chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 29Apr2022 as dose 4 (booster), single (Lot number: FK9894), in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 29Jan2021 as dose 1, single (Lot number: 042L201), in right arm, on 26Feb2021 as dose 2, single (Batch/Lot number: unknown), in right arm and in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "pollen allergies" (unspecified if ongoing). Concomitant medication(s) included: PERRIGO, start date: Jul2022, stop date: Aug2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-1 test: (2022) Positive; (10Aug2022) Positive, notes: I have mild symptoms and am Ag(+) again. Therapeutic measures were taken as a result of drug ineffective, covid-19. From 01Aug2022 to 06Aug2022, the patient had paxlovid as treatment of COVID-19.  Clinical Course: The other medical history was reported as none. Paxlovid rebound. Patient was Covid+ and symptomatic, and started Paxlovid on Aug 1. Patient was nearly symptom free and Ag(-) on Aug. 6. Today, Aug 10 patient have mild symptoms and am Ag(+) again.  No follow-up attempts are possible. No further information is expected.
Pos. seizure activity - pupils got big child began shaking then had blank stare, wouldn't respond for 3 min. afebrile.
Malignant neoplasm of lower lobe of left lung; procedure - Left Lower Lobectomy w/ Mediastinal Lymph Node Sampling and Bronchoscopy. This admission was within 6 weeks of receiving the COVID vaccine.
breakthrough case; got COVID; This spontaneous case was reported by a consumer and describes the occurrence of VACCINE BREAKTHROUGH INFECTION (breakthrough case) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 VACCINE BREAKTHROUGH INFECTION (breakthrough case) (seriousness criterion medically significant) and COVID-19 (got COVID). At the time of the report, VACCINE BREAKTHROUGH INFECTION (breakthrough case) and COVID-19 (got COVID) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient reported that he and his wife were exposed to their 27-year-old daughter, who also received the Moderna COVID-19 vaccine. The patient stated that she also had a breakthrough case. The patient's daughter's vaccination information was unknown. He stated that she was vaccinated around the same time he was.  No concomitant medication was reported. No treatment information was provided.  Company Comment: This spontaneous case concerns a 27-year-old, female patient with no medical history reported, who experienced the unexpected, non-serious  of COVID-19 and vaccine breakthrough infection after administration of an unspecified dose of the Moderna mRNA-1273 vaccine. The start dates of the events were not provided. No further information was provided. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report. Further information has been requested.; Sender's Comments: This spontaneous case concerns a 27-year-old, female patient with no medical history reported, who experienced the unexpected, non-serious AESI of COVID-19 and vaccine breakthrough infection after administration of an unspecified dose of the Moderna mRNA-1273 vaccine. The start dates of the events were not provided. No further information was provided. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report. Further information has been requested.
Within 24 hours of vaccination, he had chills, HA, malaise and increased dyspnea a feeling of dyspnea that began soon after the vaccination.  All symptoms resolved within a few days except the dyspnea.  It is improving now 6 weeks post vaccine, but not yet back to his baseline.  The red rash  was a fairly classical "Covid arm".  It is resolving, but the left arm is still overall a littler redder than the right.
Edema and redness noted at site on left arm.  Keflex 250mg/tsp - If increased of redness is noted.
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 14-SEP-2016 the patient was vaccinated with an improperly stored dose of ZOSTAVAX lot # L046897 and expiration date: 23-FEB-2017. Dose and route were not provided. The vaccine was exposed to 9 Fahrenheit degrees for 4 minutes. A data logger was not used to log temperatures. No adverse effects were reported. It was not a product quality complaint involved. Additional information has been requested.
This spontaneous report as received from a registered nurse to unspecified number of patients of unknown age and gender who may have been administered unspecified number of doses of ROTATEQ, included M-M-R II, PEDVAXHIB and GARDASIL (Lot number, expiry date, route and dose were not reported for al) that were exposed to 32.4 Fahrenheit for an unspecified amount of time. At the time of the report, it was not known if the vaccine exclusions were supported or unsupported. Additional information has been requested.
Rash at injection site, 6 days post vaccine.  12 hours post vaccine chills, extemely sore arm, headache, body aches, dizziness lasting 48 hours.
Soreness on left arm; Left arm feels heavy to lift; A spontaneous report was received from a consumer concerning a 76-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events soreness on left arm, left arm feels heavy to lift.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 18 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 028L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 19 Feb 2021, the patient experienced the event(s) soreness on left arm, left arm feels heavy to lift.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), soreness on left arm, left arm feels heavy to lift was unknown.
FAINTING; DIZZINESS; VOMITING; NAUSEA; This spontaneous multiple patient report was received from physicians, consumer, media, and press release and concerned 11-13 adult male and female patients. Initial information received from a consumer on 07-APR-2021 was processed with additional information received from media and then obtained via follow up with physicians on 08-APR-2021, and from the physician and Department of Public Health and Environment press release on 09-APR-2021.  The patients' height and weight were not reported. The patients' concurrent conditions included anxiety and fainting. The patients received COVID-19 VACCINE AD26.COV2.S (suspension for injection, route of administration, dose, and site of vaccination not reported, batch number: 18008980 and 201A21A) administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, within 15 minutes of vaccination, 11-13 patients out of about 1700 who were vaccinated that day experienced varying symptoms including fainting, dizziness, vomiting, and nausea. The patients received vaccine at a "drive-up" vaccination event, then drove to a parking lot to wait for about 15 minutes with instructions to honk if they felt ill. Two or three patients were transported by EMS to the local hospital for observation. They were later released from the emergency department and were not admitted. Two patients were recommended to go to the hospital, but declined, and were observed and treated with juice and water along with other 7 patients at the site. The reporting physician did not feel that the reactions were due to the lot or the specific vaccine, but were rather due to vasovagal reactions. The press release stated that "the Food and Drug Administration has run the two lot numbers used at the site and found no worrying pattern of similar events with these lots." The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. The outcome of the fainting, nausea, dizziness, and vomiting was not reported. This case is associated to product complaint PQMS# 90000175639. This case is linked as same patient to 20210415071. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 This report concerns multiple patients who experienced adverse events after receiving an injection at a "drive-up" vaccination site. On 07-APR-2021, within 15 minutes of vaccination, 11-13 patients out of about 1700 who were vaccinated that day experienced varying symptoms including fainting, dizziness, vomiting, and nausea. Two (or three) patients were transported to the hospital for observation. It was reported that some patients had concurrent anxiety and fainting. Given the close temporal relationship and the nature of the events, the events are considered possibly related to the vaccination, the "Drive-up" circumstance likely were a significant contributory factor.
Patient given 0.5ml of original Moderna booster instead of bivalent Moderna booster.
Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with doses of PEDVAXHIB, (lot # K007258, expiration date 04-MAR-2017) (dose, route unspecified) which were exposed to 32.5F for 2 hours. This event was considered as incorrect product storage. No adverse effects reported. This is one of several reports received from same source. On 23-FEB-2015, a telephone call was placed to the nurse, nurse was unavailable at the time of the call. A voice message was left requesting a returned phone call. Additional information has been requested. Narrative was updated.
As soon as pt received vaccination, he said he felt tightness in his chest, heart racing, irregular heart rate, SOB, nurse noted he was ?swallowing hard?.  EMS called ASAP, BP 172p (pt obese) hr 108 sao2 98%.  He was soon able to get out of the drivers seat to allow is mother to drive, moved for further obs.  Stated chest felt intermittently tight and burning.  No rash, swelling of tongue lips or airway noted, pt admitted to h/o anxiety, next vitals similar, pt released after 30 min by EMS into the care of his,other
High blood pressure 2 1/4 hours after the injection,  tightness of chest
Throat thickness/swelling occurred about 5 times (feeling occurred off and on for 45 minutes) Tingling on left side of body (feeling lasting about 10 hours)
Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: pt reports left side of body including shoulder and upper chest area to be inflamed and red. symptoms not improving, progressing worse. advised pt should seek medical attention by her pcp.
elevated liver enzymes, nausea, vomit, upper abd pain w/cramps;
fever after in the night; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient received BNT162b2 (BNT162B2), on 18Feb2021 as dose 1, single (Lot number: EN6200) at the age of 52 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PYREXIA (non-serious) with onset Feb2021, outcome "unknown", described as "fever after in the night".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201377857 same reporter/patient,different dose/AE;
pt recv vax & 1-2 days later devel a huge area of redness @ the inj site;
after a week, soreness occured, hot and swollen site that is now moving up my arm to shoulder. Leg cramps and stiff neck, Dizzyness
I developed tinnitus in both ears about a day after getting the first COVID19 Moderna shot. It's steady and very high pitched and loud enough that I can't overcome it with fans running at night. It's been 11 days since the shot and has not changed. The only other side affect I had was a slight headache about an hour after the shot. Overall hearing does not seem to be affected, other than having to hear things over the ringing.
Fever +100 redness of skin, slightly swollen, no pain. Pt is ok. Come by on 10/7/04 all ok.
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with VARIVAX (Merck) (does, route and lot number were not provided). On an unknown date, the nurse reported that since unspecified date, improperly stored VARIVAX (Merck) (lot # J014152, expiry date: 07-NOV-2015 (also reported as 17-NOV-2015)) was administered to patients and no adverse effects were noted. This is one of several reports received from the same reporter. Additional information has been requested.
I received 2 of the 3 Gardisil shots. One on 10/16/07 and one on 2/2/08. In April 2008 I had a virus that lasted for 4 weeks and was treated with antibiotics. On May 24th my left side went completely numb and I was diagnosed with Multiple Sclerosis on 5/25/09 and hospitalized for 5 days. I had another flare on 6/23/08 where i was hospitalized for 3 days. 3/4/09-records received for DOS 5/23/-5/27/08-DC DX:New diagnosis of multiple sclerosis.Cephalgia exacerbated by lumbar puncture., .  Presented to ED with C/O 2 day history of neck pain, numbness and tingling in left upper and lower extremity.
Patient started getting bad headaches during physical exertion of the Physical Fitness test the following day after the Flu Mist at around 06:00 AM during the run. Patient reported a bad headache after the run and took a BC Powder to try to relieve it.  He still didn't feel better so he rested the remaining part of the day.  However, every time he exerted himself in any way (even leaning over a table) he started feeling painful headaches.  The pain continued on and off whenever he exerted himself physically.  Finally, on October 11, 2010 at approximately at 1230 hours, patient experienced another migraine headache after running up a flight of stairs. Over a period of the next 8 hours, he took Tylenol Extra Strength, aspirin, and finally a BC Power. None of the medicine helped, so at 830 PM he went to the Emergency Room.  While there he was given a CAT Scan and spinal tap.  He was released at 0100 on 12 OCT 2010. He continues to have pain and is told he needs an MRI.  He was prescribed hydrocodone 7.5mg 1 per night or as needed for headache; butalbital 1 x pill every 4 hours as needed for headache; methylprednisolone decreasing dose (ZPACK).
Headache; Suicidal; weird feeling, bad feeling in her head that was getting worse; Anxious; Nervous; This is a spontaneous report from a contactable consumer (patient).  A 53-year-old female patient received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered on arm left on 19Mar2021 11:00 (Batch/Lot Number: EP7534) as SINGLE DOSE for COVID-19 immunization at the pharmacy. Medical history included ongoing dilated pulmonary artery diagnosed 2-3 years ago. Concomitant medications were not reported. The patient received the vaccine on 19Mar2021 11:00.  After 5 hours, she had a weird feeling, bad feeling in her head that was getting worse. She was completely suicidal the next day (20Mar2021) and the day after that that lasted for like 3 days maybe. She also had a headache on 26Mar2021 that has lasted for 2 weeks. She was not suicidal anymore, but still felt anxious. She did not treat her symptoms in any way, but finally got alprazolam (XANAX) from her doctor. She was due for second one and was a little nervous. The patient recovered with sequlae from suicidal on 23Mar2021; recovered from headache on 09Apr2021; unknown for nervousness while not recovered from the remaining events  No follow-up attempts are possible. No information is expected.
Once my period started it was way worse cramps; A heavier flow than i've ever had; This is a spontaneous report from a contactable consumer, the patient. A 20-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the right arm on 27Apr2021 at 14:15 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Apr2021, the patient underwent COVID-19 test and the result was negative. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the right arm on 04Apr2021 at 14:15 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. On 10May2021, once the patients period started it was way worse cramps and a heavier flow than she ever had. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events once period started it was way worse cramps and a heavier flow than she ever had was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Received at 29 weeks pregnant, EDD april 10. Started feeling off/shivery around 6:30. Pain at injection site. Woke up around 11pm with uncontrollable shivers that lasted for about 30-40 min until I took a Tylenol. Felt ok the next day. Was tested for covid just Incase and test was negative.
heart hurts; the feeling of fainting stopped; sore throat; trouble breathing; nasal congestion and felt very hot; nasal congestion and felt very hot; had chest pain/ heart hurts; seeing stars; This is a spontaneous report from a contactable consumer (patient's parent). A female patient of an unspecified age (age 27, unit: unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date at 5:30 pm at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. E-transmitting possible duplicate AE as caller stated they already reported AE to previous agent. Caller reporting on behalf of her daughter. The patient got the 1st dose at 5:30 pm, woke up with a jolt at 1:00 am with trouble breathing, a sore throat, nasal congestion and felt very hot. She took a COVID test since then which was negative. 5 days after that, this Monday 12Apr2021, she had trouble breathing again, that didn't get better, while in the shower. She had chest pain which she described as 'my heart hurts' when she got out of the shower started seeing stars. She put her head down and the feeling of fainting stopped. Both times, the trouble breathing lasted 5-10 minutes. And she felt okay after just a few deep breaths. On the 2nd time she felt better after deep breaths, cold water and felt fine. She had a Tele-visit with a different doctor than her usual physician. She was told to go to urgent care, where they did an X-ray and EKG (electrocardiogram) and COVID test, as mentioned earlier. By the time she went to urgent care she had no trouble breathing though. The outcome of the events trouble breathing and felt faint was resolved on an unspecified date, of other events was unknown.  Information on the lot/batch number has been requested.
normal side effects; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (normal side effects) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (normal side effects). At the time of the report, VACCINATION COMPLICATION (normal side effects) outcome was unknown.        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.   No concomitant medication was reported. No treatment medication was reported.
About a month after the vaccine it began to appear as a type of warts on his neck and they have been spreading on his chest and face.
I received the new Spikevax 2023-2024 COVID-19 vaccine by Moderna, although that was not seemingly a choice from your drop box. The Pharmacy said that I'd need to contact them later to get a lot number, etc., and I do not have that yet.  Approximately, 4-5 hours after receiving the shot, my arm (in which I had the shot) started to hurt. The pain lasted all night and kept me awake, but it subsided the next day. I also had chills over night that then subsided. For the next several days after that, I've had a runny nose and cough. I can't be sure that the runny nose and/or cough are related to the shot, of course.  For every prior COVID vaccine I've received, I've never had any adverse reaction, so I wanted to report this. Thanks.
he tested positive for Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 22Dec2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: COVID-19 (non-serious) with onset Dec2021, outcome "unknown", described as "he tested positive for Covid-19". Relevant laboratory tests and procedures are available in the appropriate section.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Underage patient received the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Underage patient received the vaccine) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Underage patient received the vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Underage patient received the vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided. Treatment information was not available.; Sender's Comments: This report refers to a case of Product administered to patient of inappropriate age, for mRNA-1273, lot #: 041L20A, with no associated AEs.