chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1. vaccine given approx 1310, approx one minute later she became nauseous and then was frothing at the mouth, no vomiting 2. assistance was requested by personnel in the command center 3. as she was frothing at the mouth, her eyes rolled back and she had respiratory stridor and secretions coming from her mouth, epinephrine given in her left deltoid muscle, she was slowly assisted to the floor and her airway was maintained by a jaw lift maneuver, secretions were removed from her mouth, after several minutes a crash cart and stretcher were brought  and O2 via blow by at 15L placed, placed on code cart monitor and the emergency room staff came to take her to the ER. This is the sequence of events that led to patirnt going to the ED.   Staff from vaccine team.
10/02/2013: Left eye became bloodshot, and started watering from the outer corner, and had mucous build up in inner corner. This became worse as the day went on. 10/03/2013: Left side of face was noticeably swollen. Left eyelid was swollen at least three times normal size. The redness, mucous build up and weeping was much worse. My eye did not itch, but the symptoms were very noticeable to everyone I came into contact with. Regular doctor called in anti-biotic eye drops. These did not help. 10/04/2013: Went to eye doctor. Eye doctor prescribed erythromycin ointment and FML drops. This has helped the problem. Eye doctor confirmed this is an allergic reaction.
redness, swelling at injection site; redness, swelling at injection site; This is a spontaneous report from a contactable pharmacist via Pfizer sales representative.   An elderly (age: 65 plus) female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration at single dose on an unspecified date for immunisation.  The patient medical history and concomitant medications were not reported. The patient experienced redness, swelling at injection site on an unspecified date with outcome of unknown.  The information on the lot number has been requested.
Early evening of 10/31 began to feel very fatigued. Took nap at 20:00 before coming to work that night of 10/31. When woke up at 21:00 felt very hot and bedding patient was laying on was hot. Showered then came to work. Began chills. Started the hoarseness and scratchy throat at 24:00. Has had headache often. Has taken one dose of ALEVE. No site soreness, redness or swelling.
Knot which is hot in her upper arm; Knot which is hot in her upper arm; Received her 1st and 2nd doses from Pfizer and received a 3rd Moderna shot; This spontaneous case was reported by a consumer and describes the occurrence of MASS (Knot which is hot in her upper arm), FEELING HOT (Knot which is hot in her upper arm) and INTERCHANGE OF VACCINE PRODUCTS (Received her 1st and 2nd doses from Pfizer and received a 3rd Moderna shot) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006ZDIA) for COVID-19 vaccination.     Previously administered products included for an unreported indication: PFIZER BIONTECH COVID-19 VACCINE (Lot number: EN6200, First dose) on 27-Feb-2021, PFIZER BIONTECH COVID-19 VACCINE (Lot number: EN6206 and Second dose) on 20-Mar-2021.    On 23-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Sep-2021, the patient experienced MASS (Knot which is hot in her upper arm), FEELING HOT (Knot which is hot in her upper arm) and INTERCHANGE OF VACCINE PRODUCTS (Received her 1st and 2nd doses from Pfizer and received a 3rd Moderna shot). On 23-Sep-2021, INTERCHANGE OF VACCINE PRODUCTS (Received her 1st and 2nd doses from Pfizer and received a 3rd Moderna shot) had resolved. At the time of the report, MASS (Knot which is hot in her upper arm) and FEELING HOT (Knot which is hot in her upper arm) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
patient was administered her first dose of GARDASIL 9 / 01/08/2020 a urine pregnancy test was done which was positive; This spontaneous prospective pregnancy report was received from a nurse, referring to a 25 year old female patient. The patient did not have any historical drugs, medical history, concomitant therapies and concurrent conditions.  On 02-JAN-2020, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) intramuscularly, lot # S008154, expiration date 20-NOV-2021, for prophylaxis (strength, dose and frequency date were not reported).  On 08-JAN-2020, the patient sought medical attention and came back to an office procedure and a urine pregnancy test was performed, the result was reported as positive, with a last menstrual period (LMP) of 04-DEC-2019 and estimated date of delivery (EDD) of 09-SEP-2020. Initial exposure to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was at 4 week(s). The pregnancy outcome was pending. The patient did not receive any treatment.
Missed the window for the second dose; Tested positive; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed the window for the second dose) and SARS-COV-2 TEST POSITIVE (Tested positive) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed the window for the second dose) and SARS-COV-2 TEST POSITIVE (Tested positive). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed the window for the second dose) had resolved and SARS-COV-2 TEST POSITIVE (Tested positive) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was reported. No concomitant medication was reported.
lt arm & shoulder pain w/movements started a few wk p/inj;ASA & APAP but pain cont & movement became limited;took Relafen w/no results;saw MD 28MAY97 noted muscle weakness & limited movement d/t pain r/t vax; 1/2" size diff
cool, clammy skin, weak, vomiting, dec BP 92//60, dizziness administered 0.5ml of epi, called & transported by squad to nearest hosp;
sore arm; tired; headache; throw up; This is a spontaneous report from a contactable consumer, the patient. A 80-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6207) into left arm on 19Mar2021 at 10:30 (at the age of 80-years-old) as single dose for COVID-19 immunisation. The patient's medical history included open heart surgery. The patient's concomitant medications included atorvastatin 20 mg (MANUFACTURER UNKNOWN), levothyroxine 100 mcg (MANUFACTURER UNKNOWN) for and multivitamins (MANUFACTURER UNKNOWN) all for an unknown indication from an unknown date. The patient had an allergy towards amoxicillin. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been diagnosed with COVID-19. On 20Mar2021 at 07:00, the patient experienced sore arm, tiredness, throw up and headache. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events pain in arm, tiredness, throw up and headache was recovered on an unknown date. No follow-up attempts possible. No further information expected.
very sore Painful arm at injection site; Started chilling; ran a fever between 102- 103 degrees; headache; felt nauseous; This is a spontaneous report from a contactable nurse (patient). A 61-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration in left arm on 18Jan2021 10:00 at first single dose for COVID-19 immunization. Medical history included high blood pressure (BP) on medication, known allergies: Penicillin (PCN), levaquin, covid-19 on 18Nov2020. The patient's concomitant medications were not reported. No other vaccine in four weeks. The patient had a very sore painful arm at injection site, no redness, started chilling and ran a fever between 102- 103 degrees during the night and into the next day. Had headache felt nauseous. Events start date/time: 19Jan2021 02:00 AM. By 6 pm the next day the patient started to feel a little better. The patient tested positive for covid 19 in 18Nov2020. Covid was not tested post vaccination. No treatment was received for the events. Outcome of the events was recovering.
having pain in his left shoulder blade; pain in his left shoulder blade and into his chest; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 36 year-old male patient received bnt162b2 (BNT162B2), administration date 12Sep2021 (Lot number: FC3182) at the age of 35 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing), notes: controlled it with medication. Concomitant medication(s) included: VITAMIN C [ASCORBIC ACID]; VITAMIN D NOS. The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "having pain in his left shoulder blade"; CHEST PAIN (non-serious), outcome "unknown", described as "pain in his left shoulder blade and into his chest". The events "having pain in his left shoulder blade" and "pain in his left shoulder blade and into his chest" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of arthralgia, chest pain.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any treatment for the events.  No follow-up attempts are possible. No further information is expected.
Soreness for a day on the left arm; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170/EW0185) via an unspecified route of administration in the left arm on 29Apr2021 at 14:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20May2021 at 15:00, the patient experienced soreness for a day on the left arm. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event soreness on the left arm was resolved on 21May2021.  No follow-up attempts are needed. No further information is expected.
local rxn swelling, erythematous rash extending 7cm down lt arm;flu like sx-chills & vomited;
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) 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 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Aug-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided.  No treatment medication information was provided.  Patient received 1st dose on 10Aug2021, and has had a headache, he was asking whether to take aspirin or Advil.
Within 5 minutes of injection, patient developed hives over entire body, agitation, resolved with benadryl after 40 minutes, some vomiting, was nearly given epinephrine but monitored with slow improvement and did not require epi.
Swollen arm pit and lymph node.  Pain to raise and move arm for 3 full days so far
fridge warmed up, curious if Shingrix is still good; This case was reported by a consumer via interactive digital media and described the occurrence of incorrect storage of drug in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, 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: 18-Jul-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The reporter stated that the power went out and the fridge warmed up and he/she was curious if Shingrix was still good or needed to be disposed of. Additional Supportive Information: The reporter stated that the power went out and the fridge warmed up and he/she was curious if Shingrix was still good or needed to be disposed of, which led to incorrect storage of drug. The follow-up would not be possible as no contact details were available.
Several weeks after receiving the vaccine, I experienced a very sharp pain and a brief, loud noise in my left ear. The pain varied in intensity but was present at times for approximately 10 days. I also heard odd sounds (e.g., chimes) with the left ear. The pain was followed by sudden onset of severe tinnitus and gradual loss in hearing acuity. Sound was muffled and ear felt full. Prior to this episode, I wore a hearing aid in the left ear for a mild hearing loss. My hearing was re-tested and hearing aid technician noted decline in left ear. When hearing worsened, I went to ENT on 12/14/21 and audiologist tested and noted significant hearing loss in left ear. Saw Physician Asst. in same office on same day. prescribed Prednisone 20 MG tablit taken orally starting with beginning with 60 mgs./day and tapering down to 10 mgs over 16 days. Hearing appeared to worsen. Patient experienced episodes of vertigo. By 12/24/21, patient had difficulty hearing any sound with left ear. MRI was performed on 23/37/21 and patient was tested for Lyme Disease. On 12/29/21, audiologist re-tested hearing. Hearing in left ear had worsened since 12/14/21. Patient was referred to ENT same day. Dr. administered 3 intratympanic steroid injections (12/29/21, 1/7/22, and 1/14/22). On 1/31/22, patient consulted Dr., Otorhinolaryngology. Dr's diagnoses were Meniere's disease of left ear (H81.02) and sensorineural hearing loss unilateral (H90.5). Hearing was tested by Dr., Au.D. on 2/14/22. Significant loss of hearing confirmed during audiological testing.
Patient states he experienced migraine headache, scalp/hair sensitivity, lip numbness on left side, acne breakout, and a sore throat in the days following flu shot. He presented to me 2 weeks later and symptoms were beginning to resolve so just told him to continue using ADVIL or TYLENOL as needed. If worsens or persists, contact your doctor. He has received the FLUZONE HIGH DOSE the last 3 years and did not have these reactions.
Increased chest pain & pressure; Increased shortness of breath; increased kidney/flank pain; brief episode of tremors, severe chills
I advised the patient to wait at least 15 minutes after getting the vaccine, about 10 minutes after receiving the vaccine she came back to the pharmacy and stated that her face felt funny and itchy. She stated that she did not have any trouble breathing at all, it was more of an itchy feeling on the inside/outside of her mouth. I gave the patient 50 mg of benadryl and a bottle of water. She sat for another 10 minutes or so and then came up to the pharmacy and she said she felt that she may have been having a reaction to the soaps displayed in the store since the reaction was mainly external and she has had a reaction before.
injection site pain, arm hurts, head-ace, throwing up, body aches, fever of 101.8
HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache. This report was non-serious.
At 10:00 PM started to cough, breathing became wheezy with runny nose, itchy eyes. By 10:10 PM area of both eyes and eyelids very swollen. I took over the counter BENADRYL tablets and symptoms eased but eyes remained swollen for a day and a half...took additional BENADRYL tablet to deal with this.
She got her vaccine, had no problem, then on Friday she started having back pain but not moving as much as she does.  Then she went to sleep and did not sleep due to the pain which was all the way up the left side from buttock, including the spine.  She also had on the right side chest pain and upper back pain, upper right area, and the front area on the right as well.  She is not able to move as she had severe pain.  They have to put diapers on her, which she does not normally wear.  She has a bedside commode and was able to use it yesterday and they put a Depends on her as it was difficult for her to get out of the bed to do that.  Her daughter has been giving Ibuprofen and Icy hot on her areas that hurt, which has not started to work.  She does not want to use the Depends for fear or urinating in the bed.  Her legs are hurting, her whole entire body mainly on the left but the upper right back and chest area.    She is normally a very active person without any disabilities.  She is still working full time but from home.  She is also complaining of a headache this morning, and having problems with her vision.    She has not gone to the doctor or gone to the ER as she had been there previously and they did not take good care of her.
Patient received vaccination on 2/4. Patient's wife reported that he felt a slight soreness in his arm the day following the shot, but had no other symptoms. On 2/8 he passed away. Wife reports that it was related to his heart and they never made it to a hospital. The wife also reported that the patient had been in poor health prior to the vaccination
Client came in to receive HD flu vaccine. Paperwork was filled out accurately, client verbally verified that she was there for HD flu-vaccine. When entering the information into Immunization Record, discovered that client had a previous HD flu vaccine 13 days ago.
5-6-10  Mother called to report - 1st noticed red area.  5/4/10 - gradually increased in size to 4 " diam, raised, hard & hot to touch - on right thigh (front) at injection site.  Sl itching at site.  Given antihistamine.  5-7-10 Swelling is down.  Injection site - normal size -> only some bruising remains.
Right eye that look like a rupture of a blood vessel; This spontaneous case was reported by a consumer and describes the occurrence of CONJUNCTIVAL HYPERAEMIA (Right eye that look like a rupture of a blood vessel) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced CONJUNCTIVAL HYPERAEMIA (Right eye that look like a rupture of a blood vessel). In April 2021, CONJUNCTIVAL HYPERAEMIA (Right eye that look like a rupture of a blood vessel) had resolved.            Treatment included Paracetamol and Ibuprofen.  Concomitant medication was not reported.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD21-086966 (E2B Linked Report). This case was linked to MOD-2021-109540 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. MOD21-086966:Same reporter
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. Approximately in 2015, an unspecified number of patients were vaccinated with an unspecified doses in series of LIQUID PEDVAXHIB lot number L009649, expiration date 29-NOV-2017 (dose and route of administration were not reported). The vaccine was improperly stored between 26-AUG-2015 and 01-SEP-2015. There was no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
rash spread for whole body- breast, legs, chest , back; "bad rash" non stopping spreading; This spontaneous case was reported by a patient and describes the occurrence of RASH (rash spread for whole body- breast, legs, chest , back) and RASH ("bad rash" non stopping spreading) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included MAGNESIUM OXIDE for Product used for unknown indication, QUETIAPINE FUMARATE (SEROQUEL), VENLAFAXINE HYDROCHLORIDE (EFFEXOR), ATORVASTATIN CALCIUM (LIPITOR), MIRABEGRON (MYRBETRIQ), CALCIUM CITRATE (CALCITRATE), VITAMIN B12 [VITAMIN B12 NOS], LINUM USITATISSIMUM SEED OIL (FLAX SEED OIL), VITAMIN D NOS, MESO ZEAXANTHIN, XANTOFYL, ZEAXANTHIN (MACUHEALTH WITH LMZ3), ASCORBIC ACID, BETACAROTENE, COPPER, NICOTINAMIDE, SELENIUM, TOCOPHEROL, XANTOFYL, ZINC (LUTEIN +) and ZEAXANTHIN for an unknown indication, Meso-zeaxanthin.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (rash spread for whole body- breast, legs, chest , back) and RASH ("bad rash" non stopping spreading). At the time of the report, RASH (rash spread for whole body- breast, legs, chest , back) and RASH ("bad rash" non stopping spreading) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-169553 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Follow up received on 27-MAY-2021. contain non significant information
Woke up with severe nausea that lingered most of the day as well as increased stomach cramping (worse than normal experienced from Crohns). By 5pm, couldn't stand because the nausea was so bad, went to the emergency room. Was given IV saline to rehydrate and IV pain medicine and anti-nausea meds. Felt better until the medicine wore off and then nausea returned. Took prescribed nausea medication but did not help and patient ended up vomiting 5 times. Nausea subsided mostly by morning but patient still ate minimally and the headache persisted for the next day.