chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After receiving vaccines, pt and her grandmother walked to the check-out area. At 11:18 AM, pt was witnessed "eyes rolled back in head" and fell to the floor striking the back of head on the floor. Pt regained consciousness immediately and vital signs were WNL.
Initial report received on 13 May 2013 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a three-year-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject's medical history was not reported. The subject had received four doses of PENTACEL: dose one of PENTACEL, lot number C3305AA received on 23 June 2009; dose two of PENTACEL, lot number C3431AA, received on 01 September 2009; dose three of PENTACEL lot number C3497AA received on 22 October 2009; and dose four of PENTACEL, lot number C3670AA, received on 06 August 2010 (routes and sites of administration not reported). The subject developed cold-like symptoms on 20 April 2013, approximately two years and eight months after the last dose. On 20 April 2013, the subject developed a cough and paroxysmal cough on same date, 20 April 2013, with a whoop. The subject also experienced sleep disturbance. Laboratory testing included positive PCR on 08 May 2013. Chest x-ray findings were negative. Corrective treatments consisted of Azithromycin starting on 08 May 2013 for five days. The subject was not hospitalized. At the time of final contact on 09 May 2013, the subject's cough was still persisting. The duration of the cough was reported as 19 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. The subject's outcome was not recovered. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
I have been noticing ringing in my ears which has become much worse in the past month or so along with migraine type headaches. Tylenol does not help.
Information has been received from a certified medical assistant (C.M.A.) concerning a 15 year old female patient with asthma. There were no drug allergies/reactions. On 09-SEP-2015, the patient was vaccinated with the first dose of GARDASIL 9 (lot #, expiration date, dose and route not reported) in her arm to prevent VAQTA (lot #, expiration date, dose and route not reported) in the opposite arm. Concomitant therapies included ondansetron, albuterol sulfate (manufacturer unknown), PROZAC, chlorpheniramine maleate, ibuprofen, ADVIL ALLERGY SINUS, WELLBUTRIN XL, ABILIFY, hydroxyzine and melatonin. On 09-SEP-2015, the patient developed blurred vision and a sharp headache in the office. The patient was instructed to lie down for "a few" minutes and she then appeared "to be fine". No lab diagnostics studies were performed. The outcome of vision blurred and headache was resolved on the same day. Additional information has been requested.
Itchy Arm; Sore Arm; Red Arm  (injection Site); This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy Arm), PAIN IN EXTREMITY (Sore Arm) and VACCINATION SITE ERYTHEMA (Red Arm  (injection Site)) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced PRURITUS (Itchy Arm), PAIN IN EXTREMITY (Sore Arm) and VACCINATION SITE ERYTHEMA (Red Arm  (injection Site)). At the time of the report, PRURITUS (Itchy Arm), PAIN IN EXTREMITY (Sore Arm) and VACCINATION SITE ERYTHEMA (Red Arm  (injection Site)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
3" x 4" diameter hard area, oozing exudate, top part of skin came off; also had h/a; devel sore lymph nodes & pain under & on inside of arm; seen by MD in ER who prescribed Cipro;  itchy indurated erythematous lesion on lt deltoid area;
lower body extremity aches; headaches; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Apr-2021 and was forwarded to Moderna on 09-Apr-2021.    This spontaneous case was reported by an other and describes the occurrence of ? in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.   Reporter did not allow further contact
Had the vaccine, got shingles/Suspected vaccination failure; shingles breakthrough; pain; still have the pain (3 weeks now and it's awful); This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a 73-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included death of son (Family History) (patient's 52 year old son died in patient's arms in December 2021). Concurrent medical conditions included stress (had stress of that trauma of son's death).   On an unknown date, the patient received Shingles vaccine. In January 2022, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and feels awful. On an unknown date, the outcome of the vaccination failure, shingles and feels awful were unknown and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain and feels awful to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this report. The age at vaccination was not reported. The patient got Shingles vaccine years ago from reporting date and got shingles. The patient still had pain 3 weeks now and it was awful, and he still recommend the shot. The patient was sure that the stress of that trauma of son's death caused the breakthrough. The follow-up could not be possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding the completion of primary vaccination schedule, time to onset and laboratory test confirmation for shingles were unknown at the time of reporting.
Information has been received from a health professional concerning an 8 year old female who on 30-JAN-2008 was vaccinated IM with a first dose of GARDASIL (lot#656050/0245U). There was no concomitant medication. The patient had her period in January but did not get it in February and March. The office did a pregnancy test before administering the second dose and it was negative. The office went ahead and administered the second dose of GARDASIL (lot# 659655/1486U) on 31-Mar-2008. No medical attention was sought. The office did not follow up on the patient yet to see if her menstrual cycle was back to normal. The patient's outcome is unknown. No product quality complaint was involved. Additional information has been requested.
Noticed of redness swelling hive-like area around 5 a.m. this morning. That area has grown in size over the day. It is warm to the touch. It does not see him in the last couple of hours that it is getting any larger. When I noticed it this morning it was also tender to the touch that remains but it has been tender since I got my injection on Wednesday. The tenderness has progressed in size as with the hive- like swelling. It's now about the size of a a small orange. Prior to this morning or late last night did not know this any redness or swelling . The previous tenderness to touch was approximately about the size of a quarter with a small bruise.
Tingle; This is a spontaneous report from a contactable consumer. A 50-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EN5318) via an unspecified route of administration on left arm on 02Feb2021 at 03:00PM as single dose (Age at Vaccination: 50 years) for COVID-19 immunization. The patient medical history included drug allergy, food allergy and allergies to other products: insect bites: kissing bug and nickel. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. There was no covid prior vaccination and had no covid tested post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. 02Feb2021 03:00 PM, the patient experienced within about a minute bottom lip of the patient started to tingle and lasted for about 15 minutes. The patient inquired is tingling an allergic reaction. No treatment was received. The outcome of the event was resolved.  No follow-up attempts are needed. No further information is expected.
severe diff breathing, constriction of chest;lasted approx 24hr & sx decreased when antihistamine was taken;
pt recv vax 19AUG96 & w/in min p/vax pt arm hurt down into elbow, & wrists, hands & fingers tingled;1hr later exp pain into neck & back;
20 yo male presents to clinic for rash onset for about 3 days. Patient states he received the smallpox vaccine on 30 Aug for overseas orders and was told to keep a bandage over it for 7 days. Patient states he did that and the rash just grew 5 times the original size. He admits it itches and painful. Describes it as red and irritated. Admits its having yellowish clear purulent drainage from the area. He admits he's been having body aches, chills, hot sweats, minor cough, minor headache, diarrhea, and feels an onset of a cold. Denies any fever, blood in bowel/urine.
pt recvd vax;tired,sleepy; 4 hrs later awoke w/ chest congestion & fever 102;dph,apap given;still congested;cont apap;to MD;was given amoxicillin;mom called HD on 17jan to report pt still home w/ bronchitis;
Rash - unilateral - left scapular rgn extending down left arm to left hand. Hives - no vesicles.
pt reported dizzyness 30-40 minutes after vaccine.  Then recalled she hadn't drank anything in at least 4 hours. Lung sounds CBTA BP @2:30pm was 132/82.  HR:88 Pulse Ox: 98% Pt drank a full bottle of water (16oz) @2:35pm and felt "back to normal" by 2:45 left site @3:08pm
This spontaneous prospective pregnancy report was received from a doctor of pharmacy refers to a 27-year-old female patient. Current conditions included asthma and allergic reactions to penicillin, diphenhydramine and ketorolac. On 12-DEC-2012 the patient was vaccinated with PNEUMOVAX23 (lot #, expiration date and route not reported). Concomitant medications included albuterol, COMBIVENT, loratadine, SINGLULAIR, ondansetron and vitamins (unspecified) (reported as pre-natal vitamins). Patient's last menstrual period (LMP) was 12-SEP-2012 and an estimated date of deliver (EDD) of 19-JUN-13. Initial exposure to PNEUMOVAX23 was at 13 week(s). The patient was exposed to PNEUMOVAX23 during trimester 1. No adverse symptoms reports. Reporter mentioned that the patient was using an illicit drug "meth" on 03-OCT-2012. Additional information has been requested.
No additional AE's; temperature excursion that occurred on VARlVAX.  that underwent temperature excursions was administered.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information regarding the patient's concurrent conditions, pertinent medical history, concomitant therapies and drug and/or allergies reactions was not provided.   On 16-JUL-2021, the patient was inadvertently administered with improperly stored  varicella virus vaccine live (oka/merck)(VARIVAX)  (strength, dose, vaccination scheme, route and anatomical location of administration were not provided, with lot number S038698 verified as valid and upon internal review expiration date established as 01-DEC-2021) for prophylaxis. varicella virus vaccine live (oka/merck) (VARIVAX) was improperly stored at a temperature of 15.6 degrees Fahrenheit of a recommended range from minus 58 degrees Fahrenheit to 5 degrees Fahrenheit for a time frame 32 minutes. Another temperature excursion was called at a temperature of 8.4 degrees Fahrenheit for a time frame of 9 minutes. It was reported previous temperature excursion of 15.6 degrees Fahrenheit, and this was called because of a data logger. No additional adverse event was reported   This is one of two reports received from the same reporter.
Administered PENTACEL instead of Menveo with no reported adverse event; Initial information received from on 18-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves Child male patient who was administered pentacel instead of menveo with no reported adverse event while receiving vaccines MENVEO and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) and DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) for Prophylactic vaccination.  On 18-Oct-2022, the patient received 0.5 mL total dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (formulation and strength not reported; lot UJ594ABA) via intramuscular route in the deltoid nos instead of MENVEO not produced by Sanofi Pasteur, for prophylactic vaccination.  On 18-Oct-2022, (latency: same day) the patient was administered pentacel instead of menveo with no reported adverse event (wrong product administered).  Action taken was not applicable with both the suspects.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Mom say woke fr nap 5AM same day was very irrtable; difficult to put to sleep; woke @ 2Am crying, restless rest of noc, t104 R, myoclonic jerk while sleeping, staring episode 2-3min w/o stiffenly; seen by MD PE nl;
Fall down stairs, +EtOH, catastrophic brain injury, death. Though her death seems to be clearly caused by direct head trauma, the cause of her fall may be multifactorial including weakness from recent vaccination in combination with EtOH.
chills 12noon 11/05;fever 101 11/05 evening;fever 101.6 11/06;abd cramping, diarrhea 10/06;no fever p/11/06;11/10 still sl diarrhea;
with arthritis, that next day after shot, no swelling, tightness or pain.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "with arthritis, that next day after shot, no swelling, tightness or pain. ".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021437461 Same reporter, suspect drug and event; different patient
Severe shortness of breath and has been progressively worse/walked outside to take the trash out, about 50feet from the door and was huffing and puffing; The fatigue is really bad; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (Severe shortness of breath and has been progressively worse/walked outside to take the trash out, about 50feet from the door and was huffing and puffing) and FATIGUE (The fatigue is really bad) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 010M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021 at 2:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jan-2021, the patient experienced DYSPNOEA (Severe shortness of breath and has been progressively worse/walked outside to take the trash out, about 50feet from the door and was huffing and puffing) and FATIGUE (The fatigue is really bad). At the time of the report, DYSPNOEA (Severe shortness of breath and has been progressively worse/walked outside to take the trash out, about 50feet from the door and was huffing and puffing) and FATIGUE (The fatigue is really bad) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       patient has undergone countless blood test, x-rays, pulmonary function test, cardiac catherization test. patient used cpap machine and it still doesn't help.  Concomitant medications were not provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Event outcome is updated
Severe cold symptoms beginning 2 days post vaccine, runny nose, cough, shortness of breath leading to ER visit on 12/28, covid test results still pending as of time of this submission
pt recv vax 14APR98 in lt quad about 12-24hr p/lt quad became red & erythematous;a hard welt that was tender to palpation & fever >102;
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX injection (lot# L037561, expiry date 29-SEP-2017; dose and route of administration were not reported). There were no concomitant therapies reported. The reporter stated that the vaccines were exposed to a temperature of 7.5 degrees Fahrenheit for a total period of 14 hours (date unspecified). There was no previous temperature excursion or product quality complaint involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
3 wks post vax pt devel generalized rash x 7 days; Fever of 104 for 3-4 days & red eyes x 7 days; 2 wks prior to onset of rash & fever pt had cough & nasal disch; Mom states pt sibling devel measles 2 wks p/pt immun w/MMR;
7/19/12 - cramps on side of neck going down towards trapezoid muscle. Pt. didn't consult with MD & started feeling better. Approximately 2 days when follow up made on 7/20/12.
Information has been received from a company representative who reported that a female patient (age unknown) developed shingles within one month after she received ZOSTAVAX (dates, dose not reported). No further information was provided. Additional information has been requested.
Limited range of motion in left shoulder. Shoulder pain the same day as the shot. Pain and range of motion got worse as time went on. Saw nurse practitioner two weeks following flu vaccine. Ice three times a day, 2 aleve in morning, 2 aleve at night.  Sent to orthopedic doctor. X-ray was taken Cortisone shot was administered. Some relief in pain two days after shot, four days after shot pain is slowly coming back.
Broke out in shingles; Red arm; Swollen arm; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number 7GM34, expiry date 9th October 2022) for prophylaxis.   On 9th October 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 10th October 2021, 1 days after receiving Shingrix and an unknown time after starting Valtrex, the patient experienced erythema of extremities and swelling arm. On 14th October 2021, the patient experienced shingles. The patient was treated with valaciclovir hydrochloride (Valtrex) and gabapentin. On 12th October 2021, the outcome of the erythema of extremities and swelling arm were recovered/resolved. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix. The reporter considered the erythema of extremities and swelling arm to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received dose of Shingrix vaccine and experienced red and swollen arm and she broke out in shingles. The events red and swollen arm lasted for about 2 days and then resolved. The reporter saw her health care professional yesterday from the date of reporting and was now taking Valtrex and Gabapentin. The reporter declined to provide health care professional information. The reporter did not consent to follow-up.
Second dose given too early.  1st dose 3/18/21 2nd dose 3/26/21
Mild itchy rash developed on the face and chest; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Mild itchy rash developed on the face and chest) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A.) for COVID-19 vaccination.     The patient's past medical history included Asthma. Concomitant products included SALBUTAMOL SULFATE (PROAIR [SALBUTAMOL SULFATE]) for Asthma.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced RASH PRURITIC (Mild itchy rash developed on the face and chest). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itchy rash, at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (Mild itchy rash developed on the face and chest) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.