chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Breakthrough case admission after 2 vaccines  MOderna 2/13/21 Lot# 007M20A;  Moderna 3/16/21 Lot# 010A21A
Client called on 4/15 with questions. She had a shingles outbreak start on April 13th. She has had at least 2 shingles outbreaks in the past.  She wanted to know about getting vaccine #2 scheduled on 4/21/21 and is there any data that indicates the vaccine can precipitate a shingles outbreak in those with a hx of shingles. Explained that per CDC individuals in the midst of a shingles outbreak could receive a Covid-19 vaccine. Asked client about any medication she may be taking for Shingles. She said none. She stated her physician does not believe in medication for shingles or vaccinations. After discussion she decides she wished to cancel her 2nd vaccine appointment but will reschedule at a later time. Advised that 2nd vaccine is encouraged with in 6 weeks but if given later she does not lose the first. Additionally, she is not registered for Vsafe but would like a Vaers filed. Follow-up phone call on 4/27/21: Client's shingles are resolving (scabbing up) and she will schedule her second vaccine when she desires.
RN mixed shingrix vaccine with sterile water instead of proper diluent. IM injection given to patient with no adverse events.  Patient notified 3/31/22.  Patient denies adverse events.  She has been scheduled to be re-vaccinated.
Lower back ache, shooting pains in lower calf, can't walk normal. Right leg just flops down and doesn't have the strength in the right foot.
Joint pain in hands; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration in left arm, on 26Jan2021 at 11:00 AM, at a single dose, for COVID-19 immunization. The patient's medical history included high blood pressure and depression. The patient was taking unspecified concomitant medications. The patient previously took codeine and experienced allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Jan2021 at 01:30 AM (approximately 14 hours after injection), the patient experienced joint pain in hands. The event was considered non-serious. No treatment received for the adverse event. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the event on 27Jan2021.  No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.
Narrative: Pt received his 2nd dose of covid vaccine on 2/26/2021 at approx. 14:00. After 15 minutes of waiting in the parking lot pt experienced dizziness and tingling in bilateral hands. Pt reported to covid vaccine clinic with reaction. Pt  was monitored for an hour in the clinic. Symptoms subsided. Pt was able to walk around and able to leave. No treatment medications were given.
Moderna spikevaxDose number 4; Felt chills, mild fever, extreme fatigue and tested positive for covid; Felt chills, mild fever, extreme fatigue and tested positive for covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 69-year-old male patient received bnt162b2 (BNT162B2), on 28Feb2021 as dose 1, single (Lot number: EN6200), on 23Mar2021 as dose 2, single (Lot number: EP7534) and on 31Mar2022 as dose 3 (booster), single (Lot number: FF2587) at the age of 68 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 20Sep2023 at 11:30 as dose 4 (booster), single (Lot number: 3030342), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "GERD" (unspecified if ongoing); "BPH" (unspecified if ongoing); "pre-diabetic" (unspecified if ongoing); "Long covid", start date: 2022 (unspecified if ongoing), notes: with figure and brain fog; "Brain fog", start date: 2022 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "Felt chills, mild fever, extreme fatigue and tested positive for covid"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Sep2023 at 11:30, outcome "not recovered", described as "Moderna spikevaxDose number 4". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 05Oct2023 to 10Oct2023. Clinical Course: Patient had no known allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300331257 same patient, different drug, different event;
Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding a 3 year old female patient who experienced streptococcal pneumonia and drug ineffective. At 6 months of age, the patient received the third dose on 4/18/2002. Relevant medical history was not provided. Indication for Prevenar was immunization. Product was administered on 4/18/2002. Dose regimen was 1 dose. Concomitant therapy included IPV, Engerix B and Infanrix. On 2/4/2005, the patient developed an acute febrile illness with vomiting. The patient was hospitalized with streptococcal pneumonia, drug ineffective on 2/6/2005. It was reported the the patient recovered date unspecified. Culture results revealed streptococcus pneumoniae, serotype 4, was done on 2/9/2005. No additional information was available at the time of this report.
4 hours after receiving the vaccine, I had  a fever that went up to 106. Head was throbbing, woke up with stiff neck. For two days, the throbbing on the left and right side of neck was terrible.  Today is the first day I can turn my head and feel better.
(R) lower arm 5cm x 6cm area of erythema, warmth, tenderness; low grade fever. Benadryl QHS, Zantac AM; cool compresses.
Pt received vaccine. Pt went to 15 minute waiting room for observation. As Pt was ready to leave facility after 15 minute wait time, Pt reported feeling lightheaded upon standing. Pt sat down in a chair. Cool wet rag placed on Pt's forehead. Pt drank juice and ate crackers. Pt's pulse was checked periodically. Pt received a ride home with a friend approximately 30 minutes after episode. Pt reported feeling well before leaving facility.
Janssen COVID-19 Vaccine EUA. Day after vaccination I had a slight fever and severe fatigue. I was only able to stay awake for an hour at a time. I also had a severe headache and pain and swelling at the injection site. The next day, the fever broke (about halfway through the day) and my fatigue lightened. I was still experiencing a minor headache and continued pain and swelling at the injection site. The third day, I woke up feeling normal, until I engaged in physical activity. The fatigue returned, however I am no longer experiencing a headache and the pain in my arm has lessened considerably. The swelling hasn?t reduced.
Leg (upper left) red & swollen at injection site - over 8x6cm area - induration, discoloration, warmth at injection site - type 4 hypersensitivity reaction.
Patient had Moderna as her first dose and developed an anaphylactic reaction. She followed up with her doctor and they decided she should get her second dose and it should be Pfizer.  Patient has a high risk for blood clots which was a concern to her provider, so J&J was ruled out.  Patient developed redness on her face and mentioned her voice was raspy which was a sign of an anaphylactic reaction. She was treated with Benadryl 3 mins after vaccination and v/s were: BP: 140/114 HR: 84 O2: 98 R: 18.  Patient waited half an hour and symptoms subsided.
Hypotensive - hyporesponsive reaction approximately 10 minutes after injection. Resolved in 20 minutes. O2 administered.
administered an expired Ipol; This was dose number 2 in the series.; Initial information received on 08-Aug-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 6 years old male patient who received expired dose of vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  concomitant vaccines were Hepatitis A and Hepatitis B   On 08-Aug-2019, the patient received a 0.5 ml second dose of suspect IPV (VERO) lot N1G511M. (expiry date: 02-Aug-2019) subcutaneous in the left thigh.  It was of actual medication error due to expired vaccine used and Inappropriate age at vaccine administration.  It was unknown whether adverse event was experienced..  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.  List of documents held by sender: none.
Initial unsolicited report received from a Nurseon 14 October 2016. This case involves a female patient (age not reported) who was vaccinated with a dose FLUZONE INTRADERMAL (batch number, expiration date, dose, site and route of reaction were not reported) on an unknown date. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient developed local rash, itching, burning and swelling. Lab data and corrective treatment were not reported. Outcome of the event was not reported. List of documents held by sender: none.
4 mins after receiving the shot heart rate increased, short of breath, heaviness feeling in chest, stiffness of neck.
Headache, Myalgia, pain at injection site Narrative: Per nursing report: "called to report took 2nd dose of Moderna yesterday [6/2]. C/o severe soreness at injection site to left arm, headache, and body aching. Also states feels very fatigued."
At approximately 8pm on the day I received my first dose of  Covid 19 vaccine I was lethargic, had extreme lower back, abdominal pain which caused me to have difficulties walking because of the pain. It lasted all night and I woke up on 12/30/20 with continued lower and upper back pain but the sharp abdominal pain went away but soon was nauseous throughout the day. I?ve taken Tylenol and Ibuprofen to help but haven?t had much relief.
3 hours after vaccination, at 6:30PM I could not put any weight on my left leg, I could not walk. I am being teated for degenerative disc disease and it effects primarily my left buttock, hip and leg. There is inflammation in my lower back area due to this. After waking the next morning at 8:00 the event had passed and I felt like I did prior to vaccination, Doctor believes that the vaccination triggered an  immune response effecting cytokines and thus made inflammation much more severe.
As DTaP (Daptacel) was being injected, a 1 cm area of pallor surrounded by a 2-3.5 inch area of erythema developed immediately at the injection site.  There was a central area of induration that measured approximately 2-2.5 cm.  There was no increased warmth.  A dose of oral Benadryl was given and a warm compress was applied. The patient was observed for 25 minutes to ensure no further reaction.  The area of erythema decreased and no urticaria or other lesions developed.  The central area of pallor resolved.  Dr's clinical impression was that this was a local immediate reaction, and that it is possible that the vaccine was inadvertently injected subcutaneously.  There was no evidence of pain or pruritus.
Patient received first dose of 1 ml; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Patient received first dose of 1 ml) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026LZ0A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL from 07-Jul-2012 to 01-May-2021 for Hypotension.    On 17-Jan-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 milliliter. On 17-Jan-2021, the patient experienced ACCIDENTAL OVERDOSE (Patient received first dose of 1 ml). At the time of the report, ACCIDENTAL OVERDOSE (Patient received first dose of 1 ml) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-1 test: negative (Negative) Negative.         No relevant concomitant medications were reported.  No Known Allergies. No treatment information was provided   This case was linked to MOD-2022-535508 (Patient Link).
It was reported that a male pt received Rabies Imovax IM vaccination on 7/8/99. Reportedly 24 to 48 hours, post vax, the pt developed forgetfulness, which resolved after 48 hours. From additional information received on 9/10/99, additional patient and vaccine information was provided. (Received 4 doses-developed forgetfulness after each dose.)
Narrative: 64-year-old gentleman with a history of chronic hypersensitivity pneumonitis), HTN, HLD, GERD, NIDDM2, MDD, and hx suicide attempt in 12/2019 via self-inflicted GSW to the head now s/p mandibular repair with Plastic Surgery with titanium plates presenting with a couple of weeks of left mandibular swelling & pain and progressive pain over this area and his chin for appx the past 6 days. Patient was in the process of being admitted to Plastics as scan showed a potential plate fracture though tested positive in the ED for COVID. Admitted to medicine unit for isolation (hospitalization NOT related to COVID). Received COVID Moderna vaccine March and April 2021. Remained COVID asymptomatic during hospitalization course and did not receive steroids, COVID therapeutics, or oxygen supplementation while hospitalized.
Syncopal event after first dose; This case was reported by a other health professional via sales rep and described the occurrence of syncope in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced syncope (serious criteria GSK medically significant). On an unknown date, the outcome of the syncope was unknown.   It was unknown if the reporter considered the syncope to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as an adult as per vaccine indication. The patient experienced syncopal event after first dose and was concerned that it might exclude from future vaccination. The reporter consented to follow up.
Nurse administered Tdap (although previously documented historical ADR to tetanus). Shortly after patient was seen by physician and reported numbness/tingling in mouth and chest pain. Diphenhydramine 25 mg once, prednisone 20 mg every day, ranitidine 150 mg BID.
Systemic: Nausea-Mild, Systemic: Vomiting-Mild, Systemic: Fainting-Mild, Systemic: Visual disturbance ("blue spots," "dark visual waves")
red, hot, tender area upper (R) deltoid after receiving DTaP Told mother to apply cool compress and give Motrin for pain
Pt received dose and within a few minutes (while in observation) started coughing and complaining of chest tightness.  Sx progressed to audible wheeze  and patient was give Epinepherine 0.3mg IM X1 and was taken via wheelchair to ER.   Pt received second dose of Epi via (ER) orders.  Pt was also given solumedrol125mg, diphenhydramine 50mg, famotidine (injectable).  Pt was also give albuterol via nebulizer.  After full evaluation it was determined pt was having acute asthma exacerbation and anxiety.  About two hours after incident - plan was to observe pt for another hour and discharge home with oral steroid.
Patient reported his throat was "tight" and felt "tingling" in his lips. Reported he has an allergy to ASA and has had a reaction before. No previous reaction to previous Covid 19 doses 1 or 2.  Sat patient on the floor up against a wall and took vitals with epi pen nearby. Continued to talk with patient and asked if he had any anxieties about getting shots and vaccines. reported he did not. Asked if he would like EMS to come check him out. He reported yes. Within minutes and without intervention with epi pen, patient reported feeling  "better". EMS on site. Patient refused tx after vitals. 130/80, pulse 70. No swelling of tough, lips or face. Lips remained pink. Sat with this nurse for 30 minutes following incident. Will take Benadryl when his wife returns. She went to pharmacy to pick it up. Reports he feels safe to return home.
I sat, clinician stood. Shot felt weird when it happened - Deep, numb feeling but no feeling of being pricked by needle. Seemed to take a little longer than expected. (I had seen my dad get his and counted to 3 each time and I kept counting with mine, not sure when it was over.) I felt that the injection was too high on my shoulder and told clinician this after. I said it felt weird. She said I should feel stinging and that it went into the muscle. I never felt a stinging. After 15 minutes, I asked a different worker if the injection was too high and she said 2 or 3 fingers was appropriate and that it seemed okay. (Injection looks to be at about where the third finger would be from my shoulder bone. It is higher than I have had shots before. There was a little discomfort but real pain set in about two hours later and has continued. Upper and forearm pain. Tried a heating pad. Holding arm still. it doesn't hurt but does feel sore. Movement means sharp pain, especially in the upper arm. Would like to take Ibuprofen but not sure if it will hurt vaccine's effectiveness.
Initial information has been received from an 18 year old female with no pertinent medical history or drug reactions or allergies, for the Pregnancy Registry for GARDASIL.  In November 2007, the patient was vaccinated with the first dose of GARDASIL.  In June 2008, the patient received "her second dose of GARDASIL while pregnant".  There was no concomitant medication.  The patient did not know she was pregnant at the time of vaccination.  As of 10-JUL-2008, the patient was one and a half months pregnant.  The patient did not seek medical attention.  Follow-up information was received from the physician which reported that the vaccine was not administered in her office.  The patient had no previous pregnancy and a history of papanicolaou smear abnormal.  The LMP of the patient was 23-MAY-2008.  The estimate delivery date was 27-FEB-2009.  ON 25-AUG-2008, ultrasound was performed for twin pregnancy and the results revealed normal twins.  ON 15-SEP-2008, maternal serum alpha-fetoprotein screening was performed and the results were normal.  Follow-up information has been received from a completed pregnancy questionnaire.  On approximately 03-SEP-2008, the patient developed infection.  On 03-SEP-2008, the patient was prescribed ROCEPHIN, 250 mg once and AZITHROMYCIN, 1 gram once for the treatment of infection.  The outcome of infection was not specified.  On approximately 01-DEC-2008, the patient developed anemia.  On 01-DEC-2008, the patient was prescribed REPLIVA, daily for the treatment of anemia.  The outcome of anemia was not specified.  On 22-JAN-2009, the patient delivered normal twins baby girls with no congenital anomalies at the 33.3 weeks gestation.  It was considered prematurity.  One of the baby weighed 3 pounds 14 ounces and another weighed 3 pounds 10 ounces.  The Apgar scores of both babies were 8/9.  It was reported that there was no complication during pregnancy and delivery.  Additional information is not expected.
Patient received 3 doses of Pfizer vaccine instead of 2.  All 3 doses were 3 weeks apart. 12/29/21, 01/18/21, 02/10/21
Fever extending for 3 days, at times quite high.  Initial aching legs.  Headache.  General lethargy.  Still not completely recovered as of 11/8/2009, although no fever at present.
Patient received their moderna bivalent booster on 10/27/22 at 3:05pm. By that evening the patient, who has diabetes, tested their BG and noticed that it was ~280, which is higher than normal. The patient then waiting and tested again the morning of 10/28/22 and their BG had only dropped to ~272, which again was quite a bit higher than normal, especially for them to be fasting. The daughter was concerned and called us to ask if that was normal. We informed her that it was most likely due to the covid booster and that that is not a normal vaccination symptom. We advised her to check her BG more often than normal and call her doctor to let them know of the situation to see if they would like her to be seen. Spoke with the patient's daughter several hours later on 10/28/22 and they had called the patient's doctor and the MD just wanted them to keep an eye on her sugars and to let them know of any changes.
Dose two was administered three days after dose 1. Clinic gave prior approval for client to receive Covid vaccine. Pt came in for Covid vaccine on 12/10/2021. System checked prior to administering Covid vaccine. Client received Covid vaccine. Received telephone call 12/13/2021 from foreign speaking mother, interpreter called, language line and interpreter assisted with phone call. Mom states that child received Covid vaccine at another location on 12/07/2021.
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 10-AUG-2012, the patient was administered with a dose of VARIVAX (merck) (Lot # 0435AE, expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Expired dose of IPOL was administered to patient with no AE; Initial information regarding an unsolicited valid non-serious was received from other health professional via Agency (Reference number- 00614834) and transmitted to Sanofi on 25-May-2021.  This case involves a 4 years old female patient who was administered with 0.5 mL expired dose of suspect vaccine IPV (VERO) [IPOL] (lot R1B251M and expiry date: 13-Mar-2021) via intramuscular route in the right thigh (expired product administered) for prophylactic vaccination on 25-May-2021.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL) and 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.  The reporter asked whether dose needs repeating and wanted to know any adverse reaction to expect from receiving an additional dose of IPOL.  It was an actual medication error case due to expired vaccine used (latency: same day).  At the time of reporting, the patient experienced no adverse event.   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.