chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report received from a patient via a company representative via other company (Pfizer, Inc) concerned a 32 year old male of an unspecified race and ethnicity. Initial information was processed along with the additional information received on 16-MAY-2022. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no medical conditions. On an unspecified date, the patient previously received Covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (suspension for injection, route of admin, and batch number and expiry date were not reported) dose was not reported, (Dose number in series 1), 1 total administered for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination (Dose number in series 1). The patient received Covid-19 vaccine ad26.cov2.s (Dose number in series 2), (suspension for injection, route of admin, batch number: 213D21A and expiry date was not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. No concomitant medications were reported. On 26-APR-2022, the patient experienced suspected Covid-19 infection (suspected clinical vaccination failure), (Dose number in series 2), and had a fever of 102 degree F. constant with symptoms progressing to the chest area and throat. He was prescribed with Paxlovid 3 days later and the next day on 30-APR-2022, the symptoms seemingly dissolved within 24 hours after taking the Paxlovid. Laboratory data included: Body temperature (NR: not provided) 102 F. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected Covid-19 infection on 30-APR-2022, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000230988. Sender's Comments: V0-20220526805-Covid-19 vaccine ad26.CoV-2.s-Suspected clinical vaccination failure. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
This spontaneous report was received from a consumer concerning her female neighbor of unknown age who on an unspecified date was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported). No other co-suspects were reported. No concomitant medications were reported. The consumer stated that a couple of days later (no dates provided) she broke out in a rash in the center of her chest. The consumer described that she did not see it; she was just informed what happened after receiving the vaccine. No treatment information was reported. The outcome of rash in the center of the chest was unknown. The relatedness for ash in the center of the chest was unknown for ZOSTAVAX. Additional information is not expected.
A company representative reported that on an unspecified date a pt (NOS) was vaccinated with pneumococcal 23v polysaccharide vaccine (lot not provided). The pt developed cellulitis and was treated with an unspecified anti inflammatory medication. Subsequently, the pt recovered from the cellulitis. Additional information has been requested.
I had a lymphatic reaction The nodes around my ears, throat, armpits, breasts all swelled up. They left took 2 weeks to go down totally. All the lymph on my right side went down within 48 hrs. The node behind my ear was so swollen it was causing fluid to backup which I developed an ear infection from. I also had a fever around 100 that lasted 4-5 days. My doctor told me to take ibuprofen. The fluid in my ear started draining once I started taking an antihistamine/decongestant. The fluid in my ear also caused slight vertigo for a few days. I had bells palsy on the right side about 3 years ago and I have noticed that now on the right side of my face I'll experience if I get extremely tired, I can feel the nerves I felt with the bells palsy twitch. I have noticed this happening in the recent months and my cousin also experienced the same and she has also had bell's palsy as well.
Vomiting; abdominal pain; This is a spontaneous report received from a non-contactable consumer (patient). A 22-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date was not reported) via an unspecified route of administration, in Arm left, on 06Mar2021 at 11.30, as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. There was no other vaccine in four weeks. Prior vaccination, the patient had experienced covid. Post vaccination, the patient was not tested for covid. Other medications in two weeks was reported as Lexapro and birth control. On 07Mar2021 at 03:30, the patient had experienced vomiting and abdominal pain. There was no treatment received for the adverse events. Outcome of the event was reported as recovering  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Pt had hot, red and painful swelling (4" X 5") at injection site, lasting 3-4 days duration. No fever (98.5F).
No adverse effects reported; multiple unspecified patients received improperly stored M-M-R II; This spontaneous report as received from a nurse manager (registered nurse), refers to an unspecified number of patients of unknown age and gender. Information regarding the patients' medical history, concurrent conditions or concomitant medications was not provided.  The Nurse Manager reported that since 12-MAY-2019 the multiple unspecified patients received improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (strength, dose, route of administration, lot number and expiration date were not reported), for prophylaxis, reconstituted with properly stored sterile diluent. No adverse effects reported.   The total time and highest temperature was reported as above 47°F for 24 hours. There was no previous temperature excursion, and the call was because of a "data logger'  This report was considered as non-valid due to lack of patient identifiers.
Severe arm pain that evening. During the night severe headache left side of head behind ear area, stabbing pain. Continued till 10:30 AM the following day, July 24, 2019. At this time pain has finally subsided. Do not know if it will start up again later today.
This case was reported by a consumer and described the occurrence of general body pain in a 55-year-old male patient who received SHINGRIX (batch number 3S354, expiry date 4th July 2020) for prophylaxis. On 13th April 2018, the patient received SHINGRIX (intramuscular) .5 ml. On 14th April 2018, 1 days after receiving SHINGRIX, the patient experienced general body pain. On 15th April 2018, the outcome of the general body pain was recovered/resolved. It was unknown if the reporter considered the general body pain to be related to SHINGRIX. Additional details were provided as follows: The patient experienced extreme body ache or pain. The patient did not provide permission for follow up.
devel generalized varicella-like rash w/less than 25 pox lesion;involved face, torso & extremities;no complications;no special tx;
Inappropriate Schedule of Vaccine administered; second dose of vaccine administered after excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (second dose of vaccine administered after excursion) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate Schedule of Vaccine administered) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (second dose of vaccine administered after excursion). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate Schedule of Vaccine administered). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (second dose of vaccine administered after excursion) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate Schedule of Vaccine administered) had resolved.        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.   Concomitant medication use was unknown Treatment information was unknown
This spontaneous report as received from a male patient in his 30's who refers to himself. The patient's medical history and current conditions were not provided. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot #, expiration date, dose and route were not reported). Secondary suspects and concomitant therapies were not reported. On an unknown date, within 24 hours of receiving the PNEUMOVAX 23, the patient experienced pain and swelling in the left arm. Then, on an unknown date, "red stripes" appeared on the arm and covered his chest a day later. On an unknown date, a week later, the patient experienced tightness of the chest, shortness of breath, anxiety and soreness at the injection site. On an unknown date, the patient felt weak. It was reported that the patient underwent electrocardiogram (EKG) but the results were not performed. The outcome of pain and swelling in the left arm, "red stripes" on the arm and chest, tightness of the chest, shortness of breath, anxiety and soreness at the injection site was unknown (reported as "it was unspecified whether any other symptoms had resolved"). The outcome felt weak was reported as not recovered (also reported as "he continues to feel weak to the day of the report"). The relatedness between adverse events and PNEUMOVAX 23 was not reported. Additional information is not expected because the reporter or Health Care Professional contact details were not provided.
This spontaneous report was received from a Medical Assistant concerning to a patient of unknown age and gender. Medical history, concomitant medication and concurrent conditions were not provided. On 13-JUL-2017, the patient was vaccinated with an improperly stored dose of VARIVAX lot # M047661, the expiration date: 02-DEC-2018 (dose and route were not reported) for prophylaxis. No adverse effects. The temperature was registered between -9°C to 8°C during 5 hours. The call was made due to data logger and there was no previous temperature excursion reported. No further information to report.
PATIENT REPORTED SWELLING, REDNESS, AND ITCHING (ALL MODERATE) IN THE INJECTION SITE/ARM THAT SUDDENLY APPEARED 7 DAYS FOLLOWING THE VACCINATION. PATIENT CALLED HER PCP AND WAS ADVISED TO USE ICE, BENADRYL, AND A TOPICAL ITCH CREAM. SHE USED AN ICE PACK, TOOK CETIRIZINE, AND APPLIED TOPICAL DIPHENHYDRAMINE. SHE WAS FEELING SOME BETTER WHEN SHE CALLED THE PHARMACY TO REPORT THE EVENT.
This is a spontaneous report by a contactable physician. A Pfizer Sales Representative reported on behalf of a physician for his female nurse who received PREVNAR 13 at 0.5ml single dose, intramuscular injection for immunization in Aug2012. Relevant medical history included unspecified condition. Relevant concomitant medications were unknown. Vaccine given on the same day and vaccines taken within the last four weeks were unknown. In Aug2012 the patient experienced severe unspecified reaction at the site of administration which she explained as inflammation and cellulitis. Therapeutic measures taken in response to the events included BACTRIM oral tablet and unspecified medication. Relevant lab data was unknown. At the time of the report she had recovered from all the above mentioned events on an unknown date.
Patient was recommended to be monitored for 1 hour due to her history of allergies. About45 minutes into her waiting period  patient made us aware that she was feeling her lips were getting bigger and had an itchy nose. Vital signs were taken. BP=187/110, HR=96-110, o2sat=95-97%. Pharmacist made aware , patient received 25 mg po Benadryl. And was to remain in observation 15 more minutes. After 10 minutes of receiving  the liquid Benadryl, patient complained of generalized itching , no hives. Patient was monitored for 15 more minutes and then patient was released with slight continued itching. Consulted patient  to call primary physician concerning repeatedly high BP.
Hives all over the body that are super itchy. Never had any adverse reactions to the first 3 doses. After 3 weeks still going through a debilitating itch and pain on a daily basis.
at 10:10pm, started with chills and shivers for over an hour. Muscle aching as a result of the shivers that last over an hour. Fever of 101.5 at 1am in the morning. Head ache that was first in the temples and then went behind the eyes. Water had a metal taste to it. Did not take a tylenol or anything to relieve the fever or ache. I prefer to allow my body to fight it naturally. Used an ice pack at the nap of my neck to help with fever and also headache. Also took 2 showers to help with body ache.  1/8/21 12:20pm fever is still 100.4. Body is still achy with slight headache.
pt recvd 1st dose of Hep B vax w/no noted problem; pt recvd 2nd dose of HEP B vax  on 18AUg92 & w/in an hr following vax, pt exp sore arm w/pain @ the inject site; sx resolved w/in 24 hrs; No further details were provided;
This spontaneous report was received from a registered nurse via medical assistant and refers to a 13-month-old female patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, past drugs and drug allergies were not reported. On 11-SEP-2017, the patient was vaccinated with improperly stored VARIVAX (lot # M039317; expiry date: 20-SEP-2018) and M-M-R II (lot # M034387; expiry date: 19-JUL-2018) for prophylaxis. The dose of VARIVAX was reconstituted with properly stored sterile diluent (MERCK). The doses of VARIVAX were exposed to temperature range between 6° Fahrenheit (F) to 14°F during a time frame of 1 hour 20 minutes. There were no previous temperature excursions. Digital data logger was involved. No adverse effects were reported. Product Quality Complaint (PQC) was not involved. This is one of the several reports received from the same source. Sender's Comments: US-009507513-1709USA008861: US-009507513-1710USA013424: US-009507513-1710USA013470: US-009507513-1710USA013465: US-009507513-1710USA013440: US-009507513-1710USA013468: US-009507513-1710USA013442: US-009507513-1710USA013445: US-009507513-1710USA013460: US-009507513-1710USA013463: US-009507513-1710USA013464: US-009507513-1710USA013438: US-009507513-1710USA013439: US-009507513-1710USA013450: US-009507513-1710USA013430: US-009507513-1710USA013469: US-009507513-1710USA013467: US-009507513-1710USA013435: US-009507513-1710USA013434: US-009507513-1710USA013432: US-009507513-1710USA013428: US-009507513-1710USA013437: US-009507513-1710USA013441: US-009507513-1710USA013443: US-009507513-1710USA013444: US-009507513-1710USA013446: US-009507513-1710USA013447: US-009507513-1710USA013448: US-009507513-1710USA013436: US-009507513-1710USA013449: US-009507513-1710USA013451: US-009507513-1710USA013452: US-009507513-1710USA013454: US-009507513-1710USA013455: US-009507513-1710USA013456: US-009507513-1710USA013457: US-009507513-1710USA013458: US-009507513-1710USA013459: US-009507513-1710USA013461: US-009507513-1710USA013462: US-009507513-1710USA013466: US-009507513-1710USA013427: US-009507513-1710USA013471: US-009507513-1710USA013472: US-009507513-1710USA013473: US-009507513-1710USA013474: US-009507513-1710USA013475: US-009507513-1710USA013476: US-009507513-1710USA013425: US-009507513-1710USA013433: US-009507513-1710USA013423: US-009507513-1710USA013040: US-009507513-1710USA013426: US-009507513-1710USA013429: US-009507513-1710USA013431: US-009507513-1709USA008666: Original Case: 1709USA008666: US-009507513-1710USA014649: Original Case: 1710USA014649: US-009507513-1710USA014651: Original Case: 1710USA014649.
Late in the evening on 10/25/2010, patient developed a red, sore, swollen and feverish arm from the shoulder to the elbow.  Pt. went to see Dr. on 10/26/2010 (for a different matter, but had him check her arm).  He instructed her to use cold packs and take Benadryl as instructed.  Pt. states she did as she was instructed and the swelling and redness went away on 11/04/2010.  The fever in the arm disappeared by 10/31/2010.
vaccine given that day was 2 weeks past its beyond use date; the beyond use date was 1/20/23 and the vaccine was given on 2/3/23; this was not noticed until after the vaccine was given; NO ADVERSE EVENT OCCURRED
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL lot # K011562, expiration date 08-APR-2017 (dose, dose number and route of administration were not reported). There were no adverse effects. This is one of two reports received from the same source. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a 72-year-old female patient who received SHINGRIX for prophylaxis. In September 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injected limb mobility decreased and pain in arm. On an unknown date, the outcome of the injected limb mobility decreased and pain in arm were recovered/resolved. It was unknown if the reporter considered the injected limb mobility decreased and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. The patient experienced a sore arm for 2 to 3 days. She described it as being more sore than she usually felt with other vaccinations. The patient stated, it was hard to lift her arm for a few days. The reporter gave consent to follow up.
Soreness, fatigued, fever, chills, sweats, Took Tylenol,Swollen lymph nodes, enlarged, was positive with covid
Patient had moderate abdominal pain location was epigastric. Patient associated symptoms were change in appetite and fever (max temp of 102F). Mother was giving patient TYLENOL for the fever. Dr. whom the patient followed up with instructed mother to continue MOTRIN, considered PEPTO-BISMOL warm compresses and probiotics.
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 66-year-old male patient who received SHINGRIX for prophylaxis. On 29th August 2018, the patient received SHINGRIX .5 ml. On 30th August 2018, 1 days after receiving SHINGRIX, the patient experienced influenza-like symptoms and feeling queasy. On an unknown date, the outcome of the influenza-like symptoms and feeling queasy were not recovered/not resolved. It was unknown if the reporter considered the influenza-like symptoms and feeling queasy to be related to SHINGRIX. Additional details were provided as follows: The reporter was the spouse of the patient. The reporter said that her husband (patient) received the SHINGRIX vaccine. The reporter said that the patient came home an hour earlier from work and was asleep at the time of reporting. The patient's physician said that the patient had flu like symptoms. The reporter said that patient felt a little queasy.
This case was reported by a healthcare professional and described the occurrence of limb swelling in an infant subject of unspecified gender who was vaccinated with PEDIARIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of PEDIARIX (unknown). At an unspecified time after vaccination with PEDIARIX, the subject experienced limb swelling, nodule at injection site, pain and pharmaceutical product complaint. Sales representative was notified that the practice recently ordered 100 prefilled syringes of PEDIARIX and was concerned that there is a quality issue with this lot, lot number was not available. At the time of the report, the practice stopped administering PEDIARIX. At the time of reporting the outcome of the limb swelling, nodule at injection site and pain were unspecified. The healthcare professional considered the events were probably related to vaccination with PEDIARIX. A total of nine subjects were reported to have adverse events after vaccination with PEDIARIX, patient identifiers were not provided. For the other eight cases see A0890713A-A0890720A. Follow-up information was received from QA Product Complaints on 05 November 2010: A representative from QA Product Complaints followed up with the reporting healthcare professional. The healthcare professional reported that she did not have the lot number and was still trying to obtain it. Additionally, she stated that after some investigation, she found out that the original number of affected patients reported (9) was incorrect. She indicated that it appeared that only one patient was involved. Since only one patient was involved, the eight case ids A0890713A through A0890720A have been voided. Case id A0890710A will be retained as the case of reference. Follow-up information was received on 01 February 2011 via Quality Assurance, who reported no sample was returned and no lot number was provided, therefore no further investigation could be performed. This complaint was changed from inconclusive to unsubstantiated.
This spontaneous report was received from a physician refers to a 72 year old female patient. The patient had a history of allergic to ibuprofen, ampicillin and also allergic to flu vaccines due to the egg content of the product. On 31-DEC-2013, the patient was vaccinated with PNEUMOVAX23 (dose and frequency was not reported). Concomitant medications included VESICARE, latanoprost (eye drops) and Trimethoprim. On 31-DEC-2013, the patient experienced redness, swelling and heat in her arm after receiving a PNEUMOVAX23 shot. The patient sought medical attention and was prescribed with cold compresses and BENADRYL. The patient had routine blood work with normal results that were taken after the vaccination. On an unknown date, within the last 10 years, the patient experienced pneumonia. The physician reported that the reaction was not near the injection site the reaction goes from her elbow up. The physician also reported that the patient began feeling the reaction begin during the car ride home after receiving the shot of PNEUMOVAX23. The physician stated that the patient was receiving pneumonia vaccines 20-30 years ago once approximately every 10 years with no adverse reaction until this last dose on 31-DEC-2013. Additional information has been requested.
Patient received booster dose of Moderna on 11/10/2021 around 1420. Pt had previously had the Janssen vaccine on 3/19/2021 with no s/s of allergic reaction.  Approximate times 1420: Vaccine administered 1430: Pt alerted staff that she felt faint and dizzy during her 15 minutes of observation, denies any difficulty breathing or swelling of airway. 1445: Red rash noted down neck and on upper chest. Patient denies difficulty breathing, no signs of severe anaphylaxis. Vital signs: BP 130/84, HR 103, spo2 100%, RR 20. 1450: 50mg PO Benadryl administered per protocol. 1452: emergency number call/EMS called per protocol.  1510: Pt remained stable between emergency number call and EMS arrival. Report given and transferred care to EMS.