chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12May2021 (Lot number: EW0173, Expiration Date: Aug2021) at the age of 58 years as dose 1, single for covid-19 immunization. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Pain at injection site".  Additional information: Caller reported that the injection site swelling, and redness started the same day that she received the second dose of the Covid-19 vaccine, 02Jun2021, an hour or two after she received the vaccine. Caller is a consumer calling in regard to the Pfizer Covid-19 vaccine. Caller reported that she was given the second dose of the Covid-19 vaccine on 02Jun2021 at 8:30 AM, about 36 hours ago. Caller reported that last night, 03Jun2021, before going to bed, the lymph node under her armpit on the same arm as the injection was given was swollen. Caller reported the lymph node is swollen and it hurts. Caller inquired how long is this supposed to go on for and what can she do to alleviate the pain. Caller reported that she thought that if there's more Covids coming with different numbers on the end, like Covid-28, she wanted to just go ahead and be prepared for Covid-25 or whatever is coming next. Caller reported that she just wants to be protected. Prior Vaccinations the patient was not diagnosed within 4 weeks of covid-19.  Information on Lot/Batch number was available. Additional information has been requested  Follow-Up (20Jul2021): Follow-up attempts are completed. No further information is expected.
RECEIVED VACCINE ABOUT NOON ON 10-19-06. THAT EVENING SHE NOTICE RASH ALL OVER BODY. NOT RAISED OR IRRITATING. THE RASH WAS MOSTLY GONE BY MORNING BUT PERSISTED IN THE RT LOWER LIMB FOR 2 DAYS. MODERATE ACHES AND PAINS THROUGHOUT ENTIRE BODY FOR 2 DAYS AFTER VACCINATION. PT HAS RECEIVED THE INFLUENZA VACCINE BEFORE WITHOUT ANY PROBLEMS LIKE THIS IN THE PAST.
My symptoms were tiredness, body aches, fever , I was Ibuprofen for my symptoms
Patient received Tdap on 8/14/12 and did not recall it when asked on 8/16/12. She received two Tdap doses within two days. She reported the following: mild soreness at injection site, mild nausea, "hot flashes; she reports all resolved as of 8/21/12.
it started getting worse several days later, it had a red circle from injection, but now and the last few days; rash is bigger, 3 circle hives and looks worse each day...
Development of itching, redness and swelling about 3-4 days after the vaccination. Now with induration of about 4-6 cm in diameter. Treated with as needed ibuprofen. Started azithromycin on day 7 for possible cellulitis.
On June 12 in the am I noticed raised welts on my left cheek, near the left ear, just below where sideburns would be on a man.  On June 18 I noticed what looks like rosacea on my left cheek and additional welts in the same place as June 12. Left cheek to the ear is itchy and is raised. Cheek skin feels tight.
A LITTLE  BIT TIREDNESS; NAUSEA FOR 5 SECONDS; This spontaneous report received from a patient concerned a 78 year old female. The patient's height, and weight were not reported. The patient's past medical history included: double mastectomy, and concurrent conditions included: penicillin allergy, and occasional leg swelling, and other pre-existing medical conditions included: The patient was taking water pills everyday. The patient had allergies to pain medications and vitamin D. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: UNKNOWN) dose was not reported, administered on 23-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 23-JUL-2021, the patient experienced a little bit tiredness. On 23-JUL-2021, the patient experienced nausea for 5 seconds. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea for 5 seconds on 23-JUL-2021, and the outcome of a little bit tiredness was not reported. This report was non-serious.
Started off severe headache 30 minutes after shot.  1 hour after vaccine light headed, dizziness started and could not drive home when sent home from work.  Ibuprofen 800mg taken about 2 hours after vaccine to help with headache.  4 hours after vaccine chest tightness and wheezing.   Called online nurse consultant for advice and was told to visit urgent care if symptoms worsen.    Patient did not seek additional care that night.  Next morning , symptoms continued with dizziness, lightheaded, SOB.  That afternoon, headache turned into "migraine" - went home to sleep.  Used daughters nebulizer and took more ibuprofen that evening.  On Day 2, patient was gasping for breath having trouble breathing and went to urgent care based on PCM recommendation.  Received breathing treatment and steroid in urgent care.  Discharged with Prescription for prednisone and inhalers.   On Day 3, still had all symptoms despite starting prednisone and inhalers.  PCM Follow up on Day 4 - ordered CBP, CT scan,   To date 3 weeks later, patient still has SOB/wheezing symptoms and chronic headache.  Still using Albuterol inhaler three times daily and ibuprofen 800mg  prn to help with symptoms
Information has been received from a registered nurse concerning an 8 weeks old patient who was intended to receive RECOMBIVAX HB and instead on 16-APR-2009 was inadvertently vaccinated IM with a 0.5 mL dose of VAQTA. The nurse stated that this was due to a human error and not to product confusion. No adverse symptoms reported. Follow-up information has been received from a registered nurse who reported that patient was a 9 weeks old male (previously reported as an 8 week old patient). It was reported that on 17-APR-2009 (previously reported as 16-APR-2009) the patient received hepatitis B vaccine (lot # 657842/0494U) instead of VAQTA. The nurse confirmed that this was a case of human error since the nurse administering the vaccines was fairly new. At the time of reporting no reaction had been noted. This is one of several reports received from the same source. Additional information has been requested.
Patient had his first dose of Pfizer COVID-19 vaccine on 4/8/2021 and his second dose on 5/13/2021. He developed Shingles on 5/16/2021.
Pain in left shoulder to any movement and to the touch (seems to be an inner ball just in upper shoulder but feel on the skin to touch). This happened from 4/ Pain in shoulder with any movement; Pain in left shoulder to any movement and to the touch (seems to be an inner ball just in upper shoulder but feel on the skin to touch). This happened from 4/ Pain in shoulder with any movement; lump just in the upper part of the shoulder; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Jan2022 17:30 (Lot number: Fk9229) at the age of 43 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LABETALOL; PANTOPRAZOLE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Ew0173, Location of injection: Arm Left), administration date: 27Apr2021, when the patient was 42 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Er8737, Location of injection: Arm Left), administration date: 30Mar2021, when the patient was 42 years old, for Covid-19 Immunization. The following information was reported: PAIN (non-serious), TENDERNESS (non-serious) all with onset 31Jan2022 12:00, outcome "not recovered" and all described as "Pain in left shoulder to any movement and to the touch (seems to be an inner ball just in upper shoulder but feel on the skin to touch). This happened from 4/ Pain in shoulder with any movement"; AXILLARY MASS (non-serious) with onset 31Jan2022 12:00, outcome "not recovered", described as "lump just in the upper part of the shoulder".   Therapeutic measures were not taken as a result of pain, tenderness, axillary mass.
Day 1: mild sore throat Day 2: mild sore throat plus sniffles, mild fever Day 3: headache and congestion, lethargy, mild fever, runny nose, overall feelings of being unwell Day 4 (today): Milder symptoms from day 3
Pt had a vasovagal reaction (light headedness, increased heart rate) moments after administration of vaccine. Pt was provided with an ice pack to put on back of neck, vital were taken . Pt recovered fully after approx 10 min.
No additional AE; intramuscular route instead of subcutaneous route; This spontaneous report was received from a pharmacist concerning a patient of unknown age. No information about the current condition, medical history or concomitant therapy was reported.    On 05-DEC-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) via intramuscular route instead of subcutaneous route (lot # T002842, expiration date 23-JAN-2022; dose was not reported) as prophylaxis (incorrect route of product administration). No additional adverse event was reported.
This spontaneous report was received from a licensed practical nurse concerning a patient of unknown age and gender. Information about concurrent condition and medical history was not provided. On 22-OCT-2015, the patient was vaccinated with an improperly stored dose VARIVAX (lot # L013063, expiration date 14-APR-2015 or lot # L026408, expiration date 15-JUL-2015) (dose and route were unspecified). Concomitant therapy was not reported. No adverse effect was informed. This is one of two reports received from the same source. Additional information has ben requested.
Initial report received from a healthcare professional on 16 August 2013. An 18-year-old female patient who had no significant medical history or illness at the time of vaccination and whose concomitant medications were not reported, had received intramuscular dose of MENACTRA vaccine (batch number-U4648AA) in the left deltoid on 12 August 2013. On 13 August 2013, within 24 hours of vaccination, the patient experience fatigue, nausea, vomiting and headache. Laboratory investigations were not done and corrective treatments were not reported. At the time of this report the events were persisting. Documents held by sender: none.
got the first vaccine, break out on one spot in my bottom; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox (The patient had chicken pox as a child, every part of his/her body was covered with chicken pox even in his/her ears and nose including private parts).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. The patient was treated with acyclovir. On an unknown date, the outcome of the shingles was recovering/resolving.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 01-JUN-2022 Reporter's Comment: This case was reported by a consumer via interactive digital media. The patient was told by the doctor when he/she got the shingles vaccine that because he/she had chicken pox and he/she was a candidate for shingles. The patient broke out in one spot on his/her bottom. The patient had been taking Acyclovir it cleared it up pretty fast but he/she would rather not take any medication.  The reporter stated that, please share what homeopathy do we take. Additional Supportive Information: The follow up would not possible, as no contact details were available.
patients arm around the injection site was red and tender. It was still so after  a week. Tylenol did not help the pain, she did put heat on it.
Phlebitis, NauseaVomiting & Tachycardia Narrative: Employee received vaccine in L arm. Burning sensation experienced 5 min after dose in L arm/shoulder. Some nausea which resolved. HR 135-> 100-> 87 over 20 minutes. Emp. returned to work.
Patient is a 60yoF who is presenting to ED on 12/28/20 complaining of decreased sensation and itching on left side of face as well as darkening of peripheral vision on the left side. She received her initial COVID vaccine today at 11am, first began noticing symptoms at 1230 and took 2 benadryl around 1pm. In addition, she is reporting some light headedness. She states that her face feels swollen, but knows that it is not. Itching improved after benadryl but face continues to feel numb on left side.
This is a spontaneous report from a contactable physician via Pfizer Sales representative. A 4-month-old female patient received the second dose of PREVNAR 13 on unknown date. After vaccination, within 48 hours, had an apnoeic episode at home and she turned blue. When she had received the first dose of PREVNAR 13, at the age of 2 months, she also had had an apnoeic episode. At the time of this report, the outcome of the events was unknown. Follow-up (20Dec2013): Follow-up attempts completed. No further information expected.
15-20 minutes after nurse administered each vaccine,  the patient was noted to have developed hives and a rash on her right cheek. There was no additional treatment provided to the patient and the rash was not bothersome. There were NO signs of anaphylaxis (i.e. facial edema, airway involvement, etc). The patient was monitored for an additional 1 hour and the rash resolved.
Had pain on arm, red, swollen, inflamed (L) arm from PNEUMOVAX shot. Went to doctor put her on ZYRTEC, ALLEVE.
This spontaneous report as received from the patients mother via company representative referring to a 15 year old female patient with not known drug reactions or allergies. On 17-MAR-2014 the patient was vaccinated with GARDASIL first dose, 0.5 ml, intramuscular (site, lot number and expiration date not provided) at the nurse's office. It was also reported that on 17-MAR-2014 the patient received VAQTA (dosage, formulation site, lot number, expiration date and indication not provided). On 17-MAR-2014 the patient fainted 5-10 minutes after administration of GARDASIL. The patient also experienced generalized muscle twitching for less than 1 minute. The patient subsequently recovered completely while in the nurse's office (on 17-MAR-2014) without requiring medical treatment. None laboratories were performed. Additional information has been requested.
Information was received on 20-APR-2017 from an attorney in the from of an initial legal complaint regarding a female patient (age not reported).  Medical history, concurrent condition and concomitant therapy were not reported. On 12-APR-2013 the patient was vaccinated with ZOSTAVAX (dose not reported) as recommended for routine adult health maintenance for the prevent of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 02-MAY-2016 the patient was treated for a painful rash, which was diagnosed as shingles. On or about  23-JUN-2016 the patient was treated again for ongoing and worsening symptoms, at which time she was given the additional diagnosis of post-herpetic neuralgia. Post-herpetic neuralgia is a chronic condition resulting from nerve damage caused as a residual effect of severe shingles. On or about 16-SEP-2016 the patient was treated again for a new outbreak of herpes zoster. Although shingles is an incurable viral condition, the patient was prescribed pregabalin (LYRICA) and gabapentin (NEURONTIN) for management of her symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result the patient suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Pt received influenza vaccine on 10/22/04. On Saturday she noticed several round red areas on stomach about the size of a quarter thinks she had a fever, was diaphoretic with Nausea. Her doctor's office told her to take Benadryl. She took 25 mg and feels better, but rash is still there.
Shingles even after 2 doses/Suspected vaccination failure; Rash consistent with shingles; Rash consistent with shingles; This case was reported by a physician via sales rep and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and rash. On an unknown date, the outcome of the vaccination failure, shingles and rash were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and rash to be related to Shingrix and Shingrix.     Additional Information: GSK receipt date: 1-Mar-2023 Reporter's comment: The patient came in with a rash consistent with shingles even through she had received 2 doses of Shingrix. The reporter did not consent to follow-up. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Employee administered Fluzone "high dose" Quadrivalent  by 11-7 Supervisor on 10/5/21. Employee under 65 years of age. Currently, employee reports no adverse reactions.
dizziness with falls and decreased blood pressure which he states he recorded at 63/93 (93/63)/his blood pressure dropping and the dizziness; chills; pain on his injection site side; dizziness with falls and decreased blood pressure which he states he recorded at 63/93 (93/63?)/his blood pressure dropping and the dizziness; headache; body ache; fever; having a sleepless night; dizziness with falls and decreased blood pressure which he states he recorded at 63/93 (93/63?)/his blood pressure dropping and the dizziness; This is a spontaneous report from a contactable reporter. This 73-year-old male patient reported first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EN6203 and Expiration date was not reported) via an unspecified route of administration, in upper left Arm, on 20Mar2021 at 11:33 (at the age of 73-year-old), as 1ST DOSE, SINGLE for COVID-19 immunization. Medical history includes cholesterol and covid infection on 08Nov2020. The patient concomitant medications included Quinapril HCl at 20mg/12.5mg and takes two in the morning by mouth. He started taking it a long time ago about 30 years ago and it was probably changed during 30 years, Amlodipine (expiry date is 01Mar2022) at one pill per day of 10mg and began taking it in 2014, doxazosin mesilate (DOXAZOCIN) at 2mg and he takes 1 pill per day at night since 2014, atorvastatin calcium (ATORVASTAN, Lot number: RP0902, Expiry date: Aug2022) at 20mg and he takes one per day by mouth at night. Historical vaccine was flu shot on an unknown date in Oct2020. There were no additional Vaccines administered on same date of the Pfizer Suspect. There was no prior Vaccinations within 4 weeks. The patient reported, he went to bed and couldn't sleep at all and usually does not use a blanket but so quickly he got chills and he had most everything like headache, body ache, fever, having a sleepless night, dizziness with falls and decreased blood pressure which he states he recorded at 63/93 (93/63)? and also had pain on his injection site side, and the pain at the injection site is a small pain and is not bad. States he can sleep on the injection side a little bit. He states that he takes 3 or 4 prescription medications for high blood pressure and has never had an issue with low pressure before. He is concerned about taking the second dose of the vaccine due to the type of reaction that he experienced. However he is concerned about his blood pressure dropping and the dizziness on 21Mar2021. He states his blood pressure dropped so badly and he takes blood pressure medication for his high blood pressure. He takes the four pills for his blood pressure and one is a water pill also, but one is for cholesterol. He states he had COVID infection on 08Nov2020 and had an antibody test in Jan2021 prior to the Pfizer COVID vaccine; states he did not have to be in the hospital when he had COVID, and his lungs were good, and his oxygen was good, and he was home. Outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
The patient started with Chest Pain this a.m. (7-16-21). The patient received the vaccine on 7-13-21. The patient reports fever since 7-15-21.
BP was taken on 01/14/2021 and a bump/rash the size of a 50 cent piece was formed at the site of injection. Characterized as itchy and red. Patient also described feeling dizzy, nauseous, and chilled the day after her shot as well.
Syncope episode after admin of men b and hep a. Assisted pt to lying position and applied ice to back of neck. Pt verbalized he was feeling better, gave mcv4 & hpv. C/o of chest tightness, bp 140/90 hr 94. Remained lying for 10 min, assisted to seated position and observed for addition 10 mins. Pt stated he was feeling better.
"Moderna COVID-19 Vaccine EUA"   Fever, chills, nausea, vomiting, body aches, headaches. Started around 3 am the next morning and resolved around 9am the following morning (2 days after the vaccine).
Immediately started my period within two hours of injection and still bleeding now, two weeks since shot.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Oct2021 13:30 (Batch/Lot number: unknown) at the age of 46 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: MENSTRUATION IRREGULAR (non-serious) with onset 26Oct2021 15:45, outcome "not recovered", described as "Immediately started my period within two hours of injection and still bleeding now, two weeks since shot.". Therapeutic measures were not taken as a result of menstruation irregular.  Additional information: Pregnancy at time of Vaccination: No. Facility where the most recent COVID-19 vaccine was administered: Workplace clinic. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. List of any other medications the patient received within 2 weeks of vaccination: No. if treatment ae:  No. Prior to vaccination, was the patient diagnosed with COVID-19?:No. Since the vaccination, has the patient been tested for COVID-19?:No. Device Date : 12Nov2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt experienced sharp pain in right arm for 2 weeks, painful to sleep on affected side; decreased strength; tingling; high temperature. Pt was treated with prednisone, heat and physical therapy.
Proquad given at 6 months of age--no symptoms to date and no treatment.