chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient states rash started 24 hours after his first injection, and lasted approx 2 days.
I felt weak, achy, slight headach for one day after receiving the booster shot. This was much worse than after receiving the first two shots. I only had a sore arm after the first shot (Feb, 2021) and slight achiness after the second shot (Mar 2021)
Hospitalization: Admitted 8/25/22, discharged 9/4/22. Presentation to the ED: generalized weakness, nausea, vomiting and diarrhea, initial encounter afebrile and hemodynamically stable, examination notable for dehydration, basic labs showing severe hyponatremia 115, hypokalemia 3.1, AKI, hypomagnesemia and urinalysis suggestive of UTI. COVID-19 + date: 8/19/22. Treatment: Paxlovid. Discharge to: Hospice. Lot # for dose 1 is 031L20A. Additional info provided in response.
constipation; This spontaneous report was received from a physician via company representative, referring to a child patient of unspecified age and gender.  No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.      On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 milliliter, oral, for prophylaxis (dose, route and site of administration, lot number and expiration date were not reported).   On an unspecified date, the patient experienced constipation.  The patient's mother call into the physician's office seeking medical attention.  The outcome of constipation was reported as recovered (date not provided).   The reporter did not assess the causal relationship between therapy with  rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and the event.
Day 1- 3 tired, slight pain at injection site, fever at injection site, pain & fever at some location as injection on right arm, some body ache on second as though slept in a too small bed or hunched in a chair, slight fever end  of second day - lots of water 96 ozs or more, rest, food Day 4 still tired, legs and feet were stiff slight pain in back, fever a little worse, headache, slight sore throat, food went through we as soon as consumed - 2 Tyenol , 128 ozs  or more of water Day 5 - 7 a little tired legs below knee a still stiff 2 Tylenols  128 oz of water Day 8  felt better Day 9 very sick in the morning around 9 am  fever, weakness, nausea, headache, tired , food, Pedialyte, rested  Tylenol Day 10 - 11 very tired slightly fever headache Pedialyte lots of water
she has had them take one of the 9 valent at age 17 as a booster; she has had them take one of the 9 valent at age 17 as a booster; No additional AE; This spontaneous report was received from a consumer and referred to a 17-year-old patient of unknown gender (one of twins). The patient's medical history, concurrent condition, and concomitant therapy were not reported.  On an unknown date (at age 11 of patient), when centers for disease control and prevention (CDC) said the patient only needed the two doses' series, the patient received 2 of quadrivalent human papillomavirus (types 6,11,16,18) recombination vaccine (4 valent) (GARDASIL) (strength, dose description, lot#, expiry date, and route of administration were not provided) for prophylaxis. On an unknown date (at age 17), the patient took one of the HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (9 valent) (GARDASIL 9) (strength, dose description, lot#, expiry date, and route of administration were not provided) for prophylaxis as a booster (Inappropriate schedule of vaccine administered) (Interchange of vaccine products). The reporter provided no further information. There was no additional adverse event.  This is one of two reports received from the same reporter.
within the first hour dizziness, headache, feeling like something was stock in throat when trying to eat. progressed to all over body pain, aches, chills then severe pain in right arm. arm began swelling to double size. Then it became red and painful to the touch. Patient was seen in clinic and diagnosed with delayed hypersensitivity reaction and given steroid and benadryl and  oral antibiotic c was also given for cellulitis and shot of rocephin. Then a few days later developed severe vertigo and  difficulty walking. Patient was given oral medications for vertigo but they are ineffective .
Patient states he felt like his face was on fire, had the chills, and was shaking.
On 3/23/21 at 4:00 a.m. I woke up with severe heartburn, Migraine headache, body aches, chills, fatigue, nausea.
Dose 3; Decreased hearing from the left ear and abnormal hearing in the right ear; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 65 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose Number: 2 (MANUFACTURER UNKNOWN), Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunization; Covid-19 vaccine (Dose Number: 1  (MANUFACTURER UNKNOWN), Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 2021, outcome "unknown", described as "Dose 3"; HYPOACUSIS (non-serious) with onset 2021, outcome "recovered" (2021), described as "Decreased hearing from the left ear and abnormal hearing in the right ear". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of hypoacusis. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a healthcare worker regarding to an unspecified number of patients of unknown demographics. No concurrent condition and historical medication was reported. On an unspecified dates since 03-FEB-2015, the patients were vaccinated with improperly stored (Oka/Merck) PROQUAD lot # L005292, expiration date 17-AUG-2016, subcutaneous. No concomitant medication was reported. No adverse effect was reported. No product quality complaint was involved. The outcome of th event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Patient was administered a Pfizer Bivalent Orange cap ages 5-11 years of age, instead of Pfizer Bivalent Grey cap for 12 years of age and older.
The patient is a 74-year-old female with a history of diabetes, CAD who presents to clinic for evaluation and recommendations on receipt of an influenza vaccine due to a history of any allergy. She reports she developed an egg allergy in 1990. She states she believes she can eat eggs in small amounts, but generally avoids them including in baked goods and is not sure what will happen if she eats them. She reports she's had throat swelling and shortness of breath making it hard to swallow. It has not been treated or evaluated. She denies urticaria lesions, pruritus, oral, facial, tongue swelling, conjunctivitis, rhinorrhea, tachycardia, chest pain, nausea or emesis. She reports she had an event after receipt influenza vaccine in the 1990s consisting of throat swelling and difficulty swallowing, which occurred approximately 15 minutes after vaccine recently and was 20-25 minutes in duration. It was not treated and resolved spontaneously. She denies urticaria lesions, pruritus, oral, facial, tongue swelling, conjunctivitis, rhinorrhea, tachycardia, chest pain, nausea or emesis with this episode. She may have had anxiety. She states she received influenza vaccine last year and that it was "egg free" and given at clinic. No reaction to this vaccine.
"Pt w/ a hx of anaphylactic reaction to Amoxicillin, Penicillin G, and the Moderna Covid Vaccine.  Patient has no other known medical history. Medications at the time of vaccination: loratadine 10mg PO daily  Pt presented to the vaccination clinic for Janssen vaccination to complete the Covid vaccination series after having an anaphylactic reaction to the first dose Moderna 3/5/21. Within 5mins of Janssen vaccination, pt c/o swelling in her throat and difficulty swallowing.  The patient was noted to have some facial flushing around lips.  Assessed by RN/PA: AOx4, VSS, BP 137/77, HR 87 Resp 18 SpO2 97% @1739. Per PA recommendation, PA administered 1 dose 0.3mg EpiPen @1733 to left leg.  VSS, SpO2 97-100% on RA, GCS 15, lungs CTAB. @1739 Pt reported that she felt better after Epi injection but still symptomatic. Charge RN called 911 for transport to the hospital for additional evaluation and management. EMS arrival @1747, PA report for EMS transport. Patient left clinic via EMS transport to hospital at approx 1750. In the ED, pt was given another dose of Epi 0.3mg IM, Diphenhydramine 50mg IV x1, famotidine 20mg IV x1, methlprednisolone sod. succ 40mg IV x1, and ondansetron 4mg IV x1.  Pt was discharged with a new presciption for EpiPen 0.3mg IM PRN anaphylaxis. 24hrs post vaccination pt developed a HA w/ light sensitivity.  Pt returned to the ED 9/14 c/o HAx3 days.  Pt was treated and discharged w/ new Rx for APAP 1000mg PO TID PRN HA.  Per provider note after D/C, pt HA resolved."
Vaccine administered under doctor's orders; patient was too young to receive Pfizer 5-11.
Headache, Myalgia, Diarrhea, NauseaVomiting, Tingling and Joint pain Narrative: Seek medical attention from Facility
7/8/99 red area size of a Q tip appeared per mom;7/9/99 red area approx 5cm noted lt arm warm to touch-no irritability or fever noted;children's APAP for fever;
Patient tested positive for Covid virus after first Covid vaccine; Patient tested positive for Covid virus after first Covid vaccine; This is a spontaneous report from a contactable pharmacist via a Pfizer Sponsored Program. A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history included originally tested positive for the Covid virus on 18Apr2021. The patient's concomitant medications were not reported. It was reported that on 05Jun2021 the patient tested positive for Covid virus after first Covid vaccine. The reporting pharmacist reported for the patient who came into the pharmacy for her second dose of the Pfizer vaccine, and reported that she tested positive on Saturday for the Covid virus. It was mentioned that the patient was originally tested positive for the Covid virus on 18Apr2021 and then tested positive again, for the Covid virus, this past Saturday. The pharmacist would like to know what the recommendations are for a patient who had tested positive for Covid in getting the second Covid vaccine. The outcome of the events was unknown.   Information about lot/batch number has been requested.
Two days after the flu shot, my mother developed a headache that became so bad that she went to the hospital. It was determined that she *might* have meningitis. There was nothing ever definitive. SED rates and CRP were extremely high. Very low WBC in spinal tap. After weeks of being in and out of the hospital, she came home. She never regained her strength. Towards the end of October, she was taken by ambulance yet again for a headache. However, while she was in the ambulance it was noted that her O2 level was at 80%. They treated her in the hospital for the headache, but after I pointed it out to them, the doctor became concerned at her O2 levels as well. X-ray showed nothing substantial, but at my insistence, she had a CT scan of her lungs. Bilateral pneumonia with ground glass appearance. Diagnosed with atypical pneumonia. Started in the general admission ward. Then was moved to step down unit. And was eventually moved to the CCU and passed away on November 7, 2017, her 74th birthday. Immediate COD was ARDS.
I woke up with severe hearing distortion in my left ear.; This is a spontaneous report from a contactable consumer (patient).  A 32-year-old non pregnant (including at the time of vaccination) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 27May2021 09:45 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization at the Pharmacy or Drug Store. Medical history reported as none and there were no concomitant medications.  On 17Jun2021 05:45, the patient woke up with severe hearing distortion in her left ear. She made a doctor or other healthcare professional office/clinic visit and received steroids as treatment. The patient was not diagnosed with COVID-19 prior to vaccination and not tested for COVID-19 since the vaccination. Outcome of the event was not recovered.   Information about lot/batch number has been requested.
Symptoms began the night of the vaccination 03/22/19: Rash (arms, neck), itchiness, fever, headache, fatigue, feeling cold.
Information has been received from a consumer concerning her 17 year old daughter with no pertinent medical history or no known drug/allergy reactions who on an unspecified date, was vaccinated with a dose of GARDASIL (lot #659182/1757U).  The mother stated that in February 2009, after receiving GARDASIL vaccine, her daughter started having "flu like 6/5/09-records received for DOS 2/10/09-C/O left sided headache.  6/10/09-records received for ED visit 3/14/09-presented with multiple C/O headache, chest pain for 4 weeks, gradual onset with sharp headache on left side, numbness in fingers/hands, heels, pain in back, hips and knees bilaterally. UTI 3 weeks prior with antibiotics, developed worsening of prior symptoms. At time of ED visit headache getting better, chest pain remains. Assessment: migraine headaches. Anxiety. 4/3/09-neurology visit for evaluation of headaches with photophobia and nausea and generalized weakness. PE unremarkable. Anxiety may be a primary cause of headaches. Referral to psychiatry for anxiety issues. 4/27/09-chronic fatigue syndrome, remains anxious, hyperventilating could be cause of chest pain. 5/7/09 refused exam, screaming. 5/5/09 ED visit for C/O back pain.
15 minutes post injection patient stood up to leave.  Patient became light headed, disorientated and dizzy.  We had patient sit down.  Symptoms subsided within 1-2 minutes.  We had patient drink H2o.  Patient discharged in stable condition  45  minutes post injection
Fatigue, headache, hives from collar bone to elbow on left arm, swelling of injection site
developed a rash on her back which was a delayed reaction; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on an unspecified date as dose 1, single for COVID-19 immunisation. The patient developed a rash on her back which was a delayed reaction on an unspecified date. The patient reported that she saw reports of delayed reaction on a website but did not have any patient specific details. The outcome of event was unknown.  Information about lot/batch number cannot be obtained. No further information expected.
This spontaneous report was received from a back office lead and refers to a 43-year-old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. On 09-FEB-2016, the patient was vaccinated with an improperly stored dose of hepatitis b vaccine (recombinant) (manufacturer unknown) (place of administration was not reported, route of administration: intramuscularly, dose number not reported, lot number: L038499, expiry date: 26-JUN-2017). Concomitant therapy was not reported. There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Unknown lot # as pt left her vaccination card in her car, pt had difficultly swallowing 20 minutes after she obtained the covid vaccination, given 50 mg IM benadryl and Epipen and sent to ED
p/ pt recv vax 16 days later pt exp chickenpox w/over 100 lesions
very large axillary swelling, the size of an orange. 9cm in diameter x 7cm in height; general fatigue; headache; body aches; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (very large axillary swelling, the size of an orange. 9cm in diameter x 7cm in height), FATIGUE (general fatigue), HEADACHE (headache) and MYALGIA (body aches) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 039K20A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included CITALOPRAM, DEXLANSOPRAZOLE (DEXILANT), HYDROCHLOROTHIAZIDE, LOSARTAN, METOPROLOL and VITAMIN D3 for an unknown indication.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 04-Mar-2021, the patient experienced PERIPHERAL SWELLING (very large axillary swelling, the size of an orange. 9cm in diameter x 7cm in height), FATIGUE (general fatigue), HEADACHE (headache) and MYALGIA (body aches). At the time of the report, PERIPHERAL SWELLING (very large axillary swelling, the size of an orange. 9cm in diameter x 7cm in height) had not resolved and FATIGUE (general fatigue), HEADACHE (headache) and MYALGIA (body aches) outcome was unknown.            Other concomitant medications included OTC supplements. No treatment information was reported.  Action taken with mRNA-1273 in response to the event was not applicable
Left upper arm swelling with erythema and tenderness over upper arm, shoulder and superior chest.
received 2nd dose of covid vaccine at 1:15 pm.  No initial pain but by the time I was going to bed that evening, approximately 11 pm, my upper left arm was so sore I couldn't comfortably sleep on that side for that entire night.  Typically from the flu vaccine, etc., I do get a sore arm but this was much more painful and disruptive than that.  The next day I did not feel well.  Very tired, weak, overall my muscles felt somewhat sore.   My upper left arm was very tender and painful, felt a little swollen.  I had to take Tylenol throughout the day and that helped somewhat so that I could go about daily activities.  I would have not been able to go to work that day. Today is the 2nd day after vaccine and my arm has improved a lot to where it is only tender if I touch it.
tested positive for covid 11/22/21- asymptomatic, tested as part of follow up due to known exposure
pt rcvd vax; devel inject site rxn w/ 1cm area of redness and a 6cm area of induration
FLUBLOK Quad was accidentally given to 2 patients under the age of 18 with no reported adverse event; Initial information received on 10-Oct-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to case 2022SA419831(CLUSTER).  This case involves a 12 years old male patient to whom influenza quadrivalent recombinant vaccine [flublok] was accidentally given under the age of 18 with no reported adverse event.   On 10-Oct-2022, the patient under the age of 18 received a 0.5 ml (once) dose of suspect influenza quadrivalent recombinant vaccine with no reported adverse event (product administered to patient of inappropriate age) (lot UJ 887AA) via intramuscular route in the left deltoid for immunization. (latency: same day)  Action taken: not applicable.  Outcome Unknown  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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
headache; fatigue; Silent migraine; Lazy; Sore arm; lights around eyes; doesn't feel like doing anything; This spontaneous case was reported by a consumer and describes the occurrence of TYPICAL AURA WITHOUT HEADACHE (Silent migraine), LAZINESS (Lazy), PAIN IN EXTREMITY (Sore arm), PHOTOPSIA (lights around eyes) and MALAISE (doesn't feel like doing anything) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 04-Mar-2021, the patient experienced TYPICAL AURA WITHOUT HEADACHE (Silent migraine), LAZINESS (Lazy), PAIN IN EXTREMITY (Sore arm), PHOTOPSIA (lights around eyes) and MALAISE (doesn't feel like doing anything). At the time of the report, TYPICAL AURA WITHOUT HEADACHE (Silent migraine), LAZINESS (Lazy), PAIN IN EXTREMITY (Sore arm), PHOTOPSIA (lights around eyes) and MALAISE (doesn't feel like doing anything) outcome was unknown.            Action taken with mRNA-1273(Moderna Covid-19 Vaccine) was not applicable. No concomitant medications provided No treatment was reported   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Non-significant information.
Severe shakes, slight headache, thirst, dry mouth, sore joints, sore left arm muscle at the elbow, slight upset stomach, fever 100.1 right testicle hurt, off-balance. lasted 24 hours and the testicle hurting two days. After that was ok.
for 3 days p/vax pt had h/a, fever, dramatic local tenderness, erythema & swelling-improved x 3 days;tender sterile abscesss over the next 3wk currently under tx;
arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     The patient's past medical history included Upper respiratory tract infection.  On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm pain). At the time of the report, PAIN IN EXTREMITY (arm pain) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  No concomitant medication reported. No Treatment Medication reported.   This case was linked to MOD-2022-507719, MOD-2022-507713 (Patient Link).
This case was reported by a consumer and described the occurrence of sleep apnea in an adult male subject who was vaccinated with Flu vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Flu vaccine (unknown). At an unspecified time after vaccination with Flu vaccine, the subject experienced sleep apnea. The subject, who is in the military, "received H1N1 and developed sleep apnea round that time". The reporter refused to provide any information and she was not sure which manufacturer's flu vaccine the subject received in the military. At the time of reporting the outcome of the sleep apnea was unspecified.