chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Trouble lifting her arm; Nausea that came and went; Felt tired and fatigued; Vaccination site pain; Vaccine too high on her shoulder; A spontaneous report was received from a nurse concerning a 77-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccine too high on her shoulder/product administered at inappropriate site, trouble lifting her arm/ movement disorder, nausea, fatigue and vaccination site pain.   The patient's medical history and concomitant medications were not reported by the reporter.    On 02 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 012M20A ) in the left shoulder for prophylaxis of COVID-19 infection.   On 02 Feb 2021, patient believed the vaccine was given too high on her shoulder, and had nausea, fatigue and pain at the injection site (shoulder and arm) which increased with movements, radiating to the upper limb and had trouble sleeping, treated with Tylenol.   Action taken with mRNA-1273 in response to the events was unknown.   The outcome of events were 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.
I have a urgent need of a medicine to restore my [unintelligible] nose/he had to prescribe steroids, Prednisone for a runny nose; lungs are damaged now/run down in my lungs; I told him it was an allergy; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (I have a urgent need of a medicine to restore my [unintelligible] nose/he had to prescribe steroids, Prednisone for a runny nose), LUNG DISORDER (lungs are damaged now/run down in my lungs) and HYPERSENSITIVITY (I told him it was an allergy) in a 74-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced RHINORRHOEA (I have a urgent need of a medicine to restore my [unintelligible] nose/he had to prescribe steroids, Prednisone for a runny nose), LUNG DISORDER (lungs are damaged now/run down in my lungs) and HYPERSENSITIVITY (I told him it was an allergy). The patient was treated with PREDNISONE for Runny nose, at an unspecified dose and frequency. At the time of the report, RHINORRHOEA (I have a urgent need of a medicine to restore my [unintelligible] nose/he had to prescribe steroids, Prednisone for a runny nose), LUNG DISORDER (lungs are damaged now/run down in my lungs) and HYPERSENSITIVITY (I told him it was an allergy) had not resolved.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported.
Case number PHEH2014US008005 is an initial spontaneous report received from a medical assistant on 18 Apr 2014 and with a follow up information received from the medical assistant on 08 Sep 2014. This report refers to a 17-year-old female patient. Her medical history and concomitant medications were not reported. Her vaccination history included vaccination with unknown vaccine on unknown date. She was inadvertently given a dose of MenA powder of MENVEO (batch number: M13047) reconstituted with an unspecified Merck vaccine diluent, intramuscularly on 16 Apr 2014. Trade name, generic name or batch number of the Merck vaccine was not reported. No adverse event was reported following this medication error. Follow up information received from the medical assistant on 08 Sep 2014: Updates vaccination history.
Early January, I started noticing I had chest pains and shortness of breath. I noticed that my pulse rate was high at rest and very high when I was active. I felt like I was going to blackout. The chest pains started getting worst and I had trouble breathing, so my doctor adjusted my medicine. It didn't help. I couldn't walk without getting shortness of breath, so I referred to a Cardiologist and he found that I had pericarditis. I was told that I had fluid in my lungs. It was putting pressure on my heart. So, I had a procedure on both my lungs to drain the fluid off. It made me feel better for a short while and I was still in pain. I went back to the doctor and my left lung had filled back up. I have had three draining of my left lung since that time. I am still having trouble breathing and doing any activities. By this time, I was put on oxygen at home and since then I have been to the ER at least six times. I have been hospitalized three or more times and I am still having problems with my breathing and my oxygen.
Pt presented with a large amount of redness and swelling around the smallpox site.  The inflammation and redness covered most of the deltoid with a few spots on the inside of the arm.  Patient had no other issues at that time.  Pt was instructed to keep the site covered with a different bandage and monitor the site for increased size or any changes in medical condition.
Teammate states left arm with tingling from shoulder to wrist.  Has red, warm and raised area the size of her fist around the injection site and redness goes up shoulder and down to elbow.  States has had this type of reaction in previous years after her flu vaccine, symptoms usually go away after about 3 days.
10/19/2022 I got the Flucelvax and a month later 11/2022 on a Sunday I was sitting down because I wasn't feeling good and had a massive headache. When I yawned and I noticed I couldn't move my mouth. I was rushed the ER Hospital. They told me I had a stroke.
pt recvd vax & pt stood, felt sensation in head & fell to floor; assisted promptly to bed, where had 10-15seconds of inc upper & lower extremity tone; no incontinence, tongue, or tremor; resolved; crying no rash, respiratory distress;
No additional AE reported; a patient with HIV received VARIVAX; This spontaneous report was received from a pharmacy student and reffers to a patient of unknown age and gender. No information regarding patient's, past medical history, concomitant medications, drug reactions or allergies was provided. The patient current condition was human immunodeficiency virus (HIV) infection.  On 20-NOV-2019, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot number R011808, expiration date 23-APR-2020 for prophylaxis.  On 20-NOV-2019, the patient experienced product use issue as it was unknown if the patient had any clinical manifestations of HIV infection, when vaccination with varicella virus vaccine live (oka/merck) (VARIVAX) is contraindicated. It was also unknown if vaccination was performed in accordance to The Advisory Committee for Immunization Practices (ACIP).
This spontaneous report was received from healthcare worker concerning a 22 year old male patient.  The patient was a medical student. The patient did not have concurrent conditions, medical history, drug reactions or allergies, and concomitant medications to report. On an unknown date, the patient vaccinated with a dose of RECOMBIVAX HB for prophylaxis (dose and lot number were not provided). It was reported that the patient was vaccinated at birth, 1 month old, and 6.5 months old. On an unknown date (reported as "few days ago"), the patient's titers were less than 5 (negative). Per healthcare worker, physician had decided to provide a booster of RECOMBIVAX HB to patient in effort to treat the low titers (dose not yet administered). At the time of the reporting, the patient was doing fine other than low titers. The causal relationship between the adverse event and therapy with RECOMBIVAX HB was not provided.
Muscle pain, weakness in lower torso, legs, moving to upper torso.  Cannot sleep due to pain. Diagnosed as GBS. Immunoglibin infusions treatment prescribed.
I was very cold on Friday the 12th.    Morning of the 13th, I had leg problems, felt like I had no legs at all.   This did go away about10 minutes after it started.   Had another episode afternoon of March 13th.    Also went away about 10 minutes later
The instructions I received said to type: Moderna COVID-19 Vaccine EUA in the first line of box #18 of the report form. 1/25/2021 - evening - sore arm below injection site, not so much at site, not unbearable but noticable 1/26/2021 - evening - feeling achy before bed, rubbed Aspercreme on sore neck, wrists, elbows, etc 1/27/2021 - just after midnight, about 12:30 am - woken by uncomfortable flu-like symptoms, very achy, joints, head, no fever 1/27/2021 - evening - notable rash patch on left arm below injection site, a little swollen and a bit itchy Took Excedrin in the morning, Tylenol in the evening Uncomfortable to Very Uncomfortable symptoms but nothing that I couldn't stand
my mother collapsed in the kitchen she was rushed to hospital via ambulance she passed away, doctor said her heart was having a hard time he said there was a blood cot by lung
Patient is 59 years old and received a Fluzone Quad High Dose vaccine. According to CDC: Fluzone High-Dose Quadrivalent vaccine is approved only for people 65 years and older. Fluzone High-Dose Quadrivalent is not approved for people younger than 65 years or for people of any age with a history of severe allergic reaction to any influenza vaccine or to vaccine components other than eggs. Information about vaccine ingredients is located in the manufacturer?s package insert.
This case was reported by a other health professional via call center representative and described the occurrence of shivering in a 45-year-old male patient who received SHINGRIX (batch number B4C42, expiry date 25th April 2020). Concomitant products included AMBIEN and methimazole. On 17th April 2018 09:30, the patient received the 2nd dose of SHINGRIX .5 ml. On 17th April 2018, less than a day after receiving SHINGRIX, the patient experienced shivering, insomnia, labored breathing, headache and fever. On an unknown date, the outcome of the shivering, insomnia, labored breathing, headache and fever were recovering/resolving. The reporter considered the shivering, insomnia, labored breathing, headache and fever to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. The reporter gave permission to contact patient's health care physician and had provided contact details for the same.
PT RECEVIED FLU AND PNEUMONIA IN LEFT ARM BY REQUEST --- REPORTS CELLULITIS IN ARM AFTER SEEING PHYSICIAN - PT IS ALREADY HAS INFLAMMATION AND REDNESS TO ARM, NO DIFFICULTY BREATHING - WILL REPORT TO VAERS
Arm swollen and redness. Tender to touch. Looks like a rash in area.
received two pediatric doses instead of adult dose; This case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a adult patient who received HBV (Engerix B pediatric) (batch number HN5BE, expiry date unknown) for prophylaxis.   Co-suspect products included HBV (Engerix B pediatric) (batch number HN5BE, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Engerix B pediatric and Engerix B pediatric. On an unknown date, unknown after receiving Engerix B pediatric and Engerix B pediatric, the patient experienced adult use of a child product. On an unknown date, the outcome of the adult use of a child product was unknown.   Additional Information: GSK Receipt Date: 08-JUN-2022 Reporter's comments: The Healthcare Professional was looking for an information on a patient who received two pediatric doses (lot number: HN5BE) with 18 hours of difference instead of an adult dose.  The reporter stated that this situation happened a year ago from the day of reporting. The reporter consented to follow up via email. Additional Supportive Information: The patient received 2 doses of Engerix B pediatric instead of Engerix B adult, which led to adult use of a child product.
Child developed stuffy nose with injected both conjunctia. Low breathing sound with pale (after about 15 min later). Treated with epinephrine SC X3 and (Prednisone, Benadryl) PO
This is a serious spontaneous case, initially received from other non-health professional on 14-Feb-2018, concerning a male patient of an unspecified age. On 27-Sep-2017, the patient was administered with FLUCELVAX QIV (route of administration: intramuscular, anatomical location: left deltoid muscle, batch number and expiry date: not reported). On 13-Feb-2018 (reported as yesterday), the patient developed unspecified symptoms (reported that, the patient was exposed to a sick family member in the past weekend). On 14-Feb-2018, after 4 months 19 days of vaccination, the patient was diagnosed with influenza type A virus infection. It was not clear, whether the patient received antiviral treatment. At the time of this report, the outcome of the event was not reported.
Client received flu vaccine injection at 4:45pm on 11/14/2007.  He awoke at 4:30am on 11/15/2007 feeling nauseous and dizzy.  He had diarrhea.  The symptoms lasted for 90 minutes. He then felt better and returned to bed.
Weakness to right leg and right arm, general fatigue, shakiness/tremors to all extremities and neck.
no other AE symptoms have been observed/ no adverse event from vaccination; a baby 7 weeks old and 1 day was administere VAQTA by mistake instead of a hepatitis B vaccine; Product administered to patient of inappropriate age; This spontaneous report was received from a physician and refers to a 7-week-old patient. The patient's concurrent conditions, concomitant medications, medical history, drugs reactions or allergies were not provided.  On 19-FEB-2021, the patient was vaccinated with hepatitis a vaccine, inactivated(VAQTA) lot # T014835 with expiration date 17-JUL-2021 (dose, route of administration were not provided) for prophylaxis, by mistake, instead of hepatitis B vaccine (manufacturer unknown). There was no adverse event reported. The doctor stated that there was no problem with the baby, it was "completely unremarkable" and no adverse event from vaccination was observed. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T014835; expirationdate: 17-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
3 to 4 hours post-vaccination tachycardia measured at 109, feeling of my chest pounding, and also when feeling my pulse it seemed as though I had 3 strong beats and a soft beat very rapidly occurring which lasted for hours into the night. Upon repeat heart rate checks I found the heart rate to come down over the hours to into the 90s
Headache, Sedation, Myalgia, Arthralgia, NauseaVomiting Redness @ injection site Narrative:  Other Relevant History:
I broke out with redness and an egg shaped swollen bump on my arm. It has been two weeks and swelling has gone down some but redness seems to be getting bigger.
Inflammation; now I'm not able to do it; Mainly on the back and lower muscles/Back down; Sometimes in neck and lower part of head; Head pain; my body aches so bad; lower part of head; Extreme muscle pain; Extremely exhausted and fatigued; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Sep-2021 and was forwarded to Moderna on 22-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Inflammation), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (now I'm not able to do it), BACK PAIN (Mainly on the back and lower muscles/Back down), NECK PAIN (Sometimes in neck and lower part of head) and HEADACHE (Head pain) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced FATIGUE (Extremely exhausted and fatigued). In July 2021, the patient experienced MYALGIA (Extreme muscle pain). On an unknown date, the patient experienced INFLAMMATION (Inflammation), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (now I'm not able to do it), BACK PAIN (Mainly on the back and lower muscles/Back down), NECK PAIN (Sometimes in neck and lower part of head), HEADACHE (Head pain), PAIN (my body aches so bad) and HEADACHE (lower part of head). The patient was treated with IBUPROFEN for Back pain, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Back pain, at an unspecified dose and frequency. On 02-Apr-2021, FATIGUE (Extremely exhausted and fatigued) had resolved. At the time of the report, INFLAMMATION (Inflammation) and HEADACHE (Head pain) outcome was unknown and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (now I'm not able to do it), BACK PAIN (Mainly on the back and lower muscles/Back down), NECK PAIN (Sometimes in neck and lower part of head), PAIN (my body aches so bad), HEADACHE (lower part of head) and MYALGIA (Extreme muscle pain) had not resolved.            Concomitant and Treatment was not specified.  Doctor told patient to take Ibuprofen or Tylenol for the pain, but patient didn't like taking medication.   This case was linked to MOD-2021-329014 (Patient Link).
Lt thigh, warm, red, indurated area around DPT injection on 2MAY91, tender to touch;
Hives, face swelled, dizzy, heart rate slowed down, sob, vomiting and diarrhea
Talked to patient on 10/10/15 (1 day after receiving flu shot). Pt's health condition is the same, no serious reaction after receiving 2nd dose of the shot (didn't know pt had a flu shot previously in Aug 2015.)
COVID 19 Treatment; COVID 19 Treatment; Moderna dose: 3 15Sep2022/Pfizer dose 2: 15Oct2021; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult male patient received BNT162b2 (BNT162B2), on 29Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 15Oct2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), on 12May2022 as dose 3 (booster), single (Batch/Lot number: unknown) and on 15Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "known allergies: penicillin" (unspecified if ongoing), notes: known allergies: penicillin. Concomitant medication(s) included: LISINOPRIL. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 12May2022, outcome "unknown", described as "Moderna dose: 3 15Sep2022/Pfizer dose 2: 15Oct2021"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (18Dec2022) Negative, notes: Tested negative on Dec 18Dec, 19Dec, and 26Dec; (19Dec2022) Negative, notes: Tested negative on Dec 18Dec, 19Dec, and 26Dec; (26Dec2022) Negative, notes: Tested negative on Dec 18Dec, 19Dec, and 26Dec; (31Dec2022) Positive, notes: Retested positive on 31Dec. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300003295 Same patient, same product, different event;
CHEMOTHERAPY INDUCED PERIPHERAL NEUROPATHY, INIT 7/20/2021 UTI (URINARY TRACT INFECTION)  PERIPHERAL NEUROPATHY 8/6/2021 UTI (URINARY TRACT INFECTION)  CHEMOTHERAPY INDUCED PERIPHERAL NEUROPATHY, INIT 7/20/2021 ADENOMATOUS POLYP, COLON    BRAIN MASS  PERIPHERAL NEUROPATHY 8/6/2021 ADENOMATOUS POLYP, COLON    BRAIN MASS  CHEMOTHERAPY INDUCED PERIPHERAL NEUROPATHY, INIT 7/20/2021 METABOLIC ENCEPHALOPATHY  PERIPHERAL NEUROPATHY 8/6/2021 METABOLIC ENCEPHALOPATHY  CHEMOTHERAPY INDUCED PERIPHERAL NEUROPATHY, INIT 7/20/2021 UTI (URINARY TRACT INFECTION)   PERIPHERAL NEUROPATHY 8/6/2021 UTI (URINARY TRACT INFECTION)
chills, night sweats, and body aches, particularly back pain that was very intense and required me to visit a chiropractor to help find relief. Took 2 extra strength Tylenol and still felt pain. A few days later it was better. It took a few weeks to go away completely. It came on very suddenly.
Patient presented to the emergency room 6 hours after shots with febrile seizures. Repeat episode of febrile seizure 24 hours after first episode.
Next morning: sore arm, lump at injection site, migraine like headache and neck pain, swollen gland on left side of neck
The MD thinks he might have had rheumatoid arthritis.; Still been experiencing muscle and joint pain in knees, hands, and shoulders.; Experiencing a lot of joint pain; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (The MD thinks he might have had rheumatoid arthritis.) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Unknown and 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced ARTHRALGIA (Experiencing a lot of joint pain). On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (The MD thinks he might have had rheumatoid arthritis.) (seriousness criterion medically significant) and MYALGIA (Still been experiencing muscle and joint pain in knees, hands, and shoulders.). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Pain, at an unspecified dose and frequency. At the time of the report, RHEUMATOID ARTHRITIS (The MD thinks he might have had rheumatoid arthritis.), ARTHRALGIA (Experiencing a lot of joint pain) and MYALGIA (Still been experiencing muscle and joint pain in knees, hands, and shoulders.) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant product use was not provided by the reporter.  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.   This case was linked to MOD-2021-201893 (Patient Link).; 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.