chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Also noticed brown spot on her right middle finger; Developed a big brownish blotch spot on her right arm above wrist, underneath her arm, and around her arm.; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Developed a big brownish blotch spot on her right arm above wrist, underneath her arm, and around her arm.) and SKIN DISCOLOURATION (Also noticed brown spot on her right middle finger) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Dec-2021, the patient experienced RASH MACULAR (Developed a big brownish blotch spot on her right arm above wrist, underneath her arm, and around her arm.). On an unknown date, the patient experienced SKIN DISCOLOURATION (Also noticed brown spot on her right middle finger). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, RASH MACULAR (Developed a big brownish blotch spot on her right arm above wrist, underneath her arm, and around her arm.) and SKIN DISCOLOURATION (Also noticed brown spot on her right middle finger) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information was reported.    This case was linked to MOD-2021-052941 (Patient Link).
Headache, nausea and swollen and stiff arm where Tdap vaccine given 24 hours after shot given.
This spontaneous report was received from a 73 year old female patient. Patient's concurrent conditions included allergy to drug hypersensitivity. Historical drug included azithromycin (reported as arithromyacin), the patient had no pertinent medical history. On an unknown date in July 2016, the patient was vaccinated with PNEUMOVAX 23 (lot, expiry date, dose number, units, route and anatomical location were not specified). There were no concomitant medication. Approximately in an unknown date in July, the patient experienced severe pain at the injection site. Approximately in an unknown date in July, the patient also felt "lightheaded and exhausted". Approximately on an unknown date in 2016, outcome of dizziness, fatigue and injection site pain were reported as recovered/resolved. There were no Product Quality Concerns (PQC) involved. Relationship between the events and PNEUMOVAX 23 were not related. Additional information has been requested.
Rash on IMZ arm, a few penny sized bumps,  flu-like symptoms coming on, slight muscle aches/pain.
Right side of my face went numb; This is a spontaneous report from a contactable consumer (Patient).  A 41-years-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EN6206), via an unspecified route of administration on 11Mar2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced right side of my face went numb on 11Mar2021 after 28minutes of vaccination. Communication company: Reason of delay: Daily spike of incoming calls due to COVID19 vaccine. The outcome of the event was recovered.  No follow-up attempts are needed. No further information is expected.
Dizziness, sweating profusely, shaking, the feeling I was gonna pass out & complete loss of skin color. Shaking so bad I couldn?t hold a cup of water with 2 hands. This lasted for about 15 or 20 minutes. Then off & on for about the next week I would get moments of dizziness & feeling of I might faint, but not so severe as right after the shot.
Tinnitus in both ears, worse in the left ear. Drumming sensation in left ear sporadically. No tinnitus previous to vaccination. Sudden onset around March 10.
By the 2nd or 3rd day after vaccine, I had headaches and body aches. The body aches lasted about 2 or three days. Then I started having sinus issues. I have been to the doctor twice. My head and ears are clogged up. I do not have headache anymore. Not just the injection site hurts but it hurts going up - all the way from my shoulder to my neck to the back of my head hurt after the vaccine. It doesn't hurt anymore. But I'm very stuffy and congested and I'm probably going to go back to the doctor this week. This is a lot of days for these symptoms. I don't usually have them for this long. I've been taking Claritin, Sudafed and Nyquil for sinus at night. I had a flu shot that was maybe over a month from this website that schools and doctor's offices can look on for when I got this. I usually get shots in my left arm, so chances are it was in my left arm.
On Oct. 12, stores received an internal Urgent Removal Notice regarding Pfizer COVID-19 Vaccine- Pediatric 5-11 Years Tris-sucrose, Lot #FL2757 with manufacturer?s expiration date of Sept. 30.  Information has been received from the manufacturer indicating that stability data supports the use of this product through Oct. 19.       What I need to do:       Administration data from database indicates your location administered doses of the affected lot after the Sept. 30 expiration date but on or before Oct. 19. For doses administered between Oct. 1 and Oct. 19, with manufacturer data to support the stability and efficacy, revaccination is not indicated, and patient notification is not required. Any dose administered on or after Oct. 1 must be reported in database and VAERS.
After receiving the pneumonia vaccine on March 9th, the next day (March 10th) I noticed a raised red area on the underside of my arm. Over the weekend, I began having slight chest pains, achy joints, especially in my hips, back, and shoulders. By Tuesday, March 14th, I was very congested and coughing up/blowing out yellow mucus. On the 15th, I called my doctor and was prescribed medication to help get rid of the infection. After starting the medication, my headaches started to decrease in intensity but, I began experiencing laryngitis. By Saturday the 18th, I continued to have body aches, nausea, mild headaches, and extreme fatigue. Consequently, I sought out medical attention again. This time, I was told to keep taking the medication for the next 3 days and come back if my symptoms worsened. This was a potentially dangerous side effect for me because I was diagnosed with sickle cell at two years of age. In addition, I just recently had pneumonia back in early January so I was afraid that I would be back in the hospital again.
possible infection around hvalve; hemoglobin dropping rapidly; All over body aches; extreme all over weakness; Blood sugar over 400; This is a spontaneous report from a contactable consumer.  A 78-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL9261), via an unspecified route of administration on 02Feb2021 at 16:30 (at the age of 78-years-old) as a single dose in the right arm for COVID-19 vaccination. Medical history included esophagectomy on an unspecified date. The patient previously took morphine (UNKNOWN MANUFACTURER) and adhesive tape (UNKNOWN MANUFACTURER and experienced allergy. The patient's historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL1284) on 05Jan2021 at 16:30. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN),  atorvastatin (MANUFACTURER UNKNOWN), clonidine (MANUFACTURER UNKNOWN), cyanocobalamin (VITAMIN B-12 MANUFACTURER UNKNOWN), clopidogrel (MANUFACTURER UNKNOWN), cyclobenzaprine (MANUFACTURER UNKNOWN), empagliflozin (JARDIANCE), magnesium oxide (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN), methocarbamol (MANUFACTURER UNKNOWN), pantoprazole (MANUFACTURER UNKNOWN), "orevastatin" (MANUFACTURER UNKNOWN), terazosin (MANUFACTURER UNKNOWN), venlafaxine (MANUFACTURER UNKNOWN), hydrochlorothiazide (MANUFACTURER UNKNOWN), co-q10 (MANUFACTURER UNKNOWN), fish oil (MANUFACTURER UNKNOWN), iron (MANUFACTURER UNKNOWN), melatonin (MANUFACTURER UNKNOWN) multivitamin (MANUFACTURER UNKNOWN), turmeric curcumin (MANUFACTURER UNKNOWN), vitamin d-3, b-12-E (MANUFACTURER UNKNOWN), meloxicam (MANUFACTURER UNKNOWN), dicyclomine (MANUFACTURER UNKNOWN) all from unknown indications from unknown dates and unknown if ongoing. On 16Feb2021 at 09:00, the patient experienced all over body aches, extreme all over weakness, blood sugar over 400 and hemoglobin dropping rapidly. The patient was taken to the Emergency Room and was hospitalized. The patient received treatment for the events which included an infusion of iron for dropping hemoglobin and infusion antibiotic for possible infection around "hvalve."  Lab data included a nasal swab SARS-COV 2  test on 16Feb2021 which was negative. The clinical outcomes of the events hemoglobin dropping rapidly, generalized aching, extreme weakness, blood sugar increased and possible infection were unknown. It was also reported that since the vaccination, the patient had been tested for COVID-19 (on 16Feb2021) and it was negative.
pt stated that she was fine and then in 2 days seemed to have fatigue.  Within in 5 days pt noticed it was sore under the left arm.  Within 7 days it became itchy red and swollen.  Pt contacted her PCP on 2/3/2021 and she was told to take an antihistamine but she didnt take it since she has dry eyes.  She used hydrocortisone to help with the itching.
arthritis; sinus problem; some aches; queasiness off and on; headaches; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (arthritis), SINUSITIS (sinus problem), PAIN (some aches), NAUSEA (queasiness off and on) and HEADACHE (headaches) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012AQ1A and 011M2EA) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-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) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced PAIN (some aches), NAUSEA (queasiness off and on) and HEADACHE (headaches). On an unknown date, the patient experienced ARTHRITIS (arthritis) and SINUSITIS (sinus problem). At the time of the report, ARTHRITIS (arthritis), SINUSITIS (sinus problem), PAIN (some aches) and HEADACHE (headaches) outcome was unknown and NAUSEA (queasiness off and on) was resolving.            Concomitant medications were not provided. Treatment taken as 7UP (beverage).   This case was linked to MOD-2021-037316 (Patient Link).
Persistent infections in both eyes.  Treated 2 separate times: once with topical medications, followed up by injections into the eyes.
Vaccines: Hep A, MMR, Varicella, PREVNAR given 7/27/20. Rash began 8/3/2020. Erythomotous, macu lopapular rash on face, trunck, extremities - hands & feet. No treatment needed 8/6/2020
On and off hot flushes; Chills; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-May-2021 and was forwarded to Moderna on 24-May-2021.    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 HOT FLUSH (On and off hot flushes) and CHILLS (Chills) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided.     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 HOT FLUSH (On and off hot flushes) and CHILLS (Chills). At the time of the report, HOT FLUSH (On and off hot flushes) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided. Treatment medication was not provided.
J96.00 ACUTE RESPIRATORY FAILURE 9/12/2021 LEIOMYOSARCOMA, ABDOMEN J96.00 ACUTE RESPIRATORY FAILURE 9/12/2021 ACUTE RESPIRATORY FAILURE J96.00 ACUTE RESPIRATORY FAILURE 9/12/2021 ACUTE RESPIRATORY FAILURE
24 year old otherwise healthy male presents to the emergency room with complaints of chills, myalgias, and mild headache beginning last night after receiving the second shot of the Moderna COVID-19 vacination.  The patient denies fevers, abdominal pain, leg pain, weight loss, night sweats, worst headache of life, sick exposures, or recent travel.        Symptoms consistent with expected post vaccination reaction following the 2nd Moderna COVID-19 vaccination. No evidence of life threatening pathology and doubt pneumonia, myocardial infarction, pneumothorax, meningitis, PE.  Patient tolerating oral fluids and solids without difficulty.  Will treat symptomatically, place on 48 hours quarters, and arrange follow up with primary care practitioner.  The patient was given strict return precautions and was comfortable with the plan.  Discharged to a safe ride home.
Patient inadvertently received Pediatric Pfizer formulation (orange cap 5-11y; Lot # FL0007) although he was 12y at time of booster. Patient received 0.2mL (10 mcg) pediatric Pfizer vaccine. Error was discovered and patient was called back to receive the rest of the age appropriate dose; received 0.2 mL (20 mcg) of Adolescent/Adult Pfizer (gray cap Lot # FM9992 ) for a total of 30mcg Pfizer product booster.  Patient reported no adverse events after split booster dose.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 57-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included ENBREL. On 15th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 15th September 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain and general body pain. On an unknown date, the outcome of the injection site pain and general body pain were unknown. It was unknown if the reporter considered the injection site pain and general body pain to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX vaccine on right arm. The patient planned to continue follow up with her physician on an unknown date. The reporter did consented to follow up. For the tolerability of 2nd dose, refer case US2019GSK022635 reported for same patient.
10d s/p vaccination developed substernal chest pain, dyspnea, diaphoresis, dizziness and lightheadedness.  60-day follow up on 12/02/2003: "It is unknown if the vaccine recipient recovered from the adverse events that were reported for this vaccination.  He is still being re-evaluated per MD protocol."
Tested positive for COVID; Tested positive for COVID; This is a spontaneous report from a contactable nurse (patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration on 22Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and patient's concomitant medications were not reported. The patient received his first dose on 22Dec2020 then, nine days later, on 31Dec2020, he tested positive for COVID. He is scheduled for his second dose on 12Jan2021. However, he is still out of work. He called to see if he could get his second dose a couple of days later or does it have to be exactly 3 weeks from the first shot and if it is okay to go a little longer. During the call, he stated he just wanted his question answered about the second shot, if can he wait a little longer. The outcome of the events was unknown.   Follow-up attempts are completed. The following information on the batch number has been requested.; Sender's Comments: A causal association between reported event and suspect BNT162B2 cannot be excluded.
Was stored in a freezer, may have been administered to patients; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 11-APR-2022  Reporter's Comments: Health care professional (HCP) reported that Engerix-B was stored in a freezer and might have been administered to patients, which led to incorrect storage of drug. The Vaccine Administration Facility was the same as Primary Reporter. HCP reporting unsure if any vaccines were administered as this was not her regular clinic. HCP above email was person to be followed up with regarding this for the clinic where storage error occurred. The reporter consented to follow up.
After getting my second dose 4 hours later I developed a rash around my arm very itchy and uncomfortable i received my second dose the 3rd and today is the 5th and still have the rash i was told if it becomes worse to go to the er.
THE SHOT WAS GIVEN 2/21/22. BUT ON 6/28/23 WE WERE NOTIFIED THAT THE EXPIRATION DATE OF THE VACCINE REPORTED TO BE GIVEN WAS 11/28/21??  THE PHARMACY HAS NO WAY TO PROVE THAT THIS WAS OR WAS NOT CORRECT SINCE IT HAPPENED 1 AND 1/2 YEARS AGO
(nauseated, pale, diaphoretic, confused, Shaky, Dizzy) 1st dose. Sent to Urgent Care for evaluation. Unsure of outcome
intially soreness and knot on arm, after a week tired and lathargic, then had eye symptoms (pain and swelling) and facial swelling  been to eye Dr. 3 times so far tried allergy eye drops with no improvement. gets feeling of electrical pulses thru body. PCP sent to urgent care when talk of lupus. has blood work and allergy test coming up.
This spontaneous report as received from a physician refers to a 15 years old female patient. On an unknown date (also reported as the other day), the patient was vaccinated with GARDASIL, one dose, route of administration (unknown), for unknown indication. No concomitants were reported. Physician stated that the patient reported that she may have received a dose previously, months or years in the past. No adverse effects reported. Physician disconnected call before additional information could be collected. No product quality compliant was involved. No further information reported. Additional information has been requested.
Received MMR and Mantoux waited 20 mins "Got In car to leave, Started feeling funny, By the time I got home, I was red all over; I started swelling then I couldn't breath good; Called 911."
Red rash with numbs all over outside edge of both hands exactly one month after vaccine. Was on course of prednisone cream and tablets for 2 months before it cleared
MODERNA COVID-19 vaccine EUA  raised itchy raised rash at injection site delayed reaction  first noted 1/4/2021
Itching @ site of injection with big, hard knot red rash @ site of injection. Temperature (client did not have thermometer) and h/a. Took Tylenol that day and woke up sweaty and normal temperature. Used Benadryl for itching.
In early May, increased bruising, slower wound healing, severe bleeding with menstruation, intermittent headaches, fatigue. Admitted to medical center on 06/01/07 following referred from primary pediatrician with pancytopenia. Diagnosed with aplastic anemia. Treatment to be determined. 6/21/07-records received for DOS 6/1-6/5/07-DC DX: Severe pancytopenia. status post transfusion of RBC times 2 and platelets times 1. Seen in ER on 6/1/07 for increased bruising and pancytopenia on her blood smear. No evidence of ITP. Severe aplastic anemia.
LITTLE SORE ARM; This spontaneous report received from a patient concerned a 71 year old female. The patient's height, and weight were not reported. The patient's past medical history included: epstein barr, exposed to covid twice, and pregnancy. Concurrent conditions included: allergies, and stress. On 12-APR-2021, the patient previously received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 201A21A), 1 in total, dose was not reported (dose number in series was 1), to right deltoid for prophylactic vaccination. On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced anxiety, stress and vision impaired (vision was 20/20 previously and now wears glasses). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809 and expiry: UNKNOWN) dose was not reported (dose number in series was 2), 1 total, administered to right arm on 26-OCT-2021 for prophylactic vaccination. Concomitant medications included guaifenesin for allergies. On 26-OCT-2021, following vaccination with booster dose of covid-19 vaccine ad26.cov2.s, the patient arm was a little sore. The patient stated it was located on her right dominant arm where she got vaccine. The reporter commented that "It nothing, really, she could blew it off" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from little sore arm. This report was non-serious. This case, involving the same patient is linked to 20211031414.
unhealthy spike in blood pressure; headache; started menstrual period that was unusually heavy; periods of flush/hot flashes; melasma on face appeared; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 14Sep2021 17:00 (Lot number: FC3182) at the age of 47 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: BLOOD PRESSURE INCREASED (non-serious) with onset 21Sep2021, outcome "recovered", described as "unhealthy spike in blood pressure"; HEADACHE (non-serious) with onset 21Sep2021, outcome "unknown", described as "headache"; HEAVY MENSTRUAL BLEEDING (non-serious) with onset 21Sep2021, outcome "unknown", described as "started menstrual period that was unusually heavy"; HOT FLUSH (non-serious) with onset 21Sep2021, outcome "unknown", described as "periods of flush/hot flashes"; CHLOASMA (non-serious) with onset 21Sep2021, outcome "unknown", described as "melasma on face appeared". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of blood pressure increased, headache, heavy menstrual bleeding, hot flush, chloasma.  Additional Information: The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. It was reported that, the patient was not diagnosed with Covid-19 prior to vaccination and had not been tested for Covid-19 since the vaccination.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a licensed vocational nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with an improperly stored VARIVAX, 0.5 ml, subcutaneously, lot # K021936, expiration date 10-NOV-2016 (dose number, and anatomical location were unspecified). No adverse  effects reported. The reporter stated that he vaccine experienced previous unspecified defrost cycles with unspecified temperature and duration. The temperature excursion of this case was a defrost cycle exposed to a temperature of 13 F degrees for 30 minutes to 1 hour. Also, data logger in use was unspecified.  Additional information has been requested.