chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Carpal Tunnel; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer-sponsored program. The reporter is the patient.  A 47-year-old female patient received bnt162b2 (BNT162B2), administration date 09Apr2021 (Lot number: ER8734) at the age of 47 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Carpal Tunnel" (ongoing), notes: Carpal Tunnel. The patient's concomitant medications were not reported. The following information was reported: CARPAL TUNNEL SYNDROME (non-serious), outcome "unknown", described as "Carpal Tunnel".  Additional information: Patient scheduled on the 27th for the 2nd dose (18 days only) she mentioned that on the 29th, and will be having a surgery and aware of the side effects and wondering if the patient can take it late and like 5 days after the surgery and if it's ok. patient Scheduled for surgery related to this condition Carpel tunnel on 27 Apr 2021. The patient heard that the worst side effects happen after the second dose of the vaccine. The patient was wondering how regimented the time frame between vaccines is. Could the patient reschedule the vaccine.  Would rescheduling it ruin the vaccines. Should the patient need postpone the surgery. Would patient be okay if just got the vaccine and the surgery on the dates they are scheduled for.  Patient states that got first dose of the vaccine on 09Apr2021. The patient Says that was got it at a facility.  patient husband goes to the facility and states that they were offering the vaccine to spouses. Communication: The caller was provided with phone number of option 3, and hours of operation, prior to attempted warm transfer.  The caller provided with report reference. Unable to warm transfer due to high call volume. The caller agreed to cold transfer to facility.Caller states that  has been on hold for a long time.  Patient was under the impression from the person who transferred them to facility that  was being transferred to a different facility.    Follow-up #01(19Apr2021) : This is a Follow-up spontaneous report from a contactable consumer. This female consumer(patient) reported that: The report was not related to a study or programme. Dates for Questioning if patient should postpone second vaccine or possibly postpone carpal tunnel surgery and Reporter seriousness for Questioning if patient should postpone second vaccine or possibly postpone carpal tunnel surgery was unspecified. NDC number of COVID Vaccine was Not Provided. Expiry Date of Covid Vaccine was Not Provided. Other Products was  Not Provided. An investigation assessment was not provided.  No follow-up attempts are needed. No further information is expected.
Cold; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 16May2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated because she got the first dose for the Pfizer Covid 19 Vaccine on the 16May and she was supposed to be scheduled for the second dose on the 07Jun but she was unable to take it because she said she had cold in 2021 and she wanted to know if she could receive the second dose or she would start with the first dose again. The event outcome was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Patient was 81 years old was given FLUZONE HIGH DOSE QUADRIVALENT  with no reported adverse event; Initial information received on 24-Aug-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.   This case involves a 81 years old male patient was given INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] high dose quadrivalent with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 20V (CRM197) (PREVNAR 20) for Immunisation.  On 22-Aug-2022, the patient received less than 0.7ml once dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE Prefilled syringe (strength was unknown, lot UJ875AE and expiry date: 30-Jun-2023) via intramuscular route in the right arm for Immunization. Patient was not taking it for the first time.   It was reported that patient was 81 years old was given fluzone high dose quadrivalent with no reported adverse event (product administered to patient of inappropriate age) (onset date: unknown, Latency: same day) and few drops of the fluzone vaccine leaked while it was being administered. The vaccine leak at the connection site of the needle and the barrel when the plunger was pushed for administration of the vaccine.  Reporter wants to know if they need to revaccinate and when to revaccinate a patient who was given Fluzone as a few drops of the vaccine leaked while it was being administered. The vaccine leak at the connection site of the needle and the barrel when the plunger was pushed for administration of the vaccine.  PTC(product technical complaint) assessment medical/Physical : Physical  Action taken : not applicable.  Outcome: Unknown  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.
The pt experienced a 5 x 3 area of erythema which was flat, warm on the upper arm. The pt  was seen 2 days post vax. Treated with Benadryl.
injection site pain; aches; fever; shoulder still hurts a little from the injection; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles, sinus congestion and headache. Previously administered products included Shingrix with an associated reaction of injection site pain (received 1st dose on 2nd October 2019, refer case US2020007419).   On 10th January 2020, the patient received the 2nd dose of Shingrix. On 10th January 2020, 5 hrs after receiving Shingrix, the patient experienced injection site pain, pain, fever and shoulder pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain and shoulder pain were not recovered/not resolved and the outcome of the pain and fever were recovered/resolved.   It was unknown if the reporter considered the injection site pain, pain, fever and shoulder pain to be related to Shingrix.  Additional details were provided as follows: The patient had 2nd dose of Shingrix and within 5 hours he developed injection site pain, aches, and fever. The patient stated that his shoulder still hurts at the time of reporting a little from the injection, but all other symptoms had resolved at this time. The reporter was consented to follow up.
Dizzy; I felt really weak; Shortness of breath in getting up the stairs; The shortness of breath freaks me out, I think that's where the anxiety comes in; I think the midsternal chest pain was my anxiety but like a little bit; started feeling very like flu; Headache; Weakness; Fatigue; Muscle ache; I also have like really swollen lymph nodes, my lymph nodes feels like draining right now; The shortness of breath must have pain and issue for me; This is a spontaneous report from a contactable nurse (patient). A 32-years-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 19-DEC-2020 07:30 at single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included buspirone hydrochloride (BUSPAR), omeprazole (OMEPRAZOLE), lithium (LITHIUM), doxycycline (DOXYCYCLINE) for infection right now in her toe. The lithium cause 'sinus' reflux asthma. Nurse reported an adverse effect, was kind of confuse if it is related or not. She felt good for first 15 minutes and when she was about to leave. she was not afraid of shot. she felt dizzy and then she had to go upstairs and she felt really weak and Shortness of breath getting up the stairs, to get to her car. The shortness of breath freaks her out, she think that's where the anxiety comes in. she started driving home and she had bad shortness of breath. she think the midsternal chest pain was her anxiety but like a little bit. she am not sure. In '12' hours later she went to work she started feeling very like flu, she started flu like with headache, weakness, fatigue, muscle ache. she was working in ER and it is hard to work and then 20Dec2020 she was still feeling bad but little bit better than first day and shortness of breath that was still there like all day the day before. she also had like really swollen lymph nodes, her lymph nodes feels like draining right now. Nurse stated she was taking Omeprazole. That was wired because she have 'sinus' (Further not clarified, hence not captured in tab) reflux asthma, so the shortness of breath must have pain and issue for her but Omeprazole have stopped it, so before taking the vaccine she thought she was completely fine but then after taking the vaccine, it was like she have the issue again like it was controlled before the vaccine. Result of lab test: TSH was 8. So it was elevated but that was because of lithium and then she reduced the dose so it should be better now. So every result was normal." Results of tests and procedures for investigation of the patient: Test: CBC, CMP, Lithium level, TSH: Thyroid panel unknown result.
Anaphylaxis reaction/severe allergic reaction; arm is still sore from the vaccine; This spontaneous report was received from a consumer refers to a 6-year-old male patient. The patient had no concomitant medications. The patient's pertinent medical history included immunocompromised. The patient was recently tested positive for celiac.  On 10-DEC-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot# reported as F023835 was evaluated and changed to the valid lot # S023835, expiration date not reported, upon internal validation established as 18-MAY-2021; strength, dose and route were not reported) in the arm for prophylaxis.       On the same day within 2 minutes after receiving the vaccine, the patient had an anaphylaxis reaction. While at the doctor's office, the patient started coughing and clearing his throat a lot. The patient had a mask on, was coughing more with whole face swelling and broke out in a rash when got outside of the doctor's office. The patient had "snot coming from nose" and was wheezing and collapsed. The consumer took the patient back inside the doctor's office and reported one of the doctor's got an epinephrine hydrochloride (EPIPEN) and before administering the epinephrine hydrochloride (EPIPEN), the patient woke up and reported they did not need to use the epinephrine hydrochloride (EPIPEN). The reaction was short lived and the patient reacted well to the diphenhydramine hydrochloride (BENADRYL). After the patient woke up from the anaphylaxis reaction, they were very confused and off in space. The patient was having "face ticks" that were "very strange". The patient was not hospitalized, and his arm was still sore from the vaccine. By giving the patient diphenhydramine hydrochloride (BENADRYL) throughout the night to be sure the patient would not have another reaction. The patient was doing much better next day and recovered from the severe allergic reaction. The outcome of sore arm was not reported. The reporter considered sore arm to be related to Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23). The causality assessment between other events and Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) was not reported.  Upon internal review, anaphylaxis reaction was determined to be medically significant.
On 11/19-11/20 Symptoms included Pain at injection sight, and body aches. On 11/28 - to present Symptoms included full body aches, headache, fever, chills, stuffy nose, cough. Positive Covid-19 rapid test
Father stated that patient had mild case of chickenpox in June, 2010. Grandmother is a RN and identified this.
Left leg swollen and red at injection site 4in x 3in red area. pt given Benadryl.
Soreness of the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness of the arm) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     Concurrent medical conditions included COPD, Emphysema, Cervical cancer (Stable), Lung cancer (Stable), Immunocompromised, Tiredness and Drug tolerance decreased (Low tolerance to medicines). Concomitant products included LISINOPRIL, SIMVASTATIN, ALPRAZOLAM, AMITRIPTYLINE and UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (ANORO) for an unknown indication.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced PAIN IN EXTREMITY (Soreness of the arm). At the time of the report, PAIN IN EXTREMITY (Soreness of the arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment reported.   This case was linked to MOD-2021-270114 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: A follow up received on 22-JUL-2021 and contained No New Information. On 28-Jul-2021: A Significant follow up received on 28-JUL-2021, Action taken with suspect product was updated and second dose information was added.
Pain from shoulder down arm, sometimes burn, with or without movement. Some motions worse than others. Has not gone away. Limited use of arm at times
1 of 3 pts vaxed from the same vial who devel inject site reaction; pt vaxed 19MAR92, & 20MAR devel swelling, warmth & tenderness around inject site; low-grade fever; treated w/Keftab &  warm compresses; felt to be cellulitis;
Initial unsolicited report received from consumer (patient's mother) on 26-Oct-2017. This case involves 11-year-old female patient who was vaccinated with 0.5 ml dose of ADACEL (frequency once, batch number, expiration date, dose and site of administration was not reported)via intramuscular route on 25 Aug 2017. It was reported that, the patient did not receive any other vaccines. The patient had a medical history revealed that; the patient was allergic to peanuts and seasonal allergies. Concomitant medications was not reported. On an unspecified date, following the vaccination, the patient experienced red, swollen, arm, was unable to move arm for about 1 week, and then has experienced "migraine headaches", muscle pain, fatigue and inability to move jaw along with coughing fits. Stated she believed the vaccine was administered "too high up on the arm. Lab data and corrective treatment were not reported. The patient was not recovered from the events (continued to today 26 Oct 2017). List of documents held by sender: none.
16 days p/vax pt exp chickenpox consisting of approx 20 small lesions scattered over body.
CHIEF COMPLAINT:   pt brought to ER for cough that started 2 weeks ago. lsc bilaterally denies any pain.   HISTORY OF PRESENT ILLNESS:     Patient is a 74-year-old male, history of COPD on 4 L home O2 and CHF, typically gets his care at a HCF presents with cough for 2 weeks.  Patient states that he tested positive for Covid approximately 1 week ago at a HCF and he was discharged home.  He presented for evaluation today with shortness of breath and persistent cough.  Denies chest pain.:
Felt fine, then all at once became flush, hot and dizzy and nauseas.  Vomited,  abd pain and extreme dizziness.   Went directly to MD who said it was fairly normal side effects post COVID vaccine.  Instructed me to take zofran, APAP, andif symptoms became worse to take benadryl and my epi pen and seek emergency Tx.    At home the nausea, vomiting and abd pain continued with extreme fatigue and chills.   All continued the following day but was more mild.  01/07/2021 all symptoms relieved, body\head feels fuzzy but no illness.
Had paradise of both legs at bed time on 11/3/2021 which went away by next morning, and a stroke, effecting left side, on 11/13/2021 requiring hospitalization.
20 minutes following vaccine I suddenly experienced tingling in mouth and throat,  muscle twitches in hands, rapid heartbeat,  and rash.  I returned to vaccine clinic and was referred to ER.  I was observed for several hours and symptoms resolved.
Pain at the injection site; swelling of lymph nodes; hotness along the injection site; redness along the site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Pain at the injection site), LYMPHADENOPATHY (swelling of lymph nodes), VACCINATION SITE WARMTH (hotness along the injection site) and VACCINATION SITE ERYTHEMA (redness along the site) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 21-Jan-2021, the patient experienced INJECTION SITE PAIN (Pain at the injection site), LYMPHADENOPATHY (swelling of lymph nodes), VACCINATION SITE WARMTH (hotness along the injection site) and VACCINATION SITE ERYTHEMA (redness along the site). At the time of the report, INJECTION SITE PAIN (Pain at the injection site), LYMPHADENOPATHY (swelling of lymph nodes), VACCINATION SITE WARMTH (hotness along the injection site) and VACCINATION SITE ERYTHEMA (redness along the site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) 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.
About 2 days later, (I usually get shingles at the top of my butt just below the hip) it began to tingle like it usually does and then got a rash breakout. Shingles went away in about 2 weeks. I hadn't had an outbreak for about 3 years until I received these vaccinations.
This case was considered medically important. Information regarding PREVNAR was received from a consumer regarding a 5-year-old male patient who experienced blood work showed no antibodies, ear infections, drug ineffective, colds and tonsillitis. The patient received the fourth dose on an unspecified date. The patient had blood work done on 10-Apr-2009 which showed no antibodies, Since he has turned 5 years of age, the patient has been experiencing ear infections, colds and tonsillitis. The physician is considering a fifth dose of the PREVNAR. Outcome was unknown. No additional information was available at the time of this report.
Inflammation/infection from shot area to armpit/chest.  Was given Bactrim/Septra DS to treat infection.
Unable to get the 2nd dose in recommended time frame; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Unable to get the 2nd dose in recommended time frame) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Unable to get the 2nd dose in recommended time frame). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Unable to get the 2nd dose in recommended time frame) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication not provided. Treatment information not provided.  This report refers to a case of Product dose omission issue for mRNA-1273, lot # unknown, with no associated AEs.; Sender's Comments: This report refers to a case of Product dose omission issue for mRNA-1273, lot # unknown, with no associated AEs.
pt recvd vax & w/in 24 hrs exp tenderness, erythema, fever, difficulty walking on leg; these sx were treated w/DPH & then resolved; pt's mom felt that this was an allerg react;
hives, swollen eyelids, lt thigh swollen high welts all over body;sx began 1/2hr p/vax;took DPH & APAP;sx lasted from 9JUL97 to 11JUL97 (fever 102.5);
Itching all over the body; Red Blotches under the skin; Her tongue was swollen; Rash all over the body; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching all over the body), RASH MACULAR (Red Blotches under the skin), SWOLLEN TONGUE (Her tongue was swollen) and RASH (Rash all over the body) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A, 006M20A and 004C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Oct-2021, the patient experienced PRURITUS (Itching all over the body). 18-Oct-2021, the patient experienced RASH MACULAR (Red Blotches under the skin), SWOLLEN TONGUE (Her tongue was swollen) and RASH (Rash all over the body). At the time of the report, PRURITUS (Itching all over the body), RASH MACULAR (Red Blotches under the skin), SWOLLEN TONGUE (Her tongue was swollen) and RASH (Rash all over the body) outcome was unknown.            No concomitant medications were reported.  Patient had to visit emergency room and took 3 unknown medications as treatment.
Bells Palsy left side of the face and at the same time the right side of my face went numb (like I had novacaine at dentist)
Post injection flu vaccine febrile illness (T 100 -> 104 degrees F) x 13 days requiring hospitalization. No response to broad antibiotics.
Information has been received from a physician concerning a patient with no allergies or medical history who on 03/02/1998 was vaccinated subcutaneously with a first dose of varicella virus vaccine live (lot#625052/1579E).  There was no illness at the time of vaccination.  The physician indicated that on 05/18/2004, the patient developed about 50 vesicular lesions with an erythematous base.  The patient was seen in the physicians office on 05/19/2004.  It progressed to over 100 lesions in 2 days.  No diagnostic laboratory tests were performed.  Additional information has been requested.
Pt receive two vaccines in Rt arm one in deltoid muscle IM and one SC in fatty part of upper R arm. Swollen rt arm, cellulitis. prescribed antibiotics; doctor's visit.