in which the vaccination was received.
Began to develop rash on neck and front chest on 12/31/2020; progressive got worse and spread to upper arms on 1/3/2021.  Rash continues and on 1/5/22021 spread to lower ext extremities.  Taking Benadryl 50 Mg at night and Allegra 180 during the day to manage the rash.   Mild chest pain on the left upper chest; cannot differentiate if it was a muscular pain or actual chest pain.
Dizzy 8 days later developed itching at the injection site, a raised area the size of a quarter that was red appeared
Welts all over body like the size of a dime that itch and irritates him.
Breakthrough case admission after 3rd vaccine; Pfizer x 3 Pfizer 3/22/21 Lot# EP7534; Pfizer 4/12/21 Lot# 044B21A;  11/18/21 Pfizer Lot3 fh8028
She got her vaccine, she started to feel tired and her arm swelled up.  Has a bump that hurts and is still present.  She started getting tingling in her body and got dizzy, and felt that her brain went to the left side and lost her perspective.  Her eyes also felt dry.  She drank a sports drink.  She went to work and did not feel well.  She got home and collapse in the bed.  At 4:00 AM she was not able to walk and had to call her husband to help her go to the bathroom, her temp was 103 and she was hot, had chills, thought she had the flu.  Could not get her head off the bed and got very dizzy.  She was turning in circles as she was confused and could not figure out which direction to go and vertigo was bad.  She took Tylenol every 3-4 hours and put ice packs on her body.  She called the hospital and they advised her to do that, she works in the hospital, and this subsided.  She then realized the 2nd day that her head was itching, had tingling and numbness in her hands and all through her body, has pain around her joints.  Her left arm has the bump and is not able to raise her arm to wash her hair to weakness and pain.  She cannot drive due to not able to keep her arm for a short period of time.   She started scratching her head.  When she went to work and scratched her head and had clumps of hair in her bed and in her hand and loosing it.  She had to get her hair cut short due to the hair loss.  Her head was coming out at the roots, not just breaking.  She is trying to take Biotin and taking Vitamin B12 shots as she is mildly anemic.  She is going to have blood work to see if there is something going on.  She feels like she has brain fog, and cannot process thoughts like she used to.  Time is very slow and feels very confused.  She is depressed due to this.  She was forced to take the vaccine due to her work, as she works in the hospital, and was told that if she did not take it she would be terminated.  She then asked for religious exemption but they gave her a hard time and she had to use the mask at all times everywhere in the hospital, and could not talk to people, and if she got caught without the mask she would be terminated.  Due to the pain in her knees she went to her orthopedist who gave her a shot, and that said that it could be from the vaccine as it may attack the weaknesses in her body.    She feels that she needs a vitamin infusion.  She gets confused now with directions, feels like an onset of dementia.
Sudden Deafness in right ear. 12 days of aggressive oral steroids, then 2 injections of steroids into middle ear about 1 week apart. Outcome: PERMANENT DEAFNESS in right ear!!!!!!!!!!!
Erythema to right deltoid induration of approx 2 cm.  Warm to touch.  Noticed day after injection
Flu; Initial information received on 22-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer/non- health care professional via social media.  This case is linked to case 2020SA300020 (same reporter).  This case involves patient (unknown gender and age) who experienced flu (influenza), while he/she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received INFLUENZA VACCINE [lot number: unknown and expiration date: unknown] at an unknown dose via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, (latency unknown) the patients experienced flu (influenza) (non-serious).  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was unknown.  There will no information on the batch number for this case.
Patient fainted and was unconscious for about 10-20 seconds. Patient also felt nauseous and vomited. Paramedics were called and patient was examined. No further treatment needed.
covid 19; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (covid 19) in a 67-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 049D22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Dose 1, Lot 029L20A) on 18-Feb-2021, Moderna COVID-19 Vaccine (Dose 2, Lot 046A21A) on 18-Mar-2021, Moderna COVID-19 Vaccine (Dose 3, Lot 027H21B) on 18-Nov-2021, Moderna COVID-19 Vaccine (Dose 4 and Lot 049L21A) on 02-May-2022. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.    On 12-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 15-Aug-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced COVID-19 (covid 19). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, COVID-19 (covid 19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Aug-2023, Body temperature: 100.7. On 15-Aug-2023, SARS-CoV-2 test: Positive.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Concomitant medication details not reported by the reporter. It was reported that patient did not seek medical attention but would do so if her symptoms worsen.
2 days after immunization, patient had extensive rash all over legs.  day 3 after vaccination patient received steroid injection.  2-3 days after this, patient had swelling of hands, lips, ears.  Patient has had to receive several rounds of oral steroids.  As soon as she is finished, the rash comes back. rash may present on back, stomach
Began feeling very achy with violent chills in the evening. Took appropriate ibuprofen dose for adult. Took temperature at 11:00 PM (about one hour after ibuprofen) and oral temperature was 101.0 F. Temperature decreased during the night, but was still 99.0 F in the morning and still somewhat achy.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 22-JUL-2013, the patient was vaccinated with a dose of VARIVAX (Merck) (lot # J001179, expiration date 31-JAN-2015, dose, frequency, route and indication not reported). The vaccine was stored improperly at temperatures up to 21F from 01-JUL-2013 to 08-OCT-2013. On 08-OCT-2013, the vaccine was discarded. No adverse effects were reported. It was unspecified if the patient had sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
With the first shots, only felt tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (With the first shots, only felt tired) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Breast cancer and Thyroiditis. Concomitant products included TAMOXIFEN for Breast cancer, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroiditis NOS, VITAMINS NOS and CELECOXIB (CELEXA [CELECOXIB]) for an unknown indication.    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 FATIGUE (With the first shots, only felt tired). At the time of the report, FATIGUE (With the first shots, only felt tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication use was reported.   This case was linked to MOD-2021-396274 (Patient Link).
Follow up information received 9/2/03 from the physician provided additional patient details and concomitant vaccines administered. A nurse reported that an 11 month old female received her 3rd dose of Prevnar on 12/12/02, at the age of 6 months. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 2/11/03. Dose regimen was 1 dose (IM). Concomitant therapy included 3rd doses of Tripedia and ActHIB. On 7/12/03, the child developed pneumococcal pneumonia and sepsis, and was hospitalized. Initial treatment included IV and IM ceftraixone, followed by oral amoxicillin. No additional information was available at the time of this report.
Patient collapsed within minutes if receiving vaccine. She stated started feeling dizzy, was unconscious for a few minutes. She hit her head during the fall and had pain and a headache. Rescue was called and she was taken to ER for further evaluation.
Sore arm 2nd day, day 6 itching, day 7 red hard lump around injection site, day 11 lump and redness 8? - 8? itching stopped Treatment - ice packs, ibuprofen
some soreness at injection site & behind her ears since receiving the vaccine; Caller noticed a rash under her left breast. Caller described it as deep red & painful; Caller noticed a rash under her left breast. Caller described it as deep red & painful/She had a previous rash that came back; she had some back pain; This is a spontaneous report from a contactable consumer (patient herself) from a Pfizer sponsored program.  A 76-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot/Batch number: unknown), via an unspecified route of administration on 10Mar2021 as a single dose for COVID-19 immunization. The patient's medical history included rash (rash was prior to vaccine). The patient's concomitant medications included Pravastatin as a blood thinner; Lisinopril for blood pressure, Levothyroxine 100mg and Metoprolol-ER Scciniate (100mg once per day after a meal). On 15Mar2021, the patient noticed a rash under her left breast and described it as deep red & painful. The patient reported her previous rash that came back. The patient also had some back pain. The patient was wondering if she could take the second dose. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
This spontaneous case reported by a patient, describes the occurrence of rash (in arms and upper legs), vaccination site pruritus (very itchy wanted to tear her skin off) and vaccination site rash  (around site of injection) in a female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 023C21A and 016C21A) for COVID-19 immunization. Concomitant products included Tylenol (paracetamol) for an unknown indication. On Apr 29, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On May 27, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced rash (in arms and upper legs), vaccination site pruritus (very itchy wanted to tear her skin off) and vaccination site rash (around site of injection). At the time of the report, rash (in arms and upper legs) and vaccination site rash (around site of injection) resolved; and vaccination site pruritus (very itchy wanted to tear her skin off) outcome: unknown. No treatment details reported.
very dizzy/light headed; heart palpitations; felt like a knot in throat and could not take deep breaths; This is a spontaneous report from a contactable consumer, the patient. A 40-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: er 8727), via an unspecified route of administration in the right arm on 24Mar2021 at 13:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medications included ibuprofen (ADVIL) for unknown indication from an unknown date. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: en 6205) via an unspecified route of administration in the left arm on 03Mar2021 (at the age of 40-years-old) as a single dose for COVID-19 immunisation and buckwheat on unknown date and experienced anaphylaxis. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25Mar2021 at 18:30, after receiving second dose of vaccine 24 hours later, the patient experienced heart palpitations, got very dizzy and light headed, and felt like a knot in throat and could not take deep breaths. Since then, patient was feeling lightheaded and dizzy and it wont go away. The events resulted in doctor or other healthcare professional office/clinic visit twice and its been 5 days and events did not subside. The clinical outcome of event dizzy, heart palpitation and difficulty breathing was not recovered.   No follow-up attempts are needed. No further information is expected.
Within 24 hours local reaction of induration, pain, itching, erythema approximately 12 cm diam. Started antihistamine; Abx., cold pack.
9/26/12- onset of hives 9/27/12 - hypotension (BP 78/40) requiring IV steroids, fluids, and antihistamines in ED. Started on PO steroids and antihistamines. 9/29/12 - continued hives and eye swelling leading to ED visit, despite continued PO steroids and antihistamines 10/6/12 - continued hives and lip/tongue swelling leading to ED visit, despite continued PO steroids, antihistamines, and ranitidine. 10/17/12 - hand and finger swelling despite continued PO steroids, antihistamines, and ranitidine (hives remitted) Currently under care of an allergist.  IgE tests negative for all foods eaten the day the hives began.  ANA, ESR, rheumatoid factor, CBC, comprehensive metabolic panel, complement tests all negative / within normal limits.
About 3-4 days after vaccination, numbness started in my feet and gradually traveled up my legs to stomach, chest, arms over a period of about 2 days. Numbness receded slowly over 2-4 days.  Breathing was difficult for 2 days. Numbness still remains in my left leg.  Very overly sensitive to temperatures causing pain. Weakness in left leg. Itches at times and is painful to scratch. Sensitive to light touch. Water splashing on leg is very painful (ie showering).
Patient received the FluMist on 10/24/07.  She began having increased coughing shortly after the shot.  She took Claratin as recommended by her physician.  On the a.m. ofo 10/28/07, patient was experiencing mild wheezing but went out of town with her highschool band for a contest.  I was called at 3:00 p.m. and notified that patient was short of breath and wheezing to the point that she was "squeeking".  A physician onsite listened to her chest and said she was very restricted and wheezing and recommended using an inhaler.  Patient was then transported to a local clinic.  I was telephoned from the clinic by the physician treating patient who said her oxygen saturation was 92% and that she was very "tight" in her lungs with significant wheezing.  I spoke with patient and she was barely able to speak.  Patient was given a nebulizer breathing treatment and an injection of Rocephin and Solmedral.  It took over 1 hour for patient's oxygen saturation to raise to 95%.
On 10/30/02 received immunizations DTaP #4 R th. On 11/1/02 had reaction to DTaP R thigh upper came in at 9:40am.
pt devel 10-12 chicken pox lesions following exposure to a child who had devel chicken pox following vax
Pt. reports that she received her yearly influenza vaccine on 10/28/15 during flu clinic and was fine until 1 week later when she developed severe right upper arm pain and had difficulty moving or lifting her arm. Pt. went to the orthopedist for evaluation and had MRI dine which showed a hematoma which the doctor thinks is r/+ the vaccine. Pt. treated anti-inflammatory medication (can't remember name) and has an appt. for repeat MRI with contrast scheduled on 11/7/15.
After an hour I started feeling a headache, and bone aches, shortly after I started have shortness of breath. About 10 hours later I have all the above as well as muscle aches, coughing, and tight lungs. My arm is very sore too of course, I can barely lift it.
Moderna Covid Vaccinations 03/24/2021 AND 04/21/2021.  Patient admitted to floor bed covid positive 8/27/21
This spontaneous report was received from a physician refers to a male patient of unknown age who on 19-JUL-2012 was vaccinated with the first dose of GARDASIL (Lot number, route and dose not reported) and on 27-DEC-2012 was vaccinated with the second dose of GARDASIL (Lot number, route and dose not reported). No other co-suspects were reported. No concomitant medications were reported. The patient was not experiencing any known symptoms. Patient's outcome was unknown. Additional information has been requested.
Medical assistant ordered to give shingles - gave VARIVAX. No adverse symptoms, signs (patient says even after 2 months).
little sore arm; little woozy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 83 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 22Jan2021 (Lot number: EL9263) at the age of 83 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "difficulty walking" (unspecified if ongoing), notes: The patient had difficulty walking before, she has spinal stenosis.; "spinal stenosis" (unspecified if ongoing), notes: The patient had difficulty walking before, she has spinal stenosis.; "Arthritis" (unspecified if ongoing), notes: Verbatim: Arthritis; "Thyroid" (unspecified if ongoing), notes: Verbatim: Thyroid. Concomitant medication(s) included: SYNTHROID taken for thyroid disorder (ongoing). Vaccination history included: Flu shot (AE(s) following prior vaccinations flu shot, sore arm, in October LOT/NDC/EXPIRY unknown), reaction(s): "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "little sore arm"; DIZZINESS (non-serious), outcome "unknown", described as "little woozy".  Additional information: Reportedly, the first injection was given on 22Jan2021 was the first injection, somewhat of the side effects but not too bad. It was reported that with the first injection the patient had a little sore arm, she was ok, little woozy.  No follow-up attempts are possible. No further information is expected.
NEXT DAY STARTED WITH A SLIGHT HEADACHE, MEMORY LOSS, VERY TIRED. AND STILL HAVE THESE
Day of shot had severe swelling, redness, bruising and soreness. Soreness, swelling, redness and bruising has finally subsided after 7 days. Had chills and fever the day after the injection. Started with rash over entire body 5 days after injection. Started getting chills and fever every day rash has appeared. Rash subsides a little during day and after shower at night whole body becomes red including face. Still experiencing rash and chills. Started taking Tylenol and Benadryl.
7 hours from vaccine, my heart started palpitating and I started feeling sick. I got in my car to go home from a friends house and started severe chills and called Doctor for fear of heart attack. They told me to go to ER. I continued driving home. Chills got worse. I got in shower with heater on and chills persisted. Drank coconut water and heart palpitations resided.  Got in bed and fever spiked to 102 and every bone was inflamed in pain. Nyquil did nothing. After a few hours of severe and unbearable pain I called ER. Headed over to ER at 3:00 a.m. and sat in parking lot. Fever broke at 3:00 a.m. which was hour 14 after vaccine. Other than severe nausea, pain calmed down. Drove home with Tylenol. Took 1,000 mg and finally rested at 4:00 a.m. Woke up at 8:00 a.m. with nausea but pain gone. 24 hours from vaccine, most of the reaction gone. 48 hours out body normal but pain in injection site.
pt exp leg cramps since the vax in both legs & lt foot;spasms are in rt leg the most;pt woke up during the noc most of the time;pt has been taking physical therapy & hurt worse afterwards;