chrisvoncsefalvay/vaers-outcomes huggingface dataset:
8 hours after does I started vomiting for 14 hours.  Injection site from should to elbow, hot, red, swollen.  Now site problems gone but very swollen axillary left lymph nod.
No Symptoms reported. No further AE details.; Medical Assistant transferred from Specialist. HCP reports that a 2-week-old infant was given a dose of ROTATEQ. HCP reports that the dose was administered today 9/1/2023.; This spontaneous report has been received from a medical assistant, regarding a 2-weeks-old patient of unknown gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 01-SEP-2023, the patient was vaccinated with the first dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) oral liquid, at a dose of 2 milliliters once as prophylaxis (lot number: X008011, which was determined to be valid, with an expiration date on 25-SEP-2024) (strength and route of administration were not reported) (Product administered to patient of inappropriate age).  No additional adverse event was reported.
INJECTION SITE SORENESS, SWELLING, INFLAMMATION IMPROVED BUT SPREAD DOWN THE ARM.
A physician reported that a 28 yr old female received an injection of Flu Shield on 12/26/2000. On 12/28/2000. she developed  numbness in her left leg and treated with and pins and needles in her left foot. She was seen by the physician and treated with prednisone. She was later seen by a neurologist after her symptoms persisted and treated with more prednisone. She then developed tremors in both legs and received tx with Carbamazepine. Additional info received form the physician on 04/30/2001 indicated that her sx have slowly resolved. MRI imaging of her brain and spine were normal. Additional information have slow received on 04/03/2001 her sx have slowly resolved, but she only has numbness 0f the upper back.
Fever 100.5; diarrhea; Nausea; severe pain; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8730) via an unspecified route of administration in the right arm on 25Mar2021 at 13:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history includes neuropathy, chronic pain, Ehlers Danlos syndrome and postural orthostatic tachycardia syndrome (POTS). The patient had a history of allergy to Zanaflex and clindamycin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Mar2021, the patient had experienced fever of 100.5 (unspecified units), nausea, diarrhoea and severe pain. Adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events fever 100.5, nausea, diarrhoea and severe pain was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
PATIENT REPORTED BRUISING AT INJECTION SITE FOLLOWED BY BRUISING GOING DOWN ARM
pt recv vax & w/in 15min p/vax lip felt fat, numb & tingling like p/had novocaine;it lasted for approx 15min;also reported sore arm @ site for approx 24hr & fever (didn't take temp) the next AM tx w/APAP;
extreme body aches, shivering, chills but it was the body and joint pain that was unbearable. lasted about 10 hours then I felt normal
Low grade fever on/off Fatigue Sore arm Length of time was 2 days
The patient received fluad at the age of 57 when it is not recommended.  No signs/symptoms at that moment.
Approximately 30 minutes after injection I developed a sunburn type reaction (similar to red man syndrome), it lasted 5 hours and dissipated after.  Also developed right ear pain and jaw pain, which is still present.  At the same time my right side of my face was numb which lasted a couple days.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 19-NOV-2014, the patient was vaccinated with a dose of M-M-R II, 0.5 ml, once, subcutaneously that was expired on 08-NOV-2014 (lot number was not reported). No adverse events were reported. Additional information has been requested.
Exaggerated muscle pain after physical activity.  This first happened 12 days after the first injection, and has continued to this day.  Muscles are sore in general even without much physical activity. (I.e not necessarily in response to heavy exercise).  This is not something that I normally experience, nor have I experienced before.  Ibuprofen can help.
10/18/2000 Next morning post shot pts joints painful, hands swelled, hot and red. Suffered until11-27. Visited Rhuematologist got arthritis medication. Quickly pain subsided and swelling, redness relieved after 2 days could walk and work again without pain.
Patient was given first dose of Pfizer COVID vaccine and had no immediate pain on injection. She stated she developed increased pain in her right shoulder joint and was unable to sleep the night of the injection on 12/22/20. She stated the pain continued to increase and was unable to sleep on that shoulder. She was seen by her primary care provider on 1/8/21 for continued pain and decreased range of motion in her R shoulder, she is unable to raise it above shoulder height. She continues to have pain and decreased range of motion despite rest and ibuprofen.
Soreness at the injection site; Sore muscle; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness at the injection site) and MYALGIA (Sore muscle) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE PAIN (Soreness at the injection site) and MYALGIA (Sore muscle). On 22-Jan-2021, VACCINATION SITE PAIN (Soreness at the injection site) and MYALGIA (Sore muscle) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Second dose was taken by the patient on 23-Feb-2021.  No concomitant medications was reported.  No treatment drug details was reported.  patient didn't report any adverse reaction to the shots. There was only mild sorness in her left arm at the injection site that went away after a couple of days. No other side effects were noted. she will now waiting to qualify for the booster.   This case was linked to MOD-2021-355997 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Oct-2021: Follow up received on 21-Oct-2021 contains no new information.
I received the first shot on Feb 21st and only had the sore arm side effect. About two weeks later I had the worst period of my life. Threw up three days in a row and only felt that way in the morning, by the evening I was better. I then received the second shot this past Monday, March 21st and woke up the next day with the same reaction. Throwing up, nausea, light headed, major migraine, extremely weak, couldn't hold anything down. It has me worried I will feel this way again when my next period arrives.
Pt very difficult to console for 2 days following vax. Pt was seen by physician and used Motrin instead of Tylenol which alleviated symptoms. Did not have fever and was able to sleep through the night.
Pt was given PREVNAR on 5-23-16. Mother called office on 5-24-16 c/o redness and swelling at site of injection. Advised to give MOTRIN, apply cool compress. Mother called 5-25-16, increased redness. OV scheduled.
Severe induration/edema with erythema of left thigh covering about 7x5cm.
Localized pain at injection site without evidence of muscle atrophy. Possible SIRVA (R) deltoid.
rash following Shingrix shot; This case was reported by a consumer and described the occurrence of rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had rash. The reporter looking for information on rash following Shingrix shot.
He was found deceased in his home by Sheriff and paramedics evening of  2/21/21.
Information has been received from a billing clerk who work in the office concerning a 16 year old female with no drug allergies, who was vaccinated with a series of GARDASIL. The last dose was given about one and a half years ago. "3 months ago" (on approximately 14-FEB-2010) the patient had been losing hair. It was unknown if the patient sought medical attention. At the time of the reporting, the patient had not recovered. This is one of several reports received from the same source. Additional information has been requested.
16cm x 16cm hard raised red, hot area (L) deltoid region encompassing site of hep A and MENACTRA-that were given more than an inch apart, developed within 24hrs of immunization, rapidly changing in size and in hr-red w/in 24 hours.
Never went back for the second dose; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received in 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 28-MAR-2022 Reporter's Comment: The patient's daughter/son reported this case via interactive digital media. The patient never went back for the 2nd dose of Shingles vaccine. Additional supportive information:  Till the time of reporting, the patient did not receive the 2nd dose of Shingles vaccine, which led to incomplete course of vaccination. The follow-up would not possible, as no contact details were available.
Headache, Myalgia, chills, fatigue, left arm soreness at injection site Narrative:  Other Relevant History:
No other AEs; a temperature excursion on ROTATEQ that was administered; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, drug reactions, allergies and concomitant medications.   On 22-APR-2021, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 time dose, route defaulted to oral, lot # T033812, has been confirmed to be a valid lot #, expiration date 29-DEC-2021) (exact dose, route of administration and anatomical location were not provided), for prophylaxis. Administered dose of vaccine experienced temperature excursion of 48.2 degrees Fahrenheit (above 47 degrees Fahrenheit) for 2 hours. There was no adverse event reported. Data logger was not involved. There were no previous excursions reported.  This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-2104USA007514:
Went into A fib less than 48 hours after vaccination. Occurred approximately 7:15 am while getting dressed for work.  Transported to ER. Underwent a series of tests.  Returned to normal heart rhythm approximately 9:45 am on its own.
Felt like I had the flu for a few days. Fever, chills, body aches, exhaustion, weakness. Did not fully recover and kept feeling sick. Missed about a month of work because I had ?mono?-like symptoms and barely had enough energy to walk or take a shower. My legs felt extremely heavy and I felt like I was moving in slow motion. I had a tingling/pins and needles sensation in the back of my arms. White spots had developed in the back of my throat and my tonsils felt swollen. Then tested positive for Epstein Barr Virus (never previously diagnosed), and my doctor would not follow up with me and was not interested in discussing the fact that I never felt better after the second dose of Moderna. I still have exhaustion and joint pain, especially in my lower back.  My energy levels have been consistently low and it?s harder to do simple things I used to love such as daily yoga. The mind fog has not gone away either.
At 01:30, 1/7/21, I developed Extreme chills, then body became hot but temperature was normal, At around 02:30, my whole body ached with a sharp pain just above my right wrist and a sharp pain at the ball of my right foot.  It's 07:05 right now and still have body aches, pain in right foot and right wrist.
This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. In approximately 2016 (since 08-FEB-2016), the patients were vaccinated with improperly stored doses of M-M-R II lot # L020189, expiration date 03-JUN-2017; lot # L026551, expiration date 16-JUL-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccine experienced the temperature excursion of 9 degrees Celsius for 9 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Follow up has been received on 14-SEP-2016, reporting the administered vaccine doses that have experienced multiple temperature excursions. It was reported that the patients were vaccinated with M-M-R II (lot # L020189, expiration date:03-JUN-2017) on 23-FEB-2016, 25-FEB-2016, 08-MAR-2016, 17-MAR-2016 and 18-MAR-2016. The longest duration of temperature excursion with M-M-R II was 18 hours at the range of temperature excursion was between 0.4  to 1. 8 Celsius degrees. The temperature excursions were detected by a data logger. Additional information has been requested. General, product, event information and narrative were updated.
Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium
right eye swelling; right side face sensitivity; right side scalp sensitivity; right side throat soreness/throat soreness; right ear soreness/ear and throat soreness; This case was reported by a physician via call center representative and described the occurrence of sore throat in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st June 2020, the patient received the 1st dose of Shingrix (intramuscular). On 31st August 2020, 91 days after receiving Shingrix, the patient experienced sore throat and ear pain. On 8th September 2020, the patient experienced eye swelling, hyperesthesia and scalp tenderness. The patient was treated with antibiotics nos (Antibiotic (Details Unknown)), ambiguous medication nos (Cortisone (Nos)) and antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the sore throat and ear pain were recovered/resolved and the outcome of the eye swelling, hyperesthesia and scalp tenderness were not recovered/not resolved.   It was unknown if the reporter considered the sore throat, ear pain, eye swelling, hyperesthesia and scalp tenderness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix in right arm. After receiving Shingrix, the patient experienced right ear soreness and right sided throat soreness. On 04th September 2020, the patient was seen by ENT specialist examined ear and throat and all presented as normal. The patient also developed right eye swelling, right side face sensitivity and right-side scalp sensitivity, which were reported as ongoing at the time of the reporting. The reporter consented to follow up.
Toughness/tightness of skin, red and giving off heat. Soreness, size of mango
unhealthy symptoms,crummy; malaise / crummy; fatigue / felt tired; weak; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (malaise / crummy), FATIGUE (fatigue / felt tired), ASTHENIA (weak) and ILLNESS (unhealthy symptoms,crummy) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     Concomitant products included CELECOXIB (CELEXA [CELECOXIB]), DEXMETHYLPHENIDATE HCL and BUPROPION HCL for an unknown indication.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, the patient experienced MALAISE (malaise / crummy), FATIGUE (fatigue / felt tired) and ASTHENIA (weak). On an unknown date, the patient experienced ILLNESS (unhealthy symptoms,crummy). At the time of the report, ASTHENIA (weak) outcome was unknown. Not Provided      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.
Nightmares, head aches, Central/obstructive sleep apnea, hypertension, Systemic Lupus Erythematosus, nervousness, etc.
patient complained of severe redness, irritation, arm swelling and itching requiring doxycycline and Medrol dose pack
Moderna COVID-19 Vaccine EUA Nausea, pain at injection site, fatigue
Vaccines were administered at 11 year wcc (Tdap and Menveo given in left arm) on 7/23/19. Mom states she noticed the injection site on her left arm was "a little yellow looking" the following morning (7/24/19). By that afternoon (on 7/24/19), the area was reddened and warm to the touch. The area of redness was approx. 3 inches in diameter. Pt seen on 7/25/19 in the office at 1115. The area of redness was lighter than it was on 7/24, but still 3 inches in diameter and a little sore. Denies any other symptoms beyond the local reaction on her left arm.
10/29/2010 Patient presented at flu clinic today, reported experiencing fever of 10 degrees F, swelling of tongue and difficulty of breathing on the evening of 10/08/2010. She had received flu vaccination earlier that day on 10/08/2010. The patient did not seek medical attention on 10/08/2010 for above symptoms.
DEATH; This spontaneous report received from a consumer via a company representative via media concerned a 25 year old female of an unspecified race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry date: unknown) dose not reported, 1 total administered on an unspecified date for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, in less than 3 days after first vaccination, the patient died from unknown cause of death. An autopsy was performed on an unspecified date. It was reported that "The first Covid shot to my female partner of 25 yrs, she was gone in less than 3 days. Of course her autopsy read differently. They didn't want any responsibility". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20220940058-covid-19 vaccine ad26.cov2.s-Death. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Information has been received from a registered nurse referring to an unknown number of patients. On unspecified dates the patients were vaccinated with doses of RECOMBIVAX HB (dose and route not reported) that had been improperly stored. No adverse effects reported. This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not wish to be contacted.
About 4 months after the vaccine I got a raging case of shingles that lasted about 2 months. Since then my chronic fatigue has gotten much worse. Then I got a rare condition called Persistent Genital Arousal Disorder which is basically female priapism and is EXTREMELY uncomfortable and debilitating. I went to a urogynecologist and was diagnosed with this along with pelvic floor dysfunction,  vaginal atrophy, and some other condition: vaginismus I think but not certain on that last one. I am in PT for all those issues. As for the chronic fatigue, I have no idea how to get back to where I was pre-vaccine. This vaccine seems to be destroying whatever was left of my immune system.
felt a tinge of pain in my sacral area/It got worse each hour/ It worsen daily/It became painful; Became limited in movements such trying to picking up items from the floor; difficulty running or walking fast as I usually do; Lots of spasms in the sacral area; Difficulty sleeping; Difficulty sleeping and going from sitting to standing; This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiry date: unknown), via an unspecified route of administration in the left arm, on 09Jan2021 15:30, at single dose, for COVID-19 immunization, at the pharmacy. There was no medical history and no known allergies. Concomitant medication included acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN), diphenhydramine hydrochloride (BENADRYL), herbal nos, minerals nos, nutrients nos, vitamins nos (CATALYST) and "Muscle Strength". The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The patient did not have other vaccines in four weeks. The patient reported that on 12Jan2021 at 14:00, "I ardently felt a tinge of pain in my sacral area. Then it got worse each hour. Then I became limited in movements such trying to picking up items from the floor and difficulty running or walking fast as I usually do. It worsened daily. I would workout and then I experienced lots of spasms in the sacral area. It became painful. The patient experienced difficulty sleeping and going from sitting to standing." The events resulted to "Doctor or other healthcare professional office/clinic visit". Treatment for the events included prescription muscle relaxants (unspecified), ibuprofen and "topi". The patient was recovering from the events.
shingles; This is a spontaneous report from a contactable other health care professional (patient). A 71-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EL9262), via an unspecified route of administration on 30Jan2021; 9.30, on right arm, at single dose for covid-19 immunisation. The patient's medical history included ME (myalgic encephalomyelitis) and CFS (Chronic fatigue syndrome). Concomitant medication included Levoxyl and Restasis. On 15Feb2021; 20.00, patient experienced on day 16 after the first dose developed what patient thought were hives. Today, after patient second dose, it was diagnosed on telehealth as shingles. The outcome of the event was recovering.