chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Diagnosed with Covid-19; Dizziness; Weakness; No appetite; Fever; Chills; Tiredness/Fatigue; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Diagnosed with Covid-19), DIZZINESS (Dizziness), ASTHENIA (Weakness), DECREASED APPETITE (No appetite) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced DIZZINESS (Dizziness), ASTHENIA (Weakness), DECREASED APPETITE (No appetite), PYREXIA (Fever), CHILLS (Chills), FATIGUE (Tiredness/Fatigue) and HEADACHE (Headaches). On 22-Feb-2021, the patient experienced COVID-19 (Diagnosed with Covid-19). The patient was treated with AZITHROMYCIN for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Diagnosed with Covid-19), DIZZINESS (Dizziness), ASTHENIA (Weakness), DECREASED APPETITE (No appetite), PYREXIA (Fever), CHILLS (Chills), FATIGUE (Tiredness/Fatigue) and HEADACHE (Headaches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  The patient reported that she diagnosed with Covid-19 on 22-feb-2021 with positive test. She went to an urgent care on 27-feb-2021 where she was received azithromycin, and symptoms resolved in 3-4 days. She stated that she got covid-19 from her son who was visiting to them, and not from the vaccine. She is scheduled to get second dose on 19-mar-2021. She was asking if she should get the second dose of the vaccination or wait.
Nearly exactly 2 weeks after my second dose, I've begun to have muscle and joint stiffness in my legs and hands.  My feet and hands feel numb at times and it feels as if I'm retaining water or swollen.  My ankles, knees, leg muscles, wrists, hands and fingers are encountering this.  I've never had this issue before in my entire life.
INCREASED RR AND DIFFICULTY BREATHING, VSS, BP 94/70, HR 78, NO TRANSPORT.
Shot 1 taken on 4/22/2021.  Shot 2 taken on 5/13/2021.  (side effects) (both shots) ? Extreme Dry Mouth for approx. 24-36 hours ? Headache (top of the head only) for approx. 7 hours. intermediate ? Arm pain at the injection spot (onset occurred 8 hours later)  (side effects) (2nd shot only) ? Extreme exhaustion and tiredness (felt like I could sleep for days) ? Elevated Sugars (bgs) for 13 hours (could have impacted the sleepiness feeling above) ? Palpitations (still ongoing) but Sinus Pause only ? micro events ? Tinnitus (very loud ringing in my ears) ? loudness comes in waves but is constant now and won't go away.
Client reported itching approximately 15-20 minutes after Tdap vaccine. Hives appeared on trunk & arms. No facial swelling, no SOB. Gave client BENADRYL 25 mg PO. Client showed improvement 30 minutes later. Cetirizine 10 mg daily. To ER for T sxs or severe sxs.
Impression and Plan    #Fatigue weakness secondary to underlying COVID-19.   Currently patient is on room air   #COVID-19 mild symptoms. Monitor for any oxygen desaturation   #Hypertension Lisinopril, metoprolol   #COPD Breathing treatment as ordered    #Schizophrenia History of traumatic brain injury Patient is on lithium Depakote   # history of ITP Platelets are stable monitor for now.   #Anemia of chronic disease     #History of pulmonary embolism Patient is on Eliquis we will continue     DVT: on Eliquis        PATIENT CLASS : Observation ADMISSION Date & Time : 1/20/2022  4:44 PM     CHIEF COMPLAINTS :  Chief Complaint Patient presents with ? Fatigue     per house keeper, pateint becoming increasingly week the last 3 days. PE in Nov.         HISTORY OF PRESENTING ILLNESS :  Patient is a 76-year-old male with past medical history significant for COPD, hypertension came to the ED from group home with complaints of fatigue.  Patient having chest pain abdominal pain.  History from the patient is limited.  Patient was found to have increasing weakness falls.  When he came to the ER patient vitals has been stable.     Blood work reviewed creatinine of 1.17, sodium 140, hemoglobin of 11.9, WBC of 4.1 Lithium level was low,   Chest x-ray no acute process. CT head done no acute process.   COVID was checked came back  positive Low, RSV came back negative. Valproic acid level was 60
Client states that one day status post vaccine she took Sudafed to prepare for singing. She then experienced hearing loss in her left ear. She stated the hearing loss resolved the next day. She took Sudafed again and then experienced hearing loss in her right ear. She stated the hearing loss resolved however, she has had tinnitus and ringing in her right ear since the second Sudafed dose 2 days post vaccine.
This case was reported by a consumer via call center representative and described the occurrence of sickness in a 62-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included mastectomy (on left side). On 6th March 2019, the patient received SHINGRIX. In March 2019, several hours after receiving SHINGRIX, the patient experienced sickness, pain in arm, swelling arm and swelling. On an unknown date, the outcome of the sickness, pain in arm, swelling arm and swelling were unknown. It was unknown if the reporter considered the sickness, pain in arm, swelling arm and swelling to be related to SHINGRIX. Additional details were provided as follows: In the afternoon, the patient was received SHINGRIX on an unknown deltoid. The patient woke up sick on 7th March 2019, with an very severe pain in upper arm, it hurt to even move it. The patient asked if she could use heat or ice or Lidocaine patch. The patient arm and chest were swollen too. The patient called her healthcare provider and the healthcare provider advised her to come in if it gets worse. The patient had mastectomy on left side so it was likely lymphedema.
Pt had a lab drawn and one immunization. He acknowledged verbally through that he was ok when asked. He came out to hallway and we checked his college form. As I turned to say something, his eyes rolled and I was able to catch him as he went down. Leg elevation and water. His parent was called and came and got him.
Large area of swelling/redness.  Diagnosed as infection and treated with antibiotics.  Patient inadvertently given a higher dose (1.0mL instead of 0.5mL).
pt recvd vax; rash generalized day p/ vax w/ signs of lethargy; gone by sunday; MD prescribed dph
Patient started having itching in arm, said it felt like itching was coming "from inside out".  Instructed patient to take oral benadryl tablet.....ended up throwing up and then dry heaving for an hour or so.  Also gave Tums, had patient lay down, elevate feet, sip water.  Put fan on patient and ice pack on forehead/arm.  Felt better in a few hours.
he would die; paralysis; severe chest pain; could not move or walk; felt very bad; Itching; This is a spontaneous report from a contactable physician (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE,), dose 1 via an unspecified route of administration on 31Aug2021 as 0.3 mL single dose for covid-19 immunisation. Patient stated his patient card was handwritten and the lot was FC3182 or FG3182 and he cannot see the handwriting clearly. The patient's medical history and concomitant medications were not reported. Caller (patient) received first dose of the Pfizer Covid 19 vaccine on 31Aug2021 and second dose was scheduled for 21Sep2021. The first day he was ok and on day two he had such severe chest pain that lasted 24 hours and he paralysis while lying on the floor as he could not move or walk and thought he would die that day on 02Sep2021. He asked his wife to watch over him and to check on him from time to time to make sure he was not dead yet. He explained that 24 hours after the onset it resolved. He could walk, breathe and everything was normal. He was healthy at baseline. He had not experienced that kind of pain and heard about myocarditis regarding the vaccine but could not go that day to his doctor and he felt very bad in Sep2021 and 24 hours later the symptoms resolved. He stated the chest pain and itching in Sep2021, he told his wife to look into that and he may die that day. He was supposed to get the 2nd dose at 11:00am tomorrow.  Caller stated he was concerned and heard reports that after the 2nd dose people get very bad myocarditis. But he did not know what the symptoms were and thought he was going to die that day and asked his wife to come check on him often and he was lying flat. He stated 24 hours later his symptoms resolved and he was able to function again. He did not go to the doctor and did not know what this was and still can go check his EKG and all that and can do that still. Caller stated on his patient card for the Pfizer Covid vaccine has numbers. As a physician he was aware of the reports of myocarditis. While he has not been evaluated by his HCP for a formal diagnosis he would like to know if it was safe to get his second dose of the vaccine. Outcome of itching was unknown, of severe chest pain was recovered on 03Sep2021, of other events was recovered in Sep2021.   The lot number for BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Near death experience (Life threatening) and Paralysis and BNT162B2.  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.
Patient received 3rd dose; 1st dose on 04SEP2019, 2nd dose on 04FEB2022; Expired vaccine used; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 70-year-old male patient who received Herpes zoster (Shingrix) (batch number FS52T, expiry date 11th June 2023) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number P9733, expiry date 4th February 2020) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 4th September 2019 from batch number unknown, expiry date 4th September 2019).   On 13th May 2022, the patient received the 3rd dose of Shingrix (intramuscular). On 4th February 2022, the patient received the 2nd dose of Shingrix. On 4th February 2022, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced drug dose administration interval too long and expired vaccine used. On 13th May 2022, the patient experienced extra dose administered. On an unknown date, the outcome of the drug dose administration interval too long, expired vaccine used and extra dose administered were unknown.   Additional Information: GSK Receipt Date: 13-MAY-2022 Reporter's comment:  The reporter consented to follow up. Additional supportive information: The patient received the 2nd dose of Shingrix later than recommended interval also which was already expired in 4th February 2020, which led to lengthening of vaccination schedule and expired vaccine used.  The patient received the 3rd dose of Shingrix, which led to extra dose administered.
Jaw started to lock; Body was shaking badly; Shortness of breath; Felt like chills; Fever of 100.8 to 101; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), TRISMUS (Jaw started to lock), TREMOR (Body was shaking badly), DYSPNOEA (Shortness of breath) and CHILLS (Felt like chills) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in January 2021. Concomitant products included VITAMINS NOS for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced DIARRHOEA (Diarrhea). On 17-Mar-2021, the patient experienced TRISMUS (Jaw started to lock), TREMOR (Body was shaking badly), DYSPNOEA (Shortness of breath), CHILLS (Felt like chills) and PYREXIA (Fever of 100.8 to 101). The patient was treated with PARACETAMOL (TYLENOL) for Fever and Chills, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea), TRISMUS (Jaw started to lock), TREMOR (Body was shaking badly), DYSPNOEA (Shortness of breath), CHILLS (Felt like chills) and PYREXIA (Fever of 100.8 to 101) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, Body temperature: 100.8 (High) 101 and 101 (High) 101.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included unspecified asthma inhaler
After PNEUMOVAX injection, pt became diaphoretic (sweating profusely), dizzy/lightheaded, tachycardic (felt heart racing), short of breath/wheezing. BP & HR was elevated. Patient was monitored (BP, HR & pulse ox) at clinic until 2:30 pm 9/21/11.
pt t103 R for 3 days beginning 1JUN93 & awoke @ 630AM crying on 4JUN93; pt's 4 extremities were shaking in a sz; lasted about 15 mins; seen in ER;
Information has been received from a health professional concerning a 5 year old female who on 12/17/99 in the AM was vaccinated SC with a dose of varicella virus vaccine live (lot # 631168/0710J). Concomitant vaccination the same day included a dose of MMR (lot # 632457/1084J) given SC. On 5/5/04, the patient broke out with chicken pox. The patient did not go to the physician. The patient's mother reported that it was a fairly sever case with multiple pox all over the patient's body. The nurse was told by the patient's mother that the pox have started to crust over. Unspecified medical attention was sought and no treatment was required. There was no product quality complaint involved. Follow up information indicated that all available information was reported. No further information is available.
Was called by outside institution. Pt is admitted for acute mental status change. Physician caring for Pt states she is very disorganized in her thinking. Pt prior was normal functioning. Pt is still hospitilized in psychiatric hospital x 5 days.
The patient came in for his booster in the evening.  Later, when we were processing the vaccines, it was discovered that his second dose was approx 4.5 months prior, which does not meet the 6 month requirement.
This spontaneous report as received from a nurse refers to a 5 year old female patient (also reported as granddaughter of the reporter). The patient did not have any pertinent medical history and no drug allergies or reactions. On 10-OCT-2011 the patient was vaccinated with first dose of unspecified HPV vaccine (GARDASIL could not be ruled out) (dosing regimen and frequency unknown) (lot number and expiry date unknown). The patient was not taking any medications concomitantly. On 04-DEC-2011 the patient was vaccinated with second dose of the unspecified HPV vaccine (GARDASIL could not be ruled out). On an unknown date approximately in July 2016 (also reported within the last month or so) the patient experienced headaches and black spots in her vision (visual impairment) (medically significant). The nurse also reported that her granddaughter had an appointment with a physician in September to address these adverse events. No treatment was given for the events. No lab diagnostic studies were performed. There was no product quality complaint reported. The action taken with the therapy was unknown. The outcome of headache and visual impairment was reported as not recovered. The relatedness of the events to the suspect therapy was unknown. Additional information has been requested.
After 1st Dose I was up all night unable to sleep. Had a strange feeling that is hard to explain other than I wanted to jump out of my skin. Had headache and eye pain.   After 2nd dose I was up all night with strange feeling and wanted to jump out of my skin. The next day I had severe headache and eye pain, sharp pains going down arms and legs with tingling in hands and feet. That lasted 5 days. When numbness and tingling went away I had really bad skin pain, It hurt to touch my skin for 3 weeks. Day 4 I had extreme tooth pain that started in right side of mouth and worked its way through each tooth for 1 week. My menstrual cycles have been irregular since 1st dose. I still have twitching in hands and feet today.
Initial report received on 30 September 2009 from a consumer, who is the patient's parent. An 11 year old male patient with no known allergies and no medical history, received a dose of ADACEL (lot number not reported) on 28 September 2009. On the same day, an unspecified amount of time later, the patient developed swelling, redness, and pain at the injection site. Two days later, the patient had pain and swelling under the armpit, he had swelling on the side of the body (same side as injection), and he stated that he "feels it moving when he walks". At the time of the report, the patient was to consult his health care provider later in the day. The patient's outcome was unknown. Follow-up information received on 21 October 2009 from a health care professional. On 28 September 2009, the patient had received ADACEL intramuscularly in the right upper extremity. The lot number for the ADACEL was reported to have been UF499AA (which corresponds to Sanofi Pasteur Ltd. lot number C3107). The patient had received five previous doses of DTaP on 26-AUG-1998, 14-ICT-1998, 18-DEC-1998, 21-JAN-2000, and 12 -May-2003 (no reaction to the fifth dose). On 30 September 2009, the patient was seen by the reporting physician and noted to have mild erythema of the right deltoid region and right axillae. The area was non-tender to palpation, was negative for induration, and full range of motion was noted for the right upper extremity. The diagnosis was localized shot reaction with no evidence of cellulitis. Corrective treatment was unspecified analgesics, warm compresses, and return for follow-up if symptoms worsened. At the time of the report the patient had not sought further follow-up for the reported events.
10 days after receiving one dose of varicella virus vaccine live the pt developed 10 varicella like lesions with blisters.
13:18:04 checked into pharmacy For Flu shot. Sat on bench waiting For Wife to pick up a Few groceries. About 14:00 P.M. Grandson stopped to talk to me, he noticed L side of face drooping. I checked out groceries at 14:30:03 pm. Went to restaurant to eat. Sat across from my husband Noticed L side of Face drooping. Checked for signs of stroke None Noted, walking, talking ok, NO ARM weakness, no slurred speech, Eating & drinking OK. Arrived home checked again for stroke symptoms, NONe, gave him a 325 mg. aspirin, watched him closely aLL day. Night. In morning Looked worse, could not drink without straw. Took him to Hospital ER. While checking in they said a nurse had a Flu shot & got Bell's palsy. Seen Dr. and another Dr., stated Bell's Palsy, very rare but happens. Ordered Lab drawn & brain scan. Put him on Valacyclovir HCL 1 gram t. 21 tabs -1- tab every 8hrs for -7- days & Prednisone 20 mg tabs -3- tabs a day For -7- days & eye drops, said ENT Dr. usually takes care of this. We had an appointment with Dr. Nov 7th said okay to wait untill then. Dr. said Full blown Bell's Palsy, added Prednisone packet For -6- more days. Could not close L eye, continue with eye drops, showed me how to tape eye shut at Not time. Noticed eye getting red & yellowish green drainage so took him to Ophthalmologist Dr, changed meds and showed me how to tape eye the right way, stated, can get ulcer in cornia. Eye has to be checked every 4-6 wks. Patient has difficulty seein eating, has to drink with a straw. I took him to his Family Dr., have seen Dr. three times, Dr 2 times, have appointment 01-14-2020 Have heard of three others plus patient got Bells Palsy after getting the Flu shot. My husband is depressed over it.
This was for SpikeVax. I have undifferentiated arthritis with a high ANA and have had pretty strong flare of symptoms since last night. My distal joints are swollen and my hands are painful enough to have woken me up several times last night. In addition, I'm suffering from severe back and side pain, though that may not be the arthritis. I am submitting this because I realize some researchers are following vaccine reactions in persons with autoimmune disorders. I always react strongly to Covid vaccines, btw.
Patient reports pain that developed later in the day after vaccination. Pain is same arm as injection occurred, but the injection itself was painless. She notes pain when lifting the arm, stretching, lifting and extending.  Unknown treatment. Planning on following up with pcp.
Vomiting, diarrhea, dizziness, nausea, head congestion
She had arthritis in her knees; This is a spontaneous report received from Regulatory Authority via contactable female consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on 26Mar2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient's second dose scheduled on 16Apr2021. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had arthritis in her knees and wanted to know if she could take Ibuprofen or advil. She just wanted to make sure that she would not mess up with the vaccine. The patient had arthritis in her knees on an unspecified date. The outcome of event was unknown.  No follow-up attempts are possible. Information on lot/batch number cannot be obtained.
feeling cold/coldness; increased temperature/she took her temperature and it was 100.2/fever; body numbness/body started to feel numb; This is a spontaneous report from a contactable nurse reported for herself. A 44-year-old female patient receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), intramuscular at left deltoid on 13Jan2021 16:00 at single dose for covid-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient historic vaccine included the first dose of BNT162B2 on 22Dec2020 for covid-19 immunization. The patient body started to feel numb on 13Jan2021, she was feeling cold/coldness on 14Jan2021, increased temperature on 14Jan2021 and she took her temperature and it was 100.2, stated that she knew that a fever is a side effect. She was only concerned with the body numbness and wanted to know if body numbness was anything to be concerned about. The reporter assessed events was related to Pfizer Covid vaccine and as serious due to medically significant. The outcome of the events was not recovered.; Sender's Comments: Based on the compatible temporal association, the Company considers the reported events of hypoesthesia, pyrexia and feeling cold are possibly related to suspect vaccine BNT162B2. 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.