chrisvoncsefalvay/vaers-outcomes huggingface dataset:
my right arm is starting to hurt; arthritis pain; muscle hurts/muscle pain; injection pain; joint pain; pain is in her shoulder to the hip bone on the left side; pain is in her shoulder to the hip bone on the left side; Chills; three days after not feeling well/ didn't feel well; tired; lousy; last night I didn't sleep; whole left side from her shoulder to bottom of her back bone hurts; she couldn't get her temperature. It was reading like 93.0 when her normal was 97. something; This is a spontaneous report from a contactable consumer reported that. A 87-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 17Sep2021 (Batch/Lot Number: FE3592; Expiration Date: 28Feb2022) as DOSE 1, SINGLE for covid-19 immunizations (Age at vaccination 87 years). The patient past Medical history included ongoing arthritis, ongoing atrial fibrillation. Concomitant medication was none.  Caller states "I just feel tired and lousy and like I was telling her, I take my vital signs every morning and everything is usually pretty low, my temperature is normally 97. something and last night I didn't sleep at all because of the pain in my left side and now my right arm is starting to hurt I guess because I'm using it more on an unspecified date in 2021. The patient reported she had chills and didn't feel well on 17Sep2021. She reports she was tired and so she just rested. The next day she didn't have chills but still rested that day. It is explained that the night before, the pain in her left arm, where the shot was given, and that whole left side from her shoulder to bottom of her backbone hurts and this is not going way. She has been using the right arm, and now that muscle hurts too. The caller explains she feels unwell and wants to know how long this and the muscle pain will last. The caller clarified that the pain is in her shoulder to the hip bone on the left side. This started on 18Sep2021 but last night it was the worst. Today it is a little better. Treatment- The caller notes that she checked her vitals, her temperature and blood pressure, like she does every morning. On 20Sep2021, she couldn't get her temperature. It was reading like 93.0 when her normal was 97. Something. She had to use the heating pad and it took a while to get her temperature back up. She doesn't take vaccines because she is so sensitive to things, she doesn't even the flu shot. She might have gotten it 5 years ago. Caller states "they said in 3 or 4 weeks I'm supposed to get my second dose, but that seems awfully close. The event outcome Unknown for fatigue, lousy, Insomnia, Pain in arm, Joint pain, Pain in spine, Muscle pain, Body temperature decrease, Vaccination site pain and Arthritis flare up, Not recovered Feeling unwell, recovered for Chills, recovering for Shoulder pain and Pain bone
on March 25 I had intermittent severe shooting pain at vaccine site. It lasted about an hour.  Vaccine site also felt very sore.  Arm remained mildly sore  but becoming slight more painful each day. with some tingling in fingers the following week.    By April 10  muscle sore and painful to lift lift for shoulder adduction at 90 degrees.
2/19/14 soreness at injection site (L) arm, itchy, warm. 2/20/14 red circle at injection site, itchy, sore. 2/24/14 subsiding, pt feeling better with itchy and redness.
Information has been received from a nurse referring to unspecified patients of unknown age and gender. There was no information about concurrent condition, medical history or concomitant medication. The unspecified patients received improperly stored various unspecified doses of VARIVAX, (lot # L032395, expiration date 09-MAY-2018; lot # M000761, expiration date 06-JAN-2018), (dose, frequency and route not reported) on 16-JUN-2016 and 17-JUN-2016. The vaccines were exposed to temperature 70 F for 45 minutes due to power outage. There was no previous temperature excursion. No adverse reactions were reported. This is one of several reports received from the same reporter. Additional information has been requested.
04/18/2022 vaccination. 06/18/2022 I woke up in the morning, I had chills, fever a lot of sweating, body aches and exhaustion. I took COVID-19 test, positive. I didn't feel better for 3 days. Lots of exhaustion, body aches. I started to develop a cough. 06/21/2022 I started PAXLOVID. Within a few hours, I was feeling so much better. I still had some body aches and fever but a lot less intense. Some sinus issues still; 3/10 on a scale.
COVID infection. Specimen collected on 8/27/21. Patient died on 9/9/21.
Developed covid symptoms and tested positive on 26Nov; Developed covid symptoms and tested positive on 26Nov; This is a spontaneous report received from a contactable reporter(s) (Consumer- patient) for a Pfizer sponsored program (005570). A 9 year-old patient received bnt162b2 (BNT162B2), administration date 08Nov2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 26Nov2021, outcome "unknown" and all described as "Developed covid symptoms and tested positive on 26Nov". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (26Nov2021) positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Broke into a skin rash over entire body; This is a spontaneous report from a contactable consumer, the patient. A 13-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 06Aug2021 (at the age of 13-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, allergies, heart murmur and seasonal allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included ibuprofen (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 16Jul2021 (at the age of 13-years-old) as a single dose for COVID-19 immunisation. On an unknown date in Aug2021, within 18 hours of second vaccination, the patient broke into a skin rash over entire body. The adverse event did not result in doctor or other healthcare professional office/clinic visit/emergency visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the event which included treatment with Ibuprofen (MANUFACTURER UNKNOWN) and diphenhydramine hydrochloride (BENADRYL). The clinical outcome of the event broke into a skin rash over entire body was resolved on an unknown date in 2021.
Bells Palsey for 3 days. Brown, itchy large rash in left side of body.
This case was reported by a nurse via call center representative and described the occurrence of local swelling in a 50-year-old female patient who received FLUARIX QUADRIVALENT (batch number NR952, expiry date 25th June 2016). On 12th October 2015, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. On 12th October 2015, several hours after receiving FLUARIX QUADRIVALENT, the patient experienced local swelling. On an unknown date, the outcome of the local swelling was not recovered/not resolved. It was unknown if the reporter considered the local swelling to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: On 12th October 2015, in the evening, the patient began experiencing tiny bumps across both shoulders and on back. The bumps were described as being a bit red and not itching.
third one was crayola bleeding; low platelets; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for Covid-19 Immunization; Bnt162b2 (DOSE 2), for Covid-19 Immunization. The following information was reported: HAEMORRHAGE (medically significant), outcome "unknown", described as "third one was crayola bleeding"; PLATELET COUNT DECREASED (medically significant), outcome "unknown", described as "low platelets". The patient underwent the following laboratory tests and procedures: Platelet count decreased: low, notes: low platelets. Therapeutic measures were taken as a result of haemorrhage, platelet count decreased. Additional information: The caller said she had experienced problems with all three shots; however, the first two shots were severe, and the third one was crayola bleeding, low platelets, protectia, and ten months of medications to finally clear the problem.   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-PV202300179280 Same patient/vaccine, different dose/event;
Vaccine given 8 days past the BUD (6/23/2022). Moderna contacted and lot analyzed. Per Moderna, this lot was still active. The patient did not need to be revaccinated.
Pain in the injection area (left arm), headache, Congestion, breathing difficulty. Consulted with the Dr. and prescribed the usual asthma treatment (Albuterol every 4 hours) and Acetaminophen for the pain. The 1st dose of the vaccine was received.
Extremely ill; fever; extreme fatigue; pain; muscle aches; headache; fuzzy head and foggy thinking; feeling like my brain was burning; Erratic heartbeat; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 46-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date Apr2021 (Lot number: EW0161) at the age of 46 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "NSAIDS" (unspecified if ongoing), notes: Known allergies: NSAIDS. Concomitant medication(s) included: SYNTHROID. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8730, Location of injection: Arm Left), administration date: Mar2021, when the patient was 46 years old, for COVID-19 Immunization, reaction(s): "extreme fatigue", "Fuzzy head and foggy thinking", "feeling absolutely miserable beginning 24 hours after 1st dose", "headache", "Erratic heartbeat", "extremely ill", "could not work", "muscle aches", "pain", "fever". The following information was reported: ILLNESS (non-serious) with onset 2021, outcome "recovered", described as "Extremely ill"; PYREXIA (non-serious) with onset 2021, outcome "recovered", described as "fever"; FATIGUE (non-serious) with onset 2021, outcome "recovered", described as "extreme fatigue"; PAIN (non-serious) with onset 2021, outcome "recovered", described as "pain"; MYALGIA (non-serious) with onset 2021, outcome "recovered", described as "muscle aches"; HEADACHE (non-serious) with onset 2021, outcome "recovered", described as "headache"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "recovered", described as "fuzzy head and foggy thinking"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "recovered", described as "feeling like my brain was burning"; HEART RATE IRREGULAR (non-serious) with onset 2021, outcome "recovered", described as "Erratic heartbeat". The events "extremely ill", "fever", "extreme fatigue", "pain", "muscle aches", "headache", "fuzzy head and foggy thinking", "feeling like my brain was burning" and "erratic heartbeat" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of illness, pyrexia, fatigue, pain, myalgia, headache, feeling abnormal, feeling abnormal, heart rate irregular.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID since the vaccination.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. On 29-AUG-2011 the patient was vaccinated with the first dose of VAQTA 25U injection (Lot # not reported) (0.5 ml, intramuscular route). On 20-JAN-2012 the patient was vaccinated with the second VAQTA 25U injection (Lot # not reported) (0.5 ml, intramuscular route). It was reported that the second dose was administered "too early". No adverse effect reported. Additional information has been requested.
the daughter had both doses of the Pfizer covid 19 vaccine/ tested positive for covid on 24Sep2021; the daughter had both doses of the Pfizer covid 19 vaccine/ tested positive for covid on 24Sep2021; This is a spontaneous report from a contactable consumer (parent) via medical information team. A 34-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported) on an unspecified date, at dose 1, single and on Mar2021 at dose 2, single (at the age of 34-years-old) both via an unspecified route of administration for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had both doses of the vaccine and tested positive for covid on 24sep2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 24Sep2021. The outcome of the events was unknown.   The lot number for [bnt162b2], was not provided and will be requested during follow up.
5/28/21 noticed redness of skin at and around injection site on left upper arm - looks like sunburn; skin feels 'bumpy'.  5/29/21 the same area was now sore to touch and redness cont.'s to present.
The patient did not receive at least half of the dose after being administered the shot/The patient's body expelled the vaccine from her arm; Malfunction with the plunger and the vaccine leaked out and squirted out the patient's arm; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (The patient did not receive at least half of the dose after being administered the shot/The patient's body expelled the vaccine from her arm) and PRODUCT DELIVERY MECHANISM ISSUE (Malfunction with the plunger and the vaccine leaked out and squirted out the patient's arm) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033B21A and 042B21-2A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Jun-2021, the patient experienced UNDERDOSE (The patient did not receive at least half of the dose after being administered the shot/The patient's body expelled the vaccine from her arm) and PRODUCT DELIVERY MECHANISM ISSUE (Malfunction with the plunger and the vaccine leaked out and squirted out the patient's arm). On 08-Jun-2021, UNDERDOSE (The patient did not receive at least half of the dose after being administered the shot/The patient's body expelled the vaccine from her arm) and PRODUCT DELIVERY MECHANISM ISSUE (Malfunction with the plunger and the vaccine leaked out and squirted out the patient's arm) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Patient demographics, suspect product dosage regimen, and outcome of the event updated.
Soreness in joints of both arms. Starting with wrist of arm of injection spreading to left arm. wrist joint. Tenderness at injection site.
Lightheaded, Near Syncope Nausea Dizziness at 09:45am BP 199/80 P80 Resp: 24   O2 96 at 10:05am BP 102/80 P82 Resp: 18 O2 97
Pain at injection site; much less than flu shot. No treatment. Resolved by Jan 2. Brief bouts of dizziness and nausea; stayed home from work and rested. resolved by Jan 1. Seasonal allergy symptoms- runny nose, including bloody nose from left nostril. Resolved by Jan 2. Allergic reaction to a scented hand cream used by wife- burning eyes, nasopharyngeal tightness, nasal discharge. Wife since removed so I can't tell you brand. Occurred/Resolved Jan 1 when product was removed.
ache across her neck; Left arm soreness; tiredness about half an hour; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (ache across her neck), FATIGUE (tiredness about half an hour) and MYALGIA (Left arm soreness) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced FATIGUE (tiredness about half an hour). On an unknown date, the patient experienced NECK PAIN (ache across her neck) and MYALGIA (Left arm soreness). At the time of the report, NECK PAIN (ache across her neck) had resolved and FATIGUE (tiredness about half an hour) and MYALGIA (Left arm soreness) outcome was unknown.            This case was linked to MOD-2021-081265 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Follow up received on 19-Apr-2021 contained new event details. On 25-May-2021: Follow up received on 25-May-2021 contained no new information.
on day 7 after receiving the vaccine the patient developed a 9.5 x 12 cm raised patch with erythema; no pain, no itching, no systemic effects; today the area of erythema has widened but less heat and feels softer; continues to feel well
red lump under injection site, painful to touch.; Injection site bruising; Red lump under injection site; red lump under injection site, painful to touch.; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 05May2021 at 11:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications include multivitamins- one a day women's (MANUFACTURER UNKNOWN) since an unknown date for unknown indication. It was not reported whether the patient had allergies to medications, food, or other products.  The patient received medications within two weeks prior the vaccination. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Previously, the patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 15Apr2021 at 9:30 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. On 06May2021 at 11:00, the patient experienced injection site bruising, red lump under injection site, painful to touch. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events injection site bruising, red lump under injection site, painful to touch were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
pt recvd Engerix-B & protein levels & globulin levels were found to be elevated;
Localized erythema at injection site; discrete area of erythema at separate site with some swelling on same thigh.
After administration of the flu and Hep B dose 2 of the series, the patient fainted for approximately 10 seconds. She was sitting in a chair and begin slouching down and lowered her head. I asked if she was ok and received no response. I lowered patient to the floor, and laid her flat on her back and began to sternal rub her. She arouse to this. Vital signs were taken and stable. She remained conscious and lying down for about 10 minutes following the episode. Father was in the waiting area and notified of the event. She denied headache, blurry vision, confusion, difficulty breathing, shortness of breath or other associated symptoms. Had patient arise slowly from a lying position to a sitting position after 10 minutes. Patient remained sitting for another 10 minutes or so. She continued to deny ill feelings or effects following the episode. Following the episode she and father stated that she has had similar fainting episodes with blood draws, but never vaccines. Advised to follow up with PCP or Urgent Care in 1-2 days for re evaluation. Advised to report to ER if symptoms of fainting return or other associated symptoms present. Patient understands and agrees with plan of care. No further action taken.
Patient stated within 4-5 hours after the vaccination they began to experience mild symptoms; heart pain, elevated heart rate, and tightness on the left side of their chest. Over time they experienced other symptoms like mild fatigue, weakness and increased pain on their left side. Patient went to urgent care 14 Dec 2022. Patient currently reports no chest pain and still mild weakness if they have to exert themselves.
Pt received 4 shots and fainted. No wheezing. V/S stable. Patient assisted from chair to lying down position. After 15 minutes, pt was able to sit up and walk without feeling dizzy.
Pt call call center on 5/7/21.  Stated pt got Pfizer on 5/6/2021  and then pt has headache(pain score 6-10), vomiting, body aches from this morning. Pt is taking tylenol for symptoms. Scheduled UC visit. ED precautions instructed to patient
This spontaneous prospective pregnancy report as received from a other health professional refers to a 17 year old female patient. There was no pertinent medical history and drug reactions/allergies. On 08-SEP-2014 the patient was vaccinated with GARDASIL lot # J010668 dose 2, 0.5 ml  (route unknown). No concomitant medication was reported. It was reported that patient was 2 weeks pregnant when she received second dose of GARDASIL. The patient became pregnant with approximately LMP of 24-AUG-2014 and EDD was 31-MAY-2015. Initial exposure to GARDASIL was at 2 week(s). The pregnancy outcome was outcome pending. The healthcare worker did not know the date of first dose administration. The patient has had no complications in her pregnancy. No adverse effects were reported. The patient sought medical attention and contacted the physician by phone. No treatment was given for the events. No lab tests were performed. The outcome of events was unknown. Additional information has been requested.