chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt was given HPV vaccine and had adverse reaction- Per MA, after vaccine as administered, pt fainted and fell back onto table, she made some jerking movements and then became awake, mother and MA were with pt entire time. Pt vitals with pulse ox 98, heart rate and respirations within normal limits, BP 120/70 lying down. Pt AAO X3, says she remembers getting vaccine, then she says she "saw mickey mouse" and woke up lying down on the table. Pt tolerated sitting in room for 10 minutes, excused for rest of school day per moms request. We will wait for other vaccines at next PE, I reviewed all known side effects with mother, reassurance that this is a common and known side effect- gave her HPV information so she can choose if she wants to continue with series. Advised rtc if any further concerns or symptoms rest of the day.
Developed a reddened, raised local reaction at the injection site (R deltoid) about size 6cm (length) X 6cm (width).
Information has been received from a nurse concerning a 14 year old female patient who on 09-AUG-2010 was vaccinated SC with her second 0.5 ml dose of VARIVAX (Merck) (lot number 665967/0224Z) on the right arm. The date of her first dose of VARIVAX (Merck) was not provided. After receiving the second dose of VARIVAX (Merck), the patient experienced warmth, swelling and a knot at the injection site on her right arm on 11-AUG-2010. The patient sought unspecified medical attention. At the time of report the patient's status was unknown. Additional information has been requested.
MUSCLE STIFFNESS; WEAKNESS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on AUG-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 AUG-2021, the patient experienced muscle stiffness, and weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle stiffness, and weakness. This report was non-serious.
Fever, chills, swelling and itchy injection site, rash on injection site arm, extremely sore arm-could not lift above head, swollen lymph nodes, GI upset.
the swelling and extreme tenderness of the site of injection; the swelling and extreme tenderness of the site of injection; headache; I couldn't sleep last night because I have headache, thrombing headache and back pain; Nausea; I had like metallic taste; Dizziness; The initial case was missing the following minimum criteria: suspect drug. Upon receipt of follow-up information on 27Jan2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable physician. A 61-year-old male patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685, expiration date Mar2021) on his left arm, intramuscular on 18Dec2020 at 0.3 mL, single for COVID-19 immunization.  Medical history included hypertensive, 2 stents in heart in 2016, Hyperlipidemia, hypothyroidism, coronary artery disease in 2016 and Allergic (Allergic rhinitis + Chronic sinusitis). Concomitant medication included acetylsalicylic acid (ASPIRIN), clopidogrel bisulfate (PLAVIX). It was reported that the patient had swelling and severe tenderness left his arm. He couldn't sleep last night because he had throbbing headache and back pain on 18Dec2020. Initially, he had nausea. Patient stated further stated that Headache and swelling and extreme tenderness of the site of injection, that is the swelling, no redness but the swelling and tender and painful. Initially, he had till now the mild back pain. He patient said she took Tylenol. She also mentioned that initially she had like metallic taste and then disappear. The patient also had dizziness a little bit. The outcome of the event vaccination site swelling, dysgeusia and tenderness was recovered on unspecified dates, headache and back pain was not recovered, recovering for nausea while unknown for the remaining events.
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medicines were reported No treatment medicines were reported   This case was linked to MOD-2021-395985.
Devel h/a, proximal arthralgia, then dizziness & fever; also had heavy exercise water-sking over weekend p/inject;
2 weeks after 2nd shot symptoms similar to UTI and or kidney stones, back pain. Given 10 days antibiotic, blood test and CT scan, results were negative for UTI and kidney stones were not blocking
Symptoms of preterm labor started on Oct 1, 2021 with losing the mucus plug and beginning of periodic contractions. Spontaneous rupture of membranes occured on Oct 6, 2021 leading to unmedicated delivery on Oct 6. Estimated due date was Nov 9, 2021. Baby was born at 35 weeks 1 day. Birth weight was 4 lbs 12 oz. Mother and child spent 2 days in hospital following labor and delivery. One week later, the child was readmitted to the hospital due to complications from being born prematurely.
Flu vaccine and Covid booster both administered Left upper arm. Pain with movement of arm since I jextion. Pain worse with movements like dressing, undressing. Pain still present since date of injection, no improvement. Celebrex prescribed by PCM
pt became obtunded p/receiving MMR vax; stabilized in clinic & subsequently transferred to hosp; treatment for cerebral edema given;
patient developed diffuse myalgias,  paresthesias in all extremities 3 days after receiving vaccine. has progressive weakness in hands and legs
Within 3 min of shot, could taste metal in my mouth. After 15/20 min, got in the car and drove down the street and got a major headache I've never gotten before in the back of my head. Later that evening, needed to nap. Felt really exhausted. Sunday night, started feeling body aches. Temp was rising. Monday morning, started getting body chills and body began to hurt more.
Patient recieved in the left deltoid-IPV 0.5ml and DTAP 0.5ml.  In the right deltoid-MMR 0.5 and Varicella 0.5ml.  This was on 2/9/06.  On 2/11/06 mother presented child to hospital.  Child's complaints at time were left arm swelling and tenderness.  Pediatric History & Physical in assessment physician entry of Cellulitis arm left? allergic reation.  Plan: IV antibiotics, compresses warm.
Systemic: Dizziness / Lightheadness-Medium, Systemic: metal taste in mouth-Medium, Systemic: Headache-Mild, Systemic: Hyperventilation-Mild, Systemic: Shakiness-Mild
Fever: 101.5-102 for 9 hours : treated with aspirin and Ibuprophine  Fatigue/ body aches. Same treatment. Lasted two days
fever; headache; Lymphadenopathy, axillary left arm. Mild for 1st dose, moderate-severe for 2nd dose, still present 13 days post 2nd dose. Mild lymphadenopathy other axilla; This is a spontaneous report from a contactable Other Health Professional. A 49-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 20Jan2021 14:30 (Batch/Lot Number: EL8982) as single dose for covid-19 immunization.  Medical history included historical vaccine, dose 1 via an unspecified route of administration, administered in Arm Left on 30Dec2020 at 14:45 (Batch/Lot Number: EJ1685) as single dose for covid-19 immunization. Concomitant medication included lansoprazole (PREVACID) taken for an unspecified indication, from unspecified date. Lymphadenopathy, axillary left arm. Mild for 1st dose, moderate-severe for 2nd dose, still present 13 days post 2nd dose. Mild lymphadenopathy other axilla on 02Jan2021 08:00 AM. The patient had fever and headache The patient was treated ibuprofen for fever and headache. The patient underwent lab tests and procedures which included, Nasal Swab (labcorp pixel): negative on 29Jan2021. Facility type vaccine is Clinic Name. The outcome Lymphadenopathy, axillary left arm. Mild for 1st dose, moderate-severe for 2nd dose, still present 13 days post 2nd dose. Mild lymphadenopathy other axilla was not recovered and outcome for fever and headache was unknown.
" by 8pm that night, i had nausea, body aches, back pain, diarrhea and arm pain.  Except for the arm pain, symptoms lasted 24 hours.  The arm pain lasted from 12/28/20 to 1/2/21"
The next day post vax pt developed arm stiffness and a welt as large as her palm at the site. She also experienced flu-like symptoms which included body aches, sweats and headache. She reported this event to her physician, who instructed her to take ibuprofen and apply ice to the site. The pt recovered.
The parent reported some fever the evening of the vaccine. Normal day of 09/21/01. The family put the child down to bed, no symptoms 09/21/01 at 8:00 pm. Family checked at 9 pm, the child's color was white, unresponsive. Rushed to the hospital, the child arrested. Autopsy findings for cause of death were bronchopneumonia, laryngitis, cerebral edema.
Patient came down approx., 3 hours after vaccine and had a slight rash on left arm and shoulder around injection site, Was told to take benadryl  and if it got worse to let us know or report to local ER. The next morning around 8:30am the patient came in and her left upper arm now was red, swollen and hot to touch with a rash around the shoulder area. She was told to ice the area and take benadryl for the localized reaction. Note and pictures were documented in patients chart but patient was not seen for an office visit after the reaction.
This is a spontaneous report from a contactable physician (pediatrician) via a Pfizer sales representative. A patient of unspecified age, race, ethnicity and gender received a single dose of TRUMENBA via an unspecified route of administration on an unspecified date for immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced Guillain-Barre on an unspecified date. Outcome of event was unknown.; Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.
A 68 y.o. male admitted with pna due to covid-19.  Initially with elevated inflammatory enzymes, elevated procal. Treated with remdesivir, steroids, nebs, abx. Pt improved to room air and resp symptoms resolved. Will continue lower dose steroids / abx. Nephro consulted for HD. Trop elevated. Echo reviewed and cards cleared. HD during quarantine set up for pt. Pt also with known right pleural effusion that recurs, appears stable now. Is already established with pulm / IR for thora as needed, but does not appear to need one emergently.
The patient was given an expired vaccine on 06/22/22 @10:40 am.  The vaccine had expired on 05/29/22.  Dr. and nursing supervisor informed by this nurse. This nurse called mom and informed her of the above incident and inquired about any adverse signs and or side effects pt. is experiencing.  Mother reported that presently he seemed fine and showed no ill signs or symptoms.  Mother encouraged to call Dr. at any time if his condition changes or for any concerns.  I expressed deep apology
right arm has not stopped hurting since the first shot; This is a spontaneous report from a contactable consumer. A (Age: 74; Unit: Unknown) female patient received first dose of bnt162b2 (Solution injection; Batch/Lot Number: EL3302), via an unspecified route of administration, administered in Arm Right on 12Jan2021 as single dose and second dose via an unspecified route of administration, administered in Arm Right on 03Feb2021 (Batch/Lot Number: EL3247) as single dose for (at the age of 74-years-old) covid-19 immunisation. Medical history included diabetic, blood pressure high and cancer all three since 20 years and bad back. There were no concomitant medications. Patient reported that she received the 1st dose of the Pfizer covid vaccine on the 12Jan2021. She took her last shot of the Pfizer covid vaccine on the 03Feb2021, her right arm has not stopped hurting since the first shot. She had cancer on her left side, so everything she had to do has to be administered on her right side. The only thing that eases the pain was ice, and she used the sleeve that she used in her left arm, it relieves the pain, but when she remove the sleeve the pain comes back. She said that she did the ice, rested her arm, and wore sleeves that she used to wear years ago and those stop the pain while she was wearing them but when she takes the sleeves off, it starts hurting again. She stated that her arm is still hurting like the dickens, and actually never stopped hurting from the first shot. She said that she has done everything that the sheet said to try to help it, like using ice and resting it. She questioned how long will this continue to hurt, or what do she need to do, does she need to call her doctor. Later, she stated that the vaccine card was handwritten, and they did not provide NDC/EXP. She said that she had her last labs done in December. No further details provided about those lab results. She stated that she had not seen her doctor about her arm hurting. She stated that she did take some tramadol made by manufacturer Unichem Pharmac, which she got through Pharmacy in a brownish pharmacy bottle and is 50mg. She says she has a bad back, which is what that is prescribed for back ache. She said that she also took some Aleve PM with EXP May2022 and LOT NAA84DR. She said that there was no barcode on the bottle to provide UPC. The outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
Customer called and left (5) messages on VRU that when Flu shot was administered it was given by the pharmacist in his ligament. He claims that use of his arm has been affected for the past 10 days.
8:30 pm on day of vaccine until 8:30 am the next day (12 hrs) - chills, nausea, joint and muscle aches, headache, fatigue 8:30 am-11:30 pm on 2nd day: moderate joint and muscle aches, mild headache, fatigue 11:30 pm on 2nd day until 11:30 on 3rd day: moderate fatigue, mild headache
Pt complained about being nauseas, light headedness, difficult to breath & tingling sensation in left arm. mimicking signs of a syncope. pt was made to lie down for 1/2 hr with legs up & pt returned to feeling well & normal. pt was also observed for another 15 min sitting upright & was cognitive & alert. pt was followed later in the day via phone to see how she is doing. pt stated she is alert, cognitive & normal with no signs of any discomfort or adverse reactions. pt has been advised to check with her pcp too.
Patient reported that on Thursday evening after receiving her vaccine she had a HA that lasted until Friday that resembled her Covid HA. On Friday evening around 9 pm she had a temp of 99.0. She took ibuprofen. She also reported body aches. After taking the ibupofen, the HA, temp, and body aches resolved and she felt fine.
Information has been received from a Physician Assistant who received a call from a 59 year old male patient who was new to his practice complaining of experiencing tinnitus since receiving a 0.5 ml dose of M-M-R II, live (lot # not reported) intramuscularly on 09-JAN-2013. At the time of reporting, the outcome of tinnitus was unknown. The physician assistant reported that he had not seen the patient yet, and so had little medical history and very little patient specific information. The patient was not given treatment for the event. The patient sought medical attention via office visit. Additional information has been requested.
post herpetic neuralgia; herpes zoster; Information has been received from a lawyer regarding a case in litigation concerning a currently 89-year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 28-SEP-2011, the patient was vaccinated with zoster vaccine live (ZOSTAVAX), (dose, route of administration, anatomical location, lot # and expiry date were not provided) at a pharmacy, for the long-term prevention of shingles and zoster-related conditions. Subsequently, the patient was treated by a provider for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: herpes zoster and post herpetic neuralgia. The outcome of the events was not reported. The reporter felt the events were related to the suspect vaccine.
This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. The patient's past medical history included fibromyalgia. Concurrent medical conditions included cold sores (in eye). Concomitant products included valaciclovir hydrochloride (Valtrex). In September 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. In September 2018, immediately after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced pain in arm, swelling arm, sickness, fever and blister. On an unknown date, the patient experienced product supply issue. On an unknown date, the outcome of the pain in arm, swelling arm, sickness and product supply issue were unknown and the outcome of the fever and blister were recovered/resolved. It was unknown if the reporter considered the pain in arm, swelling arm, sickness, fever and blister to be related to SHINGRIX. Additional details were provided as follows: The patient had 2 previous bouts of cold sores in her eye and was getting over having cold sores when she got her SHINGRIX dose. She was taking Valtrex at the time of the vaccination. She has a preexisting condition of fibromyalgia. The age at vaccination was not reported. The patient's arm was extremely painful soon after getting the dose and it began to swell. That night, she was very sick (latency less than a day). She normally had a low body temperature, but she had a fever of 102 degrees F (latency less than a month) for 3 days. Her arm got worse and she got blisters on her arms (latency less than a month). The patient stated that, she could not get her 2nd dose of SHINGRIX due to shortage.
Swelling; Injection site pain; Fatigue; Headache; Muscle and joint pain; Muscle and joint pain; This spontaneous case was reported by a patient and describes the occurrence of SWELLING (Swelling), VACCINATION SITE PAIN (Injection site pain), FATIGUE (Fatigue), HEADACHE (Headache) and MYALGIA (Muscle and joint pain) in a 72-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Faint (Prior to 1st dose she had 2 episodes of falling in night but stated that both were faint episodes).    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING (Swelling), VACCINATION SITE PAIN (Injection site pain), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle and joint pain) and ARTHRALGIA (Muscle and joint pain). At the time of the report, SWELLING (Swelling), VACCINATION SITE PAIN (Injection site pain), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle and joint pain) and ARTHRALGIA (Muscle and joint pain) outcome was unknown.        mRNA-1273 (Spikevax) (Unknown) dosing remained unchanged.       No concomitant information were reported by the reporter.  Patient received 3 doses of the Moderna vaccine in the recommended time frame. Patient reported that she had minor side effects after her Moderna doses.  No treatment information were reported by the reporter.   This case was linked to MOD-2022-572773, MOD-2022-572771, MOD-2022-572772 (Patient Link).   Reporter did not allow further contact
Immediately following vaccination patient experienced syncope. She went pale and stated she felt dizzy then lost consciousness for about 30 seconds. She was caught and kept seated by her father and myself. She was tapped on the shoulder and spoken to until she regained consciousness (about 30 seconds). She then remained seated and took deep breathes until she began to feel better. After sitting for about 5 minutes in the consultation room, where vaccination occurred. She went out and sat in the pharmacy lobby. She sat with her father for anther 15 minutes until they said she was feeling better and left.
patient who received the ActHIB component of a Pentacel vaccine that was given by diluting it with an unknown diluent, no AE; Initial information received on 30-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a patient who received the ACT-HIB component of a DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number not reported via unknown route in unknown administration site) vaccine that was given by diluting it with an unknown diluent.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to inappropriate reconstitution technique.  At the time of reporting the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  List of documents held by sender: none.
FACIAL RASH; GENERAL MALAISE/FATIGUE ADVISED DAD TO V /C PHYSICIAN. WILL LET ME KNOW HOW PT IS.