chrisvoncsefalvay/vaers-outcomes huggingface dataset:
About 4 hours after the vaccine I felt light-headed, got a mild headache, and felt generally unwell. Days 2-4 I  had further episodes of light-headedness, fatigue, and felt pressure in my head (no headache,  just pressure) Days 4-6 I had fatigue and tired very easily with physical activity, some episodes of light-headedness, and chest tightness (but no pain when taking a deep breath) Days 7-17 Fatigue similar to when I had mononucleosis, tire very easily with physical activity, less frequent episodes of light-headedness.   No severe headaches, no sharp pains in chest or abdomen, no pain in legs. No excessive bleeding.
I had mild nausea six hours after the first dose. Eight hours afterwards, I became horribly dizzy. I could not stand or focus. I started to chill and shiver. As the night progressed I became weaker and developed a low grade fever. My left ear clogged almost completely but the dizziness became more mild. I contacted my doctor the next morning to report the experience. The dizziness remained mild but lasted for two more days. All other symptoms subsided in two to three days.  Two days after the second dose, I developed a hot, sore three inch in diameter rash on my upper left arm at the injection site. It subsided in about five days.
After 5 min Injection, they started to feel dizzy and short of breath later to have a type of seizure and would not react and became unconscious.  Then became conscious later but threw up as well after they woke up.  The next day after the injection woke up around  7:15 am and felt dizzy once again and later sat down and fell to the ground and became unconscious.
Not adverse.  It might have been a very positive result.  I had an abscessed tooth being treated with Augmentin.   It was not responding to treatment after several days of antibiotics.  On the evening of receiving the second dose of the vaccine, the infection was getting worse instead of better.  The following morning  I awoke to the near total absence of infection or pain.  As the day progressed, all symptoms disappeared.  I am seriously wondering if getting the vaccine prompted my immune system to intensively activate and in doing so, attacked the infection.  If so, it might be useful in other more serious cases to subdue a serious infection.
Patient complained of tenderness, rash, swelling and pain that radiated 4-6 inches from the injection site down her left arm.
I had an ultrasound done on my leg where a blood clot was found. I had a chest CT performed where several clots were found; Two days after my vaccine I began having severe pain in my right leg in the calf area and pain in my chest when I took a deep breath or coughed.  Over the weekend it got worse and worse, on Tuesday th; Pain in my chest; This is a spontaneous report from a contactable consumer (patient).  A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 14Apr2021 13:00 (Batch/Lot Number: Ew0153) (at the age of 51 years old) as single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included duloxetine; trazodone; pregabalin (LYRICA); oxycodone hydrochloride, oxycodone terephthalate, paracetamol (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]); and meloxicam, all taken for an unspecified indication, start and stop date were not reported. The patient previously took vancomycin and daptomycin and experienced drug allergy to these medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  On 16Apr2021 09:00, two days after the vaccine, the patient began having severe pain in his right leg in the calf area and pain in his chest when he took a deep breath or coughed. Over the weekend, it got worse and worse, on Tuesday 20Apr2021, the patient had an ultrasound done on his leg where a blood clot was found. He had a chest computerized tomography (CT) performed where several clots were found. The event resulted in doctor or other healthcare professional office/clinic visit. The treatment included blood thinners. No COVID prior vaccination and not COVID tested post vaccination.  The case was assessed as non-serious by the reporter. The outcome of the event was not recovered.
Information has been received from a medical assistant concerning multiple unspecified patients. The patients' concomitant medications, pertinent medical history, and drug reactions and allergies have not been provided. On unspecified dates multiple unspecified patients were administered improperly stored PNEUMOVAX 23 (lot # L018503, expired date 16-MAR-2017, or an unspecified lot# and expired date) (dose and frequency were unknown). No adverse effects reported. Additional information has been requested.
Had a sore arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Had a sore arm) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     The patient's past medical history included Metastasis (abdomen metastasis removed on 2019) in 2019, Nephrectomy in 2017 and Appendicitis (unknown of status such as improvement or worsening). Concurrent medical conditions included Allergy to antibiotic, Bladder cancer (malignant tumor with abdomen metastasis removed on 2019, patient made a CT scan and PET scan and doctors noticed cancer spread again) since 2010 and Pain kidney.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (Had a sore arm). At the time of the report, PAIN IN EXTREMITY (Had a sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication reported. No treatment medication reported.   This case was linked to MOD21-132152 (E2B Linked Report). This case was linked to MOD-2021-674168, MOD-2022-673532, MOD-2022-673536, MOD-2021-291235 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Nov-2022: Live follow-up received on 16-Nov-2022 with Medical history updated.; Sender's Comments:  MOD21-132152:
Sneezing; Coryza; tested positive for COVID-19 infection, was asymptomatic; Missed second dose of the Moderna COVID-19 Vaccine; This spontaneous case was reported by a non-health professional and describes the occurrence of ASYMPTOMATIC COVID-19 (tested positive for COVID-19 infection, was asymptomatic), SNEEZING (Sneezing), RHINITIS (Coryza) and PRODUCT DOSE OMISSION ISSUE (Missed second dose of the Moderna COVID-19 Vaccine) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included ENALAPRIL for an unknown indication.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose of the Moderna COVID-19 Vaccine). On 07-May-2021, the patient experienced ASYMPTOMATIC COVID-19 (tested positive for COVID-19 infection, was asymptomatic). On 12-May-2021, the patient experienced SNEEZING (Sneezing) and RHINITIS (Coryza). The patient was treated with VITAMIN C [ASCORBIC ACID] at a dose of UNK dosage form; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of UNK UNK, bid and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at a dose of UNK UNK, qd. On 06-May-2021, PRODUCT DOSE OMISSION ISSUE (Missed second dose of the Moderna COVID-19 Vaccine) had resolved. On 15-May-2021, SNEEZING (Sneezing) and RHINITIS (Coryza) had resolved. At the time of the report, ASYMPTOMATIC COVID-19 (tested positive for COVID-19 infection, was asymptomatic) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-May-2021, SARS-CoV-2 test: positive (Positive) tested positive for COVID-19 infection. On 17-May-2021, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   .
After the flu shot, developed Bell's Palsy.  Left side face drooping, cannot close left eye, mouth is pulled to the right side of the face., plue headache, etc.  Went to clinic the 2nd day and was treated with predniSONE 60mg per day.
Initial information received on 05-Mar-2019 regarding an unsolicited valid non-serious case received from a physician. This case involves a 9 months old female patient who was vaccinated with a 0.5 mL dose of MENACTRA (lot number, expiry date and site of administration were not reported) via intramuscular route instead of PNEUMOCOCCAL VACCINE on 5-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to wrong vaccine administered. It was unknown whether patient experienced any adverse reaction. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 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 party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender - none.
Emergency Dept. Walk-in: 01/26/2021: Chief Complaint: sinus drainage, sinus tenderness, denied cough, denied fever, denied sore throat. Symptoms of URI/nasal drainage x 4 days.  Diagnosis and Plan: Sinusitis, sinus infection, or URI;  Treatment recommended: Rest more, drink plenty of water, saline nasal spray, recommend application of warm, damp towels on face to reduce pain, use of decongestants, over-the-counter medicines for pain.  Prescribed: Fluticasone PROP 50MCG 120D NASAL INHL, LORATADINE 10MG TAB, PSEUDOEPHEDRINE HCL 30MG TAB
Pt has history of seizures. Has C.P. She developed grand mal seizures the day after BOOSTRIX given.
Pt became limp momentarily x 2 in clinic; OK on observation x 1hr & follow up call in 3hr;
Salty taste in her mouth; Little sore at injection site; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Salty taste in her mouth) and VACCINATION SITE PAIN (Little sore at injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included METOPROLOL for Hypertension.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSGEUSIA (Salty taste in her mouth) and VACCINATION SITE PAIN (Little sore at injection site). At the time of the report, DYSGEUSIA (Salty taste in her mouth) and VACCINATION SITE PAIN (Little sore at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information reported.
Small hives appeared on both thighs within 10 minutes of vaccine administration on (L) upper thigh.
8/5/11 - LA-lateral deltoid rash. Macular tender pink 8 x 8cm swollen. Dx: Cellulitis. Tx: Advised TYLENOL, ADVIL, cool compresses. Abx-cephalexin 250mg one TID #30.
not feeling well/general malaise; stomach pain; red-purple; injection site redness; injection site warmth; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 5-year-old male patient who received DTPa-IPV (Kinrix) (batch number G9P35, expiry date 15th September 2019) for prophylaxis.   On 28th May 2019, the patient received Kinrix. On 29th May 2019, 1 days after receiving Kinrix, the patient experienced injection site erythema and injection site warmth. On 30th May 2019, the patient experienced feeling unwell, stomach pain and injection site discoloration. On an unknown date, the outcome of the injection site erythema, injection site warmth, feeling unwell, stomach pain and injection site discoloration were unknown.   It was unknown if the reporter considered the injection site erythema, injection site warmth, feeling unwell, stomach pain and injection site discoloration to be related to Kinrix.  Additional details were provided as follows: The age at vaccination was not reported. On 28th May 2019, The patient received Kinrix. On 29th May 2019, the site of the vaccination turned red and warm. On 30th May 2019, the site of vaccination is red-purple, very warm, and approximately 4 inches in diameter. The patient was not feeling well, complaining of stomach pain and general malaise.  The reporter was asked for confirm to the expiration date of Kinrix lot number G9P35.
Event occurred after full vaccination. Patient was diagnosed with COVID Remdesivir, Tylenol In-patient
pt recv vax & devel an inj site rxn characterized as a raised, red, hot skin lesion 15cm in diameter, 3 to 7 days p/vax;this is 1 of 2 patients who exp the above rxn from lot# 4948030;
Saw primary care Dr. 11/20/18 severe shoulder pain (left). Visit to Orthopedic Dr. for injection shoulder. Prescribed anti-inflammatory medicine 11/30/2018. Told me I was 5th person, same situation.
Pneumonia shot in right upper arm reaction--Severe swelling (2 times normal) of upper arm from elbow over top into shoulder with redness and radiating heat. By 9:00 PM unable to move arm even slightly without severe pain, 9 on a scale of 1-10 with 10 being worse.  Pain, redness, swelling, heat lasted through 2/17/2013. Suffered from systemic moderate body aches for a full day on 2/16/2013.
Pt had MENVEO vaccine given in right deltoid on 5/15/12. Seen on 5/17/12 with 12 cm x 14 cm red warm swollen area about injection site. No discharge. Area slightly itchy per patient.
Came up positive for COVID; Came up positive for COVID; I took the booster shot...I started feeling like woozy like on Tuesday and Wednesday and then I thought I had allergy and all and I went to get tested last night and I came up positive for COVID; I took the booster shot...I started feeling like woozy like on Tuesday and Wednesday and then I thought I had allergy and all and I went to get tested last night and I came up positive for COVID; Woozy; I thought I had allergy and all; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, batch/lot number and expiry date were unknown), dose 3 via an unspecified route of administration on an unspecified date in 2021 (Lot Number: EW0175) as dose 3, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient historical vaccine includes bnt162b2 dose 1, single in Jan2021 and dose 2, single on 22Jan2021; both doses for covid-19 immunization. Patient got both the Pfizer shots back in January, the last one in January was 22Jan2021. Last week, they had the booster shot and patient took the booster shot on an unknown date in 2021, it was of Pfizer EW0175 patient thinks, it was the booster. The side effect was that, patient was surprised, took that last Saturday and started feeling like woozy like on Tuesday and Wednesday and then thought had allergy and all and patient went to get tested last night and came up positive for COVID on an unknown date in 2021. This was the Pfizer booster that the patient got which was administered last week, last Saturday. The patient underwent lab test which included Covid (sars-cov-2 test) was positive on an unknown date. The outcome of the events was unknown.
flu like symptoms the first three days. Arm remained very sore for several weeks. My joints are inflamed and very sore. Hard to raise my arms due to pain. Literally every joint in my body hurts. My husband has the same symptoms as well. We had the shots at the same time.
Fatigue, Moderate Level Headache which is still going on at 8:00 PM 06/02/2017 from about 10:30 AM (about 30 minutes after the administration of the MENACTRA (Meningococcal conjugate vaccine), and mild fever.
After 10 mins of shot had hot flash,  nagging headache, nausea in waves. Driving home more hot flashes and nausea, pain in left hip. Got really sleepy. Had problems with left hip, problem getting out of car very stiff. Couldn't stand on the left leg. Had stinging with every step.  Burning sensation in the hip. Right arm started having nagging pain with tingling, took Tylenol.  Tried to get out of bed, left hip felt like something was poking with fire. Saw bumps on hip, left back. Upper arm was still having tinge. Took Benadryl.  Next morning woke up with lesions on left hip, some ruptured that felt like acid and then form a scab. The right arm started with the lesions. Went to urgent care. Dr. diagnosed patient with shingles.  Patient questions the Shingles at her age.  Pt was given Valtrex for the shingles.
no adverse effects; patient received first dose in 2015 and second dose on 20-JUN-2020; This spontaneous report was received from a physician referring to a patient of unknown age and gender.  No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.    On an unspecified date in 2015 and on 20-JUN-2020, the patient was vaccinated with first and second doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), respectively, for prophylaxis (for dose 1, dose, route and site of administration, lot number and expiration date were not reported;  for dose 2, lot # R009615, expiration date not reported, but upon internal validation established as 07-DEC-2020, route intramuscular) (inappropriate schedule of product administration).  The patient had not experienced any adverse effects from any of the doses administered.
Information has been received from a physician concerning a 88 year old male patient with many chronic health issues, who in January 2007 was vaccinated with ZOSTER vaccine, In September 2008 the patient had a case of shingles around his eye. The patient was started on treatment and seen by opthomologist. The physician was not interested in obtaining specimen and was not interested in being contacted. The reporting physician reported that shingles had nothing to do with ZOSTER vaccine the vaccine just did not work. No further information is available.
Pfizer on 3/2 and 3/23. Positive on 9/17
This spontaneous report concerning 19 patients of an unknown gender and age was received from a nurse. The patient's concurrent conditions and medical history were not provided. The reporter stated that multiple unspecified patients were vaccinated with improperly stored doses of PROQUAD (lot # L031603, expiration date 18-FEB-2016) on 16-FEB-2016, 22-FEB-2016, 11-MAR-2016, 17-MAR-2016, 24-MAR-2016, 01-APR-2016, 19-APR-2016, 06-MAY-2016 and 29-JUN-2016; (lot # M006104, expiration date 01-AUG-2017) on 23-MAY-2016, 25-MAY-2016, 06-JUN-2016, 22-JUN-2016 and 30-JUN-2016; (lot # K010319, expiration date 22-JUL-2016) on 10-MAY-2016 and 19-MAY-2016; (lot # L050909, expiration date 14-JUN-2017) on 08-JUN-2016; (lot # L040411, expiration date 13-APR-2017) on 16-JUL-2016 (strength, dose, route and frequency were not provided). There were no concomitant medications and adverse events reported. No product quality complain was involved. Additional information has been requested.
Information has been received from a physician assistant concerning her child who was vaccinated with a first and second dose of Rotateq. It was reported that several days after each dose the patient had blood in it's stools that lasted three days each time. The patient was not given a third dose of Rotateq. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Upon internal review, blood in stool was considered to be an other important medical event. Additional information is not expected.
Pt. experienced redness and swelling on left upper arm near injection site which has moved to inner upper arm area. Slightly warm to touch.
Patient reported arm was bright red and swollen past the elbow. Symptoms: and pain, swelling.
Initially on 12/29/2020 the injection site began to itch but this subsided by the end of the Day. On Thursday 12/31/2020 I had pain, erythema and redness around the site of injection. For treatment I took an OTC Benadryl, applied hydrocortisone cream and used topical Arnicare gel for the pain. By the next day 1/1/2021 the redness was decreasing and again applied hydrocortisone cream & Arnicare gel. By 1/2/2021 the redness and erythema was improved and on 1/3/2021 it was back to normal
This spontaneous report as received from a Medical Assistant referring to a 5 month old male patient. The patient did not have concurrent condition, medical history or drug reactions. On 20-APR-2016, the patient was vaccinated with the second dose of ROTATEQ orally, lot # L039297 and expiration date on 19-JUN-2017 (strength was not provided), date of first dose of ROTATEQ was unspecified. The patient did not take concomitant medications. The reporter states the patient experienced blood in his stools on 21-APR-2016. The patient's parents brought him to the doctor's office on 22-APR-2016. The reporter stated the physician was examining the patient and had not ordered any treatment. The case did not involve cancer or overdose. The outcome of haematochezia was not reported. The reporter did not assess the relatedness between the event and suspect therapy. Additional information has been requested.