chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a medical assistant referring a 1 year old patient of an unknown gender. No information was provided regarding the patient's historical medication, concurrent conditions or concomitant medications. On 28-NOV-2018, the patient inadvertently administered one dose of with PROQUAD with lot number R013575 and expiration date on 10-NOV-2019 (dose, dose number, route of administration and anatomical injection site were not reported), for prophylaxis, and one dose of VARIVAX (dose, dose number, route of administration, anatomical injection site, lot number and expiration date were not reported), for prophylaxis, at the same visit (Accidental overdose). No adverse effects were reported.
Exp vaccine given, exp date 10/13/21 given on 10/14/21
Two days later rash on chest, bumpy and red. Did not not itch but had teleconference with the doctor and advised to Benadryl. By the 5th days rash still there so went to the doctors office. Dr. still said to take the Benadryl and rash lasted about a week.
Fever after shingles shot; This case was reported by a consumer and described the occurrence of fever in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced fever. On an unknown date, the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the fever to be related to Shingles vaccine.  Additional details were provided as follows: The age at the vaccination was not reported. The age group was not reported but was selected as an adult  per the vaccine indication. The patient asked how long would run a fever after shingles shot.
coughing;  severe difficulty breathing;  itching of inner ear; rash around neck; headache
Patient reported throat "tightness" that progressively was getting worse. She denied breathing nor swallowing difficulty.  0.3cc Epi given IM in left deltoid, per facility protocol. Patient was then transported to the ER via wheelchair and admitted to Pediatrics unit for observation. Her mother was with her the entire time.
This spontaneous report as received from a certified medical assistant via a company representative refers to a female patient of unknown age. The patient's pertinent medical history, drug reactions or allergies and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose, route and lot number were not reported). The patient's concomitant therapies were not reported. On an unknown date, the patient development cellulitis at the injection site after administration of PNEUMOVAX 23; the patient was evaluated at unspecified hospital but it was unknown if the patient was admitted. At the time of the report, the outcome for cellulitis at the injection site was unknown. Additional information has been requested.
Arthralgia, NauseaVomiting, injection arm pain, paresthesia Narrative:
On 4/9/21 approximately 11 days after receiving the Moderna vaccine 1st dose at Walgreens, I woke up at 6:15 am, by 7:30 I noticed my vaccine site was itchy with raised rash approximately 2 1/2 inches diameter and another on top of it approximately 1 1/2 inch diameter. The raised rash is red and hot to the touch at 2:00 pm.
approximately 1 week after receiving an MMR pt had a hard red area at injection site. One month later, pt continues to have  a red/hard warm area on skin with streaking down arm from injection site.
Injection site was red and hard, then rash the size of a baseball appeared.  Is now getting better.
nausea; Chest pain; dizziness; drop in Blood Pressure; increase in pulse; palpitations/heart racing; This is a spontaneous report from a contactable consumer or other non-health professional (patient). A 46-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number FF2588 and expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Right on 28Aug2021 16:00 (vaccination at the age of 46 years) as dose 1, single for covid-19 immunisation. Medical history included Anxiety, depression, allergies, asthma, pericarditis, Chronic Systolic Heart Failure, mixed connective tissue disease (MCTD) all from an unknown date and unknown if ongoing. The patient previously took erythromycin and experienced drug hypersensitivity. The concomitant therapy was reported as yes. On 30Aug2021 15:00, the patient experienced nausea, chest pain, dizziness, drop in blood pressure, increase in pulse, palpitations, heart racing. The patient underwent lab tests and procedures which included drop in blood pressure: drop on 30Aug2021, pulse: increase on 30Aug2021 increase in pulse. The patient had physician office visit for adverse event. Therapeutic measures were taken as a result of adverse events. The outcome of all the events was not recovered.   Follow-up attempts are completed. No further information is expected.
Started with extreme irritability and screaming. Would not move, walk, crawl etc for a day. Scared to be alone or sleep alone. Next few days he was slow to move and limping. Severe muscle pain. Lots of screaming and fussiness. Followed by high fever over 103 for 3 days.
BODY ACHE; DRY MOUTH; THROAT DRY; CHILLS; NAUSEOUS; FATIGUE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on FEB-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced body ache, dry mouth, throat dry, chills, nauseous, and fatigue. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from body ache, chills, dry mouth, throat dry, nauseous, and fatigue. This report was non-serious.
HIVES ON HER RIGHT ARM; BLOODY DIARRHEA; BLOOD FROM A HEMORRHOIDS; HUGE MIGRAINE/VISION IMPACTED; This spontaneous report received from a patient concerned a 64 year old female. The patient's weight was 208 pounds, and height was not reported. The patient's past medical history included breast cancer left side, and hay fever, and concurrent conditions included allergic to anti-seizure drug cipro, pregabalin (Lyrica) and gabapentin, irritable bowel syndrome (IBS) (C and D), chronic migraines, hashimoto disease, seizures, non alcohol user, and non smoker. The patient did not have any drug abuse, illicit drug use. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, Expiry: Unknown) dose was not reported, 1 total dose administered on 06-APR-2021 in right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 06-APR-2021, after 45 min of vaccination, the patient experienced a huge migraine, which was worst in her life due to which she could hardly make it home. Her vision was impacted. On the same day, in evening she developed bloody diarrhea, blood from a hemorrhoid. She believed, the vaccine has exacerbated her underlying medical conditions. She also reported that, when she took off her clothing, she noticed that she developed hives on her right arm. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from huge migraine/vision impacted on 07-APR-2021, and had not recovered from hives on her right arm, bloody diarrhea, and blood from a hemorrhoids. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210420554-Covid-19 vaccine ad26.cov2.s-Bloody diarrhea. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
flu like symptoms lasted for several days; redness at the injection site lasted for several days; swelling at the injection site lasted for several days; burning at the injection site lasted for several days; Initial information received on 23-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse by phone.  This case involves a 32 years old female patient who developed flu like symptoms lasted for several days, redness at the injection site lasted for several days, swelling at the injection site lasted for several days and burning at the injection site lasted for several days, while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].   Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The gestation period at onset was reported as 30 weeks The date of last menstrual period was not reported. The estimated due date was not reported.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication: None.   On 08-Jul-2019, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number: U62103AA, expiry date: 24-Apr-2021, dose in series not reported) via unknown route in the left deltoid.  On an unknown date, the patient developed a non-serious flu like symptoms lasted for several days (influenza like illness), redness at the injection site lasted for several days (vaccination site erythema), swelling at the injection site lasted for several days (vaccination site swelling) and burning at the injection site lasted for several days (vaccination site pain) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  No Lab data was reported.  Final diagnosis was burning at the injection site lasted for several days, swelling at the injection site lasted for several days, redness at the injection site lasted for several days and flu like symptoms lasted for several days.   It was not reported if the patient received a corrective treatment.  The events outcome were reported as Recovered / Resolved on an unknown date for all the events.  Additionally, at time of reporting, the outcome of the pregnancy was unknown.   Documents held by the sender: none.
pt recv vax 9/3/98 then on 10/17/98 pt exp ``swelling of the left ear & parotid glands.''  lab tests reveled viral throat swab that was positive for mumps by immunoflourescence. f/u pt put on med & dx acute right parotiditis
My entire body broke out in hives. The hives started on the skull and then went to the chest.; This is a spontaneous report from a contactable consumer. A 48-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6205), dose 2 via an unspecified route of administration, in right arm on 13Mar2021 at 10:15 am (at 48-years age) as 2nd dose, single for covid-19 immunisation and patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9267), dose 1 via an unspecified route of administration, in right arm on 19Feb2021 at 02:30 PM as 1st dose, single for covid-19 immunisation. Medical history included type 1 diabetes mellitus, hypothyroidism and hypertension. The patient had allergies to oxycodone, biaxin and clindamycin. Concomitant medication was not reported. Patient did not receive any other vaccine in four weeks Prior to vaccination, patient became now not diagnosed with COVID-19. On 15Mar2021 at 10:30 am patient's entire body broke out in hives. The hives started on the skull and then went to the chest. Patient visited to doctor or other healthcare professional office/clinic visit for reported adverse event. Treatment was provided with Prednisone, Benadryl and Cetirizine. Since the vaccination, the patient was not tested for COVID-19. Outcome of the event was recovering.   No follow-up attempts are possible. No further information is expected
This spontaneous report was received from a nurse and refers to a currently 15-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided. On an unknown date, the patient was vaccinated with improperly stored GARDASIL 9 lot # N032284, expiration date: 22-SEP-2020 (dose and route of administration were not provided) for prophylaxis. Temperature and time frame were reported as: below 0 degrees Celsius (-0.6 degrees Celsius) for 7 hours and 38 minutes and 9 degrees Celsius to 25 degrees Celsius (13.3 degrees Celsius) for 1 hour and 14 minutes. Previous temperature excursion was reported as: 9 degrees Celsius to 25 degrees Celsius (11.7 degrees Celsius) for 3 hour and 53 minutes and 9 degrees Celsius to 25 degrees Celsius (23 degrees Celsius) for 11 hours and 21 minutes. Digital data logger was involved. No adverse effects were reported. Sender's Comments: US-009507513-1811USA007947: US-009507513-1811USA007949: US-009507513-1811USA007950: US-009507513-1811USA007951: US-009507513-1811USA007952: US-009507513-1811USA007946: US-009507513-1811USA007945: US-009507513-1811USA007948.
This patient was admitted on 5/1/21 with chest pain. He was found to have an inferior STEMI with a thrombotic lesion in the proximal circumflex artery that was stented. He was also found to have a chronic right gastrocnemius deep vein thrombosis on a lower extremity ultrasound on 5/3/21. He is currently undergoing a hypercoagulable workup. There is potential concern that the thromboses may have been related to his COVID vaccine, as he received the second dose on 4/25/21.
I tested positive a couple days after a person told me they were positive with Covid. It felt like a flu.
Reaction to vaccine similar to historical reaction to flu vaccine. Starting with cold hand and progressing to coughing fit. Patient  took medication recommended by allergist. 50mg Benadryl and 2x puffs albuterol inhaler from home.
This case was reported by a physician via call center representative and described the occurrence of injection site tenderness in a male patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2020). On 10th January 2018, the patient received the 1st dose of SHINGRIX. In January 2018, less than a week after receiving SHINGRIX, the patient experienced injection site tenderness, injection site erythema, injection site induration, fatigue, myalgia, fever and nausea. On an unknown date, the outcome of the injection site tenderness, injection site erythema and injection site induration were unknown and the outcome of the fatigue, myalgia, fever and nausea were recovering/resolving. It was unknown if the reporter considered the injection site tenderness, injection site erythema, injection site induration, fatigue, myalgia, fever and nausea to be related to SHINGRIX. Additional details were provided as follows: The patient experienced a very severe local reaction with pain and tenderness, erythema and induration. The erythema was extended approximately 3 inches in diameter around the injection site. The patient had myalgias and fevers and some intermittent nausea with fatigue. All the symptoms and signs were improving at the time of reporting although the injection site remains erythematous indurated and quite painful. No additional information provided.
Covid-19 virus test positive; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Covid-19 virus test positive) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    Concurrent medical conditions included Hidradenitis suppurativa.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free (Solution for injection in pre-filled pen). On 19-Mar-2022, the patient experienced SARS-COV-2 TEST POSITIVE (Covid-19 virus test positive). At the time of the report, SARS-COV-2 TEST POSITIVE (Covid-19 virus test positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Mar-2022, SARS-CoV-2 test: (Positive) Positive.         Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.   This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.
Pt stated feeling mild chest tightness and hands warm and clammy, mild distress, lung sounds clear, BP 120/80, RR 12, PR 78, O sat 99%. Stated missed iron medication this morning, had bread and nothing to drink. Nurse offered water. Pt left against medical advise 10mins after symptom onset. ER precautions given to pt. Pt denies lightheadedness, denies N&V, denies heart palpitations.
pt recv vax in 1996 & became pregnant (LMP 11MAY96) & expected date of delivery was 18FEB96;IGG antibody EIA test revealed that pt failed to seroconvert;
pt recv vax; w/in mins, devel 8x6cm area of redness on arm, hot area, pain & swelling near inject site;broke out in sweat; recovered;
The evening of vaccination pt reported severe pain in neck and upper arm. Pain continued for several days and radiated down pts arm and into top of hand. Pt reports a sharp pains at times but usually a throbbing pain in bicep area. (All problems on (L) arm.)
lower back hurt where she couldn't sleep; Her left  arm where she received all 3 shots was sore all three times.; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (lower back hurt where she couldn't sleep) and VACCINATION SITE PAIN (Her left  arm where she received all 3 shots was sore all three times.) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 03F21A2, TT2643 and TT2643) for COVID-19 vaccination.     The patient's past medical history included Polymyalgia rheumatica (PMR) and Back disorder NOS (Lower Back problems). Concurrent medical conditions included Autoimmune disorder.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BACK PAIN (lower back hurt where she couldn't sleep) and VACCINATION SITE PAIN (Her left  arm where she received all 3 shots was sore all three times.). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, BACK PAIN (lower back hurt where she couldn't sleep) and VACCINATION SITE PAIN (Her left  arm where she received all 3 shots was sore all three times.) outcome was unknown.            No concomitant medication were provided by the reporter.  Patient had take Tylenol for able to sleep because her back hurt again.   This case was linked to MOD-2021-306253 (Patient Link).
This spontaneous report was received from a certified medical assistant and refers to a child of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 04-SEP-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # L007578 with an expiration date on 05-MAR-2017; dose and route of administration were not provided). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected because there was no consent for further contact.
It feels like an MS flare; left eye blood vessel rupture with pain; left eye blood vessel rupture with pain; pressure emanating to left eye; Dizziness; off-balance; headache and head pressure; headache and head pressure; chest heaviness; exhaustion; nausea; This is a spontaneous report from a contactable consumer (patient). A 44-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 31Mar2021 17:45 as single dose  for COVID-19 immunization on an unspecified facility. Medical history included multiple sclerosis, ulcerative colitis, rheumatoid arthritis, and seasonal allergy from an unknown date. The patient took several unspecified concomitant medications taken within two weeks. The patient previously took metoclopramide (REGLAN) for nausea and experienced drug allergy. No other vaccines were taken in four weeks. No COVID-19 prior to vaccination and not tested for COVID-19 post vaccination. On 02Apr2021, the patient had MS flare, left eye blood vessel rupture with pain and pressure emanating to left eye, dizziness, off-balance, headache and head pressure, chest heaviness, exhaustion, and nausea. The patient visited the emergency room and physician's office where she was given an unspecified treatment. The outcome of the events was not recovered.   Information on the lot/batch number has been requested.
Pt with negative varicella titers and two previous pregnancies received two doses of varicella virus vaccine live, one on 3/26/98 and one on 5/21/98. The pt became pregnant (confirmed by a pregnancy test on 7/16/98) and delivered a normal male at 40 weeks gestation. During her pregnancy the pt experienced hyperemesis and chondritis.
pt recv vax & devel a fever & an inj site rxn characterized by swelling, redness & pain;
Severe Hypotension,  Diaphoresis, Dizziness, Tachycardia, shaky, confusion From 1:45 to 2:30  when she left the building. o.3 mg Epinephrine injection auto injector to the right lateral thigh Activated AMR Epinephrine RX called into local pharmacy Hypotension  and confusion, and dizziness and diaphoresis were resolved with epinephrine,
Vasovagal reaction to vaccine, patient had a near fainting experience, a few seconds after receiving her vaccine. We had the patient lie supine on the table and drink juice. The patient stated she felt better so we had her sit up on the table, she then felt faint again and her skin was pale and clammy, we had her lie back down on the table and continued to give her fluids of juice and water while monitoring her blood pressure and pulse. Patient was monitored for 1.5 hours and given 50 oz of water to drink while in the office. Patient was released to leave our office after her vital signs stabled and she was feeling better.
Patient's first time getting flu shot. Patient felt flushed, dizzy, nauseated 5-10 minutes after flu shot. BP 141/93, Pulse 93. Recheck 5 min, 125/83, Pulse 83. Called corporate. Found out patient had not eaten yet, gave crackers, orange juice. Patient felt better. Cold compress applied.
Pt experienced dizziness, balance disturbance, rapid heart rate, beginning approximately 10 hours post vax. Still persists.
This spontaneous report as received from a nurse refers to a patient of unknown gender and age who on 24-MAY-21012 was vaccinated with dose 1 GARDASIL injection (dose, route and lot number not provided). It was reported that the patient also received dose of GARDASIL on 03-AUG-2012 and on 10-OCT-2012. No adverse effect reported. Additional information has been requested.