chrisvoncsefalvay/vaers-outcomes huggingface dataset:
At 9:00 am on 11/29/2021, patient began to notice a partial loss of vision and a severe headache.  This progressed to inability to speak, rapid breathing, and some loss of motor function.  She was at school and went to the school nurse.  As the symptoms progressed, the nurse called 911 at approximately 11:00 am.  Symptoms began to clear in transit to the ER.  By approximately 12:30 pm symptoms were mostly gone except for headache.  Her headache subsided over the next 24 hours.  The ER doctors, patient, diagnosed patient with a hemiplegic migraine.  patient had never experienced any of these symptoms previously. patient is scheduled to follow up with a neurologist on 12/15/2021.
Within minutes of receiving one dose of varicella virus vaccine live the pt developed one hive below the injection site. By the time the pt left the office the hive was 50% better.
Information has been received from a consumer concerning her older son who on an unspecified date was vaccinated with a dose of MMR II (lot number, injection site and route not reported). The consumer reported that her son became very ill after his DPT/MMR (manufacturer not reported) shots. The consumer (patient's mother) would always question if that was part of his attention deficit/hyperactivity disorder (ADHD) issue. No further information is available.
30 minutes after shot my throat was swollen.  I had previously taken a Benadryl.  After 1.5 hours I felt very weightless and felt like I was going to pass out.  Then a wave of nausea came over me.  That went back and forth for about 20 minutes.  The following 2 days, I had those same rounds of nausea and thinking I'm going to pass out.  My left arm got a large red, itchy and red bump and red streaks going up my arm.
Injection site pain 3 days Tiredness 1 day Mild Headache 2 days Feeling unwell 1 Day Mild stomach cramping on and off 2 days
This is a spontaneous report from a contactable nurse through a Pfizer sales representative. A 53-year-old female patient received PREVNAR 13 (lot# F45137; expiration date 01Mar2014) at 0.5 ml single dose intramuscularly in left deltoid on 04Mar2013 at 9:31 for the prevention of pneumonia. The patient had received the following previous vaccinations: FLUZONE (on 02Oct2012 and 11Oct2011), influenza vaccine (in Oct 2012), and PNEUMOVAX (on Mar2013). Relevant medical history included diabetes, hypertension, hypothyroidism, leg swelling, GERD, hyperlipidemia and neck pain. In the past the patient showed allergy to TYLENOL with Codeine, and Minoxidil. She also had edema in her legs after treatment with Synthroid. Relevant concomitant medications included: PLAVIX, Alprazolam, Aspirin; TEGRETOL), Neurontin, KEPPRA, ALLEGRA, MICARDIS, Bd Insulin, Atorvastatin, LASIX; KLOR-CON, Nifedipine, NITROSTAT, NOVOLOG Flexpen, Levothyroxine, Folic Acid, and, Glucagon. After administration of PREVNAR 13, she experienced redness, swelling and hardness at the site of administration. Relevant therapeutic interventions included antibiotics in response to above mentioned events. The patient recovered from mentioned events in Apr2013. Follow-up (13Jun2013): Follow-up attempts completed. No further information expected. Follow-up (03Jul2013): New information received from the contactable nurse includes: patient's details, patient's medical history, vaccination details, previous vaccines administration, and concomitant medications.
Severe headache, back and hip pain, fever,  with random pain spots all over body.
No adverse event; Patient received Bivalent Moderna COVID-19 vaccine as the first primary dose; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received Bivalent Moderna COVID-19 vaccine as the first primary dose) and NO ADVERSE EVENT (No adverse event) in an 82-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7145B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Oct-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 18-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received Bivalent Moderna COVID-19 vaccine as the first primary dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received Bivalent Moderna COVID-19 vaccine as the first primary dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received Bivalent Moderna COVID-19 vaccine as the first primary dose).    No concomitant medications was provided. No treatment medications was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-666604 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-666604:67-year old female patient
COVID Arm: swelling, pain, redness to the right of injection site (not directly at injection site)
This spontaneous report as received from a consumer refers to a 26 year old female patient. On an unknown date in 2009, when the patient was 26 years of age, the patient was vaccinated with GARDASIL dose 1. Lot number, route of administration and anatomical location were not reported. On an unknown date, the patient became pregnant and missed dose 2 and 3 of GARDASIL. In the summer of 2012, when the patient was 29 years of age, the patient was vaccinated with GARDASIL dose 2, 3 and 4. For dose 2, 3 and 4, no information was reported regarding the lot number, anatomical location and route of administration. The patient had experienced no adverse event, but was worried about her health as she received 4 doses of GARDASIL. Additional information has been requested.
Within hours, developed welt around R deltoid injection site of Varicella vaccine. 1 1/2 days later it is 4" diameter with central welt 1.5". + erythema + tender + pruritis no trtmnt.
I received a flu shot and a Pfizer Bivalent booster for COVID-19 on 10/26/2022. On 11/18/2022, I was driving when I suddenly felt nauseous. I pulled over on the side of the road and threw up into a storm drain. As I threw up, there was what felt like one big slam from a hammer on the back of my head, and it was the beginning of a severe headache. It took me about 10 minutes to recover. I just stood outside and held onto my car until I felt I would be able to manage driving. I still had the headache at this point, but it was less severe. I then drove to my daughter's and lay down. As I was lying down, the pain slowly faded away. I had never had this happen before, so I didn't know what was going on. I had had nausea the day before, also, but it wasn't as severe. I was just queasy and had a loss of appetite. On 11/20/2022(?), I was on the toilet straining, and the explosion in the back of my head occurred again. I had a severe headache that was like the one I had had on 11/18/2022. I sat on the toilet for a while and massaged the back of my head. The severe pain continued, but for how long I can't say. After the pain eased up a little, I got up and had another lie down. After I went to lie down, the pain lasted for about another hour. On 11/21/2022, the headache started again. This time, there was no explosion. It was in the back of my head, and it felt like a shadow of the headaches I had had on 11/18/2022 and 11/20/2022. The pain lasted all day. After my grandchildren got out of school later in the day, I made arrangements for their care and went with my son to the ER. At the ER, I had a severe anxiety attack or panic attack. Because of the attack, I ended up not being treated at the ER. I then went home. At the time of this writing, the headache from 11/21/2022 continues. The pain isn't so severe, and rather than being concentrated just in the back of the head like the previous headaches, it affects every area of my head. The only parts not affected are the areas behind the ears and the crown of my head. I saw a doctor on 11/22/2022 and I was prescribed 800mg of ibuprofen for my headache and diazepam for my severe anxiety. Since I have been taking the ibuprofen, the pain has persisted, but it is no longer debilitating.
Feeling signs of vertigo; Started to feel dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Started to feel dizzy) and VERTIGO (Feeling signs of vertigo) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     no medical history information was reported.     On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced DIZZINESS (Started to feel dizzy). On 08-Feb-2021, the patient experienced VERTIGO (Feeling signs of vertigo). At the time of the report, DIZZINESS (Started to feel dizzy) and VERTIGO (Feeling signs of vertigo) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
At 11pm the day of the vaccination I felt significant fatigue. For the following two days I felt flu symptoms, specifically significant fatigue and I called out sick for the next two days. On the third day I felt about 98% better and returned to work though the fatigue persisted for several more days. Arm pain (in deltoid of left arm where the intramuscular injection occurred) persisted for five days after the vaccination and then also resolved.
4/23 - EARLY MORNING STARTING HAVING TINNITUS IN BOTH EARS.  4/26 - TINITTUS PROGRESSIVELY WORSE 5/6 - DR VISIT TO DISCUSS THE HEARING ISSUE 5/13 - MRI LOOKING FOR TUMORS CAUSING TINNITUS - NOTHING FOUND 5/18 - HEARING AIDS PRESCRIBED TO HELP WITH HEARING ISSUES.
Appeared with elevated HR 120s to 130s and facial flushing.  Did not utilize personal epi pen.  Was assessed by EMS not given any medication and reluctantly transported.    Pt requested a 1st Moderna booster today. Hx of allergic reaction to the 1st and 2nd primary Moderna doses (rash, difficulty breathing). An epipen was used and pt went to the ER after the 2nd dose. Pt stated she was in contact with the CDC about the reaction. Pt reported she has asthma and chronic kidney disease. Pt reported she has been cleared by her doctor to receive the booster today and has been taking prednisone for a week in preparation. Pt reported her doctor advised her to receive Moderna again. RN team lead was notified and gave approval to proceed. Pt stated she wants to proceed with the vaccination today. Pt stated she carries an epipen with her at all times and has it with her today. Allergies to mold, beta blockers (difficulty breathing), iodine (hives), and a reaction to a flu shot a long time ago (pt could not remember the details). Denied allergies to PEG and/or polysorbate. Pt was strongly advised to wait 30 minutes post vaccination, she verbalized understanding and stated that she will. No to all other questions, denied being immunocompromised. 1st Moderna 039K20A on 1/23/21 and 2nd dose Moderna 028L20A on 2/19/21 at FACILITY according to pt's vaccine card.
Patient has pain, soreness, swelling, induration, redness and pruritus of about 3cm x 5cm at injection site.
Patient said she was dizzy and had a blurry eyes. Syncope. She did not fall or faint but stayed in pharmacy for about 45 mins feeling same way. After 1 dose of Benadryl she said symtoms were subsiding. She rejected emergency or doctor visit and sai she will call if she ends up going.
After vaccine, I felt really hot, my fingers remained ice cold. The same evening I had elevated temperature and headache. The next morning, my fingers and left lower leg (vaccine received into left arm) were swollen. Headache and elevated temperature continued. On 3rd only mild headache. Treated symptoms with Ibuprofen. This was not severe and it is my understanding that these side affects are common. I just wanted to report these in case it can help others.
Arm Pain; Sore; red; hard; Feeling tired; little fever with 2 readings (99.8 & 100.1 F); A spontaneous report was received from a healthcare facility staff member concerning a 29-year-old, female patient who was participating in the mRNA-1273 Emergency Use Program and who experienced arm pain, sore, red and hard on the injection site, feeling tired and had a little fever with 2 readings (99.8 & 100.1 F).   The patient's medical history includes Covid-19. Dates were undisclosed. Products known to have been used by the patient, within two weeks prior to the event, included vitamins B, C and zinc.    The patient received their first of two planned doses of mRNA-1273 on 26-Dec-2020 intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.   Patient received the Moderna vaccine on the evening of 26-Dec-2020.  Following vaccine administration, she experienced arm pain and soreness as well as redness and hardness at the injection site.  Additionally, she reported feeling tired and had fever with 2 readings (99.8 & 100.1 F).  Patient admitted to taking paracetamol for pain.   Treatment for the event included paracetamol for pain.   Action taken with mRNA-1273 in response to the events, experienced arm pain, sore, red and hard on the injection site, feeling tired and had a little fever with 2 readings (99.8 & 100.1 F), was not provided.   The outcome of the events, experienced arm pain, sore, red and hard on the injection site, feeling tired and had a little fever with 2 readings (99.8 & 100.1 F), was not provided.   The reporter did not provide an assessment for the events, experienced arm pain, sore, red and hard on the injection site, feeling tired and had a little fever with 2 readings (99.8 & 100.1 F).; Reporter's Comments: This case concerns 29-year-old, female patient experienced non-serious, expected  injection site pain, injection site rash, injection site swelling, fever and fatigue, as well as non-serious unexpected event of arm pain events following administration of the 1st dose of the Moderna vaccine mRNA-1273. Treatment for the events included paracetamol for pain, however outcome was not reported. All events were assessed as possibly related due to temporal plausibility.
expired Havrix was administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 19-year-old male patient who received HAV (Havrix) (batch number EK59B, expiry date 26th February 2022) for prophylaxis.   On 29th April 2022, the patient received Havrix. On 29th April 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.       Additional Information: GSK Receipt Date: 2-May-2022 Reporter's comments: An expired Havrix was administered to the patient.  The consent to follow up was given via email. the vaccine administration facility was the same as primary reporter. Additional Supportive Information: The patient received expired Havrix, which led to expired vaccine used.
testing positive for covid on 10Sep2022; testing positive for covid on 10Sep2022; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team and product quality group. The reporter is the patient.  An 87-year-old female patient received BNT162b2 (BNT162B2), on 17Jan2021 as dose 1, single (Lot number: EK9231), on 07Feb2021 as dose 2, single (Lot number: EL9261), on 28Sep2021 as dose 3 (booster), single (Lot number: 30135BA) and on 03Apr2022 as dose 4 (booster), single (Lot number: FK8985) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10Sep2022, outcome "unknown" and all described as "testing positive for covid on 10Sep2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Sep2022) Positive.  Clinical course: Patient received the primary series and 2 boosters of Pfizer Covid vaccine and is now looking for timing on when patient can get the 5th vaccine, the bivalent booster due to testing positive for covid on 10Sep2022. Patient stated that experienced minimal symptoms and thought she had a cold. The patient is now off of isolation.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the Vaccination failure (LOE) and COVID-19 cannot be ruled out.
After patient took off his vaccination site bandage, surrounding skin also removed, and patient noted tenderness, redness and swelling. Over 24 hour period, significant increase in redness and swelling of RUE surrounding vaccination site. Also, tenderness in right axilla. No systemic symptoms. ON EXAM on 21 SEP 2015: +2 CM right axillary lymph node appreciated Right arm: tender to palpation, vaccination site red, warm, indurated area about 5 cm in diameter across Pain rated as 8/10 Dx: cellulitis Treated with doxycycline 100 mg twice daily x 14 days
first dose 2 years ago, never received second; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix approximately 2 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The case was self reported by the patient. The age at vaccination was not applicable for this report. Till the time of reporting, the patient had not received the second dose of Shingrix, which led to incomplete course of vaccination. The patient did not wish to provide name or contact information patient provided limited information. The reporter did not consent to follow up.
sore arm down to elbow; Sick feeling after first dose; Delayed Muscle soreness in leg down to knee; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm down to elbow), MALAISE (Sick feeling after first dose) and MYALGIA (Delayed Muscle soreness in leg down to knee) in a 79-year-old male patient who received mRNA-1273 (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (unknown route) at an unspecified dose. On 24-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm down to elbow), MALAISE (Sick feeling after first dose) and MYALGIA (Delayed Muscle soreness in leg down to knee). At the time of the report, PAIN IN EXTREMITY (sore arm down to elbow), MALAISE (Sick feeling after first dose) and MYALGIA (Delayed Muscle soreness in leg down to knee) outcome was unknown.        The action taken with mRNA-1273 (Intramuscular) and mRNA-1273 (Unknown Route) was unknown.       concomitant medications were not reported
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 69 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), 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: "Asthma" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "hep c" (unspecified if ongoing), notes: cured. Concomitant medications included: PRILOSEC [OMEPRAZOLE MAGNESIUM]; PAXIL CR; SINGULAIR; ZYRTEC ALLERGY; LOSARTAN; PROBIOTICS. Past drug history included: Demerol, reaction: "Drug allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19, which included Paxlovid from 26Apr2023 to 30Apr2023.
3 pm - came back with c/o urticaria both forearms; skin felt cool and moist. Sat him down - BP 120/70. No other s/s. 330 pm took 50mg BENADRYL PO of his personal meds. Opted out of IM injection of diphenhydramine. 345 pm symptoms lessening. Reviewed vaccine info sheet to watch for further symptoms. Instructed to call 911 if they occur. He arranged for someone to drive him home. 4 pm symptoms gone - was okay to leave.
Fainted, blurred vision, ringing in the ear, 911 was contacted, EMT came and shortly ambulance, patient was taken away shortly
approximately 3 hours after first vaccine:  light-headed, dizzy, SOB.  Called Hospital who asked if I needed to go to ED.  I didn't think so at the time.  Over then next day or so, sig fatigue, lost my voice, ongoing intermittent SOB, chest pressure.  These symptoms continue today.  Allergist consulted prior to 2nd shot, took Benadryl pre-injection, same symptoms afterwards.  Hoarseness x 2-3 weeks after 2nd shot, eventually improved.  Ongoing fatigue, worsening asthma which required 2x ED visits, use of epipen, course of steroids.  I'm 53, I've never needed any of these interventions prior to vaccine.  Symptoms are not resolving.  Currently seeing allergist and PCP, but both indicate they aren't sure what to do.
Flu; Muscle Aches; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Flu) and MYALGIA (Muscle Aches) in a 72-year-old female patient 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 an unknown date, the patient experienced INFLUENZA (Flu) and MYALGIA (Muscle Aches). At the time of the report, INFLUENZA (Flu) and MYALGIA (Muscle Aches) outcome was unknown. Not Provided          No Concomitant  and Treatment medications was reported.
Reported lightheadedness within 15 minutes of receiving vaccine; resolved within approximately 3 hours.
Left deltoid redness & pain noted 36 hrs after influenza vaccine administration; no fever; puncture site has scab & surrounding green hue or ecchymosis; beneath ecchymosis is a 5cm x 4cm red, warm, nontender patch.