chrisvoncsefalvay/vaers-outcomes huggingface dataset:
48 hrs after injection experienced temp of 102 for 2 days; chills; body aches; headache; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 68-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Lot Number: EL9266), via an unspecified route of administration, administered in right arm on 23Feb2021 10:30 pm (68-year-old at the time of vaccination) as dose number unknown, single for covid-19 immunisation. Medical history included Osteoarthritis, osteoporosis, small vessel disease from an unknown date and unknown if ongoing. The patient previously took Imitrex (IMITREX) and Toradol (TORADOL) and experienced allergy. The concomitant medications were reported as none. The patient had not received any vaccine within four weeks. The patient did not have COVID prior to vaccination. The patient was not tested since vaccination. On 25Feb2021 02:00 pm, 48 hrs after vaccination, the patient experienced temperature of 102 for 2 days with chills and body aches and headache. No treatment was received for the events. The outcome of the events were recovered on an unspecified date on 2021.  No follow-up attempts are possible. No further information is expected.
I (the patient) experienced severe symptoms about 10 hours after receiving the vaccine. The serious symptoms lasted for 24 hours after receiving the vaccine: Serious Symptoms: -Intense Chills/Hot flashes -Joint and muscle pain -Headache -Nausea/Diarrhea -Dizziness -Difficulty sleeping  Moderate symptoms lasted for 48hrs after receiving the vaccine: -headache -Muscle and Joint pain -Chills
PATIENT STATED THAT SHE FELT ITCHING ALL OVER THE DAY AFTER RECIEVING A SINGLE DOSE OF PREVNAR 13.
Was 30 weeks pregnant. Had no prior issues, just normal pregnancy things. 36 hours after vaccine injected, swelling of legs started. 11:30pm blood pressure was checked and it was 190/82. Admitted to OB clinic in hospital with dehydration and strong contractions 4 minutes apart. Gave something to slow down contractions and ordered me to rest the next few days. 5 days after the injection a rash over my entire body formed (thinking it was a heat rash). Went to urgent care and they only gave me a low dose steroid cream that did nothing. Rash lasted for 13 days. Rash was raised red bumps, itchy and nothing helped soothe. 3 weeks after injection terrible gut issues started. Diarrhea multiple times a day. I watched my diet and nothing helped. Went to OB and they tried to do a stool sample and it came back normal. Continue having gut issues to this day. I was in the hospital 4 more times with contractions and swelling over the course of 7 1/2 weeks following injection. Baby's estimated due date was 9-3-2018 and baby was born early 6lbs 13oz.
Headache, nausea, muscle, joint and bone pain.  charley horses in calves, arms, legs, neck, back.  Dizziness, swelling coughing sinus, gas, burping, stomach pain, pain eye, digestive pain - 97.6 temp.
23NOV91 devel hives & itching;pain in lt shoulder & lt wrist. Some wheezing noted @ present & taking meds. Most of rash gone by 25Nov91 w/ new hives devel on legs. Joint swelling,better 25Nov91. 6Dec91 only exp mild wheezing.
Fever, throat closing, red hives all over body, swollen eyes, swollen jaw, swollen cheeks, muscle aches
Information has been received from a physician concerning a 22 month old female with no drug allergies and no medical history who in approximately October 2009 (about 20 months ago), was vaccinated with a dose of ROTATEQ orally according to the prescribed schedule (dose/frequency reported as "3-dose/between 6 and 12 weeks of age"). In April 2011, the patient experienced contracted rotavirus and was dehydrated from diarrhea. it was tested positive for rotavirus. Patient was treated with oral rehydration. And the adverse events improved. On an unspecified date, the patient recovered from contracted rotavirus and dehydrated from diarrhea. No further information is available.
immediate 2 days was 100 fever, nauseous, shaking, terrible headache, pain all over. The following several weeks included extreme fatigue, on and off headaches, sometimes nauseous, brain fogginess and dizziness
pt devel rash, macular sl pruritic w/discrete petechiae;also lt leg-child says leg hurt p/shot;
Swelling of entire left side from underarm down to feet immediately after injection swelling started for a week. Received Cephalexin 500 MG CAPSULES to counteract effects. Weak from 10/30/2017 to present. Confusion that required hospitalization on 12/25/2017 with more testing. Threw a clot and ended up with DVT along with bilateral pulmonary emboli for which disability continues to present.
My left leg behind my knee started hurting first. It moved down over a few days, then within weeks both legs from the knees down were hurting and almost not working where I fell a few times from it. It is now December and I have had ct scans done and other tests and no diagnosis from anyone. I am now walking with a cane and my legs hurt horribly.
Right arm has pain that radiates down from elbow to hand; Swelling, discoloration of skin (turns purple as if bruised); Swelling, discoloration of skin (turns purple as if bruised); Extreme pain; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date an unknown date in Sep2021 at 10:30 (Lot number: unknown) at the age of 30 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "None" (unspecified if ongoing). There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset an unknown date in Nov2021, outcome "not recovered", described as "Right arm has pain that radiates down from elbow to hand"; SKIN SWELLING (non-serious), SKIN DISCOLOURATION (non-serious), both with onset an unknown date in Nov2021, outcome "not recovered", and both described as "Swelling, discoloration of skin (turns purple as if bruised)"; PAIN (non-serious), with onset an unknown date in Nov2021, outcome "not recovered", and described as "Extreme pain". Therapeutic measures were not taken as a result of pain in extremity, skin swelling, skin discolouration and pain.  Additional information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctors or other healthcare professional office/clinic visit, and emergency room or urgent care.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Pain over injection site left deltoid. I took 2 Advil 3 hours before my injection and  8 hours post injection. I felt more tired than usual and went to bed at 8:45 pm. I woke up at 1:30 am (2/5/21) due to chills , body aches and headache . I could not sleep because of the chills. I checked my temperature at 4:00 am and it was 100.4 F.  I also started having palpitations.  I took  Vitamin C 250mg  gummies #3 and Advil 200mg at 7:00 am .  My  body ache, headache and fever  100.3 until 1:00 pm. I took acetaminophen 500 mg . I fell asleep from 2:30-4:00 pm and woke up feeling 50% better, no more headache.  I never lost my appetite and I tried to drink more fluids.  I took acetaminophen 500mg at  5:00 pm and 9:00 pm.  I still have  some soreness on the injection Site.
Per conversation with LVN: Patient came in today for Covid19  vaccine #2 of Moderna. It was noticed after the fact, that the patient is only 17, not 18 years of age. Patient states received 1st dose on 04/16/2021 at another facility. Stated that they checked her identification and determined that it was okay. Mother and patient notified. Patient states also that she received a call to come in and get 2nd vaccine by either appointment or walk-in.   *Per Record, it states that the patient had Janssen Medical Center on 04/16/2021. Jannseen is a 1-dose Covid19 vaccine by Johnson and Johnson. I informed her that there will be a report.
itching and rash all over and hasn't stopped / Itching; itching and rash all over and hasn't stopped / Nothing Working ongoing Rashes; This is a spontaneous report from a contactable consumer (Patient). An 83-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ER3782) via intramuscular route, administered in Arm Left on 27Mar2021 11:00 (at the age of 83-years) as dose1, single for COVID-19 immunization. Medical history included chronic obstructive pulmonary disease. There were no concomitant medications. No known allergies reported. Prior to vaccination, patient was not diagnosed with Covid-19. Patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. Patient did not receive any other medications within 2 weeks of vaccination. On 03Apr2021 03:00 the patient experienced itching and rash all over and hasn't stopped / itching, itching and rash all over and hasn't stopped / nothing working ongoing rashes (rash). Events assessed as non-serious. Therapeutic measures were taken as a result of events. Since the vaccination, patient has not been tested for Covid-19. Patient refused to take 2nd dose Covid-19 vaccine. The outcome of the events was not resolved.  Follow-up attempts are completed. No further information is expected.
I got my HPV shot today I was given two doses, an hour later I was not able to use the arm that was injected at all without sever pain to the point of crying, my back then started to develop severe pain as well feeling similar to my arm felt like I got the shot in my spine it took over my entire lower back, I then developed shooting pain down both legs more serious in one then the other. And developed a headache and weakness. I recently came out of recovery from a car accident and I cna say the pain was almost worse then the pain had from my injuries from that witch is astonishing. Ibuprofen was not successful in reliving my pain nor was Tylenol. I had to take a sleeping pil in order to fall asleep so I couldn't feel the pain even then I woke up a little and had a lot of pain still in severe pain and if not gone in a couple days I will be going to the hospital and then making another report I spend hours online trying to find and answer only one similar to mine was from another country this needs to be talked about and resolved because this is not safe.
Received vaccine approx. 12:30 PM. Developed "hot" feeling at injection site, developed throat clearing symptoms, metallic taste, chest tightness toward throat. Taken to health urgent care onsite, observed 15 min and transferred and was administered Claritin and observed for 3 hours.  10/31 - Instructed by ED physician and OB/GYN not to take influenza vaccine again.
Injection @ 1600. At approx 1830 Pt felt very hot and sweaty, hands shaky, and sensation of inability to take a deep breath with spontaneous cough. Evaluated by factory first aid attendant and taken to ER @ 2115. Received injection of Benadryl in ER. No relief from this. Pt then went home @ 0000 and vomited at home, symptoms then subsided. Pt went to bed @ 0115 and woke up feeling fine.
tested positive for COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (tested positive for COVID-19) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 077c21b and 027B21a) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Unspecified drug).   On 21-Apr-2021 at 7:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Nov-2021 at 7:00 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-May-2022, the patient experienced COVID-19 (tested positive for COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 17-May-2022 to 22-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. On 23-May-2022, COVID-19 (tested positive for COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-May-2022, SARS-CoV-2 test: positive Positive. On 23-May-2022, SARS-CoV-2 test: negative Negative. On 28-May-2022, SARS-CoV-2 test: positive Positive.         The patient did not taking any other medications, products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. Company comment: This spontaneous case concerns a 65-years-old female patient with no relevant medical history, who experienced the unexpected non-serious adverse events of special interest, COVID-19 (tested positive for COVID-19) which occurred 5 months 25 days after the third dose of mRNA-1273 vaccine .However, it was stated that the patient took Nirmatrelvir + Ritonavir (Paxlovid) as SARS-CoV-2 test was positive on 17-May-2022,which was negative after 5 days and again positive as on 28-May-2022. Ongoing Covid 19 pandemic could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns a 65-years-old female patient with no relevant medical history, who experienced the unexpected non-serious adverse events of special interest, COVID-19 (tested positive for COVID-19) which occurred 5 months 25 days after the third dose of mRNA-1273 vaccine .However, it was stated that the patient took Nirmatrelvir + Ritonavir (Paxlovid) as SARS-CoV-2 test was positive on 17-May-2022,which was negative after 5 days and again positive as on 28-May-2022. Ongoing Covid 19 pandemic could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.
On the morning of Monday April 19, 2021, 1 1/2 days from receiving the Johnson & Johnson shot, I walked upstairs after coming down for breakfast and felt something off with my heart and I felt my heartbeat and noticed that I was in AFib. My heart had an irregular heart beat. I was taken by ambulance to the hospital where they had to shock my heart to get it back to a normal rhythm. They were able to get it back to a normal rhythm with one shock. Since then I have still noticed more heart palpitations, but have been alright since. I am a healthy 32 year old (now 33), with no health issues.
weakness; severe headaches; body aches; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), HEADACHE (severe headaches) and MYALGIA (body aches) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jun-2021, the patient experienced ASTHENIA (weakness), HEADACHE (severe headaches) and MYALGIA (body aches). At the time of the report, ASTHENIA (weakness), HEADACHE (severe headaches) and MYALGIA (body aches) outcome was unknown.            Concomitant medication were not reported .  Treatment medication were not reported .
once in a while pricks at you; itches; hot; bruised; at injection site it looked like the size of the coaster; covid rash; in pain; dark red; quite a rash and wraps around the biceps; 102.5 fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (once in a while pricks at you), PRURITUS (itches), FEELING HOT (hot), VACCINATION SITE BRUISING (bruised) and VACCINATION SITE MASS (at injection site it looked like the size of the coaster) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. H030H21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroid disorder and Blood pressure high. Concomitant products included THYROID (ARMOUR THYROID) for an unknown indication.    On 09-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Dec-2021, the patient experienced PYREXIA (102.5 fever). On 12-Dec-2021, the patient experienced PAIN (once in a while pricks at you), PRURITUS (itches), FEELING HOT (hot), VACCINATION SITE BRUISING (bruised), VACCINATION SITE MASS (at injection site it looked like the size of the coaster), RASH (covid rash), VACCINATION SITE PAIN (in pain), VACCINATION SITE ERYTHEMA (dark red) and VACCINATION SITE RASH (quite a rash and wraps around the biceps). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) for Pain, at an unspecified dose and frequency and IBUPROFEN for Pain, at an unspecified dose and frequency. On 11-Dec-2021, PYREXIA (102.5 fever) had resolved. At the time of the report, PAIN (once in a while pricks at you), PRURITUS (itches), FEELING HOT (hot), VACCINATION SITE BRUISING (bruised), VACCINATION SITE MASS (at injection site it looked like the size of the coaster), RASH (covid rash), VACCINATION SITE PAIN (in pain), VACCINATION SITE ERYTHEMA (dark red) and VACCINATION SITE RASH (quite a rash and wraps around the biceps) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Dec-2021, Body temperature: 102.5 (High) 102.5 fever.         Concomitant medications include blood pressure medications.   This case was linked to MOD-2021-410138, MOD-2021-410125 (Patient Link).
Local reaction with redness, pain followed by purulent drainage. Positive culture for CWG; neg staph. Responded to oral antibiotic.
This is a spontaneous report from a contactable Pharmacist. This Pharmacist reported similar events for two patients. This is second of two reports. A patient of unspecified age and gender received PREVNAR 13, (Lot number: W51924, expiry date: Jul2020), via an unspecified route of administration on 04Oct2018 at single dose for immunization. The patient's medical history and concomitant medications were not reported. In 2018, the patient experienced cellulitis with outcome of unknown. Sender's Comments: The current information is very limited to allow a full medically meaningful assessment, especially lack of the following: complete medical history, concomitant medications, vaccination details and event description including onset date and location of the event. 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 and Investigators, as appropriate. Linked Report(s): US-PFIZER INC-2018499708 same product and event, different patient.
Localized redness and erythema at injection site (left deltoid) after receiving a Pneumovax Vaccine on Jan 23, 2008. Further investigation proved pt had received a previous vaccine 1 year ago on 1/2/08 which was not documented. The cellulitis was an immune reaction.
could not get out of bed; could not move; fever of 103.4; A spontaneous report was received from a consumer concerning a 80-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  could not get out of bed/asthenia, could not move/movement disorder, fever of 103.4/pyrexia.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 27 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 013A21a) via unknown route for prophylaxis of COVID-19 infection.  On 28 Feb 2021, the patient experienced could not get out of bed/asthenia, could not move/movement disorder, fever of 103.4/pyrexia.  Treatment details included Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.  On 1 Mar 2021 the outcome of could not get out of bed/asthenia, could not move/movement disorder, fever of 103.4/pyrexia was resolved.
Edema and erythema at site of injection - 4 mm x 7 mm of induration.
Fever and chills began around 11:30 p.m. and lasted about 7 hours. Fever peaked at 101° and chills were most severe about three hours in, at 2:30 a.m.
Sore left shoulder, green, pus-filled area at site of vaccine, foul odor.
This spontaneous report as received from a nurse refers to a 2 months old patient. The patient was inadvertently vaccinated with single dose, live, oral ROTATEQ (1659Z) on 19-NOV-2012, that had expired on 29-AUG-2012 No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. No treatment information was reported. Additional information has been requested.
Severe muscle pain and spasms, extreme fatigue, nausea, headache, joint pain, abdominal pain, fever 100.7 and slight rash around injection site started late evening/early morning on Sunday 9/12. Rash around injection site left upper arm increased in size spreading down toward elbow (pain, redness, swelling, warm to tough and itching). Muscle pain, fatigue, headache, fever and rash continued through Weds 9/15. I made contact with PCP on Tuesday 9/14 and Medrol Dose pack called in and I started taking on 9/15 with last dose 9/21. I was not able to work or function as normal from 9/12 through 9/19. I returned to work on Monday 9/20 but as of today 9/22 I continue to have moderate to extreme fatigue, muscle aches and daily headaches; rash has resolved but still have some residual itching sensation near injection site.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Indication: Covid-19 treatment; (2022) Negative; (2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Other medication in 2weeks: Yes. Anti viral details: [product=COVID 19 Treatment, brand=Pfizer, treatment start date=23Jun2022, treatment stop date=27Jun2022, indication=Treatment of COVID-19]. Patient was tested negative at conclusion of antiviral. 4 days later symptoms returned and began testing positive again.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
CC: RED, SWOLLEN, PAINFUL-TO-TOUCH INDURATION AT INJECTION SITE. APPEARED *8 DAYS POST VACCINATION* AND LASTED 1-5 DAYS BEFORE SELF-RESOLVING.
When patient was leaving he said he felt lightheaded so sat on floor, then fainted from sitting position.  He was non resposive for about 1 min. Then was talking, knew where he was and what had just happened.
PATIENT SKIN COLOR BECAME PALE, C/O FEELING NAUSEOUS AND LIGHT HEADED, BP 94/60 @ 12:15PM, 110/70 @ 12:20PM. 12:20PM AT THIS TIME PATIENT "FEELS GOOD" NO PALLOR. DURING THE EVENT NO TRAUMA, NO LOC, NO FALL, NO TWITCHING, NO EMESIS. PATIENT WAS ADVISED TO RETURN AT 3:00PM TODAY.