chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning an 8 year old male patient who on 07/21/1997 was vaccinated subcutaneously in the right arm with a second dose of varicella virus vaccine live.  On 09/02/2004 the patient began breaking out with chickenpox.  The patient was seen by the physician and the diagnosis of chickenpox was confirmed.  Unspecified medical attention was sought.  Additional information has been requested.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 70-year-old patient of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unknown date on or about 2015, the pt was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiration date were not specified) by a healthcare provider at the clinic for the long-term prevention of shingles and zoster-related conditions. Subsequently, on an unspecified date, the patient was treated by healthcare providers for the following injuries resulting from the patient's zoster vaccine live (ZOSTAVAX) use: shingles and other zoster-related conditions. The outcome of all the events were not reported. The reporter considered all the events to be related to zoster vaccine live (ZOSTAVAX).
Pt received 3rd dose; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 2nd dose on 31st July 2019) and Shingrix (received 1st dose on 30th March 2019).   On 12th January 2022, the patient received the 3rd dose of Shingrix. On 12th January 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The patient received 3rd dose of shingrix, which led to extra dose administered. The reporter consented to follow up.
Patient complained of a sore throat and red, puffy eyes the  morning following the injection.  She came to our office at 1345 hours and requested Benadryl.  By the next morning the sore throat and red puffy eyes were gone, after taking the Benadryl.
Red, swollen, hot, itchy, tender in left arm  3 inches around injection   Took prednisone 10 hours ago, swelling is going down
Pink macular rash trunk & extremitary.  Seen in ER 9-16-09.  Treated with DECANDRON and BENADRYL.  Sent home in MEDROL dose pak.
I had a sore arm and felt off for one day after receiving the vaccine. I started not feeling well on 01/03/2022. I had a very bad sore throat, try cough, my eyes where red, nasal congestion and pain in my ears. I went to the doctor four times and two telehealth visits. I had an antibiotic prescription for my ear because they thought it was an ear infection. I was tested for COVID-19, strep throat, influenza and RSV and all negative. I was diagnosed with acute bronchitis. As of today, I still have a cough and hives.
bodyaches; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (bodyaches) and PYREXIA (fever) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced PAIN (bodyaches) and PYREXIA (fever). At the time of the report, PAIN (bodyaches) and PYREXIA (fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment medication include ibuprofen.
130mm by 230mm erythematous, hard, swollen left leg. No other symptoms. Cellulitis, large reaction. Topical cream and oral Benadryl. Augmentin 400mg/5ml, 3/4 teaspoon BID for five days. Orapred 15mg/5ml, 2 teaspoons OID for 24 hours.
At 10 days:  6"x4" oval, raised, red, itchy patch at vaccination site. Patch lasted three days, faded gradually At 18 hours: silver dollar raised, hard red itchy patch at vaccination site. Faded after five days
Headache, nausea, chills, felt unwell until about 24 hrs after vaccine
Should have administered pfizer vaccine instead of moderna. pt is only 17 y/o. no symptoms during the 15 min observation period.
On 1/2/2022: Tingling and Numbness in left thumb and palm starting at 3:45 pm. As of 1/4/2022 it persists but has decreased in intensity. On 1/3/2022: Numbness and decreased sensitivity in left shoulder at 10:00 am.  On 1/3/2022: Pain under left armpit and down left side of ribs at 5:00 pm. This persists as of 1/4/2022. On 1/3/2022: Pain on left shoulder near injection site at 10:30 pm. This persists as of 1/4/2022. On 1/4/2022: Pain and inflammation at left collarbone area at 7:00 am
Pt was given Pfizer dose that did not have enough diluent. Only diluted with 1mL of saline instead of 2.2 mL of saline.
fever; chills; extreme muscle aches; constant nausea; Right deltoid was swollen and hot; Right deltoid was swollen and hot; This is a spontaneous report from a contactable healthcare professional (patient). A 59-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EL1284), via an unspecified route of administration on the right deltoid on 04Jan2021 09:15 at SINGLE DOSE for COVID-19 immunization at the hospital.  Medical history included high blood pressure (BP), gout, and shingles. The patient also had allergies with minocycline. Concomitant medications included allopurinol (ALLOPURINOL), amlodipine (AMLODIPINE), and valaciclovir hydrochloride (VALTREX).  The patient previously received the first dose of bnt162b2 (lot/batch number: EH9899) for COVID-19 immunization on 18Dec2020 10:00 AM on the left arm and no reaction. Prior to vaccination, the patient was not diagnosed with COVID-19 and had not been tested for COVID-19 since vaccination. The patient received 2nd dose of vaccine 04Jan2021. When the patient woke up on 05Jan2021 05:00, she had fever, chills, extreme muscle aches and constant nausea which continued until the morning hours of 06Jan2021. It was also reported that the patient's right deltoid was swollen and hot noted on 05Jan2021. Outcome of the events of right deltoid was swollen and hot were unknown while the patient recovered from the remaining events on 06Jan2021.
Employee experienced soreness at site of injection for several days then on 10/23/18 woke up with sharp pain in the shoulder same side of injection (left shoulder). Feeling pain when raising arms to reach for anything. Pain is worse while sleeping. Treated with TYLENOL, ADVIL and Ice.
p/ pt recv vax approx 1mo later pt lab eval revealed neg IgG varicella titer. on may28 pt devel red raised rash mostly papular, complained of itching, lightheadedness, transient nausea, highest temp 99.4f. repeat titer was neg in july.
Had severe chest pain on 11/20/2022 after taking the Covid booster about 3 weeks earlier, diagnosed as pericarditis, and was hospitalized for 72 hours. Pain was sudden and unexpected, and the pain was extreme enough to cause ambulance ride, given a high dose of ibuprofen (600 mg). Given colticin (anti-inflammatory) as well. The chest pain was gone soon after the medicine was first administered. Doctors told me this was due to a covid booster reaction. Long-term, I experienced fatigue and gastritis (from ibuprofen), but have made a full recovery.
Breakthrough case admission after three vaccines Pfizer 3/11/21 Lot# EN6207;  Pfizer 4/1/21 Lot#ER8732;  Pfizer 1/7/22 Lot# FR0809
Mom with child, stating that approx 1 hour after receiving Flu vaccine yesterday, she noticed a small rash on child face yesterday. She gave child BENADRYL and rash went away. But today she checks on child at school and notice that the rash returned with 2 other small areas on the child's face. Mom states child has history of breaking out in rash when she has viral infections. Small circular maculopapular red rash on face near left side nare.
Information has been received from a physician concerning a caucasian 23 year old female with a history of attention deficit/hyperactivity disorder, allergic reaction to Macrobid and an allergic reaction to Lorabid who on 29-Dec-2006 was vaccinated intramuscularly with her first dose of GARDASIL in the left arm (lot #654389/0961F).  Concomitant therapy included amphetamine aspartate/amphetamineSO4/dex (ADDERALL XR bid) and drospirenone (+) ethinyl estradiol (YASMIN).  On 02-May-2007 the patient was vaccinated intramuscularly with her second dose of GARDASIL in the left arm (lot #657617/0384U).  The patient complained of pain and throbbing during both injections.  On approximately 16-May-2007 the patient returned to the office with a dent with pain and ache in her left arm a few inches below the injection site.  On 10-Oct-2007 the patient was vaccinated intramuscularly with her third dose of GARDASIL in the right arm (lot #657617/0384U).  On 30-Nov-2007 the patient was seen by the orthopedist for the dent in her arm.  He feels it is muscle mass deterioration related to absorption of the GARDASIL.  The patient has not recovered.  The nurse also mentioned many other patients have had pain at the injection site. Additional information has been requested.
eyes have been watering; swelling; Pain; fatigued; cant even drive with left had; This spontaneous case was reported by a consumer and describes the occurrence of LACRIMATION INCREASED (eyes have been watering), VACCINATION SITE SWELLING (swelling), VACCINATION SITE PAIN (Pain), FATIGUE (fatigued) and MOBILITY DECREASED (cant even drive with left had) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ETHINYLESTRADIOL, NORGESTIMATE (TRI-SPRINTEC) for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 11-Feb-2021, the patient experienced LACRIMATION INCREASED (eyes have been watering), VACCINATION SITE SWELLING (swelling), VACCINATION SITE PAIN (Pain), FATIGUE (fatigued) and MOBILITY DECREASED (cant even drive with left had).   At the time of the report, LACRIMATION INCREASED (eyes have been watering), VACCINATION SITE SWELLING (swelling), VACCINATION SITE PAIN (Pain), FATIGUE (fatigued) and MOBILITY DECREASED (cant even drive with left had) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No treatment information was provided.
7-10 days post injections (both), I experienced extreme shortness of breath, pressure in my chest, difficulty breathing, unable to speak without gasping for air.  O2 saturations when recorded were 93 or 94%.  My first injection was on 1/28/2021.  I started with the above symptoms after several negative Covid tests.  I went for a PFT test to see if my lung function was normal.  I desaturated in the doctor's office and was sent for bloodwork and a CT Scan.  The scan showed bloodclots in 2/3 of each lung.  I was rushed to the ED given Lovenox.  I was admitted for 3 days and put on blood thinners (Xarelto) post discharge.  I asked if I was ok to get the second vaccine on 3/5/21.  I was told to go ahead.  10 days after second injection, I had a repeat of the symptoms above, but recovered in 4 days on my own.
Pt mom called on 9/11 and stated the son woke up with the injection site severally swollen to where you could see where the needle was stuck at. The child had been scratching the area alot but said it did not hurt.  It was swollen almost to his elbow. I asked if he was having any breathing difficulties she stated no. I told her to place an ice pack on it for about 15 minutes and also to give him to ibuprofen every 6 hours for the next 24 hours. I told her if the swelling continued to progress down his arm or his breathing became affected to take him to the ER. She stated ok.
Rash, nausea, vomiting, diarrhea, chest pain, headaches, muscle and joint pain.  after having received her 1st Pfizer vaccine on Jan 4th, 2022. Patient reports that she received the vaccine and midday and during the evening, she developed multiple symptoms
7/11/09: Abdominal pain, nausea, vomiting, prolonged weakness, dizziness, low bp, tachycardia, required 911 call on side of highway. Amylase >500; Lypase >1350 - Admitted to Hospital. Initial diagnosis: Acute Pancreatitis.  Dizziness and fast heart rate continued. All tests proved normal. Following day Amylase & Lypase normal. 7/15/09 Headache - controllable. 7/17/09: Fever up to 102.4 no other symptoms other than still had severe headache. Unable to get fever below 99.9 7/18/09  BP drops to 80/50 (pulse 126) upon standing; shortness of breath; headache & fever. Fluids including gatorade up to 2-3 liters/day. Urinating well; no other vommiting or stomach issues aside from itiatial episode.  7/24/09 Hospital records received DOS 7/11/09. Assessment: Acute pancreatitis, mild leukopenia. Patient presented with severe epigastric pain radiating to the abdomen and back. Family member noted that patient became pale diaphoretic, with severe nausea and vomitng. Loose fatty stools,   ICD-9 Codes: 577.0  558.9  288.50  244.9
12 hrs after receiving the first dose, noticed welts on the same arm as the injection site. About 4 welts carrying in size. Not red or itchy/had hives on her arm, not red or itchy; This is a spontaneous report from a contactable consumer (patient).A 31-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6206, expiration date not reported), via an unspecified route of administration, administered in left arm on 17Mar2021 at 08:45 AM (31 years age at vaccination) as single dose for COVID-19 immunisation. Medical history included allergies to Sulfa drugs. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient had not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID -19 vaccine. Concomitant medications included drospirenone, ethinylestradiol birth control (GIANVI), Health hair product and an unspecified energy supplement, all taken for an unspecified indication. On 17Mar2021, at 9:30 PM, (12 hours of vaccination), the patient experienced hives on her arm which she elaborated as welts on the same arm as the injection site. About 4 welts carried in size and were not red or itchy. She monitored them for 3 hrs and they did not change in size at all. Treatment medication was not received. The outcome of the event was reported as recovered the next morning (18Mar2021).  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
pt recv vax 21MAR97 & 29MAR97 pt was seen in MD office because of an inability to move the lt arm;MD dx sx as brachial neuritis r/t tetanus;
pt recvd MMR vax 1MAY91 & on 10MAY91 devel fever x 2 days & maculopapular rash over most of body for 1 wk; it was also noted that pt had a URI; pt recovered; no further details were provided;
Extreme swelling, redness and very warm to touch noted in both arms. Right arm swollen to neck knots in left arm and skin discolored. Red streaks, noted in both arms, Started on Bactrim and Keflex. Right arm improved by 9/10/06. Left arm is still improving.
Fatigue, heart fluttering, difficulty sleeping, started approximately 1 week after the vaccine. Relief only when I do nothing but rest.
No adverse effects; 2 patients received unspecified doses of ROTATEQ that were improperly stored; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's medical history, concomitant medications, drug reactions or allergies were not reported.  On 12-APR-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # R016791, expiration date: 16-APR-2020, administered orally (dose was not provided) as prophylaxis. The vaccine underwent a temperature of 48.2 Fahrenheit (F) degrees during a time frame of 1 hour as recorded by a data logger. No previous temperature excursion was reported, as well as no adverse effects.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA006649:
Patient received first dose of Pfizer COVID 19 vaccine at 0845.  Patient mentioned history of mast cell activation syndrome as well as history of several anaphylactic events to the vaccinator.  Patient related that she had her personal Epi-pen with her on site.  Vaccinator elected to have patient wait  recommended 30 minutes.  At 15 minutes post vaccination, patient stated that she was experiencing the sensation of throat and facial swelling, elaborating that this is typical for her anaphylactic reactions.  Patient was addressed by the PA-C on site.  Upon exam, some edema of the brow bones were noted.  No edema noted in the oropharynx.  Dermatographia noted on the patient's tattoos, however, no generalized rash or injection site reaction noted.  Heart rate and rhythm regular.  Pulse 60bpm, strong.  BP 118/72.  Bilateral lungs clear to auscultation in all fields.  No wheezing or stridor noted.  Patient denied presence of cramping abdominal pains, nausea, and vomiting.  Patient was provided with  10mg Claritin ODT and 25mg PO Benadryl.  Patient related that she had famotidine at home that she normally takes when such events occur.  At 30 minutes post po  meds, Patient related she felt better and did not feel the need to be transported by EMS, though it was offered.  Discussed at length with patient regarding follow up care and low initiation threshold for emergency response.
Information has been received from a health professional concerning a 4-5 year old patient, who was vaccinated with a dose of Varivax. "Within the past 2 weeks", in April or May 2006, the patient experienced mild breakthrough. Unspecified medical attention as sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Headache, Myalgia, Fever & NauseaVomiting Narrative:
she also mentioned that she has a friend around the same age that also had a titer done in the past which showed no immunity to at least 1 of the viruses despite being vaccinated.; This spontaneous report was received from a company representative and refers to an adult patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (rHA) (M-M-R II) (dose, route of administration, anatomical location, lot #, and expiration date were not provided).   On an unknown date, the patient got Measles, Mumps and Rubella (MMR) titer test that showed no immunity to at least 1 of the viruses despite being vaccinated (Antibody test negative). Outcome of the events was unknown.  Causality assessment was not provided.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2311USA000494:
Fever, chills, pain at injection site, fatigue, headache. Unable to sleep well for a night.
pt recv vax & exp loss of consciousness (periodically), muscle spasms, & frontal lobe headache;hosp p/3wek;no tx was given;
Noticed an itching and then looked. It is red and there is a hard lump underneath the redness. The red area is about 3/4 of an inch.
chills; slight fever; rashes on the stomach; This is a spontaneous report from a contactable consumer or other non health care professional.  A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 21Jan2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation  .The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced chills  on 22Jan2021 with outcome of unknown , slight fever  on 22Jan2021 with outcome of unknown , rashes on the stomach  on 22Jan2021 with outcome of unknown.  The action taken in response to the event(s) for bnt162b2 was not applicable.
Numbness and pain in left arm after injection, radiating down arm. Improved with ice pack. Also reported having anxiety being in large crowds so took ativan that he had from home. Wheelchaired out safely in car.
Staff called out that there were 4 children to be vaccinated under 12 and the Pt was included in that group upon arrival at the vaccination site. Medical Assistant misinterpreted patients date of birth and administered a pediatric dose of Pfizer PEDS to pt. just turned 12 years old.  Patient was monitored for 30 minutes after administration, vital signs were stable and patient was released into parent custody also per CDC protocol recommendations for after care.
Patient developed back pain, progressing to involve shoulders and neck...Eventually diagnosed with polymyalgia rheumatica with elevated ESR and CRP. Treated with IV then PO steroid with clinical response. He is following up with a rheumatologist.
1. Pain in right achillies tendon , lower near heel, 3-4 days could not walk, xrays at clinic inflammation, pain gradually resided in a week. 2. 4-5 days later right side neck muscle pain developed, MRI performed with no indications of injury or cause, pain still exist.
Joint pain with history of arthritis and degenerative back issue; new health problems with interjection and chest pain with GI. H Pylori  infection which Clarithromycin 500mg twice a day/Amoxicillin 500mg twice daily. Cholenoscopy 2 cm polyp/ stain results was rare organism. GI issue was negative issue intergestion and chest pain located on the left side radiant her cardiac enzymes levels with heart test and cardio blockage. 08/19/2021 Flu vaccination at pharmacy.
dizzy, lightheaded, b/p 224/104 , did not eat  all day
feeling "light headed and foggy. PT was moved to Private Treatment Area For observation. PT was A/oxy. Vitals were Monitored. PT was observed For 40 min and Released to home. PT. Advised to Seek additional Treatment iF Needed.
Within 10 minutes following the shot, elevated heartrate 30-40BPM above normal resting HR. Elevated blood pressure well above normal range for patient. Normal BP, and BP at last doctor's visit 4/28/2021 was 97/70, and is usually around 100/60. BP within 15 minutes following vaccine was 122/80+.  Within the next 24 hours patient experienced abdominal pain, diarrhea, sore arm, headache, extreme fatigue, body aches. Over the next week following the vaccine patient experienced headaches, fatigue, body aches and abdominal pain/nausea every day. 14 days later, patient is still experience headaches, fatigue, body aches daily. And in the past 5 days, patient has started experiencing numbness/tingling in both arms from shoulder to tip of pinky. On 6/3/2021 (date of filing this report), patient has experienced numbness and tingling in both arms all afternoon into the evening at the time of filing this report. Regarding daily headaches since the first dose, patient never experiences headaches unless there is a problem or illness. Patient now experiences headaches every day.  Patient has been messaging primary care physician about these symptoms and messaged one of her specialists about these symptoms on 6/3/2021.