chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had an allergic reaction with the Pfizer BioNTech Covid-19 vaccine and asked if Paxlovid can be crushed; had an allergic reaction with the Pfizer BioNTech Covid-19 vaccine and asked if Paxlovid can be crushed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 41-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "had an allergic reaction with the Pfizer BioNTech Covid-19 vaccine and asked if Paxlovid can be crushed". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course:Consumer's mother mentioned her daughter also will be getting Epipen after getting vaccinated and she finds it hard to swallow Paxlovid. Unable to offer warm transfer to program during the call. E-transmitting to program.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
headache; tiredness; This is a spontaneous report from a contactable consumer. A male patient of an unknown age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. On an unknown date the patient experienced headache and tiredness. It was reported by the reporter that during chatting with a friend, he said he had headache and tiredness after receiving the 1st dose and he did not experience any side effects. The clinical outcome of the events headache and tiredness were recovered on an unknown date.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient and mother both here for COVID vaccine. Upon arrival into exam room,  patient stated "feeling anxious about getting the vaccine," but was "prepared  with EpiPen." After vaccine injected, patient had a coughing episode, stated  "feeling mucous-y," "no not yet" when encouraged to use EpiPen, and "I just want  to lay on the floor." Ice pack, cold compresses given to patient for calming  measures. Called provider, NP to assess patient. SpO2 at 93%. Gave  Diphenhydramine Hcl 50mg/ml Lot# 010016 exp 01/2022 NDC 0641-0376-21 0.5ml IM  injection into right deltoid per provider's orders. Nebulizer administered by MA per provider's  orders. Encouraged patient to rest. SpO2 99%.  Patient slept for 1 hour, stated felt much better. Waited 30 minutes for mother  to return and get some rest. Encouraged patient to establish care with new  provider (was this patient's provider and is no longer  here) and seek advice on getting vaccine #2. Second vaccine scheduled 4/21/21 at  12:30pm, but will cancel if decides not to pursue. Appointment scheduled with  NP for 4/14/21 via telemedicine.
High heart rate ( elevated for 12 hours), some chills and warm (but no temperature), and achey body
SIDE EFFECTS; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from side effects. This report was non-serious. This case, from the same reporter is linked to 20220200584 and 20220200610.
Tingling; Arms and hands going numb; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: en6207) via an unspecified route of administration in the left arm on an unknown date in Mar2021 at 13:00 (at the age of 58-years-old), as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis, high blood pressure , erythema multiforme and known allergy to sulfa. Concomitant medications included prednisone (MANUFACTURER UNKNOWN), nortriptyline (MANUFACTURER UNKNOWN) and vitamin d nos (MANUFACTURER UNKNOWN); all for unspecified indication from an unknown date. The patient previously took codeine (MANUFACTURER UNKNOWN) for unspecified indication on unknown date and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Mar2021 at 00:00, the patient had been having tingling and the arms and hands went numb at night. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events tingling, arms and hands gone numb were not recovered at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Patient stated at 12:30 am on 9/27/19 started having fever of 102 F, swelling in her neck, and hives all over her left arm. Today she came in to tell us about the reaction. No swelling evident anymore, and hives were slowly going away. She took nyquil and tylenol.
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 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Dec2020 as dose 1, single (Lot number: EL0140), in left arm, on 20Jan2021 as dose 2, single (Lot number: EL3302), in left arm, on 04Oct2021 as dose 3 (booster), single (Lot number: 30145BA), in left arm and on 09Jun2022 as dose 4 (booster), single (Lot number: FJ9943) at the age of 65 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient received Paxlovid from 14Jul2022 to 19Jul2022 as treatment of COVID-19.
Fussiness, swelling of eyes & lips, hands and feet with flushing of legs, palms of hands, soles of feet, hives, drooling no wheezing or difficulty breathing.
Anaphylactic reaction; a lot of "brain fog"; Diarrhea; Her hip pain has gotten progressively worse; This is a spontaneous report from a contactable consumer via  Program.  The 46-years-old female consumer (patient) received BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown,) on 19Mar2021 via an unspecified route of administration as a single dose for COVID-19 immunization. The medical history and concomitant medication were not reported. The other medication included XELJANZ XR TAB 11MG since 28Jul2020. Patient reported that she had an anaphylactic reaction to her first Pfizer COVID-19 vaccine on 19Mar2021. Since this reaction she has had a lot of brain fog and diarrhea, that was not happening before the reaction. Patient also said that her hip pain has gotten progressively worse and affecting her ability to dress herself. Further patient explained she will miss 2 doses of Xeljanz before she receives the medication on 15Apr2021. The outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Swelling in hands and feet, high blood pressure and sharp pain of arthritis in thumbs.
Spontaneous report received on 23JAN2013 from a company representative. On 22JAN2013 a 27 year old female received dose B of Bio Thax intramuscularly in the left arm (FAV439). On 23JAN2013 she complained of itching, redness, induration, pain, and swelling at the injection site. She treated her symptoms with 25 mg of BENADRYL. She reports that all symptoms received and she has recovered as of 30JAN2013.
TOOK VIVOTIF THAT WAS STORED ABOVE THE RECOMMENDED TEMPERATURE RANGE; A spontaneous case report was received from a consumer on 21-Oct-2019 for two consumers.  Based on the information obtained from the consumer two individual case safety report PVX201911-000893 (PVX2019-2878; husband) and PVX201911-000894 (PVX2019-2879; wife) were created and cross-linked in the database.  This case (PVX2019-2878) described a male consumer who "took Vivotif that was stored above the recommended temperature range" (PT: Product storage error). He was receiving oral Vivotif (lot number: 3003297 and expiry date: Sep 2020) for typhoid fever prophylaxis.  Case report: The consumer stored Vivotif in his refrigerator above the recommended temperature range for the whole time (52-degree Fahrenheit), and took the first dose of Vivotif on 15-Nov-2019 and his last dose was due on 21-Nov-2019.  Action taken with Vivotif with respect to reported event was not applicable.  The clinical outcome of the reported events was unknown.  Company Comment: A patient took Vivotif doses where the Vivotif was stored above the recommended temperature range (product storage error). Considering the nature of the event, the causality of the event is assessed as not related to Vivotif.  Additional information (PVX2019-2895) was received by a healthcare professional on 27-Nov-2019.   It was reported that the consumer completed the course of Vivotif. The storage requirement for Vivotif was 36-46 Fahrenheit and the consumer set the refrigerator at 40 Fahrenheit. But the temperature reading on thermometer showed 52 Fahrenheit.  Company Comment: A patient took Vivotif doses where the Vivotif was stored above the recommended temperature range (product storage error). Considering the nature of the event, the causality of the event is assessed as not related to Vivotif.; Sender's Comments: A patient took Vivotif doses where the Vivotif was stored above the recommended temperature range (product storage error). Considering the nature of the event, the causality of the event is assessed as not related to Vivotif. US-PaxVax Berna GmbH-PVX201911-000894:
Information has been received from  62 year old female patient with no pertinent medical history or drug reactions who 2 days ago (26-MAY-2010) was vaccinated with a dose of ZOSTAVAX (Merck). Concomitant therapy included KEFLEX. On 27-MAY-2010 (yesterday), the patient experienced redness and swelling at the injection site after receiving ZOSTAVAX (Merck). The patient sought medical attention via office visit. No laboratory diagnostics studies were performed. At the time of this report, the patient had not recovered. Additional information has been requested.
Cellulitis at vaccine site. Lymph node sweeping under arm, redness spreading  Steroids and antibiotic
Patient received the FLUBLOK vaccine into the left deltoid on 10/16/18. Approximately 2 hours later her shoulder was achy, which she expected after a vaccine. However, the achiness continues 8 weeks later and now she is experiencing decreased ROM and weakness to the left shoulder/arm.
Beginning in June 2022 I began having dull/nagging headaches initiated by sexual activity/orgasm. The headaches increased in severity until I began experiencing debilitating thunderclap headaches with sexual activity/orgasm in July 2022. I spoke with my primary who referred me to neurology at Medical Center where I received an MRI on 11/21/22. It was discovered that I have sudden onset demyelination of the blood vessels in my brain. I was then sent for a CT Scan and CT Angiogram on 3/6/2023 which confirmed the demyelination.
This spontaneous report as received from a healthcare medical student refers to an approximately 60 year old female patient with lymphoma. No allergies reported. On approximately 04-APR-2014, reported as "about two weeks ago", the patient was vaccinated with ZOSTAVAX (dose and lot# were not reported). Concomitant therapy was not reported. In approximately April 2014, the patient experienced localized rash. It was unspecified where the rash was located. The reporter stated that the patient had lymphoma at the time of ZOSTAVAX vaccination but did not know it. No treatment was given for the localized rash. The patient sought medical attention. The outcome of localized rash was unknown. Causality was not reported. Additional information is not expected.
Started with injection site reaction with erythema and pruritis. Diffuse hives starting on 12/30/09.  Still with intermittent hives at this time.
have administered an expired Pentacel with no reported adverse event; Initial information received on 27-Jul-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 years old female patient who was administered an expired Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRc5)/HIB(PRP/T) Vaccine [Pentacel] with no reported adverse event.  Concomitant medications included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for Immunisation; and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation.  On 26-Jul-2022, the patient received a 3rd dose (0.5ml, Once) of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRc5)/HIB(PRP/T) Vaccine (lot UJ530AAA, expiry date: 10-Jul-2022; strength: Standard, formulation: unknown) via intramuscular route in the right thigh for immunization.  On 26-Jul-2022, (latency: same day) the patient was administered an expired pentacel with no reported adverse event (expired product administered).  First time product used: No  Still using product: No  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 guidelines. 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 has been received from a consumer concerning her 7 year old son with no pertinent medical history who in early June 2003, was vaccinated SC with a 0.5mL dose of varicella virus vaccine live. There was no concomitant medication. Beginning sometime in July or August, the child began to develop lesions on his stomach, cheek, mouth, and around his eyes. The mother reported that these lesions were herpes zoster or shingles. The zosterlesions were also noted to be in the eyes, face, and mouth. The pt also developed heart palpitations, disorientation, difficulty swallowing, and neck twitching. In addition, the child complained of throat pain and being unable to swallow. He also developed "severe ticks" where he would complain that his "heart hurt" and his eyes would roll. The pt recovered only to have the symptoms appear again "more severe" in September. The pt was treated with various antibiotics and topical medications and had visited the ER on several occasions. "Extensive bloodwork" was obtained. Unspecified medical attention was sought. There was no product quality complaint. The outcome was reported as both not recovered and recovered with sequelae. Heart palpitations, herpes zoster, disorientation, difficulty swallowing and neck twitching were considered to be disabling. Additional info has been requested.
1 to 2 days p/receiving vax mom states pt began having swelling of hands/feet/intense itching; Called MD & given oral DPH; Resolved w/in 48 hrs;
Initial information received on 14-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA227515 (same reporter). This case involves a six-months-old patient (gender not reported), who was vaccinated with a once dose of PENTACEL (batch number: C5551AA and expiry date: 10-Oct-2019) in the right thigh (dose, dose in series and route of administration were not reported) on 13-Aug-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to incorrect product storage because the vaccines were unpacked and storage of the vaccine may not have been within recommended temperatures which puts into question the viability of the vaccine. It was reported that the patient was visited to the doctor on 13-Aug-2018. It was unknown if any adverse event was occurred or not following the vaccination. 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 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. Documents held by the sender: None.
Patient experienced syncope, flushing/sweating, and dizziness, likely vasovagal response. Patient fell, fall braced by healthcare provider, did not hit head. BP 96/46, HR 49, R16. Given water and crackers, stabilized within 30 minutes, BP 124/49 P52, stable and released from vaccination site
shoulder pain; shoulder discomfort/Developed discomfort in shoulder; bilateral knee pain/Right knee and left knee have been very painful when I bend it, when I change position; This is a spontaneous report from a contactable consumer or other non hcp.  A 66-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9267 Expiration date: unknown), dose 1 via an unspecified route of administration on 17Feb2021 as1ST DOSE, SINGLE for covid-19 immunisation.  Medical history included high blood pressure, blood cholesterol increased, diabetes mellitus, knee arthroplasty, knee replacement in both knees. Concomitant medication included insulin (INSULIN) taken for diabetes mellitus, simvastatin (SIMVASTATIN) taken for unspecified indication, losartan (LOSARTAN) taken for unspecified indication and oxybutynin hydrochloride (OXYBUTYNIN CHLORIDE) taken for unspecified indication. The patient previously took tylenol and experienced drug ineffective. The patient experienced Musculoskeletal discomfort /Developed discomfort in shoulder, bilateral knee pain/Right knee and left knee have been very painful when I bend it, when I change position on an unspecified date in 2021 and shoulder pain on 17Feb2021. It was reported that the patient received first Pfizer Covid vaccine dose on 17Feb2021. She had since experienced shoulder discomfort and bilateral knee pain. She had a history of knee replacements in both knees - her right knee was replaced in Jan2021 and the left in 2020. and she also has a history of a knee replacement in both of those knees and she feels that it might be related to that somehow. The shoulder pain was later that afternoon on the 17th and she is not totally sure about knee pain. It was probably that day or the next day. She is still experiencing with the events in the knee and not in the shoulder. Consumer stated that the outcome has probably gotten worse. She has been icing it and taking Tylenol and neither one seems to do a whole lot. As long as she is holding her knees still, it's fine, it's when she bend it, when she change position. She stated that she was just hoping to get some information on how long this pain is going to last. The discomfort in shoulder was reported as worsened. Upon on 24Feb2021, it was reported that the patient do not just need to report a side effect with the Covid vaccine but she has a enquired about how long side effect generally last. She asks if there are some websites she can go to for that information or if she can get that from Pfizer. Patient also reported her Weight: 89.81 kg and height : 160 cm. NDC and UPC number was not provided. Outcome of the events were not recovered. Follow up (24Feb2021): This is a follow up spontaneous report from a contactable female consumer new information included suspect product detail, medical history, concomitant medication.  Follow up (24Feb2021): This is a follow up spontaneous report from a contactable consumer.
Headache, Rash, UrticariaPruritus, NauseaVomiting, lethargy Narrative:
Pt. admitted to ER 10/9/10, pale, vomit, bloody stools, transferred to hospital until 10/14/10
Fever, cough wheeze and injection site pain. Tramadol 50 mg once, Acetaminophen 650 mg once.
8 days after shot 1/22/2021 approximately 5pm, I have a rash on my left arm that grew slightly larger over night. Treated at night 1/22 with Cortizone, grew slightly larger, took Benadryl 12pm 1/23 which seems to have helped the rash go down slightly
My fever (99.4 max) and chills started around 1pm on Saturday (3/20/21) but were over by 6pm-ish that same day. Thereafter, body aches through Monday, and fatigue was ongoing. Additional morphing (but not incapacitating) symptoms from Monday through Thursday night including mild nausea, loss of appetite, nightsweats, feeling really cold (but not having chills), feeling really hot (but not having a fever), brain fog, low energy, and generally feeling off and weird. I felt really space-y and had a really hard time focusing. Thursday night was the first time I felt almost back to normal.