chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; Vaccine brand: Moderna, Vaccine dose number: 4; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 as dose 5 (booster), single (Lot number: GH9693) at the age of 59 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 01Apr2022 as dose 4 (booster), single (Lot number: 066K21A), in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EN5318), in right arm, on 20Feb2021 as dose 2, single (Lot number: EN6198), in left arm and on 24Sep2021 as dose 3 (booster), single (Lot number: EW0191), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); " Irritable bowel syndrome" (unspecified if ongoing), notes: IBS; "anxiety" (unspecified if ongoing). Concomitant medication(s) included: BUPROPION HCL, start date: Jan2012; OMEPRAZOLE, start date: Jan2012; LIPITOR, start date: Jan2016; NATROL, start date: Jan2018; CENTRUM WOMEN, start date: Jan2016; D3, start date: Jan2012; SUPER B COMPL, start date: Jan2012. Past drug history included: Phenergan, reaction(s): "Known allergies: Phenergan". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 01Apr2022, outcome "unknown", described as "Vaccine brand: Moderna, Vaccine dose number: 4"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Feb2023) Negative, notes: Negative test 20Feb in a.m; (21Feb2023) Positive, notes: Positive test. Therapeutic measures were taken as a result of vaccination failure, COVID-19: the patient received Paxlovid from 13Feb2023 to 17Feb2023 for COVID-19 treatment.
Started in the morning with chest pain and tightness. Uncomfortable to sit up straight or stand or lay down. Went to the emergency room and they did ECG, Echocardiogram and blood work. Blood work revealed high troponin levels the highest reaching 2.9 ng/ml. Stayed overnight to monitor my condition. The hospital reached out to a cardiologist who diagnosed me with Pericarditis
Seizure occured. Never had a seizure before. Hospitalized . Started on Lamictal. Neurologist felt seizure was direct relation to Covid Vaccine
Initial physician report received on 03 Dec 2010: This patient with an unknown medical history was vaccinated with MENVEO (batch number: unknown) on 24 Aug 2010 which was stored for about 2 months at 30 F. No adverse event was reported following this incorrect storage.
1/15/2023 I had a cough and it persisted for three days. I tested positive for COVID with an at home COVID test on 1/15/23. On 1/16/23 I called my primary care physician who prescribed Paxlovid. I took the Paxlovid for the five days. The symptoms disappeared and I felt better, and all is well.  I continued to test positive for COVID for two or three weeks.  I never tested negative for COVID.
Info has been received from an RN concerning a 2 year old female who on 3/26/04, was vaccinated with a dose of varicella virus vaccine live. The nurse reported that on 3/29/05, the pt experienced a case of breakthrough varicella, with about 50 lesions and a low-grade fever. The pt was not treated at the time of the report. Unspecified medical attention was sought. No product quality complaint was involved. Additional info has been requested.
Approximately 10 mins after receiving vaccine he complained of pain in the back of his neck going up the back of his head and feeling short of breath. He was placed on vs monitor and cardiac monitor. He was in SR, BP 140/82, HR 66, O2sat 100%. At 16:25pm he started having dry heaves, vs 136/81, 74, R 19, O2 sat 100%. Code Green was called to transport to Emergency Department. 16:35pm 155/90, 88, R 24, O2 sat 100%. He vomited x1, complained of feeling lightheaded. 16:43pm He was transported to ED by Code Green team.
Persistent deltoid pain despite AROM, ice and regular work including manual labor, also redness at injection site.
Onset of temperature low grade, after shots. Seizure 4 minutes with apnea, requiring 1 day hospitalization; after ER visit.
cough, shortness of breath.  Patient is a 70 year old male with PMH of HLD, CLL diagnosed in 2015 in remission for 5 years and Covid 19 diagnosed on 2/12/22. At the time patient had c/o loss of appetite, dry cough, congestion, and lack of energy. Patient receive monoclonal antibodies on 2/14/22. Patient reports that he has had the same continued symptoms since his diagnosis. Patient is vaccinated with Moderna, 2nd shot June 2021. Today his daughter, who is a nurse, told him "it is time to be checked out". Patient denies nausea, vomiting, diarrhea, and chest pain.   In the ED, Na 126, Cl 92, GFR 60, anion gap 19, trop <0.03, PT 14/inr 1.29. DDimer 407. K, AST, and total protein hemolyzed. Rapid flu and Covid negative. CXR shows shows bilateral infiltrates, (-)effusion, (-)pneumothorax, (-)cardiomegaly. CTA of the chest shows diffuse bilateral infiltrates, no evidence of pulmonary embolism. EKG shows SR @84bpm, Nonspecific ST-T wave changes, no STEMI. Patient received Zithromax and Rocephin
This spontaneous report was received from a nurse who referred to an unspecified patient of unknown demographics. The patient's pertinent medical history, concomitant therapies and drug reactions or allergies were not reported. On 18-MAY-2017, the patient was administered an expired dose of PNEUMOVAX 23 (lot# L031459 and expiration date: 30-APR-2017; dose, route of administration and anatomical location were not reported) as prophylaxis. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Shingles now, had 2 shots/suspected vaccination failure; Shingles; Worse pain ever; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and COVID-19 VACCINE (COVID VACCINE) for prophylaxis.   The patient's past medical history included chickenpox (had chickenpox as a child).   On an unknown date, the patient received the 2nd dose of Shingles vaccine, the 1st dose of Shingles vaccine and COVID VACCINE. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Shingles now, had 2 shots/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and pain (Verbatim: Worse pain ever). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved and the outcome of the pain was resolved (duration 2 months).   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.   It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 17-MAR-2023 This case was reported by a patient via interactive digital media. The patient had the two shingles shots. The patient was suffering with shingles now. The patient had a lot of other painful problems but this was the worse pain ever and he/she was not young.  The patient had for two months.  The reporter stated that wonder if the Covid shots caused this. The reporter considered the adverse event to be related to Covid vaccine. The reporter further stated that an evil. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
vaccine was mixed after the 2 hour window from when pullout out of refrigeration. (it was mixed at 3 hours after removed).  Per Pfizer excursion data, product still good as a valid dose. (excursion data: can be mixed up to 8 hours after removed from refrigeration).
Vaccine was administered on 6/8/11. On 6/9/11, the patient noticed pain and redness at the injection site. Patient presented today 6/10/11, with c/o worsening redness, pain, itching and swelling at the site 6.5 x 9 cm area of erythema and induration is present over (L) upper arm. Positive increased warmth & tenderness to touch. Rx for KEFLEX 500mg 1 po qid x 7dy, Naproxen 550mg 1 po BID prn & BENADRYL 25mg 1-2 po q6h given.
DIZZYNESS, METALIC TASTE IN MOUTH, NAUSEA, SYMPTOMS IMPROVED AFTER 30 MNUTES.
Patient vaccinated 2/21/21.  That evening patient had myalgia and chills, and noticed swelling of the R testicle.   US performed:   acute R testicular epididymo-orchitis.  Symptoms resolved without treatment.
After 24 hours, (R) arm swollen, red, warm from shoulder -> elbow.
Pt on apnea monitor- pt recvd vax & eyebrow was edematous; resolved by 8PM, no fever, alert, eating well, no edema;
June 17-swelling of hands and arms, pain, tingling, burning sensations in arms and legs.  Dizziness and fatigue.
I woke up at 2 AM on 10/23/2021 with severe vertigo; the room was spinning and I could not move my head without a feeling of dizziness and nausea.  Any time I attempted to move I felt as if I was going to either throw up or pass out.  After sitting on the bathroom floor for an hour I moved to sitting at the kitchen table with my head on the table.  I stayed there for the next several hours, covered in a blanket.  The sense of severe vertigo passed by 6 AM or so and I returned to bed.  I still had mild vertigo for about a week and this was then followed by mild ringing in my right ear which progressed to moderate ringing in both ears.  The bilateral tinnitus continues to this day.
The same day arm was heavy and hurt, next day fever up to 100.9, chills/sweats, fatigue, body aches, little bit of tight chest
Five days post vax, the pt developed an injection site reaction characterized by pain, swelling, blisters, and redness extending to the elbow.
Chills and achiness and intense pain in armpit (armpit on the same side as the vaccinations). Chills and achiness lasted a few hours, went to sleep, when I awoke, they were gone. Pain in armpit less intense in morning, but still painful.
3-4 hours after receiving vaccination, I developed swollen throat and congestion in sinuses. Later that night swollen throat developed into a sore throat and sinuses continued to be congested. I've next 3-4 days cold symptoms progressed with lethargy but seem to dissipate after day 4. Soon after cold symptoms disappeared, I developed bloodshot eyes specifically in the inner corners of my eyes - this lasted 3-4 days and was not helped by Visine allergy eye drops. After my eyes cleared up, I developed a tension-like headache with stiffness in my neck - the pain was exacerbated whenever I lifted my head up from laying down or bent over. This headache lasted 3-4 days with little relief after taking ibuprofen. During the last few days of the headache, I developed hard, raised red bumps on my face, neck, chest, shoulders, scalp, legs, and back. They were not clustered and developed blister-like heads 1 day after appearing along with an urge to itch. Total, I probably had 40-50 blisters. Additionally, at the onset of the blisters, I developed an enlarged, swollen lymph node located behind my right ear. I made an appt to get checked out ASAP and was seen by a nurse practitioner who diagnosed me with a mild case of chickenpox. The blisters began to form scabs 4-5 days after appearing and have begun to clear up - no new blisters have formed. I am not pregnant nor do I have an immunodeficiency disease to my knowledge.
Post vax, on 09/16/2001 the patient's temp was 103F and he had a seizure. The patient was treated at the ER for Otitis Media. On 09/27 the patient had another febrile seizure. The mother feels this is due to the MMR vax. Mother advised if any further problems go the the ER.
Extreme soreness in left arm extending into the chest and back. Continued as of 3/13/2021
Patient was feeling light headed, shaky and started to sweat. She then fainted and was caught by myself.  We immediately called 911 , her blood pressure was taken and it was within normal limits. She did not have any difficulty breathing, swelling of the tongue or other side effects that were showing signs of anaphylaxis. Patient received water and started to feel cooler and less shaky. Once the paramedics arrived, she was assessed and was monitored for at least 25 minutes by myself and the paramedics. Patient was not disoriented and was given the OK to go home by the paramedics. Patients husband was contacted to come and drive her home.
About 2 weeks after getting the ZOSTAVAX vaccine, the patient got shingles. The patient was prescribed some Mupirocin ointment.
Severe nausea without vomiting; severe diarrhea 2-4 times a day; This is a spontaneous report from a contactable consumer, the patient. A 19-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: unknown) via an unspecified route of administration in the  left arm on 07Apr2021 (at the age of 19-years-old) as a, single dose for COVID-19 immunisation. Medical history was and concomitant medication were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021, the patient experienced severe nausea without vomiting and severe diarrhea 2-4 times a day. The events were impacting on the patient's functioning. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of severe nausea without vomiting and severe diarrhea 2-4 times a day were not recovered.  No follow-up attempts are needed; information about lot number cannot be obtained.
The onset was within two days, the patient presented with an expanding redness on left deltoid. The primary care provider had marked it on Tuesday and by Wednesday it had expanded to twice the size. There were no other symptoms reported.
at bedtime p/vax pt had 15-20 polka dots like rash on back & shoulders; 2 spots are raised c/white heads; no T; no complaints; sl itching
Client called today stated that she has continued to have pain in the arm she received the vaccination in.  Stated that it is difficult to lift her arm to put on her shirt and it feels weaker. No other adverse reactions to immunization, called regarding persistant pain-thought it would have gone away by now.  Pain began a couple hours after receiving vaccination.
Morphea; A lump developed/ lump on his abdomen; Eczema; itch all over his body; large bruise on his abdomen; This is a spontaneous report from a contactable nurse (patient). A 41-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL3248), via an unspecified route of administration, administered in the right arm on 22Dec2020 at 16:15 as a single dose in the hospital for COVID-19 immunization.  Medical history included hypertension and hyperlipidemia both from an unknown date and unknown if ongoing. The patient had no known allergies. The patient did not have COVID prior to the vaccination. The patient did not receive other vaccines in four weeks prior to the vaccine and received other medications in two weeks prior to the vaccine. The patient was not tested for COVID post vaccination. On 22Dec2021, shortly after the first dose vaccine, the patient started to get eczema and started to itch all over his body. On an unknown date in Dec2020, about 4-5 days after the vaccine, he noticed a large bruise on his abdomen. The bruise went away, however a lump developed on 28Dec2020. He saw his primary care physician (PCP) and he did an ultrasound on an unknown date in Dec2020 that was inconclusive. It wasn't until he went to the dermatologist about the itching and eczema and mentioned the lump on his abdomen that they did a biopsy on 28Dec2020 and diagnosed the patient with with Morphea. The patient received steriods and UVA 1 treatments for the events. The events were reported to have resulted to a disability or permanent damage. The outcome of the event large bruise on his abdomen was recovered on Dec2020 with the outcome of the other events was not recovered. The patient received the second dose of bnt162b2 (lot number: EL0140) on 15Jan2021.; Sender's Comments: Based on the available information and known product profile, the causal relationship between the event Morphea and the symptoms reported with it together with the use of BNT162B2 cannot be fully excluded. The case will be assessed further upon receipt of additional information.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Migraine Headache, Pressure behind the left eye, Stabbing headache, Weakness, Fatigue, Hot Flashes, Chills, Night Sweats, Shingles
pt had a positive COVID test on 7/18/22 and again on 7/31/22; pt brought to hospital and was transitioned to comfort measures; pt passed away in the hospital
Patient received flu vaccine and about 7 minutes later, she complained of blurred vision, dizziness, and tight chest. EMS was called. NP was 104/88, Pulse 80. EMS arrived and assessed patient at about 16:12. Patient was feeling better; believed she was having an anxiety attack. Patient stated all symptoms were gone. She signed a consent to refuse transport. Patient was released to her husband, a deputy sheriff.
The patient experienced a Syncopal episode immediately after receiving these immunizations and regained consciousness without intervention
Took the first dose of the Moderna COVID-19 vaccine on 20Jan2021; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and PRODUCT DOSE OMISSION ISSUE (Took the first dose of the Moderna COVID-19 vaccine on 20Jan2021) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 27-Jan-2021. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Took the first dose of the Moderna COVID-19 vaccine on 20Jan2021). At the time of the report, COVID-19 (COVID-19) had resolved and PRODUCT DOSE OMISSION ISSUE (Took the first dose of the Moderna COVID-19 vaccine on 20Jan2021) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product included Lilly COVID-19 antibody infusion.  No treatment reported.   This case was linked to MOD-2021-068432 (Patient Link).
History of Guillain-Barre' syndrome.  Saw private provider 10/16/2008 with complaints of fever, chills, nasal drainage, lower back numbness. Given injection of depo-medrol, dexamethasone, and rocephin.  RX for claritin.
It started with a throbbing and it was almost like I was a punching and it started hurting but that throbbing kept going. It was very painful and it just got worse. And I called my doctor. He had ordered me some Ritzapan, for my migraines I get them already but it is not like this. Taking the meds did not help so we concluded it was from the vaccination. They went on for about 2 weeks. And it was like stay in the bed stay under the covers.
After the vaccine he felt bad from his stomach/ he always had stomach; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (After the vaccine he felt bad from his stomach/ he always had stomach) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     The patient's past medical history included Tumorectomy (He had an ablation to kill a 5 centimeters tumor) in August 2021. Concurrent medical conditions included Immunocompromised, HIV disease (For many years), Cancer (For many years), Cirrhosis liver (For many years), Tumour (Cancerous and he has been given Chemotherapy treatment and an Embolization) and Heartburn. Concomitant products included OMEPRAZOL [OMEPRAZOLE] for Heartburn, ABACAVIR SULFATE, DOLUTEGRAVIR SODIUM, LAMIVUDINE (TRIUMEQ) for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (After the vaccine he felt bad from his stomach/ he always had stomach). At the time of the report, ABDOMINAL DISCOMFORT (After the vaccine he felt bad from his stomach/ he always had stomach) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Alpha 1 foetoprotein: high (High) High, Found in Blood test. On an unknown date, Platelet count: low (Low) Low, blood platelets are through the floor.         Treatment information was not provided. Patient stated that after second dose he received Flu shot on an unknown date.
Diagnosis of prostate cancer, Gleason score 6+7 and 6.  No family history of any type of cancers, discovered during a regular screening.  No symptoms or signs.  Scheduled for IRE on April 5, 2022
JULY 2009 UNSURE OF EXACT DATE, CLIENT BROKE OUT WITH SHINGLES TO HER UPPER QUADRANT OF FACE AND SCALP INCLUDING EYE.  NOTICED ON A FRIDAY OR SATURDAY.  WENT TO PCP ON MONDAY.  DIAGNOSED WITH SHINGLES AND WAS GIVEN MEDICATION.  CLIENT DOES NOT REMEMBER WHAT MEDICATION SHE WAS GIVEN.  STILL HAS ITCHING TO EYE.  DAUGHTER AND MOTHER RECEIVED VARICELLA ZOSTER VACCINE ON 2/4/09.  DAUGHTER REPORTED THAT SHE CURRENTLY HAS SHINGLES TO SAME AREA OF FACE WITH EYE INVOLVEMENT AS HER MOTHER DID.  STATED SHE HAD CALLED ABOUT HER MOTHER IN JUNE OR JULY OF LAST YEAR AND TALKED WITH RN ABOUT HER MOTHER'S OUTBREAK. RN RECALLS THAT IT WAS BROUGHT UP/MENTIONED DURING FLU CLINIC LAST FALL.  CALLED AND TALKED WITH CLIENT AND DAUGHTER TODAY.  STATED SHE DID NOT REMEMBER WHEN HER OUTBREAK WAS, BUT THAT IT WAS ON THE LEFT UPPER QUADRANT OF HER FACE AND SCALP.  STILL HAS RESIDUAL ITCHING TO UPPER EYE AREA/EYEBROW AND IT IS WORSE AT NIGHT.  DID TAKE MEDICATION THAT DR PRESCRIBED BUT DOES NOT REMEMBER WHAT IT WAS.  DOES NOT RECALL HOW LONG OUTBREAK LASTED.
Patient states that the day after she received her flu shot, she started experiencing pain at the injection site. Over the last two months the pain has gotten worse and it especially flares up when she makes certain movements like reaching for something or putting on a jacket.