chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a consumer refers to her husband, a patient of unknown age. The patient's medical history, and concomitant therapies were not reported. The patient's concurrent condition included basal cell carcinoma. It was reported that her husband was possibly considering getting vaccinated with GARDASIL 9 series because their dermatologist had informed him that there was an unknown "study trial" conducted using GARDASIL 9 in a 90 year old woman to specifically treat her basal cell carcinoma. There was no adverse reactions reported. No product quality complaint was involved. This is one of the two reports received from the same reporter. Sender's Comments: US-009507513-1901USA007612.
Given VARIVAX 6/30/2011. Seen 7/3/11 with (2) 1 cm vesicles to (L) tricep.
flu like sxs-chills-fever-chest pain-weakness;went to MD prescribed Doxycycine
1st day: sore injection site,  diffuse joint and bodily pains 2nd day: symptoms from first day continued as well as nausea, fatigue, malaise, fever, chills, blurred vision  3rd day: symptom severity decreased, blurred vision present then resolved.  By the fourth day, symptoms resolved.
This spontaneous report as received from an office manager refers to a unspecified number of patients of unknown age and gender. Approximately in August 2014, reported as after 18-AUG-2014, the patients were vaccinated with PROQUAD (Merck). Dose, route, lot number and expiration date were not reported. Approximately in August 2014, reported as after 18-AUG-2014, improperly stored PROQUAD (Merck) was administered. No adverse effects were noted. This is one of several reports from the same source. Additional information has been requested.
This is a spontaneous report from a contactable via a Pfizer sales representative and then from a contactable Pharmacist reporting on behalf of physician. This is the third of three reports. A 3-year-old child female patient of an unspecified ethnicity received PREVNAR 13 intramuscular on right thigh on 19Mar2012, Lot # F24141 and expiration date 31Mar2013. The patient received also second dose of HEPATITIS A VACCINE, intramuscular on left thigh, lot # AHAVB462BA and expiration date 17Mar2013. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced reaction to PREVNAR vaccinations including the following symptoms: unusual redness, pain, fever, and swelling across the entire upper thigh radiating up into the upper back within 24 hours post vaccination. The pharmacist describes the events as right thigh very swollen, red, hot, swelling up and around back. The pharmacist provided onset date of the events as 19Mar2012 and recovery date as 24Mar2012. Treatment was provided: BENADRYL, Ice and MOTRIN. Follow-up (24Apr2012): New information received from the contactable Pharmacist reporting on behalf of physician included: updated suspect drug info, cosuspect Hepatitis A vaccine, onset date and recovery date, outcome, treatment and demography. Follow-up attempts completed. No further information expected. Follow-up (10MAY2012) Follow-up attempts completed. No further information expected.
Per parent, patient experienced chest and back pain along with shortness of breath and fever (did not take actual temp with thermometer but felt warm) for 2 days starting one day after his first dose of Pfizer vaccine. They did not take the patient to the ER, just self monitored at home. Symptoms have resolved.
Information has been received from a physician concerning a female who "three months ago" on approximately 10-MAR-2010 was vaccinated with her second dose of GARDASIL injection. "Three months ago" on approximately 10-MAR-2010 the patient fainted a few minutes after injection. The patient sought unspecified medical attention. At the time of report, the patient was recovering. Additional information has been requested.
pt recv vax 26JAN96 & 1MAR96 & pt exp a failure to seroconvert (Igg <10 acu/ml);pt had no other adverse experiences;
This is a spontaneous report from contactable physician via a Pfizer Sales Representative. A 16-17 year old male patient of an unspecified race/ethnicity received TRUMENBA at single dose via an unspecified route on unknown date. Medical history and concomitant medication were unknown. On the same date the patient also received diphtheria vaccine, pertussis vaccine, tetanus vaccine (TDAP IMMUN) and a meningococcal vaccine. On an unknown date the patient experienced a temperature of 103 approximately for 24 hours. The event recovered on an unknown date.
Within 5 minutes felt dizzy, got very hot,  face went pale, and had a fast heart beat
She had a severe vaginal reaction; This is a spontaneous report from a contactable pharmacist. A 51-years-old female patient (nurse)  received  BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: Unknown)  via an unspecified route of administration as a  SINGLE DOSE for covid-19 vaccination. The patient medical history and concomitant medications were not reported.  The patient experienced she had a severe vaginal reaction. The nurse  informed the pharmacist that she had used a personal lubricant during intercourse. The pharmacist asked if a common ingredient in the personal lubricant and most cosmetic fillers, hyaluronic acid, could be the culprit for the reaction that was experienced by the nurse. When the patient originally reported the adverse event she did not have the details regarding the use of the lubricant.   The clinical outcome of the event was unknown.  Information about batch/lot number has been requested.
RA Flare Up that affected all joints of my body for approximately 5 hours beginning around 12 Noon to 1 PM.. Had taken my regular dosage of Celebrex 200 mg at around 10 AM.  Took Tylenol 500 mg. Bed rest with warm blankets.  Had never had a flare-up that affected all my paired joints at once.  8 hours later I had no symptoms other than fatigue.
pt recvd vax & exp nausea, dizziness, weakness, vomiting & diarrhea following vax;
Information has been received from a 60 year old male pharmacist with no allergies and hypertension and cholesterol who on 10-JAN-2009 was vaccinated with one dose of ZOSTAVAX (Oka/Merk) SQ. Concomitant therapy included losartan potassium, CARDIZEM CD, simvastatin (manufacturer unspecified) and aspirin (manufacturer unspecified). On 11-JAN-2009 the pharmacist stated that his ears "plugged up" and had remained "plugged" ever since. On 14-JAN-2009 the pharmacist stated that he felt "extremely dizzy" while at work. The pharmacist stated "all the sudden it was like I was drunk". He could not drive home, his wife had to come to pick him up. The pharmacist stated that he vomited three times and then went to bed and slept for 13 hours. The pharmacist stated "I had to call out of work for the next three days because I was so bad". On 16-JAN-2009 the pharmacist had seen his physician and the physician thought it might be vertigo. The pharmacist had an appointment with an otolaryngologist on 05-MAR-2009. The patient's adverse events persisted and were considered to be disabling. Additional information has been requested.
This spontaneous case was reported by a consumer and describes the occurrence of MENTAL FATIGUE (Mental fatigue / Brain fatigue), THERAPEUTIC RESPONSE SHORTENED (Wearing off effect), INFLAMMATION (Inflammation), COVID-19 (COVID-19) and FATIGUE (Fatigue extreme) in a 59-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In February 2022, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced MENTAL FATIGUE (Mental fatigue / Brain fatigue), THERAPEUTIC RESPONSE SHORTENED (Wearing off effect), INFLAMMATION (Inflammation), FATIGUE (Fatigue extreme) and ARTHRALGIA (Joint pain). At the time of the report, MENTAL FATIGUE (Mental fatigue / Brain fatigue), THERAPEUTIC RESPONSE SHORTENED (Wearing off effect), COVID-19 (COVID-19), FATIGUE (Fatigue extreme) and ARTHRALGIA (Joint pain) outcome was unknown and INFLAMMATION (Inflammation) was resolving.    The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter. The reporter's causality for the events of Inflammation after COVID vaccination with HUMIRA (ADALIMUMAB) was a reasonable possibility. Company comment: This spontaneous case concerns a 59-years-old female patient with no medical history reported, who experienced the unexpected non-serious  event of COVID-19 that occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date was not disclosed. There was administration of Co-suspect product and non-company product ADALIMUMAB (HUMIRA) on unspecified date for unspecified indication. The Clinical course, and treatment details were not provided, and the event outcome was unknown.  Ongoing COVID-19 Pandemic remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information. Sender's Comments: This spontaneous case concerns a 59-years-old female patient with no medical history reported, who experienced the unexpected non-serious event of COVID-19 that occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date was not disclosed. There was administration of Co-suspect product and non-company product ADALIMUMAB (HUMIRA) on unspecified date for unspecified indication. The Clinical course, and treatment details were not provided, and the event outcome was unknown.  Ongoing COVID-19 Pandemic remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.
On the day after the injection, a severe stiffness in both legs occurred.  It was a soreness and stiffness similar to the day after running a marathon race .  The soreness and stiffness would not change if I was sitting, walking, standing or kneeling.  It was constant discomfort and irritation.  It was not painful and therefore I originally did not go to medical.  There was no discomfort in my left arm at the injection site.  The discomfort increased for the rest of the day.  A headache started in mid afternoon and kept increasing throughout the rest of day.  I have not had a headache in years.  Around 7:00 PM on Thursday, I had to sleep.  I was extremely tired.  My body had chills and I had to wear a sweatshirt and full set of clothes to bed just to stay warm.  That is very unusual.  I am usually throwing off covers every night throughout the entire year.    I did not eat dinner because there was no appetite.  I slept in bed for at least 12 hours.  Typical night sleep = 8 hours.  The next morning was no issue and therefore I did not go seek medical help because there are supposed to be side effects to vaccines.  Now, I am reporting it because headache and the stiff muscles were identified on the news.  However, it was around 24-36 hours and not the 6 days on the news.
Felt dizzy and passed out. Felt fine afterwards. Clinic required patient to go to emergency room. Released in good condition.
This case was considered medically important (OMIC). Information regarding Hib-Titer Vaccine was received from a consumer regarding a 26 month old male patient who experienced autism. At 4 months of age, the patient received the second dose on 10/30/02. The patient also received the second dose of Prevnar on 10/30/02. The indication for Hib-Titer Vaccine was immunization. The product was administered on 10/30/02. The dose regimen was 1 dose 1 time per day (IM). Additional suspect medication included Prevnar. Concomitant medications were not reported. The mother reported that her son was diagnosed with autism in August 2004. No additional information was available at the time of this report. This is one of two reports from the same source where a patient developed autism follow receipt of Prevnar and Hib-Titer vaccines. See related case: HQWYE803809AUG05.
Painful stomach cramping; Injection site soreness; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Painful stomach cramping) and INJECTION SITE PAIN (Injection site soreness) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included FISH OIL and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced INJECTION SITE PAIN (Injection site soreness). On 14-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (Painful stomach cramping). On 12-Mar-2021, INJECTION SITE PAIN (Injection site soreness) had resolved. At the time of the report, ABDOMINAL PAIN UPPER (Painful stomach cramping) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment medications included activated charcoal. No laboratory details were  provided.  No treatment medications were reported.
T of 105F.Vomiting /win 6 hrs.T 102-105 for 48 hrs.Arm red & swollen X 4 days.
Pt. seen in office Dr. 3-14-14 at 4:16 PM. Mother reported child awakened from nap 45 minutes ago with hives on face. Improved at time of office visit. (KINRIX, PROQUAD) pt. received on 3-13-14 in our office at 10:58 AM.
Varivax given 06/29/04, DX with chicken pox 01/03/07.
When I had COVID, my heart would race to 105 bpm, basically walking 15 ft. After I was finished with COVID, my heart rate went back to normal. After receiving my first vaccine, I was okay for while, but then I started experiencing the high BPM right before my second dose. I had chest pain along with the high BPM. When I had COVID, I was worried about my heart because of high BPM, so my doctor put me on Zio (heart monitor) for two weeks. I sent the Zio back to the company and they provided the report. I was told I have Super Ventricular Tachycardia. The highest my HR went was to 200 BPM and it was a resting HR. My doctor told me to continue to monitor my situation. I had some extra pain and my doctor ordered for me to have a stress test, scheduled for 07/02/2021.
suspected vaccination failure/ got both shots two years ago,I have shingles right now; shingles; hurts; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, more than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got both shots of Shingles two years ago and had shingles right now at the time of reporting. The patient also reported that it really was hurting. This case was considered as suspected vaccination failure since the laboratory test confirming shingles were unknown at the time of reporting
headache; chills; This is a spontaneous report from a contactable consumer. An adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 11Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 11Feb2021 patient experienced headache and chills. Patient did not have COVID prior vaccination. Patient did not test COVID post vaccination. Outcome of the events was not recovered.  Information on the batch/lot number has been requested.
Symptoms occurred 12 hours after shot - approx 2 am.  Chills all over body - hands freezing, body aches- whole body, heart racing.  After approx 6 hours - developed additional symptoms of a headache - location was back of head and  severe teeth and jaw pain on right side of face.  Unable to sleep all night.  At noon -   got up and read vaccine literature to see if I could take anything for the pain.  Took Extra Strength Tylenol - 2 00 mg  gel caps .  Stayed awake for a 1/2 - pain in teeth, jaw and head got got better.  Went back to bed for 4 hours.  When work up later in the afternoon - felt okay.
Initial unsolicited report received from a physician on 18 May 2016. This case involves a 16-years-old male patient who was vaccinated with a dose of Meningitis vaccine (batch number, expiry date, route of administration and site was not reported) on unspecified date. The patient medical history and concomitant medications were not reported. On unspecified date, after administration of following the vaccination, the patient had experienced lost the use of arm for two weeks. Laboratory data and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
Red, swollen area at injection site of rt. arm. Put on cephalexin & BACTRIM (onset day #6 after vaccine).
(+) vesicular rash on face, back and chest since 11/3/03. No fever. Tx Acyclovir 200mg syrup 1tsp tid x 10 days. Zyrtec 5mg 1 tsp prn for pruritis.
fever Advised caller injection site pain, fatigue, headache, muscle aches, chills, joint pain, and fever can occur following COVID-19 vaccination. Swollen lymph nodes and nausea have also been reported, but not as common. Please seek medical attention if experiencing any shortness of breath, throat swelling, weakness, or diffuse body rash.
Extreme arthritis. I previously had minor arthritis in a few knuckles. Two weeks after my second vaccine my hands and wrists became extremely inflamed, weak and painful. I could barely use  my use my hands for any activity.
Less than 12 hours after receiving the first dose of the influenza vaccine at healthcare clinic , my eight month old daughter started having repeated seizure clusters, which had never happened up until this day, which led us to take her to emergency room. Healthcare clinic is affiliated with hospital so all her medical records, including this recent influenza vaccine record, were viewable by the ER staff. Not one person suggested these seizures could be a result of  the influenza vaccine and I didn?t connnect the dots at the time. She now continues to have seizures and will require anti-seizure medication for the duration of her life.
Admit 7/5, vaccine 3/6, 3/27. H/O type II DM, HTN, CAD. Admit for weakness, cough, fever. COVID+, COVID PNA. Treated with abx, steroid, O2. Not a candidate for remdesivir d/t acute renal fx. Pt gradually improved, DC'd home on 2L home O2.
Pt recvd vax & following vax pt devel hematuria which was picked up on routine school physical; No further details were provided;
pt recvd vax 3OCT95 & following vax pt became irritable & lost appetite;LMP 15SEP95;pt was subsequently found to be pregnant;estimated date of delivery was on 22JUN96;
Starting 1-2 days later my son became more quiet, stopped responding to his name, decreased eye contact and stopped talking (he said 3-4 words prior to) he is now 18 months and still non verbal, won't say mama or dada and has been evaluated and approved for early intervention speech therapy.
pt recv vax;redness & swelling,extending fr shoulder to elbow in lt arm,arm of inject;extreme fatigue,low grade fever,sweat & chills for 1 wk;saw MD p/ several days of persisting sx;
Pt called pharmacy evening 1-17-12 said she passed out 5 days after the shot while at home. Pt said she has been feeling achy and running a fever. Advised pt to see dr if still feeling this way. Could not find anything in pkg insert page. Immediate time of vaccination about passing out or syncope.
This spontaneous case was reported by a patient and describes the occurrence of ORAL DISCOMFORT (lip was strange), LIP SWELLING (lip swelled up), PARAESTHESIA ORAL (tongue tingling), TONGUE DISCOMFORT (strange feeling at the end of her tongue) and ORAL HERPES (fever blisters) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054a22a, 011h21a and 017b21a) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. The patient not had any reaction to previous vaccination. The patient's current conditions were just the same might be a little bit better. The patient's past medical history included Fever blister. Concurrent medical conditions included Heart disease, unspecified, Sulfonamide allergy (Sulfa) and Penicillin allergy. Concomitant products included FLECAINIDE for Heart disease, unspecified. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Jun-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2022, the patient experienced ORAL DISCOMFORT (lip was strange), LIP SWELLING (lip swelled up), PARAESTHESIA ORAL (tongue tingling), TONGUE DISCOMFORT (strange feeling at the end of her tongue), ORAL HERPES (fever blisters) and IMMUNISATION REACTION (a reaction not listed in the fact sheet). At the time of the report, ORAL DISCOMFORT (lip was strange), LIP SWELLING (lip swelled up), PARAESTHESIA ORAL (tongue tingling), TONGUE DISCOMFORT (strange feeling at the end of her tongue), ORAL HERPES (fever blisters) and IMMUNISATION REACTION (a reaction not listed in the fact sheet) had not resolved. Patient was administered with 1st Booster dose. Following vaccination with the booster patient started to experience the following: lip was strange, lip swelled up, tongue tingling, strange feeling at the end of her tongue, fever blisters, a reaction not listed in the fact sheet. The AE did not cause patient to seek medical care. The AE looked the same and were ongoing. Patient went to the pharmacy and was about to put borage oil for lips.
Covid positive PCR. Moderate case. Experienced chills, aches, headache, severe sore throat, hallucinations and brain fog. Duration of illness was about 10 days. No one else in household tested positive.
C/o of dizziness and tingling in upper extremities. Without resp, difficulty, BP wnl per school nurse. Teacher called Dr and went. Was told told to go home and rest. Dizziness had resolved but some tingling still in cheeks.