chrisvoncsefalvay/vaers-outcomes huggingface dataset:
about 8 hours post shot, I had uncontrollable shivering and head to toe aches and muscle stiffness as well as a moderate headache.  24 hours post shot, Shivers were gone body ache and headache persists with cold sweats  (sweats lasted for about 3-4 hours)  32 hour post shot to now still pretty achy, mostly left arm (where I got the shot), back (mostly left side) and both hands.  The achiness is fading (in line to how I've felt after Tetanus shots in the past).
Initial information received on 05-Mar-2019 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 18 months old male patient who received a 0.5ml fourth dose of vaccine IPOL batch number and expiration date not reported via unknown route in thigh on 04-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included was DAPTACEL in thigh from a multi dose vial. It was an actual medication error due to inappropriate schedule of vaccine administered. A 18 months old patient was administered a fourth dose of IPOL vaccine. It was unknown whether patient experienced any adverse event following vaccination. 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. List of documents held by sender: none.
Myocarditis/Pericarditis started July 24th and Dx at ER with labs/Echo on July 26th
Patient went to local emergency room due to swelling in arm and streaked rash around injection site. Patient phoned pharmacy on 1-7-13 to report event. Patient reported she was diagnosed with cellulitis in the emergency room.
Short period of dissociation (drove "on autopilot" home from work without feeling self-aware. Followed by a tingling in hands and feet.
Severe chills; Joint pain; Fever; headache; neck pain; This spontaneous case was reported by a health care professional and describes the occurrence of NECK PAIN (neck pain), CHILLS (Severe chills), ARTHRALGIA (Joint pain), PYREXIA (Fever) and HEADACHE (headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis and Migraine. Concomitant products included ZOLMITRIPTAN (ZOMIG) for Migraine, HYDROXYCHLOROQUINE for Rheumatoid arthritis, OMEPRAZOLE for an unknown indication.   On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced NECK PAIN (neck pain) and HEADACHE (headache). On 11-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHILLS (Severe chills), ARTHRALGIA (Joint pain) and PYREXIA (Fever). On 11-Feb-2021, CHILLS (Severe chills) had resolved. On 13-Feb-2021, NECK PAIN (neck pain) and HEADACHE (headache) had resolved. At the time of the report, ARTHRALGIA (Joint pain) and PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Feb-2021, Body temperature: 101.4f (High) Fever got to 101.4F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient was on hormone replacement therapy. Treatment information for the event  was not reported action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), was unknown   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Additional information received included reporter details. On 18-May-2021: New AE Added
Sore Throat; Chills; Hives; This is a spontaneous report from a non-contactable consumer, the patient. A 65-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 30Mar2021 at 17:00 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high and arthritis. The patient was not aware of any known allergies to medications, food or other products. Concomitant medications included acetylsalicylic acid (ASPRIN), meloxicam (MANUFACTURER UNKNOWN) and vitamins plus 50 (MANUFACTURER UNKNOWN); all for an unknown indication from an unknown date and unknow if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in Apr2021 at 02:00, the patient experienced chills, sore throat and hives. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of reported events. The clinical outcome of the events chills, sore throat and hives was resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Temperature Excursion in their freezer with the Moderna vaccine; Patient received expired Moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna vaccine) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature Excursion in their freezer with the Moderna vaccine) in a male patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 10-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna vaccine). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature Excursion in their freezer with the Moderna vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna vaccine) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature Excursion in their freezer with the Moderna vaccine) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  It was reported that, as per video footage, administrator explained that while one of their inventory employees was working in their freezer they took the thermometer alarm off and put it back on. administrator further stated that the thermometer was put on and off docking station and did not record while employee was working. They had only one report that showed that the freezer temperature went out of range and timeframes. other timeframes and durations were unknown.   Patient received the vaccine that was placed in the refrigerator.   Frozen storage condition at the time of the excursion.  On 07-FEB-2022, 17.8F maximum, at 9:25 pm and 12.6F maximum at 10:07 pm.  Excursion duration reported as 15-30 minutes but not sure.  Expiration date of vaccine reported as 31-Dec-2069.  No treatment information was provided.
Information has been received from a nurse concerning a 26 year old female who was vaccinated with a first dose of GARDASIL, lot number not reported. The nurse stated that one of the patient's ankles swelled after receiving the GARDASIL vaccine. The patient sought unspecified medical attention. Her outcome is unknown. Additional information has been requested. Follow-up information has been received from a nurse concerning the patient. It was reported that she did not recall the patient's name and was not able to access the information. She also did not know her date of birth, vaccine dates or the lot numbers for those vaccines. She noted that thee patient had a job which required her to be on her feet, so she felt as though the AE of joint swelling was due to her job and not to her exposure to GARDASIL vaccine. The nurse stated that the patient had not been back to see them, sho she figured she had recovered. Also she said that she was not aware that the patietn required any treatment for the swelling. Additional information will be provided if available. Additional information has been requested.
rash on the arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on the arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A.) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (rash on the arm). The patient was treated with CORTISONE ACETATE (CORTISONE [CORTISONE ACETATE]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, RASH (rash on the arm) outcome was unknown. Not Provided          No concomitant  medications were provided   This case was linked to INC.-MOD-2021-015612 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments: INC.-MOD-2021-015612:First dose vaccination
Information has been received from a physician who heard from a friend, concerning a 17 year old female who was vaccinated with GARDASIL (lot # not reported). The patient, who had apparently been healthy, became quadriplegic within a month. No further information was available. Upon internal review, the patient's quadriplegia was considered to be an other important medical event. Additional information is not expected.
Information has been received from a physician, via a company representative, concerning a 23 year old female patient, who on 25-Oct-2007 was vaccinated with the third dose of Gardasil (lot # not reported).  Concomitant therapy included hormonal contraceptives (unspecified).  On 12-Nov-2007, the patient visited her physician with swollen inguinal lymph nodes, and was sent to the emergency room (ER).  The ER sent the patient to surgery, as they considered that she had a hernia, however, it was then confirmed that the patient did not have a hernia but only the swollen inguinal lymph nodes.  It was unclear if the patient had surgery.  At the time of this report, the outcome of the event was unknown.  The physician considered swollen inguinal lymph nodes to be serious as an other important medical event (intervention required).  Additional information has been requested.
Myocarditis: increased heart rate , shortness of breath, chest pain, fatigue. Pt went to PCP. Lasted about six weeks before some improvement. pt still has some sx.
235PM p/napping woke up feeling fine x 2mins then cried & screamed in pain <1min then became pale in color, eyes rolled back breathing became very shallow & labored; 1 mins later became limp, lips blue, stopped breathing (lasting-2min)
Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2021-292978, MOD-2021-293498 (Patient Link).
Migraine; felt like a punch; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MIGRAINE (Migraine) and FEELING ABNORMAL (felt like a punch) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Myasthenia gravis.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced MIGRAINE (Migraine) and FEELING ABNORMAL (felt like a punch). At the time of the report, MIGRAINE (Migraine) had resolved and FEELING ABNORMAL (felt like a punch) outcome was unknown.            No concomitant medications were provided. Treatment medication included Aleve twice a day.   This case was linked to MOD-2021-055176 (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.
Two days after receiving the vaccine I get a really bad fever and along with the onset of the fever came super swollen lips. I promptly visited urgent care the next morning and was prescribed prednisone and Benadryl to deal with the swelling. However the swelling has not been reduced and a burning sensation at the area of swelling persists. Please I need assistance with this side effect. My bottom lip has blown up like a balloon much worse than any case I?ve seen online.
Beginning on morning of 11th symptoms included moderate headache, pain/pressure behind the eyes, sensitivity to sound, pain in ears, nausea, fatigue, drain in thinking.  continued, with some variability throughout day but responded to ibuprofen.  symptoms continued on the 12th, with enough intensity to cause me to take a sick day from work. pain behind eyes was especially uncomfortable.  continued to treat with rest.  13th and 14th symptoms gradually improved. only reporting here for completeness. I also hit my head on the 10th fairly hard. This could certainly have contributed to or caused my symptoms but given recent news about , reporting here to be diligent and contribute to any learnings visa aggregation.
SARS-CoV-2 (2019-nCoV) Nucleic Acid Amplified Test performed on 7/23/21 at 10:49. Test came back detected. Case investigation interview with patient has not been conduced as of the time of this note.
This case was reported by a nurse and described the occurrence of burning sensation in eye in a female patient who received INFANRIX (batch number F43Z7, expiry date 31st October 2015). On 28th October 2014 09:30, the patient received INFANRIX .5 ml. On 28th October 2014, an unknown time after receiving INFANRIX, the patient experienced inadvertent exposure to vaccine. On 28th October 2014 09:32, the patient experienced burning sensation in eye, headache, nasal discharge and pain. On 28th October 2014, the outcome of the burning sensation in eye, headache, nasal discharge and pain were recovered/resolved. On an unknown date, the outcome of the inadvertent exposure to vaccine was unknown. It was unknown if the reporter considered the burning sensation in eye, headache, nasal discharge and pain to be related to INFANRIX. Additional information received: Per HCP, while RN was administering INFANRIX vaccine, the needle and syringe came apart causing the liquid portion of the vaccine to come in contact with right eye. RN reported right eye began to burn and become achey within 2-3 mins after the event. Shortly after then started with a headache and right nasal drainage. RN stated she removed her right eye contact lens, flushed her right eye with saline. Per RN all symptoms resolved completely within an hour of the occurrence.
Unsure of exact time of onset. Experienced significant swelling of thigh.  It had improved some, when parent called on 8/2/14.
Patient was given a COVID-19 pfizer shot in july, she is still experiencing arm pain from the injection area. Patient states it's painful to raise her arm
I made a mistake my vaccine was jan 16th not 15th.  That evening i was Very tired got a  sore arm and fever  blister break out on my upper lip 10 hrs after vaccine. Next day Sharp pain in my right big toe joint on day 2, then day 3 burning and stinging  pain above my left knee last 6 or 7 hours and also a very sharp pain between my toes like a splinter on the same side as knee pain.  I Have felt tired and bad brain fog since vaccine, just have felt really off.   Now i am scared to get the second dose.  My father had a rare neurological  disease after being exposed to chemicals in the army.  I then got a cough and had some off color mucous for several days.   I am thinking of waiting to get second does, please advise.
severe headache; soreness of injection arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness of injection arm) and HEADACHE (severe headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, the patient experienced PAIN IN EXTREMITY (soreness of injection arm). On 05-May-2021, the patient experienced HEADACHE (severe headache). At the time of the report, PAIN IN EXTREMITY (soreness of injection arm) and HEADACHE (severe headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Swelling and itching around mouth, approx. 45 mins, treated with oral Benadryl 50 mg @ home after calling nurses line.
8 days later woke up with arm soreness, swelling,  and itchiness at injection site. Continued to get worse throughout the day.  Still hurts
pain between her right scapula and spine; pain between her right scapula and spine; This is a spontaneous report from a contactable nurse (patient herself). A 22-year-old female patient started to receive BNT162B2 (lot number: EJ1685; expiry date unknown) intramuscular (right arm), on 28Dec2020, at a single dose, for COVID-19 vaccine injection/ vaccination. The patient's medical history and concomitant medications were not reported. This nurse was administered her first dose of Pfizer COVID-19 Vaccine on 28Dec2020, in the morning. Her first concern was that the nurse put the COVID-19 Vaccine injection really low into her right arm, but believes it did go into the muscle. She was concerned that it did not really go into her muscle but the more she has been lifting her arm and seeing where the shot was administered and where her muscle in her arm ends she believes it did go into the muscle. She contacted her primary care provider today because about 30 minutes to 1 hour after she was administered the COVID-19 vaccine injection on 28Dec2020 she had a pain in between her right scapula and spine, which is the side she got her vaccine on. She also reported that her right arm does not hurt at all, she has no pain at injection site for COVID-19 Vaccine which she finds really weird. She also felt the pain if she hunches her shoulders backwards, sits up really straight, crosses her arms or hunches forward; she does not really feel it if she takes a deep breath. She was wondering if these events are normal or expected or serious. Outcome of the events was not recovered.
pt recv vax & 13OCT97 reporter indicated pt devel hematoma w/in the last wk;
Rash around their waste; This spontaneous report as received from a medical assistant refers to a currently 29 years old female patient. Patient's concurrent conditions, medical history and concomitant therapies were not provided.  On an unknown date, when the patient was a child, she was vaccinated with a first dose of varicella virus vaccine live (oka/merck)(VARIVAX) (dose, route, lot # and expiration date were not provided) for prophylaxis.   At that time, the patient developed a rash around their waste and recovered from it on an unspecified date. The reporter would like to know if it would be a contraindication in getting the vaccine as an adult, as the patient is 29 years old now and needed a varicella virus vaccine live (oka/merck)(VARIVAX) booster. The reporter inquired if there is a possibility of getting the rash again. No product quality complaint (PQC) reported.
Injection site was red; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Injection site was red) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (Injection site was red). At the time of the report, INJECTION SITE ERYTHEMA (Injection site was red) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Woke up with nausea, vomiting, diarrhea, lightheadedness, dizziness, aching (typical flu like symptoms); headache; chills, fever
12/31/2022 you woke up in the middle of the night with a sore throat. I was drained of energy, had a cough, chills and achy body off and on. On 1/3/23 I saw a nurse practitioner. She ran a COVID test and it came back positive. I was prescribed PAXLOVID and started it that day. Today I am about the same, but the throat is not as bad.
This spontaneous report as received from a Registered Nurse regarding a 5 year old child patient of unknown gender. There was no information about concurrent condition, historical medication and concomitant medication. On 29-OCT-2018, the patient was vaccinated with improperly stored PROQUAD for prophylaxis (product storage error). Vaccine was stored out of range at -6 degrees for an approximate time of 15 minutes. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1902USA001085.
This spontaneous report has been received from a pharmacist concerning to a patient of unknown age and gender. Current conditions, medical history and drug reactions/allergies were not reported. On 09-OCT-2013, the patient was vaccinated with the first dose of RECOMBIVAX HB 1 ml, intramuscular (lot# and expiration date were not reported). Concomitant medication was not reported. On 02-DEC-2013, the patient who received the first dose of RECOMBIVAX HB came to receive his second dose which was outside of recommended dosing interval. No adverse effects reported. Additional information has been requested.
pt recv vax 24AUG97 & pt devel urticaria p/vax on the same day;pt was treated w/antihistamines-DPH & zyrtec;urticaria is still intermittently persisting;
Pt was at her scheduled medical appointment when she asked her nurse to fill out a new COVID vaccine card for her because she misplaced her other one. Our clinic is this patient's primary care clinic. We administered her second dose of Pfizer covid vaccine on 5/16/22 (she received her initial dose elsewhere on 3/31/22). When the nurse pulled up the state immunization website to verify all vaccines given she noticed the pts booster dose was administered by a grocery store pharmacy on 6/2/22, only 17 days after her second dose. Pt had no adverse health issues. This vaccine administration error was done by the grocery store pharmacy, not our clinic.