chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles affected his right side around his waist) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced HERPES ZOSTER (Shingles affected his right side around his waist). At the time of the report, HERPES ZOSTER (Shingles affected his right side around his waist) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided by the reporter.  Patient started getting symptoms 5 days after the first dose and was later diagnosed with shingles. No treatment information was provided.
One minute post vax, the pt became diaphoretic and pale; then his eyes rolled back, he stiffened, then he was observed to have involuntary movement in all four extremities lasting 5 seconds. He responded spontaneously.
Information has been received from a registered technician concerning a 43 year old white female who on 10/22/99 was vaccinated with pneumococcal vaccine 23 polyvalent, via left deltoid. Subsequently, the pt experienced left deltoid pain and was presented to a physician. Follow-up information received from a physician indicated that the pt had recurrent left deltoid area discomfort for over a month, post vax. At the time of reporting, the pt's outcome is unknown. No further information is available.
Back pain; Irritable bowel syndrome; Stomach problems; This is a spontaneous report from a non contactable consumer (Patient). This female consumer reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection) via an unspecified route of administration on 07Apr2021 as a single dose for COVID-19 immunization. The patient reported that 2 days after receiving the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine on 7Apr2021, on 09Apr2021, she had back pain and irritable bowel syndrome accompanied by stomach problems. She said the symptoms had not gone away, and was only relieved when she ate bland mild food. She wants to know if this was a normal reaction to the vaccine, and if she could still get the 2nd dose. She was scheduled to receive the 2nd dose of the Pfizer-BioNTech Covid-19 Vaccine a month after her 1st dose. The outcome for the events was not recovered.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained
pt devel welt on site of inj 5min p/vax;no signs of anaphylactic rxn;DPH given immed;
This spontaneous report as received from a physician refers to a 13 month old male patient with no drug reactions or allergies. The patient's medical history included cold, which he had on 01-SEP-2014, reported as 2 days prior to receiving VARIVAX (Merck). On 03-SEP-2014, the patient was vaccinated with one dose of VARIVAX (Merck) in the right thigh (dose, route and lot number were not reported) and with a dose of hepatitis A (manufacturer unknown) in the right arm (dose, route and lot number were not reported). There were no concomitant medications. On 13-SEP-2014, reported as 10 days after vaccination, the patient experienced weakness of the left arm. There was no rash. The patient sought medical attention. On 15-SEP-2014, the patient was admitted to a hospital and was given supportive care. The patient was discharged on 18-SEP-2014. On an unknown date in 2014, Varicella Zoster Virus DNA Testing was positive, Magnetic resonance imaging (MRI) of brain and cervical spine was normal, West Nile virus testing was negative, HSV (Herpes Simplex Virus) Testing was negative, Cerebrospinal fluid (CSF) culture was performed with an unspecified result. The outcome of weakness of the left arm was reported as not recovered. The relatedness between weakness of the left arm and VARIVAX (Merck) and hepatitis A (manufacturer unknown) was not reported. The event caused significant disability or incapacity. Additional information has been requested.
got a booster dose from a vaccine after Use by date 30; fever; body sores and body aches; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (got a booster dose from a vaccine after Use by date 30), PYREXIA (fever) and MYALGIA (body sores and body aches) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (got a booster dose from a vaccine after Use by date 30), PYREXIA (fever) and MYALGIA (body sores and body aches). At the time of the report, EXPIRED PRODUCT ADMINISTERED (got a booster dose from a vaccine after Use by date 30) had resolved and PYREXIA (fever) and MYALGIA (body sores and body aches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-402678 (Patient Link).
pulse went from 70 something to 150 pulse; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 31-Mar-2021 and was forwarded to Moderna on 31-Mar-2021.    This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 31-Mar-2021 and was forwarded to Moderna on 31-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (pulse went from 70 something to 150 pulse) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (pulse went from 70 something to 150 pulse). At the time of the report, HEART RATE INCREASED (pulse went from 70 something to 150 pulse) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided  No treatment product information was provided
After the third dose, the patient experienced pain in the arm and lymph nodes near the injection site for four days; After the third dose, the patient experienced pain in the arm and lymph nodes near the injection site for four days; Dose number: 3; This is a spontaneous report from a contactable reporter (consumer or other non-HCP).  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 15Dec2021 at 11:00 (Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: Unknown; Route of administration: Unspecified), for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: Unknown; Route of administration: Unspecified), for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 15Dec2021 at 11:00, outcome "unknown", described as "Dose number: 3"; LYMPH NODE PAIN (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 16Dec2021 at 01:00, outcome "recovered" (20Dec2021), and all described as "After the third dose, the patient experienced pain in the arm and lymph nodes near the injection site for four days". Therapeutic measures were not taken as a result of lymph node pain and vaccination site pain.  Additional information: It was reported that the patient had no fever. It was unknown if the patient received any other vaccines within four weeks prior to the COVID-19 vaccine. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I have soreness in the area of injection - both at the site and surrounding tissues and joints. Last night I had hives on my abdomen, chest, & back. I took BENADRYL and ZYRTEC & TYLENOL yesterday. This is worse than what I would expect. My boss ultimately sent me home today- because of this. I have chills, muscle and joint pain, new today. My hands are white and cold. My injected arm is warm to the touch. I am experiencing intermittent dizziness. Also mild nausea - although maybe secondary to pain-?. I have decreased range of motion in rt shoulder. It is difficult to don a jacket and shirt.
Diaphoretic Tachycardic Large area of erythema to injection site, warm, painful Tx Benadryl, Keflex
This spontaneous report was received from a medical assistant, and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies. On 18-JAN-2019, the patient was vaccinated with an improperly stored VARIVAX lot # R010466, expiration date 10-APR-2020, for prophylaxis (route of administration and anatomical location were not reported). The vaccine was diluted with properly stored MERCK STERILE DILUENT. No adverse effects were reported. On an unspecified date, the dose of VARIVAX underwent a temperature excursion of - 14 Celsius degrees (°C) to -10°C for a time frame of 2 hours and 55 minutes. There were no previous temperature excursions. The call was because of a digital data logger.
Developed fatigue, cough, and shortness of breath 1 day after 2nd dose of vaccine.   Started on antibiotics and steroids empirically prior to admission 02/15. Initial CT with diffuse centri-lobular tree and bud opacities.  Infectious (including BAL) and autoimmune work-up without clear explanation for infiltrate. Underwent VATS wedge resection for tissue diagonsis.  Post-op developed hypoxia requiring up to 10L O2 and worsening infiltrates on CT in a pattern consistent with organizing pneumonia (possibly drug reaction).   Started empirically on steroids for concern for organizing PNA/hypersensitivity pneumonitis.   Pathology returned with organizing pneumonia with increased eosinophils.  Timing of onset of symptoms is concerning for a hypersensitivity reaction to the COVID vaccine.   Symptoms are improving with steroids (started 02/26).  Recovery to be determined but I am optimistic for a good recovery.
RASHES ON  LEFT ARM, BELLY, LEFT ARM PIT AND GROIN AREA; This spontaneous report received from a patient concerned a 52 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (form of admin and route of admin were not reported, batch number: Unknown) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-APR-2021, the subject experienced rashes on left arm, belly, left arm pit and groin area. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from rashes on left arm, belly, left arm pit and groin area. This report was non-serious.
Redness, warm to touch and swelling x 2 days -ice/MOTRIN.
SHOULDER PAIN; INJECTION SITE PAIN; This spontaneous report received from a patient via a company representative concerned an adult female. The patient's height, and weight were not reported. The patient's concurrent conditions included moderate to severe rheumatoid arthritis..The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. 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 subject experienced shoulder pain, and injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The outcome of the injection site pain and shoulder pain was not reported. This report was non-serious.
pt recv vax & exp abd discomfort w/o diarrhea followed w/in day by progressive limb weakness & fasciculations that evolved over a 5-day period;pt parapatetic & then wheelchair bound;lab studies nl;
not been feeling well; very tired; body hurts; This is a spontaneous report from a contactable consumer (patient). A 74 (unit unknown) female patient of received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Feb2021 (lot number and expiry date: unknown) as dose 1, single, for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On unspecified date in Feb2021, after receiving the vaccine, patient has not been feeling well, has been feeling very tired, and her body hurts. Outcome of the events was not recovered. Patient was scheduled for the second dose on 12Mar2021.   No follow-up attempts are possible; information about lot/batch number cannot been obtained. No further information is expected.
pt had about 20 lesions on trunk w/o any fever;lasted for 3 to 4 days & dried up;
Arm pain; arm with shot is swollen getting red; arm with shot is swollen getting red; Injection site is swelling and the pain is worse; Injection site is swelling and the pain is worse/Injection site pain; Arm was stiff; Crohn's disease went crazy/worse Crohn's flare; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A female patient of an unspecified age (reported as '75', units unknown) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration in the arm on 06Feb2021 at a single dose for COVID-19 immunization. Medical history included ongoing Crohn's disease. The patient's concomitant medications were not reported. The patient previous had her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), on an unspecified date for COVID-19 immunization. The patient had her Pfizer second shot received on Saturday (06Feb2021) and after the shot she had arm pain (same as after the first shot) and Crohn's disease went crazy and she keep wanted to run to bathroom. Arm hurt a few days then it went away. Injection site pain started again last night and her arm with shot is swollen and getting red, she put ice on it and it's hurting. Today, it was slightly more red and swollen. The injection site is swelling, and the pain is worse than the 1st dose. The patient has Crohn's disease and was having a whole problem with that at the moment. She had gotten the second Covid shot on Saturday and on Sunday (07Feb2021), had the worse Crohn's flare she's actually ever had in 35 years. The day after the shot (07Feb2021), her arm was stiff and that is what happened after the first shot also. It cleared up on Monday and Tuesday. Last evening, Wednesday, her upper arm on the injections site arm started to hurt and get swollen. Since it was last night, she had no one to call and called the pharmacy and was told to put ice on it and she did. It's getting worse and worse and angry like and getting more swollen. The patient wanted to know what she should do in this situation. The outcome of the event "arm was stiff" was recovered on Feb2021 while the other events were unknown.  Information about batch/lot number has been requested.
Dizziness; This is a spontaneous report from a contactable consumer reported for herself. A 54-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL3246 and expiry date unknown) via unspecified route of administration at right arm on 12Jan2021 11:30 at single dose for Covid-19 immunization in a hospital. Medical history was none. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), metformin, and amlodipine; all from unspecified date for unspecified indication. On 12Jan2021 19:00, the patient experienced dizziness. The patient has not been tested for COVID-19 since the vaccination. The patient did not receive treatment due to the event. The outcome of the event dizziness was not recovered. The event was reported was non-serious; did not results in death, was not life threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and no congenital anomaly/birth defect.
SEVERE CHILLS; HIGH TEMPERATURE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (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. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced severe chills, and high temperature. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103. The action taken with covid-19 vaccine was not applicable. The outcome of the severe chills and high temperature was not reported. This report was non-serious.
After dose 1 my left lymph node under my armpit became very large and sore.  After dose 2 a rash has formed in different spots all over my my body.  They locations of the rash are relatively small but they resemble a heat rash or even some could be confused with poison ivy.  Most of the rash is located on the inner part of both arms and the front part of both legs .  It is very itchy  In all spots
Chills night of vaccine, contracted Shingles and had chills again when it got bad.
pt recvd 1st dose of Engerix-B w/o incident; pt recvd 2nd dose of vax & c/o vax hurt & burned @ time of inject; approx 2 days p/2nd doses of Engerix-B; c/o stiff, sore muscles all over body & throbbing pain on inject side of body;
This spontaneous case was reported by a patient and describes the occurrence of JOINT SWELLING (both ankles are swollen intermittently), URTICARIA (non-itchy welt on the right wrist) and RASH MACULAR (a non-itchy, big area on left calf which was red and blotchy/my right hip has non-itchy blotches on it,) in a 63-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 057F22A) for COVID-19 vaccination.     The patient's past medical history included Von Willebrand's disease (A bleeding disorder diagnosed 26 years ago, which has since healed.), Platelet dysfunction (Platelet function defect in the secretion part of the blood.) in 2015 and COVID-19 in 2020. Previously administered products included for Drug use for unknown indication: Influenza in September 2022. Past adverse reactions to the above products included No adverse event with Influenza. Concurrent medical conditions included Drug allergy (Epinephrine), Soap allergy (Zest Soap), Drug allergy (Ibuprofen), Oil allergy (Fish oil), Ankles swollen (intermittently which started 2 years ago.), Alopecia (diagnosed 4 yrs ago.), Osteoporosis, Dry eye (Chronic Blepharitis Rosacea) and Vitamin D deficiency.   On 02-Nov-2022 at 5:15 PM, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 09-Nov-2022, the patient experienced RASH MACULAR (a non-itchy, big area on left calf which was red and blotchy/my right hip has non-itchy blotches on it,). On 10-Nov-2022, the patient experienced JOINT SWELLING (both ankles are swollen intermittently). On an unknown date, the patient experienced URTICARIA (non-itchy welt on the right wrist). At the time of the report, JOINT SWELLING (both ankles are swollen intermittently), URTICARIA (non-itchy welt on the right wrist) and RASH MACULAR (a non-itchy, big area on left calf which was red and blotchy/my right hip has non-itchy blotches on it,) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2020, SARS-CoV-2 test: Positive.         No treatment medications was reported.
Moderna COVID-19 Vaccine EUA    Initially fatigue, fever and slight body aches.  On January 25th had a dental procedure and within a few hours developed severe and extremely, multiple  painful canker sores. Called and texted photo of the sore to my dentist Dr. and spoke with office staff.  Since that date I have developed 4 more in my younger and lip. I have treated them with swabbing them with milk of magnesia combined with Benadryl. That brought some relief but I still cannot eat.
Fever, chills, nausea, vomiting, vaccination site pain. Documents held by sender: None.
This is an initial spontaneous report by a contactable Pfizer internal colleague. This Pfizer internal colleague reported to a Pfizer Sales Representative. A patient who is currently 3-years-old (age at vaccine and age onset of event were unknown) received PREVNAR 13 on an unspecified date intramuscularly along with "two other unspecified vaccines". Relevant medical history and concomitant medications were not provided. On an unknown date in 2010, the patient walked around with a limp after she received the injection in her thigh. Patient recovered on an unspecified date. Follow-up (06Jan2011): New information reported from a contactable Pfizer District sales Manager for Vaccines included outcome of event: recovered.
pt recv vax & not long p/pt exp h/a, joint pain, edema, chest pain & palpitations;initial dx was made of lyme disease;
Vaccine given on 09/02/2021. Expiration date was 08/31/2021.
gradual, but progress sx of fever, chills, diffuse h/a, gen muscular twitching & dyspnea;no rash, chest pain or LOC;IV NS, 02, epi, Solumedrol, DPH;