chrisvoncsefalvay/vaers-outcomes huggingface dataset:
He has tested the patient for allergic reaction to the flu shot and she is negative; hives; This spontaneous report was received from a physician referring to a 12 year old female patient with allergy to shrimp/shellfish. The patient's pertinent medical history and concomitant medications were unknown by reporter.      On 13-NOV-2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) by intramuscular route for prophylaxis (indication also reported as "HPV for age hpv and flu vaccine") and received a flu shot (influenza virus vaccine (unspecified)). The immunizations were given at a different providers office. later, on this same vaccination date, patient developed hives and took diphenhydramine (BENADRYL); patient had no other sign and symptoms. One day after, on 14-NOV-2019, she recovered from this condition. Physician requested information to advise of patient should take the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) or was there a way to refine of the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was the cause of the hives. Physician had tested the patient for allergic reaction to the flu shot and she was negative (allergy test negative). He did not know a way to test for allergic reaction to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). No product was retrieved as the immunization was given almost a year ago.  At reporting time, the outcome of allergy test negative was unknown. The causality assessment was not reported.
Fever of 104, went down to 102 with Tylenol.  The fever and body aches lasted untill 3/30/21 approximately 9 pm.
Information has been received from a physician concerning a 15 year old female with sulfonamide allergy who on 14-Dec-2006 was vaccinated with a first dose of Gardasil vaccine (yeast) (lot#653650/0697F) pre-filled syringe IM into the left deltoid. Concomitant vaccination on 14-Dec-2006 included a dose of influenza virus vaccine (unspecified) (manufacturer unknown). On 14-Dec-2006 the patient experienced broke out in rash all over her body. There was no fever associated with the rash. It was unclear if there was any local rash or reaction at the injection site. At the same visit the patient was given amoxicillin for an unknown reason. As of 15-Dec-2006 the rash persisted. Additional information has been requested.
Immediate swelling to fist size bump. Slight itchiness. Resolved in 24 hours.
He initially felt numbness on his entire left leg and a small amount on his right leg. He then felt weak and had trouble walking, but was able to walk. He felt that he could not feel his feet so it made it harder to walk. His neuro exam was negative except for an unsteady gait. He had normal sensation to pinprick, light touch and proprioception. He had an MRI of his LS spine and it was unremarkable. The following day, he was numb from his buttock down both legs. He could not effectively push out a bowel movement and was more unsteady on his feet. He was admitted to the hospital and had an LS spine and thoracic spine MRI with gadolinium that were negative. Of note, his B12 level was 249 and he received a B12 shot. His symptoms started to improve slightly. He had less of a sensation of numbness and his gait improved slightly. He went home against medical advice because he felt that this was likely GBS from the flu shot and since his case was mild, he did not want further treatment. He is able to walk without a cane, but is someone unsteady. His breathing is fine and I will follow him weekly.
Started with body aches, chills, 102 degree temperature for about 15 hours, severe headache with neck, spine and hip pain, low appetite, nausea, unable to sleep.  For 2 weeks after vaccine, fatigue, brain fog and forgetfulness, exhaustion and some depression
Information has been received from a physician concerning a 13 year old female who on 26-MAY-1997 was vaccinated with the first 2.5 mcg dose of RECOMBIVAX HB. Concomitant therapy included TETRAMUNE, ORIMUNE and ENGERIX-B. Per serum hepatitis B surface antibody screen done on 29-JUL-2010, the patient did not have immunity to hepatitis B. Result was less than 5. At the time of the report, the outcome of the patient was unknown. Additional information has been requested.
Received Tdap (rt. arm) & pneumonia (left arm) 6/21 at 9:30 am. By end of day, left arm limp & having chills. 6/22 very ill & couldn't move left arm away from body. Gradually improved until 6/25 when rt arm couldn't be raised. Have seen doctor 2 times since because I'm experiencing painful arms - it's just not going away as doctor tells me it should. Never had daily aches & pains in arms prior to shots.
Developed a period of dizziness 30 mins after recieving MMR vaccine, later in the evening started to develop a rash. 4 days later, had muscle pain and a headache. Took 650mg of Tylenol.
My daughter received her second Pfizer vaccinations at 2:15 pm.  At 1230 at night she work up with stabbing chest pain in the center of her chest that lasted three hours.  She initially said her felt faint and couldn?t catch her breath as well as initial nausea.  Being an advanced healthcare professional, I spent five minutes of asking her questions:  did she eat something bad, did she feel like she needed and inhaler, did she need to use the restroom, checked her pulse (100bpm with palpitations), no resolve.  We live 5 minutes from hospital where we prefer to go, but my daughter didn?t think she could make the five minute ride there.  We went to ER that is around the block from us  and it was total chaos.  40 + people in the waiting room to be seen. My daughter was visibly in distress, crying and couldn?t keep still because of the intense chest pain she rated a 10 out of 10.  Finally they did a 12 lead EKG.  The rolled us to the back of the waiting room.  After 15 minutes, I rolled back out to the front desk and no attention to her and her severe chest pain.  Finally I announced we were going to hospital.  The called back to us? ?Good Luck!? Got pt to hospital and the  immediately did EKG, lab work, chest x ray, urinalysis. The  chest pain became intermittent then final subsided.  The doctors ruled out pneumonia, No PE, EKG WNL, lab work fine.  The Doctor stated it was chest wall pain and gave us a NSAID prescription. I talked to my sister who is an nurse works in the vaccination clinics.  She said she has  had patients who have had bouts of pericarditis and pleurisy after the second shot.  That motivated me to google second dose Pfizer reaction in teens.  There is a rare side effect of myocarditis in the teen population after the second dose.  The publication date was June 4  the day before my daughters reaction.  I didn?t thinsk the ER physician was aware of the the possible rare side effect of myocarditis in teens.  I was happy with the care we did receive.
Client received Hepatitis B #3 07/20/04.  07/21/04 noted itching to site left deltoid with a little red bump. Still itching after 1 week, then red bumps spread to left leg. By 07/31/04 notes red raised areas all over body. Client states Cortizone 10 used, will help with itching for a short time. Benadryl also used, but itching and red areas always return. Client has red, raised, itchy areas today 08/10/04.
Little redness but went away; Redness at the vaccination site; Size of half a dollar; Warm; Itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Size of half a dollar), VACCINATION SITE WARMTH (Warm), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE ERYTHEMA (Little redness but went away) and VACCINATION SITE ERYTHEMA (Redness at the vaccination site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE MASS (Size of half a dollar), VACCINATION SITE WARMTH (Warm), VACCINATION SITE PRURITUS (Itchy) and VACCINATION SITE ERYTHEMA (Redness at the vaccination site). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Little redness but went away). At the time of the report, VACCINATION SITE MASS (Size of half a dollar), VACCINATION SITE WARMTH (Warm), VACCINATION SITE PRURITUS (Itchy) and VACCINATION SITE ERYTHEMA (Redness at the vaccination site) outcome was unknown and VACCINATION SITE ERYTHEMA (Little redness but went away) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitants or treatment medications were reported.
Information has been received from a RN concerning a 41 month old white male with eczema and no allergies who on 15Nov02 was vaccinated SC in the right thigh with the first dose (0.5mL) of varicella virus vaccine live (lot 643529/0598M). Concomitant vaccinations on the same day included the third IM dose of hep B virus vaccine rHBsAg (yeast) (lot 543757/0781M) and the third IM dose of poliovirus vaccine inactivated (lot W0010). There was illness at the time of vaccination. The RN reported that on 10Apr05, the pt presented to the ER with scattered lesions on his trunk, face and groin. A diagnosis of chickenpox rash was made. The pt was not hospitalized. No treatment or lab/diagnostic tests were required and the pt was released from the ER. Subsequently, the pt recovered from his chickenpox rash. Additional information is not expected.
Blood pressure it was 200/ 110 pulse was 112; pulse was 112; Pains in  my chest; Left arm is tingling and numb at times; Left arm is tingling and numb at times; This case was initially received on 12Jul2021 and it was previously submitted under the incorrect Sender's (Case) Safety Report Unique Identifier JE-PFIZER INC-2021881208. The information for this patient is now filed under US-PFIZER INC- 02101295783. All subsequent follow-u p information will be reported under this manufacture number. This is a spontaneous report from a contactable consumer (patient).  A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in Arm Left on 01Jun2021 10:00 (at the age of 41-year-old) (Batch/Lot Number: Ew0178) as single dose for covid-19 immunisation. Medical history included hypertension, pain, post laminectomy syndrome, arthritis. Concomitant medications included oxycodone hydrochloride (OXYCONTIN) taken for an unspecified indication, start and stop date were not reported; oxycodone taken for an unspecified indication, start and stop date were not reported; diazepam (DIAZEM) taken for an unspecified indication, start and stop date were not reported; metoprolol taken for an unspecified indication, start and stop date were not reported; ondansetron (ZOFRAN) taken for an unspecified indication, start and stop date were not reported; certolizumab pegol (CIMZIA) taken for an unspecified indication, start and stop date were not reported; amlodipine taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 11May2021 (lot number Ew0182. Vaccine location=Left arm) for COVID-19 immunization. The patient received the second shot at 10am. At 3 pm, had pains in her chest, took blood pressure it was 200/ 110 pulse was 112. called Dr they sent her to ER; she still have chest pains and have to see a heart doctor. She has never had any heart issues. She had 4 back surgical procedures done. Her left arm was tingling and numb at times. Events onset date was 01Jun2021; outcome was not recovered.
After the first vaccine, patient had a severe headache and some fatigue for about 24 hours, but after the second vaccine she has a major ME/CFS relapse and has been unable to get out of bed or care for herself in any way for the past two weeks.
Patient had a reaction on her right side arm.  She described a softball size red reaction.  It was warm to touch and was sore for a week.
61 years old received Fluzone High-Dose/no AE; 61 years old received Fluzone High-Dose/no AE; Initial information was received on 05-Mar-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2020SA062083 and 2020SA065020 via same reporter.  It was reported that 61 years old patient (unknown gender) was vaccinated with INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (product administered to patient of inappropriate age),(overdose) on an unknown date for prophylactic vaccination [lot number, dosing details, expiry date, route and site of administration not reported]   Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to inappropriate age at vaccine administration and overdose.   At the time of reporting, no adverse event 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.  Information on the batch number was requested.
Left arm hurt really bad when the needle was injected; Skin look like it got a sunburn over her shoulder; This spontaneous case was reported by a non-health professional and describes the occurrence of RASH ERYTHEMATOUS (Skin look like it got a sunburn over her shoulder) and INJECTION SITE PAIN (Left arm hurt really bad when the needle was injected) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) injection for Atopic dermatitis.    Concurrent medical conditions included Rash (the patient had a rash that comes back intermittently, it's still coming back, it was black, dry and itchy, it's on her abdomen, shoulder, back of neck, and her face under her nostrils) since 2020, Rash pruritic since 2020, Hypersensitivity and Atopic dermatitis. Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Sleep disorder, HYDROCORTISONE ACETATE (HYDROCORT [HYDROCORTISONE ACETATE]) for an unknown indication.   On 04-May-2021, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) 600 mg. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INJECTION SITE PAIN (Left arm hurt really bad when the needle was injected). In May 2021, the patient experienced RASH ERYTHEMATOUS (Skin look like it got a sunburn over her shoulder). At the time of the report, RASH ERYTHEMATOUS (Skin look like it got a sunburn over her shoulder) and INJECTION SITE PAIN (Left arm hurt really bad when the needle was injected) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This patient reported she was participating in a patient support program "PSP_DUPILUMAB_SAGLB.DUP.17.03.0229". and she was receiving dupilumab injections.  No treatment information was provided. Treatment information was not provided by the reprorter.   This case was linked to MOD-2021-215140 (Patient Link).
Late 2nd dose Shingrix; This non-serious case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received a dose of Shingrix on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Late 2nd dose Shingrix). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 18-May-2023 The reporter reported that if it had been more than 6 months since a patient received the first dose of Shingrix. The reporter asked that the patient did need to restart the series or could still get the second dose as soon as was feasible. The medical information did not speak with the health care provider, so please follow up with the sales representative for more information. Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Medium, Systemic: Shakiness-Severe, Systemic: Vomiting-Medium, Systemic: Weakness-Medium
About 6 days after receiving the Moderna vaccination my arm is itching, is sore to the touch and sore when I move it, it feels warm to the touch, is slightly red, and is swollen in that area.  The area is about 2" away from the injection site and is about 2" wide and 1" high.  It is now 3 days of having this.
Covid arm: injected area started getting swollen, tighten, and itchy after 5-6 days.
local 4cm swelling redness & pain, 5mm red macules on arms & trunk;
I started to experience weakness.  I cannot lift my saddle up on my horse.  I went to my PCP due to failing more.  I did physical therapy.  I also went to a doctor in another location, and I had neuropathy treatment.  I am still experiencing falling more than normal.  My PCP in another location and she has referred me to Clinic.  I am an active person.  I did have COVID in December of 2022.  I had symptoms of extreme headache and nauseous for three days.
pt recv vax & devel an inj site rxn characterized by swelling & redness approx 6 cm in size;
Woke up from dead sleep shivering. had chills; muscle ache; a fever of 102.8F; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EH9899 ) intramuscularly at the right arm on 22Dec2020 11:00 at single dose for covid-19 immunisation. Medical history was reported as none. The patient's concomitant medications were not reported. On 24Dec2020 01:30, the patient woke up from dead sleep shivering, had chills, muscle ache and a fever of 102.8 Fahrenheit. The patient did not receive treatment for the events reported. The patient underwent lab tests and procedures which included nasal swab SARS-CoV-2 test: negative on 24Dec2020. Outcome of the events was recovering.
PATIENT REPORTS SEVERE ARM PAIN FROM SITE DOWN INTO WRIST AND FINGERS. PAIN IS SO SEVERE SHECANNOT LIFT OR USE A SPATULA TO EVEN TURN EGGS OVER IN FRYING PAN.  STARTED ON SUNDAY 1/24/21  3 DAYS AFTER RECEIVING FIRST DOSE OF VACCINE. PAIN MINIMAL AT INJECTION SITE, BUT PAIN ALSO OCCURS IN SHOULDER.  UNABLE TO RAISE ARM ABOVE HEAD OR EVEN STRAIGHT OUT.  WAS SEEN IN URGENT CARE. PROVIDER REPORTS NO SIGNS OF PROBLEMS AT INJECTION SITE.  NO REDNESS, NO SWELLING, NO NECROTIC TISSUE.
When I first got it, I had a sore arm, about three days later my legs and ankles started to swell. On march 20th I have had the first of 5 stomach episodes, severe cramping like labor or menses  cramps, excruciating pain, I broke out into a sweat, vomiting this lasted about an hour. I felt like my heart wasn't going to make it bc I was in such pain, I had a bowel movement and felt better, then on May 19 I had the exact same stomach attack and I went to doctor and since then I have had 3 more of these attacks. The stomach episodes seem to be getting more frequent. I'm still having swelling in my legs. I still have tightness and pail behind my right ankle. Elevation doesn't help the swelling. They did find a blood clot in my right leg.
Numbness and weakness in arm at injection site and below; Numbness and weakness in arm at injection site and below; Numbness and weakness in arm at injection site and below; This is a spontaneous report received from a contactable consumer (patient). A 24-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: el 3249, expiry date: unknown), via an unspecified route of administration in the arm, on 26Jan2021 10:45, at single dose, for COVID-19 immunization, at the hospital. Medical history included anxiety and depression. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. Concomitant medication included vilazodone hydrochloride (VIIBRYD), lamotrigine, acetylcysteine (NAC), betaine, citric acid monohydrate, cobamamide, cocarboxylase, flavine adenine dinucleotide, folic acid, folinic acid, iron amino acid chelate, magnesium ascorbate, magnesium levomefolate, nadh, nutrients nos, phosphatidyl serine, pyridoxal phosphate, sodium citrate, zinc ascorbate (ENLYTE), and probiotics. The patient previously took cefaclor (CECLOR) and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2 vaccine. The patient experienced numbness and weakness in arm at injection site and below on 26Jan2021 10:45. No treatment for the events was given. The patient was recovering from the events.
Child started a 104.3 T about 24 hours after receiving vaccines. Marked irritability noted by mother but no other symptoms. Fever lasted about 6 days - would reduce but not to normal after ibuprofen. Evaluated by MD - no additional findings - MD attributed to "shots" per mom. See attached notes for details - Rx: Ibuprofen as needed. Referred to PMD for future shots.