chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report was received on 22 July 2008 from a health care professional. A 45-year-old female patient with a history of allergy to Lotrimin cream, developed fatigue that same day she had received a first dose subcutaneous left deltoid injection of YF VAX, lot number UF303AA. The following day (12 July 2008), the fatigue increased, and she developed a severe headache, shortness of breath and became feverish (temperature not reported). The following day (13 July 2008), she developed nausea and her headache decreased, but her fatigue increased. Her symptoms were noted to have been improving on 14 July 2008, however the fatigue continued. On 19 July 2008, the patient developed an 8mm circular rash on her trunk and extremities which expanded over her body. On 21 July 2008, she had worsening muscle weakness and was unable to lift her arms to type. It was not reported if the patient had received any concomitant vaccines. The patient was evaluated by a physician and her CBC and liver function studies had been normal. According to the reporter, they had been seeing an increase in the number of Lyme, West Nile, and Ehrlichiosis in their area. The patient had been referred to her regular health care physician for further evaluation and may be admitted to the hospital to facilitate evaluation and follow-up. Her recovery status at the time of the report was reported as unknown.  8/15/08 Reviewed employee health medical records. FINAL DX: none provided Records reveal patient experienced HA, felt unwell, rash all over, extreme fatigue, pale, shortness of breath, impaired ADLs, sluggish, nausea, loose stool, puffiness & water retention in face & hands.  ID & travel clinic consults done.  Referred to PCP (new). Tx w/antibiotics for possible Lyme disease empirically.  Travel out of country was d/c.     10/21/08 Reviewed PCP medical records of 7/22-7/24/2008. FINAL DX: viral syndrome w/exanthem, fatigue, malaise & SOB. Records reveal patient experienced viral illness w/macular rash, HA, low grade fever, sore neck muscles, SOB x approx 5 days when seen 7/22. Had been out of country 6/2008 & had tick bite 5/2008.  Tx w/antibiotics.  RTC 7/24 feeling better & rash fading.
gastroparesis; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (159558). The reporter is the patient.  A 57-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, unknown manufacturer), for COVID-19 Immunization. The following information was reported: IMPAIRED GASTRIC EMPTYING (medically significant) with onset 01Nov2021, outcome "unknown", described as "gastroparesis". Clinical course included: Caller wants to know if she could develop gastroparesis after receiving the Pfizer COVID-19 vaccine. She also wants to know if her husband could give her COVID if he receives the second booster shot and she does not. Caller wants to know if she can switch to a different COVID-19 vaccine (like Moderna or Johnson) to receive her second booster shot.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
DTaP immune given to pt (12 yrs old) instead of Tdap. No reaction to DTaP noted. Consulted with CDC to see if Tdap should still be given, per CDC not recommended because of possible local reaction
5/31/07 developed weakness of right lower arm. Unable to completely close right eye, unable to smile or _. C/W Bells Palsy
localized swelling, redness and pain, 2 days later, started having headache. 7 days later, started having cough, 9 days later, the patient vomited, passed out and having generalized weakness, which required hospitalization
Initial unsolicited report received from a pharmacist on 08-Sep-2016. This case involves a male patient (age unknown) who was vaccinated with DTAP (lot number, expiration date, dose, dose in series, route of administration not reported) on an unknown date. The medical history and concomitant medications were reported as unknown. On an unknown date, after vaccination, patient experienced bad reaction. Laboratory data and corrective treatment was not reported. Patient had recovered from event on an unknown date. List of the documents held by sender: none.
Vaccine was administered 32 days after thaw.  RN contacted Pfizer and was advised that vaccine may be stored at 2-8 degrees Celsius for a total of 32 days after thawed  (31 days labeled in prescribing information plus one day excursion time). Patient will not need to be revaccinated.
This spontaneous report was received from an office manager refers to a patient of unknown age and unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 08-JUN-2017, the patient was vaccinated with one expired dose of VAQTA, (25 units/0.5 ml) injection, route of administration was not reported, (lot # K019560 and date of expiration: 02-JUN-2017). No adverse effects were reported. Additional information has been requested.
Later in the day of injection, patient experienced light pain and soreness at injection site. Eventually developed a small rash.
Case number PHEH2016US020879 is an initial spontaneous case received from pharmacist on 15 Aug 2016. This report refers to a 30 year old female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (manufacturer: unknown, batch number: 1619401) at a dose of 0.5 ml intramuscularly on 13 Aug 2016 which was stored at 32 F for up to 11 hour (open and unopened), and it was not frozen. The one vaccine had been administered and it was the first time excursion. No adverse event was reported following this medication error. Following internal review done on 02 Sep 2016, for the data received on 15 Aug 2016: Significant case correction was performed. Changed the suspect product coding FLUVIRIN which was wrongly coded.
Patient has an induration of appp. 3 cm at vaccine site on left arm, redness, heat and pain in an area app. 10 X 12 cm. Reports fever of 101. Reports pain interferes with sleep and use of arm. Patient reported this reaction on 9/17/2012 when we found it to be as above. Patient saw a private MD 9/17/2012 and was given "a cream and an antibiotic".  Pt has a recheck with PMD in a few days. Patient had small induration on Right Arm, with no redness or swelling.
her doctor said it may have been during incubation period so she should take a test again.; her doctor said it may have been during incubation period so she should take a test again.; not feeling well; flu like symptoms; This is a spontaneous report from a contactable consumer (patient) received via Medical Information Team. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient reported that she was not feeling well and want to know if she needed to reschedule the 2nd dose (scheduled for 15Apr2021). The patient reported flu like symptoms.  The patient underwent lab test and procedures which included a PCR test done (rapid test) it was negative but her doctor said it may have been during incubation period so she should take a test again. The patient outcome of the events was unknown.  No follow up attempts are possible. Information on lot/batch number cannot be obtained.
Narrative:  Fully vaccinated COVID positive upon admission; patient presented with chest pain and dyspnea. Noted to have had outside positive test month earlier, so thought to be convalesced upon admission. No hx of prior COVID infections.
Left deltoid swollen, red and warm to touch. Temperature the next day and 2 days after of 102. All joints achy and crampy. Lymph nodes in left axillary area swollen up to left cervical area. After swelling went down on day 5 post shot a huge hive developed in area where shot was given. Believe this compromised my immune system and lymph nodes in neck got swollen and had a sore throat and sinus infection developed day 7 post shot. A Z-pack was given on day 7 post shot.
6.29: Patient recently seen on 6.29.21 at hospital ER and was diagnosed with COVID-19. He was sent home and told to return if symptoms worsened. 7.5.21: patient presents with shortness of breath and cough that have become increasingly worse. Hospitalization due to COVID-19 infection. diagnosed with community acquired pneumonia secondary to COVID-19, acute hypoxic respiratory failure. Patinet has history of receiving the J&J COVID-19 vaccine in April 2021.  7.16: as of the date of this report submission, the patient is still admitted.
Left arm cellulitis,  lymph node enlargement left neck/collar bone.  Pt scheduled and seen by provider. Prescribed cephalexin 500 mg  every 6 hours for 7 days.  IF no improvement in next 1-2 days will consider ultrasound.
The Decedent's son described that she was having GI issues between four days to a week before death (they could not be more specific). Unknown if this is related. She was reportedly also suffering from alcoholism per her son. Death of patient occurred 21 days after Vaccination. It is unknown at this time if this death is related in any way to the vaccination. This is being submitted at the request of Pathologist.
Ipsilateral lymphocyl in the left axilla, 5 cm in diameter, about 1 cm in thickness. Tender, painful with movement, mild, without discrete palpable lymph node enlargement.
On Saturday April 4, I had intense itching is the left arm where I received injection about 25 min after injection and started to get a migraine about 1 hour after the injection. I went home and took Benadryl and Ubrely, slept for about 10 hours, then there was no more itching and no more Migraine. On Sunday April 4, I felt achy, took two Extra Strength Tylenol on onset and right before bed, and I was fine for work on Monday April 5, 2021.
Instant left arm pain, left arm tingling into 5th digit, upper and lower lip tingle/numbness, left face and eye lid tingle/numbness, upper trachial tightening - all symptoms lasting 1-4 hours post injection. Facial hot flashes starting hour 4 into hour 6 post injection. Continued severe left arm pain/numbness/tingling and swelling at injection site. Ice application to Injection site as well as ibuprofen use for treatment.
Sore throat, difficulty swallowing, cough, oral thrush noted on 10/20/2015 (white patches on tongue and hard palate, inappetance.
Generalized pruritic rash about 24 hours following administration. Treated with antihistamine and topical calamine lotion.
redness, pain , warm area; redness, pain , warm area; Shingrix -warm area in site of injection; This case was reported by a physician via call center representative and described the occurrence of injection site erythema in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number 3454N, expiry date 23rd August 2022) for prophylaxis.   On 3rd August 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injection site erythema, injection site pain and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site pain and injection site warmth were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site pain and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and presented redness, pain, warm area for over a week. The reporter did not consent to follow up.
Right after injection arm felt warm to the touch  and face became slightly flushed. The next morning injection site was red warm and slightly swollen and tender to the touch. Injection may have been given to low on arm
My arms is getting heavy and pain; I feel pain,my arms is getting heavy and pain; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (My arms is getting heavy and pain) and MYALGIA (I feel pain,my arms is getting heavy and pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (My arms is getting heavy and pain) and MYALGIA (I feel pain,my arms is getting heavy and pain). At the time of the report, LIMB DISCOMFORT (My arms is getting heavy and pain) and MYALGIA (I feel pain,my arms is getting heavy and pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use was not reported.   Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow-up received and event outcome updated.
This spontaneous report was received from a company representative. The field representative state that the doctor indicated all three female patients were administered PNEUMOVAX23 at an unknown date all three patients developed swollen lymph nodes, flu symptoms and injection site reactions. All fields apply to all three patients. No other co-suspects were reported. No concomitant medications were reported. The outcome of swollen lymph nodes, injection site reactions and flu symptoms is unknown. The relatedness for swollen lymph nodes, injection site reactions and flu symptoms is unknown for PNEUMOVAX23. No further information is available.
Pt received Flu vaccine on 9/15/14. C/O malaise and fatigue x 4 days post vaccine. Started having severe pain in Lt shoulder 2 weeks ago from today. Pain extended to LUE x 2 days ago with numbness. Numbness on Lt side of lips today.
Generalised rash; Vaccination site pain; This spontaneous case was reported by a physician and describes the occurrence of RASH (Generalised rash) and VACCINATION SITE PAIN (Vaccination site pain) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   On 29-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) 1 dosage form. On 29-Mar-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). On an unknown date, the patient experienced RASH (Generalised rash). At the time of the report, RASH (Generalised rash) was resolving and VACCINATION SITE PAIN (Vaccination site pain) had not resolved. Not applicable      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The reporter's causality for the events of RASH ALL OVER BODY with RINVOQ (UPADACITINIB) was a reasonable possibility. The reporter's causality for the events of PAINFUL INJECTION/COVID-19 VACCINE HURT ARM with RINVOQ (UPADACITINIB) was no reasonable possibility. No Concomitant medication were reported. Treatment medication was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Additional information  received on 25 May 2021 and does not contain any  new information.
Injection site and surrounding area became hot, red, sore and painful approx 27 hr after injection.   On 3/7 symptoms had improved and nearly resolved.    3/8  redness and pain worse today.
The pt experienced a fever of 104, neurological symptoms (prolonged twitching and lip smacking.)
Pt. presented with pallor->itchiness on thigh area->no SOB; some puffiness under eyes->some redness around nose->mom says daughter not acting herself->pt also presented with diaphoresis. 911->hosp.
Chills, shaking uncontrollably. Than hot and sweaty with fever. Started about 30 hours after 2nd vaccination shot. Lasted about 17 hours. It felt like Montezuma?s Revenge
Fever; Fatigue; Under left armpit it feels a knot and looks swollen; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Under left armpit it feels a knot and looks swollen), PYREXIA (Fever) and FATIGUE (Fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A, 012A21A and 043L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LYMPHADENOPATHY (Under left armpit it feels a knot and looks swollen). On an unknown date, the patient experienced PYREXIA (Fever) and FATIGUE (Fatigue). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency; DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (DAYQUIL) for Adverse event, at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) for Adverse event, at an unspecified dose and frequency. At the time of the report, LYMPHADENOPATHY (Under left armpit it feels a knot and looks swollen), PYREXIA (Fever) and FATIGUE (Fatigue) outcome was unknown.            Patient has been given third dose as the patient was on immune suppressive medication.   This case was linked to MOD-2021-348370 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Oct-2021: Follow- up received contains batch number of suspect drug, reporter address and updated start date of second dose.
Red itchy rash that was warm to touch at vaccine injection site - all was gone by the next day without any medical treatment needed.
heart beat was real fast/heart rate going faster; it was 140 then I got it down like 126 but it does not seem going to the normal; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 59 year-old male patient received bnt162b2 (COMIRNATY), administration date 15Dec2021 (Lot number: FT0809) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid" (unspecified if ongoing), notes: Caller states he just went threw Covid and is still recovering. The patient's concomitant medications were not reported. The following information was reported: HEART RATE INCREASED (non-serious) with onset 16Dec2021 06:30, outcome "recovered" (Dec2021), described as "heart beat was real fast/heart rate going faster; it was 140 then I got it down like 126 but it does not seem going to the normal". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter stated that he received his first shot of the Pfizer BioNTech Covid-19 vaccine yesterday. Reporter states this morning at 6:30-7:00 AM his heartbeat was fast and went up to between 144 and 130. He was worried and couldn't get his heartbeat down, so he did not go to his therapy appointment this morning. He checked his blood pressure, and the heartbeat was on there. He could not get it down, so he put his oxygen back and it helped bring his heart rate down. His heart rate was now okay, and it was down to 81. He just went through COVID and was still recovering as he was out of work for 3 months. He will be getting his second dose on 13Jan2022 which was 4 days before going back to work. Reporter would like to know if this was a normal side effect after getting the vaccine.  No follow-up attempts are possible. No further information is expected.
Patient received Gardasil and Menveo vaccines during her routine PE. Patient sat in exam room for 10 minutes after receiving vaccines and then parent requested to move to chairs in hallway prior to leaving for final 5 minutes. During that time, pt started to put on her coat and felt faint and passed out. Patient remained alert the whole time and did not lose consciousness. Fall was witnessed by patient's mother who was with her. Patient did not hit head. Patient was able to get to chair in hallway with assist and was cooled down with ice packs and drinking cold water as well as taking deep breaths. Patient was wearing 2 face masks which were removed during recovery. Patient recovered fully within 20 minutes and walked out of office to taxi to go home. Parent and patient were instructed to take note of reaction for future vaccines and call office if symptoms recurred or additional symptoms occurred.
Tdap 1/30/09- Rx scarred immediately - dizziness, 1/31/09 Temp 103 redness- swelling and warmth. Decreased appetite. Dizziness relieved by antivent. No Temp 2/2/09 Lump still growing 12 x 10 cm. Very warm. Redness up to shoulder
Pt presented with SOB and CP with EKG findings consistent with pericarditis. Symptoms began 1 day after vaccine and worsened.
sore at the injection site for the previous vaccines/sore arm at the injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient.  A 78-year-old male patient received BNT162b2 (BNT162B2), on 18Jan2021 at 19:00 as dose 1, single (Lot number: EL3249, Expiration Date: May2021) at the age of 78 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Pacemaker placement", start date: 2021 (unspecified if ongoing); "Atrial fibrillation" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Had all vaccines, from shingles to whatever, for immunization.  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "sore at the injection site for the previous vaccines/sore arm at the injection site".  Additional Information: Patient had the first shot Jan2021. Patient didn't have any side effects with the previous vaccines except maybe just a sore arm at the injection site. He has noticed references to heart issues, and he has a pacemaker. Pacemaker placed: sometime in the year of 2021, but he had issues before the COVID-19 vaccines. More recently he had atrial fibrillation and was given two medications. The atrial fibrillation was light, so they didn't want to shock his heart. Appears the atrial fibrillation was gone. Had symptoms of that at night before receiving the COVID-19 vaccines. Thought muscles were twitching before they discovered it was tied in with the heart. When he would lay on his left shoulder, it felt like a light vibration. He was given the pacemaker, then had Atrial fibrillation, then given the medicine to take care of it. Investigations: none. Primary doctor and specialist are really good about keeping bloodwork up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300029209 same reporter/patient, different events/doses;
Vaccine administered on 10/12/13. Patient noticed red area where shot was administered on 10/14/13. No pain or itching, just very hard to the touch.