chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pain in arm injjection local; uncomfortable; Fever; in bed 20 hours; very sick; unable to get up; too sick to walk; shaking; moaning; dry heaves; Fever; chills; pain in arm; could not sleep; locally warm to touch; locally felt lumpy; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Feb-2021 and was forwarded to Moderna on 26-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of BED REST (in bed 20 hours), MUSCULAR WEAKNESS (very sick), POOR QUALITY SLEEP (could not sleep), TREMOR (shaking) and MOANING (moaning) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025T20A and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 mg. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 mg. On 07-Jan-2021, the patient experienced POOR QUALITY SLEEP (could not sleep), PAIN IN EXTREMITY (pain in arm), INJECTION SITE WARMTH (locally warm to touch) and INJECTION SITE MASS (locally felt lumpy). On 05-Feb-2021, the patient experienced TREMOR (shaking), MOANING (moaning), RETCHING (dry heaves), the first episode of PYREXIA (Fever) and CHILLS (chills). On 06-Feb-2021, the patient experienced BED REST (in bed 20 hours), MUSCULAR WEAKNESS (very sick), MALAISE (uncomfortable), IMPAIRED WORK ABILITY (unable to get up), MOBILITY DECREASED (too sick to walk), INJECTION SITE PAIN (pain in arm injjection local) and the second episode of PYREXIA (Fever). At the time of the report, BED REST (in bed 20 hours), MUSCULAR WEAKNESS (very sick), POOR QUALITY SLEEP (could not sleep), TREMOR (shaking), MOANING (moaning), RETCHING (dry heaves), MALAISE (uncomfortable), PAIN IN EXTREMITY (pain in arm), IMPAIRED WORK ABILITY (unable to get up), MOBILITY DECREASED (too sick to walk), INJECTION SITE WARMTH (locally warm to touch), INJECTION SITE MASS (locally felt lumpy), INJECTION SITE PAIN (pain in arm injjection local), CHILLS (chills) and the last episode of PYREXIA (Fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   She takes no concomitant medications and has no health conditions. She  mentioned that she is extremely healthy person. No treatment medication were reported.She drank fluids to help with the fever. The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable
This pt in her 30's to 50's experienced injection site reaction with swelling and redness which extended down the arm.
Patient received her second Pfizer dose and began to complain of stomach cramps, feeling flushed and itchiness in her hands. Patient received 50mg of Benadryl IM and was transported to the hospital via ambulance.
Rash on abdomen, back, papular, erythematous, multiple + upper thighs.
Pt received Hep-B vaccine on 9/18/01 at 12:30. Pt reported approx. 1 hour later, that she developed a rash on right arm with itching. That evening, she noticed rash on right trunk but it was gone the next day. No other symptoms. Reported on 9/21/01. Reported that she went to donate blood and couldn't because ESR was low.
swollen cheek and tongue; severly swollen tongue; swollen lip; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (severly swollen tongue) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0394209) for an unknown indication. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Proctitis from 01-Jan-2021 to 01-Apr-2021.    On 08-Feb-2021 at 9:30 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 09-Feb-2021 at 7:00 AM, the patient experienced LIP SWELLING (swollen lip). On 10-Feb-2021, the patient experienced SWOLLEN TONGUE (severly swollen tongue) (seriousness criterion hospitalization). On 11-Feb-2021 at 7:00 AM, the patient experienced SWELLING FACE (swollen cheek and tongue). At the time of the report, SWOLLEN TONGUE (severly swollen tongue), LIP SWELLING (swollen lip) and SWELLING FACE (swollen cheek and tongue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Client reported difficulty breathing after receiving her vaccine. She received her shot in an offsite drive through clinic. Epi was administered by EMS and she was transported to Medical Center. She reports she was released later that day.
"57yoF requesting covid eval teacher, got 2nd covid vax 2/24 at 12:15pm, had ha started that night maybe 8 hrs later, fatigue also since 2/24 night and missed work 2/25 and 2/26. started feeling better fri 2/26 around 1pm. needs dr note to rtw or covid test. 1st vax asx other than little bit of arm pain."
Intermittent shooting pain in legs, arms, and chest (both sides).   The pain mainly persists in my arms.   Some days are better than others.
The day after my shot. I developed a burning sensation in my wrist. It has never went away and over time my arm has become weaker. Then a few month later my arm was in a blind from sleeping on it and I could not move it away from my body or raise it up to me head. It has stayed stiff (with pain.
Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team and product quality group.  A 72-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) and as dose 1, 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), outcome "unknown"; COVID-19 (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Clinical course: Reporter on behalf of his wife who took doses of Pfizer Covid-19 vaccine and tested positive for Covid-19 virus. His wife was given a prescription for Paxlovid and not taken it yet since his wife weighs 80 lbs which was 8 lbs less than the required weight to take Paxlovid. his wife still tested positive after taking 4 doses of the Pfizer Covid-19 vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information currently available, there is a reasonable possibility of a causal  association between the reported adverse events drug ineffective, Covid-19 and the suspect  product BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5).
left pontine stroke  patient had right sided weakness of upper and lower extremity 3 days after vaccination and presented to the emergency department on day 6 when he was found to have a stroke on MRI
Vaccine dripped out while the pharmacist was injecting her arm, did not get the full dose; A spontaneous report was received from a consumer, concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and did not get the full dose, some of the vaccine dripped out while the pharmacist was injecting her arm, and about ninety percent of the vaccine got into arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unspecified date, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.  On an unknown date, the patient reported that she did not get the full dose of the vaccine when she received her first shot. She also reported that some of the vaccine dripped out, while the pharmacist was injecting her arm. The patient is not sure how much dripped out but reports about ninety percent of the vaccine got into arm.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events, did not get the full dose, some of the vaccine dripped out while the pharmacist was injecting her arm, and about ninety percent of the vaccine got into arm were resolved.; Reporter's Comments: This report refers to a case of underdose for mRNA-1273. There were no reported AEs associated with this case.
Fatigue; Body aches; Chills; Fever; Headache; This is a spontaneous report from a contactable consumer. A 42-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, (Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, (Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. On an unspecified date, patient experienced fatigue, body aches, chills, fever, and headache and Symptoms improving after 48 hours. Outcome of the events was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
The patient received the second dose 14 days after the first dose of pfizer.  No adverse reactions reported.
The vaccine was given into right arm and at the time of administration, she reports she felt severe pain, winced and told the administering nurse that it was very painful. She reports immediate pain and worsening discomfort and limited range of motion of the right shoulder.  Demonstrates symptoms consistent with SIRVA.
discomfort in arm of shot injection location.; wake up during the night while sleeping; headache; cold like symptoms; feeling hung over; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 21 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 21 years as dose number, unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INJECTION SITE DISCOMFORT (non-serious), outcome "unknown", described as "discomfort in arm of shot injection location."; SLEEP DISORDER (non-serious), outcome "unknown", described as "wake up during the night while sleeping"; HEADACHE (non-serious), outcome "unknown", described as "headache"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "cold like symptoms"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "feeling hung over".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Myalgia, Arthralgia, Night sweats Narrative:  Other Relevant History:
Information has been received from a physician for GARDASIL, a Pregnancy Registry product, concerning a 20 year old female with a history of polycystic ovarian syndrome who on 15-APR-2008 was vaccinated IM with the first dose of GARDASIL (655327/1287U). Concomitant therapy included PROMETRIUM and Metformin. The physician reported that the patient is pregnant (LMP = 23-MAR-2008) and that gestation is 2 days prior to vaccination. The patient sought unspecified medical attention in the physician's office. Prenatal labs were performed; results were normal. No adverse effects were reported. Patient outcome was not reported. Follow up information was received from a health professional who initially reported that the patient had a pregnancy and delivery with "no complications". The health professional later stated, "that the patient was not without complications since the patient had pre-eclampsia and also had a cesarean section." Follow up information was received from the physician who stated that the patient had a healthy and normal male, with no congenital anomalies. He was born full-term and weighed 6lb, 8oz. Additionally, the patient had a history of chronic hypertension and developed pre-eclampsia, for which she was induced at 37 weeks gestation. Her induction failed and as a result the patient had a cesarean section, from which she has recovered "just fine". At the time of the report the patient was pregnant again. Upon internal review cesarean section was considered to be an other important medical event. Additional information is not expected.
My arm started to become red and sore at the injection site. Then it became itchy and hot and the redness spread to about a 3-inch by 3-inch oval below and to the side of the injection site. My arm also became swollen in the area where the reaction occurred. The extreme redness, swelling, itchiness and heat lasted for about 2 days. On the 3rd day (the day I am filing this report), the swelling, heat, itchiness went down dramatically. Now all that remains is a red patch, but the red seems to be fading. It is still warm to the touch, but nowhere near as hot as it had been the previous 2 days.
Potentially breakthrough case; admitted for covid. tested positive covid-19 05/31/2021. Admitted to hospital. Still hospitalized as of 06/15/2021.
Loss of taste; A spontaneous report was received from a consumer, concerning his wife, a female patient of unspecified age, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced loss of taste.  The patient's medical history was not reported. Concomitant product use was not provided by the reporter.  On 15-Jan-2021 (Friday), approximately one day prior to the onset of event, the patient received their first two planned doses of mRNA-1273 (lot number unknown) for the prophylaxis of COVID-19 infection.  On 16-Jan-2021 (the following day), after the first shot of vaccine, the patient experienced loss of taste. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of event, loss of taste was considered unknown.; Reporter's Comments: This case concerns a female patient, who experienced event of loss of taste. The event occurred the next day after the first and last dose of mRNA-1273 vaccine administration. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded and the event is assessed as possibly related.
A lot of pain at the injection site; This spontaneous report was received from a company representative concerning an elderly, female patient. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.       On an unknown date, the patient was vaccinated with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) for prophylaxis (strength, dose, route of administration, anatomical location, lot number, expiration date and formulation were not provided).         On an unknown date, the patient experienced a lot of pain at the injection site (vaccination site pain), and after 15 minutes, the pain went away.      The outcome of vaccination site pain was reported as recovered.  The causal relationship between the suspect vaccine and the event occurrence was not reported. ; Sender's Comments:  US-009507513-2208USA009259:
The patient received his first Moderna vaccine on 4/8 at 9:45 am.   At 9:55 the patient reported feeling a bit nauseous and like he "broke out in a cold sweat."  Denied dizziness, lightheadedness, difficulties breathing or any other symptoms.  Patient accepted to laydown and was provided water.  Reported feeling better after that.  VSS...BP 110/70  Pulse 65  Resp 16.  Staff sat with the patient and his dad for an additional 10 minutes.  Reviewed symptoms to watch for at home.  Confirmed with the patient that he felt back to base line then allowed him to leave with his dad. On 4/13  a follow up call was made.  Patient reports he has had no further symptoms and felt it was due to being nervous.  I encourage him to inform his vaccinator when he comes in to get his second dose.  Patient stated he appreciated the call and denied having any questions or concern.
Influenza vaccine given on 12/10/04. 1/24/05: URI symptoms. 1/25: shoveled snow. 1/26: Nausea, vomiting, weakness. 1/27: Lost movement and feeling in lower half of body. Per follow up report received 05/06/2005:  Patient still has paraplegia and bladder control symptoms.
This spontaneous report as received from a Nurse Practitioner refers to a patient of unknown age. The Nurse Practitioner noted that she had a patient in the office and that "it has been over a year since the patient was administered the second dose in the GARDASIL (lot # and dose not reported, intramuscularly) vaccination schedule." The Nurse Practitioner noted that she did not know the date that the first two dose in the GARDASIL vaccination schedule were administered to this patient. At the time of report, there was no known adverse event. No other co-suspects were reported. No concomitant medications were reported. It was unknown if the patient sought medical attention. Additional information has been requested.
Patient stated she had developed groin area pain/muscle, lower abdomen pain after 24 hours of vaccination. Spoke with Local Physician confirmed he had symptoms and patient's Mother had same symptoms. N/A medications
Lost of taste and smell, intermittently; Lost of taste and smell, intermittently; This is a spontaneous report from a contactable consumer, reporting for himself.  A 73-year-old male patient received the first and second doses of the bnt162b2 (BNT162B2) on 24Feb2021 at 16:40 (Lot Number: EN6203) and on 16Mar2021 about 10:30-11:00 (Lot Number: EP7534), respectively via an unspecified route of administration in the left arm at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced lost of taste and smell, intermittently, which was assessed as medically significant. The events did not require visit to emergency room.  The patient underwent lab tests and procedures which included ear, nose and throat (ENT): everything was fine on 30Mar2021. No treatment was administered. The clinical outcome of the event was not recovered. His symptoms started but said they were gradual and persisting.   No follow-up attempts are needed. No further information is expected.
Dizzy, jittery, pain all over, jerking, tremors. She was given Diazepam, Promethazine, Fentanyl and normal saline in the ER. She went home and slept that night and was fine the next day. She has had no further symptoms since then.
No adverse event. Patient stated he only felt slight body aches and sore arm. No other reactions.
Very red face and splotched face/chest.  No reactin to injection sites.  Report given to patient at ER 2:35 p.m.
started with numbness and tingling in both legs, feet, arms and hands. Since vaccine, had numbness and loss of sensation in forehead, cheeks, jaw, upper lip and gums.  Also numbness and nerve issues behind eyes, nose, throat.  Inflammation problems from head to toe on and off, different parts of body at different times. Currently now have chest/lung wall inflammation and recurring burning sensation in arms hands legs and feet. Have been suffering from nerve pain and inflammation since May and still hasn?t resolved.
No additional AE reported; infant received an expired dose of ROTATEQ; This spontaneous report was received from a medical assistant and refers to an infant of unknown gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On 29-MAR-2022, the patient was vaccinated with expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot #T034512, expiration date: 25-MAR-2022 (dose was not provided) administered orally for prophylaxis (expired product administered). No additional adverse event was reported (no adverse event).
Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 60-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 01-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication was reported.  Patient took booster dose of Moderna Vaccine.  The vaccines was stored in freezer, and they took out one to two vials and placed in fridge each day as needed.
Cellulitis at injection site. Treated with antibiotics Levaguin 500 mg.
Swollen face; Swollen puffy eyelids and below eye; itchy rash on face,neck, and chest; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration in left arm on 14Feb2021 at 12:30 at single dose for COVID-19 immunization. Medical history included allergies to dust mites, dogs, and corn; Hashimoto's thyroid; and high blood pressure. Prior to vaccination, the patient was not diagnosed with COVID-19. She was not pregnant and did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included fluvoxamine maleate (LUVOX), thyroid (ARMOUR THYROID), and amlodipine. The facility where the most recent COVID-19 vaccine was administered was reported as other. The patient experienced swollen face, swollen puffy eyelids and below the eye, and itchy rash on face, neck, and chest on 14Feb2021 at 17:30. The events resulted in doctor or other healthcare professional office/clinic visit. The patient was told to take ALLEGRA and PEPCID in the morning and CLARITIN AND PEPCID in the evening by the allergist. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered. The events were assessed as non-serious.   Information on the lot/batch number has been requested.
Pt recvd 3 doses of Engerix-B vax & it was determined that pt did not seroconvert; 4th & 5th dose of Engerix-B was administered;
Labial ulcers that lasted approximately 10 days, verified by healthcare provider at college campus clinic. Ruled out all STD's. Cleared with time and topical lidocaine cream.