chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 29 year old female patient with no pertinent medical history an no known drug allergies/drug reactions who on 28-APR-2009 was vaccinated with a 0.09 ml dose of PNEUMOVAX (Lot # 661527/0112Y) intradermally. Concomitant therapy included oral hormonal contraceptives (unspecified). It was also reported that the patient received her TB test on 28-APR-2008. It was reported that there was a pink line at the injection site. It was reported that the patient was not supposed to received PNEUMOVAX; it was given due to human error, not product confusion. The patient sought medical attention with an office visit. It was reported that the patient had not recovered at the time of the report. Additional information has been requested.
Chills, then fever, splitting headache, nausea, brain fog. Next morning most symptoms had abated but brain fog remained and chest pain had started. Visited doctor, then continued resting. Tests showed general inflammation. Will follow up for further blood clotting tests. Chest pain and brain fog have slowly reduced.
Headache; nausia; diahrea; lathargic ; sore injection site-24 hours
Patient felt a pressure, upon getting vaccinated,  like something was there on his heart.  He said to me, "I think the vaccine damaged my heart."  He said this twice on two different occasions at which time I urged him to see a doctor.  He said he could feel it "more" when he exerted himself.  I believe it was sometime late summer or early fall, maybe October, he again said he believed the vaccine had damaged his heart and said whatever he felt in there, felt like it was moving.  On December 9, 2021 he died suddenly of a massive heart attack. He had no history of heart disease and was not being treated for any heart problem, nor did any of his family have a history of heart disease.
Nausea and Vomiting for at least 2 days after vaccine administration. Patient suspected cause was PNEUMOVAX 23 because he has not received that vaccination in the past. He has received FLUCELVAX QUAD in the past with no side effects.
Moderna COVID-19 Vaccine EUA Started feeling chills late evening of 01/14 after having the shot at 10am. Was miserably cold (even under 4 blankets made for warmth) and achy, with occasional bursts of pain in random places, and a headache from hell. I finally got up at 7 the next morning and my fever was 102. Lasted all day. By night, I was down to fever of 101 and everything else was a little less. Saturday morning 01/16 I only had a regular headache and soreness, some nausea after I ate. Almost 11pm now and the only thing left is a minor headache.
Seizure; This case was reported by a other health professional via sales rep and described the occurrence of seizure in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced seizure (serious criteria GSK medically significant). On an unknown date, the outcome of the seizure was unknown.   The reporter considered the seizure to be unrelated to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 14-Nov-2022. Reporter's Comment:  The reporter think Seizure not related to product. The reporter agrees to follow up from GlaxoSmithKline
Dx. localized cellulitis-blister at puncture site. Tx IV Levoquin in hosp. d/c home on clindomycin.
Patient reported left arm swelling and local erythema at injection site, with itching and sore arm. All symptoms subsided after 24 hours.
No adverse event; Received expired Bivalent booster after 30-day Use By Date; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired Bivalent booster after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event) in a 59-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 31-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired Bivalent booster after 30-day Use By Date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired Bivalent booster after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Received expired Bivalent booster after 30-day Use By Date).    Concomitant product use was not provided by the reporter.  It was reported that vial was received as liquid with note use by date was 30-Oct-2022.  On 31-Oct-2022, the patient received bivalent booster after 30-day Use By Date.  Vial did not undergone any temperature excursions.  Treatment information was not provided.
Information has been received from a 17 year old female who was vaccinated with Gardasil (lot number was not reported). Concomitant therapy included TRI-SPRINTEC. Subsequently the patient fainted after receiving Gardasil. Subsequently, the patient was revived within minutes of episode. No further information is available.
On 03/1/14 upon waking up at 9 AM child had fever of 99 degrees F. On 03/3/01 swollen glands in his neck accompanied the low grade fever. On 3/10/14 child's face broke out in a rash. By 3/11/14 child's entire face, neck and torso were covered in a raised, red, itchy, rash. Low grade fever was off and on. Still has swollen glands in his neck.
I had a fever, headache and chills for two days after receiving the vaccine. On 11/13/2022 I had bilateral hand pain and had a rash. Throughout the day it progressed. The rash moved to my feet on the soles. I reached out to my doctor but could not get in to see her. I went to a clinic, and they gave me a prescription for prednisone. Everything resolved after taking steroids. I keep a recurring cough. I developed vasculitis. I had a very large bruise develop on my left leg 12/11/2022. I have had bruises just randomly showing up. I do have abnormal labs indicated towards autoimmune disease.
On 05/08/23, 58 yo F presented to clinic for Nurse Only visit for vaccination with dose #2 of RZV(>=50YR -OR-19 YRS IF IMMCOMP) VACCINE (SHINGRIX). Pt reported experiencing chills after the first dose. At 1633, 0.5 mL was injected into right deltoid (Lot #9S252; Exp: 06/18/2024). During post-injection observation, pt reported dizziness and mouth numbness with a erythematous rash to forehead and bilateral arms. Provider notified, vitals assessed as BP: 117/71, P: 78 and pt ordered and administered diphenhydramine 50 mg IV. Pt then c/o chills and numbness progressing into right cheek. Pt administered methylprednisolone 125 mg IM. After intervention, pt reported symptom improvement. After final MD assessment, pt was discharged in stable condition.
The patient called today to report ADR after receiving PNEUMOVAX and FLUZONE HD on 9/27/2017. She reported that her arm was swollen and red at nighttime and she had chills. She became very sick and went to see the doctor. The patient said that she is fine now. The patient was counseled on possible ADR before administering the vaccinations including soreness in arms, muscle aches, fever and what to expect in case of allergic reaction.
Swollen lymph nodes under left arm; generalized muscle aches; nasal congestion; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 at 11:30 as dose 4 (booster), single (Lot number: GH9693) at the age of 48 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes Type 2" (unspecified if ongoing), notes: Diabetes Type 2. Concomitant medication(s) included: METFORMIN; VICTOZA. Past drug history included: Tramadol, reaction(s): "known allergies: Tramadol"; Nexium, reaction(s): "known allergies: Nexium". Vaccination history included: Covid-19 vaccine (Dose Number: 01, MANUFACTURER: UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (Dose Number: 02, MANUFACTURER: UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (Dose Number: 03, MANUFACTURER: UNKNOWN), for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 23Sep2022 at 22:15, outcome "not recovered", described as "Swollen lymph nodes under left arm"; FATIGUE (non-serious) with onset 23Sep2022 at 22:15, outcome "not recovered"; MYALGIA (non-serious) with onset 23Sep2022 at 22:15, outcome "not recovered", described as "generalized muscle aches"; NASAL CONGESTION (non-serious) with onset 23Sep2022 at 22:15, outcome "not recovered". Therapeutic measures were not taken as a result of lymphadenopathy, myalgia, nasal congestion, fatigue.  Additional information: The patient did not received any other vaccine in four weeks. Other medications in two weeks were Metformin, Victoza. The patient was not tested COVID post vaccination and no COVID prior vaccination.
Severe muscle pain  left arm x 3 days with difficulty moving arm due to pain; soreness at injection site x 7 days; redness at injection site and extending to more generalized area in upper arm x5 days.  Mild headache days 2-4 & 6-7; severe headache day 5,  Diarrhea, nausea, severe vomiting day 5; nausea day 6-7 Great toe (L) joint pain and swelling days 6-7; bilateral hip pain (left > right) days 6-7
This spontaneous report as received from a other health professional refers to an unspecified number of patients of unknown age. On an unknown date the patients were vaccinated with VAQTA lot # N003194 for prophylaxis. On an unknown date the patients experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event was unknown. The reporter considered incorrect product storage and no adverse event to be not related to VAQTA. This was one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1708USA003517: US-009507513-1708USA004079: US-009507513-1708USA004080.
Hives; Chills; Shakiness; Achy; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives), CHILLS (Chills), TREMOR (Shakiness) and PAIN (Achy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concomitant products included birth control pills for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives), CHILLS (Chills), TREMOR (Shakiness) and PAIN (Achy). At the time of the report, URTICARIA (Hives), CHILLS (Chills), TREMOR (Shakiness) and PAIN (Achy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
She received all vaccines as needed on time at her 2 month checkup on 1/9/19. She initially cried when vaccines were given, of course. Most babies do. The nurse went over "normal" behaviors after vaccines with me and when to call, etc. Around 2 PM 1/9/19 she woke up from a nap with an inconsolable cry/scream. I tried everything to get her to calm down. Nothing would work. I knew something didn't seem right due to her being a very happy baby and rarely ever crying. She most definitely has never screamed like that without being able to be calmed down. I called her doctor's office and told them what was happening. I took her in. The doctor checked her out, legs (injection site), head, other body parts and she said everything looked fine but this was definitely not a normal reaction. She was still screaming at this point. They gave her TYLENOL and we sat in the office for roughly 30-35 minutes. She was still crying but I did get her a little more calm to eat. It was around 5 PM when we finally were leaving. I called the doctor back the next day or so (can't remember the date) and she proceeded to let me know this was not a normal vaccine reaction again. I was at work with her while all of this took place so there were multiple people at my work as well as her doctor's office who witnessed this.
3/6/21  Low grade fevers and severe chills  3/8   Coughing, bad rash upper body, Covid test negative, went to medical facility- put him on Cefdinir 300mg and Prednisone 5 mg pak - Meds helped fever but not rash  3/15  swelling in legs  3/16 legs started feeling numb   3/20 getting much worse, really unstable with legs, sleeping all the time and complaining of dry mouth, no appetite  3/22 so unstable having to use walker first time in his life, noticed slurred and slow speech  3/23 took him to ER- did blood work, urine, chest x-ray, CT scan of head and EKG - all normal released  3/24 really dizzy and speech much worse  3/25  Took him to another ER and admitted - admitted for dangerous levels of Calcium 16.9 (First ER had missed it)
sudden rapid slightly irregular heartbeat; My pulse rate was in 148 and remained in the 140's/rapid heartbeat; associated nausea; This is a spontaneous report from a contactable nurse. This nurse (patient) reported that the 45-year-old female patient received first dose of bnt162b2 (BNT162B2, Covid-19 Vaccine), on Arm left on 19Dec2020 09:30AM at single dose for covid-19 immunisation. She is not pregnant at the time of vaccination. Medical history was none. Known allergies was none. Allergies to medications, food, or other products was none. Concomitant medications were none. Facility type vaccine was other. No other vaccine in four weeks. Other medications in two weeks was none. The patient experienced "I had just received the vaccination was pulling into the area where you sit and wait in case you have an adverse reaction, was just looking at my phone and felt a sudden rapid slightly irregular heartbeat. Came on very suddenly with associated nausea I am a ER nurse with 22 years experience and so I began to take my pulse and record it with my phone, I wasn't sure if it was a reaction because I didn't fell like I " couldn't breathe" . Just a very rapid heartbeat. My pulse rate was in 148 and remained in the 140's. I beeped my horn on my car in case it was an adverse reaction. They placed a pulse ox on my finger and my heart rate then was 138 and O2 sats 98% . I sat for a bit and then it just went away. My heart rate was back down to the 70's." The events started from 19Dec2020 09:30 AM and outcome of the events was recoverd. No treatment was received. No covid prior vaccination. No covid tested post vaccination. Facility where the most recent COVID-19 vaccine was administered was Other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination was none. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Vaccine Facility information available. Location of injection information is available for all vaccines received on the same date.  Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events heart rate irregular, heart rate increased, and nausea cannot be excluded based on a compatible temporal relation. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Tested positive for COVID on 12/1/21.  Admitted on 12/7/21. Also noted to have elevated procalcitonin and thought to have secondary bacterial pneumonia.  Noted AFib RVR in the setting of known atrial fibrillation.  Treated with low-dose beta-blocker cautiously given possible hypotension as midodrine is listed on his home medication list.  Also started on dexamethasone, remdesivir, and antibiotics.  Rates slightly improved today roughly 1 teens.  He is on 6 L nasal cannula.  Labs show improving creatinine, improving procalcitonin, continued mildly elevated lactate at 2.5.  Normal white blood cell count.  Urinalysis yesterday not suggestive of infection.known history of atrial fibrillation not on anticoagulation due t
t104 ax; extreme irritability & abn crying sound; mom unable to get pt completely comforted; advised mom to contact pvt MD;
Patient seen on 11/21/2016, for vaccines KINRIX and MMRV (PROQUAD) given correctly. Patient was seen on 02/02/2017 for CHE and Provider order KINRIX and MMRV repeated dose vaccine error.  Patient is ok no treatment needed, actions taken MA and Provider PNP got retrained in vaccines schedule and protocols for our Health Center.
RED ERYTHEMA TO BACK SIDE OF LEFT ARM APPROXIMATELY 6 CM IN DIAMETER. TREATED WITH BENADRYL 125/5ML 2CC PO Q 6 HRS X 3 DAYS, CEPHALEXIN 250MG 4CC PO Q 6HRS X 5 DAYS
Per history and physical on 1/26/22: " Patient is a 83 y.o. female with PMH of hypothyroidism, HTN, HLD, dementia who tested positive for COVID-19 with an at home rapid test on 1/17/2022; her symptoms started earlier that day. She has had a productive cough and for the most part has had mild symptoms thus far per her son (who I spoke with over the telephone). Her PCP encouraged MVI, zinc, vitamin C/D. Over the past week the patient has been more confused, weak, falling and not eating or drinking well. Does not have a thermometer at home. Today had an episode of diarrhea. She had been vaccinated with the J&J single dose in September 2021. ER w/u w/ chest xray showing multifocal pneumonia"    I have no information on the receipt of the Janssen vaccine in September 2021.  Our records indicate patient received a series of mRNA Pfizer vaccines, the second dose being indicated above.
I am hard of hearing; I am so tired; This is spontaneous report from a contactable female consumer(patient) via Pfizer Sponsored Program. A female patient of an unspecified age received both dose 1 and dose 2 bnt162b2 PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient received tofacitinib citrate (XELJANZ), via an unspecified route of administration from an unspecified date (Batch/Lot Number: Unknown) to an unspecified date, at unspecified dose for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient received the first and second dose of the the Pfizer Covid-19 vaccine and after that or in between her doses, she had been taking her Xeljanz medication. Patient had both of them taken, the first and the second and I am looking into taking the third one and before that I would like to know if I am supposed to stop taking Xeljanz for a week or so before that or I don't have to. On an unspecified date, the patient reported that she was hard of hearing and tired. The patient is enquiring whether she is supposed to stop taking Xeljanz for a week or so before taking the third one. The action taken in response to the events, for tofacitinib citrate was unknown. The clinical outcome of events was unknown.  Follow-up attempts completed; information about lot/batch number cannot be obtained. No further information is expected.
Facial flushing; Lips felt funny; This is a spontaneous report from a contactable physician via the Medical Information Team. A female patient of an unspecified age (reported as age: 81, unit: unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection), via an unspecified route of administration on an unspecified date (lot number was not reported) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The physician reported that the patient got her first dose of BNT162B2 and experienced facial flushing and lips felt funny a few days later. The physician wanted to know if the patient can get the second dose and if Benadryl can be taken before the vaccine. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Severe swelling at injection site extending from upper arm to elbow . Note pt self monitored site.
She had the first dose of Pfizer vaccine at the Campus on Friday 1/15 at 4:30 pm. After the vaccine, she had no new symptoms or signs of vaccine reaction and MD friend reports that he checked her pulse which was not elevated from baseline. On 1/16,  she awakened and continued to feel at her recent baseline. However, in the early afternoon, she complained of  headache, nausea/epigastric pain, and chest heaviness. These apparently were not unusual symptoms for her to feel intermittently.  Per her niece, who has a home O2 sat device, her 02 sat that morning was 97 with a HR of 87 irregularly irregular. She was afebrile. (continue on page 2)
This is a spontaneous report from a non contactable consumer via Pfizer sales representative. A male patient of an unspecified age and ethnicity received TRUMENBA via an unspecified route of administration at single dose on an unspecified date on a Monday afternoon. The patient medical history and concomitant medications were not reported. On an unspecified date, about 12 hours after injection, the patient experienced patient had sweats. On an unspecified date he also experienced fatigue, headache, muscle pain. Patient reported shortness of breath and possible swelling of tongue about 36 hours after injection. The outcome of the events was unknown. Patient was still having symptoms of headache, fatigue, muscle pain on Friday. The outcome of the other events was unknown. No follow up attempts possible. No further information expected.
PT received the Covid-19 vaccine. He reports symptoms of rash/itchy/redden palms within approximately 15/20 minutes of vaccine administration. VS as follow: BP 114/73, HR 70, O2: 99%  Treatment/intervention: 50 mg of oral diphenhydramine administered. No further complaints. PT discharged home at 1150 in stable condition
Soon after receiving the shot, the patient felt light-headed and fell off her chair onto the floor (luckily, a thick wool hat caught the fall). Shortly after that, she complained of throat swelling and difficulty breathing. No redness was observed. Patient was coherent but appeared out of it and sometimes had difficulty sitting up in her chair. The swelling became worse and she stated it was becoming very difficult to breath and that her vision was blacking out. At this point, I administered an EpiPen injection as a technician contacted 911. Soon after receiving the Epi dose, the patient's breathing and vision improved and within a few minutes she was breathing without difficulty. Approximately 10-15 minutes after Epi injection, paramedics arrived. Although her condition had improved, advice from paramedics convinced her to go to the hospital. This was her first dose of any Covid vaccine. No medical history is known for this patient.