chrisvoncsefalvay/vaers-outcomes huggingface dataset:
headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in an adult female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Oct-2023 at 4:30 AM, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 03-Oct-2023, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-743694 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-743694:Husband case
Patient suffered a seizure approximately 30 min after receiving the covid vaccine.  EMS was contacted.... and patient regained consciousness at time of EMS arrival.  She refused transport to the hospital and stated that she was feeling some better.  EMS then left the scene  and which time patient suffered from a second seizure.  EMS returned and then transported patient to our local emergency room.
A sales representative reported that a pt received an injection of Pnu-Imune 23 on 11/28/00 and subsequently, developed an injection site reaction characterized by redness and swelling from the top of the shoulder to the elbow. As of 11/29/00, no further information was available. This is 1 of 2 pts from this facility who experienced an adverse event following receipt of Pnu-Imune 23.
I developed Iritis in my right eye 15 days after receiving my first dose of the Covid 19 vaccination.  My eye is blurry, I also have it on my cornea as well.  I still have the Iritis now 8 days later.  I am putting dilating drops in 4 times a day and prednisone every 2 hours.
My arm hurt immediately down to my fingertips. Later that night my heart was racing. The next day I needed a TYLENOL to be able to work. My body ached everywhere.
I started experiencing arm stiffness in my right arm a week and a half after my first Pfizer shot. I also experience lock arm where I can't extend my arm at the elbow. I feel pain when trying to extend in my bicep area. Today 5/3/2021 symptoms are real bad and they always happen randomly and can last for hours. They can also come and go with no symptoms in between days.
This case was reported by a pharmacist via call center representative and described the occurrence of rotavirus infection in a child patient who received ROTARIX. On an unknown date, the patient received ROTARIX at an unknown dose. On an unknown date, an unknown time after receiving ROTARIX, the patient experienced rotavirus infection. On an unknown date, the outcome of the rotavirus infection was unknown. It was unknown if the reporter considered the rotavirus infection to be related to ROTARIX. Additional information was provided as follow: The patient received series of ROTARIX and then got sick with the virus. There was no further details about the patient or the vaccine.
I have pain in my left shoulder area on and around my deltoid muscle, especially when lifting my arm up (e.g., like when I am trying to put on  a T-shirt). This pain was severe for the first 3 days or so before becoming only moderate/mild pain.  The problem is that it has now been almost exactly TWO MONTHS since I had that injection, and I still have that same mild/moderate pain when lifting my arm.  I am surprised that it has not healed, and so I am reporting it.  I will note, if it matters, that I don't think they administered this second dose very correctly-- instead of the middle of my deltoid muscle, they placed the injection very high and posterior on my shoulder, almost on the acromion process(I am an RN myself, which is why I feel qualified to talk about proper IM injection technique).
6cm x 5.5cm erythematous purplish discoloration on (L) central thigh area which developed the day after the vaccine was given. Slightly itchy per patient but mother didn't see her scratch the area.
Rash, diarrhea and peripheral edema, fever. Clindamycin 600 mg MG once.
arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm soreness). At the time of the report, PAIN IN EXTREMITY (arm soreness) outcome was unknown.            Caller received 2nd shot of vaccine yesterday 01Mar2021, caller enquired if she can take Advil for his Arthritis Pain.
administered MMR II that was improperly stored in the freezer.; This spontaneous report has been received from a physician concerning a patient of unknown age and gender.The patient's concurrent conditions, historical drugs and medical history were not reported.      On 24-JUL-2020,  the patient was vaccinated with one dose of improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (rHA)  Lot # S020161 and expiration date 30-JUN-2021 for prophylaxis (strength, frequency and patient route of administration were not reported).    The temperature excursion was reported to be at -10°F, and a previous temperature excursion was reported below 36 °F (10°F) for 50 minutes.There was digital data logger involved in the report.   It was reported that  the improper storage was adverted until 04-AUG-2020 due to an updated guidance regarding the storage of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II).  This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-2008USA001689: US-009507513-2008USA002399:
She got her vaccine, probably had tiredness adn achy.  2 weeks later she started having chest pain, two episodes that felt like pressure on her chest.  It was not muscular or pleuritic, was definitely chest pain.  On 3/1/21 she was working, was a busy day (nurse), hustling more than she used to, all of a sudden her chest pain was there, and going up to the pain level of a 5 and decided she could not work with the chest pain and went to the hospital.  She was put on a monitor and had a slight ST depression.  Left work, went to the ER and by the time they saw her was an hour and it's around the corner from where she works.  She was walking to her car and with exertion had more chest pain.  When she got to the ER they put her in a COVID area, did not ask her any questions, they were blaming it on COVID.  They did an EKG that was normal sinus rhythm and was not having chest pain and had not had for over an hour.  They did labs, and she decided to go home.    She went home and called a cardiologist.  She then had an echo, nuclear stress test, and then in October of 2021 she had an echo/stress test.  She had ST depressions on both of them.  The echo's were normal other than mitral valve regurgitation which was minimal.    She just feels terrible, has no endurance and does not know if this is from the vaccines or from COVID.  She did not have any chest pain until she had the vaccine.  At the time she had the vaccine, her coworkers had the same vaccines and one had a blood clot to her spleen and the other PE to the lung.   She is just trying to deal with all of it now.  She has been working but she struggles.
This spontaneous report was received from a pharmacist and refers to a 68-year-old female patient. The patient's pertinent medical history, concurrent conditions and information about concomitant medications were not reported. The patient had no drug reactions or allergies. Pharmacist reported that the patient received PREVENAR 13 in approximately 2016 (reported as "at least one year ago"), and experienced an injection site reaction, which was red, swollen, "heat", pain and it extended to the elbow. On 02-OCT-2017, the patient was vaccinated with PNEUMOVAX 23, 1 dose, 0.5 ml, intramuscularly in the right arm (lot # N013521 with expiration date on 23-JAN-2017) for routine immunization. In approximately October 2017, the patient experienced the same injection site reaction, which was red, swollen, "heat", pain. Pharmacist reported that patient was seen in the pharmacy, on 5-OCT-2017, when the injection site reaction to the PNEUMOVAX 23, had traveled down the arm, past the elbow and forearm, to the wrist. No laboratory diagnostic studies were performed. No treatment was given for the adverse events. The outcome of the events was not reported (also reported as "On 06-OCT-2017, the pharmacist reported she spoke to patient and injection site reaction was "almost all gone"). The causality between PNEUMOVAX 23 and the event was not reported.
Consolacion Sannicolas is a 61 Y female with DM, HTN, ESRD on dialysis (Tues, Thurs, Sat), CHF, atrial flutter/atrial fibrillation who presents to the emergency department with fevers and shortness of breath. Pt notes a chronic cough as well. She states fevers and chills began last night. + nausea. No vomiting. She notes the shortness of breath began last night as well. Pt is due for dialysis today. No abdominal pain. Pt notes she has a right arm fistula. Differential diagnosis includes COVID-19, pneumonia, bacteremia from other source, viral illness, occult infection  shortness of breath, fevers and chills is due to COVID-19 and not significant volume overload -Covid19 infection: Fully vaccinated/boosted. Suspect moreso cause of her SOB > hypervolemia.  Reviewed excellent HBS note. Symptom onset 3/16. Given this + hospitalization, would be considered contagious for 20 days after symptom onset. She will need to isolate until 4/5 (out of isolation 4/6). Decadron 3/17-3/26. No other meds given.  Once stable for d/c, will need to dialyze at Satellite Covid19
Nosebleed 2-3 minutes after receiving nasal preparation H1N1. Stopped immediately -no reoccurrence
Information has been received from a licensed visiting nurse concerning an 8 year old caucasian male patient with no allergies and no past medical history who on 09JAN1996 was vaccinated with a dose of varicella vaccine live. There was no illness at the time of vaccination. On 10MAY2003, the patient developed break through chickenpox with approximately 100 lesions and a fever. Unspecified medical attention was sought. No laboratory tests were performed. The child was reported to be otherwise healthy. Subsequently, the patient recovered. It was noted that a product quality complaint was not involved. Additional information is not expected.
Few seconds after the vaccine I felt a metallic taste in my mouth  (not as strong as with the first dose). 3 minutes later I started feeling  hot, sweaty and shaky, fuzzy in the head I also had a headache. The body aches, headache and the chills ( I woke up with a fever 101.3F and about an hour ago it was 100.8F)  are more severe than with the first dose.  I also have joint pains that I did not have with the first dose (my lower back and hips and my right elbow are the worse). My injection site is also swollen and it was not with the first dose.
This was a booster shot. I had J&J back on March. I felt fine when I first came home but the next day around noon I started feeling really cold. Got a fever and headache. I went to bed. When I woke up an hour later I was in agony. Every joint (most especially my hips) felt like I had been stabbed. I could not get up at all. It was so excruciating, I could only lay there until the next day.  I thought I was better, but I tried to work and had a relapse. I hurt so bad I had to go home.
Immediately after the shot I felt light headed and my pulse quickened considerably. A nurse took my blood pressure which was normal but said my pulse was over 80 which is high for me (usually 62). Later that night I started to not feel well. During the night my heart and pulse were racing, I had a headache and my body felt like I fell down a flight of stairs. This continued all day the day following the vaccine. Today, Nov. 1 I have recovered.
Patient began having substernal chest pain that radiated to his left arm that started 2 hours after his second dose of the COVID-19 vaccination. Pain lasted for 30 hours and then he presented to the emergency department. He was diagnosed with an NSTEMI and underwent myocardial perfusion scan and cardiac catheterization.
Recieved vaccine on 03.20.2021 and complained of severe pains to her legs next day, was admitted on 03/23/2021. Diagnosis of blood clots to leg. Placed on blood thinner. Pulmonary Embolism resulting in DEATH on 03/31/2021.
Patient got her 3rd dose (booster) of Moderna covid vaccine on 12/13/21 (she had gotten moderna for first two doses as well). She states that the day she got the vaccine she was on day 4 of a very very heavy period. And the moment she got the vaccine she states her period completely stopped. She has never had that happen before and was concerned that it would be a problem if her period did not completely clear out. she was directed to follow up with her pcp or obgyn if she has one. She states she felt fine otherwise. This did not happen on her first two doses, but she was not on her period at the time of administration for those
administrated with an incomplete dose of Havrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 4-year-old male patient who received HAV (Havrix) (batch number 7HJ74, expiry date 21st August 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th June 2021, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 14th June 2021, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate dose of vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received incomplete dose of Havrix, which led to inappropriate dose of vaccine administered. No adverse events reported. The reporter consented to follow up.
Patient called the pharmacy to let us know she would not be coming for her 2nd dose of the Moderna Covid-19 vaccine at the recommendation of her rheumatologist due to marked increase in her liver enzymes upon lab draws at a regular visit. Along with abnormal lab values she experienced yellowing of the eyes and skin, abdominal pain and distension. The liver enzymes peaked on April 13th and have trended toward normal as of April 23rd per her doctor.
56 adults patients received doses after its expiration date 13-Jul-2022; no adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 004m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date 13-Jul-2022).    No relevant concomitant medications were reported.  The vial did not undergo any temperature excursions. Dose administered after 30-day Use By Date or after manufacturer date of expiry. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-701125 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-701125:Master case
REACTION NOTED DIZZINESS, NAUSEA THROAT PAIN AND SHORTNESS OF BREATH.
NECK AND BACK ACHE IN THE MORNING (1/19). FEVER 98.9. TOOK TYLENOL
A serious spontaneous report of myoclonic spasms of lower and upper extremities was received from a physician concerning herself, a then 35-year-old female subsequent to FLUMIST. The patient's past medical history includes attention-deficit hyperactivity disorder, auto-immune disorder not otherwise specified and a hyperactive immune system. Concomitant medications were not reported. The patient received FLUMIST intranasally in Oct-2006 for prevention of influenza. Approximately one week after receiving FLUMIST the patient experienced brief "tic-like" myoclonic jerks of lower extremities and upper extremities when relaxed. The patient saw a neurologist and was determined to have borderline multiple sclerosis. The symptoms improved gradually and resolved completely after approximately five months. Required followup attempts have been performed, requested information unable to be obtained.
This literature report (initial receipt 18-Nov-2011) concerns a 74-year old patient, who had a past medical history of chronic proctitis. The patient received trivalent inactivated influenza vaccine and PPV. The patient developed an acute polyneuropathy one day later. The event outcome was not reported. Reporter's comments: The reporter considered event to be possible in relation to the suspect drugs.
mo observed pt's eyes rolling back & arms flailing; 4/15, pt had 6 episodes as previously described; to ER & admit; EEG showed abn brain activity; valproic acid started but d/c'd due to adverse rxn; eval @ UVA; MD's agree not vax related
Pt recv vax on 11/30/98; 5 min post vax pt exp nausea, dizziness, fever, joint pain & lethargy x 3 -4 day; sx reoccurred 12/98 & 1/27 to present
pt recv vax 18OCT96 & 25APR97 pt devel greater than 50 lesions, a mild fever & h/a;
temp of 101.5 p/vax did not respond to APAP;hosp x 3 days;
102 FEVER; This spontaneous report received from a consumer via a company representative concerned a male 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 not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced 102 fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from 102 fever. This report was non-serious. This case, from the same reporter is linked to 20210900975.
Narrative:  Patient was immunized at facility. There were no specifications in notes regarding type of rxn patient had to vaccine or which dose. There was a report on 10-20 stating patient had covid 6 week prior. No labs or notes in system regarding infxn
patient states he had enlarged lymph nodes under left arm 2 days after receiving 2nd shingrix shot, swelling has improved, no treatment
Patient had significant swelling of arm, red, painful and hot. Advised patient to visit ER and call PCP.
This spontaneous report was received from a medical assistant referring to multiple unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23, lot # N010106 with expiration date 15-NOV-2018, lot# N011305 with expiration date 20-JAN-2019, for prophylaxis.  No adverse event was reported. The doses of PNEUMOVAX 23, were exposed to a temperature excursion of 47 degrees Fahrenheit (°F) to 77 °F during a time frame of 2 hours 45 minutes which was detected by the data logger. Previous temperature excursion was reported as 47 °F to 77 °F for 45 minutes. This is one of several reports from the same reporter; Sender's Comments: US-009507513-1708USA002992: US-009507513-1708USA002993: US-009507513-1708USA002994: US-009507513-1708USA002863:
100.8F fever; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received BNT162B2 (PFIZER COVID-19 VACCINE), via an unspecified route of administration on 24May2021 (Batch/Lot number was not reported) at an unknown dose number, single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that he was vaccinated on previous day and was still experiencing the fever in May2021 and had temperature of 100.8 Fahrenheit. The reporter wanted to know how long the fever usually lasts after the administration of the Pfizer BioNTech Covid-19 Vaccine. The outcome of the event was not recovered. Information on the lot/batch number has been requested.
pt recvd vax; in nov95 lab eval revealed a lack of varicella antibodies;
? Patient was vaccinated with booster dose of Pfizer COVID-19 vaccine on 10/15/21 at 13:27 and Patient had what appeared to be a hypersensitivity reaction within 10 minutes of receiving the COVID-19 (Lot: EW0150; Exp 10/31/2021) and flu (Lot: 309616, Exp: 6/30/2022) vaccines.  ? She reported feeling numbness and tingling in the back of her throat, bilateral numbness and tingling on her arms and legs. She also developed a rash behind her ear (she denied scratching or touching the area). Her O2 saturation was 98% and pulse was 89. I called our Medical Director and followed the clinic protocol to administer diphenhydramine 50 mg IM. Patient was monitored for 1 hour. By the end of the monitoring period, her symptoms had resolved, pulse ox remained stable (97%) and pulse was 86. I let her go home with a coworker. ? Patient answered no to all COVID-19 vaccine screening questions and did not divulge that she had reactions to dose 1 and 2. However, when I probed the patient for more information while treating this reaction, the patient reported that she had developed tingling in the back of her throat within 5-10 minutes of prior COVID-19 vaccines but the symptoms resolved without interventions.  ? Other allergies: latex that cause rash ? Patient is not on any home medications
approximately 15 minutes after vaccination patient had elevated blood pressure, pulse,. He appeared very flushed, pale and sweating profusely.  He was complaining of chest tightness, dizziness, ringing in ears, nausea.  Continued to monitor blood pressure and pulse, after approximately 5-10 minutes heart rate, pulse and appearance back to normal. Patient stated at this point he was feeling back to normal.
(L) armpit pain/lump. 3-4 -> 1-2 cm warm, tender mass with a slight bluish appearance just below (L) axilla.
Patient with anaphylaxis to COVID-19 vaccine.  Onset of symptoms occurred five minutes after receiving vaccine.   Urticarial rash occurred on chest and abdomen.  Shortly after, she developed a wheeze.  EMS was onsite so they administered methylprednisolone, diphenhydramine, Zofran, Phenergran and epinephrine IM.  Second and third dose of epinephrine was administered due to partial response from previous doses.  Patient was taken to Health care hospital for further evaluation and treatment.