chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 8/2/02 crabby from the time he had shots until 8/7/02. Had a low-grade fever of 102F (rectally). On 8/8/02, no fever, then a rash on chest, belly and back and up to neck. Small, not raised rash, pink and confluent. Rash nearly gone by 8/10/02. He's back to normal on 8/10/02. Saw MD.
Fever 100.5, nausea, vomiting, dizziness x approx 24 hrs only.
Patient received the vaccine in his right arm and within a few seconds, he blanked and leaned towards the vaccinator on his right. He gained consciousness soon after and was given orange juice to drink. He recalled having a similar reaction after giving blood. He was aware of where he was and was able to carry on conversation normally. We did not call for paramedics and he remained in the pharmacy area further for observation.
It was reported that a 45 year old female received Fluzone WV '99-'00 vaccination on 10/15/99. Reportedly, on 10/16/99, the pt experienced swelling of lips and face and also shortness of breath.
Information has been received from a medical assistant referring to a 7 month old female patient. Information about concurrent condition, concomitant medication, drug reactions/allergies and medical history was not provided. On 25-SEP-2018,  the patient was vaccinated with a dose of VAQTA (25/0.5 with unspecified unit, lot#R013858, expiration date was 12-JUN-2019, intramuscular; dose number was not reported) for prophylaxis (drug administered to patient of inappropriate age). No adverse effect was reported.
This spontaneous report has been received from a medical assistant referring to a 10 year old patient (gender was not provided) No information was provided regarding the patient's medical history, concurrent conditions, drug, allergy history or concomitant medications. On 13-DEC-2018, the patient was vaccinated with an adult dose of VAQTA (strength, frequency and route of administration were not provided) lot # R022983, expiration date 09-AUG-2019, for prophylaxis. No adverse event was reported. This is one of two reports from the same reporter (MARRS#1812USA007232); Sender's Comments: US-009507513-1812USA007232.
Severe body aches and high fever . Swollen arm and enlarged lymph node on left arm .
Patient immediately had pain throughout all of her joints. She stayed at pharmacy for 20 minutes and then went to the ER (4/4/16) later that night. ER gave her IV fluids and medication for her reaction to MMR vaccine. She was released at 5 am 4/5/16.
Impotent; Muscle pain; Chills; This spontaneous report was received from a consumer concerning a 56-years-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chills, muscle pain/ myalgia and was impotent/ erectile dysfunction.  The patient's medical history was not provided. Concomitant medications included metformin, glimepiride, atorvastatin, losartan, pantoprazole and doxazosin.  On 26 Feb 2021, approximately one day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 037K20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 27 Feb 2021, the patient experienced the got chills, muscle pain and the patient was impotent a medically significant event. Treatment details included paracetamol.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, chills, muscle pain and was impotent was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
11MAY93 3PM pt irritable & drowsy 6PM; pt cried x's 1 hr; temp 103 ax; 7PM; pt face puffy c/o difficulty swallowing; 9PM mom called MD;MD said give APAP & DPH; dec appetite, sleepy, irritable, lt arm red, blue, swollen from shoulder to elb;
Pt. said the evening of getting the IMZ 5-1-18 her arm swelled up the area turned red and it was hot to the touch. Pt. came by pharmacy 5-4-18 to show reaction the swelling has gone down, but the area was still red the size of a baseball and still hot to the touch.
Itching and redness covering an 8"x6" area from the injection site down along the mid to inner aspect of the arm. Definite outline of the patch and the needle entry.   This occurred 4 1/2 days following injection.  At the time of this report redness and itch present but less after applying Benadryl topically this morning.
My menstrual cycle was longer and heavier/bleeding was more than normal; My lower abdomen was also more swollen with my cycle; My menstrual cycle was longer and heavier/ The cycle lasted for almost 2 weeks; This is a spontaneous report from a contactable consumer (patient). A 49-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the left arm on 01Apr2021 15:30 (Batch/Lot Number: ER8734) (at the age of 49-year-old) as dose 2, single for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was school or student health clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient's medical history included Polycystic ovarian syndrome (PCOS), and known allergies to wheat, soy, peanuts, eggs, berries, trees. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in the left arm on 11Mar2021 at 03:30 PM (Batch/Lot Number: EN6207) (at the age of 49-year-old) for COVID-19 immunization. The patient previously took Azithromycin and Ceftin and experienced allergy with both drugs. The patient reported that her menstrual cycle was longer and heavier. The cycle lasted for almost 2 weeks and bleeding was more than normal (for the patient). Her lower abdomen was also more swollen with her cycle. The onset of events was on 13Apr2021. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive treatment for the events. The outcome of the events was recovered on an unspecified date.   Follow-up attempts are completed. No further information is expected.
I got COVID in mid-May 2022/The biggest things I dealt with during that time were fatigue, brain fog, and muscle soreness.; I got COVID in mid-May 2022/The biggest things I dealt with during that time were fatigue, brain fog, and muscle soreness.; The initial case was missing the following minimum criteria: No Adverse Event. Upon receipt of follow-up information on (22Aug2022), this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (003110). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 26Apr2021 as dose 1, single (Batch/Lot number: unknown), on 10May2021 as dose 2, single (Batch/Lot number: unknown) and on 04Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "I got COVID in mid-May 2022/The biggest things I dealt with during that time were fatigue, brain fog, and muscle soreness.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (May2022) Unknown results, notes: I got COVID in mid-May2022.  Clinical course: it wa reported that 1st injection on 26Apr2021 At a nursing home in RI. 2nd injection on 10May2021 at a pharmacy in RI. Both were Pfizer injections. 3rd dose of a booster was on 04Dec2021 at a doctor's office in NYC. This was also a Pfizer injection. I got COVID in mid May2022. The biggest things I dealt with during that time were fatigue, brain fog, and muscle soreness. I was in bed for a few days. Since then, I still experience fatigue and brain fog and my anti-depressants stopped working. I've gained weight. It isn't fun and I've been struggling with my mental health and feeling motivated. What I'm saying is, I'm not taking any more boosters from anyone until y'all figure this out. I see how pharma is making more money by requiring more injections. But I'm not taking any additional injections from Pfizer or any other company until we know that they are both safe for humans long term and effective long term effective as in preventing getting COVID completely and suffering from it's symptoms. If you still have questions, feel free to send me an online form via your website.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Follow-up (22Jun2022): Follow-up attempts are completed. No further information is expected.
Chest pain, shortness of breath, tachycardia, high blood pressure, St elevations on an EKG, raised red swollen injection site hot to the touch.
Vaccine not given at this facility.  Patient came in c/o hearing loss right ear, sensation of being blocked, intermittent numb sensation of ear, dizziness, imbalance and repetitive vomiting x 2 days.  Sent to Emergency department after being given zofran which did not help.
Initial report received from a consumer on 16 Aug 2010: This patient was vaccinated with only the MenCWY liquid conjugate component of MENVEO (batch number not reported), (dose: 0.5 ml) intramuscularly without being reconstituted with the MenA conjugate component. No adverse events were noted following this administration.
Body aches; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-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 MYALGIA (Body aches) and HEADACHE (Headache). At the time of the report, MYALGIA (Body aches) and HEADACHE (Headache) 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.
This spontaneous case, initially received (combinedly processed with follow-up received on 02-Oct-2018) on 28-Sep-2018, from a pharmacist, concerns a 72-year-old, elderly, female patient. It was reported that the needle was attached to the syringe which seems to be looser on the other side (explicitly coded as needle issue). On 28-Sep-2018, the patient received partial dose of FLUAD (TIV) [ dose: less than 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 250799 and expiry date: 31-May-2019] (explicitly coded as incomplete dose administered), as the vaccine was leaked out through the patient's arm when the plunger was pressed (explicitly coded as syringe leak and exposure via skin contact). This case was associated with product quality complaint, hence quality assurance investigation (QAI) had been requested ant the corresponding product technical complaint (PTC) reference number was 1033865. The reporter assessed the case as non-serious. Non-significant follow-up received from a pharmacist on 01-Nov-2018: No new information obtained. It was reported that the primary reporter no longer works in the pharmacy. Hence, they do not have further information on the case to provide.
Fever of 102.   Complete fatigue.   I slept for 18 out of 24 hours.   Every joint in my body hurt.  I could not lie on my right side because the pain in my right arm.   I had no appetite.   The fever lasted 28 hours as well as the sore joints. Took ibuprofen on a 4 hour basis.
warm to the touch; swollen all the way around; My arm [left] swelled up almost completely from the top of my shoulder at injection site to my elbow; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm to the touch), SWELLING (swollen all the way around) and VACCINATION SITE SWELLING (My arm [left] swelled up almost completely from the top of my shoulder at injection site to my elbow) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A20A) for COVID-19 vaccination.     Concurrent medical conditions included Acid reflux (esophageal), Hernia (Patient had hernia between her esophagus & top of her stomach.) and Drug allergy (Augmentin). Concomitant products included POTASSIUM CHLORIDE and PANTOPRAZOLE SODIUM SESQUIHYDRATE (PANTOPRAZOLE 40) for an unknown indication.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced SWELLING (swollen all the way around) and VACCINATION SITE SWELLING (My arm [left] swelled up almost completely from the top of my shoulder at injection site to my elbow). On 08-Mar-2021, the patient experienced VACCINATION SITE WARMTH (warm to the touch). At the time of the report, VACCINATION SITE WARMTH (warm to the touch), SWELLING (swollen all the way around) and VACCINATION SITE SWELLING (My arm [left] swelled up almost completely from the top of my shoulder at injection site to my elbow) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       The  patient was wondering what she can take for the pain.  No Treatment medications reported.   This case was linked to MOD-2022-489376 (Patient Link).
Within one hour of receiving my second Covid-19 Vaccination , I began to have severe left hip, back and leg pain.  Walking was very difficult.  This pain has continued, some times it is less and other times more severe.  I have not talked with a health care provider about these symptoms.
This spontaneous prospective pregnancy report as received from a female consumer of unknown age reporting herself. Medical history and concurrent conditions were not provided. On an unknown date reported as "five days before she conceived", the consumer was vaccinated with a dose of GARDASIL (dose, route, lot number and expiry date were not reported). The consumer did not specify which dose she received in the GARDASIL series, and it was not confirmed if the consumer received any subsequent doses, after conception. On an unknown date, the patient became pregnant. The Last Menstrual Period (LMP) and Estimated date of delivery (EDD) was not known. The pregnancy outcome was pending. Additional information is not expected because no demographics were provided for the patient or physician.
I had vaginal bleeding/spotting; slight cramping two weeks after my menstrual period; This is a spontaneous report from a contactable other hcp (patient). A 25-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 23Mar2021 08:30 (at the age of 25-year-old) as dose number unknown, single for covid-19 immunization. Medical history included asthma from an unknown date. Prior to vaccination, was the patient diagnosed with COVID-19 as reported as no. Concomitant medications included montelukast taken for an unspecified indication. The patient had vaginal bleeding/spotting and slight cramping two weeks after my menstrual period on 28Mar2021 at 07:00. This was not normal for me as patient always have her periods at the same time each month since patient was on birth control. Event resulted in doctor or other healthcare professional office/clinic visit. No treatment was received. The patient underwent lab tests and procedures which included sars-cov-2 test was negative (nasal swab) on 21Jan2021. The clinical outcome of events was recovered in Apr2021.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
L deltoid et axillary swelling - started/noticed 6/20/08 at 0700. Pt took ice et ibuprofen for pain/swelling. Pt saw provider NP on 6/23/08.
Dose 1 and Dose 2 on same date (23Dec2020 13:00); Dose 1 and Dose 2 on same date (23Dec2020 13:00); I had totally regular periods until I got the vaccine, then NOTHING to date. Menstrual cycle disruption.; This is a spontaneous report from a contactable consumer (Patient). A 52-years-old Non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration on 23Dec2020 13:00 (at the age of 52-years-old) in Arm Right, as dose 1, single and bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration on 23Dec2020 13:00 (at the age of 52-years-old) in Arm Right, as dose 2, single for COVID-19 immunization. The patient Medical history included , migraine from an unknown date and unknown if ongoing. Concomitant medications included topiramate (TOPIRAMATE) taken for an unspecified indication, start and stop date were not reported. The patient was not pregnant at the time of vaccination. The patient did not received any other vaccinations within four weeks. The patient was not diagnosed with COVID-19 prior to vaccination and post vaccination patient was not tested for COVID-19. On 03Jan2021, the patient experienced she had totally regular periods until she got the vaccine, then nothing to date menstrual cycle disruption and Dose 1 and Dose 2 on same date (23Dec2020 13:00). The patient did not received treatment for the adverse event. The outcome for the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Information has been received from a physician concerning a 9 week old male who on 29-JUN-2007 was vaccinated with Rotateq (LOT # 656845/0409U). On 09-JUL-2007 the patient started vomiting and on 15-JUL-2007, the patient was hospitalized, with bloody diarrhea. He was diagnosed with gastroenteritis. The child had bloody diarrhea during the duration, and was unable to feed, off and on, for 7-8 days, event on nutrimagen, while hospitalized. The child had IV's, intravenous therapy, and a GI biopsy performed (results unknown). The child was seen by GI specialists. On 30-JUL-2007, the patient was discharged from the hospital. On 01-AUG-2007, the child was seen at the physician's office for a post hospitalization follow-up visit. The child's present status was not reported. Additional information has been requested.
Information has been received from a registered nurse concerning a 6 year old female patient with no pertinent medical history and no known allergies who on 22SEP1998 was vaccinated with a dose of varicella virus vaccine live. On 04MAR2004 the patient presented with varicella at the panty line, right shoulder and on her side. There was not treatment. The nurse reported that the patient experienced "chicken pox break through thru post vaccination with varicella virus vaccine live. It was noted at the time of the report that the patient was not recovered. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Arm Pain 2 days after injection (2/28/21, 2/29/21) Mild body aches  and fatigue (2/28/21, 2/29/21) Rash at injection site size of quarter (3/6/21, 3/7/21 AM) Rash at injection site size of palm (3/7/21 PM, 3/8/21) Arm Pain (3/8/21)
Red hot raised lump on arm around injection site about 2 inches. Itchy.  Still present on day 9.
Staff pharmacist administered FLuzone HD to adult under 65 years old. Pt is only 32 years old at time of vaccine was given. Patient was notified on the same day. Patient is doing fine, no side effects at this time. Patient and family member ( dad) was advised to call pharmacy/ MD  if patient experience any symptoms.
Severe headache one hour after injection.  Followed by nausea, chills, muscle aches and fever of 101.5
Redness at injection site. 2.5 cm of erythema on left deltoid. Hot to touch. Pt has mild headache and nausea. No fever. Advised to apply warm compresses and watch area for increased redness, swelling and/or fever.
Small papular on both arms, trunk and legs - resolved by now soreness and swelling on the shot area L deltoid 05/07/2008.
R upper arm red and swollen.  Vac given on arm DTaP and varicella.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 25-JAN-2016 the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (lot # L030587, expiration date 10-FEB-2017, dosage and route not specified). It was reported that the vaccine was stored at -13.7 degree centigrade for 15 hours. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
I was coughing, I had congestion and I ached all over. The coughing was pretty intense and I ached all over and it hurt to move. The worst of it lasted 24 hours and I started getting better the following day. I still was coughing but the 1st day was the worst. Each day it got better.
pt recv vax p/12noon;p/approx 5PM pt devel high pitched cry, including squealing;also followed by fever of 104;sx lasted into next AM;pt wouldn't straighten out legs easily the next day;rx w/APAP;
Information has been received from a pharmacist referring to a 62 year old male patient. Information about patient's medical history or drug reactions/allergies was not reported. On 25-FEB-2015 the patient was vaccinated with ZOSTAVAX (lot # K009810 with expiration date 10-OCT-2015, unspecified single dose, subcutaneous). The pharmacist reported that the patient had ZOSTAVAX reconstituted with sterile diluent (lot # reported as K011199). Concomitant therapies included COUMADIN and multiple unspecified prescription drugs. On 27-FEB-2015 the patient experienced injection site reactions (a red, bruised, hard lump, 6 to 8 inches in size, that was warm to touch and swelling of lower and upper arm) after receiving ZOSTAVAX. The patient saw a physician on an unspecified date. KEFLEX was given for the events. The pharmacist contacted patient and patient stated that injection site reaction was improving (recovering). The causality was not provided. This is one of several reports received from the same reporter. Additional information has been requested.
My fertility had not yet returned after having a baby on 7/14/2020. I track my cycles using the Creighton model of Natural Family Planning and have for the past 7 years. This was my third child (all planned), and I have never had a problem identifying fertile periods and likely ovulation day. Exactly two weeks after my second dose of Moderna, my first postpartum period started out of nowhere. I had no fertile signs before. My instructor said that it could be a withdrawal bleed without ovulation, and that may be why I didn't see fertile signs. Given that it was exactly two weeks after my second dose, it could have also been that the vaccine triggered ovulation, and then I had my first period 14 days later.  My period was extremely heavy (filling a menstrual cup in 30 mins-an hour on the first day), but that may just be because it was the first postpartum period. After it was over, I continued to not see any fertile signs. However, I must have ovulated at some point without showing a change in cervical mucus pattern because I am now pregnant.  I therefore wonder whether the vaccine jumpstarted my return of fertility and also whether it somehow interfered with my usual fertile signs.