chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shivers; pain in both shoulders and in his neck like aching pain; pain in both shoulders and in his neck like aching pain; a slight sore throat; he had shakes; This is a spontaneous report from a contactable consumer or other non hcp. A 73-years-old male patient received bnt162b2 (BNT162B2), dose 1 (Lot Number: EN6206 expiry date was unknown) via an unspecified route of administration on 09Mar2021 11:18 as a single dose for covid-19 immunisation. Medical history included blood cholesterol increased from an unknown date and unknown if ongoing. Concomitant medication(s) included warfarin sodium (COUMADIN) taken for an unspecified indication, start and stop date were not reported. Additional Information for Concomitant Products Coumadin: He started taking that about 10 years ago. He takes 10 mg once daily 6 days per week and there is one day out of the week that he takes 7.5 mg once that day. Consumer was called about the got the Pfizer shot, he had the first one yesterday, he confirms the COVID 19 vaccine. He had it about 11:18 in the morning and had no side effects at that time but about 5 in the afternoon he started having pain in both shoulders and in his neck like an aching pain and he still has both of those and a slight sore throat. Then last night from about 9PM until midnight he had shaken and the shivers and turned over on his side and it went away in about hour or so, he doesn't have that any longer, but he still has the aching pain in his neck and in both shoulders. He asked what your advice about that is. Event details: He got the first dose 09Mar2021, it was given at 11:18 AM in the morning and his shoulders and neck started hurting the same day and that night at about 9 or 10 PM he started shivering like he was cold and a couple hours later that was gone, he confirms the chills and shivers have recovered completely at this time. Product details: He sees a number on the vaccine card PH2330171. He also sees Pfizer and then EN6206, he sees the date 09Mar2021 which is the date he got it, they did not write an expiration date. No NDC number, just a PH number. He was on a blood thinner, and he's got high cholesterol and he was on medication for that. His medication for blood thinner, in fact today once he gets off the phone, he was going to call his heart doctor, they are the ones that monitor his Coumadin numbers, he was going to call them to see if it is okay for him take something for the pain in his neck, he was going to see if there is anything he would be okay to take. Communication: Advised caller to follow up with his physician for medical    No follow up attempts are Possible. No further information is expected.
Fever to 102.7 (with ibuprofen) during night with vomiting.  Fever spiked again in morning with 2 bouts of vomiting
Dizziness,headache,palpitations with increased heart rate to 132/min,mild increase in BP,cold and clammy hands and both legs below knees . I didn't have any shortness of breath or chest pain. My pulse ox was 98-99.My symptoms started within 20  mins of  vaccination and lasted for almost 2 hours on and off before they were resolved. I didn't need any medical intervention like O2 or IV administration of fluids or any medications. I was under observation and dranks about 30 oz of water to keep myself hydrated . Once I felt better I drove home and rested for whole day and didn't go out. I didnt have any recurrence of these symptoms later that day or next day.
Upon receiving both doses, was scheduled to have an injection for lower back pain.  Pre-admission testing required that I be Covid tested.  I was notified this a.m. that I had tested positive so I notified my friends.
he have all symptoms of COVID headache, runny nose, cold; he have all symptoms of COVID headache, runny nose, cold; This is a spontaneous report from a contactable consumer (patient). A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 23Jan2021 (Batch/Lot number was not reported) at a single dose for COVID-19 immunization. Medical history included abdominal discomfort from an unknown date and unknown if ongoing. Concomitant medication included esomeprazole sodium (NEXIUM) taken for stomach, start and stop date were not reported. The patient got the first vaccine on 23Jan2021 Pfizer Covid vaccine and second one will be on Saturday, 13Feb2021 but his colleague tested positive on Monday, they are working at the same room and now he have all symptoms of COVID headache, runny nose, cold. Onset of the events reported as Feb2021. There was no treatment in response to events. The events were reported as non-serious. Outcome of the events was unknown.  Information about lot/batch number has been requested.
Large reddened area from injection site to lower part of elbow. Slightly raised and warm to touch pt says it is not uncomfortable.
Erythema greater than 120mm 3 days to date; enduration 3 days to date; constant itching 2 days to date
Vaccine area very red and painful, doctor thought it was not administered deep enough or high enough on arm per mother. Dr. recommended ice packs and BENADRYL, if not better in a few days come see Dr. again.
onset of fever 2 hrs p/vax-fever all next day 101; refused to put wt on leg-area puffy; refused to let anyone touch area; very lethargic x 1 1/2 days;
Hot, swelling, red, full body muscle pain especially to touch, fever, aches, nausea, vomiting, headache now weird hive rash developing
patient was mentally foggy/mental fogginess; patient experienced headaches; chills; patient experienced fever; uncomfortable flu-like symptoms; patient started to feel off; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (uncomfortable flu-like symptoms), DEPRESSED MOOD (patient started to feel off), FEELING ABNORMAL (patient was mentally foggy/mental fogginess), HEADACHE (patient experienced headaches) and CHILLS (chills) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (uncomfortable flu-like symptoms), FEELING ABNORMAL (patient was mentally foggy/mental fogginess), HEADACHE (patient experienced headaches), CHILLS (chills) and PYREXIA (patient experienced fever). In March 2021, the patient experienced DEPRESSED MOOD (patient started to feel off). In March 2021, INFLUENZA LIKE ILLNESS (uncomfortable flu-like symptoms), DEPRESSED MOOD (patient started to feel off), FEELING ABNORMAL (patient was mentally foggy/mental fogginess), HEADACHE (patient experienced headaches), CHILLS (chills) and PYREXIA (patient experienced fever) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no concomitant medications are provided. treatment to the events not reported. Patient gave a more detailed description: second shot was administered at 9 o'clock. By 11 o'clock patient started to feel off, by 12 o'clock patient had a headache, by 1 o'clock patient had chills, headache, and uncomfortable flu-like symptoms. As patient said, these lasted around 36 hours, and the mental fogginess for 8 hours more.   This case was linked to MOD-2021-329486 (Patient Link).
No effects on same day or next, except for sore arm and a bit tired. Woke up the 2nd day after and had broken out in hives all over my trunk area and up the neck. These lasted for about 24 hours as well. The hives were raised and red, but no other side effects like itching or swelling. No fevers with any of the doses either.
PATIENT RECEIVED  FLUZONE  VACCINATION IN RIGHT ARM.  PATIENT  PRESENTED  WITH PARENTS AND APPEARED  VERY ALERT AND KNOWLEDGABLE  ABOUT GETTING A VACCINE. SHOWED NO SIGNS OF PALENESS, WEAKNESS, OR HEAVY BREATHING.  PRESENTED WITH NORMAL APPEARANCE AND ACTIONS.   ABOUT  10 MINUTES AFTER VACCINE, PT VOMITED ONCE.  AFTER EVALUATION AND DISCUSSION WITH PARENTS AND PATIENT,  PATIENT FELT COMPLETELY FINE AND VOMITING.  HE REMAINED AT PHARMACY FOR ANOTHER 20 MINUTES TO WATCH.  PT DRANK WATER AND STATED FEELING FINE.  CHECKED ON PT AT 12:30 AND 7 PM.- PT COMPLETELY FINE PER MOTHER
leg cramps; arm soreness/soreness of the site; head is pounding; chills; 38 days between the first and second dose of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (38 days between the first and second dose of the vaccine), MUSCLE SPASMS (leg cramps), VACCINATION SITE PAIN (arm soreness/soreness of the site), HEADACHE (head is pounding) and CHILLS (chills) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 93989B and 015621A or 0512H) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included AMLODIPINE for Hypertension.   On 18-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (38 days between the first and second dose of the vaccine). 27-Jul-2021, the patient experienced VACCINATION SITE PAIN (arm soreness/soreness of the site), HEADACHE (head is pounding) and CHILLS (chills). On an unknown date, the patient experienced MUSCLE SPASMS (leg cramps). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (38 days between the first and second dose of the vaccine), MUSCLE SPASMS (leg cramps), VACCINATION SITE PAIN (arm soreness/soreness of the site), HEADACHE (head is pounding) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jul-2021, Body temperature: 101.2 (Inconclusive) oral temperature was 101.2 degrees Fahrenheit.         No treatment medications were reported. After the first dose patient had soreness of the site. She has arm soreness today and 2 hours ago. She had headaches and her head is pounding. 30 minutes ago she started having chills and took her oral temperature which was 101.2 degrees Fahrenheit. She hasn't eaten or drank anything. She also has leg cramps. She intends to take ibuprofen for her side effects.   This case was linked to MOD-2021-270098 (Patient Link).
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Gave one booster dose from an expired vial) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination. No Medical History information was reported. On 12-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Gave one booster dose from an expired vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Gave one booster dose from an expired vial) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The health department brought vaccines and when they went on the website too look up the expiration date they did not realize when they wrote it down it was already expired. No concomitant medication was reported. No treatment information was reported.
Symptom onset 03/17/2022, symptoms include, dyspnea, fatigue, difficulty breathing, pale, gray or blue colored skin, lips or nail beds, hospitalization date 03/18/2022
(R) arm (upper) redness, warm to touch, itching. Induration 8cm x 6.8 cm. Cellulitis vs. Local reaction. Tx - ice 15-20 mins TID, BENADRYL q 6-8 hrs, KEFLEX 500mg PO BID x 10 day.
patient was given an expired dose of Tenivac with no adverse event; Initial information regarding an unsolicited valid non-serious case received from a other health professional via Global Medical Information (GMI) (reference number: 00360472) on 16-Nov-2020.  This case involved a 32-year-old male patient for whom it was reported that patient was given an expired dose of tenivac (Expired product administered), while he received vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC].  Medical history, medical treatment, vaccination and family history of the patient were not provided. Concomitant medication was not reported.   On 13-Nov-2020, the patient received a dose (0.5 ml) of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (lot number U6101AA, expiration date 23-Oct-2020) via unknown route in unknown administration site for prophylactic vaccination.  On 13-Nov-2020, it was reported that patient was given an expired dose of tenivac (Expired product administered), following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT.  This is a case of actual medication error due to expired product administered.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
Rash present.     Comments: Papulovesicular rash located diffusely on body but concentrated on LEs with one large vesicle on L calf
Ovulation 4 days early on March 19, 2021. Inflammation of R cervical spine and shoulder.  Menstrual period  April 2 through April 23 (22 days of bleeding).  My typical, and very regular, menstrual cycle  is 27-28 days, with 6-10 days of bleeding.  I have never had anything like 22 days of bleeding.
Information has been received from a healthcare student concerning a 19-year-old female patient who was vaccinated with the first dose of GARDASIL on an unspecified date. After receiving the vaccine the patient developed dizziness, nausea and difficulty breathing. The patient had sought office visit medical attention. At the time of the report, the patient's status was recovered. The patient's dizziness, nausea and difficulty breathing was considered to be life threatening. Additional information from a phone call to a nurse stated that the patient received the first dose of GARDASIL (Lot# 661953/1130X) on 20-APR-2009. There were no concomitant vaccinations given at that time. Approximately 30 minutes after the patient received the GARDASIL (Lot# 661953/1130X) vaccination she had dizziness and nausea. On 21-APR-2009, the patient had difficulty breathing and had a headache. The patient went to her PCP to sought medical attention, and was given BENADRYL (route not reported). The patient came to office on 22-JUN-2009 for the second GARDASIL vaccination. The N.P. stated that she did not administer the GARDASIL vaccination. The N.P. stated that she felt the patient's difficulty breathing was considered life-threatening. Additional information from a phone call to the patient's PCP doctor reported that on 22-APR-2009 the patient was seen by a P.A. The patient complained of having difficulty breathing. The P.A. did not think that the patient's difficulty breathing was related to the GARDASIL vaccination. The P.A. documented that she thought the difficulty breathing was "coincidental and was possibly due to a viral infection". The patient was prescribed a MEDROL (DOSE PACK). The P.A. documented that she wanted to speak with the patient's GYN physician before the patient received the second dose of GARDASIL. The patient had not been back to the doctor's office since 22-APR-2009. No further information is available.
Chronic Hives...They were first noticed around mid January 2009.  We first saw our pediatrician who thought it was viral.  Then we went to see an Allergist who noticed she had a sinus infection.   She has been on prednisone for facial swelling, Xyzal, Cingular, Benedryl, Zyrtec and 3 different antibiotics.  She has had her blood drawn 4 times to see if there is anything serious like lupus or thyroid.  Everything is fine.  She has just had sinus surgery for her chronic sinus infection.  We were hoping this was the case but her hives had been much worse since the surgery on June 24, 2009.  My instincts have always told me it was a reaction to Gardasil.  I have been hoping it was the sinus infection but it looks like it is not.
Covid Arm. Severe rash which is very large at injection site on left arm. Feels like a severe sunburn & like blisters may form. Can be itchy. Hurts all day. Can?t sleep on left side & hurts to have clothes touching it.
This spontaneous case report was received from a certified medical assistant regarding 2 unspecified patients of unknown age and unknown gender. On an unknown date, the patient was vaccinated with improperly stored GARDASIL (lot number # K010215 and expiry date 05-MAY-2017). No adverse effects were reported. No product quality complaint was reported. This is one of the two cases from the same reporter. Additional information has been requested.
AFTER RECEIVING THE VACCINE HE FELT ANXIOUS. ONSITE EMS AND MD WERE REQUESTED.  BP 160/98 HR 76 96% OXYGEN ON ROOM AIR HE REFUSED ADDITIONAL EVAUATION AND CARE. LEFT AGAINST MEDICAL ADVICE.
Hard, hot, red swelling below injection site.  Lasted 3 days.  Site was off and on pruritic.
1 hour after Flu vaccine-felt cold, hands numb, next few days-fatigue, weakness, malaise, weak-weakness (especially proximal legs and arms).
the patient was administered improperly stored VARlVAX; This spontaneous report was received from a physician and refers to a 12-month-old patient of unknown gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 13-AUG-2020, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S032355, expiration date 14-OCT-2021, subcutaneously (exact dose, dose number and vaccination site were not provided) as routine vaccination. The vaccine was reconstituted with properly stored sterile diluent (lot # S032591, expiration date 16-AUG-2022).  Administered dose of vaccine was exposed to the temperature excursion of 13.6 degrees Fahrenheit for 12 hours (reported as multiple excursions) and 16 degrees Fahrenheit for 30 minutes. There was no previous temperature excursion. Digital Data Logger was involved.
Pt says arm hurts as she raises it from the date that she was vaccinated. PCP stated to take APAP and to ice it.
Initially patient felt feverish with body aches after receiving the vaccination but this improved after 48 hours. Two weeks after vaccination patient presented to hospital with ascending  paresthesias and urinary retention.  MRI cervical/thoracic spine with evidence of longitudinally extensive lesion from C6 distally to throughout thoracic cord. Findings overall concerning for transverse myelitis v demyelination.
Starting on 2/2 (about 12 days after my first dose), I developed rashes across my forehead and chest. I also developed some rashes on my left arm only. Subsequent to my second dose on 2/9 of the vaccine, the rashes started to spread all over my left arm, and some started to develop around my ears,  nape of neck and on my right arm.  I am not allergic to anything, and have never had a reaction like this. I went to urgent care and they suspected it was vaccine related because of the timing.
Right deltoid where vaccine given about 15 minutes after receiving shot area was reddened and client said it was hot.  Client was scratching area.  Ice pack applied to site for 15 minutes afterwards redness lessened.
Started getting a headache around 30 minutes after the shot.  I had a little dizziness too.  The headache got worse throughout the day.  I took Advil for the symptoms with little help during the first 24 hours.  I had muscle aches throughout my body, the worst feelings being mostly concentrated in my neck and head.  My left arm and leg felt like it had some nerve damage issues.  I had a 101.8 fever the first night and I couldn't sleep well.  I developed nausea that lasted for 2 days.  I was too weak and depressed to do anything, but sleep those first two days.  It wasn't until the third day that my headache finally subsided.  I still have neck and arm pain.
PREVNAR 13 administered in the right arm - sore muscle, swollen arm and under rt armpit.
4x4 area at injection site w/ redness, swelling and itching w/duration of 7 days. Tx: Aveeno anti-itch lotion.
RECEIVED VACCINE AT 3PM, ONSET OF SYMPTOMS AT 6PM-VOMITING, CHILLS, FEVER, HEADACHE
A non-serious spontaneous report of a 52-year-old received H1N1 Mist was received from a registered nurse concerning a healthy 52-year-old female. The patient's medical history and concomitant medications were not provided. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event was considered resolved.
COVID-19 treatment; COVID-19 treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Nov2022 as dose 5 (booster), single (Lot number: GJ3275) at the age of 61 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 08Mar2021 as dose 1, single (Lot number: EN6206), in left arm, on 29Mar2021 as dose 2, single (Lot number: ER8732), in left arm, on 19Nov2021 as dose 3 (booster), single (Lot number: FF8841), in left arm and on 14Jun2022 as dose 4 (booster), single (Lot number: FM7553), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Celiac" (unspecified if ongoing). The patient's concomitant medications were not reported. No known allergies. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 which includes Paxlovid (COVID 19 Treatment) from 20Mar2023 to 21Mar2023.
Fever for 96 hours ranging between 100.4 to 102.5 degrees. Body aches, chills & headache. Dizziness and nausea.