chrisvoncsefalvay/vaers-outcomes huggingface dataset:
severe reaction; This case was reported by a pharmacist via sales rep and described the occurrence of adverse drug reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was captured as adult as per Shingrix indication. The patient experienced severe reaction to first dose of Shingrix. The reporter unaware of characterization of severe reaction, but would forward safety report to patient's provider upon receipt for more detailed completion of report. The reporter consented to follow up.
Patient developed difficulty breathing and shortness approximately 2 minutes following vaccine administration. Patient also had difficulty responding to verbal stimuli. A chair was brought immediately to the patient and she was sat down. Epinephrine 0.3mg was provided in left thigh immediately after identification of respiratory distress and 911 was called requesting the presence of emergency medical services. Ten minutes following the initial dose of epinephrine a second dose of 0.3mg epinephrine was administered in left thigh. Emergency medical services arrived and took patient to nearest hospital within 15 minutes of onset of reaction. Following patient's arrival at hospital pharmacy followed up and was informed patient's status was improved and she would be kept for observation.
felt "run down" for 2 days; cough; fever; headache; muscles ache; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (felt "run down" for 2 days), COUGH (cough), PYREXIA (fever), HEADACHE (headache) and MYALGIA (muscles ache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced ASTHENIA (felt "run down" for 2 days), COUGH (cough), PYREXIA (fever), HEADACHE (headache) and MYALGIA (muscles ache). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. On 19-Mar-2021, ASTHENIA (felt "run down" for 2 days), COUGH (cough), PYREXIA (fever), HEADACHE (headache) and MYALGIA (muscles ache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was reported.
Patient reported loss of mobility and numbness of left arm in the evening of vaccine administration. Patient claims also that a "knot" developed at the injection site.
Information has been received from a consumer concerning a male who was vaccinated with MMR and subsequently, the pt "screamed when given vaccination and then slept for 6 hours, post vax. Additional information has been requested.
Horrible chills beginning at 11:30pm the day of the shot, lasting for several hours.  Nausea, intermittent fever and chills for the next 24 hours.  Then, severe fatigue, nausea, loss of appetite, and aches for the following 3 days.
Patient complained of disrupted sleep for 2 nights following the immunization. Patient claims that after the 2 nights, his sleep resumed back to his normal schedule.
pt recvd vax;fever 105 in eve & sz;to er 30mar95;
Pt administered Pneumovax 0.5mL SC x 1. Pt experienced local reactions outside of normal. Pt experienced malaise in addition to severe redness and pain at injection site. Temp was not recorded.
Pt exp high pitched abnormal screaming inconsolable x 24 hrs & fever 101 immediately following immun;
Information has been received from a registered nurse concerning a female patient who was intended to received a second dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD) 26-MAR-2007 inadvertently was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). It was reported that improper vaccination was not due to product confusion. The patient received second dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD) on 02-APR-2007. No problems were reported. A product quality complaint was not involved. Additional information has been requested.
Day one typical chills starting at 10 hours post-vaccine.  By 16 hours she had all-over body aches and a migraine, treated with 4x Motrin 200 mg tabs with good improvement by 28 hours.  Chills again at 36 hours and some shoulder and low back muscle aches, treated with 3 x Motrin 200 mg tabs.  She did well the rest of day 2.  Day 3 started by feeling well, but by 9 am she felt cold, weak, and nauseated.  I covered her with multiple blankets and a heating pad and lay her in bed.   About an hour later she felt less nauseated but still cold.
ear pain; Ear disturbance; vertigo; runny nose; headache; Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of EAR PAIN (ear pain), EAR DISCOMFORT (Ear disturbance), VERTIGO (vertigo), RHINORRHOEA (runny nose) and VACCINATION SITE PAIN (Pain at the injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic, Blood pressure management and Seasonal allergy. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) and AMLODIPINE BESILATE (NORVASC) for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE PAIN (Pain at the injection site). On 07-Feb-2021, the patient experienced EAR PAIN (ear pain), EAR DISCOMFORT (Ear disturbance), VERTIGO (vertigo), RHINORRHOEA (runny nose) and HEADACHE (headache). The patient was treated with AZITHROMYCIN (Z-PAK) for Adverse event, at an unspecified dose and frequency. At the time of the report, EAR PAIN (ear pain), EAR DISCOMFORT (Ear disturbance), VERTIGO (vertigo), RHINORRHOEA (runny nose), VACCINATION SITE PAIN (Pain at the injection site) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other treatment medication included nasal spray.
I was down for like a week; but I did have COVID last month; but I did have COVID last month; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown) and in Apr2021 as dose 2, 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), SUSPECTED COVID-19 (medically significant) all with onset Apr2022, outcome "unknown" and all described as "but I did have COVID last month"; DEPRESSED MOOD (non-serious), outcome "unknown", described as "I was down for like a week".  Clinical course: Consumer stated, "Yeah, it is the booster shot, the COVID-19 booster shot from Pfizer and consumer stated, "I just want to know if I got this shot too soon because I did have COVID last month but, and I did have (incomplete sentence). I took the Pfizer both shots like a year ago like in April and then I got both shot (COVID-19 vaccine) and then I got booster now, but I did have COVID last month, I was down for like a week."   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received the Moderna COVID-19 vaccine at 1127 and approximately 5 minutes post injection patient reported feeling warm/hot.  Patient taken into procedure room 2 for direct assessment and observation. NP was also present.  Patient placed on gurney, VS: BP 130/84 HR 86.  Patient given an ice pack to place behind her neck and alternative distraction techniques were used.  Patient observed for 10 minutes.  Symptoms resolved and patient was discharged from vaccine clinic.
Complained at first about pain. Then became exceedingly beligerant.  This lasted nearly 1 hour.  Then she became tired.
Early Menstrual Period; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION IRREGULAR (Early Menstrual Period) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015MZ0A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced MENSTRUATION IRREGULAR (Early Menstrual Period). On 13-May-2021, MENSTRUATION IRREGULAR (Early Menstrual Period) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication was reported. No treatment information was provided. Patient called in stating that she received the first dose of the Moderna COVID-19 vaccine on 26Feb2021. Following the administration of the vaccine the patient claims that her period started on 11Mar2021, which was 11-12 days sooner than normal. The caller did note that she received the vaccine while on her period which may be a correlation   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Patient said AE is resolved and they feel better now.
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 23-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: 6206), in left arm and on 01Apr2021 as dose 2, single (Lot number: ER8733) at the age of 22 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 01Dec2021 as dose 3 (booster), single (Lot number: 034F21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Allergies (mostly seasonal and pets)" (ongoing); "Allergies (mostly seasonal and pets)" (ongoing). Concomitant medication(s) included: XYZAL taken for hypersensitivity; EQUATE ALLERGY RELIEF [FLUTICASONE PROPIONATE] taken for hypersensitivity. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin"; Azithromycin, reaction(s): "Known allergies: Azithromycin"; Clindamycin, reaction(s): "Known allergies: Clindamycin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 09May2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09May2022) Positive; (25May2022) Positive, notes: Today on day 16 a dark line showed up again. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Patient had been testing positive for COVID-19 for the past 16 days on at home rapid tests. patient never experienced rebound symptoms after taking paxlovid and symptoms improved, but patient did want to share that have simply not tested negative since original positive test on 9May22. Sometimes the line is faint, but today on day 16 a dark line showed up again.
Patient received first dose of vaccine and 1-2 min after, began "nodding off", snoring loudly, then fell out of his chair into the concrete ground, hit his head, and began convulsing. He awoke about 10 seconds later and was afebrile, aware of his surroundings, and showed no signs of anaphylaxis. He vomited after awakening. I asked him to sit in in the post-vaccination area for 30 more minutes while I monitored him. He refused EMS services, but I was able to get him to have a family member pick him up to take him to the emergency room.
shortness of breath; I have been more pain than I was before I got the shot; arthritis on my leg; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: ZL7PHD, Expiration date was not reported), via an unspecified route of administration, on 04Mar2021 as dose 1, single for covid-19 immunization. The patient medical history included that patient have been more pain than was before patient  got the shot and ongoing arthritis (Cortisone shot for arthritis). Concomitant medications was not reported. On an unspecified date, consumer stated, "I received my vaccine on 4th (04Mar2021) of this month and on the 8th (08Mar2021) I got a cortisone shot for my arthritis on my leg and I have been reached, I have been shortness of breath and also on my leg when I got the cortisone shot I called the doctor and told to call me back. I have been more pain than I was before I got the shot. So, consumer wanted to know is these side effects due to vaccine. Consumer stated, "It do not have no number. It is a number here ZL7PHD. Is that the number I do not have it and wanted to know that he could take 2nd shot on 25th. This was all I have, I do not know. I just want to know what the side effects is when I take the shot". Outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Pt developed dyspnea next day of vax, has no hx of asthma or any respiratory illness, had wheezing both lungs, treated with albuterol nebulizer, rx given for albuterol inhaler.
Upon receiving vaccine, felt her arm felt limp.  Felt sensation in finger tips.  She was in a lot of pain especially for 4 nights - having difficulty sleeping.  ROM has been impacted.  Difficulty holding heavy objects.  Went to physician, Dr. who felt injection given in shoulder capsule which possible pinched nerve 9/8/09.  Arm is beginning to improve, less pain, more movement.
administered an expired / Menveo dose / powder was the expired component of vaccine not the diluent; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 62-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA266A, expiry date 31st March 2021) for prophylaxis.   On 14th May 2021, the patient received Menveo. On 14th May 2021, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: On 14th May 2021, the patient was inadvertently administered Menveo, which was expired on 31st March 2021. The reporter stated that, lyophilized powder was the expired component of vaccine not the diluent. The reporter did not consent to follow up.
Pain and numbness in arm of injection; Pain and numbness in arm of injection; This is a spontaneous report from a contactable consumer. A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El1282 and expiration date not provided), via an unspecified route of administration in the left arm on 11Jan2021 12:00 at a single dose for COVID-19 immunization. Medical history included diabetes mellitus.  The patient was not pregnant at the time of vaccination. The patient had no known allergies. Concomitant medications included metformin, lisinopril, and aspirin (ACETYLSALICYLIC ACID). The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. On 11Jan2021 14:00, the patient experienced pain and numbness in arm of injection. Treatment was not provided in response to the events. The outcome of the events was not recovered. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since vaccination.
Shortly after injection of Moderna COVID19 vaccine (Lot 009C21A) in LA via IM, the patient states lightheaded. Denied chest pain or difficulty breathing.
I am a breastfeeding mother to a 10 month old infant. I received vaccine on 9/1/21 and about 12 hours later (9/2/21) developed fever, headache, body aches and soreness at the injection site. On 9/3/21 my baby developed a fever, fussiness, and decreased appetite and this continued until 9/7/21. He also developed diarrhea on 9/6/21. He was seen at his pediatrician's office on 9/7/21 and they could find nothing wrong (CBC was normal, COVID negative, ears clear) and said he probably had a viral infection that was resolving. He did not have fever the morning of 9/7/21. The fever returned that evening and continued the rest of the week as well as the fussiness and decreased appetite- I took him back to the pediatrician on 9/10/21 and they could again find nothing wrong (this was day 8 of fever > 101). On the morning of 9/11/21 he became inconsolable and was running a fever of 102.1 and I took him to the emergency room at Hospital. They did more intensive lab work, x-ray, respiratory panel and it only showed atelectasis vs. early pneumonia in his lung and they decided to treat with antibiotic and nausea medication.  He continued to breastfeed for the duration of his illness, as it was the only way the he would take fluid
Pt. reports severe headache 1 hour following flu vaccine. This resulted in several ER visits and a hospitalization resulting in being diagnosed w/ pseudotumor cerebri, having LP shunt placed 1/24/15.
Patient in clinic for sick call. Pt having random bruising and pain in his LE patient does have limp favoring his rt leg. Pt reports having random bruising ever since he received the Johnson and Johnson vaccine. states that he has been having headaches and pain in his feet.  Pt reports head aches started about 3 days ago. Pt does report history of family members having clotting issues. Tem 97.8, B/P 105/75, P88, resp 16
This spontaneous report was received from nurse practitioner regarding 3 unspecified patients of unknown age and gender. The medical history of patients and their concurrent conditions were not reported. On an unknown date in 2016 (also reported as unspecified dates since 27-JAN-2016) 3 unspecified patients were vaccinated with improperly stored doses of PROQUAD (Merck) (lot # L009208, expiry date 17-SEP-2016 and L031602, expiry date 18-FEB-2017) dosage regimen and route unknown. The nurse reported that the doses were exposed to several defrost cycles. No adverse effects were reported. Product quality complaint (PQC) was not filed. This is one of the several reports received from the same reporter. Additional information has been requested.
Delayed hypersensitivity reaction; huge nodules; severe edema to lips; This is a spontaneous report from a contactable other healthcare professional. A female patient of an unspecified age received BNT162B2 (COVID-19 Vaccine - Manufacturer Unknown, Formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as a dose 2, single for COVID-19 immunization and the patient received HYALURONIC ACID, LIDOCAINE HYDROCHLORIDE (RESTYLANE DEFYNE), via an unspecified route of administration on an unspecified date as a dose unknown. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (COVID-19 Vaccine - Manufacturer Unknown, Formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as a dose 1, single for COVID-19 immunization. It was reported that, on an unspecified date in 2021, the patient experienced delayed hypersensitivity reaction. Stated that, the patient had 2nd COVID-19 vaccine (unspecified), 4 days after having the Restylane Dewne fillers and 2 months later she developed severe hypersensitivity reaction to the Defyne as well as huge nodules and severe edema to lips. The outcome of the events was unknown.
Experienced moderate fever and chills post vaccination; Experienced moderate fever and chills post vaccination; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 14 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number unknown, Manufacturer Unknown), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious), CHILLS (non-serious), outcome "unknown" and all described as "Experienced moderate fever and chills post vaccination". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Three hours after vaccine, I started to get body aches, stiff neck and fatigue. Starting around 12 after vaccine I developed chills, headache, fever and extreme weakness which lasted for 10+ hrs. The weakness improved slightly, but continued.  Starting 4 days after vaccine, I started to get stinging eyes, nose and mouth, increased nasal congestion and burning in my sinuses.   These symptoms are debilitating and are the same ones I had when I was at my sickest with Covid.  Whatever sense of smell or taste I had regained disappeared.  These symptoms  continues to the present.
Moderna COVID-19 Vaccine EUA A day after the test began experiencing stiffness in my neck and pain from the back of my head down to my upper back and shoulders.  I took Tylenol to relive the pain  at first and went to bed. The next day it started again to the point that I needed to use a heating pad for some relief. Everyday since then I?ve been taking ibuprofen and  using a heating pad. The pain and stiffness comes and goes.