chrisvoncsefalvay/vaers-outcomes huggingface dataset:
61 year old male patient received dose of FLUZONE HD QIV vaccine with  no AE; Initial information received on 29-Sep-2021 regarding an unsolicited valid non-serious case from a other health professional via Agency (Reference number- 00791077).  This case involves a 61 year old male patient who was vaccinated with INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT], (product administered to patient of inappropriate age).  The patient's past medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On 28-Sep-2021, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ749AA and expiry date: 30-Jun-2022) (frequency: Once) via an intramuscular route in the left for prophylactic vaccination.  It was an actual medication error case due to inappropriate age at vaccine administration (latency on same day).  It was reported "office manager calling about the administration of FLUZONE HD QIV to a patient younger than 65. Caller would like to know how to proceed?"  At time of reporting, 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 the 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.
full body rash, conjunctiva;pt recv vax 12MAR97 & rash appeared 19MAR97;
I received my first dose of Pfizer vaccine on 1/11/2021 in my left upper arm. The next day, I developed swollen lymph nodes in my arm pit/neck region. I contacted my provider on 1/14/2021 regarding the swollen lymph nodes. The swollen lymph nodes went away about 7-8 days after the first vaccine but a lump in my neck remained. I continued to monitor. I received the second dose of Pfizer on 2/1/2021 with suggestion from the pharmacist to receive in the right arm due to adverse reactions in the left arm during the first dose. I again had a reaction of swollen lymph nodes however they were not as painful and only lasted approximately 3 days. However, the lump in my neck from the first dose remained and continued to develop symptoms. I had an appointment with my PCP on 2/9/2021, which resulted in an ultrasound of my neck. From this ultrasound, a large nodule (as well as another smaller nodule) was located on my left thyroid and a small nodule noted on the right thyroid.  Due to the large size, a fine needle aspiration(FNA)  was recommended. The FNA was completed on 2/24/2021  and was determined to be non-cancerous. However, symptoms continued and another ultrasound was ordered. From this ultrasound, growth was noted. I was then referred to ENT for follow up. From this, surgery was an option due to the large size and compressive symptoms that were occurring. Surgery to remove my left thyroid and nodules was completed on 7/7/2021.
Cellulitis at injection site. Cephalexin po 500 q 8 hours x 10 days
I had a small red spot around the injection spot that went away in 24 hours. I started not feeling well on 01/13/2023 as I had a lot of drainage and flu like symptoms. I test positive for COVID-19 on 01/14/2023. I had a telehealth visit with my provider. I did not receive a prescription but advised to take ADVIL or TYLENOL as needed. As of today, I don't have my sense of smell or taste and fatigue. It's getting better but I'm not back to normal.
Left Axilla/Underarm pain; Left Axilla/Underarm swelling; lymph node swelling; pain in neck.; Red rash on both arms, chest.; This is a spontaneous report from a contactable nurse (patient). A 53-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), via an unspecified route of administration on 26Dec2020 14:00 at single dose in left arm for COVID-19 immunization. Medical history included complete thyroidectomy in 2000 and known allergies included Sulfa. Concomitant medications included losartan, levothyroxine, thyroid (ARMOUR THYROID). The patient didn't receive other vaccine in four weeks. The patient had no covid prior vaccination and no covid tested post vaccination. The patient experienced left axilla/underarm swelling/pain, lymph node swelling/pain in neck. Red rash on both arms, chest on 27Dec2020. The patient did not receive the treatment for events. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Patient was diagnosed with oppositional defiance disorder and was recommended Concerta (a Schedule II drug) at three years of age.
approx 10hr p/vax pt lt arm started to ache & have tingling numbness;the next day pt started to run a fever of 103;also exp chills;23JAN97 cont to exp pain in lt shoulder & arm & malaise;unable to lift lt arm;referred to MD on 23JAN97;
2 days post first covid vaccine shot, tightness in chest, and pressure on left side of the neck, lasting 30-1 hour ocurrig intermittently. in addition to 5 days of nausea, headache, low grade fever. 3 weeks later experiencing difficulty getting a full breath intermittently. Negative SARS -CoV-2 PCR nasal swab.
This case was reported by health professional and described a 50 year old male who did not respond to the hep B vaccine recombinant (Engerix B) immunization series. The pt's medical history, concurrent conditions, and concurrent medications were not reported. The pt received injections of Engerix B on 8/24/01 (5239A4), 9/25/01 (5239A4) and 5/7/02 (5242A4). On 4/23/03, a hep B surface antibody titer measured less than 2.0.
Pain, perioral cyanosis. Patient called 911. Taken to Hospital for evaluation. Tylenol given for pain.
soreness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 18th December 2021 and experienced injection site erythema and swelling, refer case US2022058853).   On 1st April 2022, the patient received the 2nd dose of Shingrix. On 1st April 2022, less than a day after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.     Linked case(s) involving the same patient:  US2022058853   Additional Information: GSK Receipt Date: 01-APR-2022 Reporter's Comments: The patient experienced soreness at the injection site on her left arm. The information provided to the reporter as per content and package insert and gave medical disclaimer and referred to health care professional (HCP). The reporter consented to follow up.  Additional Supportive Information:  This case was linked with case US2022058855, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022058855:Husband's case US-GLAXOSMITHKLINE-US2022058853:Same patient and reporter US-GLAXOSMITHKLINE-US2022058855:Same patient and reporter
Suffering after booster; Swelling all over her body after booster; Itching all over her body after booster; Irritated after booster; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Suffering after booster), SWELLING (Swelling all over her body after booster), PRURITUS (Itching all over her body after booster) and IRRITABILITY (Irritated after booster) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032H21A, 013L20A and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Dec-2021, the patient experienced VACCINATION COMPLICATION (Suffering after booster), SWELLING (Swelling all over her body after booster), PRURITUS (Itching all over her body after booster) and IRRITABILITY (Irritated after booster). At the time of the report, VACCINATION COMPLICATION (Suffering after booster), SWELLING (Swelling all over her body after booster), PRURITUS (Itching all over her body after booster) and IRRITABILITY (Irritated after booster) had not resolved.            Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-416977, MOD-2021-416984 (Patient Link).
Tonic-Clonic seizures; Nausea; Vomiting; Severe body aches; Headache; Moderate - severe neurological events; Tics; Tremors; Confusion; Inability to speak or walk or use restroom on own; Inability to speak or walk or use restroom on own; Fine motor skills deficit; This is a spontaneous report from a contactable consumer (patient). A 14-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EW0876, Expiration Date: not reported), via an unspecified route of administration in left arm on 15May2021 at 15:00(Age at the of 14-years old)as dose 1, single for COVID-19 immunization at Pharmacy or Drug Store. The patient was not pregnant at time of Vaccination. Medical history was none. Known allergies was Nka. The patient received unspecified medications within 2 weeks of vaccination. The patient did not received any other vaccines within 4 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 17May2021,the patient experienced nausea, vomiting, severe body aches, headache, moderate - severe neurological events, tics, tremors, confusion, inability to speak or walk or use restroom on own, fine motor skills deficit and tonic-clonic seizures. Adverse events resulted in Emergency room/department or urgent care. The patient was hospitalized for 4 days. Hospitalization was not prolonged. The patient received treatment and stopped suspected interacting medicine. The patient also received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EW0191, Expiration Date: not reported), via an unspecified route of administration in left arm on 06Jun202114:00 as dose 2, single for COVID-19 immunization. The outcome of the events was recovering. ~~ No follow-up attempts are possible. No further information is expected.
we got a Pfizer shot on 01Sep. We had very small reaction; received our 2nd Moderna shot on 05Feb. Because we had 4 weeks of travel planned we got a Pfizer shot on 01Sep; received our 2nd Moderna shot on 05Feb. Because we had 4 weeks of travel planned we got a Pfizer shot on 01Sep; This is a spontaneous report from a contactable consumer reporter for wife via a Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), third dose via an unspecified route of administration on 01Sep2021 as dose 3 (booster), single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine given to patient previously was MODERNA (MODERNA COVID-19 VACCINE Batch/Lot number was not reported), second dose via an unspecified route of administration on 05Feb2021 as dose 2, single for COVID-19 immunization; MODERNA (MODERNA COVID-19 VACCINE Batch/Lot number was not reported), first dose via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. It was reported that patient's wife and patient received their 2nd Moderna shot on 05Feb2021. Because they had 4 weeks of travel planned, they got a Pfizer shot on 01Sep2021. They had very small reaction. The patient feels that the mixture may give more immunity. The outcome of adverse event NOS was reported as unknown.  The lot number for [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101300166 Different patient, same drug and event
29 yo female received first dose of Moderna COVID-19 vaccination on 1/2. Received second dose on 2/1. Pt s/p SVD @ 40w0d presented to hospital in labor on 4/25. Delivered infant on 4/26. Delivery was uncomplicated. The pt did test positive for COVID-19 on 4/26, but was asymptomatic. All COVID-19 precautions were taken. She delivered a liveborn female infant weight 3440 grams. Post partum course was uncomplicated. Pt discharged on 4/28.
I contracted Covid19 5/9/2022 with symptoms of runny nose, congestion, cough, and those symptoms resolved after 24 hours. I was prescribed Paxlovid 5/11/2022 and my symptoms are still fully resolved.
1. Swelling left arm from injection site to fingertips. Pain at injection site unable to lift arm above shoulder level 2. body aches and headache  treatment: NSAID, ice pack to injection site
Treatment of COVID-19; Treatment of COVID-19; .This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old male patient received BNT162b2 (BNT162B2), on 10Mar2021 at 16:00 as dose 1, single (Batch/Lot number: unknown), in left arm and on 31Mar2021 at 15:00 as dose 2, single (Batch/Lot number: unknown) at the age of 42 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 10Nov2021 at 16:00 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Fatty Liver" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 12Jul2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Indication: Treatment of COVID-19; (12Jul2022) Positive, notes: Positive home test results. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient had no known allergies. Positive home test results and recurrence of symptoms after 7 days. Patient was not received other medication in 2 weeks.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient inadvertently was given COVID-19 Pfizer 10mcg/0.2ml  UNDILUTED..  Patient  low grade fever x 24 hours and sore arm.  No redness or swelling.  Pt. was contacted daily x 2d and returned to office on 5/10/22 for follow up.
Suspected Vaccination failure; I got shingles a year ago; two pimples on my left buttock; unable to walk; pain was so bad; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria hospitalization and GSK medically significant), shingles (Verbatim: I got shingles a year ago) (serious criteria hospitalization), pimples (Verbatim: two pimples on my left buttock ) (serious criteria hospitalization), unable to walk (Verbatim: unable to walk) (serious criteria hospitalization) and pain (Verbatim: pain was so bad) (serious criteria hospitalization). The patient was treated with morphine. The outcome of the vaccination failure was unknown and the outcome of the shingles, pimples, unable to walk and pain were resolved (duration 5 months).   It was unknown if the reporter considered the vaccination failure, shingles, pimples, unable to walk and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, pimples, unable to walk and pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 30-JUL-2023 The case was received from the patient interactive digital media. The patient got shingles a year ago and it only took two pimples on his/her left buttock for him/her to be unable to walk for a couple of months.  The patient was in the hospital many times and the pain was so bad that he/she was put on morphine and his/her recovery took up to five months. The patient was already been vaccinated for shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
3.5 cm X 3.5 cm erythematous, mildly tender bump on left arm developed 1 day after vaccine was administered. No other side effects. Cold compress was advised. Symptoms resolving 4 days after vaccine was given.
She got her vaccine, she had flu like symptoms for the first 24 hours.  After that her right arm on the upper portion where the shot was administered she has extreme swelling, red, swollen and looks like an allergic reaction.  She took a shower, put ice on it, took some Ibuprofen.  The area is a baseball size on her arm, swollen and red.  She is going to call her doctor today.    She has not had any reactions to previous vaccines that she has had.
local erythema upper rt lateral arm @ site of Td given 22MAR93; area of erythema irregular approx 5x6cm; no induration, no tenderness; cool compresses to affected area; 10-15mins 3-4 x day;
Patient recieved a booster dose of Pfizer BioNtech. After the dose was administered it was discover that she had initially received the Moderna vaccine. Pt has reported no side effects.
A physician reported that a 46 year old pt received an injection of Pnu-Imune 23 on 9/29/00. On 9/30/00, the pt developed an injection site reaction characterized by redness, swelling and pain. Additional information received from the physician on 12/5/00, indicated that the pt recovered.
7-14-09 8:35 AM - Patient received MENACTRA and ADACEL vaccine. Patient is placed in chair to be observed for 15min. Patient fainted and fell out of chair onto floor and hit R side of head. (mother witnessed fall). Patient placed on exam table examined. Patient c/o nausea, abd pain, and legs tingling - Doctor in at 8:25 BP 120/62, P. 72, pulse ox 100 %. PEARL exam, mouth clear, CV regular, chest clear, abd. completely NT and palp. Symptoms gradually resolved with observation, no specific treatment given. 9:25 AM patient states " I feel fine now". Mother inst. to go to ER if symptoms return.
Headache similar to migraines; headache similar to migraines; nausea; tired; This is a spontaneous report from a contactable consumer. This 44-years-old male consumer(patient) reported that: A 44-year-old male patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EN6203), via an unspecified route administered in right arm on 15Feb2021 16:00 (age at vaccination 44-year-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history was reported as none. The patient had no known allergies. Concomitant medication included hydrocodone bitartrate, paracetamol (NORCO) within two weeks of vaccines from an unspecified date. The patient did not receive any other vaccines within four weeks prior vaccination. The patient not had COVID prior vaccination and not tested for COVID post vaccination. On 16Feb2021 05:30, the patient experienced headache similar to migraines, nausea and tired. The patient did not receive any treatment for the events. The outcome of the events was recovered on an unspecified date in 2021.  Follow-up attempts are completed. No further information was expected.
Fever Chills and Sore Arm.  Does not want revaccinate at this time
Menstruation period has shortened from its normal length of around 32 to 35 days to 26 to 30 days.
Large cluster of red/purplespeckles.; Spots on my right thigh; This is a spontaneous report from a contactable consumer, the patient. A 22-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 25Mar2021 at 11:15 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history included epstein-barr and pectus excavatum (her sunken chest puts pressure on her heart and lungs) from an unspecified date. The patient did not receive any other medications in two weeks of receiving the COVID-19 vaccine. The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 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 01Apr2021 at 13:00, the patient experienced a large cluster of red/purple speckles and spots on her right thigh (one week after first dose of vaccine). Therapeutic measures and treatments were not taken for the reported adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of red rash, spot like rash was not recovered at the time of reporting.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
I began to run a low grade fever with headache and nausea. Over the next week I lost my appetite, began losing weight, had dark urine, and had difficulty sleeping. On 12/16 I had a CBC and my platelets were low and my white count was high. On 12/20 a metabolic panel revealed very high liver enzymes. I was told to go to the ER. I was diagnosed with an autoimmune reaction that caused hepatitis. On 12/18 I developed tonsillitis.
Well circumscribed confluence of papules 4x3 cm, red/purple in color at injection site.  Left posterior upper arm.  No drainage, no pain/paresthesia.
Patient received Prevnar20 (PCV20)and should have been given Prevnar13 (PCV13). Risk and legal involved. System smartset updated to remove PCV20 from selection options for peds. Updated by PCP on each patient impacted. Family contacted personally by PCP.
I would not necessarily say these were "adverse" event, but somewhat expected post-vaccine symptoms: Fever (101 degree F at the highest) and signifiant body aches