chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fainted; Nauseous; This is a spontaneous report received from a contactable Other-healthcare professional via a Pfizer sales representative. A 21-year-old female patient received meningococcal group b rlp2086 (TRUMENBA, lot number:  W62470)and diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) both via an unspecified route of administration in same arm on an unspecified date at single doses for immunization. The patient's medical history and concomitant medications were not reported. The patient felt nauseous and fainted after vaccination. The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: A possible contributory role of the suspect product cannot be excluded for the event faint based on the known safety profile
No adverse event; Second dose of the Moderna Covid 19 vaccine was administered 5 days before the recommended interval; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose of the Moderna Covid 19 vaccine was administered 5 days before the recommended interval) and NO ADVERSE EVENT (No adverse event) in a 6-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9237B) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Aug-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Aug-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose of the Moderna Covid 19 vaccine was administered 5 days before the recommended interval). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose of the Moderna Covid 19 vaccine was administered 5 days before the recommended interval) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose of the Moderna Covid 19 vaccine was administered 5 days before the recommended interval).    No concomitant medication was reported.  The patient did not ever tested positive for Covid 19.  No treatment medication was reported.
Patient came in on 03/19/21 and indicated on his form that they had not received any prior vaccine, so the vaccine administrator had likely told them to come back in 3 weeks. However, the patient should have waited a minimum of 8 weeks as he received his booster on 03/19/21 after completing the series on 1/11/21. The repeated booster on 04/09/21 was invalid because it was only 3 weeks from his last booster.
headache, sore throat, cough, fever, chills, shortness of breath, body aches, ear pain, sinus congestion, nasal congestion, post nasal drainage. starting 1/14/2022
24 hours, post vax, the pt's left thigh became swollen, red and hard. Fever denied. Saw MD, the next morning (6/6/01) who reported a 14cm induration; prescribed Benadryl and Ibuprofen.
Systemic: Fainting / Unresponsive-Mild, Systemic: Seizure-Mild, Additional Details: This lasted about 20 seconds. Patient fainted some seconds after receiving the vaccine. Patient reports previous history of fainting after a vaccine administration.
Stuffiness; Loss of taste; Loss of smell; couple of headaches that were really bad; Pt tested positive after receiving the 1st dose; This spontaneous case was reported by a health care professional and describes the occurrence of COVID-19 (Pt tested positive after receiving the 1st dose), NASAL CONGESTION (Stuffiness), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell) and HEADACHE (couple of headaches that were really bad) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 14-Jan-2021, the patient experienced COVID-19 (Pt tested positive after receiving the 1st dose). On an unknown date, the patient experienced NASAL CONGESTION (Stuffiness), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell) and HEADACHE (couple of headaches that were really bad). At the time of the report, COVID-19 (Pt tested positive after receiving the 1st dose), NASAL CONGESTION (Stuffiness), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell) and HEADACHE (couple of headaches that were really bad) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications provided. Patient received Tylenol and Ibuprofen treatment for the symptoms. Patient received 1st dose of vaccine at the health center.   Most recent FOLLOW-UP information incorporated above includes: On 02-Feb-2021: No specific follow-up information recorded.
there was a lump on my clavicle bone; my arm was little sore, but my clavicle area was very sore was reported as worsened; my arm was little sore, but my clavicle area was very sore was reported as worsened; Just tired and achy; my arm was little sore, but my clavicle area was very sore was reported as worsened; Chills; Just tired and achy; This is a spontaneous report from a contactable Consumer or other non-HCP (patient).  A 55-years-old an unspecified gender patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot Number: EN6204), via an unspecified route of administration on 06Mar2021 (age at vaccination was 55 years) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The concomitant medications were none. On 07Mar2021, patient's arm was little sore, but clavicle area was very sore was reported as worsened. On 08Mar2021, this morning patient noticed that there was a lump on clavicle bone,  patient did not know if that is normal and last night, and was little worried about the lump on clavicle bone. On an unknown date patient had chills, was breathing fine, just tired and achy. Outcome of the events arm was little sore, but clavicle area was very sore was not recovered and for other events it was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
5 minutes after 1st dose Pfizer, patient experienced high anxiety leading to vasovagal episode. Patient reported flushing/sweating and dizziness that led to patient falling forward from his chair, face first into the ground. Patient was transported to bay on wheelchair.  Vitals: @16:41: 129/83, 75, 30 -> @16:44: 111/75, 78, 24 -> 17:12: 119/74, 84, 20 Vitals stable. Patient slowly regained consciousness, diaphoretic oriented with full motor control. Hyperventilation subsided. O2 stable. Patient given juice and crackers and continued resting. Patient was released from vaccination site once stable at 17:25.
Patient reported site of injection became hard and red half dollar size approx. 12 hours after the injection. On 12/10/21 Left arm redness increased to surrounding area of the upper arm.  On 12/12/21 Patient reports her Lymph-nodes under her arm became swollen and tender and her upper left arm was red and hard.
fever; chills; headache; nausea; This is a spontaneous report from a Contactable Consumer. A non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration on 10Mar2021, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. No other vaccine in four weeks. No COVID prior vaccination. COVID tested post vaccination was unknown. Patient has known allergies was unknown. On 11Mar2021, the patient experienced fever, chills, headache, and nausea. Patient received treatment for adverse events was unknown. The outcome for all the events was unknown.  Follow-up(16Mar2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation of the awareness date for report. The response included: Aware date of the adverse events, the events occurred about 24 hours after the first shot; not the same day.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
patient became light headed approximately 1-2 minutes after vaccination. Described feeling "cloudy" and sweaty.
Resident recieved 2nd dose of Moderna vaccine 2/13/2021.  During routine testing, resident tested positive for COVID-19 on 3/8/2021 -- 24 days out from last dose of vaccine.  Resident is asymptomatic.  Resident previously tested positive for COVID-19 on 11/30/2020.
pt.recvd vax & developed measles rash,cough,coryza,conjunctivitis, & Koplik spots.
Patient had about 2 weeks of diarrhea - towards the end developing blood & mucous in it along with not feeling well [and eating less].  She was seen in my office 12 days after having received her scheduled 4mos set of immunizations [Pediarix, hib-omp, Prevnar, Rotarix].  Diaper brought from home showed stool mixed with mucous and blood.  Clinically looked ok, and was released home with symptomatic care and observation.  Prior to having received these vaccines, mom noted that after the 2mos set of vaccines [same set] that patient had diarrhea that lasted 2 weeks as well [but no blood or mucous noted]. These both resolved spontaneously.
Experienced fever of 101, severe headaches, nausea, chills, body aches for 24 hours.
The day following the vaccination, noted new onset dizziness and that continues. This is not triggered by position change but does worsen with change in head position. The severity varies. He fell once and he has had to change his activity level on two days. The other days have been milder but annoying. He is in the middle of a building project and is unable to climb ladders.
Heat and Tender Arm; This is a spontaneous report from a contactable consumer (patient). A 74-years-old non pregnant female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6203),via an unspecified route of administration, administered in Arm Left on 26Feb2021 (at 74-years age) 09:45 as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. The patient was not tested for COVID-19. On 27Feb2021, the patient experienced heat and tender arm. No treatment was received for the event. The outcome of event was recovered on an unspecified date in 2021. No follow-up attempts are possible. No further information is expected.
5 days after the covid vaccination some smells permanently changed. Some meals that used to smell pleasing now have a pungent repulsive smell. Have not identified what ingredients cause the smell but have smelled the same repulsive odor frequently in different meals and restaurants and stores. It's as if ~15% of my smell receptors have been replaced with this odor; like they've been reprogrammed to tell me it's a repulsive smell instead of pleasing like it used to be.
A medical assistant reported that subsequent to receiving a dose of Prevnar, a pt developed a high fever along with an injection site reaction characterized by redness, swelling and pain. The pt recovered. The reporter indicated that several pts experienced these events, however they are presently not identifiable.  Additional reports will be generated when identifying information is provided.
Reaction to Dtap red, swollen, warm to touch, fever, pain from right deltoid to elbow.
My symptoms started late morning of July 26th with sinus congestion and sore throat and cough. The next day I got a fever that lasted on and off for 5 days. Fever was 100.7, body aches, lots of fatigue. I pretty much slept for the first 3 days. I was concerned because my cough was becoming tight in my throat. I have a history of asthma so this was concerning to me. I consulted with my doctor who prescribed benzonatate for the cough. I never felt like it got into my chest but it was starting to feel like my throat was swelling. I was concerned this would affect my breathing. I still have fatigue, cough and congestion. My energy levels are back to normal.
Area around injection site became red within 30 minutes. As time progressed it became swollen, hot and the redness continued toward the elbow. On Friday she used oral benadryl and motrin. She applied topical benadryl and hydrocortisone 1% cream. By Saturday there was some improvement. As of 10/11/12 she still has a little pinkness to the area.
This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. On 09-JAN-2015 the patient was vaccinated with M-M-R II (route, dose, frequency and lot # not reported) which had undergone an temperature excursion. This is one of several reports from the same source. Additional information has been requested.
Information has been received from a physician concerning a female (age not reported) with diabetes who on 07-NOV-2007 was vaccinated with a 0.5 mL dose of pneumococcal 23v polysaccharide vaccine (lot # 658443/0989U). There was no concomitant medication. On 08-NOV-2007 the patient experienced inflammation and swelling in the vaccinated arm (which arm unspecified). The patient went to the emergency room and this reaction was diagnosed as cellulitis. The patient was given unspecified antibiotics. On 11-NOV-2007, the patient recovered. Inflammation and swelling in the vaccinated arm and cellulitis were considered to be immediately life-threatening. Additional information has been requested. Follow-up information was received from a Lot check investigation summary. The summary of investigations revealed that there were no Investigations related to the manufacturing of 0989U, 0658449, and 2119750. A review of the release testing data revealed that 0989U, 0658449, and 2119750 conformed to all required testing at the time of product release. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.
Fever 104, pale, limp & drowsy; Devel whelps on body called MD who prescribed DPH; Was better by next day;
Patient had an episode of syncope and was found to be in v-tach. He required cardioversion and is currently hospitalized for further workup for cause of event
This spontaneous report was received from a physician refers to a 10 patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On 02-MAR-2015, 09-MAR-2015, 10-MAR-2015, 17-MAR-2015 and 16-APR-2015, the 10 patients were vaccinated with doses of PROQUAD (Merck), (strength, dose, frequency, route and anatomical location were not reported) (lot # K020747, expiration date 30-APR-2014) which were improperly stored. No adverse events were reported. Additionally, it was reported that the temperature excursion for PROQUAD (Merck) was supported with in-house stability data. This is one of several reports received from the same reporter. Additional information has been requested.
freezing cold; shivering; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of feeling cold in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 27-AUG-2023, the patient received the 2nd dose of Shingles vaccine. On 27-AUG-2023, less than a day after receiving Shingles vaccine, the patient experienced feeling cold (Verbatim: freezing cold) and shivering (Verbatim: shivering).  The outcome of the feeling cold and shivering were not resolved.   It was unknown if the reporter considered the feeling cold and shivering to be related to Shingles vaccine.     It was unknown if the company considered the feeling cold and shivering to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 01-SEP-2023 The patient self-reported this case. It was reported that the patient got his/her Abrysvo (RSV vaccine) shot, and 2nd Shingles shot on 27 August 2023, and less than a day after vaccinations, was freezing cold and shivering even though it got up in the 100s on 27 August 2023. It was unknown if the reporter considered the adverse events related to Abrysvo.
138 doses administered after date of expiry/Dose administered after 30-day Use By Date or after manufacturer date of expiry; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (138 doses administered after date of expiry/Dose administered after 30-day Use By Date or after manufacturer date of expiry) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (138 doses administered after date of expiry/Dose administered after 30-day Use By Date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (138 doses administered after date of expiry/Dose administered after 30-day Use By Date or after manufacturer date of expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported. No treatment information was reported by the reporter.  Reporter estimated 138 doses have been administered from point of expiration which was 10-Oct2-021 until 4-Nov-2021.Reporter stated she only discovered that 14 vials were received from the Health Department and out of the 14 vials only 1 vial has not been punctured .Date the vial was initially stored in the refrigerator; HCP stated the vial was taken out on freezer each day of administration. 13 vials in total, approx. 138 expired doses have been administered from 10-Oct-2021 until 4-Nov-2021.
Initial and follow up information has been received through the Merck pregnancy registry for GARDASIL from a Registered Nurse concerning an 18 year old female who in August 2007 was vaccinated with a first dose of GARDASIL. On 08-NOV-2007 the patient was vaccinated with a second dose of GARDASIL and was pregnant. There was no concomitant medication and diagnostic laboratory tests included Complete Blood Count (CBC), Human immunodeficiency (HIV), rubella, Hepatitis B, and antibody type and screen. No results were given. The GARDASIL was given by another physician at another office.  The patient experienced chlamydia and upper respiratory infection during her pregnancy (dates unknown). Since 27-NOV-2007 the patient has been prescribed pre-natal vitamins. On 17-DEC-2007 the patient experienced heartburn and was treated with PREVACID and had a maternal serum alpha fetoprotein survery (MSAFP) and the result of the test was negative. On 21-DEC-2007 the patient experienced gastroesophageal reflux disease and was treated with PREVACID. On 18-JAN-2008 the patient had an ultrasound for anatomical survey and the result of the test was unremarkable and within limits. On 17-MAR-2008 the patient experienced anemia and was treated with REPLIVA 21/7). On 25-MAY-2008 the patient delivered a normal, healthy female baby weighing 7 pounds and 14 ounces and length was 20.5 inches. At the time of the report the outcome of the heartburn, gastroesophageal reflux disease, anemia, chlamydia and upper respiratory disease were unknown. Additional information has been requested.
Information has been received from an RN concerning a 15 month old pt with no known allergies who on 1/12/02 was vaccinated with MMRII (lot 639619/0594L). On 1/21/02, the pt developed a fever of 102F and widespread measles-like rash all over the body. The nurse requested a lot check of lot 639619/0954L. Unspecified medical attention was sought. The records of testing prior to release of this lot had been checked by Compliance and found to be satisfactory. The lot complied with the standards of the Center for Biological Evaluation and Research and was released. The nurse reported that another pt developed a fever and a measles-like rash, post vax, with MMRII. See (WAES0201USA02367). Additional info has been requested.
Sudden onset 5.5 hours after injection: sudden temporary drop in oxygen saturation (measured at 82 at fingertip, returned to normal over 10 minutes when patient was warmed), nausea (lasting 24 hours), headache/migraine (lasting 36 hours), fever (up to and including 103 F, sustained between 101-102 for over 6hrs), chills and shaking (lasting approx. 1-2 hours), muscle aches (lasting approx. 12 hours),
Patient started experiencing  fatigue and developed rash within 24 hours. Rash has persisted on chest for several days (5 days and counting). Patient has contacted PCP and was told to return to pharmacy in order to issue VAERS.
This case was reported by a pharmacist via call center representative and described the occurrence of unwell in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced unwell. On an unknown date, the outcome of the unwell was unknown. It was unknown if the reporter considered the unwell to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The pharmacist did not have any further details as the patient did not get the injection at this pharmacy. The patient felt ill after the 1st injection. The pharmacist called to ask about efficacy after only one dose. The patient had an adverse reaction to it the first time she used it and it happened with other pharmacy that why she did not report it. The patient felt really ill, now the patient wanted to know how effective it would be if she did not get the 2nd dose of this SHINGRIX.
Body allergies throughout the body itching, bruising, edema, involuntary movements, swelling, loss of strength in the legs body weakness, loss of appetite, blurred vision twitching in both feet, sprouting of veins chest pain, headaches, fever, breathing problems.
Patient had visible bruise around injection site that she said was visible since she had been vaccinated.  She complained of an extremely sore arm that had not stopped hurting since she received the vacation on 10/27/20 and report to pharmacy on 11/11/20.  She said felt number at time and was in constant pain.
Aches, chills, headache, intense mental disturbance (the aches were so bad, my mind kept trying to think of ways to rearrange them within my body. It felt like a horrible anxiety attack, and my brain felt exhausted).