chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine Interaction 1st dose Moderna 2nd dose Pfizer; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Vaccine Interaction 1st dose Moderna 2nd dose Pfizer) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH 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) (unknown route) 1 dosage form and second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Vaccine Interaction 1st dose Moderna 2nd dose Pfizer). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Vaccine Interaction 1st dose Moderna 2nd dose Pfizer) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were provided.
pin point rash; rash just below the injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Feb-2021 and was forwarded to Moderna on 20-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of RASH (pin point rash) and VACCINATION SITE RASH (rash just below the injection site) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced RASH (pin point rash) and VACCINATION SITE RASH (rash just below the injection site). At the time of the report, RASH (pin point rash) and VACCINATION SITE RASH (rash just below the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
SHINGRIX 1st shot. Terrible arm pain, the worst I've ever had with a shot. I also had achy back pain from that shoulder to the base of my neck. Had to put arm in and out of sling, aspirins, and iced it for two days. The pain in the arm started about 4 hrs after shot and continued to get worse through the day. I don't believe I slept that night due to the slightest movement cause the arm to hurt so much. It took about days to really feel better. Certainly not wanting to go through this again.
Severe chills and fever of up to 102.8F.  Headache and body aches.  Took over an hour to get over chills the first time.  It happened twice more.  At noon on the 15th and again around midnight the 15th.  Fever got the highest that night.  Took Tylenol for the fever.
Initial unsolicited report received from a pharmacist (Director of Pharmacy) on 12-OCT-2016. This case is linked with 2016SA189772, 2016SA189781, 2016SA189791, 2016SA189792, 2016SA189793, 2016SA189794, 2016SA189795, 2016SA189796, 2016SA189797, 2016SA189798, 2016SA189799, 2016SA189800, 2016SA189801, 2016SA189802, 2016SA189803, 2016SA189804, 2016SA189805, 2016SA189806, 2016SA189807, 2016SA189808, 2016SA189809, 2016SA189810, 2016SA189811, 2016SA189812, 2016SA189813, 2016SA189814, 2016SA189815, 2016SA189816, 2016SA189817, 2016SA189818, 2016SA189819, 2016SA189820, 2016SA189821, 2016SA189822, 2016SA189823, 2016SA189824, 2016SA189825, 2016SA189826, 2016SA189827, 2016SA189828, 2016SA189830, 2016SA189831, 2016SA189832, 2016SA189833, 2016SA189834, 2016SA189835, 2016SA189836, 2016SA189837, 2016SA189838, 2016SA189839, 2016SA189840, 2016SA189841, 2016SA189842, 2016SA189843, 2016SA189844, 2016SA189845, 2016SA189846, 2016SA189847, 2016SA189848. This case involves a patient (age and gender not reported) who was vaccinated with a dose of FLUZONE Quadrivalent batch number: UI669AA, expiration date: 30-JUN-17, intramuscularly, on 04-OCT-2016. Patient's Illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as unknown. Concomitant medications were not reported. On 06-OCT-2016, two days following the vaccination, the patient experienced local reaction: size of half dollar red spot around site and warm. On an unspecified date (over the past month), following the vaccination, the patient experienced local reaction: lump at site and systemic reaction: noticed cough, not sure related. It was reported that the patient required emergency room/doctor visit. Lab data and corrective treatment were not reported. The outcome of the events was reported as unknown. Follow up report received from a pharmacist (Director of Pharmacy) on 28-Nov-2016: This case involves a 31-year-old female patient. List of documents held by sender: none.
Rashes all over my legs and hands. Went to Hospital and was given Benadryl and Steroids.
more frequent Migraines, cough, congestion, fever, headaches and body aches ever 2-3 weeks.
Unknown exact onset time of adverse event. Patient said he had severe injection arm pain in the middle of the night. Said he had to go to the ER. Said he was given an Epipen shot on 10/29/2013.
Pt had arm swelling at the time of adverse event. Treatment occurred at ER under Dr. Chest x-ray revealed immune reaction to PNEUMOVAX. Treatment included BENADRYL, steroids and antibiotics. That night pt was discharged from ER to home with no further events.
trouble breathing like there are something in her chest; trouble breathing like there are something in her chest; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient.  A female patient of unspecified age received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown) via unspecified route, administered on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date after the vaccination, the patient experienced trouble breathing like there are something in her chest. They didn't experience reaction immediately. And they did not report the reactions also. The outcome of the events was unknown.  No follow-up attempts possible. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021298908 similar report from same reporter
Pt stating she felt dizzy, and then fainted shortly after, pt lowered down on exam table. Legs elevated, MD called to bedside, pt alert by the time MD at bedside. Pulse taken, cool cloths applied. Pt was alert within 40 seconds. Pt stating she had not eaten anything and that she has a fear of needles. VS were taken, pt given crackers. Pt stable and driven home by father.
Information has been received from a physician concerning an 18 year old female who on 28-JAN-2008 was vaccinated with a second dose of Gardasil (lot #659964/1740U). Concomitant therapy included hepatitis A vaccine (inactive). The patient came to the physician's office for a sore throat, cough and congestion. On28-JAN-2008 the patient experienced an 8 minute episode of feeling panicky, short of breathe, feeling "out of it" and had numbness and cramps in her hands. Unspecified medical attention was sought. The physician diagnosed her with syncope, upper respiratory infection and panic attack. A strep throat test came back negative. As of 29-JAN-2008 the patient was recovering. Additional information has been requested.
Violent chills happened while working on computer. Laid on heat pad to assist in bed. Chills lasted about 20 minutes. Parasthesia happened immediately. Myalgia in legs happened immediately. No fever at this time.  Woke in morning with no fever, but muscle aches, malaise, lethargy, parasthesia were all present. Spent entire day in bed napping occasionally.  Measured temperature in evening at 100.7F.  Painful stomach pain happened in evening. Patient never gets acid pain or similar so this was very abnormal. Antacid helped but stomach pain continued all evening at a lesser degree.  When going to bed most symptoms had subsided. Still some parasthesia and Myalgia. Woke up on 4/9 feeling much better after lots of sleep.  No fever or other symptoms on morning of 4/9.
I had shingles / I had the shot; SHINGLES; This case was reported by a consumer via interactive digital media and described the occurrence of  suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. The patient received Shingrix and experienced shingles which hurted. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Nov2022 as dose 5 (booster), single (Lot number: 6739) at the age of 72 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 07Jan2021 as dose 1, single (Lot number: fk9231), in left arm, on 28Jan2021 as dose 2, single (Lot number: el9262), in left arm, on 25Sep2021 as dose 3 (booster), single (Lot number: ff8839), in left arm and on 16Jul2022 as dose 4 (booster), single (Lot number: fpf150), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The patient has no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid treatment from 16Nov2022 to 20Nov2022.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective (LOE) and covid-19 cannot be ruled out.
Local faintly pink Rxn with induration and itching - likely secondary latex in DTaP stopper. (Location - Deltoid- IM) Exam DOS 4/21/10. No Rxn around VARIVAX injection.
Injection received at 9 am. At 10:00 pm, I had severe uncontrollable hand and arm shaking and chills (not relieved by two heavy blankets). I went to bed. Next morning, I stayed in bed mostly.  Mild fever. At 3 pm I tried to go downstairs but could not do so. I stayed in the hall and rolled over onto my stomach. I was unable to raise myself on my hands and knees in order crawl to the bed. Complete muscle weakness. My wife called the paramedics. They got me off the floor and onto the bed. I still could not move in order to get toward the center of the bed. I was able to be pulled up on the side of the bed by 6 pm to eat. My wife said I was leaning to one side. I was ok the next day.
Shot 12 pm 1/23/21 Woke up at 2:30 am with chills, headache, dizzy Got up at 5:30 am nauseous, very sore arm, and every part of my body hurt. Sickest I have ever felt. Worse than when I had covid. Lasted until 3pm. Then felt exhausted through 1/25. Felt normal 1/26. However, I have not been able to go to bathroom (bm) since 1/26 without using laxatives. This pronto have now was never a problem before.
This spontaneous report was received from a pharmacist refers to a 82 years old female patient. On 21-JAN-2013, the patient was vaccinated subcutaneously (SQ) with a dose of live ZOSTAVAX, 1 vial, Lot # H0148090, Exp date: 04-JAN-2014. No other co-suspects were reported. No concomitant medications were reported. On an unspecified day in January 2013, the patient developed shingles after receiving a dose of live ZOSTAVAX on 21-JAN-2013. The redness and painful blisters started on the belly and spread to her sides. The patient was treated with acetaminophen, NORCO and VALTREX. Patient's outcome was reported as not recovered. The patient sought Medical Attention, she saw the physician. The relatedness for shingles was unknown for live ZOSTAVAX. Additional information has been requested.
After dose 1 (Mod R Na Lot 014M20a) localized swelling, malaise, hives. Duration 48 hours. After dose 2 (Mod R Na Lot 017/b21A) fever, malaise, swollen lymph notes. Duration 72 hours. Bleeding gums - ongoing. No prior issues known. No treatment required.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL 9 lot # N007931 for prophylaxis. On an unknown date, the patient experienced incorrect product storage, circumstance or information capable of leading to medication error and no adverse event. The outcome of incorrect product storage, no adverse event and circumstance or information capable of leading to medication error is unknown. The reporter considered incorrect product storage, circumstance or information capable of leading to medication error and no adverse event to be not related to GARDASIL 9. (Additional information has been requested. / Additional information is not expected.) Upon receipt of follow-up information it was determined that this case is now valid because patient identifiers were identified. It was reported that there were 5 patients who were vaccinated with the lot# N007931 involved in the temperature excursion. Follow up information received on 10-MAY-2018: This spontaneous report was received from a nurse practitioner refers to a 16-year-old female patient. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant therapy were unknown. On 09-OCT-2017 the patient was vaccinated with doses of improperly stored GARDASIL 9 (dose, units and frequency were unknown) (lot # N007931 and expiration date 17-NOV-2019). The temperature excursion was at 9 C to 25 C (10 C) [C (degree centigrade)] for 1 hour. No adverse effects were reported. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was reported. This is one of several reports received from the same reporter (1805USA004616, 1805USA004664, 1805USA004665 and 1805USA004666).
chills; terrible aches and pains; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "terrible aches and pains".  Additional information: Reporter mentioned that two other people that had very similar side effects just like herself. Two friends of reporter mentioned the same thing and they never had the same response like this before. So, reporter don't know whether the patient is supposed to take Tylenol afterwards.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Fever x 36hrs after, mild redness and swelling/induration at injection site, 1 in diameter. Morebilliform rash on trunk,groin, gluteal fold neck and scalp. Baby is well
Nosebleed that lasted for over 25 minutes. I have not had a nose bleed since I was a child nor am I currently sick or have irritated nostrils.
a patient who got his 1st Moderna Covid-19 Vaccine on 24May2021 & he wants his 2nd dose today; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (a patient who got his 1st Moderna Covid-19 Vaccine on 24May2021 & he wants his 2nd dose today) 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 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (a patient who got his 1st Moderna Covid-19 Vaccine on 24May2021 & he wants his 2nd dose today). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (a patient who got his 1st Moderna Covid-19 Vaccine on 24May2021 & he wants his 2nd dose today) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information was not provided. Treatment information was not provided.
4x3 knot on Rt back of arm where Varicella was given. Red-swollen-hot-itching-last night soreness, this arm huge knot getting bigger. 10/01/13 (day received vaccination) Ibuprofen 400 mg po at 4:30 PM, applied cool paper towel and wrapped arm. Called in Benadryl. Will come to clinic tomorrow.
allergic reaction; body rash; Blood pressure has gone up; Ears ring a little bit; This is a spontaneous report received from a contactable consumer (patient). A 63-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: EP4534) via an intramuscular route of administration in left arm on 28Mar2021 at 10:15 AM (at the age of 63-year-old) as single dose for COVID-19 immunization. Patient medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities, diabetes and obesity. The patient concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 28Mar2021 at 10:15 AM, the patient experienced body rash, blood pressure has gone up and ears ring a little bit, on an unspecified date patient experienced allergic reaction. The events were considered as a non-serious. Therapeutic measures were taken as a result of body rash and treatment included diphenhydramine hydrochloride (BENADRYL). The outcome of the event body rash was reported as not recovered and other events was reported as unknown.     No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Not feeling very energetic; I did not feel good; Chills; Fever; Headache; Did not feel like eating much; Achy; This 72- year-old female patient contactable consumer (reported for herself) received the BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (lot EL9265; expiration not provided), via an unspecified route of administration, on 28Jan2021 at 09:15 AM (at the age of 72-years-old) as a single dose for COVID-19 immunization. The facility where COVID-19 vaccine was administered was at a hospital. Medical history included: COVID in Mar2020 and was hospitalized for 10 days, hypertension, thyroid disorder, and flu shot. Concomitant medication included: Hydrochlorothiazide 12.5 mg, once a day for blood pressure and medication for thyroid reported as: "NP" 0.5gms. On 28Jan2021 later on after vaccine, she reported 9:15 pm that she did not feel good. She had chills, fever, headache, did not feel like eating much, was achy, and not feeling very energetic. During the night temperature was 101.4. At 8 in the morning, I started taking 2 Tylenol, 500 mg and it went lower but then it would come back up, so I take more. So, it never went over 101.8. now here we are on the Saturday morning and I am not feeling very energetic and I still have just a 99 temperature. Treatment included: Tylenol. The clinical outcome of the events I did not feel good, chills, fever, headache, did not feel like eating much, Not feeling very energetic, and Achy were unknown.   No follow-up attempts are possible. No further information is expected.
strong metal taste; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via unspecified route of administration on 12Apr2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of on unspecified date at single dose for COVID-19 immunization. The patient reported within one hour, she started with a strong metal taste in her mouth. She is now on her 15th day and it has not changed. The outcome of the event was unknown.  No follow up attempts are needed. No further information is expected.
Freezing, shaking, headache, increased temp, joint pain in jaw, shoulder and hips most of the night.
Within 2 hours after receiving Shingrix vaccine, had ringing in ears that grew increasingly louder until the 4th hour after vaccine, and have had chronic tinnitus ever since.
Local rash at the site of both injections. 3in x 3in rash on (Rt) vastus lateralis. 1in x 1in rash on (Lt) outer vastus lateralis.
PNEUMONIA TREATED WITH DOXYCYCLINE 100MG ON 6/11/21 AND 7/1/21
Approximately 10 minutes after administering the Moderna vaccine patient began to feel warm and then fainted.
excessive bleeding from her nose; flu like symptoms; having a cold for a couple of days now; Runny nose; She has phlegm; She has a lot of headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 37 year-old female patient received bnt162b2 (BNT162B2), administration date 30Aug2021 (Batch/Lot number: unknown) at the age of 37 years 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: EPISTAXIS (non-serious), outcome "unknown", described as "excessive bleeding from her nose"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "flu like symptoms"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "having a cold for a couple of days now"; RHINORRHOEA (non-serious), outcome "unknown", described as "Runny nose"; PRODUCTIVE COUGH (non-serious), outcome "unknown", described as "She has phlegm"; HEADACHE (non-serious), outcome "unknown", described as "She has a lot of headache". Relevant laboratory tests and procedures are available in the appropriate section.  Information on lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.