chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Nov2022 at 13:15 as dose 4 (booster), single (Lot number: GJ6738), in right arm and on 03Mar2023 at 13:15 as dose 5 (booster), single (Lot number: fm0689) at the age of 67 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Sleep apnea" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25Sep2023, outcome "recovered" (30Sep2023) and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (25Sep2023) Positive; (27Sep2023) Positive; (30Sep2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient did not have known allergies. Tested positive on 25Sep and began course of treatment that evening. Took doses through Saturday morning 30Sep. Tested positive on Wednesday (27Sep), negative on Saturday (30Sep). Only mild symptoms during week of (30Sep). Only mild symptoms during week of sore throat - somewhat severe Sunday (24Sep) during the night and next morning leading to testing.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300318294 same patient, different drug/AE;
This spontaneous report was received from a medical assistant refers to a 39 year old female patient the patients relevant medical history includes measles titre negative. On 30-AUG-2013, the patient was vaccinated with a dose of 0.5 ml PROQUAD (Merck) (lot # H015624, expiry date was 21-FEB-2014) instead of M-M-R II as intended. The patients past drug history and concomitant medications were unknown. It was unknown if any relevant testing was performed after receiving PROQUAD (Merck) vaccine. The outcome was unknown. Additional information is not expected.
COVID-19; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (COVID-19) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Jul-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Patient received additional booster dose.  Patient had two  primary series and two booster dose. Patient treatment medication included product used for unknown indication for COVID pills for 5 days.
Itching and some hives, patient took Benadryl and was fine the next morning.
itchy; Rash; This is a spontaneous report from a contactable Pharmacist. A 54-year-old female patient received first dose of bnt162b2 (Pfizer COVID-19 vaccine, Solution for injection, Batch/lot number: not provided, Expiration date: not provided), via an unspecified route on 19Jan2021 (age at vaccination: 54-year-old), as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 19Jan2021, patient experienced rash. Patient wanted to know if she can get the second dose. Patient got her first dose on 19Jan2021 and today is the 21-day mark. Today, patient still has a rash on her arm and body from the last time got vaccine now still has rash and itchy. The clinical outcome of the events was still having rash and itchy.  Follow-up attempts are completed. No further information is expected.
This spontaneous case was reported by a physician assistant and describes the occurrence of PRODUCT STORAGE ERROR (received third dose from vial refrigerated for more than 30 days) in an 82-year-old female patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, the patient experienced PRODUCT STORAGE ERROR (received third dose from vial refrigerated for more than 30 days). On 01-Oct-2021, PRODUCT STORAGE ERROR (received third dose from vial refrigerated for more than 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported No  treatment Drug was reported   This case was linked to MOD-2021-358921, MOD-2021-358773 (Patient Link).
Patient reported facial edema in the eye area and a scratching sensation in her throat. She was monitored and one dose of epinephrine was administered in the right anterio-lateral thigh by way of epi-pen. Patient was placed on O2 2L via N/C and transported by EMS to hospital A/A/Ox3 and in stable condition.
Patient reports cold symptoms for 2 weeks including rhinorrhea, cough productive of white mucus, body aches, lethargy. Denies fever, but has not taken temperature.
This spontaneous report was received from a 76-year-old male patient referring to himself. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported. On 06-APR-2019, the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot number and expiration date were not reported) for prophylaxis. The shingles shot nicked a vein and it started to bleed. On an unknown date in 2019, the patient's arm was hurting, blood clot formed and it slowly went into chest. On an unknown date in 2019, the patient was hospitalized for 6 days to suck out the blood clot. While he was hospitalized, they put something in so he could not swallow his tongue so he had a sore throat on an unknown date in 2019. His arm was still puffed out on an unknown date in 2019. The outcome of thrombosis, pain in extremity, venous injury and venous haemorrhage was unknown. The outcome of oropharyngeal pain and peripheral swelling was reported as not recovered. Causality assessment between the events and ZOSTAVAX was not reported. Upon internal review, the events of venous haemorrhage, venous injury and thrombosis were considered to be medically significant.
Information has been received from the Merck Pregnancy registry for GARDASIL from a female who was vaccinated with a first dose of GARDASIL. Subsequently the patient became pregnant and had a miscarriage. The patient required an doctor office visit. The patient reported that she felt her "doctor was inept and responsible for this." Upon internal review, miscarriage was considered to be an other important medical event. Additional information has been requested.
Flusing/sweating, dizziness. Patient laid down, given water. Stable & released from vaccination site.
A 58-year-old female patient received Pneumovax vaccine, 0.5 mL, on 16Jan2007. The patient had no previous allergy or reaction to the Pneumovax vaccine. On 16Jan2007, about 2 hours after the Pneumovax vaccine was administered, the patient noticed an allergic reaction involving redness and pain at the injection site. The redness and pain increased throughout the night and became more painful for the patient to move her left arm. Due to the adverse drug reaction, the patient was started on Keflex. The outcome of the event is unknown.
Pfizer-BioNTech COVID-19 Vaccine EUA  metallic taste
pt recvd Engerix-B vax & devel abnormal liver enzyme levels; tx unk;
The pt developed pain in upper arm to shoulder (red, swollen) initially week of 02/11/2002. Treatment was antibiotic and hot soaks. Redness went away, but pain continues in upper arm to date.
12 Feb 2021 at 17:00 patient report electrical shoot pain felt from left foot to left knee. Pain lasted for approximately 10 sec.  Pain repeated twice during the night, waking from rest. 13 Feb 2021 painful episode repeated at 7:30 am.  Painful episode repeated at 7:00 pm and continued for every 20 minutes. Pt reported to ER on 13 Feb 2021 at 10:30 pm. Facility conducted ultrasound on 14 Feb 2021 and identified left popliteal near occlusive blood clot. Prescribed Eliquis 5 mg and discharged home; f/u with PCP and Hematology. Continued course of treatment: Continue Eliquis as prescribed for 6-8 wks, f/u with PCP and Hematology.
Patient tripped and fell at home bringing in groceries .Hit back of head and fell on back. Complaining of mild headache and neck pain. Has small subarachnoid hemorrhage and min displaced fracture of anterior inferior osteophyte at C2.
lot of pain; couldn't sleep at night; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: lot of pain) and difficulty sleeping (Verbatim: couldn't sleep at night). The outcome of the pain and difficulty sleeping were not reported.   It was unknown if the reporter considered the pain and difficulty sleeping to be related to Shingles vaccine.   It was unknown if the company considered the pain and difficulty sleeping to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 21-JUL-2023 This case was reported by a patient via interactive digital media. The second shingles vaccine dose caused him/her a lot of pain, to the extent that he/she could not sleep at night for the pain.
This spontaneous report as received from a pharmacist who refers to herself a 50 year old female patient with depression and arthritis. Drug reactions or allergies were not reported. On 27-JUN-2013, the patient was vaccinated with ZOSTAVAX injection (0.65 ml once, lot # H021712, expiration date: 06-MAR-2014) subcutaneous. Concomitant therapies included CYMBALTA, Ibuprofen (manufacturer not provided) and SKELAXIN.  The patient stated my boss gave me the shot then the next day on 28-JUN-2013, patient noticed at bump at injection site within 2 days, a 12 inches diameter welt developed on arm with welts upon welt. The patient also stated my eyes felt funny and lips were tingling. On 28-JUN-2013, the patient went to an unspecified immediate clinic and received a dose of MEDROL and additionally a pack of MEDROL to take home, it was also ordered BENADRYL as needed. The patient stated that the reaction was diagnosed as allergic reaction. She also stated that it took a week (05-JUL-2013) to go down (welts on arm). At the time of the report the patient was doing fine. The causality between the adverse events and the vaccine was unknown.  Additional information has been requested.
Unbearable pain on the left hand (Vaccine was given on left hand) for about two days. I could not even move my left hand. Was not able to do my day-to-day activities and could not sleep. Pain is now reducing but it is almost a week since I took this shot, my left hand is not yet normal. Some activities are causing lot of pain and some movements are restricted.  This is due to second shot of Shingles vaccine. Not sure if this falls under adverse effect. But I am reporting it anyways.  I contacted the manufacturer (Glaxosmithkline) immediately but no advise came from them. My family Doctor helped.
Hospitalized became hypoxic to 40s during chemotherapy infusion (for ovarian cancer), per imaging she has pneumonia
Light fatigue after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Light fatigue after the first dose) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced FATIGUE (Light fatigue after the first dose). At the time of the report, FATIGUE (Light fatigue after the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-392438 (Patient Link).
Rash that comes up daily for about 15-20 minutes then goes away, is itchy, and comes up in different parts of her body. Started on left arm and then started popping up in different places including bilateral arms, torso, neck and ears. Dr prescribed steroids, patient refused but took Corecetin, over the counter antihistamine
Large red ring, approximately 2 inches around injection site, followed by rash appearance bilaterally both thighs, only, hives, that itch Also, started diaper rash, then thrush, then diaper rash worsening  got better at few days shy of 2 month mark, 2nd shot given, dtap, within 4 hours, approximately 2 inch red ring reappears and bilaterally both thighs rash/hives that itch reappear.  24 hour mark, after seen by pa for reactions,  told hand foot mouth disease,  wait for fever. No fever appears,  recheck on day 8, after dtap, rash/hives are still present.  Told instead of benadryl,  give claritin and being sent to hematology
After first dose, developed shingles; This case was reported by a other health professional via sales rep and described the occurrence of shingles in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 2 weeks after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 14-APR-2022 Reporter's Comments:  The reporter stated that, the patient came in on 12th April 2022, which was almost exactly 2 weeks after her first dose of Shingrix, and she had shingles. The reporter consented to follow up.
T104.6; jerking activity @ home x 5min; child stiff, back arched, stayed rigid 30-45'; admitting - poss. sepsis vs febrile seizure vs reaction to vax; dismissal - UTI, rt OM; on IV ATBs x 2 days; home on Septra; f/u 10 days for UA;
Patient reported at his second COVID vaccine appointment to the nurse that after his first COVID vaccine he got a rash on both of his arms on day 2 after receiving the COVID vaccine and lasted until day 5.
My son was given the Dpt#5 and MMr at his 12 month checkup. The next day he vomitted a lot and then started chronic diarrhea. The diarrhea was so bad that it would be over ten times a day at times including nights. It was liquid or extremely loose. It went on for 8 months before my pediatricians finally started to listen and made a G.I. appointment, who diagnosed toddlers diarrhea. I found their behavior odd and also the fact that his chart was misplaced on his 18 month checkup. By the way there are two other kids with the same first name with a very similar last name as ours that go there. He is 2 now and I had his vaccine records faxed to me. The 12 month vaccine was missing so it was refaxed. Not only is there absolutely no info or signitures for the MMR and DPT #5 shots given at his 12 month checkup, but on the second form they tried to switch the DPT #5 to 18 mths. and the DPT # 4 to 12mths. I'm very worried about getting his next vaccines because I find it odd that toddlers diarrhea would come on so severe (especially since it was starting to harden like a toddlers should before the vaccine)and I don't know if I really have a good record of vaccines to give to his new doctor. Also, I did not know about the mix up at the time to mention it to the G.I.
Headache, chest tightness and discomfort, elevated heart rate (resting heart rate bpm in the high 90s as measured by a home pulse oximeter). Resolved  the following day, resting heart rate back to low 80s.
I have never missed a period since the year 2011. I had my first shot in January after my January period. My next period was due to start on February 19, 2021. I had my Second shot February 11 and I have not started my period. I took a pregnancy test and they have been negative.  I find this very unusual that I have not started my period yet and pregnancy tests are negative. The only thing different in my life at this time was the Covid shot
This spontaneous report as received from a physician refers to a 10-year-old male patient with no pertinent medical history and no drug reactions/allergies. The patient had never had chicken pox. There was no concomitant medications. On 20-SEP-2007, the patient was vaccinated with a dose of VARIVAX (dose, route of administration, lot number and expiration date were not reported)for prophylaxis by another unspecified healthcare provider. On 21-SEP-2010, the patient was vaccinated with a dose of PROQUAD (dose, route of administration, albumin status, lot number and expiration date were not reported) for prophylaxis. Other suspect products included sterile diluent (route of administration, lot number and expiration date were not reported) administered on 20-SEP-2007 and 21-SEP-2010. On 27-SEP-2016, the patient developed herpes zoster, which was confirmed by the dermatologist. He sought medical attention. The reporting physician saw the patient for a well visit on 28-SEP-2016, and at that time, the herpes zoster was located on the patient's right shoulder. On 27-APR-2017, the patient was seen by the physician and the herpes zoster was developed for the second time and was located on the dorsum of his right hand. The reporting physician explained that he sent the pictures of the patient's experienced to an other physician and she said that the patient looked like he had a zoster. At the time of the report, the patient was being treated with acyclovir 4 grams a day (no other details was reported). No lab diagnostics/studies were performed. The outcome of herpes zoster was reported as not recovered. The reporter was interested in varicella zoster virus (VZV) analysis by Polymerase Chain Reaction (PCR). The patient's sample was sent to the laboratory on 03-MAY-2018, for PCR analysis. The causality between the herpes zoster and VARIVAX, PROQUAD and sterile diluent was not provided.
A serious report of vomiting, diarrhea, and abdominal pain has been received from a physician and a consumer (patient's mother) concerning a nine-year-old male subsequent to FLUMIST. Concomitant medications included dexmethylphenidate hydrochloride for attention deficit disorder. The patient had a history of constipation. The patient was an otherwise healthy child and had no known allergies to food or medications. The patient received FLUMIST on 08-Sep-2008 for health maintenance. On 09-Sep-2008, the patient experienced vomiting, diarrhea, and abdominal pain. His symptoms were intermittent. The second episode occurred when he awoke on 13-Sep-2008 and the patient went to the physician's office. The patient's symptoms continued at least daily to every other day. He went to the doctor twice for treatment. An abdominal X-ray was normal. The physician reported stool testing was ordered but no results were available and questioned if the patient did not go for the testing. On 17-Oct-2008, the patient had another episode of vomiting, diarrhea, and abdominal pain. Three or four days after that, the patient had another episode of vomiting, diarrhea, and abdominal pain. Both times the patient had eaten something "that had egg proteins in it like a muffin" during the day and experienced the episodes in the middle of that night. The patient did not have an egg allergy. In between episodes, the patient was "fine". On 05-Nov-2008, the patient was seen by a general pediatrician in a different medical center. The pediatrician did not perform any testing because he indicated that patient previously had a normal abdominal X-ray. He also reported that the patient had a history of constipation and thought his symptoms might be related to constipation. As of 05-Nov-2008 when he saw the general pediatrician, the patient's episodes were occurring "far less frequently". The physician indicated the vomiting, diarrhea, and abdominal pain were considered serious (important medical event) due to frequent school absences. Additional information received on 14-Oct-2008 from the physician was incorporated into the above narrative and included serious criteria, event outcome, additional patient information, indication and lot number for FLUMIST, concomitant therapy and medical history. Additional information received on 27-Oct-2008 the patient's mother was incorporated into the above narrative and included event outcome and details on additional episodes of the events. Additional information received on 06-Nov-2008 from a general pediatrician was incorporated into the above narrative and included additional details regarding the event.
Patient came in after receiving flu vaccine on 10/4/2011. Patient came in Friday 10/7/11 morning reporting swelling bump where vaccine administered. Bump is fluid filled, 1/2cm diameter, 2 mm height. No treatment provided. Instructed patient to put on antibiotic if bump breaks and opens up.
blurred vision, ringing in ears, sweating, faint/light headed;sat down on floor-BP 118/60, P72;BP remained stable;pt remain seated or 15-20min;
Approx 15 mins after receiving vaccine became faint color pale skin cool to touch. Placed head low between legs. In about 10 mins she states she was fine. On the way home. C/o tingling in arms and numbness. Had abd pain with nausea and loss of appetite c/o extreme weakness started feeling better at 2PM.
Chills from approximately 6:00pm on 1/18/21 until approximately 7:00am on 1/20/21 Low grade fever from 8:00pm on 1/18/21 until approximately 7:00am on 1/20/21 (~99.6F-101.8F, with average temperature of about 100.4 for duration of symptom) -- ibuprofen taken during night of 1/18/21 and at ~9:30pm on 1/19/21 Headache at approximately 2:00pm on 1/18/21, was relieved using ibuprofen Nausea (very mild) while sleeping on the night of 1/18/21 and morning of 1/19/21 Sore arm from evening of 1/18/21 until evening 1/19/21
I am an officer. The day I received the first shot I had a hard crash of fatigue. Not a big deal, but it didn't stop. Since day 1 I've had fatigue that won't go away, shortness of breath, and absolutely terrible circulation to all four limbs. My legs have gone completely numb on more than one occasion and both hands/feet appear blue.   I've had tingling (similar to what your arm feels like if you hook your arm over a chair while sitting and put the chair's back right into your armpit) in both arms from the shoulders down to the fingertips, but mainly below the elbows. Sleeping on my side has proven difficult due to the sensation of no circulation. My legs have the exact same thing.   I am cold all the time----and I've never had this problem my entire life.
Patient was given an adult dose of COVID vaccine (gray top, do not dilute), instead of the pediatric dose for 5-11 year olds that he should have gotten.
Large localized injection site reaction, measuring 7.5 x 8.5 inches 24 hours post injection.
Two days after receiving the vaccine I woke with a large bruise on my right arm 4"x3" across with a flesh colored center. There were two rings of color, one dark blue and an outer ring which started out as light blue and turned very dark red. I have a picture but nowhere to upload it. I had done nothing the day prior but sleep as I was exhausted from the vaccine. When I awoke there was this scary looking bruise like nothing I've ever seen.