chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient began experiencing symptoms on day 10 and tested positive on day 11; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Jun2022 at 15:30 as dose 4 (booster), single (Lot number: FM7563) at the age of 63 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hoshimoto's Thyroiditis" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin ( maybe?). Concomitant medication(s) included: LEVOTHYROXINE; CYCLOSPORINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19"; DISEASE RECURRENCE (medically significant) with onset 30Aug2022 at 19:00, outcome "recovering", described as "Patient began experiencing symptoms on day 10 and tested positive on day 11". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive, notes: COVID 19 Treatment; (Aug2022) positive, notes: 14 hours after testing positive on a rapid test; (27Aug2022) Negative, notes: negative on days 7 and 8; (28Aug2022) Negetive, notes: negative on days 7 and 8; (31Aug2022) positive, notes: tested positive on day 11. Therapeutic measures were taken as a result of drug ineffective, covid-19. Therapeutic measures were not taken as a result of disease recurrence.  Additional information: Anti viral details: Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 21Aug2022, Treatment stop date: 26Aug2022, Indication: Treatment of COVID-19, Other medication in 2 weeks product: Levothyroxine 50 MCG, Cyclosporine Opthalmic Solution .05% Emulsion (Restasis), Patient started a course of Paxlovid about 14 hours after testing positive on a rapid test. Patient had been experiencing mild symptoms about 36 hours before that. Felt much better within a day and tested negative on days 7 and 8. Patient began experiencing symptoms on day 10 and tested positive on day 11. Patient am currently experiencing symptoms (a little more congestion than before).
Hard lump under injection site - sore 2 weeks later;  weak, nauseated, dizzy, tired for 3-5 days
Developed swelling and redness 24hrs post injection. Swelling from deltoid to decronon area. Warm to touch. Pt given Augmentin and Benadryl. Symptoms resolved within 48 hrs.
Onset of Nausea/Vomiting, later in day area became reddened and hard to touch.
RAISED RASH AT THE INJECTION SITE; Injection site papule; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (RAISED RASH AT THE INJECTION SITE) and VACCINATION SITE PAPULE (Injection site papule) in an elderly female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Plaque psoriasis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced INJECTION SITE RASH (RAISED RASH AT THE INJECTION SITE) and VACCINATION SITE PAPULE (Injection site papule). At the time of the report, INJECTION SITE RASH (RAISED RASH AT THE INJECTION SITE) had not resolved and VACCINATION SITE PAPULE (Injection site papule) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of RAISED RASH AT THE INJECTION SITE unknown onset with HUMIRA(ADALIMUMAB) was a reasonable possibility. The reporter's causality for the event(s) of RAISED RASH AT THE INJECTION SITE unknown onset was not provided.
After leaving facility, had numbness in tongue, trouble swallowing. Waited 20-40 more minutes, then felt dizzy and began to have hives in addition to previous reactions. I went to Urgent Care where they took vitals. Blood pressure and heart rate were elevated, throat was abnormal, and I had hives. They gave me antihistamine and steroid shot.  After 30minutes - and hours, vitals returned to normal.
Case number PHEH2013US02159 is an initial spontaneous report received from a health care professional on 11 OCT 2013. This report refers to an 11-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: A1214/A1105, expiry date: 30 AUG 2014/30 APR 2014) at a dose of 0.5 ml intramuscularly in the left deltoid on 09 AUG 2013. It was reported that he was vaccinated with MENVEO vial that had a temperature excursion of 32F on two occasions. Crystallization of vaccine might have occurred which destroyed it and the vaccine was not good. The reporter believed that the patient should be revaccinated. During the call back, it was identified that the patient had a local allergic reaction of left deltoid characterized by firmness, redness, and warmth at the vaccination site. The vaccination site reactions were reported to be resolved.
By 5:00 PM on date of administration, child was extremely and uncharacteristically irritable.  From 2/24/11 - 3/4/11 a few mild fevers were experienced along with continued irritability.  On 3/6/11 child suffered severe rash which became worse and spread over entire body and face.  On this date child began to experience trouble sleeping. Reduction in appetite occurred, sores are present inside of throat, fevers and continued irritability.  Child has become less active and much more lethargic since vaccine administration.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On 20-AUG-2015, the patient was vaccinated with an improperly stored dose of VAQTA (lot # L009445, exp.date: 01-JUN-2017) (strength, dose and route were not reported). There were no adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
ED to Hosp-Admission Discharged   10/25/2021 - 10/28/2021 (3 days) Hospital  * (Principal) COVID-19 virus infection Yes       Essential hypertension Yes   Overview Signed 12/22/2017  3:17 PM       Last Assessment & Plan:  Formatting of this note may be different from the original.  Her blood pressure is  BP Readings from Last 1 Encounters:  08/09/17 149/64   .  Continue current blood pressure regimen and follow with her PCP.            Hyperlipidemia Yes   Overview Signed 12/22/2017  3:17 PM       Last Assessment & Plan:  She follows with her PCP.           Insomnia Yes       Multiple myeloma not having achieved remission Yes   Overview Signed 8/13/2018 12:19 PM  Added automatically from request for surgery           Paroxysmal atrial fibrillation Yes       Generalized weakness Yes        Presenting Problem/History of Present Illness/Reason for Admission Elevated troponin [R77.8] Generalized weakness [R53.1] COVID-19 virus infection [U07.1] COVID-19 [U07.1] Multiple myeloma Chronic sacral wound   Hospital Course   Very lovely 78-year-old who has multiple myeloma which she has been battling for many years as well as recurrent MRSA bacteremia for which she is on prophylactic doxycycline and a coccygeal decubitus ulcer.  Sadly despite getting the Covid vaccine end of booster she contracted Covid.  She really did not have a lot of dyspnea and in fact was not hypoxic although she did have a cough and some crackles she was just wiped out.  She had become completely wheelchair-bound had not been able to eat for 3 days.  Her blood work really did not look bad but she was completely wiped out.  She was admitted and given IV fluids started on Decadron because she was not hypoxic she was not started on remdesivir.  She improved steadily.  On the date of discharge she is eating more in the past 3 days then in the past 2 weeks she says.  She feels stronger wound care saw her in fact general surgery as her wound care person and they felt nothing needed to be done differently.  Blood work remained stable.  Chest x-ray was negative, hemoglobin hematocrit 10/31.5 and white count normal renal function unremarkable 10/25/2021 1814  Respiratory virus detection panel  Collected: 10/25/21 1814 | Final result | Specimen: Swab from Nasopharynx   Adenovirus Not Detected Mycoplasma pneumoniae Not Detected Chlamydophila pneumoniae Not Detected Parainfluenza Not Detected COVID-19 SARS-CoV-2 Overall Result Detected Critical  Enterovirus/Rhinovirus Not Detected Coronavirus Not Detected Respiratory Syncytial Virus Not Detected Influenza A Not Detected Bordetella pertussis Not Detected Influenza B Not Detected Bordetella parapertussis Not Detected Metapneumovirus Not Detected
feels lousy / does not feel right; doesn't get a lot of sleep; not hungry; severe diarrhea; had a fever; This case was reported by a consumer via call center representative and described the occurrence of feeling bad in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd July 2020, the patient received the 1st dose of Shingrix (intramuscular). On 23rd July 2020, immediately after receiving Shingrix, the patient experienced fever. On 5th August 2020, the patient experienced diarrhea. On an unknown date, the patient experienced feeling bad, insomnia and decreased appetite. On an unknown date, the outcome of the feeling bad was not recovered/not resolved and the outcome of the insomnia, decreased appetite and diarrhea were unknown and the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the feeling bad, insomnia, decreased appetite, diarrhea and fever to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient still feels lousy. The patient doesn't get a lot of sleep, she's not hungry and she does not feel right. For a couple of days she will start to feel better then the bad feeling comes back again.  The patient had a fever right after the injection and that has gone away.  On 5th August 2020 she had severe diarrhea, 22 episodes of diarrhea that day. Shingrix administered by pharmacist   The reporter did not consent to follow up.
Tonsil kinda of closes so that i could not breath well for a few seconds; Tonsil kinda of closes so that i could not breath well for a few seconds; Burning of the tongue from the tip then to the middle and towards the throat; Burning of the tongue from the tip then to the middle and towards the throat; This is a spontaneous report from a contactable healthcare professional.  A non-pregnant 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular, administered on left arm on 08Apr2021 12:00 (Batch/Lot Number: Unknown) as unknown, single (at the age of 54-year-old) for COVID-19 immunisation.  Medical history included undifferentiated connective tissue disorder and allergy to dust and pollen.  The patient's concomitant medications were not reported. The patient stated on 08Apr2021 12:00, "burning of the tongue from the tip then to the middle and towards the throat. Tonsil kind of closes so that I could not breath well for a few seconds. They put me on oxygen, gave me Benadryl and Tacid". Prior to vaccination, the patient was not diagnosed with COVID-19 and has not been tested for COVID-19.  The outcome of the events was recovered on an unspecified date.   No follow up attempts are possible; information on the lot/batch number cannot be obtained.; Sender's Comments: Based on information available, the reported tonsillar disorder with symptom of dyspnea was likely related to the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to temporal relationship.  The case will be reassessed should additional information become available.  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.
" I started itching and noticed welps on my legs on Wednesday. They moved up to my back and neck." Pt reports  taking benadryl before she went to PCP. Reports PCP prescribed steroids.
Allergic reactions at injection site - skin atrophy, itching, redness. (Swelling about half dollar size). Pt taking BENADRYL and HYDROCORTIZONE 1% CREAM.
congestion Narrative:  Patient contacted telephone triage nurse today requesting to speak with PCP clinic. Patient states he received Johnson & Johnson covid vaccine on 4/30/ 2021, "Almost immediately, I got a headache, horrible body aches, felt like I got hit by a train." Patient states body aches and headache are gone, "but now I'm vomiting, and having diarrhea." Patient states he has vomited twice in the past 8 hours, "I start coughing, and mucous comes out, I'm not sure if it's really vomiting, more of expelling phlegm." + Sinus congestion, cough and chest congestion. Bringing up yellow phlegm, some mild intermittent wheezing. Denies dyspnea, SOB or chest pain with cough or deep inspiration. Patient also admits to some diarrhea, estimates around 8-10 episodes over the past 12 hours, but also states h/o IBS. Feeling "tired out, like I have a bad case of the flu." Frequent harsh, productive cough noted throughout conversation, no conversational dyspnea. Patient called to discuss symptoms. Patient feeling a little under the weather s/p vaccine. States cough has resolved and stomache feeling better. He states he has diarrhea and that is not abnormal. Denies any SOB or distress. He denies any concerns that needs addressed by team.
Changes in menstrual cycle to include longer cycle with premenstrual bleeding, longer periods, lighter flow, and lack of ovulatory signs. Irregular cycles. Sometimes a week longer than usual and sometimes a week shorter.
On the 3rd day 6/27/2021 my injection site was feverish, red, itchy and swollen and covered my whole upper arm. This lasted for 3 to 4 days.  I took generic Benadryl, ice packs and hydrocortisone  cream until it subsided. On January 19, 2022 the booster (3) vaccine (received on 9/17/2022) same reaction has done the same but not as severe.
had the shot and got shingles, but was very mild; got shingles, but was very mild; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Family History) ( to mother ) and pain (Family History) ( to mother ).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient's mother had shingles twice and worst pain ever. The patient received Shingles vaccine and experienced shingles, but was very mild. The reporter stated that get the shots. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided.
In the evening of 25-Jan-2021, after my dinner I was watching the TV that after 15 minutes my Left arm from shoulder downwards felt suddenly numb with no sensation. I called my wife and sensing that it may be a stroke took 4 tablets of 81 mg of Baby Aspirin. Some sensation seem to come back after some time (may be an hour or so afterwards), but half of my left palm and little finger remained some what numb. Night passed quietly and kids were anxious that I did not call ambulance or go to ER. Next morning I went to the nearest ER and was diagnosed with Transient Ischemic Attack. All the tests were negative CT scan of Head & Trunk did not reveal anything, only D-Dimer was slightly elevated. I was given a tablet of Aspirin 325 mg and prescribed Eliquis 2.5 mg twice daily for use and advised to follow up with a Neurologist. ER did advise for admission in hospital and a MRI work up, but I declined.
Stark dark red rash on lower left breast and abdomen.  Started 03/14/21 in the middle of the night when I was sleeping. In the morning it was still there so I took a benadryl with no relief. It became more inflamed, started itching and came with discomfort. Began feeling feverish and dizzy. Saw an NP 03/15/21 around 2:00pm and was given steroid cream to treat what she thought was an allergy.   Steroid cream and cold compresses were used over the course of the next two days with no relief. Rash seemed to get bigger and darker. The rash is 4-5  irregular, textured and raised clusters about 1-2 cm in size, with mildly erythematous areas surrounding them. Saw an MD 03/17/21 around 1:30pm, believes it's a vascular response to the vaccine as the color of the rash doesn't fade when pressed on. Advises getting a biopsy if issue does not resolve or improve after 1 week. He also advised holding off on the second dose until further information is obtained
11/5/09 at 1720 received H1N1 vaccine; 11/05/09 at 2200 started having a severe headache, got worse through the night. Tossed & turned for hours, felt feverish & nauseated. Fell asleep 11/6/09 around 1100am. Slept till 1:00pm. 11/11/09 reports has 3 bruises (1 is at injection site) & has foggy vision.
Arm  is swelling; Has nodes under armpit/makes painful; Has nodes under armpit; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm  is swelling), LYMPH NODE PAIN (Has nodes under armpit/makes painful) and LYMPHADENOPATHY (Has nodes under armpit) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Arm  is swelling), LYMPH NODE PAIN (Has nodes under armpit/makes painful) and LYMPHADENOPATHY (Has nodes under armpit). At the time of the report, PERIPHERAL SWELLING (Arm  is swelling), LYMPH NODE PAIN (Has nodes under armpit/makes painful) and LYMPHADENOPATHY (Has nodes under armpit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.
Pancreatitis; pancreas issues; felt unwell; sore arm; fever; cluster headaches; This case was reported by a consumer via call center representative and described the occurrence of pancreatitis in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included cluster headaches.   On 10th March 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 11th March 2022, 1 days after receiving Shingrix, the patient experienced feeling unwell, pain in arm and fever. On 13th March 2022, the patient experienced cluster headache. In May 2022, the patient experienced pancreatitis (serious criteria hospitalization and GSK medically significant). On an unknown date, the patient experienced pancreatic disorder. On an unknown date, the outcome of the pancreatitis, cluster headache, feeling unwell, pain in arm and fever were recovered/resolved and the outcome of the pancreatic disorder was not recovered/not resolved.   It was unknown if the reporter considered the pancreatitis, pancreatic disorder, cluster headache, feeling unwell, pain in arm and fever to be related to Shingrix.     Additional Information: GSK Receipt Date: 3-Aug-2022. Reporter's Comments: The caller was the patient itself stated that she received her Shingrix vaccine and the following day she started with a fever, sore arm and felt unwell in general for a few days. On 13th March 2022, 3 days after receiving Shingrix, the patient experienced cluster headache. She also had a history of getting cluster headaches and 2-3 days post vaccine, she started with a series of cluster headaches that lasted for about 8 weeks. In May 2022, less than 3 months after receiving Shingrix, the patient experienced pancreatitis. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced pancreatic disorder. In addition, she developed pancreatitis in May that had subsided, but continued to have ongoing pancreas issues. The patient did not want to give any further demographics or have in more information about the vaccine itself. The consent to follow was not granted. Additional Supportive Information: This case was linked with US2022114898 reported by same reporter. Note: As per narrative the onset date for Pancreatitis was considered as May 2022. As per vaccination date and event onset the TTO for Pancreatitis was captured as less than 3 months.; Sender's Comments:  US-GSK-US2022114898:Same reporter. Patient 2
This is a spontaneous report received from a female consumer with allergy to FLAGYL who received a dose of ZOSTAVAX on 07-MAR-2017 intramuscularly, for the prevention of shingles. Concomitant medication included SYNTHROID 150 mg, simvastatin 10 mg, vitamins (unspecified) and probiotics (unspecified). The patient reported that she is experiencing an injection site reaction. It is bright red, hard, and sensitive. She also stated that she has a slight rash on both arms. No treatment was received and the patient did not seek medical attention. The outcome of these events was reported as 'not recovered'. The causality was not reported. Additional information has been requested.
High temperature above 103, constant crying, lethargic, lack of eye contact. Told by on call nurse to give infant Tylenol and if temperature did not come down with in one hour take to ER.  Temperature did decrease.
shot at 9:15 am, about 2:45 pm I started to feel a bit nauseous, but it was gone by 3:30 pm, but I then started to get a headache.  it started in the back of my head/neck area then more in the forehead then both by 5:00 pm.  At same time (3:30 pm) I felt very tired, achey.  I took 2 Aleve and went to bed and slept till about 6:15 pm, ate dinner and went to bed for the evening.  Headache persisted, aches, and general tiredness.
This spontaneous report as received from an other health professional refers to a patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ lot # L008054 and L004466 for prophylaxis. No adverse effects were reported. Data logger was involved. This is one of several reports received from the same reporter. Additional information is not expected. Sender's Comments: US-009507513-1708USA000870: US-009507513-1708USA002369: US-009507513-1708USA002370: US-009507513-1708USA002372: US-009507513-1708USA002373.