chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a certified medical assistant (CMA) refers to a 7 month old patient of unknown gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with a first dose of ROTATEQ vial (lot # reported as K024700, expiration date 30-JUL-2016, route of administration default to oral, dose was not provided). The patient's concomitant medication was not reported. No adverse effect was reported. Product quality complaint (PQC) was not involved. This is one of two reports received from the same reporter. Additional information has been requested.
Gave 6 month vaccines accidentally at 9 months clinic visit.  No negative outcome has been reported to clinic.
Starting in December, my menstrual cycle was late by 4 days(I'm always regular), 5 days late in January and 10 days late in February. I just went to the OBGYN yesterday and all my lab work was normal. So, they contributed my menstrual cycles being late to the COVID19 vaccine due to other women experiencing it as well.
Sore arm; Tender at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and INJECTION SITE PAIN (Tender at injection site) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 042L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and INJECTION SITE PAIN (Tender at injection site). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, PAIN IN EXTREMITY (Sore arm) and INJECTION SITE PAIN (Tender at injection site) outcome was unknown. Not Provided          No concomitant medications were reported.    Action taken with mRNA-1273 in response to the events was not Applicable.   This case was linked to MOD-2021-054651 (Patient Link).
ADMINISTRATION OF EXPIRED VACCINES; This spontaneous report received from a health care professional concerned multiple (two) patients. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced administration of expired vaccines. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccines was not reported. This report was non-serious.
Patient admitted to ED for unrelated medication issue and found to be COVID positive.  Still inpatient
Information has been received from a physician concerning a 14 year old female who in February of 2008 was seen for an emergency contraceptive prevention. On 21-APR-2008 the patient was vaccinated with a first dose of GARDASIL (lot number) 0.5 ml by intramuscular injection (injection site not reported). Concomitant therapy included DEPO-PROVERA. Later the patient was found to be pregnant. At the time of this report the patient was in her 21st week of gestation. Unspecified medical attention was sought. Follow-up information was received from a nurse practitioner who reported that on 24-JUL-2008 the patient had a prenatal ultrasound performed, which revealed possible atrial septal defect of the fetus. Possible atrial septal defect was considered to be a congenital anomaly. Additional information has been requested.
Weakness and pain in arms and legs, especially knees and shoulders (cannot raise arms or legs) Unable to get out of bed without assistance, or rise unassisted from sitting position Walking with great difficulty Unable to get clothing on and off without assistance General weakness and extremely tired-sleeping a lot
maybe 5-10 minutes after the 2 shots, patient was sitting in waiting area for her wait time after shot administration. Technician notified me that the person was not feeling well.. I went out to check on her and she was sweating pefusley..(sweat beads on her forehead) and she said, she felt like she was going to pass out.. so I talked with her to calm her down, because she was very nervous before receiving the shots anyways.. I explained to her that I might need to give her an Epi shot and she said she was beginning to feel better.. I gave her some water and after drinking some water she said she was feeling normal again and I asked if someone could drive her home instead of driving herself and she said she was talking with her sister and she was calming her down as well. I insisted she stay for 30 more minutes to make sure she was still ok.. I checked on her multiple times and had the tech near her..keep an eye on her and while i was giving other shots I had the manager in training of the store stay with her.. she was doing just fine and  she wanted to drive home and I told her to stay another 10 minutes, which she agreed to and said she is completely fine and apologized to me for causing  this and was very appreciative for our help
This is a spontaneous report from a non-contactable pharmacist via a Pfizer Sales Representative. A patient of unknown age, gender and race/ethnicity received on an unknown date a single dose of PREVNAR 13 for immunization. Medical history and concomitant medications were not reported. On an unknown date, the patient had pain at the injection site. Outcome was recovering. No follow-up attempts are possible. No further information is expected.
Systemic: Vomiting-Medium, Additional Details: recieved vaccine about 11:50 am pt stayed here for 15 minute observation and was fine when he left he stated that he was nauseous on way home, called pharmacy at 4:30pm and stated that he had vomitted 5 or 6 times since he got home. I counseled him what to do and if needed he should contact md. Followed up with pt 1/18 and he stated that he continued to have vomiting that evening and nausea the next day.  He stated that he never contacted md. and Today 1/18 he is feeling better.
It is the ringing in the ear; felt like a siren was going both of his ears; Headache; His arm was hurting; Throwing up; losing his balance; He was running a temperature; This is a spontaneous report from a contactable consumer. This consumer reported that a 38-year-old male patient (son) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for Covid-19 immunization on 19Feb2021. Relevant history and concomitant drugs were unknown.  Relevant concomitant drugs were unknown.  The patient previously received the first dose of BNT162B2 in 05Feb2021 for Covid-19 immunization on, when he received the first one he felt headache a little bit and his arm was hurting and all of a sudden he suffered from tinnitus in his ear. He had lost 8 pounds in like 4 days since he got that shot. He weighs not like a 117-118 pounds. When he received the second shot he experienced headache, tinnitus in his ears, which became so worse that he felt like a siren was going both of his ears and he landed up in the hospital plus he was throwing up and he was losing his balance and he was running a temperature and he was still in the hospital. It was the ringing in the ear; felt like a siren was going both of his ears. His arm was hurting. He was in the hospital since Tuesday and ringing in his ear, it would not stop. He said it was started, he always had this but not to this extent he started after the first vaccine that he had. He wanted to know because his ear nose and throat doctor said that another patient had the same reaction (Further clarification was unknown, hence split was not captured) and he wanted to know why is that not listed on the reactions. The outcome of events tinnitus and throwing up was not resolved. Outcome of other events was unknown.  Information on the lot/ batch number has been requested.
half dose of bivalent moderna booster was given.  We gave 0.25 mL instead of 0.5 mL.
Blotchy rash on back, face, and neck.  Many of the rash lesions are small like mosquito bites and raised a little.  Mom noticed this when she picked her up from daycare 8/04/11 around 6:00 PM.  Treatment:  topical hydrocortisone or topical Benadryl.  Call is symptoms worsen.
10 days after my vaccination my hands started itching, then progressed to breaking out in extremely sensitive bumps.
Since the day after 2nd dose, absolutely horrible migraines constantly. Present from the minute waking up to minute going to sleep. Had NEVER had headaches in the past. Seeked medical attention from my doctor. Sent for a contrast brain MRI. Showed a small cyst in sinuses. Tried amoxicillin.  Didn?t help at all. Have been taking Tylenol/excedrin for a month now. In intense discomfort everyday. I need some guidance as to what to do and how medical attention will be covered. I am extremely sensitive to light now since the 2nd dose. Again, I experienced no headaches before this 2nd dose
On Jun 2011, patient received Gardasil, the first dose and Gardasil 9 on 18-APR-2019; No adverse effects reported; On Jun 2011, patient received Gardasil, the first dose and Gardasil 9 on 18-APR-2019; On Jun 2011, patient received Gardasil, the first dose and Gardasil 9 on 18-APR-2019; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concomitant medications, concurrent conditions and drug allergies were not provided.  On an unspecified date in Jun 2011, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) for prophylaxis (strength, route of administration, anatomical site of injection, lot # and expiry date were not reported).  On 18-JUN-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (Lot No. R004689 has been verified to be a valid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast), expiration date not reported, but upon internal validation established as 29-NOV-2020) (inappropriate schedule of product administration) as the second dose of HPV (human papillomavirus infection) vaccination series for prophylaxis (interchange of vaccine products/wrong product administered) (strength, route of administration, anatomical site of injection were not reported). No adverse effects reporter nor product quality complain involved.
The first day, fatigue and diarrhea. Day 7 started as a  lump now day 8 today, its the size of a grapefruit, redness, and warm to the touch
Today I was supposed to be given my first ever covid vaccine, the monovalent. But instead was given the Bivalent Vaccine Booster as my first initial Dose.
Low fever, body aches, chills, nausea, swelled armpit, stomach ache, headache
Patient came back to Mass vaccination site to report that after he received 2nd dose of Pfizer COVID vaccine, he had angioedema with Left eye swelling completely shut.  T99.3   He reports he did not notify his PCP, did not go to urgent care or ER for treatment as he does not believe in doctors.  He reported to his cardiologist who instructed him to come back to vaccination site to let us know of his reaction.   Patient states he is a doctor himself.  At time of patient report, on 4/29/21, symptoms had resolved.
Pain, muscle ache and spasm down entire left arm. All day. Continued into 2nd day (3/16). Forearm & fingers twitching nonstop.
within minutes of receiving vaccines became hot/flushed and developed hives over body and experienced swelling of tongue. Has history of severe allergic reactions ands carries treatment medications with her. She took benadryl, doxepin, and chlortrimeton. Symptoms resolved without taking epinephrine as well.
Mild symptoms from vaccine but I did get Covid on 12/25/2022 and had extreme fatigue.
After the second dose of the vaccine, she developed a bleeding that turned into a menstrual period again.; After the second dose of the vaccine, she developed a bleeding that turned into a menstrual period again.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 62-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 01), for Covid-19 immunization. The following information was reported: HAEMORRHAGE (non-serious), MENSTRUAL DISORDER (non-serious), outcome "unknown" and all described as "After the second dose of the vaccine, she developed a bleeding that turned into a menstrual period again."  Consumer was a 62-year-old female patient. She explained that she had 3 doses of the Pfizer-BioNTech COVID-19 Vaccine so far. Prior to vaccination, she had been in menopause for 16 or 17 years. After the second dose of the vaccine, she developed a bleeding that turned into a menstrual period again. She wanted to know if similar cases have been reported before.  The information on the batch/lot number for (BNT162B2), has been requested and will be submitted if and when received.
Narrative: COVID infection following COVID vaccine series 02/04, Pfizer dose #1 02/25, Pfizer, dose #2 1/10, Pfizer, dose #2 12/28 COVID swab, result: detected 12/20 COVID swab, result: not detected 12/30 COVID swab, result: detected 1/5 COVID swab, result: detected 12/27 pt cc: cough/congestion and weakness exposure: unknown 12/30 pt admit ED cc: cough/congestion and weakness dx: COVID LOS: 1 day 12/30 CXR impression: No acute abnormality.
7 x 15 cm erythema; induration (L) deltoid c/o fever, but (R) lower lip swelling onset 12/3/12 C/W herpes labialis mild erythema (R) deltoid 2 x 4 cm.
Information has been received from a nurse in a physician's office concerning a 17 year old female who in approximately September 2006, was vaccinated with the second 0.56ml dose of HPV vaccine. On 21 Nov 2006, the patient developed swelling of lips and swelling of face. The patient sought unspecified medical attention. On 22 Nov 2006 within 24 hours, the patient had recovered from the events. Additional information has been requested.
her right hand is slightly swollen; Where she got the shot is a little red, warm, and swollen; Where she got the shot is a little red, warm, and swollen; Where she got the shot is a little red, warm, and swollen; a little sore; This is a spontaneous report from a contactable consumer.  A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: 3248), via an unspecified route of administration in the right arm on 18Jan2021 at 08:40 A.M. (at the age of 50 -years-old) as a single dose, dose 2 for COVID-19 vaccination. Medical history was unknown. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EK9231), single dose, dose 1 in the left arm on 28Dec2020 and a flu vaccine on 29Aug2020. There were no concomitant medications. On 19Jan2021, the patient's right hand is slightly swollen. It was still mobile. She can move all digits. It was puffy and a little sore  and where she got the shot was a little red, warm, and swollen. There were no relevant tests  done. The patient had no emergency room or physician office visits. The clinical outcome of right hand is slightly swollen, puffy and a little sore and where she got the shot was a little red, warm, and swollen  was not recovered.
concerns of liver failure; Severe rash; dark urine; yellow eyes; Severe itching; This case was reported by a nurse via sales rep and described the occurrence of liver failure in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th July 2020, the patient received the 1st dose of Shingrix. In July 2020, less than a week after receiving Shingrix and an unknown time after starting triamcinolone, the patient experienced pruritus. On an unknown date, the patient experienced liver failure (serious criteria GSK medically significant), rash, urine discoloration and yellow ocular coloring. The patient was treated with triamcinolone and methylprednisolone. On an unknown date, the outcome of the liver failure, pruritus, rash, urine discoloration and yellow ocular coloring were unknown.   It was unknown if the reporter considered the liver failure, pruritus, rash, urine discoloration and yellow ocular coloring to be related to Shingrix.  Additional details were provided as follows: It was reported that the patient received Shingri and on 27th July 2020 returned to office due to severe itching. The physician prescribed triamcinolone On 3rd August 2020, the patient returned to office again due to ongoing itching, the physician prescribed methylprednisolone. On 13th August 2020, the patient returned to office again due to rash and itching, the physician prescribed methylprednisolone again (to continue using triamcinolone). On 18th August 2020, the patient returned with itching but no rash, labs were checked and patient had LFTs more than 10 time upper normal limit. The patient also had dark urine and yellow eyes (concerns of liver failure).  It was unknown if it was started prior to Shingrix The patient cannot clearly identify when symptoms of itching started (pre or post Shingrix dose). The reporter consented to followup.
Patient received second dose of Shingrix immunization. Immediately after administration, she reported feeling like she was about to faint. She proceeded to lie down and was brought some cold water to drink. After 10-15 minutes, the patient reported feeling much better. She got up and left the store.
A week after the injection, I notices red dots all over my belly, thighs, chest,  and my doctor said they are cherry angiomas. Cause unknown, but  vaccine is the only thing different in the previous week. Note: I did have gallbladder surgery on 3/26/2021
He got his vaccine, he felt fine.  He went home, and told his wife he was vaccinated, and gradually throughout the day he started to feel sick.  He felt nauseous, throwing up, diarrhea, stomach pain, extremely cold.  The next day he was bedridden all day, and also for the next 3-4 days, and also had vertigo.  He took Tylenol, Advil, cold/flu medicine.  He was feeling better about 2 weeks later, vertigo for a week and a half (never had this before).   He went to the UC who told them there was nothing he could do, rest and take some OTC medicine and to just fight it off, stay hydrated.
Patient received again 1 dose of the Moderna monovalent vaccine; she had a stem cell transplant on Sep2022; This spontaneous case was reported by an other health care professional and describes the occurrence of IMMUNISATION REACTION (she had a stem cell transplant on Sep2022) and EXTRA DOSE ADMINISTERED (Patient received again 1 dose of the Moderna monovalent vaccine) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. In September 2022, the patient experienced IMMUNISATION REACTION (she had a stem cell transplant on Sep2022). On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (Patient received again 1 dose of the Moderna monovalent vaccine). At the time of the report, IMMUNISATION REACTION (she had a stem cell transplant on Sep2022) and EXTRA DOSE ADMINISTERED (Patient received again 1 dose of the Moderna monovalent vaccine) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 60-year-old female patient who received SHINGRIX for prophylaxis. On 22nd June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but it could be 59 or 60 years. The patient experienced arm soreness. The patient did not consent to follow-up. For tolerance to the 2nd dose of SHINGRIX refer case US2018221114, for the same patient.
Extreme fatigue, whole body rashes (urticaria from scal to feet), facial swelling, tongue swelling, eye swelling, tightness in throat, cough,  Rashes itch, were painful and felt like fire, and something crawling on my skin that came and went in waves. I rceived IM decadron x2, IV benadryl x3, epinefrine x 2 , normal saline IV infusion during less than 48 hours on four visits to the Urgent care and Emergency Room and left with a few prescription. The results lasted fot 12 hours and would come back. I have myself a shot of epinefrine for the 3rd time.. I than was seein by my primary care that put on all the folowing medications to try to stop the allergy reaction I am having.   I am now on Prednisone, Benadryl, Hydoxizine, Singulair, Pepcid, Cromolyn Sodium, Naltodrexone and cannot stop any that I feel the symptoms coming back. I also started having loss and blurry vison and it has gottend progressively worse. I saw my eye docuter the diagnosed acute changes in my vison and prescribed me eye drops and to follow up in a week to continue to monitor,.
About 3 weeks after receiving my fourth dose of the vaccine, I woke up with a racing heart rate. It was so fast, I was not able to count the beats. My son tried also, but he was not able to either. I called for an ambulance, but by the time they got there, my heart rate had slowed a little. It was still high, as well as my blood pressure when they checked it. I made an appointment with my Cardiologist and he has me wearing a heart monitor which I will take back tomorrow. I had an EKG done and everything was fine.
Patient reported receiving an influenza vaccine from pharmacy on 12/7/11 on her left arm.  The next morning, she started feeling pain and warmth in that upper arm.  She thought it was due to her sleeping position.  The injection site did not have inflammation.  A few days later, she believed that this reaction was from the vaccine because she thought that the injection site was up higher toward the shoulder blade than it should be.  The pain persisted for 7 days.  Now, it is resolving.
muscle ache, especially neck and hips and fever of 99.8 F. the  evening of day after injection . Feeling normal by second day.
I am allergic to wintergreen. I have full body aches and pain for three days if I come in contact with it, even through my skin. My reaction to this vaccine felt like I was injected with wintergreen oil. I felt like I had been hit by a truck. Breathing hurt, moving hurt, speaking hurt. The feeling of anything touching my skin was painful. I was light sensitive. I was able to get through it by taking Benadryl for three days, and by the end of the third day I felt mostly back to normal enough to function. But it felt like my blood was on fire for most of the three days following the vaccination. Because I was able to handle the symptoms using benadryl, I did not seek medical attention. But when I spoke about it to my