chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Adminitered in Gluteal Region Instead of Deltoid; Initial Report Received on 17-Sep-2020 and 18-Sep-2020  Non-Significant Follow-up Received on 19-Oct-2020:  Duplicate information that was previously received.   A Nurse Practitioner reported that a 46-year-old female received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization intramuscularly in the left gluteus.  No medical history was reported.   No concomitant medications were reported.  On 18-Aug-2020, the patient received a dose of HEPLISAV-B (Lot # 933625, expiration date 12-Sep-2021, NDC # not reported) from Occupational Health at a hospital. The injection was administered intramuscularly in the left gluteus medius instead of the deltoid. The patient did not report any adverse reactions to the injection and no other vaccines were administered at the same time.  No additional information was reported.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
This spontaneous report was received from a pharmacist via company representative referring to a male patient of unknown age, whose concurrent conditions and medical history were not provided. On 30-NOV-2015, the patient was vaccinated with ZOSTAVAX, subcutaneous (dose, dose number, site of administration, lot number and duration were not provided). Concomitant therapies were not reported. On 30-NOV-2015, the patient experienced influenza reported as "the flu". On an unknown date, the patient sought for medical attention through an office visit. However, no treatment was given for the adverse event. The outcome of influenza was reported as not recovered. Additional information has been requested.
Pt began c/o rt arm pain in the evening of 7/1/10. No redness or swelling was noted to arm at that time. On 7/2/10 at aprox 1930 patient c/o rt arm pain and was found to have redness, swelling, heat and extreme pain from deltoid to just distal of elbow. Patient seen by ANP. Symptoms remain-less pain today 7/6/10. Pt being treated with MOTRIN, TYLENOL, KENALOG; prednisone, vancomycin, and ROCEPHIN.
Vomiting; Paraesthesia foot; Bed ridden; Unable to walk; Vaccination site pain; This is a spontaneous report from a contactable physician.    A 26-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 intramuscular on 26Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for rheumatoid arthritis.The patient medical history was not reported. The patient's concomitant medications were not reported. On 29Mar2021, patient experienced unable to walk with outcome of recovering , vaccination site pain with outcome of recovering , vomiting on 30Mar2021 with outcome of unknown , paraesthesia foot  on 29Mar2021 with outcome of recovering , bed ridden on 29Mar2021 with outcome of unknown.  The action taken in response to the event(s) for bnt162b2 was not applicable , for adalimumab was unknown.  No follow up attempts are needed. No further information is expected.
Case PHEH2016US023585 is an initial spontaneous report received from nurse on 13 Sep 2016. This case refers to female patient of an unknown age. Past medical history and concomitant medications were not reported. The patient was vaccinated with expired FLUVIRIN, batch number: 1516501, expiry date: Jun 2016) at a dose of 0.5 ml single dose intramuscular on 13 Sep 2016. No adverse event was reported following this medication error (expired vaccine used). The seriousness of event was reported as non serious.
Hives; This is a spontaneous report from a contactable consumer (patient). A 63-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in right upper arm on an unspecified date (batch/lot number: EN6201) as a single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medication included omeprazole (PRILOSEC, 20 mg capsule) taken for an unspecified indication, start and stop date were not reported. The patient stated, "I got the Pfizer shot and I got the hives from it on 12Feb2021 and they just told me to call you and tell you and report it." The patient stated it's the first dose Pfizer BioNTech it's all the patient knows. The patient was still having the hives, it was still persisting, the patient got some medicine to take it away. Therapeutic measures were taken as a result of hives which included prednisone, 50 mg. The outcome of the event was not recovered.  No follow-up attempts are needed. No further information is expected.
Violent chills, fever, muscle stiffness, muscle pain, sharp nerve pains, mild shortness of breath, stomach upset, frequent urination, fatigue, brain fog
Initially, patient had right side (side of vaccine) get warm and flushed: arm and neck. Then scratchy and swollen throat; started coughing and unable to speak complete sentences due to coughing.
Fever; Headache; Fatigue; Muscle weakness; Exercise intolerance; Photosensitivity; This case was reported by a consumer via call center representative and described the occurrence of fever in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced fever, headache, fatigue, muscle weakness, exercise tolerance decreased and photosensitivity. On an unknown date, the outcome of the fever, headache, fatigue, muscle weakness, exercise tolerance decreased and photosensitivity were recovered/resolved.   It was unknown if the reporter considered the fever, headache, fatigue, muscle weakness, exercise tolerance decreased and photosensitivity to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received dose of Shingrix vaccine and immediate after the vaccination experienced fever, headache, fatigue, muscle weakness, exercise intolerance, and photosensitivity. The patient stated that the fever resolved after approximately 24 hours.  The patient also stated that the headache, fatigue, muscle weakness, exercise intolerance, and photosensitivity resolved after approximately 3 weeks, after the first dose of Shingrix. The patient did not remember when the first dose of Shingrix was received, but confirmed it was more than 6 months before they received the second dose.  The reporter did not consent to follow-up. For 2nd dose tolerance, refer linked case US2021259887, reported by the same reporter for same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021259887:2nd dose case, same reporter
About 45 minutes after receiving vaccine, I broke out into hives (minor) on the left shoulder/upper arm (surrounding injection site) and right forearm (more severe than left arm). Experienced slight drowsiness around 6pm into the rest of the evening. Currently taking two antihistamines at night (Xyzal and Hydroxizyne). Woke up the next morning (01/05) very drowsy and stayed in bed well into the afternoon. Drowsiness continued into Wednesday (01/06), but not as severe. Wednesday evening was when the drowsiness subsided.
Information has been received from a certified medical assistant concerning a 33 year old female with a history of an abnormal papanicolaou smear, on 01-OCT-2007 was vaccinated with a prefilled syringe IM in the arm with a first dose of GARDASIL (Lot# 658282/0929U). It was reported that the patient insisted on getting the vaccine, despite the recommendation of the physician. On 03-DEC-2007 the patient was vaccinated with a second dose of GARDASIL (Lot# 659437/1266U). Concomitant therapies included hormonal contraceptives (unspecified) and "hormones."  About a month post vaccination, on 07-JAN-2008 the patient developed a "hive type rash." The rash was reported to be itchy and burning. The patient called the office. On 08-JAN-2008 the patient saw an allergist. The patient recovered on an unspecified date. No product quality complaint was involved. Additional information is not expected.
Staff gave the patient a flu shot. 15 minutes later, the patient and her mother told the pharmacist that they were having no interactions to the flu shot and that they were leaving the store. 5 minutes after that, the mother returned with the patient and said that the child was breaking out in hives and was having an allergic reaction to the flu shot. She requested some BENADRYL be given to the child. Staff noticed one small spot on the child's back. Staff gave the child 10 mls of BENADRYL liquid. Upon discussing the reaction further with the mother, it came to light that the child has had hives for the past 5 days. The mother said that the child gets allergy shots, but had to stop them because they couldn't make it to the clinic during school hours. She asked which antihistamine is best for hives, and staff told her ZYRTEC. Staff instructed her to continue to watch the hives and go straight to the ER if she noticed any swelling around the mouth or difficulty breathing. She said she would.
Soreness around the injection site with pressure; Headache; Soreness; A spontaneous report  was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events soreness around the injection site with pressure, headache  The patient's medical history covid-19, stroke were provided by the reporter. Concomitant medications metoprolol 50 mg, gabapentin 600mg, lodopine 5mg, atorvastatin 40mg, clopidogrel bisulfate, hydrochlorothiazide, losartan 100 mg were reported.  On 25 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 006M20A) via unknown route in his left arm for prophylaxis of COVID-19 infection.  On 25 Feb 2021, the patient experienced the events soreness on arm injected with pressure and headaches. Treatment included calcium, woman's multi vitamin, bare aspirin 81mg , ibuprofen was provided by the reporter.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of events, soreness on arm injected with pressure and headaches were unknown at the time of this report.
I had an immediate histamine reaction. Lots of mucus and snot that would not stop. It was just pouring down my throat uncontrollably. I was held at the clinic for about an hour before they sent me home. They did not know what was wrong. I lost 4 whole days after receiving this one. I have never had this happen before but I literally slept and was unconscious for 4 days.
Current pregnancy: no issues (currently week 19, EDD 7/2/21). Previous pregnancies: 1.  ADE: fatigue X 48 hours, nausea X 24 hours, headache X 72 hours after immunization. Prevented normal function over the weekend. Headache was mild as of today (Monday). Symptoms generally treatable with moderate dose acetaminophen. Symptoms waning and are consistent with robust immune response to vaccine.
Swelling, erythema and induration around injection site (5cm in diameter). Benadryl and topical Triamcinolone cream.
Systemic: Patient fell and was having difficulty to get up-Severe, Systemic: Weakness-Severe, Additional Details: Patient fell and was having a hard time getting up as the day went on her felt worse and asked his wife to take him to the ER. He was at the hospital from Sunday until Tuesday and then transported to rehab to get his strength back.
had a 103 degree fever; nausea; myalgia; This is a spontaneous report from a contactable other hcp (patient). This report was received via a Pfizer sales representative.  A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection lot no. and expiry date not reported), via an unspecified route of administration on 21Jan2021 at a single dose for covid-19 immunization.  The patient's medical history and concomitant medications were not reported. The patient had 1st dose of covid-19 vaccine on unspecified date. Caller stated that she got a call from a Nurse Practitioner (patient) who gets samples from her, and the patient informed the caller that she got the second dose of the COVID vaccine, and she informed about side effect she experienced. Caller stated that the patient seemed fine with consent for follow up from Pfizer, however, the caller wishes to only provide the reporter's (patient's) email address at this time. Caller confirms that the reporter is also the patient and does not know the reporter's date of birth, age, height, weight, or ethnicity. Caller confirmed the patient had the experience.  Caller does not have prescriber information for the person who prescribed the product to the patient.  It was reported that patient got the second dose of the COVID vaccine on Thursday 21Jan2021, and after that, she had a 103 degree fever, nausea, and myalgia. She reported that symptoms started 12 hours after receiving the second shot, and they lasted for about 24 hours. Caller does not know if the patient received any other vaccines on the same day as the COVID vaccine. Outcome of the events was unknown.
This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (high fever 102.9) and HEADACHE (crazy headache/constant headache/brain is sick inside my head/bigger pressure) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. # 009C01A) for COVID-19 immunisation.     No Medical History information was reported.   On 14-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, the patient experienced PYREXIA (high fever 102.9) and HEADACHE (crazy headache/constant headache/brain is sick inside my head/bigger pressure). On 16-May-2021, PYREXIA (high fever 102.9) had resolved. At the time of the report, HEADACHE (crazy headache/constant headache/brain is sick inside my head/bigger pressure) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-May-2021, Blood pressure measurement: 100/70 (normal) 100/70. On 14-May-2021, Body temperature: 102.9 (High) 102.9 degree.         No concomitant medications were reported. No treatment details were reported.
PATIENT DESCRIBED GETTING "CHILLS" AND SHAKING/COLD FEELING AROUND 2 AM. WOKE HIM FROM SLEEP. LASTED ABOUT 2-3 HOURS PER THE PATIENT'S MEMORY. NO OTHER ADVERSE EFFECTS. PATIENT'S SISTER EXPERIENCED SAME SIDE EFFECTS AFTER SHE RECEIVED SHINGRIX.
inadvertently given the 10 mcg dose of Pfizer COVID vaccine by nursing staff (instead of the appropriate 3 mcg dose) - no signs/symptoms of adverse outcome
scared to receive her 2nd vaccine; shoulder pain at injection site; muscle pain; joint pain; severe at times where she could hardly get out of bed to get to the restroom; This spontaneous case was reported by a consumer and describes the occurrence of FEAR (scared to receive her 2nd vaccine), VACCINATION SITE PAIN (shoulder pain at injection site), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and MOBILITY DECREASED (severe at times where she could hardly get out of bed to get to the restroom) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     The patient's past medical history included Emergency care examination abnormal (Patient tested positive for COVID-19  in nov2020 and went to the emergency department because her blood pressure went very low.) in November 2020 and Fluid replacement NOS (Patient received fluids in the emergency department.) in November 2020.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced VACCINATION SITE PAIN (shoulder pain at injection site), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and MOBILITY DECREASED (severe at times where she could hardly get out of bed to get to the restroom). On an unknown date, the patient experienced FEAR (scared to receive her 2nd vaccine). On 16-Apr-2021, VACCINATION SITE PAIN (shoulder pain at injection site), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and MOBILITY DECREASED (severe at times where she could hardly get out of bed to get to the restroom) had resolved. At the time of the report, FEAR (scared to receive her 2nd vaccine) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, COVID-19: positive (Positive) Positive. In November 2020, Hypotension: low (Low) Blood pressure went very low..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  Treatment information was not provided.    Reporter did not allow further contact
Saturday, Mar. 6th ? Noticed itching at injection site.  Found oval-shaped, slightly raised, red area about 1? x 3/4? wide.  Itched only when touched.  After 10 minutes, began to fade slightly, but still very noticeable.  Rash area began to enlarge toward evening.  Mar. 7th ? rash area enlarged to 2? x 1.5?.   Mar. 8th & 9th ? rash still same size, but fading out,  Mar.10th ? reduced size, very faint.  Since Mar 11th, basically gone, but looking closely, I could still see a small, very slightly pink ring around the injection until one week after I got the second dose of the vaccine.
No adverse effects; the patient was administered improperly stored VARIVAX; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 05-SEP-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) injection, lot # R002506, expiration date: 25-JAN-2020 (exact dose, injection site and route of administration were not provided) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (MERCK) injection (exact dose, injection site, route of administration, indication, lot # and expiration date were not provided). Administered dose experienced the temperature excursions of (7.7 degrees Fahrenheit) 6 degrees Fahrenheit to 14 degrees Fahrenheit for 3 hours 55 minutes. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. No adverse effects were reported.
PT EXPERIENCING NECK STIFFNESS ONE DAY AFTER RECEIVING HIS HIGH DOSE FLU SHOT. THE NECK STIFFNESS IS CAUSING SLEEP DISTURBANCE.
PATIENT FAINTED AFTER VACCINATION. PATIENT REGAINED CONSCIOUSNESS WITHIN 30 TO 60 SECONDS.
c/o pain @ inj site where shot recv;arm cont to be painful;c/o rash that looks like bruising;
Case number PHEH2014US024301 is an initial spontaneous report from a nurse received on 02DEC2014 and with a follow-up from a nurse received on 21JAN2015. This report refers to a 45 year old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient had tolerated vaccines (no further details provided) well in the past. The patient was vaccinated with FLUVIRIN 2014/2015 (seasonal influenza vaccine, batch number: 14511P, expiry date: MAR2015) into left deltoid intramuscularly at a dose of 0.5 ml on 05NOV2014. The nurse reported that FLUVIRIN 2014/2015 was stored at 49F for one hour and 15 minutes before administration to the patient. The nurse reported that before vaccination the prefilled syringe (PFS) of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. No adverse event was reported following this maladministration (incorrect storage of drug). No further information was provided. Follow up from a nurse received on 21JAN2015: Site of vaccination (left deltoid) and other clinically relevant information on previous vaccinations in the narrative was updated.
My son had a few hives on his chest. Within a week a rash started to appear in the area where the vaccination was given. The rash gradually became worse and red bumps continue to appear on his body.
Narrative:  66 yo MALE with metastatic bladder cancer including brain mets now s/p XRT cranium, adrenal, L lymph, bladder went to home hospice on 9/25/2021. Pt died peacefully at home on 11/24/2021. Pt had received covid vaccines on 2/5/21 & 8/31/2021. Vaccines not related to pt's death.
FLUVIRIN given Sunday 8/29/10 at 5:50 PM. Patient presented at pharmacy 9/3/10 at 2:00 PM with large injection site reaction. Patient claims that site has worsened since 8/29. No other complaints - just injection site reaction. Raised circle (~ dime size). Patient taking BENADRYL and ibuprofen. Will contact Doctor if condition worsens.
Fainted approximately 24 hours after receiving vaccine.  Prior to fainting felt nauseous and light headed.  Fainting lasted very short period of time (minutes or less), felt better afterwards.
COVID-19; Face was swollen, just an arch on either side of my nose down to my lip.; Lump hot and sore; Tired and sleepy; arm sore a little bit; A spontaneous report was received from a nurse concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event, arm a little bit sore, lump hot and sore, tired and sleepy , Face was swollen, just an arch on either side of my nose down to my lip and tested positive for covid following the vaccination.    The patient's medical history were unknown.   Relevant concomitant medication included Crestor for cholesterol.   On 02Jan2021 prior to the onset of the events, arm a little bit sore, lump hot and sore, tired and sleepy , Face was swollen, just an arch on either side of my nose down to my lip and tested positive for covid the patient received their mRNA-1273 (lot/batch: not provided) unknown route for prophylaxis of COVID-19 infection.    Laboratory details included covid 19 tested positive on 21JAN2021.     Treatment included Benadryl and nasal corticosteroids for day 13 Ice pack and Advil and for day 2  Action taken with mRNA-1273 in response to the events was not reported.      The outcome of  reported events  like  a little bit sore, lump hot and sore, tired and sleepy  were recovered/resolved. Outcome of , swollen face, just an arch on either side of my nose down to my lip were recovering/resolving, and outcome of covid 19 was not recovered/not resolved.  The reporter assessment for the event(s) arm sore, lump hot and sore, swollen face, nose and lips and covid 19 were not provided.