chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shingles; rashes coming out of the belly, under of breasts, from the left side to her back; have pain under the rib on the left side/ On Tuesday (26Jan2021), the pain increased; This is a spontaneous report from a contactable other health care professional (Nurse). A 74-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown), dose 1 via an unspecified route of administration on 20Jan2021 as 1st dose, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 22Jan2021, the patient experienced pain under the rib on the left side. On 24Jan2021, the pain was still there, it never left but just continued. The patient went to the emergency room to get checked by results returned okay so patient returned home. On 26Jan2021, the pain increased, more tests returned normal. On 28Jan2021, the patient noticed rashes coming out of the belly, under of breasts, from the left side to her back. On 29Jan2021, she had a doctor's appointment, and with a cardiologist on 02Feb2021. The cardiologist confirmed that patient's heart was fine, and gave Valtrex for shingles. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Got shingles after having the shot/Suspected vaccination failure; Got shingles; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and 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 and Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. As per the patient vaccine did not work for everyone. The patient got shingles after had the 2 Shingles shots and hoped better results. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation of shingles were unknown at the time of reporting. This case has been linked with the case US2021AMR186902, reported by the same reporter.
Woke up the next day with slight fever and chills. Minor body aches are also present.
Patient has a very sore arm with redness that has persisted for 2 weeks after administration also tingling in the left hand started 10 days after administration.
On 12/2/02, cough with congestion, red cheeks, droopy eyes and real weak X 2 weeks. On 12/6/02, bad cough with congestion and rash.
Immediately upon vaccination, I began to feel "weird".  After about 10 minutes, I advised the observation nurse that I was feeling unwell.  I was not quite dizzy and not quite lightheaded, but I definitely felt "off".  She gave me some water.  I felt progressively worse during the next 4 hours.  At 4 hours after vaccination, I was so dizzy I could no longer stand for very long.  The next morning, I awoke and was so dizzy I could not get out of bed and collapsed on the floor.  I remained extremely dizzy the rest of the day.  I felt slightly better the next morning, but I was extremely dizzy within a couple of hours and had to return to bed.   I remained dizzy enough I could not function for 10 days.   The 11th day after vaccination, I began to feel slightly less dizzy, however, I still have intermittent dizziness 18 days after vaccination.  I also had severe arm pain the evening after my vaccination.  I was unable to use my arm at all.  The extreme pain began to subside after 2 days, however, I still have a mild ache in my arm 18 days post-vaccination.
Initial information received on 20 February 2009 from a consumer. A 65 year old male patient who at the age of 5 years suffered severe chest pain and was diagnosed with pleurisy after being vaccinated. No further details were provided. The patient also reported having polyps removed from his colon (date not provided). On 10 February 2009 the patient received ACAM2000 (lot number was not reported). The patient stated that he had a "take" at the vaccination site. Two to three days post vaccination he developed an "engrossing but not sharp" pleuritic chest pain which resolved after two days. There was no associated shortness of breath but the patient had nasal itching and sneezing. No further information was reported. List of Documents held by Sender: none.
A report was received from a health care professional on 27 October 2003 concerning a vaccinee of unknown demography who experienced a red, hot arm with a rash, neck redness and difficulty breathing an unspecified length of time after receiving Fluvirin vaccine on an unknown date. On an unknown date, the vaccinee's arm became red and hot with a rash. The redness extended from the arm to the vaccinee's neck. The vaccinee also experienced difficulty in breathing. The outcome of the events was not reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Cross reference with PJP-2003-01009.
Felt fine on the day of vaccine (March 8) but during the following night flu-like aches, pains, shivering and lethargy set in. Woke up at 2.30am feeling like I'd been knocked down by a bus and shivering uncontrollably. Really rather like a HUGE flareup of my Fibromyalgia. Tylenol didn't really help. Tossed and turned until 6am at which point I decided a cup of tea would be nice, especially as I couldn't stop shivering. Plus some stronger pain meds (Tylenol #3, which I usually take at bedtime to help get full and restful sleep). Put day clothes on for warmth and returned to bed. Finally able to get back to sleep around 9am.  Day 2: spent most of the day in bed trying to get/keep warm in order to overcome the extreme whole-body pain. Only got up to get hot drinks and to eat something. Brain fog meant I couldn't concentrate on doing anything. Slept a lot.  Day 3: Feeling MUCH better. My arm was a bit swollen and painful at the site of the shot. The body still felt like it had been in a boxing match and I was a tad sluggish, but the aches and pains were nowhere near as bad as the day before.  Day 4: Most of the strong adverse symptoms were gone, except for milder pain and brain fog.  Day 5: Now almost back to what constitutes 'normal' for me. Back to regular life but with plenty of rest as I find myself getting tired after moderate exertion.
Initial report received from a healthcare professional on 18 January 2013. An 18-year-old female patient, with no illness at the time of vaccination and had no known allergies, had received an intramuscular dose 2 of MENACTRA vaccine (lot number U4292AA) in left arm, on 18 January 2013. On 18 January 2013, the patient experienced numbness from injection site in left arm down to left hand. Laboratory investigations and corrective treatment were not reported. The patient's outcome was not recovered. Documents held by sender: None.
Nausea; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 13-Apr-2021 and was forwarded to the company on 13-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included IBUPROFEN, CITALOPRAM, VERAPAMIL and PRAVASTATIN for an unknown indication.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced NAUSEA (Nausea). On 24-Mar-2021, NAUSEA (Nausea) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   This case was linked to MOD21-074326 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  MOD21-074326:
Patient experienced headache and was extremely tired the following day. She also had a swollen and red arm after both the first and second doses.
Arm was hot to touch and itchy; Purple hue around the injection site; hot and warm from the elbow to her shoulder; Had inflammation; Arm was hot to touch and itchy; Sore arm; Welt that was hard and hot at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Arm was hot to touch and itchy), VACCINATION SITE DISCOLOURATION (Purple hue around the injection site), FEELING HOT (hot and warm from the elbow to her shoulder), INFLAMMATION (Had inflammation) and VACCINATION SITE PRURITUS (Arm was hot to touch and itchy) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension. Concomitant products included ATORVASTATIN and ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    On 11-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Arm was hot to touch and itchy), VACCINATION SITE DISCOLOURATION (Purple hue around the injection site), FEELING HOT (hot and warm from the elbow to her shoulder), INFLAMMATION (Had inflammation), VACCINATION SITE PRURITUS (Arm was hot to touch and itchy), PAIN IN EXTREMITY (Sore arm) and VACCINATION SITE URTICARIA (Welt that was hard and hot at the injection site). At the time of the report, VACCINATION SITE WARMTH (Arm was hot to touch and itchy), VACCINATION SITE DISCOLOURATION (Purple hue around the injection site), FEELING HOT (hot and warm from the elbow to her shoulder), INFLAMMATION (Had inflammation), VACCINATION SITE PRURITUS (Arm was hot to touch and itchy), PAIN IN EXTREMITY (Sore arm) and VACCINATION SITE URTICARIA (Welt that was hard and hot at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications include Benadryl and advil.
tested positive for covid on 09Jan2022; tested positive for covid on 09Jan2022; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from regulatory authority. The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 04Nov2021 13:00 (Lot number: EW0217) at the age of 44 years as dose 3 (booster), single, intramuscular, administration date 16Feb2021 (Lot number: EL3247) as dose 2, single and administration date 26Jan2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), administered in arm left, administration date 04Nov2021 (Batch/Lot number: unknown) as dose number unknown, single for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CELEXA [CITALOPRAM HYDROBROMIDE]; PRILOSEC [OMEPRAZOLE]; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Past drug history included: Amoxicillin, reaction(s): "Known allergies: amoxicillin". The following information was reported: IMMUNISATION (non-serious) with onset 04Nov2021 13:00, outcome "unknown", described as "booster"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 09Jan2022, outcome "not recovered" and all described as "tested positive for covid on 09Jan2022". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (09Jan2022) positive; (18Dec2021) negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. No follow-up attempts are possible. No further information is expected.
[t recv vax 20NOV97 & 28NOV97 pt devel a fever, rash & flu like sx;
Patient received monovalent Pfizer instead of bivalent Pfizer. No adverse side effects reported at this time.
pt recv vax; stiffen legs & arms;inc sleep;no fever; seen in er & was eval;
Jan 10 noticed hole in lower abdomen upper groin where I have had a under the skin Hidradenitis supprativa lesion for a year. I have never had one break through the skin before. It was a hole. I was given Doxycycline twice a day, Metronidazole topical cream twice a day and the doctor gave me some steroid shots in the actual lesion on Jan 10th. I went back for a follow up on 2/24/21 and it had closed up but still a place I needed to put meds on and antibiotic.  I stopped all the meds March 10th.  There is still an area that is healing but it isn't open any more. Not sure if since inflammatory disease did it worsen with the vaccine- maybe caused and inflammatory response.
within 24 hours of receiving vaccine (2nd booster of `Pfizer, 1st booster received 12/3/21), I experienced building extreme upper arm pain.    As over the counter pain relief was ineffective, I went to clinic on 4/24/22 in attempt to get care.  X-ray was taken, negative, pain relievers were given.    The pain evolved to feeling like a "tight" and inflamed nerve throughout my arm and hand .  This cause considerable discomfort, loss of sleep and did not begin to lessen for at least 2 weeks.   As of 6/4/22 it is mostly gone but some residual numbness, tingling and pain occurs daily.
Pt. states after receiving the Shingrix 07/15/2021 an hour later started experiencing hand soreness/injection site, numbness. Continuing to monitor.
Flu like symptoms, shivers, headache, tiredness, aches especially legs, arm pain at shot sight, fever, weakness, dizziness for 6 days.
10 day history starting around 8/15/21 of sinus congestion with headache. Has minimal non productive cough. No SOB but had fever yesterday. (8/23/21)
Uncontrollable shivering and fever for 24 hours.  Body aches and sweating for 48+ hours.  Has not subsided as/of this reporting.  Sweating caused dehydration with brown urine and severe headache.  I am working on getting rehydrated but have not requested  any medical attention.
Client contacted NJCRI on 3/11/21 complaining that on 3/10/21 at 10 pm he began feeling tire, achy throat and this morning 3/11/21 at 8 am began with profuse diarrhea, shortness of breath and heart palpitations. BP taken by patient at home 164/90 and pulse of 140 bpm while nurse triaged on the phone.
EVERY DAY, A RASH TOTAL BODY, USUALLY IN THE MORNING BUT CAN BE TRIGGERED BY TEMPERATURE CHANGE LATER IN THE DAY. THE RASH WILL LAST 45 MINUTES TO OVER AN HOUR. TAKING 1, 25MG  TAB UPON ONSET HELPS IF NOT TAKEN THEN SHORTNESS OF BREATH AND LONGER LASTING RASH UP TO 2 HOURS.
Pt recvd 1st dose of vax w/no noted problems; pt recvd 2nd dose of vax 18AUG92 w/in an hr following vax, pt exp sore arm w/pain @ inject site; sx resolved w/in 24 hrs; No further details were provided;
limited mobility in injection site arm/ she can't lift shoulder and arm pass her head; This spontaneous report was received from a 56 years old female consumer referring to herself. Information about medical history, concurrent conditions and concomitant therapies were not provided.     On 19-OCT-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) single dose shot (route, lot number and expiration date were not reported) for prophylaxis (reported as prevention of pneumonia).   On the same day, the patient experienced limited mobility in injection site arm. She stated she could not lift shoulder and arm pass her head. The patient received medical attention for the issues she was having by her physician. The patient was given antibiotics and pain medication, but did not know the name of the medications given. She stated that she had a follow up appointment on 12-NOV-2020. The outcome of injected limb mobility decreased was recovering. The causality between the event and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.
she gave an expired menactra vaccine to a patient with no reported adverse event; Initial information was received on 13-Jul-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age male patient who reported that she gave an expired meningococcal a-c-y-w135 (d conj) vaccine [Menactra] to a patient with no reported adverse event.  The patient's past , medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.   On 11-Jul-2023, the patient received a dose of 0.5 ml of expired suspect meningococcal a-c-y-w135 (d conj) vaccine (solution for injection) (Frequency : 1x Once) of standard strength, (lot number not reported, Expiry date: 24-Apr-2023) via unknown route in unknown administration site for Immunization with no reported adverse event (expired product administered) (latency : same day). The information on batch number was requested.  It is unknown if there were lab data/results available.   Action taken: not applicable.  At time of reporting, the outcome was Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Breakthrough hospitalization for COVID -19 in fully vaccinated patient with 2 dose primary series of vaccine
onset 4SEP98 described as small pimple bumps-no fever;10 or 11 on shoulder & neck, 3 on back of neck, 1 on abd, 1 on leg;no other sx varicella rxn dx by PMD:
Pt called at 6:30 stating that they had developed hives post their first administration of the covid vaccine, no other issues than a bilat. rash (hives) on upper arms. pt took benedryl before calling and stated no signs of anaphylaxis and will follow up with their dr in the am
3 days following the vaccine I felt as though my blood pressure might be elevated.  I checked it several times and it was over  200 (208, 212), so I sent to the ER where they did tests and found everything to be normal.  BP dropped to 167 while there, so  no medication was given.  Advised to follow up with primary care doctor, which I did 2 days later.    BP still in the 160s.  Advised to monitor and if not improved to begin an additional BP medication..  That medication was started today.  The vaccine was given through the County Health Department.
Employee vaccinated with Moderna- stayed during 15 min observation. Reports leaving and feeling weird so she came back to the facility. Reports unable to catch breath/shortness of breath, weird feeling, and shaky. Returned approximately 45 mins after vaccination. BP elevated, glucose normal, pulse ok 97. No report of swelling. BP was monitored by nursing staff and after remaining elevated, employee was sent to ER for evaluation.
Fever p/DTP 3-4 hrs later developed generalized convuls 2OCT90 & sz recurred in JUN91;
Received Moderna 2/6/21 Received Pfizer 3/3/21  Patient came in for 2nd dose of COVID-19 vaccine on the incorrect day. Patient stated to vaccinator he was receiving his first dose during screening then after injection was administered stated no this is my 2nd dose. The clinic was supporting a National Guard event, so the medical record system did not have the previously received Moderna dose documented. Patient did not have any immediate adverse event or experience any symptoms during the 30 minute monitoring period.
Anxiety; Mood swings; Depression; Feeling sick; Panic; Fogginess; Difficulty focusing; Fatigue; Nausea; Feeling hot; Sweating; 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.  An 54 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 26Mar2021 07:15 (Lot number: ER8730) at the age of 54 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: FATIGUE (non-serious) with onset 27Mar2021, outcome "unknown", described as "Fatigue"; NAUSEA (non-serious) with onset 27Mar2021, outcome "not recovered", described as "Nausea"; FEELING HOT (non-serious) with onset 27Mar2021, outcome "recovering", described as "Feeling hot"; HYPERHIDROSIS (non-serious) with onset 27Mar2021, outcome "recovering", described as "Sweating"; ANXIETY (non-serious) with onset 31Mar2021, outcome "not recovered", described as "Anxiety "; MOOD SWINGS (non-serious) with onset 31Mar2021, outcome "not recovered", described as "Mood swings"; DEPRESSION (non-serious) with onset 27Mar2021, outcome "not recovered", described as "Depression"; MALAISE (non-serious) with onset 27Mar2021, outcome "unknown", described as "Feeling sick"; PANIC REACTION (non-serious) with onset 27Mar2021, outcome "not recovered", described as "Panic"; FEELING ABNORMAL (non-serious) with onset 27Mar2021, outcome "not recovered", described as "Fogginess"; DISTURBANCE IN ATTENTION (non-serious) with onset 27Mar2021, outcome "not recovered", described as "Difficulty focusing". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information:  The patient was not Vaccine Administered at Facility. The patient did not any Adverse event require a visit to ER or MD office.   No follow-up attempts are possible. No further information is expected.
This medically confirmed spontaneous report (initial receipt 16-Nov-2011) concerns a 85-year old female patient, who had a medical history of hypertension. Concomitant medications included blood pressure and bladder medications. On 13-Sep-2011 the patient received AFLURIA and PNEUMOVAX 23. On 13-Oct-2011 the patient received a single dose of 0.65 mL ZOSTAVAX subcutaneous injection. On 24-Oct-2011 the patient was diagnosed with an episode of shingles by the physician. The patient presented to the physician's office with a 'zoster-like rash in the upper right quadrant'. She was prescribed acyclovir ointment for the rash. The event outcome was recovering.
Patient reported dizziness about 3 minutes after injection.  BP 88/60, pulse 92.  Given water to drink, declined snack and states she did eat breakfast.  Observed for 30 minutes, and BP 94/70 and pulse 81.  No further complaints and able to ambulate independently.