chrisvoncsefalvay/vaers-outcomes huggingface dataset:
At inj. site 4 x 4 cm area of erythema, induration, heat; pain. Area increasing x 2 days Tx Ceclor 250, 1 TSP BID x 7d Moist, heat to area; Tylenol for pain.
This case was reported by a nurse via call center representative and described the occurrence of generalized rash in a female patient who received Seasonal flu vaccine. On an unknown date, the patient received Seasonal Influenza vaccine at an unknown dose. On an unknown date, an unknown time after receiving Seasonal Influenza vaccine, the patient experienced generalized rash. On an unknown date, the outcome of the generalized rash was unknown. It was unknown if the reporter considered the generalized rash to be related to Seasonal Influenza vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient received a GlaxoSmithKline flu vaccine (didn't know which one) and had a generalized fine rash all over her body.
Pt was given flu vaccine at approximately 11:20 am on 9/11/17. Within 30 minutes, pt developed voice hoarseness, difficulty swallowing, coughing, and feeling of throat swelling. Pt sent to Emergency Room. ER administered benadryl injection (25 mg, IV push), epinephrine injection (.3 ml, subQ), ipratropium-albuterol (3ml, raindrop nebulizer), pepcid intravenous (20 mg, IV med infusion), sodium chloride 0.9% intravenous (1000 ml/hr, IV Med Infusion), and Solu-Medrol Injection (125 mg, IV Push). Pt was discharged to home at approximately 14:30 pm. Pt reports benadryl taken PO on 9/12/17 due to continued feeling of throat swelling.
Pregnancy history: early pregnancy, 5 weeks. Symptoms included pain at injection site, mild muscle aches, and fatigue. Symptoms starting about 12 hours after shot. 500mg tylenol taken twice.
pt recv vax & devel nausea,resp diff,dizziness & numbness;pt taken to an ER for tx;
He says that "a few hours" after this, he developed numbness of the entire right arm and all fingers, which progressed to the point where he could not do buttons with the right hand. Pt reported numbness in right leg to another provider. Symptoms lasted ~1 month and resolved. Nerve conduction studies were normal. Pt reported event initially to mental health provider ~1 month after injection. He had not mentioned it previously to other providers. No treatment was needed.
Case completed Covid vaccine primary series in April 2021, then was hospitalized overnight in February 2022 for Covid.  Hospitalized at Hospital. COVID-19 virus infection Assessment & Plan Tested positive for COVID on admission 2/11. Developed symptoms with weakness and lightheadedness 2/10 overnight. Met sepsis criteria on presentation with fever and AKI but not hypoxoic. CXR negative for acute process. Not treated for COVID as she was relatively asymptomatic. Likely what triggered adrenal crisis.
This case was reported by a other health professional via call center representative and described the occurrence of adverse event in an unspecified number of the patients who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported for the patients. The age group was not reported, but was selected adult as per vaccine indication. The healthcare professional stated that they have noticed that when the patients received the 2nd dose of SHINGRIX closer to the 6 month period the side effects seem to be less severe than when patients were received the 2nd dose at 2 months. The reporter did not give consent to follow up. No specific patients were provided.
Developed severe right leg pain within two days after the vaccine. She had confirmed deep venous thrombosis on ultrasound confirmed on 4/23/21 without other known provocation.
Tested positive for COVID on 26Nov2022/ Coughing, muscle aches, fatigue; Tested positive for COVID on 26Nov2022/ Coughing, muscle aches, fatigue; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A 21-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Mar2021 as dose 1, single (Batch/Lot number: unknown), on 16Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 09Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 20 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Nov2022, outcome "not recovered" and all described as "Tested positive for COVID on 26Nov2022/ Coughing, muscle aches, fatigue". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Nov2022) Positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Severe, Additional Details: IMMEDIATELY UPON INJECT THE PT FAINTED. I GOT HIM ON THE FLOOR AND ELEVATED HIS FEET. CHECKED HIS PULSE AND BREATHING. GAVE HIM WATER. HIS MOTHER KEPT CALLING HIS NAME. WHEN HE SAID HE WAS FINE. HE SAT DOWN THEN FAINTED AGAIN. 911 WAS CALLED. EMT ARRIVED AND TOOK CARE OF HIM. HIS MOTHER DROVE HIM HOME. MOTHER STATED HE DOES THIS EVERY TIME HE GETS A SHOT
Patient experienced adrs relating to mouth pain, sloughing of skin in mouth, dryness in mouth as well as swelling of tongue.
This spontaneous report as received from a registered nurse refers to a 19 year old patient. On 30-AUG-2013 the patient was vaccinated with a pediatric VAQTA, injection, (lot # expiration date, route and indication unspecified) due to a human error. No PQC. No adverse effect reported. Follow up information has been received from a registered nurse reporting that the 19 year old female patient with no illness at time of vaccination and no pre-existing allergies, birth defects or medical conditions. On 30-AUG-2013 at 16:00, was vaccinated intramuscularly on her left arm with the first pediatric dose of VAQTA, injection (lot number J000366). It was reported that on 18-OCT-2013, the patient came in and received 1.0 ml dose of VAQTA (lot number and route not reported). Additional information is not expected.
About three minutes after receiving the injection, i was placed in a waiting room to rest/wait for the 15 minutes to be up. I put my head back to rest and quickly fainted. I'm not sure how long i was out, but i awoke to people yelling "CALL 911". I was given water and sat up, quickly feeling better. When i was out, i do not remember anything nor could i hear.
Patient had sudden onset of severe headache, nausea, vomiting, diaphoresis and photophobia.
Pt called 9-23 to state that arm she got PNEUMOVAX in was really hurting. Instructed to ice and see if got worse. Pt came to pharmacy 9-24 and arm was very red. Instructed pt to be seen at nearby walk-in clinic and let us know what happens. Pt given prednisone, ATARAX and doxycycline.
Stroke at the base of the head/neck - affecting sight and giving me a migrane-like headache Outcome - Memory loss
I'm a healthy female who exercises 6 days a week, is of a healthy weight and no chronic conditions.  My Menstrual cycle has been abnormal following the Pfizer Covid 19 shots.  I have had extremely heavy bleeding and lots of large clots which I have never experienced before. My cycle prior to the shots was always extremely consistent both in occurrence, flow etc.  I have had days where I've had to stay in the bathroom because the clotting was causing me to bleed through everything within minutes.
Flu-like symptoms - mild fever, chills, all-over pain in joints and muscles, extreme fatigue, eyes sensitive to light. Was in bed for an entire day. Took ALEVE, aspirin, extra strength TYLENOL over the 24 hour period with no lessening of symptoms. Symptoms subsided after 24 hours. Had a similar response to the first dose received in March, but this was much more severe.
5 minutes after vaccination rapid heart beat and dizziness. Day after vaccination ran fever 100.4, headache, dizziness, sore muscles and joints lasted 2 days.  Headache and dizziness off and on for 14 days. Severe headache, tingling arms and hands on day 12. Stiff/sore neck on day 16.
Right arm has spot where shot was given that has continued to be sore and hurt since injection on 11/3/99. Denies redness or swelling. Area that's sore is size of postage stamp, according to patient.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information on the patient's concomitant medications, pertinent medical history, drug reactions or allergies was reported. On 23-JUN-2017, the patient was vaccinated with an expired dose of VAQTA, lot # K018181 with expiry date on 04-JUN-2017 (dose and route of administration were not reported) for prophylaxis. No adverse effects were reported. Product quality complaint was not reported. Additional information has been requested.
rash appeared at site of injection, very painful, hot to touch, hard, with rash spreading to torso
Pt mistakenly given the orange cap dose for children 5-11 even though he's 12.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with a dose of VARIVAX lot # N014630, expiration date 11-AUG-2019 (also reported as 11-MAY-2019) (dose and route of administration were not reported) for prophylaxis. The vaccine was reconstituted with improperly stored sterile diluent (manufacturer unknown) (lot # and expiration date were not provided). No adverse events were reported. The sterile diluent had been improperly stored at a temperature of -1 degree Celsius or colder (-10 degrees Celsius) for 6 days, through unknown number of cycles. There had been no previous temperature excursion. Digital Data Logger was involved. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1711USA003734:
10/1 lights were being changed in her office noted a dime size frizzy patch in Left fiscal field eyes very watery - frizzy patch and feeling of looking through rippling water. Continued for 10-15 minutes and then cleared. 10/12 Rippling water vision 10-5 minutes recovered.
Vaccine given 4/22/15. Patient at clinic. 4/24/15: Left arm swollen - red - Patient states that she applied VICKS VAPOR RUB to site. MD order cold compress and ADVIL BID with food PRN.
Information has been received from a nurse concerning a 27 year old female who in approximately February 2007, "6 months ago" was vaccinated with a first dose of Gardasil (lot # unknown).  Concomitant therapy included hormonal contraceptives (unspecified) for 5 years.  On an unspecified date the patient was vaccinated with a second dose of Gardasil.  On an unspecified date the patient was vaccinated with a third dose of Gardasil 0.5 mL injection.  The patient came into the office and said she developed melasma (brown spots on her face).  Medical attention was sought.  At the time of reporting the patient's melasma persisted.  Additional information has been requested.
diarrhea; Cold; fatigue; headache; chills; body aching really bad; unwell; feeling like nausea; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (unwell), DIARRHOEA (diarrhea), NASOPHARYNGITIS (Cold), FATIGUE (fatigue) and NAUSEA (feeling like nausea) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Patient had COVID-19 at the end of December, She had COVID for almost for 1 month) in December 2020. Concurrent medical conditions included Broken leg (Fell off the bike while exercising) since 23-Jan-2021. Concomitant products included ACETAMINOPHEN for Pain, CYCLOBENZAPRINE, AMLODIPINE BESYLATE, METOPROLOL SUCCINATE, VALSARTAN, ROSUVASTATIN, GABAPENTIN and FAMOTIDINE for an unknown indication.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced MALAISE (unwell) and NAUSEA (feeling like nausea). On 14-Mar-2021, the patient experienced DIARRHOEA (diarrhea), NASOPHARYNGITIS (Cold), FATIGUE (fatigue), HEADACHE (headache), CHILLS (chills) and MYALGIA (body aching really bad). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, MALAISE (unwell), DIARRHOEA (diarrhea), NASOPHARYNGITIS (Cold), FATIGUE (fatigue), NAUSEA (feeling like nausea), HEADACHE (headache), CHILLS (chills) and MYALGIA (body aching really bad) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jan-2021, SARS-CoV-2 test: negative (Negative) Negative PCR test. On 15-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
4/2/21 day after noticed hands swelling, arthritis worse than before, unable to use hands because of pain and swelling and stiffness even 3 weeks after 1st vaccine. 5/1/21 day of 2nd vaccine, tired, about 6hours after right leg swelled, from hip to toes, 5/3/21 still same pain, tightness, pain, swelling, tight calf and foot.
pt. c/o headache, sweating, tingling.  pt. went home after symptoms was resolved.
pt recvd pneumovax & flu vax on 3OCT94 & inadvertently recvd 2nd dose of pneumococcal vax 17OCT94 & 18OCT94 pt devel a sore arm & recovered;
On 11/22/21, a Pfizer vial was reconstituted at 10:45 AM. All doses were kept in the vial. On 11/23/21, patient received the reconstituted vaccine from 11/22/21 at 10:29 AM.
Patient developed vomiting and decrease in appetite followed by altered mental status and lethargy.  She was admitted to hospital then was transferred to another hospital where she was diagnosed with acute disseminated encephalomyelitis.
This spontaneous report was received from a medical assistant, referring to an unspecified number of patients of unknown genders and ages. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored dose from 24-APR-2017 to 09-MAY-2017 of M-M-R II with Lot # M022407 with an expiration date of 02-MAY-2018 (strength, dose and route of administration were not reported) for prophylaxis, however no adverse effects were reported. It was reported that the vaccine was exposed to a temperature of 47 Fahrenheit degrees (°F) to 77 °F range for a time frame of 28 minutes. The temperature excursion was recorded by a data logger and it had previous temperature excursions on 19-APR-2017 of 32 °F to 35 °F by 29 minutes. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested. This is an amended report, as corrected.  The preferred term (PT) for the event improperly stored dose of vaccine was corrected to Incorrect product storage.; Sender's Comments: US-009507513-1705USA005357: US-009507513-1705USA009721.
Patient presented 24 hours later with redness about the size of a half dollar, with tenderness to the touch.  Recommended cool compresses and treating localized symptoms.  Will follow up with Physician.
The second time I had OVID-19 thought it was allergies because my throat was raw. I took five rapid tests that all came back negative. I went to the pharmacy to get a PCR and it came back positive. A couple days later the cough started and it was a horrible cough. I didn't get a fever or lose my sense of taste and smell. This time I had less symptoms, but the cough has lasted until today. I went to urgent care a month after for chest x-ray due to the cough. I was put on a Z-PAK and albuterol.
Post vax the patient complained of itching skin and by evening the patient had an urticarial rash on his trunk and earlobes.
Swelling of the face for 4 days; injection site swelling on both arm and leg for 4 days; pain on leg because of swelling and difficulty at stepping on it/walking for 4 days; injection site pain for 3 days; tiredness, headache, mild muscle pain, mild joint pain for 2 days; injection site bruising, feeling unwell for 3 days; rash and itching for 4 days.
itchy; Arm is swollen; Redness; Lymph nodes swollen; headache; This spontaneous case was reported by a physician and describes the occurrence of PRURITUS (itchy), PERIPHERAL SWELLING (Arm is swollen), ERYTHEMA (Redness), LYMPHADENOPATHY (Lymph nodes swollen) and HEADACHE (headache) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. CX4M20a) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced PRURITUS (itchy), PERIPHERAL SWELLING (Arm is swollen), ERYTHEMA (Redness), LYMPHADENOPATHY (Lymph nodes swollen) and HEADACHE (headache). At the time of the report, PRURITUS (itchy), PERIPHERAL SWELLING (Arm is swollen), ERYTHEMA (Redness), LYMPHADENOPATHY (Lymph nodes swollen) and HEADACHE (headache) outcome was unknown.        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 reported by a consumer via call center representative and described the occurrence of injection site nodule in a female patient who received SHINGRIX for prophylaxis. Concomitant products included TYLENOL. On 5th April 2019, the patient received SHINGRIX. On 5th April 2019, less than a day after receiving SHINGRIX, the patient experienced injection site pain. In April 2019, the patient experienced injection site nodule. On an unknown date, the outcome of the injection site nodule and injection site pain were not recovered/not resolved. It was unknown if the reporter considered the injection site nodule and injection site pain to be related to SHINGRIX. Additional case details were reported as follows: The age at vaccination was not reported. The patient received SHINGRIX in unknown arm. On Friday, the patient received the vaccine into the back of her arm and reported that her injection site was still painful without much relief from TYLENOL and reported that less than a week after receiving SHINGRIX had a 2 by 3 nodular welp. The patient asked how long did SHINGRIX side effects last. The patient abandoned call before reporter was able to obtain consent to follow up.
unconsolable p/1st vax & bery irritable/few days;mom states not alert when awake
Pt was due for primary series of Pfizer, age group 5-11.  Vials are stored in correct labels slots after they are initially open.  A previous Medical Assistant had opened a Pfizer Bivalent Booster for the same age group but she stored it under the Primary series.  Unfortunately,  once vaccine was give and I was documenting , the Lot number on the database and the Lot number on  my paper documentation did not match. I went to check on Vial that was under 'Primary Series' and realized it was Bivalent.  Pt sat in lobby for 15 min after vaccine and so far has not had any reactions.
Itchiness; Rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) and PRURITUS (Itchiness) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Patient mentioned taking medication for Blood sugar, Blood Pressure and cholesterol). Concomitant products included LOSARTAN for Blood pressure, ROSUVASTATIN for Cholesterol, GLIPIZIDE and METFORMIN for Diabetic.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced RASH (Rash) and PRURITUS (Itchiness). At the time of the report, RASH (Rash) and PRURITUS (Itchiness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment: Patient was using calamine lotion for the Symptoms
Patient received her second dose 14 days from the first Pfizer dose, she was supposed to have 21 days in between.
Janssen COVID-19 Vaccine EUA.   Fever 3/14 from 7:30pm-11:30pm. Fever 3/15 6:30-7:30am. Headache 3/14 starting at 7:30pm-3/15, ending at 9:00pm. Fatigue starting 3/14 at 6pm. Arm pain at injection site.
Adverse event is developing shingles after the second shot for the COVID vaccine. After the first shot therirwas a increase in POTS symptoms but did not attribute to vaccine but pregnancy itselfs. ( increased POT symptoms included more uncontrolled heart rate, increasing to 160 at certain positions, and more silent migranes and dizziness) One week after the shot back and side started to hurt then developed a rash and was diagonsed with shingles. The shingles as of today has still not completely gone away. There is no indication of adverse effects to baby at this time since the development of the shingles was in third trimester. The treatment plan was collidal oatmeal baths and Valacyclovir (10 days 3x a day)
Case number PHHY2011US47416 is an initial spontaneous report received from a health care professional (nurse) on 31 May 2011. This report refers to an 18 year old male patient. He was vaccinated with MENVEO (batch number 100001) intramuscularly on 31 Mar 2011. However, the patient was given only 0.5 ml of Men CYW liquid conjugate without reconstituting it with Men A powder component. No adverse events were reported following this drug administration error.
Following vaccinations, the pt experienced a "burning sensation" in "all of her joints". the pt believed that she had pre-existing Lyme disease which was exacerbated by the vaccine. Reportedly, prior to vaccination she was absolutely symptomatic and believed herself to be Lyme disease free. The most recent information received on 6/26/00 reports the outcome of the event as unknown.