chrisvoncsefalvay/vaers-outcomes huggingface dataset:
7/9/21 9:33am- Spasms and tightening in throat on and off 30 minutes resolved after 30 minutes 7/9/21 9:40am- Feeling of fullness or tightening of nose and lip felt swollen, pain in teeth, resolved after after 5 hours not treatment 7/9/21 9:30pm- felt cold took temperature on two different thermometers it was 95.5 took two and a half hours to warm up. Did hot tea and heat as well as layers. Took 24 hours to get back up to 98.0 resolved 7/10/21- 10am- Body aches severe in places I have never had body pain before, NOT RESOLVED YET 7/10/21- 10am- Fatigue and feel like I cannot get up after laying down or kneeling NOT RESOLVED 7/11/21 am- Bruising easily from simple pressure NOT RESOLVED 7/11/21 7:30pm- Pain in left side of stomach felt like a nerve pain and radiated out lasted 5 minutes then resolved.  7/12/21 4pm- Dr. visit regarding suede effects 7/16/21 4pm- Migraine and pain in my head on both left and right side also trigeminal nerve pain. Lasted 10 days. Blood work was done as well as a CT scan of brain. Blood work showed very high WBC count, Hemocrit, and CRT three times normal levels. CT scan was clear.  7/19/21- Doctor visit primary care regarding migraine and sever pain in body 7/26/21- CT scan of brain 8/4/21- Doctor visit primary care regarding lasting side effects 8/5/21- Allergist visit regarding side effects 8/10/21 - Rheumatologist visit regarding pain 8/16/21- Dr. visit regarding side effects and pain...told I cannot get the flu sot until inflammation markers in my blood decrease.  8/17/21- Noticing bulging varicose veins on my legs that are painful and were either not bulging or not there before. NOT RESOVLED 8/21/21- Still have pain, fatigue, and bruising including little purple dose that look like bruises. My life functioning has severely decreased as a result of the vaccine.
Was sick; Immune system was terrrible; Kept getting virus; Kept getting colds; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: Was sick), immune system disorder (Verbatim: Immune system was terrrible), viral infection (Verbatim: Kept getting virus) and cold (Verbatim: Kept getting colds). The outcome of the sickness, immune system disorder, viral infection and cold were resolved (duration 3 months).   It was unknown if the reporter considered the sickness, immune system disorder, viral infection and cold to be related to Shingles vaccine.     It was unknown if the company considered the sickness, immune system disorder, viral infection and cold to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 18-MAR-2023 This case was reported by a patient via interactive digital media. The patient got the first shot her immune system was terrible. The patient was sick for almost 3 month she kept getting virus and colds. The patient still have to get the second shot but she have to be healthy.  The patient not sure she  want to get it.  The patient got the shot because her husband got shingles and he had Cancer too. The follow-up could not be possible as no contact details were available.
blood clot in superior mesenteric vein found with Abd CT scan placed on lovenox then xarelto with relief of sxs - abd pain
Muscle ache, tiredness, no appetite, pt says he feels "feverish" no temp taking though, began about 2 days after vaccinations and is still persisting as of today.
pt recvd vax & w/in 24hrs p/dose 3 pt exp fever, chills, & diarrhea;
Information has been received from a nurse concerning a 76 or 77 year old female patient who in Mary 2008, was vaccinated with ZOSTAVAX (Oka/Merck), lot number was not reported. Concomitant therapy included lovastatin (manufacturer unknown), vitamins (unspecified) and "PANOLA". In December 2008, the patient experienced shingles. The patient sought unspecified medical attention. Her outcome is unknown. Follow up call information received on 12-FEB-2009. The physician reported that as of 12-FEB-2009 the patient's skin lesions completely healed and he wouldn't be able to send a sample. The patient was seen in the office the same day for follow-up and she was having pain in the left thoracic area, where she had the skin lesions. The patient reported that about 2 weeks ago she also developed another little crop of blisters under her left arm on the same side as the initial outbreak, but in a different dermatome. This area also healed and the patient had no remaining scabs. The physician indicated that he would report again if the patient develops another episode of herpes zoster in order to process a sample through the Varicella Zoster Virus Identification Program. Additional information has been requested.
This spontaneous report as received via a company representative from a 68 year old female patient refers to herself. Two weeks ago, on 29-MAY-2013 the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not provided). The patient stopped the company representative to show her a rash that had appeared on her leg a week ago, on 05-JUN-2013. The patient had not yet contacted her primary physician who prescribed the ZOSTAVAX or the pharmacy where she received the vaccine. She stated she would ask the physician for whom she works to take a look to determine if it was in fact a rash or bug bites. She would contact her primary physician as well as the pharmacy (no specified timeframe was given). At the time of the report the patient had not recovered. The causal relationship was not provided. Additional information has been requested.
Heart attack on 04Apr2021, two weeks after second dose of vaccine; This is a spontaneous report received from a contactable consumer (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EW0162), via unspecified route of administration in left arm on 13Apr2021 (at the age of 58-year-old) as 2nd dose, single for COVID-19 immunization. The patient was not pregnant. Facility where the most recent COVID-19 vaccine was administered was school or student health clinic. The patient's medical history included allergies, migraine, high blood pressure (HBP) and high cholesterol, all from unspecified date. The patient was not diagnosed with COVID-19 prior vaccination. The patient's concomitant medications received within 2 weeks of vaccination included aspirin, atorvastatin, cetirizine, lisinopril and met (as reported), all from unspecified date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EW6207), via unspecified route of administration in left arm on 22Mar2021 (at the age of 57-year-old) for COVID-19 immunization, and she had also received sulfamethoxazole/trimethoprim (BACTRIM), hydrochlorothiazide, both reported as known allergies. The patient experienced heart attack on 26Apr2021 22:45, two weeks after second dose of vaccine. The event resulted in emergency room/department or urgent care visit and it was reported as serious with life-threating criteria. Treatments received for the event included angioplasty and stent placement. The patient was tested for COVID post vaccination on 26Apr2021 with test type reported as blood test and negative result. The outcome of the event was resolved with sequel (reported as recovered with lasting effect).
Itchy around eyes, behind the knees, abdomen, and arms. Patient received vaccine in April and symptoms began right after. Patient indicates maybe itchy eyes previous to getting vaccine. MD was contacted and appt. has been made.
Following a demonstration of Hep-A vaccine, pt stood upright arching back in chair. Body went into tonic clonic posturing with incontinence of urine. Episode lasting 10 seconds. Recovery 1-2 minutes. Rescue squad called. Pt referred to ER.
Patient passed out within 5 minutes of getting the vaccine. Administered ammonia inhalants to stimulate consciousness. Gave juice, water and snacks. Patient was able to stand up and leave 45 minutes after vaccine administration.
Since 9/99, the first symptoms were rash on hands, numbness up back and in to neck, chronic fatigue, light-headedness, severe migraines, joint pain, tingling in lower arms and hands. Initial reaction was a huge red area at injection site with light rash which lasted for weeks afterwards. Can't take direct sunlight, dizziness, "panic attacks" with sore chest muscles afterwards, vomiting, chills. Pt is still having symptoms as of 9/1/00.
Pt recvd vax JUN92 & devel burning sensation upon inject as well as soreness & or an aching sensation in arm; heaviness in the arm;
Pfizer COVID19 vaccine administered for dose 2 after Moderna COVID19 vaccine administered for dose 1.
14 days p/vax pt devel chickenpox w/greater than 75 vesicular lesions on & around mouth, trunk, arms, legs.
Fatigue, beginning about 2 hours after shot, Seems to have gone away by next morning.
Severe chills, with fever. Lasted about 4 hours and broke with sweating.
1 I had fever till 99.8F so I took tylenol twice. it lasted about 6 hours the second day. 2 I had rash on my neck. 3 i had sore muscle for over 48 hours since i took the vaccine. 4 arm pain for over 72 hours. 5 tired for over 5 days after the vaccine. 6 vagina blood a little bit 2 weeks later 7 the next period late for 5 days 8 most important. i went to antibody test 33 days after the vaccine and it showed all negative.
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Chills-Mild, Additional Details: tightness started 30 minutes after reaction--pt received epi 3 minutes after reaction. Tightness gradually emerged, pt felt very cool. Sx subside after epipen given. Pulse read 98 bpm, pt has anxiety and started to feel anxious. Called 911--paramedic accessed. After assessment recommend to transport through ambulance but patient refused.
15-20min post incetion developed chills and high fever 105.3.  Resolved after 12 hours, pt states felt fine afterwards....Per review of records seasonal shot given at 0945am, patient seen by PCP at 10am (no complaints of above in PCP progress notes.  No active signs of infection.  Hep C liver enzymes mild elevated at visit 01/21/2010 08:59  PLASMA     SGOT(AST)             110 H  U/L         17 -  59 01/21/2010 08:59  PLASMA     SGPT(ALT)             113 H  U/L         21 -  72 ) and upon discharge was given H1N1 at 10:30.
The patient received GARDASIL 9 on an unspecified date of 2019 did not receive the 2nd and 3rd doses.; No additional adverse event reported; This spontaneous report was received from a pharmacist and refers to a currently 20-year-old male patient. The patient's concurrent conditions, drug reaction or allergies, pertinent medical history and concomitant therapies were not reported.      On unknown date in 2019, the patient was vaccinated with a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (quantity dose, lot #, expiration date and route were not reported). The patient did not receive second and third doses. The pharmacist asked if the patient need to begin the series or would the next doses be considered the second and third doses (inappropriate schedule of product administration). No additional adverse events and nor product quality complain were reported.
Skull/head (Left side) - Lesions, scabs, intermittent excruciating, lightning-like pains. Any type of touch would trigger the pain. Pain in left side of face and lt side of neck. Sore, enlarge lymph nodes left neck and under jaw bone. Intense itching, burning. Upper left side of chest sensitive to touch and clothing. Left side of throat sore.
Information has been received from a physician concerning a male (age not reported) who was vaccinated with a dose of PNEUMOVAX 23 (lot # not reported).  Subsequently, within a 5 year time limit, the patient developed a benign rash on his hand.  The patient's status was not reported.  There was no product quality complaint.  Additional information has been requested.
Hallucination and paranoia that lasted for about one hour and then went away on its own. Has never had these feelings occur before or since.  Did not seek medical care.
pt recvd vax; c/o induration at rt deltoid,50mm;not tender; denies pain;6dec94 induration gone; pt denies complications;
Left upper arm became swollen, red, hot and tender to touch, Cold compress T2D, Keflex T2D x 10D.
No adverse effects reported; Multiple patients were vaccinated with improperly stored ROTATEQ on multiple dates; Information has been received from a medical assistant concerning a patient of unknown age, gender and race. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 12-JUN-2019, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally for prophylaxis (lot number R029815 with expiration date in 18-JUN-2020) (strength and anatomical location were not provided).  The Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was stored at an unknown temperature for an unknown time frame. There was a previous temperature excursion and the call was because of a data logger.  No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA001848: US-009507513-1907USA001849: US-009507513-1906USA011434: US-009507513-1907USA001793: US-009507513-1907USA001794: US-009507513-1907USA001795: US-009507513-1907USA001796: US-009507513-1907USA001797: US-009507513-1907USA001798: US-009507513-1907USA001799: US-009507513-1907USA001800: US-009507513-1907USA001801: US-009507513-1907USA001802: US-009507513-1907USA001803: US-009507513-1907USA001804: US-009507513-1907USA001805: US-009507513-1907USA001806: US-009507513-1907USA001807: US-009507513-1907USA001808: US-009507513-1907USA001809: US-009507513-1907USA001810: US-009507513-1907USA001811: US-009507513-1907USA001812: US-009507513-1907USA001813: US-009507513-1907USA001814: US-009507513-1907USA001815: US-009507513-1907USA001816: US-009507513-1907USA001817: US-009507513-1907USA001818: US-009507513-1907USA001819: US-009507513-1907USA001820: US-009507513-1907USA001821: US-009507513-1907USA001822: US-009507513-1907USA001823: US-009507513-1907USA001824: US-009507513-1907USA001825: US-009507513-1907USA001826: US-009507513-1907USA001827: US-009507513-1907USA001828: US-009507513-1907USA001829: US-009507513-1907USA001830: US-009507513-1907USA001831: US-009507513-1907USA001832: US-009507513-1907USA001833: US-009507513-1907USA001834: US-009507513-1907USA001835: US-009507513-1907USA001836: US-009507513-1907USA001837: US-009507513-1907USA001838: US-009507513-1907USA001839: US-009507513-1907USA001840: US-009507513-1907USA001841: US-009507513-1907USA001842: US-009507513-1907USA001843: US-009507513-1907USA001844: US-009507513-1907USA001845: US-009507513-1907USA001846: US-009507513-1907USA000952: US-009507513-1907USA000989: US-009507513-1907USA000962: US-009507513-1907USA000988: US-009507513-1907USA000963: US-009507513-1907USA000953: US-009507513-1907USA000959: US-009507513-1907USA000968: US-009507513-1907USA000967: US-009507513-1907USA000964: US-009507513-1907USA000966: US-009507513-1907USA000954: US-009507513-1907USA000969: US-009507513-1907USA000970: US-009507513-1907USA000965:
Head felt like it was on fire. Shivering , but not cold. Tremendous headache. Throwing up, huge lump on my neck painful. Hard time lifting my left arm. Body aches. Started 730 p.m.4/5-4pm 4/7
My sugar level used to be between 100 to 129 before the shot. after taking covid 19 vaccine when i got my blood test it came around 266.; This is a spontaneous report received from a contactable consumer (patient). A 48-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration administered in left arm on 29Mar2021 13:30 (Batch/Lot Number: EP7534) (age at vaccination: 48 years old) as single dose for COVID-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had previously received the first dose of  BNT162b2 on 10Mar2021 07:30 (Batch/Lot Number: EN6206) for COVID-19 immunisation. Concomitant medication(s) included budesonide, formoterol fumarate (SYMBICORT) taken for an unspecified indication, start and stop date were not reported. The patient's sugar level used to be between 100 to 129 before the shot. After taking the COVID-19 vaccine, he got blood test it came around 266, on 04May2021 07:45. No treatment was received for the event. The event resulted in doctor or other healthcare professional office/clinic visit. The outcome of the event was unknown.
Covid vaccine, Moderna, given in right deltoid. Immediate swelling and redness at site of injection. Benadryl 25 mg. given by mouth with no further swelling, no signs of anaphylaxis. Monitored patient x 30 minutes whereupon patient states feeling
Rash - appeared within 5 minutes of vaccine face and neck. No wheezing. Resolved in 25 minutes with PO Benadryl (given immediately after onset of rash).
A MCAS flare that was manageable for the first 5 days and then unbareable for the next 10 days.  Ear ache. Low grade fever. Exhaustion. Nasal drip. Sore throat. Respiratory steaming.  Elevated heart rate. Diaphragm pain. Brain fog.
This pt experienced his first seizure (after a 17 year seizure-free period) following administration of vax. A flu-like syndrome appeared after the seizure episode. He has not regained his previous level of functioning, with paranoid ideation response to internally generated stimuli, disorganized speech, which has continued although abated with anti-psychotic treatment. No previous history of hallucinations or paranoid thinking.  Follow up received 06/05/00, indicates that the pt is still suffering from auditory hallucinations and cognitive disorganization.
paralysis; rapid heartbeat; heart palpitations; cold sweats; chills; muscle pain; in arm; nausea; difficulty breathing; This is a spontaneous report from a Contactable Consumer (patient). An 88-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER2613), first dose via an unspecified route of administration, administered in Arm Left on 05Apr2021 (at 88 years old) for covid-19 immunisation. Medical history included breast cancer. She had breast cancer surgery on that side previously. She had chills on and off before the Covid vaccine also. Says it started after her Pneumonia and Flu shots that she believes were in Nov2020; possibly 12Nov2020. Concomitant medications included spironolactone  and other unspecified medicines. She had them go over her medications to see if any of them would interact with the vaccine. They said that all of her medications were okay. On Apr2021, patient experienced heart palpitations, paralysis, cold sweats, chills, muscle pain, in arm, nausea and difficulty breathing about three weeks after the vaccine. She noticed that it mentioned concerns if you experience a rapid heartbeat. States she did, and is wondering about getting her second vaccine. Her rapid heartbeat became so bad this past Tuesday night she thought she was having a stroke. It came over her and she could not move. She went to an urgent care center. They did a Covid 19 Test and it was negative on Apr2021. Also states she has been having lots of chills. The outcome of the events Heartbeats increased, palpitations, Chills was not recovered, other events was unknown.
I had mild headaches, worse than the first. I had neck and back pain. I also had chills. I took Advil and Tylenol. I let things run it?s course. It had resolved within 24 hours.
Injection site was hard; redness at the injection site; pain at injection site; Headache; Malaise; This case was reported by a consumer via call center representative and described the occurrence of injection site induration in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th January 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced injection site induration, injection site redness, injection site pain, headache and malaise. On an unknown date, the outcome of the injection site induration, injection site redness, injection site pain, headache and malaise were recovered/resolved.   It was unknown if the reporter considered the injection site induration, injection site redness, injection site pain, headache and malaise to be related to Shingrix.     Linked case(s) involving the same patient:  US2022046162  Additional details were provided as follows: The patient self-reported this case. The patient received 1st dose of Shingrix vaccine and she noticed the injection site was hard, redness at the injection site, pain at injection site, headache and malaise. The patient was referred to HCP (health care professional) and provided medical advice disclaimer. Offered PI (package insert). The reporter consented to follow-up and permission to contact health care professional. This case was linked to US2022046162 for same patient second dose.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022046162:Same patient, 2nd dose
Patient was administered 0.5ml of expired Ipol with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from Physician via Agency (Reference number- 00563648) and transmitted to Sanofi on 15-Apr-2021.  This case involves a 12 years old female patient who experienced was administered with an expired 0.5ml dose of IPV (VERO) [IPOL] (lot R1B251M and expiration date: 13-Mar-2021) via intramuscular route in the left deltoid (expired product administered) for prophylactic vaccination on 15-Apr-2021.  Medical history, medical treatments, past vaccinations and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE), HEPATITIS B VACCINE (HEPATITIS B VACCINE) and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation.  It was an actual medication error case due to expired vaccine used (latency: same day).   The reporter wanted to know if it needs to be re-administered or does she need to watch out for anything.   At the time of reporting, the patient experienced no specific adverse 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.
Information has been received from a medical assistant concerning a female patient who on 05-OCT-2000 was vaccinated with a dose of MERUVAX II (route and lot no. not reported). The patient was diagnosed with possible Guillain Barre Syndrome after receiving the vaccine. The date of onset of symptoms was unknown. The patient's outcome was not reported. It was unknown if the patient sought medical attention. Upon internal review Guillain Barre Syndrome was considered to be an other important medical event. Follow-up information has been received from a physician who reported that the patient did not have side effects but questioned the possibility or likelihood with this vaccine ZOSTAVAX (Merck). No further information is available.