chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist referring to herself a currently 67 years old  non pregnant female patient. Patient's concurrent conditions and medical history included hypertension, hypothyroidism, arthritis and allergy to nitrofurantoin. On an unknown date in 2013 (reported as at least 3 years ago) the patient was administered a dose of ZOSTAVAX (concentration, dose, lot # and expiry date were not provided) intramuscularly, rather than recommended subcutaneous. Concentration, dose, lot # and expiry date were not provided. Concomitant medications were reported as none. The patient reported that on 14-AUG-2016 she was "been diagnosed with a zoster like rash". She received an unspecified treatment. At the reporting time the outcome regarding of the "zoster like rash" was not recovered. Additional information has been requested.
Upper arm and axilla soreness. Fatigue. Took Aleve and the symptoms lessened.
Lymphedema; This spontaneous case was reported by a patient and describes the occurrence of LYMPHOEDEMA (Lymphedema) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Mastectomy.    In May 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, the patient experienced LYMPHOEDEMA (Lymphedema). At the time of the report, LYMPHOEDEMA (Lymphedema) had not resolved.            Concomitant medication was not reported.  Patient got lymphedema in the opposite arm (mastectomy side) immediately after the 2nd shot in May. Patient had no history of lymphedema. Felt the effect happening while waiting the 15 min afterwards. It was not temporary, patient still had it. Treatment medication not reported.   Most recent FOLLOW-UP information incorporated above includes: On 11-Sep-2021: Upon internal review on 26-May-2022, significant correction was performed. Report type updated as Spontaneous. Reporter details added. Country of incidence, Reporter country, patient details updated, Obtain and Drug authorization country updated. Suspect coding, dose details and event outcome updated. Narrative regenerated.
Initial report received on 24 January 2012 from the Investigator participating in a study under the reference number M5A16. A case of pertussis disease in a 2-year-old female subject (initial not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance System electronic database. The subject had received 3 doses of PENTACEL, lot number C3430AA received on 20 October 2009, lot number C3498AA received on 18 December 2009 and lot number C3579AA received on 18 February 2010 and a dose of DAPTACEL, lot number C3514AA on 26 November 2010 (routes and sites of administration not reported). The subject developed cold-like symptoms and cough with a whoop on 20 November 2011, approximately one year after the last dose. The subject also experienced posttussive vomiting, sleep disturbance and apnea. Laboratory testing included positive PCR on 29 December 2011. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 29 December 2011 for 5 days. The subject was not hospitalized. At the time of final contact on 03 January 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 45 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Developed chicken pox rash following vaccination, as diagnosed by a physician. Rash on top 2/3 of back, neck, and a few spots of neck and two spots on leg.  After six days the rash is still ongoing, the patient (5 years old) describes it as itchy and painful.
lump in neck; pea sized lump under skin; fatigue; weakness; arm movement only up to shoulder; felt like a pinched nerve; extremely sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (extremely sore arm), LIMB DISCOMFORT (arm movement only up to shoulder), NERVE COMPRESSION (felt like a pinched nerve), NECK MASS (lump in neck) and SKIN MASS (pea sized lump under skin) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Codeine- nausea). Concomitant products included VITAMIN A [RETINOL], COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), TOCOPHEROL (VITAMIN E [TOCOPHEROL]), ASCORBIC ACID, BIOFLAVONOIDS NOS (VITAMIN C [ASCORBIC ACID;BIOFLAVONOIDS NOS]), ZINC and BIOTIN for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced PAIN IN EXTREMITY (extremely sore arm). On 20-Mar-2021, the patient experienced LIMB DISCOMFORT (arm movement only up to shoulder), NERVE COMPRESSION (felt like a pinched nerve) and ASTHENIA (weakness). On 23-Mar-2021, the patient experienced FATIGUE (fatigue). On 26-Mar-2021, the patient experienced NECK MASS (lump in neck) and SKIN MASS (pea sized lump under skin). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 600 mg. On 23-Mar-2021, PAIN IN EXTREMITY (extremely sore arm), LIMB DISCOMFORT (arm movement only up to shoulder), NERVE COMPRESSION (felt like a pinched nerve) and ASTHENIA (weakness) had resolved. On 26-Mar-2021, FATIGUE (fatigue) had resolved. At the time of the report, NECK MASS (lump in neck) and SKIN MASS (pea sized lump under skin) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Anxious - BP 156/8, HR 128 throat closing/pain - 100% pulse ox on room air 1 liter IV fluid, PEPCID, BENADRYL & Steroids.
Fever, weakness, hives beginning on left nipple to groin anterior side only, denies drainage or blistering. Reports some small "little bumps." (patient described feeling like she was getting shingles again.)
pt recvd vax 12noon 16SEP92 mom called 430PM to say that pt had been crying unconsolably since 1230PM; t100, vomiting, coughing;
chills shakes nausea vomiting  cough sob sore throat  maliase
Got second dose more than 36 days after first dose; As of the moment she only felt burning sensation on her leg; felt whole body was burning; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (felt whole body was burning), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got second dose more than 36 days after first dose) and BURNING SENSATION (As of the moment she only felt burning sensation on her leg) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037121A and 096821A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS for an unknown indication.   On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-May-2021, the patient experienced BURNING SENSATION (felt whole body was burning) and BURNING SENSATION (As of the moment she only felt burning sensation on her leg). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got second dose more than 36 days after first dose). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, BURNING SENSATION (felt whole body was burning), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got second dose more than 36 days after first dose) and BURNING SENSATION (As of the moment she only felt burning sensation on her leg) had resolved.            Most recent FOLLOW-UP information incorporated above includes: On 25-Jul-2021: Event outcome updated.
Receive varicella vaccine 2/27/06. 3/19/06 had a few pox on body. Now 3/27/06 has total body pox rash. Will see infectious disease MD today.
non-febrile local erythema, induration area 9cm x 11cm surrounding inject site 24 hrs p/pt seen 34 hrs p/vax;
Information has been received from a registered nurse concerning a 37 month old male with no known drug allergies who on 30-MAR-2005 was vaccinated with a first subcutaneous dose of varicella vaccine live (Oka/Merck) (Lot# 64855B/0443P) in the left thigh. Concomitant vaccines administered on 30-Mar-2005 included a first subcutaneous dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (HPV-77) (MSD) (Lot# 647647/0991P) in the right thigh. There was no illness at the time of vaccination. On 01-MAY-2007, the patient started breaking out in spots on the left lateral thigh. On 03-May-2007, his mother noticed more spots. There were no laboratory or diagnostic tests performed. Subsequently, the patient recovered. Additional information has been requested.
This spontaneous report was received from a podiatrist physician referring to his wife, a 59 year old female patient. The patient had none pertinent medical history, drug reactions or allergies and had none concomitant medications. On 08-OCT-2017 the patient was vaccinated with ZOSTAVAX 19400 plaque-forming unit (PFU) vial, subcutaneously in the in the posterior area of her left arm (dose, lot number and expiration date were not provided) for prevention of shingles and was reconstituted with sterile diluent (MRK). On 08-OCT-2017, "a few hours" after receiving the vaccination, the patient began experiencing "a well defined area of swelling approximately 7 cm in diameter at the injection site, as well as erythema, itchiness, hives, and warmth at, as well as surrounding the injection site". The reporter stated that, the patient began taking BENADRYL as treatment for the events and continued to take it at this time, the reporter also stated that, none laboratory diagnostics studies were performed and that "she had not needed to seek medical attention at this time." It was reported that, the swelling seemed to be enlarging but at a slow rate, therefore, at the reporting time the patient had not recovered from swelling. The outcome of the patient for erythema, itchiness, hives, and warmth surrounding the injection site injection was unknown and  the causality assessment between ZOSTAVAX and the sterile diluent (MRK) with the events was not reported.
I usually get very light headed from needles so I brought a coke and luckily didn?t pass out in the process. However, the following night I had severe stomach pains and felt like I could throw up all night. I also was freezing but had so many blankets and sweatshirts on I was sweating too. But what?s really concerning me is that I usually wear glasses to help me see and they worked up until yesterday. I cant see things close up anymore and my glasses only work for further away things.
Late in the day on 8/31/22, the FDA rescinded the EUA order for the use of the monovalent Pfizer and Moderna vaccine as boosters for people aged 12 years and older. The information took a little time to trickle from the Government to the HCF staff and then to our facility and the staff administering vaccine. Because of this delay, some monovalent vaccine throughout the HCF was inadvertently given after 8/31/22. The CDC stated that any monovalent vaccine administered as a booster dose after the EUA was rescinded would be considered a vaccine error. At a recent Immunization Subcommittee meeting, we discussed this and our medical providers stated that any monovalent vaccine given as a booster dose on 9/1/2022 or after should have VAERS report completed on them per the CDC's requirements.
Reaction to DTaP adm. at L thigh 10/16/02. L thigh warm, edematous to L knee on 10/17/02. Office visit 10/17/02. Advised Motrin/observe monitor for red streaks extending upward on L thigh. Swelling con't and came in for office visit 10/19/02. 10/19/02 no warmth, induration or tenderness. Reassured, rec. Tetanus q 10 years.
On 2/3/21 at 2:30pm joint pain and body aches. Next morning 2/4/21 fever of 100.4F was recorded and continued body and joint aches. As of 2/16/21 patient continues with fatigue and joint pain
convuls, temporary brain damage, loss of reflexes, extreme whooping cough & damage to lungs, high prolonged fever, unconsolable screaming, vomiting of extreme amounts of phelegm;
nausea; This is a spontaneous report from contactable consumer (patient) via Pfizer-sponsored program. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via an unspecified route of administration on 27Feb2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had historical vaccine first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via an unspecified route of administration on an unknown date as single dose for covid-19 immunisation. The patient experienced nausea on 28Feb2021 (this morning). Patient wanted to know what medication she can take for nausea. The outcome of the event was unknown.  Information about lot/ batch number has been requested.
Patient stated that about 2 hours after the immunization she started experiencing echoing sensation in her ears when someone was speaking to her. Her symptoms resolved after 1 week.
Nausea, Diarrhea, Muscle Aches, Headache, Joint Pain, Ringing in Ears, Tiredness - last 4 days
expired dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 037B21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included LOSARTAN, TROMANTADINE and DILTIAZEM (CARDIAZEM [DILTIAZEM]) for an unknown indication.   On 14-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose). On 12-Oct-2021, EXPIRED PRODUCT ADMINISTERED (expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications reported.   This case was linked to MOD-2021-350559 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Oct-2021: Follow up received on 12-Oct-2021, additional reporter details and product dosage details updated, event verbatim updated.
Tenderness at injection site; A spontaneous report was received from a consumer, concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced tenderness at injection site.   The patient's medical history was not provided. The current medical history included (UTI) urinary tract infection for which the patient's treatment included cefalexin (500mg) and paracetamol. No relevant concomitant medications were reported. The patient went to Urgent Care for UTI on the day before 2nd dose of vaccine was scheduled and was started on antibiotic for UTI . Nurse said it would be ok to start taking the antibiotic the day before the 2nd dose of COVID vaccine  On an unknown date, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection. The patient reported experiencing tenderness at injection site.   On 12 Feb 2021, the patient received their second of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection with no side effects.  Action taken with mRNA-1273 was not applicable as the patient had already received both scheduled doses  The outcome of the event, tenderness at injection site was unknown.; Reporter's Comments: 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.; Sender's Comments:  MOD-2021-018804:same reportrer, For Husband/Male patient
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 14-SEP-2011, the patient was administered with a dose of VARIVAX (oka/merck) (Lot # 0345AA expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of 121 reports received from the same source. Additional information has been requested.
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041BZIA) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown. Not Provided          Concomitant product use was not provided by the reporter.  Treatment medication use was not provided by the reporter.
Pt recvd vax 1PM on 6NOV91 & when pt woke up from nap next day @ 3PM babysitter noticed 2 white raised areas "like hives" on stomach & back which spread to 1/2 of pt back & stomach; MDs assistant saw pt; small knot @ site caused itching;
sweats; site pain/redness; site pain/redness; fatigue; body aches; headache; This spontaneous case was reported by a nurse and describes the occurrence of HYPERHIDROSIS (sweats), INJECTION SITE PAIN (site pain/redness), INJECTION SITE ERYTHEMA (site pain/redness), FATIGUE (fatigue) and MYALGIA (body aches) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039k20a and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Panic attack.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Dec-2020, the patient experienced HYPERHIDROSIS (sweats), INJECTION SITE PAIN (site pain/redness), INJECTION SITE ERYTHEMA (site pain/redness), FATIGUE (fatigue), MYALGIA (body aches) and HEADACHE (headache). At the time of the report, HYPERHIDROSIS (sweats), INJECTION SITE PAIN (site pain/redness), INJECTION SITE ERYTHEMA (site pain/redness), FATIGUE (fatigue), MYALGIA (body aches) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-012594 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Followup  ADR attached on 25-MAY-2021: No new information
On Sept 15th all of a sudden I felt numbness set in starting in the left shoulder, neck area.  It continued to grow through my entire left arm to my fingers and then up to my face on the left side.  I ended up going to the emergency room thinking I may be having a stroke, though I did not have the droopy face symptom.  At the hospital they did a CAT scan with contrast and found nothing obvious.  A couple of weeks later I saw my physician and she had an MRI done which showed no abnormalities That evening the numbness lessened and the doctor sent me home.  I didn't think anything more of it, but have now seen where others have had neurologicial side effects to their vaccine. I told all the doctors I saw when I had my vaccine, but they didn't feel it was connected.   I now feel it was.
Large local reaction to right arm 10x8 cm red, raised, warm to the touch.  Treated with cold compresses, continue with Claritan and Medrol DosePak started on 11/12/2003.
Respiratory symptoms; Sinus symptoms; Cough; experiencing phlegm and green mucous; Typical fatigue; Headache; Muscle pain; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY SYMPTOM (Respiratory symptoms), SINUS DISORDER (Sinus symptoms), COUGH (Cough), PRODUCTIVE COUGH (experiencing phlegm and green mucous) and FATIGUE (Typical fatigue) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Sinusitis (Sensitive sinuses and prone to getting cold.) and Common cold. Concomitant products included CALCIUM PANTOTHENATE, FOLIC ACID, VITAMINS NOS (MULTI-VITAMINS VITAFIT) and BIOTIN (HAIR, SKIN & NAILS [BIOTIN]) for an unknown indication.    On 29-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced FATIGUE (Typical fatigue), HEADACHE (Headache), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain). On 06-Jan-2021, the patient experienced PRODUCTIVE COUGH (experiencing phlegm and green mucous). On 10-Jan-2021, the patient experienced RESPIRATORY SYMPTOM (Respiratory symptoms), SINUS DISORDER (Sinus symptoms) and COUGH (Cough). On 04-Jan-2021, FATIGUE (Typical fatigue), HEADACHE (Headache), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain) had resolved. At the time of the report, RESPIRATORY SYMPTOM (Respiratory symptoms), SINUS DISORDER (Sinus symptoms), COUGH (Cough) and PRODUCTIVE COUGH (experiencing phlegm and green mucous) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) She received a covid test for her symptoms which was negative..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: no information was provided On 22-Jul-2021: Contact information updated; 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.
Severe hives. MEDROL dose pack. Rx given - BENADRYL 25mg two q 6 hrs for next 48 hrs.
8/15/12 8:00pm Headache and leg cramps - Given TYLENOL. 6;00am 8/16/2012- fever (100.5), chills, leg and arm cramps, Headache, nausea, stomach ache. Gave her TYLENOL @ 6:00am. 5:00p.m same symptoms. Gave her MOTRIN (400mg) and BENADRYL 10:00 p.m. better, slight HA.