chrisvoncsefalvay/vaers-outcomes huggingface dataset:
breaking out in little boils, HCP stated it was a swollen lymph node; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (breaking out in little boils, HCP stated it was a swollen lymph node) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 031B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LYMPHADENOPATHY (breaking out in little boils, HCP stated it was a swollen lymph node). At the time of the report, LYMPHADENOPATHY (breaking out in little boils, HCP stated it was a swollen lymph node) outcome was unknown.            This case was linked to MOD-2021-101675 (Patient Link).
Dizzy; Loss of smell and some taste; Loss of smell and some taste; Fever at 101.4 Fahrenheit; This is a spontaneous report from a contactable consumer (patient).   A 34-year-old male patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. El9262) at single dose, in the left arm, on 20Jan2021 at 09:00 AM, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Relevant medical history was none. No allergies to medications, food, or other products were reported. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Concomitant medication included buprenorphine hydrochloride, naloxone hydrochloride (ZUBSOLV) from an unspecified date (within 2 weeks of vaccination), for an unknown indication. On 23Jan2021, at 03:00 PM, the patient experienced dizzy, loss of smell and some taste and fever at 101.4 Fahrenheit. Treatment was required (unspecified). Physician Office Visit required. Clinical outcome of the events was recovering at time of this report. The case was assessed as non-serious (seriousness criteria-results in death: no, seriousness criteria-life threatening: no, seriousness criteria-caused/prolonged hospitalization: no, seriousness criteria-disabling/incapacitating: no and seriousness criteria-congenital anomaly/birth defect: no). Post the vaccination, the patient has not been tested for COVID-19.
When I got home I had a severe headache and my back was hurting. I took pain meds but the pain continued for about 3 days off and on. That evening I also started having abdominal pain and diarrhea followed by fatigue. When I got home I had a severe headache and my back was hurting. I took pain meds but the pain continued for about 3 days off and on. That evening I also started having abdominal pain and diarrhea followed by fatigue.
Initial unsolicited report received from a consumer on 26-Oct-2015. This case involves a 76 years old male patient who was vaccinated with a dose of FLUZONE HD via intramuscular route in the right arm (manufacturer: Sanofi Pasteur, batch number, expiry date and dose details were not reported) and a dose of PNUEMOVAX via intramuscular route in the right arm (manufacturer: other, batch number, expiry date, dose details were not reported), both on 26-Oct-2015. The patient had no illness at time of vaccination and pre-existing physician diagnosed allergies, medical conditions, birth defects were not reported. It was unknown if the patient was previously vaccinated. On 26-Oct-2015, same day after vaccination, the patient experienced general aches, his hair was hurting, headaches and backaches. Laboratory investigations and corrective treatment was not reported. The patient required ER/doctor visit. The outcome of the events was reported as unknown. List of documents held by sender: none.
Facial swelling, eye edema, excessive salivation seen in ER - ? allergic reaction to flu vaccine given Benadryl/ Solumedrol
PNEUMONIA; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient had pneumonia that almost killed him. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pneumonia was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210531006- Covid-19 vaccine ad26.cov2.s-pneumonia. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Developed cellulitis at injection site. Rx: Rocephin 1/2 given IM, Keflex 250/5 qid x 1d, Benadryl 12 s/s tid.
11/10/20-Received Flu vaccine. Week of 11/23/20- Noticed changes in eating habits where she wasn't wanting foods she normally does and she also appeared more emotional and tired. Around this same time she also started to complain about  some leg/knee pain/ankle pain 11/28/20-Noticed first signs of bruising and what appeared to look like a cluster of bumps. 12/1/20- Had telemedicine visit with Dr. She said to watch it. 12/3/20- communicated to Dr. with pics that rash was changing. She requested us to come in.  12/3/20- Saw Dr. and another phy in practice for 2nd opinion at time of visit and she discussed the possibility of HSP and wanted to run some lab work. I asked during this visit if the Flu vaccine could have caused this. Dr. said she thinks it likely was a contributing factor. During the same visit I mentioned that her and I got the flu vaccine at the same time together and I had a reaction that evening like i never had before and I have gotten the flu vaccine as far back as I can remember. She mentioned that it was interesting that I said that as they had noticed an increase in patients calling stating some reactions. During this same visit it was also discussed that most children clear this with no longterm effects, but some do not. Some children will continue to have this occur potentially anytime they get sick or possibly get a vaccine if flu or any other kind. No way to really know. 12/4/20-Lab work came back and Dr. confirmed HSP diagnosis. Weekly BP, Bloodwork, Urine checks required and lasted until first few weeks of February 2021 until she has a few more consistent results back without blood in urine. Within that time span she also appeared to be getting a little better, and then had what seemed like a resurgence that made it worse again. At a few different points rash appeared to almost be oozing in some spots. and she continued to be tired and complain of leg discomfort even while returning to normal activity and school schedule. Rash continued to worsen and finally subsided through March 2021. Took oatmeal baths, and used Motrin or Tylenol as needed and moisturizer 2 times a day. To this day she will still complain of occasional on and off leg discomfort and she can gets tired easily. I do feel like her appetite has not fully bounced back. She seems to have become more elective in her eating and does not eat much and or will skip meals frequently stating that she is not hungry. You can still see some shadow resemblance of where the rash may have been worse in a few places if you look close.
Father had Tia several weeks after receiving the COVID vaccine/ he received the moderna, not the pfizer; This spontaneous case was reported by a patient family member or friend and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (Father had Tia several weeks after receiving the COVID vaccine/ he received the moderna, not the pfizer) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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 an unknown date, the patient experienced TRANSIENT ISCHAEMIC ATTACK (Father had Tia several weeks after receiving the COVID vaccine/ he received the moderna, not the pfizer) (seriousness criterion medically significant). At the time of the report, TRANSIENT ISCHAEMIC ATTACK (Father had Tia several weeks after receiving the COVID vaccine/ he received the moderna, not the pfizer) outcome was unknown.            No concomitant medication was provided.  Treatment medication was not provided by the reporter.; Reporter's Comments: This spontaneous case concerns an unknown-years-old male patient, with  no medical history reported who experienced the medically significant AESI  of transient ischaemic attack  unknown days after a  dose of  mRNA- 1273 bivalent vaccine. Treatment medication or outcome of the event were not provided by the reporter The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events seriousness was assessed based on medical judgement.
A mother reported that her 2 month old son received a dose of Rota Shield on 6/19/99. In April 2000 at 12 months of age, the infant developed abdominal pain and chronic constipation.
SICKNESS; TERRIBLE REACTION; This spontaneous report received from a consumer concerned an elderly female. 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 (Dose number in series was 1) (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on an unspecified date in MAY-2021 for prophylactic vaccination.  The patient had no any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (Dose number in series was 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series was 2) (suspension for injection, route of admin not reported, batch number and expiry date were not reported) dose was not reported, 1 total, start therapy date was not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s the patient was sick, she had a terrible reaction for 24 hours and she was feeling bad (Dose number in series was 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from terrible reaction, and the outcome of sickness was not reported. This report was non-serious. This case, from the same reporter is linked to 20220123706.
This spontaneous report as received from a registered nurse refers to a 3 months old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 03-NOV-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M025192, expiry date: 21-MAR-2019 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706: US-009507513-1610USA008140.
This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. This pharmacist reported a similar event for two patients. This is first of two reports. A female patient of an unspecified age, race and ethnicity received a single dose of PREVNAR 13 via an unspecified route of administration on an unspecified date for immunization.  The patient medical history and concomitant medications were not reported.  The patient complained that she had swelling at the injection site on an unspecified date. The patient was recovering. No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s): US-PFIZER INC-2016573790 Same reporter/ product/ event, different patient.
patient received 2nd dose of Pfizer approved for ages 12 and older on June 2021
Pain in injection arm. Stiffness in both knees starting the night of the injection and lasting for more than one week.  Led to injury in right knee after a run.  Diagnosis was: internal derangement of right knee, with possible medial meniscus tear
this pt was living at home and tested positive for COVID on 1/3/2022; Paxlovid was ordered on 1/4/2022; the pt was found deceased in her bed on 1/6/2022; per death certificate, cause of death was Coronavirus, Stage 3 renal disease, and HTN
Information has been received from a physician concerning a female patient who was vaccinated with Gardasil (yeast). Subsequently the patient fainted. Unspecified medical attention was sought. At the time of this report the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Started out like expected side effect of receiving an injection with redness, little itching in the area.  Later felted n/v, red spots started spreading, could feel throbbing, and pain was consistent. Later developed small hives breakout around the red spots of upper arm.  PT felt like symptoms are not severe enough to warrant a ER visit, so stayed home. But was feeling tired with N/V/D, so stayed home.  3 days after her vaccination she got out of bed and visited pharmacy for a consultation.
Hives on body almost daily since shot was given about 6 weeks ago. Wheezing, shortness of breath also. Now taking Methylprednisolone. (will take meds for 6 weeks)
pt recvd vax;apap given prior to vax;had inconsolable cry for 1 hr;apap given again
Patient was administered vaccine that was greater than 12 hours post first vial puncture. Patient did not exhibit any adverse reaction post administration.
had Covid symptoms and took a home test and tested positive; had Covid symptoms and took a home test and tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (172086).  A male patient received BNT162b2 (BNT162B2), on 20Feb2021 as dose 1, single (Batch/Lot number: unknown) and on 14Mar2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Vitiligo" (unspecified if ongoing), notes: States his husband has vitiligo.; "his husband are immunocompromised" (unspecified if ongoing), notes: Caller states he was trying to be safe since the beginning of the pandemic as he and his husband are immunocompromised. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "had Covid symptoms and took a home test and tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: took a home test and tested positive. Therapeutic measures were taken as a result of covid-19 included Paxlovid.  Clinical course: Caller reported on himself and mentioned his husband the next day had Covid symptoms and took a home test and tested positive. Caller stated his husband was vaccinated and boostered just like him and he did Paxlovid also. Caller stated his husband had the Pfizer Covid 19 vaccines and went to the same site on the same days as he did for the 1st two doses on the same days. States for his boosters he does not have the dates. States he got his first booster before the caller did and was not going to do the 2nd booster so they have different dates because he got his 2nd booster after the caller did. Caller stated he doesn't have any details to provide. Caller declined to report for him stating the only side effect for him was printed on the instructions from the pharmacy. States he had a terrible terrible taste in his mouth. Caller stated that was the only side effect he had and it was printed on the instructions. Caller stated he was trying to be safe since the beginning of the pandemic as he and his husband were immunocompromised.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
flu like symptoms the day following the second vaccine.  fatigue, muscles soreness, general bad feeling two days at current time, getting better
This spontaneous report as received from a medical assistant refers to a 16-month-old patient of unknown gender. No information on the patient's concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On 12-OCT-2016, the patient was vaccinated with improperly stored dose of VARIVAX injection (lot # M025867 with expiry date on 24-MAY-2018; dose and route of administration were not reported) for prophylaxis. The administered dose experienced a temperature excursion of 6.3 degrees Fahrenheit for 1 hour and 50 minutes, 6.6 degrees Fahrenheit for 1 hour and 40 minutes, 40.5 degrees Fahrenheit for 2 hours, 5.2 degrees Fahrenheit for 20 minutes and 6.3 degrees Fahrenheit for 1 hour and 50 minutes. Previous temperature excursion included 13.3 degrees Fahrenheit for 80 minutes and 9 degrees Fahrenheit for 420 minutes. Data logger was involved. No symptoms were reported. This is one of several cases received from the same reporter. Additional information is not expected as all relevant information has already been received. Sender's Comments: US-009507513-1610USA010748: US-009507513-1701USA000675: US-009507513-1701USA000676: US-009507513-1610USA004609: US-009507513-1701USA000678: US-009507513-1701USA000679: US-009507513-1701USA000680: US-009507513-1701USA000681: US-009507513-1701USA000682: US-009507513-1701USA000683: US-009507513-1701USA000684: US-009507513-1701USA000685: US-009507513-1701USA000686: US-009507513-1701USA000687: US-009507513-1701USA000688: US-009507513-1701USA000689: US-009507513-1701USA000690: US-009507513-1701USA000691: US-009507513-1701USA000692: US-009507513-1701USA000693: US-009507513-1701USA000694: US-009507513-1701USA000695: US-009507513-1701USA000696: US-009507513-1701USA000697: US-009507513-1701USA000698: US-009507513-1701USA000699: US-009507513-1701USA000700.
Tongue sore and red after 2nd vaccine. After a few days after the tongue cracked and has never healed. Painful to eat and drink.
Dosage administered was what the vial had labeled as 0.5ml. It was a booster dose that was supposed to be 0.25ml. No adverse effects or treatment required.
I got very dizzy at the time of injection and the room was spinning, I sat for 30 minutes and they watched me and let me go after. I immediately begin to feel very tired and couldn't think, my neck began to hurt and feel stiff and started having  chills and still having chills.
her arm was just sore with no other side effects; This is a spontaneous report from a contactable consumer or other non hcp. A 14-years-old female patient received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 11Aug2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced her arm was just sore with no other side effects on an unspecified date. The outcome of the event pain in extremity was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
I had congestion in my chest, sore throat, headache, general exhaustion. I got a runny nose and a dry cough. I felt pretty crummy. The simplest way to describe it was that every molecule in my body was a t war with every molecule in my body. I felt terrible for a couple of days. I took Paxlovid.
Red rash blotches, several inches each and apart around injection site. Swelling and tenderness of upper left arm. Possible dizziness.
Immediately after getting the shot, I felt a tightening and pain in my chest. I have been having chest pain and heart rhythm problems now for the past 4 hours. I have taken one Tylenol tablet but it has not helped. The irregular heart beating comes and goes. I also have leg and arm aches.
inflammation of spinal cord + in brain (Multiple Sclerosis was diagnosed a few months later)
Next day after the vaccine I had Flooding of the heart. It feels like butterflies around my heart. Everyday after the vaccine. Muscle pain, my back is constantly hearting. On and off sharp pain around my heart. I am going to see a Cardiologist.
pt recv vax 27FEB98 & 2-3wk later began to c/o abd pain (not r/t menses) that waxed & waned & then worsened wk of 13APR;AST 242;alk phos 89, total bilirubin 0.8, WBC 15.8 electrolytes & renal function test wnl;15APR repeat ALT 674, AST 439
Pain in left lower molar followed by pain in left jaw.  (treated with Advil) As more severe, went to DDS who xrayed and prescribed Medrol steroid.  Steroid helped for a few days then left face pain became more severe requiring steroid plus Advil plus Tylenol.  When nothing would releive pain I went to  Medical Clinic.   FNP diagnosed Trigeminal Neuralgia prescribed Gabapenton for the extreme facial pain left side.
tested positive for the Covid 19 virus after taken the second doze of the vaccine; tested positive for the Covid 19 virus after taken the second doze of the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for the Covid 19 virus after taken the second doze of the vaccine". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  Clinical information: Reporter also wanted to let know that reporter's son tested positive for the Covid 19 virus after taken the second doze of the vaccine and it wasn't a good experience for reporter's family  The lot number for bnt162b2 was not provided and will be requested during follow up.
Localized allergic skin reaction. Initially bled, within 1/2 an hour became hard and some redness at injection site (about the side of the tip of ballpoint pen. Before the end of the night redness grew to the size of a pea. Next morning about the same. By the 2nd day redness grew to an oval shape that measures apx 1inch by 2inches. The 3rd day, redness expanded by apx 1/4 inch. It is red, hot, hard, sore. I traced around the redness with a pen to measure growth (I?m familiar with this from getting allergy testing and allergy shots in the past).
p/receiving flu vax pt exp redness @ inject site as well as general fatigue; no febrile rxn was noted; an elevated sedimentation rate was noted 4 days later;
Experienced crescendo and decrescendo abdominal pain with pain scale of 8/10 .  CT findings consistent with small bowel closed loop obstruction requiring exploratory laparotomy.  Discharged from hospital 5 days after surgery.