chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient stated she had a swollen arm, that felt like a knot, the area was painful to the touch and hot, patient couldn't move arm for 2 weeks
Headache, chills, sore injection site - nothing out of the ordinary - but became nauseous, had diarreah and then  FAINTED in middle of night.  Never fainted in my life.
Got super sick; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  A male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) as dose number unknown, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Got super sick".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Ache in arm by injection site in addition to elbow, then wrist area.  Pain escalated and got worse after the 1st day into the 6th day.  Dull ache is still present after the 9th day.  In addition, to ache in elbow and wrist occasionally.  Also, got very dizzy on 4/12/21 around 9PM . Not sure if vaccine related.  With dull ache around injection site continues.
White Rash located on the client's face, arms, and stomach.  Client's caregiver states that the sites where the rash appears does not itch. Also, the rash appeared on the face and has begun to spread throughout the last few days to rest of the body.
bells palsy seen at ER on 03-26-21; treated by ER physician with prednisone, valtrex
Pt reported dry mouth 2 hours after getting the vaccine. Five days later she noticed that her current size (#16) didn't fit her anymore.  She tried on size 16W, and didn't fit her either.  She realized her current size is 18.  Pt believes this is due to the vaccine she received on 04/11/2021.  Pt stated she will change her PCP because she wanted to report this and they scheduled her an appt in August 2021. Pt is looking for a new PCP.  Pt insists her pants are "unusually tight"
About 23 hours after shot, arm was very sore not only at injection site but in armpit area.  Later in the day, there was a knot in armpit area size of a golf ball.  Started feeling achy all over, had 3 blankets on and was still cold, vomiting for about 3 hours and extreme fatigue. Late same evening stopped vomiting and chills stopped, but still very tired and achy all over.  The next day still had extreme fatigue all day, no appetite and armpit still hurting.  Monday morning just felt tired and armpit just mildly sore with the knot that was there gone. As day goes on feeling better.
Swelling, fever, chills, could not move arm without severe pain. Dizziness, fast heart beat, weakness, hoarseness, difficulty breathing, nausea, pain, tiredness.
This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 68-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included hot flashes. Previously administered products included SHINGRIX (received 1st dose in fall of 2018). On 15th February 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). On 16th February 2019, 1 days after receiving SHINGRIX, the patient experienced fatigue and pain in arm. On 17th February 2019, the patient experienced chills, upset stomach, headache and malaise. On 26th February 2019, the patient experienced increased blood pressure and heart rate increased. On an unknown date, the outcome of the fatigue, pain in arm, upset stomach, headache and malaise were recovered/resolved and the outcome of the chills, increased blood pressure and heart rate increased were not recovered/not resolved. The reporter considered the fatigue, pain in arm, chills, upset stomach, headache, malaise, increased blood pressure and heart rate increased to be related to SHINGRIX. Additional details were provided as follows: The patient arm was sore and she was a little tired. Two days after vaccination, the patient experienced chills, upset stomach, headache and malaise. When she woke up on 17th February 2019, and stepped out of bed, she was exhausted and started to have chills, shivering, headache, and an upset stomach. She did feel good in general. The stomach problems lasted only one day but the other symptoms resolved after about five days except the chills which she still experiences. Eleven days after vaccination, the patient experienced blood pressure increased and heart rate decreased. Last week, she noticed her blood pressure had increased to around 150/90. Emergency room visit was required. It normally stays in the regular range but had increased at times with medication. However, it was remaining high and went to 189/117 this morning so her doctor prescribed medication. She was seeing her doctor tomorrow to try and determine if this might have been caused by the SHINGRIX or a new condition she was developing. Along with the increased blood pressure, her heart rate had increased. It usually was in the 80s but now falls within the 80s or 90s. The reporter consented to follow up.
Stuffed head and nose, sore throat, left side of neck sore, sores on tongue and cheek.
Pt's left deltoid to elbow to clavicle is red, swollen, hard, hot and itching. The right deltoid area is red, swollen and hot.
Information was received via a company representative from a female patient of unknown age referring to herself. The patient's medical history, concurrent condition and concomitant therapy were unknown. On 15-JUN-2016 the patient was vaccinated with ZOSTAVAX injection, subcutaneously (dose unknown). On 08-JUL-2016, the patient discovered lesions on the inside and the outside of her mouth and on the upper right side of her face and by her lip. The patient was treated with unspecified medications for the events. It was unknown of the patient assessment between the events and ZOSTAVAX was not reported. Additional information is not expected as there is no consent for follow-up.
After about 30 minutes post-injection, throat started to get tight and scratchy. After about an hour and a half, tongue went numb and throat did not get better, and was still tight and closing. Gave me prednisone and Benadryl and took albuterol inhaler that opened throat and that helped open throat and Benadryl helped with the scratchiness.
This spontaneous report was received from a male consumer of unknown age who reported on himself. It was reported that in January 2013 the patient was vaccinated with a 1st dose of GARDASIL (lot #, expiration date and dose was not reported) and on 04-MAR-2014 (reported also as today) he was vaccinated with his 2nd dose of GARDASIL (lot #, expiration date and dose was not reported). No adverse effects reported. Additional information is not expected.
Headache, Myalgia, chills for 3 days; nasal congestion since 2cd vaccine, continuous Narrative: Emp. reports permanent damage regarding nasal congestion that has been continuous since 2cd Covid vaccination
a patient was given fluzone high dose on 28-Oct-2019 and 12-Feb-2020; Initial information received on 12-Feb-2020 regarding an unsolicited valid non-serious case received from a non-health care professional.  This case involves 83 years old female patient who received an extra dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] on 28-oct-2019 and 12-feb-2020 (Extra dose administered).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 28-Oct-2019, the patient received first dose of the INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE prefilled syringe with an unknown batch number via unknown route in unknown administration site for prophylactic vaccination. On 12-Feb-2020, the patient received a second dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE  prefilled syringe(lot UJ307AA and expiration date 29-Jun-2020) via intramuscular route in the right deltoid for prophylactic vaccination.   It was an actual medication error case due to extra dose administered.  Since, patient received the annual vaccine frequently).   At the time of the report, no adverse events were 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.
Extreme itching, hives all over body, swelling, redness, overall feeling terrible. Still have no energy and not feeling well after 8 days. Treatment: given an IV and prescriptions.
Could not put my arm over my head for 10 mo!!; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 05-Dec-2020.  This case involves a patient of unknown demographics who could not put his/her arm over his/her head for 10 months (Injected limb mobility decreased), while the patient received vaccine Influenza Vaccine.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date were not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date, the reporter stated that he/she could not put his/her arm over his/her head for 10 months (Injected limb mobility decreased).  Action taken was not applicable.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown.  There will be no information about the batch number in this case.  The reporter assessed the causal relationship with suspect vaccine as related.  No further relevant information was reported.
Pt is 37 weeks pregnant.; Pt was supposed to have received Pfizer's RSV vaccine, but erroneously received Arexvy; Inappropriate age at vaccine administration; This non-serious prospective pregnancy case was reported by a consumer via call center representative and described the occurrence of wrong vaccine administered in a 35-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 05-OCT-2023, the patient received Arexvy (intramuscular, left arm). On 05-OCT-2023, an unknown time after receiving Arexvy, the patient experienced wrong vaccine administered (Verbatim: Pt was supposed to have received Pfizer's RSV vaccine, but erroneously received Arexvy) and inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: Pt is 37 weeks pregnant.). The outcome of the wrong vaccine administered, inappropriate age at vaccine administration and vaccine exposure during pregnancy were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK receipt date: 02-NOV-2023 The patient was 37 weeks pregnant.  The patient did not have any adverse reaction after vaccine was administered. The patient was supposed to have received Pfizer's RSV vaccine, but erroneously received Arexvy, which led to wrong vaccine administration. A35 year old patient received Arexvy, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
started treatment with Pfizer BioNTech COVID-19 vaccine dose 1 on 13MAR2021, and dose 2 on 16AUG2021; chest inflammation; chills; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP). The reporter is the patient. Other Case identifier(s): 2023NVX-US-000001244 (Novavax).  A 64-year-old female patient received bnt162b2 (BNT162B2), on 16Aug2021 as dose 2, single (Lot number: 033H21A) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: bnt162b2, administration date: 13Mar2021, for Covid-19 immunization, reaction(s): "chest pain", "tachycardia", "myocarditis". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "started treatment with Pfizer BioNTech COVID-19 vaccine dose 1 on 13MAR2021, and dose 2 on 16AUG2021"; INFLAMMATION (non-serious), outcome "unknown", described as "chest inflammation"; CHILLS (non-serious), outcome "unknown".; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300170002 same patient, different dose/event;
Tingling hands and feet whenever in warm/hot water, or on hot surface (ground, steering wheel, etc).
pt recv vax & 2wk post vax pt devel an afeb rash;
Patient described tightening to the throat. Went to the hospital and they gave him a Benadryl. Condition was then reversed. Patient is now fine and no further treatment was needed.
pt recv vax 26SEP94 & 15OCT94 pt devel an inch-long lump or nodule @ inj site;pt believes it was a delayed rxn to vax;no discomfort was noted;OCT95 raised area remained;
Fingers were turning red and itching; Itching in her toes; This is a spontaneous report from a contactable pharmacist (Patient). A 65-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: not reported, expiration date: not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced fingers were turning red and itching, itching in her toes. She had both doses of the vaccine and had potential side effects that were strange. A week after the first vaccine her fingers were turning red and itching. At first it was mild and she didn't pay much attention to it and it kept happening. Then she had itching in her toes and she was a little nervous about second vaccine but she ended up getting it. Clinical outcome of the events was reported as unknown.  No follow-up attempts are possible. No further information is expected. information about batch/lot cannot be obtained
Information has been received from a pharmacist concerning a patient who on an unspecified date was vaccinated with VARIVAX (Oka/Merck) when ZOSTAVAX (Oka/Merck) was intended. This was a misuse error not product confusion. No symptoms were noted. Additional information has been requested.
Patient is due for second shingles vaccination however she states that with the first shot in August about 3 or 4 days later she had itchy, swollen, red arm and also some headache.
Patient presents to clinic for symptoms which began today. Her PCP suggested she get covid tested.  This morning she developed left arm soreness at site of vaccine, significant nausea, mild malaise, and mild sinus congestion. No erythema or swelling to the vaccine site.  She had covid vaccine at Vaccine Center. She received Pfizer dose #1 on 3/29/21 and dose #2 on 4/19/21 Dose was Pfizer #2  LOT: EW0158 in left deltoid.  Dose #1 was Pfizer in right arm with no SE. OTC Tylenol for symptoms which helped arm.  Pain 0/10, but expresses nausea is quite significant  Patient was treated with ondansetron OCT 8mg tablets TID x 3 days as needed for nausea. She was instructed to take Benadryl as needed for  potential site reaction and NSAIDs for discomfort. She was instructed to watch for signs of evolving infection to injection site.
Fevers and Headache 1d following 2nd dose on 2/25/21. Fevers persisted for 3 weeks. LP showed +VZV PCR though normal protein, glucose, and WBC. No skin lesions and not immunosuppressed. Treated with 14d of IV acyclovir though headaches and fevers persisted. VZV may have been false positive, though treated regardless. He had 8 weeks of fevers and headaches started 1 day following 2nd dose. Extensive FUO workup has been otherwise unrevealing. Subjectively improved 2 months later.
Pt given the vaccine bivalent on 9/15/2023 after Agency redacted Bivalent. pt will be getting updated vaccine
Three days post vax, this pt experienced pain and redness at the injection site. Also, the pt's eyes were rolling back in his head. A neurological was planned The pt's eyes rolling back in his head was considered a significant medical event. A neurological assessment was negative for any type of seizure activity or disorder. The only abnormal finding was fluid in the ears, which the reporter said the physician indicated could account for some of the child's abnormal eye movements if he were experiencing ear pain. The pt was placed on rhinotan as treatment for fluid in the ears.
1st dose Sep2021, 2nd never; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in September 2021 batch number 75BA4 and expiry date 5th February 2023).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 14 NOV 2022 Reporter's comment: The reporter stated that the patient had the first dose of Shingrix in September 2021, but never received the second dose of Shingrix. The patient stated that plans to get the second dose at the beginning of the new year. Additional supportive information. Till the time of reporting the patient did not received the second dose of Shingrix which led to incomplete course of vaccination. The reporter consented to follow up.
C/o body achy, right arm, neck, back sore, no fever. Right upper arm swollen and warm to touch, Patient states these events started this morning. Mother questioned use of PRN O.T.C. anti inflammatory/pain reliever meds. This RN told mother and patient to take what is recommended by their doctor.
dose from vial that was opened on 18June2021 was administered on 21June2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose from vial that was opened on 18June2021 was administered on 21June2021) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. #039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jun-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 EXPIRED PRODUCT ADMINISTERED (dose from vial that was opened on 18June2021 was administered on 21June2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose from vial that was opened on 18June2021 was administered on 21June2021) 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 and treatment information were reported by the reporter.
I am a healthy non immune comprised person under no stress (retired)  and after the vaccine I had a shingles out break on my face.
Information has been received from a consumer her 12 months daughter with allergy to gelatin, who on 04-Sep-2008 was vaccinated with VARIVAX (Oka/Merck) and developed a rash on her face and chest and became very irritable. At the time of the report, the patient was recovering. The patient sought unspecified medical attention. No further information is available.
FATIGUE AFTER FIRST COVID VACCINE; HEADACHE AFTER FIRST COVID VACCINE; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (FATIGUE AFTER FIRST COVID VACCINE) and HEADACHE (HEADACHE AFTER FIRST COVID VACCINE) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Plaque psoriasis.    No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On 08-Feb-2021, the patient experienced FATIGUE (FATIGUE AFTER FIRST COVID VACCINE) and HEADACHE (HEADACHE AFTER FIRST COVID VACCINE). At the time of the report, FATIGUE (FATIGUE AFTER FIRST COVID VACCINE) and HEADACHE (HEADACHE AFTER FIRST COVID VACCINE) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.   Treatment information 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.   This case was linked to MOD-2021-631413 (Patient Link).
Stingingness in the right eye; Blister on the right eye; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (Stingingness in the right eye) and EYE DISORDER (Blister on the right eye) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EYE PAIN (Stingingness in the right eye) and EYE DISORDER (Blister on the right eye). At the time of the report, EYE PAIN (Stingingness in the right eye) and EYE DISORDER (Blister on the right eye) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
emergency room because of generalized weakness status post fall due to weakness inability to get up and pain from the fall he admit having some cough but he deny any shortness of breath he denies any nausea or vomiting abdominal pain in the emergency room COVID-19 did come back positive for COVID-19 infection  admitted to floor started for zosyn for possible PNA , but CXR back unremarkable , home meds started , treated supportive mangement for COVID , pt currently on RA
7/6, 7/7: headache, stomach ache. 7/8: headache, stomach ache, tiredness. 7/9-7/10: extreme fatigue, headache, stomach ache, high fever (101.6-102 degrees)--no relief yet.
I conceived after my second dose of the vaccine. I was getting tested for hormones because of a previous miscarriage and they were low. I had some bleeding. After Sonogram it was confirmed that I had an Ectopic pregnancy. at seven weeks after low hormone levels. It was five weeks after the second dose of the vaccine. Two doses of Methotrexate were given.   Positive Test early January Due Date-9/21/2021 Pregnancy-two
Severe arm pain at injection site and headache within 2-4 hours. About 36 hours later, Painful swollen lymph nodes in armpit on left / same side as booster shot injection. 3-4 days later, this continuous to be main side effect (painful swollen lymph node)
In 11th day of diarrhea after dose of Negative for Rotavirus no blood in stools. Baby gaining weight. No fever. Other vaccinations on same day unk type.