chrisvoncsefalvay/vaers-outcomes huggingface dataset:
9:40 am; person reported this person having problems after vaccination of  the Moderna Covid-19 vaccine.  Experiencing difficulty swallowing; "feels like a lump in my throat", headache.  Proceeded to her vehicle and assessed, she reports having a little difficulty swallowing and felt a little funny, alert and oriented.  BP 120/60, R 12 P62, continued to monitor - BP rechecked at 9:44 am 132/90, R 12 P 66.  Pt. complained of itching around face and neck, 9:45 am EMS/911 contacted and Pt. given Benadryl 50 mg/ml 1cc IM to Rt. Deltoid.  Pt. developed redness to face/chest and continued to complain of itching.  9:49 am EMS on scene and report given.  PT. was able to walk to back of ambulance and enter for further evaluation and treatment as needed.
Nine to ten days after MMR injection developed a rash on lower abdomen and then progressed to chest and back also.  Not very itchy.  Treated with Claritin 10 mg daily for seven days with one refill available
crying started immediately p/vax; cried continously-seen by MD 7JAN94 & 10JAN93 dx BOM; 11JAN94 tx DPH; 17JAN94 still crying, vomiting, not eating; 26JAN94 hosp w/acute bronchitis;
Patient had sore arm, redness around injection site, and body aches/chills. Also developed body wide rash that is responding to steroids
I was experiencing left ear pain. I called the nurse line, and she suggested I go in to make sure I didn't have an ear infection on top of COVID-19. It was not an ear infection. The doctor prescribed Paxlovid. I didn't pick the Paxlovid up until December 19, 2022. The cough, sore throat, fever and chills at night, headache, and sinus pressure has persisted for five days at least.
Red, swollen, hot to touch. Benadryl given total of three times since onset.  Ice pack applied.
Patient experienced hypertension 30 minutes after vaccination. vaccine was administered at 10:37am, at 11:10am she reported feeling badly and her heart felt like it was beating hard. checked her blood pressure 1st reading was 198/123 HR66, a minute later I rechecked and it was 187/99 HR61. rechecked at 11:19AM 168/99 HR 59, continued monitoring patient, checked at 11:30 147/88 HR 57, checked at 11:41AM 153/86 HR 59., rechecked at 11:46 149/82 HR61. she said she was feeling better after last check and went to do her shopping in the store.
BODY ACHES; CHILLS; MASSIVE HEADACHE LIKE HEAD WAS GOING TO EXPLODE; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, non alcoholic, and non smoker, and other pre-existing medical conditions included patient had no drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 09-JUN-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On 09-JUN-2021, the subject experienced body aches. On 09-JUN-2021, the subject experienced chills. On 09-JUN-2021, the subject experienced massive headache like head was going to explode. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body aches, massive headache like head was going to explode, and chills. This report was non-serious.
About five-ten minutes after the injection, tinnitus began ( both ears)... Immediately, I notified the nurse overseeing the vaccination event, Then next day, I notified my primary. The tinnitus started to subside a little after about two weeks, but still there as of 1/19/2021. I have my second dose tomorrow...
3/26 slight tenderness at injection site by 9PM.   3/27 7 AM Fatigue, general malaise., headache begins. 12:00 noon fever of 100.1 F, chills, headache, Slept off and on all day. 9PM still 100.1F fever . Took 1 Acetaminophen tablet for headache. Woke at6AM with no symptoms.
Itchiness across back and chest, no rash, did change laundry soap a couple of weeks ago.
Chills, shivering, fever, paleness in hands and face, vomiting, intense headache, faintness. Felt chills and fever for 1.5 hours, stood up, vomited. Vomited again 2 hours later. Intense headache overnight.
Afew days after receiving shot shoulder starting hurting a little bit.swelling at stick site.By Friday severe pain in should. Sunday morning went to urgent care.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 at 12:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 56 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Recent emergency appendectomy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Neomycin, reaction(s): "known allergies: Neomycin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2023) Positive; (01Feb2023) Faint positive, notes: with mild symptoms; (02Feb2023) Strong positive, notes: with full symptoms. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 24Jan2023 to 28Jan2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2, BNT162B2 OMI BA.4-5 cannot be excluded. The case will be reassessed once new information is available.
Initial and follow up information has been received, via the Merck pregnancy registry, from a registered nurse, concerning a 26 year old female patient with chronic hypertension, who on 24-JAN-2007 was vaccinated with the first dose of GARDASIL (Lot # not provided), and on 04-APR-2007 was vaccinated with the second dose of GARDASIL (Lot #656051/0244U).  Concomitant therapy included ALDOMET and prenatal vitamins (manufacturer unspecified).  The patient later found out she was pregnant, with the date of the LMP on 14-APR-2007, and an estimated date of delivery on 19-JAN-2008.  The nurse confirmed that the pregnancy was normal to date.  On an unspecified date, the patient delivered at 39 weeks a healthy and normal male.  The patient had spontaneous rupture of membranes and ultimately had a cesarean section.  The patient's cesarean section was secondary to fetal macrosomia and chronic hypertension.  The baby weighed 10lbs 1.6oz.  There were no complications for the baby and mother postoperatively.  The baby was discharged home along with the patient.  Upon internal review, fetal macrosomia and chronic hypertension were considered other important medical events.  Additional information is not expected.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions or allergies and medical history provided.  On 22-DEC-2016, the patient was vaccinated with an expired dose of VARIVAX injection, lot # K026385, expiration date 15-DEC-2016 (dose and route of administration were not reported). No adverse effects were reported. No product quality complaint was involved. Additional information is not expected because there was no consent to contact the reporter.
Patient had deep pain in her left arm described as growing pains with numbness and tingling in her left arm to her left hand. Pain and numbness lasted about 3 days and then subsided. It was hard to move her arm due to symptoms.
p/vax pt devel hives; itching over arms; neck; tx z-pack; itching better; hives resolved spontaneously
Information has been received from a doctor of pharmacy concerning a 14 year old female patient who on 29-SEP-2010 was vaccinated a dose of GARDASIL (Lot # and route not reported). The pharmacist reported that on 30-SEP-2010 the patient's mother took her to the emergency room for blurred vision. At the time of the report, the patient outcome was not reported. No further information is available.
Swollen and red hands; Swollen and red hands; Late for the second dose; This spontaneous case was reported by a nurse and describes the occurrence of PERIPHERAL SWELLING (Swollen and red hands), ERYTHEMA (Swollen and red hands) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Late for the second dose) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Swollen and red hands), ERYTHEMA (Swollen and red hands) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Late for the second dose). At the time of the report, PERIPHERAL SWELLING (Swollen and red hands) and ERYTHEMA (Swollen and red hands) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Late for the second dose) had resolved. 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.   No concomitant medications reported. No treatment information provided.
1/12 PATIENT RECEIVED VACCINATION 1:30PM IN RT UPPER ARM AND REPORTED 1 HOUR LATER THAT 10 MINUTES AFTER RECEIVING VACCINATION, SHE HAD TINGLING IN RIGHT HAND AND PAIN IN RIGHT ARM BETWEEN SHOULDER AND ELBOW.  1/13 AT 1:00 SPOKE WITH PATIENT ON PHONE.  REPORTS PAIN AND TINGLING SUBSIDED AT ABOUT 9:00 PM 1/12 AND THEN SHE NOTED HIVE-LIKE SPLOTCHES ON FACE AND BODY.  TOOK BENADRYL AND THEY ARE GOING AWAY.  AWAITING RETURN PHONE CALL FROM HER MD.
Headache - 10 hours after receiving lasted a couple hours subsided with ibuprofen Fever- highest 101.3 on 1/9/2021- had fever/chills from 1/8/2021-1/9/2021- subsided with ibuprofen but would come back up after several hours. Nausea- started 1/8/2021 through 1/10/2021 Vomiting- started 1/8/2021 through 1/10/2021- not able to keep any foods/ drinks down with the exception of water. Tried BRAT foods and still vomited within 10-15 mins of eating.
Vaginal Bleeding; This is a spontaneous report from a contactable other HCP (patient) reported herself that a 45-years-old non-pregnant female patient received first dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, lot number: FA6780), via an unknown route of administration in left arm on 18Jul2021 at 16:45 (at the age of 45-years-old) as single for COVID-19 immunisation. Facility type vaccine was other. No other vaccine in four weeks prior to the COVID vaccine. The patient's medical history included IBS (Irritable bowel syndrome), cervical polyp and Gastriris; all were from an unknown date and unknown if ongoing. Concomitant medication was not reported. No other medications in two weeks of vaccination. The patient previously took Reglan and experienced allergy. On 20Jul2021 at 18:45, the patient experienced vaginal bleeding. No COVID prior vaccination. No COVID tested post vaccination. No treatment received for event. The outcome of the event was not recovered.  Follow up (26Jul2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation below mentioned query.   Follow up (27Jul2021): This follow-up report contains no new safety information.  Follow-Up (16Aug2021): Follow-up attempts are completed. No further information is expected.
Huge red area, lasting at least 3 days and getting bigger, fever, chills, joint pain worse than usual, terrible fatigue.
Within minutes of recieving vaccine, child developed a hive like reaction around the site of the injection.  No anaphylactic symptoms. Childs chest was clear and she experienced no difficukty breathing.
This spontaneous report as received from a office manager refers to an unspecified number of patients of unknown demographics. The patient's medical history and concurrent conditions were unspecified. On an unspecified date in 2016 (reported as since May 2016), the patients were vaccinated with improperly stored VARIVAX (strength, lot#, dose#, dose, route and anatomical location unspecified). No adverse effect was reported. Product quality complaint (PQC) involved. No further information was available. Additional information has been requested.
Extremely nauseous, vomiting, pain at injection site, neck, shoulder, and back. No energy, severe headaches.
Information has been received from a physician concerning a 60 year old female with stomach virus, allergy to Levaquin and drug hypersensitivity to codeine who on 10-OCT-2007 was vaccinated with a dose of Zostavax (Oka/Merck) (invalid lot# 0761409). There was no concomitant medication. In October 2007, the physician reported that "after receiving Zostavax (Oka/Merck) the patient had severe motor weakness of all extremities, but with no sensory loss, onset reported as 26-Oct-2007. The patient then saw a neurologist then admitted the patient immediately to the hospital. At the hospital the patient was diagnosed with Guillain-Barre Syndrome and was hospitalized for 6 days. Unspecified medical attention was sought. No product quality complaint. The physician reported that the patient is recovering and is going through physical therapy" Guillain-Barre Syndrome was considered serious due to hospitalization, immediately life-threatening and disabling. Upon internal review, Guillain-Barre Syndrome was also considered an Other Important Medical Event. Additional information has been requested.  11/19/07-records received for DOS 10/30-11/4/07-DC DX: Guillain-Barre syndrome. Benign essential hypertension, severe cerebromicrovascular disease, headache and low grade fever related to intravenous gamma globulin (presumed).  Presented with several day history of pure ascending paralysis approximately two weeks after they vacationed in which she had a multitude of mosquito bites. Treated with IV gamma globulin.
Post vax, the pt was sad and had a fever at home. The mother states it went up to 104. The pt was given Motrin, however, fevers persisted all day and the mother brought the pt to the ER where pt was dx with otitis media and given amoxicillin. The pt went to sleep without any events. On 7/23/00, the pt continued to have fevers and began vomiting two to three times. The mother also noted two episodes of watery diarrhea. The pt was taken to the ER and was evaluated and found to be dehydrated. The pt was admitted to hospital and began seizing. The pt was intubated and had a gastrostomy tube placed. The pt was dx with acute disseminated encephalomyelitis and anemia.
2 other patients received Moderna Bivalent vaccine past it's beyond use date.; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2 other patients received Moderna Bivalent vaccine past it's beyond use date.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 044H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (2 other patients received Moderna Bivalent vaccine past it's beyond use date.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2 other patients received Moderna Bivalent vaccine past it's beyond use date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (2 other patients received Moderna Bivalent vaccine past it's beyond use date.).    Concomitant medication was not provided.   Treatment information was not provided.  This case contains information for the first out of 2 patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-712104, US-MODERNATX, INC.-MOD-2023-712526 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 22-Feb-2023: Follow-up information received includes patient details, vaccine details (lot number) and new event (expired vaccine used) were added. Report type from invalid to spontaneous, and I-narrative supplement were updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712104:Same reporter(Monovalent Dose) US-MODERNATX, INC.-MOD-2023-712526:Patient 2
Influenza vaccination given on 10/27/15. On 10/29/15 the pt. presents with tenderness, redness, and swelling at vaccination site, well demarcated, 35 x 60 mm.
Transferred from facility by EMS on 1/19 with worsening cough, congestion and shortness of breath after COVID + on 1/8. O2 sats in 80s and hemodynamically unstable. Started levophed. Given amiodarone, metoprolol and diltiazem for a fib. Placed on BIPAP . Respiratory panel resulted + for rhinovirus/enterovirus, RSV and Covid 19.  CT showed no embolism but concern for pneumonia. Intubated with noted respiratory distress. Started on zyvox, zosyn, and doxycycline for sepsis. Extubated on 1/23. Reintubated on 1/28 due to encephalopathy and increased O2 requirements. Blood cultures no growth. Continued with increasing O2 requirements and persistnet hypotension requiring vasopressors. Daughter arrived from out of state and met with critical care and pallative care. Decided to transition to comfort care and extubated with pressors turned off.
Chills, fever, joint pain, headache, dizzy, unable to get myself out of bed, extremely hot, paralyed from the waist down, no control over legs.
cc: itching all over, swollen lip, intense crying and very upset causing emesis. Exam: erythema, rash entire body, swollen lips, chest clear. No obvious stridor. Treatment: Orapred 2tsp given in office; Benadryl 1 tsp every 6-8hrs at home.
Hospice patient with multiple comorbidities. Within hours of injection became lethargic and unresponsive, she remained in this state for 3 days.
I started with sneezing and congestion. It progressed to a really bad headache and a cough a few days later. I tested positive for COVID 19 via a home test. I had an appointment with the local clinic, and they prescribed PAXLOVID. My symptoms improved and I had a negative test on October 18. I felt pretty good by then I still had congestion. Then I started to feel sick again on October 21st. I was sneezing a lot and had a super stuffy nose. I tested positive again on October 24, 2022. I took DAYQUIL since my symptoms were so mild. I have since completely recovered and had a negative test on the 28th. I feel good now.
About 7 days after receiving Moderna Booster dosage og .25mg, notice extreme itching, welps and hives on torso, legs and bilateral arms starting around 6:00 pm.
Patient fainted in hallway after vaccination while waiting for physical form to be copied. Patient seemed fine when receiving vaccination and after vaccine was administered.
MODERATE TO SEVERE  SHOULDER PAIN WHEN SHE MOVES SHOULDER SINCE RECEIVED FLU SHOT. SHE HAS NOT SEEKED ANY MEDICAL TREATMENT
The Pfizer covid vaccine was given in the afternoon and immediately after the vaccine, he had tingling and numb feeling on right arm and leg. The next day he had pain in his heart. The pain increased to a severe level and he felt like his heart was being constricted. He continued to have severe pain in my his heart, back and should and continued to feel numb and tingling all over arms and legs. He was very afraid he was having a heart attack, so we called 911 and they came and did an EKG, which had a normal result. He decided to still go into ER, where they did blood work, chest X-ray and another EKG, all tests came back with normal results, so he went home. That night, he was up the entire night with severe pain in his heart and pain all over his body, but the pain was concentrated in his heart and chest. He said he thought he was dying. He could not think clearly and could hardly walk or function, so early the next morning, I took him back to the ER and they admitted him to the hospital. He stayed overnight in the hospital and they repeated all the previous tests and did an EEG as well because he felt like he could not think clearly and felt something was neurologically wrong, it was hard for him to explain. He was also having frequent panic attacks because of the trauma of the heart pain and not knowing what was wrong. I am reporting this a week after the event and at this time he still has tingling/numbness and a small amount of pain, but it is much less than at onset.
Patient had her vaccine on 2/11/2021. Felt fine the rest of that day and did not notice any issues. She got up around 3:00 AM on 2/12/2021 to go to the bathroom and stated she felt dizzy. She had difficulty finding the bathroom. She returned to bed and got up around 7:30 AM. Noted that she had on feeling on her left side, including arm and foot/leg. On 2/13/2021 her daughter stated she was informed of this and notified a pharmacy and asked if this could just be side effects of the vaccine and was told it probably was. Daughter stated she was no better by Monday, 2/15/2021, and she called patient's physician Dr. who informed them to take patient to the emergency room. Daughter stated that a CT Scan was done and they were informed by ER physician that the CT showed a "recent" stroke. States they wanted to keep patient in hospital, but patient's brother had just passed the previous day from COVID19 complications so the patient chose to go home. She did have a follow up MRI that also showed the stroke. She has appointment to see a neurologist and is doing physical therapy three times per week. Stated weakness has improved somewhat.
PUI stated that symptoms started on 07/18/2021 With slight fever loss of taste and smell, sore throat, Cough, fatigue nausea Symptoms resolved by 08/04/2021 PUI Was admitted to hospital from 8/1/2021 to 8/4/2021 PUI was in ICU the entire stay and he was on mechanical ventilation, but he was never intubated. Patient is fully vaccinated and has tested positive.
I developed severe pain and limited range of motion of my left arm several hours after the vaccine was given. I was seen by primary care provider a week or so after the injection and was referred to Orthopedics for evaluation of a possible shoulder injury possibly due to the vaccine being injected  too high along the arm. I was evaluated Dr at Hospital where an MRI was ordered and completed on 8/8/19.  I was then seen for follow-up and given a cortisone injection into the left shoulder on 8/13/19.
Pt came in with a 3inch in diamter inflamed site with slight welping. Pt also stated the site was slightly itchy and grew in size since sat 11/12/16 till today 11/14/16. (injection was administered 11/8/16). pt was recommended to use an ice pack, liquid benadryl, and APAP/NSAID.