chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapy were not reported. On an unspecified dates in 2012, the patient was vaccinated with the first and the second (0.5 ml each) dose of GARDASIL (route of administration, lot numbers and expiration dates were not reported). On the day of the report (26-SEP-2016), the patient visited the physician's office to receive the 3rd dose of GARDASIL. Follow-up information has been received from the registered nurse on 13-DEC-2016. The vaccine was purchased with private funds and vaccine at private doctor's office. She called with a question about spacing of GARDASIL if patient refused third dose for 2 years. She was told to give the third dose not to start immunization schedule over. There was no adverse event. Additional information is not expected as all follow-up information had been received. Reporter, event and narrative were updated.; Sender's Comments: MERCK 1609USA012654: Mfr number.
SVT x 45 minutes, went to ER, SVT broke before adenosine administration, discharged to home
swollen lymph nodes under her armpits from the side where she got the shot; swollen lymph nodes under her armpits from the side where she got the shot; This is a spontaneous report from a non-contactable nurse (patient herself) via Medical Information team. A female patient of an unspecified age received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; batch/lot number and expiration date were unknown), via an unspecified route of administration on 06Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received her first dose of bnt162b2 vaccine on an unspecified date for COVID-19 immunization. On an unspecified date in Jan2021, the patient experienced swollen lymph nodes under her armpits from the side where she got the shot, which was assessed as non-serious. She said she wanted to know if there were any recommendations on what she should do about this. The outcome of the event was unknown.  No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.
More short of breath and having to use the inhaler more; Muscle aches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (More short of breath and having to use the inhaler more), MYALGIA (Muscle aches) and CHILLS (Chills) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.   On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced MYALGIA (Muscle aches) and CHILLS (Chills). On an unknown date, the patient experienced DYSPNOEA (More short of breath and having to use the inhaler more). On 05-Mar-2021, CHILLS (Chills) had resolved. On 06-Mar-2021, MYALGIA (Muscle aches) had resolved. At the time of the report, DYSPNOEA (More short of breath and having to use the inhaler more) outcome was unknown.            No concomitant medications was reported Treatment information was not provided  Action taken with mRNA-1273 in response to the event was Not Applicable
I experienced hives approximately one week after having the vaccination.  I have pictures of the hives.  They initially started around the site of the vaccination and then spread to other places on my body.  I am continuing to experience multiple hives on various places on my body.
walked a mile a day and has always taken care of himself.  He ran marathons.  He never was bothered by walking the daily miles.  Nothing happened while he walked even though he has a sarcoma.  One night, after he got into bed, his hip and leg started hurting and have continuously hurt since then.  His pain is debilitating and his leg is very heavy.  He can not lift his leg to get into bed.  His wife has to lift it with two hands.  He cannot lift his leg to get into a car.  He has been given Gabapentin, Norco, Tramadol, and Tylenol for pain.  He needs ice packs during the day and night.  He cannot sleep in his bed all night.  He has gotten up to sleep in a recliner.
The site is painful and itchy.; The site is painful and itchy.; Red rash; Arm has been very sore; Headache; Body aches; Nausea; Large baseball size swelling at incision site the night after vaccination; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 20Apr2021 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to medications, food or other products. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included multi-vitamin (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 02Apr2021 at 10:30 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. On 21Apr2021, the patient experienced large baseball size swelling at incision site the night after vaccination. On 21Apr2021 at 12:00, the site was painful and itchy. The patient developed red rash. The patient's arm had been very sore and all other side effects had been present like headache, body aches and nausea. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the events large baseball size swelling at incision site, site was painful, itchy and red rash which included treatment with diphenhydramine hydrochloride (BENADRYL) and anti-itch cream (Unspecified). Therapeutic measures were not taken as a result of the events arm has been very sore, headache, body aches and nausea. The clinical outcome of the events large baseball size swelling at incision site the night after vaccination, site was painful, itchy, red rash, arm has been very sore, headache, body aches and nausea were unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Bilateral subcutaneous nodules both lower limbs, post vacination fever, rash over his body
After having shots, mother reported that her R leg was red and hot around the areas of the shot. Fever was 101.0.  Ask that the mother  gaive the child tylenolPRN fever, and if it should get worse, please call the clinic back.
trigeminal myalgia on the right side of the face and  lasted for 5 days and that happened about 2 weeks after she received the first dose
crying, fretful, hives, swelling thigh lt & t101;pt seen by MD;
Patient received second booster to soon. First booster was 2 months ago.  Patient had no reaction and left clinic in stable condition.
Systemic: Body Aches Generalized-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: patient has a history of getting nervous with vaccines and needles. said she has passed out in the past. this was her first shot and was very nervous said she felt dizzy after shot and wanted to lay down, breathing fine no trouble breathing. had some tingling in her hands and cramping so 911 was called. she was checked out and completely fine after, refused transport to hopstial. mother drove her home. she is feeling fine now
Pt had "vertigo feeling" after receiving HPV vaccine - immediately. Then vomited stomach contents.
29yo healthy female Vaccinated on 2.19.03 with a equivocal Revaccinated on 3.05.03 3.10.03 seen by Emergency Department Physician. on day two felt isolated lymph node Left axilla now has supraclavicular lymph node involvelent and day five presents with a Left central facial droop bell's Palsy type.  No other health issues at this time
Information has been received regarding a case in litigation concerning a female child who was vaccinated IM with a first and second dose of hep B vaccine on 10/23/97 (lot 624813/1190K) and 2/20/98 (lot 623501/0745E). Concomitant therapy included globulin, immune administered as intrauterine injections to the child's mother during pregnancy, a first, second, third and fourth dose of Tetramune on 8/21/97 (lot 445-539), 10/23/97 (lot 446-956), 12/10/97 (lot 447-832) and 7/7/99 (lot 462-314) and a first, second, third and fourth dose of HIB conjugate vaccine IM on 8/21/97 (lot M235RA), 10/23/97 (lot M265RE), 12/10/97 (lot M26085) and 9/15/98 (lot M240RL). It is alleged that the child has suffered devastating injuries through mercury toxicity and associated complications and sequelae and the aggravation of other conditions directly through exposure via intramuscular injections of mercury. It is also alleged that at approximately 28 months of age, in approximately September 2000, that the child was neurologically devastated by the accumulation of mercury in his body, having been exposed via intramuscular vaccinations and intrauterine injections his mother received during pregnancy and suddenly regressed developmentally, losing milestones of neurological development previously achieved, specifically including, but not limited to becoming withdrawn, unable to speak, unresponsive to his environment, engaging in repetitive behavior, loss of language skills, loss of motor skills and loss of affect. It is further alleged that the child experienced exposure during pregnancy. This is an amended report. Mercury toxicity , which was previously reported in the narrative only, has been added as an adverse event. Upon internal review, devastating injuries, associated complications and sequelae, aggravation of other conditions, neurologically devastated, suddenly regressed developmentally, losing milestones of neurological development, becoming withdrawn, unable to speak, unresponsive to his environment, engaging in repetitive behavior, loss of language skills, loss of motor skills and loss of affect were considered to be other medical events. No further information is available.
Systemic: patient fell about 10 minutes after vaccine administration and hit head-Mild, Additional Details: patient already using walker and was not stable to be stand from a sitting positon without help. patient was sitting outside the immunization room waiting for his wife to be immunized. when wife opened the door after immunization, patient was already standing with the help of his walker. He may have lost his balance when he looked over at her. Patient fell backwards and hit his head. called EMS who recommended he go the hospital due to possible cuncussion and patient being on blood thinner.
Herpes Opthlamic Zoster; A spontaneous report was received from a consumer concerning a 42 years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed Herpes Ophthalmic Zoster/MedDRA PT: Ophthalmic herpes zoster.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  The patient received their first of two planned doses of mRNA-1273 (Lot #not provided) on an unknown date. On 09 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Lot #, site of injection and route of administration Not provided) for the prophylaxis of COVID-19 infection.  On 11 Feb 2021, the patient was diagnosed with Herpes Ophthalmic Zoster. Treatment details were not provided.  The patient received both scheduled doses of mRNA-1273 prior to the event ; therefore, action taken with the drug in response to the event is not applicable.  The outcome of the event Herpes Ophthalmic Zoster was unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Patient received the Pfizer 2 shot series = first - 3/3/21  /  second - 3/30/21. Presented to ED with increased SOA, cough with yellow sputum, requiring supplemental oxygen, stated he tested positive 8 days prior to ED visit, place of result not provided.   Lung transplant 2018 = immunocompromised.
Severe menstrual cramps after each shot. Cramps have been abnormally painful.
Vaccines given 1-28-13. Mother reports swelling in (L) upper arm 1-29-13 pm. Saw dr 1-29-13, steroid inj given.
pt was shaking up and fainted after vaccination and ambulance was called. Pt was taken away by ambulance
Intense flare up of my arthritis in my entire arm; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm on 17Apr2021 at 16:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included inflammatory arthritis and known allergy to MRI dye. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included duloxetine hydrochloride (CYMBALTA) for unknown indication from an unknown date and unknown if ongoing. The patient has been in remission from inflammatory arthritis for 2 years and on 24Apr2021 at 21:00, the patient had an acute but intense flare up of arthritis in entire arm, the same arm vaccine was in. It lasted around 12 hours. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event "intense flare up of my arthritis in my entire arm, the same arm vaccine was in" was resolved on 25Apr2021.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
fever; headache; muscle pain; chills; he can't stand up very well because he feels weak; he can't stand up very well because he feels weak; This is a spontaneous report from a Pfizer received from a contactable consumer (patient). A male patient of an unspecified age received second dose of bnt162b2 (Pfizer Covid-19 Vaccine), via an unspecified route of administration on 22Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (Pfizer Covid-19 Vaccine), via an unspecified route of administration on 01Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. On an unspecified date of Apr2021, the patient experienced fever, headache, muscle pain, chills and also reported that he could not stand up very well because he felt weak. The outcome was unknown for the reported events.  No follow-up attempts are possible; information about batch number cannot be obtained.
Body aches and pains, headache, nausea, light-headedness. Felt bad all the next day, almost passed out, couldn't go to work for several hours. Subsided over next two days. Ok now and it's Friday after taking the shot on Monday.
Pain; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown".  Additional information: Patient Age Not Provided: Non-phone report; not provided in correspondence/communication. Patient Gender: Non-phone report; not provided in correspondence/communication.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Cellulitis left arm - treatment amoxicillin-pot clav 875-125 mg 1 BID x 10 days.
Initial report was received on 6/19/06 from a health care professional. A 14 year old female patient with no significant medical history had received an IM dose of Adacel, lot number C2457AA, in the left upper arm and an IM dose of Menactra, lot number U2057AA, in the left upper arm on 6/12/06. Eight minutes post immunization, the patient lost consciousness for one minute. She was subsequently evaluated by the physician. The patient had no reported illnesses at the time of the vaccinations. No treatment was given and no diagnostic tests, or laboratory data were performed. At the time of this report, the patient had recovered from these events. The reporter for this case is the same as for cases 200601528 and 200601530. (OMIC)
This case was reported by a other health professional and described the occurrence of injection site redness in a female patient who received FLUARIX (batch number 45HX7, expiry date 30th June 2015). On 28th October 2014, the patient received FLUARIX 1 ml. On an unknown date, an unknown time after receiving FLUARIX, the patient experienced injection site redness, injection site itching and injection site scab. On an unknown date, the outcome of the injection site redness was recovered/resolved and the outcome of the injection site itching was not recovered/not resolved and the outcome of the injection site scab was unknown. It was unknown if the reporter considered the injection site redness, injection site itching and injection site scab to be related to FLUARIX. Additional information received: Patient experienced a huge red spot, which resolved, then itching and now there is scabbing.
9 days after the vaccine, I developed shingles. I have several rash sites - my right side torso and on my right breast.   I have taken acetaminophen and ibuprofen at night in order to sleep.  The pain is very unpleasant, but not as bad as I have heard from others.  I sent pictures of the rash to Dr. and she also thinks this is shingles.
9/15/14 tingly feeling arms, body, headache. 9/16/14 rash, increased heart rate. 9/17/14 hypertension (high) - never issue previously.
chills,101.3 fever, eyes feels inflamed, body sore, sore throat, couldnt breathe while trying to sleep
Redness, pain, $ burning on bilateral palms of hands and soles of feet, fingers and toes; 10/25/15 @ 06:00 AM - palms hands and fingers skin started peeling; 11/1/2015 @ 06:00 AM - soles of feet and toes skin started peeling.
Sore arm; Tired feeling; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and FATIGUE (Tired feeling) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (Tired feeling). On 10-Mar-2021, PAIN IN EXTREMITY (Sore arm) and FATIGUE (Tired feeling) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment of events was reported with acetaminophen (Tylenol).
This case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a 16-year-old female patient who received BEXSERO (batch  number 159001A, expiry date 31st March 2018). On 19th May 2017, the patient received the 1st dose of BEXSERO. On 19th May 2017, less than a day after receiving BEXSERO, the patient experienced injection site erythema and  injection site swelling. On 22nd May 2017, the outcome of the injection site erythema was recovered/resolved. On 24th May 2017, the outcome of the injection site swelling was recovered/resolved. It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to BEXSERO. Additional details were provided as follows: The patient received BEXSERO on right deltoid muscle. There were no other vaccines given at that visit. The reporter was told about the occurrence on 25th May 2017 by the nurse and she also had a dosing question related to BEXSERO that she talked to a medical science liaison about in a patient room away from her. The nurse forgot to report possible adverse event to medical science liaison so the reporter followed up with her via phone and then submitted this report.
Mgraine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of MIGRAINE (Mgraine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MIGRAINE (Mgraine). At the time of the report, MIGRAINE (Mgraine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment medications were unknown.
2nd dose. Soreness started a hour after. Headache started around 3pm. Itching at the site of injection started around 6pm. Hardness at site and swelling noticed around 10pm. Headache, body aches, redness, lump, itching, and soreness at site still present at 10:30am the following day
Patient received dose 1 of the Pfizer vaccine at a clinic. After the dose was administered the patient experienced tachycardia (pulse 110), elevated BP (measured with arm cuff at ~180/120), headache, and warmth. The patient was offered a cold pack, given water, and was taken away to a secluded room to relax under supervision. After about 1.5 hours the patient improved (BP 120/76 and pulse 85). The patient informed me that his rheumatologist recently had him stop his treatments for Crohn's disease in preparation to receive the vaccine. He stated that he had similar symptoms before when trying different treatment regimens for his underlying condition. The patient left on his own and no further adverse effects were reported.
Within two hours after having the first dose of the vaccine, he broke out in hives (small red bumps) on his back and upper arms. There were several bumps, but mostly concentrated on his upper back. He said it was itchy. We gave him benadryl. The bumps stopped itching within about an hour and were gone the next morning (we looked at around 8am).
Approx 2 hrs p/vax recvd pt had persistent, high pitched, shrill cry that lasted for 3.5 hrs; low grade temp; no treatment needed x/APAP & supportive care;