chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Limp feeling; Had a strain on her neck, on left side, which is the same side the injection was given.; Soreness on the left side from his neck to the base of his skull within 4 hours of the vaccination; Extreme fatigue; Headache; Debilitating frontal headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Limp feeling), MUSCLE STRAIN (Had a strain on her neck, on left side, which is the same side the injection was given.), FATIGUE (Extreme fatigue), NECK PAIN (Soreness on the left side from his neck to the base of his skull within 4 hours of the vaccination) and HEADACHE (Headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043LZ0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in October 2020.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Limp feeling), MUSCLE STRAIN (Had a strain on her neck, on left side, which is the same side the injection was given.), FATIGUE (Extreme fatigue), NECK PAIN (Soreness on the left side from his neck to the base of his skull within 4 hours of the vaccination), HEADACHE (Headache) and HEADACHE (Debilitating frontal headache). At the time of the report, FEELING ABNORMAL (Limp feeling), MUSCLE STRAIN (Had a strain on her neck, on left side, which is the same side the injection was given.), FATIGUE (Extreme fatigue), NECK PAIN (Soreness on the left side from his neck to the base of his skull within 4 hours of the vaccination), HEADACHE (Headache) and HEADACHE (Debilitating frontal 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.   No treatment and concomitant medication information was reported.   This case was linked to MOD-2021-032172 (Patient Link).
After the booster I had a feeling like a terrible flu and I had to take off work for 2 days. Then I got COVID-19 with headaches, extreme tiredness, sore throat, nauseous, and  body aches. I received a positive COVID-19 PCR test at an urgent care. My symptoms lasted for about 3 days. After the 3rd day, I was feeling somewhat better. After COVID-19 in late March, I noticed that pain that shoots down my legs from my back. I have always had lower back pain but this is different with the leg pain. I feel like I get more colds and feeling bad more lately. I have to take off work more often since having COVID-19. It is like my immune system is weaker.  It is like the degree of my symptoms are much more stronger. When I get a headache it is more extreme than normal and with body aches as well.
Patient requested Pfizer Bivalent vaccine booster, dose should be 0.3 ml. Patient was given Pfizer 12+ grey top original vaccine 0.3 ml.
PRESENT ILLNESS: Patient is a 92 y.o. female with a PMH of hypercalcemia, hypertension, prior provoked PE, recent COVID diagnosis in April 2022 (s/p paxlovid) that presented to the ED with chills and vomiting that started several hours prior. Patient's husband noticed that his wife looked like she had rigors and she said she felt chilled and nauseous. She proceeded to vomit once, no blood in vomit. Checked her temperature at home and it was normal. Has also had some achy left sided abdominal pain for several days that has waxed and waned, no back pain. She denies any other symptoms such as lightheadedness, dizziness, cough, shortness of breath, chest pain, dysuria, hematuria or weakness. rapid COVID came back positive.  Of note, she was diagnosed with COVID back on 4/29/22, was not admitted to the hospital. She was symptomatic at the time with cough and runny nose. She was given Paxlovid prescription and took this as prescribed.
Red, hot to the touch and  raised up swollen red around injection site. Painful to touch and she had a lot of complaints moving arm day after until Friday morning with using the arm.
Left arm swelling, red patch (about 4 inches by 4 inches) near injection site, itching, painful gland under arm. Symptoms began 7 days after injection. Symptoms are improving.
Patient made an appointment for Adult Pfizer Booster vaccine at 4pm. Administering pharmacist mistakenly pulled Pediatric Pfizer vaccine from fridge, drew up the dose, and administered 0.3 ml of the Pediatric Pfizer vaccine to the patient. At closing, when submitting report, closing pharmacist noticed tally marks on Pediatric vial, not adult pfizer vial. Pharmacy manager had to review camera footage the following morning to confirm administering pharmacist pulled vaccine from pediatric section of fridge. The patient was notified the next morning. She explained she and her husband were extremely reluctant to get the booster as new data about long term side effects have been coming out regarding the vaccine. The patient was suggested the correct course of action (receiving correct dose of vaccine) but refused. She said she "feels more comfortable that her and her husband received the pediatric vaccine" and has decided against coming in again to receive adult pfizer dose.
Last night on the left side of my body by my ear and down in my neck, I began that an itching going on; Last night on the left side of my body by my ear and down in my neck, I began that an itching going on/woke up several times during the night itching; scratching; There is a red site and it seems to be possible by moving little bit down into the neck area again on the left side; I described it as a rash or hives; There is a red site and it seems to be possible by moving little bit down into the neck area again on the left side; I described it as a rash or hives; There is a red site and it seems to be possible by moving little bit down into the neck area again on the left side; I described it as a rash or hives; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got his second vaccination a week ago today and he had absolutely no problem but last night on the left side of his body by his ear and down in his neck, he began that an itching going on and he woke up several times during the night itching, scratching and then today there is a red site and it seems to be possible by moving little bit down into the neck area again on the left side, more like he do not know if he described it as a rash or hives. The outcome of the events was unknown.  QR Comment: Appropriate response could not be provided for MI because of the technical issue.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from a consumer concerning her approximately 16 year old daughter with a history of seizure disorder and no known allergies who in August 2009, was vaccinated with the second dose of GARDASIL (lot number not reported). Concomitant therapy included TOPAMAX, PROZAC, magnesium (unspecified) and unspecified oral contraceptives. Approximately in August 2009, the patient developed headaches and aching in her legs and "generally not feeling well" a few days after vaccination. Medical attention was sought via phone call. There were no lab studies performed. On an unknown date, the patient recovered. Follow-up information has been received from the consumer and a health care professional concerning the 16 year old female patient with asthma, a history of migraines and no known drug allergies who on 24-AUG-2009 was vaccinated in the left deltoid with the first dose (previously reported as the second dose) of GARDASIL (lot number 662404/0312Y). On an unspecified date the patient developed achy, leg pain and there was no treatment for the achy at the office. The health care professional thought the patient may had seen her primary care physician. Follow-up information was received which reported that on 24-AUG-2009, the 16 year old female was vaccinated with a dose of GARDASIL (lot #662404/0312Y) into the left deltoid. Subsequently, the patient experienced leg ache and body ache per phone call. The patient cancelled GARDASIL vaccination on 23-DEC-2009. Additional information is not expected.
Admission Date: 10/1/2022 Discharge Date: 10/03/2022 Admitting Diagnoses: Principal Problem:   COVID  PRESENTING PROBLEM: COVID   HOSPITAL COURSE: The patient is a 80 y.o. male with past medical history significant for hyperlipidemia, coronary artery disease, OSA, type 2 diabetes, sick sinus syndrome, pacemaker, ischemic cardiomyopathy, heart failure that presented to  emergency department for generalized weakness and fatigue. Found to be positive for COVID-19. Not hypoxic. Dry cough. Chest x-ray fshowed decreased lung volume, no evidence pleural effusions or pneumonia Fatigue and cough improved with supportive care and remdesivir. PT evaluated and recommended discharge home as he is progressing to baseline no continued PT needs identified. Patient cough improved with supportive cares and 3 doses of remdesivir. Patient discharged home on 10/3.     Close follow up advised as noted below including following up with primary care provider doctor. Patient  expressed understanding and agreement with this plan. Patient  in agreement with and requested discharge on 10/03/2022
I started getting a sore throat off and on from 11/17/22. I had a cough, vomiting, fever, body aches, chills, slight congestion, sore throat. I woke up on Monday, 11/21/22 with a fever over 101F and tested over the weekend with a home COVID-19 test. It came back negative, I called to go into the doctor but could only get a tele-health visit, then decided to bring me into the Urgent Care to do the COVID-19 test, strep test, influenza. All test came back negative. They did put me on Tamiflu as a preventative. I went back on Wednesday (11/23/22) to be retested and I was still not feeling better and my temperature was still not coming down much. Once I retested for COVID-19, it came back positive I was prescribed Paxlovid. I started taking it immediately, I started feeling better the next day and no fever since that day.
No additional adverse events; Caller is a HCP reporting a patient received an expired dose of VARIVAX.; This spontaneous report was received from Physician and refers to a unspecified age and gender patient. No information regarding the patient's medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications was provided.  On 29-NOV-2022, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter, lot #T038830, expiration date: 17-NOV-2022 (who had been verified to be a valid number), administered for prophylaxis (strength, and route of administration were not provided). No additional adverse events was reported.
only diluent portion of Menveo used; Only diluent  administered; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 18-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA721A, expiry date 20th October 2023) and (batch number AMAA721A, expiry date 20th August 2023) for prophylaxis.   On 27th July 2022, the patient received Menveo. On an unknown date, the dose was an unknown dose. On 27th July 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 27-Jul-2022 Reporter's comment: The medical assistant administered only the diluent portion of Menveo on the day of reporting. The adverse event contained all the reported information as per the health care professional. The reporter consented to follow-up. Additional supportive information: The patient was administered with only the diluent portion of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Aseptic Meningitis  -  stiff neck, body aches, headaches, nausea, diarrhea, fatigue, 15-20 ocular migraines a day, dizziness, anorexia - treatment - rest fluids Motrin - time course - on day 10 with symptoms yet but starting to improve
bruising in arm, nauseous, chills, fatigue, vomiting, migraine
Sore spot at point of injection.  100.4 temperature  Extreme weakness in the body
On 02/18/2023, I woke up with a sinus headache and congestion in my nose. I started feeling crummier throughout the day. I took a COVID-19 test around 05:00PM and that was positive. I called my doctor who prescribed Paxlovid. I had the headache all day and felt really sluggish, just all around under the weather. I began taking the Paxlovid that night and was already feeling better the next morning. I continued to have congestion, but the headache and energy improved. I took the full course of Paxlovid. The symptoms stayed the same but improved after beginning the medication. I tested negative 02/24-02/26. I was still feeling low energy and had a bit of congestion, but it wasn't worse than my normal allergy symptoms. I started feeling worse again with headache, congestion, and body aches. I also had a sore throat and lower chest symptoms. On 02/27/2023, I tested positive for COVID-19 again. Those symptoms continued to get worse over the next few days. I spoke with my doctor again who suggested I take another round of Paxlovid. After I began that, I felt better again the next morning. Most of the head symptoms went away. I did develop a deep cough that lasted for a few days. Around the following Monday or Tuesday, I was pretty much back to normal with a bit of fatigue.
Pt recv vax on 10/27/98; on 11/2/98 pt exp fever, tender Rt arm nodule
Initial information received on 13-Nov-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked with 2018SA315883, 2018SA315884, 2018SA315886, 2018SA315887, 2018SA315888, 2018SA315882 and 2018SA315885. This case involves a 56 years old female patient who had the vaccines that were exposed to a max temp of  52 f for 27 hours which was inadvertently received by patient, while she received vaccine FLUBLOK QIV. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 07-Nov-2018, the patient received a  0.5ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA1815, expiry date- 30-Jun-2019 via intramuscular route in the left deltoid. It was a case of actual medication error due to incorrect product storage. It was unknown if any adverse event occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
04/07/22 - 6 PM began feeling unwell.  10 PM severe chills.   04/08/22 - Approximately 1 AM through 5 AM elevated heart rate (140-155 bpm while lying down and trying to sleep.  Elevated heart rate and fever waking me up.  Unable to go to work.   04/08/22 through  04/10/22 - Fatigue.
Fine rash on back of arms, few spots on back of legs; no itching. Mom to get OTC Benadryl and take to PMD.
ACHES; GROIN PAIN; THIGH PAIN AND LEG PAIN; CHILLS; SHOULDER PAIN; This spontaneous report received from a patient 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 04-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced aches, groin pain, thigh pain and leg pain, chills, and shoulder pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, aches, groin pain, thigh pain and leg pain and shoulder pain was not reported. This report was non-serious.
Patient started experiencing headaches, scalp tenderness, eye pain, blurred vision, and loss of balance approximately 3 days after getting flu shot. Patient was seen here in office on 2/14/19 and then in emergency room on 2/15/19. Neurology and hematology referrals given. Multiple labs were done in emergency room on 2/15/19 to check for meningitis as well as other illnesses. Most of these labs are still pending.
The patient has not experienced any adverse event that we are aware of.  The patient was administered a Pfizer covid-19 bivalent vaccine that was improperly stored and administered past the beyond use date
rash was shingles-like i.e. on only one side, wrapping around side of body in fingers.; This case was reported by a consumer via call center representative and described the occurrence of rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included diclofenac sodium (Voltaren Arthritis Pain Gel) (batch number 879V, expiry date 30th September 2023) for arthritis.   Previously administered products included Shingrix (received 1st dose in February 2019).   In June 2019, the patient received the 2nd dose of Shingrix. On an unknown date, the patient started Voltaren Arthritis Pain Gel 130 Bq 4 times daily (520 Bq daily). On an unknown date, unknown after receiving Shingrix, the patient experienced rash. Voltaren Arthritis Pain Gel was discontinued. On an unknown date, the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient. The age at vaccination was not reported. The patient was also using Voltaren Arthritis Pain 1 percent gel 4 times/day upto 21 days to his/her right foot. On day 3 of using gel with beneficial effects, the patient developed rash. The patient stated that in pamphlet mentioned the possibility of a rash, but did not mention a location. The rash was on the right side of the patient's midriff and was shingles-like, i.e., on only one side and wrapping around the side of his/her body in fingers. The patient discontinued using the gel upon appearance of the rash. After 2 to 3 days, the rash subsided and the patient had not resumed the gel.  The patient appreciate any guidance you might provide. The patient was treated by health care professional. The reporter authorized follow-up with health care professional. It was unknown if the reporter considered the rash to be related to Voltaren Arthritis Pain 1 percent gel. The reporter did not consent to follow-up.
Patient has had ongoing issues - new skin rashes, new feeling of heaviness in legs, and abnormal menses since receiving Moderna COVID vaccine.
Within 2 to 5 days of 2nd dose, I began having an increase in eye floaters which graduated to seeing three dimensional shapes like orbs in various colors. Over a period of a week, these became full blown hallucinations of  objects floating or moving in and out of walls. This has continued on through today, increasing in intensity. Have seen visions of people and objects. Occurs while lying down either trying to go to sleep or after waking up. Also having chills off and on, predominantly in my legs. Have also been experiencing a sensation of bed shaking / vibrating for over 1.5 years. Unsure if related.
This case was reported by a consumer via patient support programs and described the occurrence of throat swelling in a 56-year-old female patient who received BENLYSTA powder for infusion for systemic lupus erythematosus. On an unknown date, the patient started BENLYSTA at an unknown dose at unknown dosing. On 5th October 2016, an unknown time after starting BENLYSTA, the patient experienced throat swelling, uvula swelling and adverse reaction. The action taken with BENLYSTA was unknown. On an unknown date, the outcome of the throat swelling, uvula swelling and adverse reaction were unknown. It was unknown if the reporter considered the throat swelling, uvula swelling and adverse reaction to be related to BENLYSTA. Additional details included that the reporter was the patient who reported the information via Patient Assistance Program. The patient reported that she took BENLYSTA "Tuesday and on Wednesday had a reaction and had to go to the hospital." The patient did not specify the reaction other than to say that her throat and uvula were massively swollen. The patient reported the use of other unspecified medications and reported that she did not know if it was due to the combination of them all. Follow up information was received on 03 November 2016 from the patient via a returned Authorization to Contact Physician form. The patient provided the BENLYSTA lot numbers of J295 and J286 (expiry dates unknown). The patient provided permission to contact her healthcare provider. Follow up information was received from the patient via GSK Response Center on 12th April 2017: The patient reported that she started BENLYSTA in June of 2016 and less than a month after receiving BENLYSTA she experienced a sinus infection which was treated with antibiotics. She resumed her BENLYSTA sometime after the infection was resolved. On 4th October 2016, Tuesday, the patient again received BENLYSTA infusion. The patient added that she had taken a flu shot that same week. On 5th October 2016, Wednesday, 1 day after BENLYSTA and less than a week after flu shot, the patient experienced throat swelling and was treated with BENADRYL, taken to the emergency department and admitted into the hospital, overnight for what she stated was an allergic reaction. The patient reported that she was taken off BENLYSTA at that time. The patient stated that she resumed the BENLYSTA infusions on Friday, 31st March 2017. On 11th April 2017, less than a month after BENLYSTA and less than a year after Flu vaccine the patient reported diarrhea which lasted until the morning of 12th April 2017. The patient stated that she had previously reported the allergic reaction from October 2016, but could not find any record of her contact information or a camel report. The patient's rheumatologist contact information was also provided.
A Spontanous  report (UNITED STATES) was received concerning a 87 Years old, Female patient who received Moderna's COVID-19 vaccine (mRNA-1273) on 9-feb-2021 and experienced events     The patient's medical history was unknown     On 09 MAR 2021 she got her first dose of mRNA-1273 vaccine  intramuscularly and batch no:030M20A,   SHE Received the first dose of the Moderna vaccine on 9feb2021, next day big, hard, hot, lump on her  arm-lasted one day. Was also itching. On the 16th or 17th of Feb2021 has had hives itching like mad.  SHE Was put on a steroid yesterday 21FEB2021 helped a lot.  Consent for safety to follow up.  Treatment information was unknown.concaminant drug also not provided  Action taken with mRNA-1273 in response to the events was not provided.     The outcome of the events were Unknown