chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 16 year old female patient with a history of seizures who on an unknown date was vaccinated with her first dose of GARDASIL (lot# not reported). The next day after vaccination the patient experienced a seizure. It was reported that two to three days later the patient went to see a pediatrician, who told the patient to go back to the Ob-Gyn physician and let him know about the seizure. It was noted that the patient did have a history of seizures but had not had any seizures for a while until the day after vaccination with GARDASIL. No further seizures were noted since the seizure the day after receiving GARDASIL. At the time of the report, the outcome of the patient was unknown. Upon internal review, seizure was considered to be an other important medical event. Additional information has been requested.
lightheaded ,dizzy feeling of passing out . sweating drop in blood pressure 90 over 40. Was given an IV with fluids plus benadryl and a steriod. was taken to the ER for observation. was given an EKG and it was normal. the outcome was  presyncope.
Information has been received from a nurse concerning a 36 month old male who in approximately 2006 was vaccinated with a single dose of VARIVAX (Merck). Subsequently on an unspecified date the patient developed shingles. The rash appeared on his legs and butt. The physician saw the patient. The patient was recovering. No product quality complaint was involved. Follow-up information was received from a physician which reported that this was a 42 month old male whom was previously vaccinated by his previous primary physician (PCP) with VARIVAX (Merck) in 2005 whom we treated for shingles 05-JUN-2008. At the time of reporting, the patient recovered from shingles. Additional information is not expected.
Rash; Take shots in leg or buttocks; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Take shots in leg or buttocks) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Breast cancer and Anaphylactic shock. Concomitant products included EXEMESTANE (AROMASIN) for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intravenous) 1 dosage form. On an unknown date, the patient experienced RASH (Rash) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Take shots in leg or buttocks). At the time of the report, RASH (Rash) outcome was unknown and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Take shots in leg or buttocks) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intravenous) was unknown.       No concomitant medications reported. Treatment medications was provided.
101.4 fever for two days, chest cough, irritation, crying, stuffy nose and cough continued for 6 days, loss of appetite for 5 days.
Adverse effect of other vaccines and biological substances, initial encounter on 2022-08-29.
Swollen, red, hot, soreness in arrm area about 2in X 2in. As days went on, soreness traveled to underarm, shoulder, neck. After 2 days, redness turned to purple almost deep black and blue marks. Area formed hard bumps. This stayed liked this for 3 days. After 8 days, I am beginning to feel a tightness in my left jaw. Vaccine was administered in left arm. I have dull shooting pain going across my shoulder blades. Vacination area now only red, itchy, with one bump left. I was treated for a spider/insect bite in 2007. May have recd a tetanus shot then, couldn't remember in 5/2012, so ER administered another one.
I had a continuous headache from about 9 pm the day of my vaccine all the way through to about 12 pm the next day. It never went away even while I was sleeping. I know this because I woke up multiple times throughout the night because of it. Tylenol, an ice pack, and peppermint oil did not help it. I get migraines often and these always work for those but didn't work for the headache caused by the vaccine.
Swelling and redness at injection site of (L) deltoid; (R) deltoid normal. Treatment ice, ibuprofen monitor f/u if worsening.
3.5 x 2.5 redness and swelling at injection sight (L) thigh.
Hepatitis B vaccine booster administered @ 3:45 PM.  At approx. 8PM, health care worker (HCW) began to experience numbness, tingling @ injection site traveling down to right handy transient chills, feeling of light headness & fatigue.  Vital signs remained within a normal range.  No skin changes at the site.  HCW took 2 TYLENOL tabs; symptoms relieved by 9:30 PM.
nausea; headache; body ache "all over"; chills; very drowsy; disoriented; This is a spontaneous report from a contactable health professional, the patient. A 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 11Feb2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On Feb2021, the patient experienced nausea, headache, body ache "all over", chills and was very drowsy and disoriented. The patient questioned the efficacy of the vaccine after the first dose. The clinical outcome of nausea, headache, body ache "all over", chills, very drowsy and disoriented was unknown.  Information on the lot/batch number has been requested.
Information has been received from a health care professional concerning an 8 year old female with no pre-existing allergies, birth defects or medical conditions who on 26-JUN-2008 was vaccinated with a second dose of VARIVAX (Merck) in her left arm (lot #654281/1890U). There was no illness at the time of vaccination. Subsequently the patient experienced swelling and redness at site of injection. The patient was treated with TYLENOL/MOTRIN and ice. Subsequently, the reaction went away between 24-48 hours after first appeared. No further information is available.
Per Report:  Client complained of lump in her throat and difficulty swallowing.  Care initiated on site by Fire Rescue.  Symptoms unchanged after treatment.  Client transported to Hospital by EMS.  Report states client began feeling better prior to arriving at ER.
First dose received 01/22/2021 and second dose on above date (02/11/2021) These events may have no relation to the vaccination but due to their concomitance, I eventually felt it might be best to report them. Three days following the first dose, I started to experience hematuria as well as constipation. It has happened before as a result of radiation treatment back in 2005/2006. Saw my urologist on 02/02/2021, and  had several tests, ruling out any return of cancer. Antibiotics improved the situation, which was getting closer to normal prior to getting the second dose. Again, three days following the second dose, hematuria returned and still prevails at various degrees. Also experience fatigue and weight loss.
small clot behind my left knee; left foot had swollen; This is a spontaneous report from a contactable consumer (patient). A 20-year-old female patient received BNT162B2 (lot number: ER2613) first dose on 20Mar2021 10:15 on left arm at single dose for COVID-19 immunisation. Medical history and concomitant medications were none. Patient is not pregnant. No other vaccine in four weeks. No Covid prior vaccination, No known allergies. She took the vaccine around 10:00am and around 6:00pm (also reported as 06:30 PM) she noticed that her left foot had swollen. She consulted with her general physician and he requested that patient did an Ultra Sound exam of her left leg. The result of the exam reported a small clot behind her left knee. Therefore, doctor suggested that she reported these events to Pfizer so an evaluation is made to identify if similar events have occurred with other patients. She was concerned if she should take the second shot on 17Apr2021. AE resulted in Doctor or other healthcare professional office/clinic visit. Patient received Eliquis 5mg (two times daily) as treatment. Patient had Nasal Swab on 01Apr2021 and tested negative. The outcome of the events was not recovered.
Peripheral Neuropathy; Numbness in hands and feet; Hands and feet feels cold; Feels super increase of headache; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (Peripheral Neuropathy) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Migraine.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced HYPOAESTHESIA (Numbness in hands and feet), PERIPHERAL COLDNESS (Hands and feet feels cold) and HEADACHE (Feels super increase of headache). On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (Peripheral Neuropathy) (seriousness criterion medically significant). At the time of the report, NEUROPATHY PERIPHERAL (Peripheral Neuropathy), HYPOAESTHESIA (Numbness in hands and feet), PERIPHERAL COLDNESS (Hands and feet feels cold) and HEADACHE (Feels super increase of headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided. She consulted Neurologist and lab tests and EMG was done and diagnosed peripheral neuropathy. 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.
I have discovered I miscarried 2 weeks after my second dose of the Pfizer vaccine; at that time I was 4-5 weeks pregnant; This is a spontaneous report from a contactable consumer (patient). A 28-year-old pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH, solution for injection, Lot Number: 301308A), via an unspecified route of administration, administered in the left arm on 20Sep2021 12:00 (at the age of 28 years old) as dose 2, single for COVID-19 immunization at pharmacy or drug store. The patient medical history included allergies to Bananas. The patient concomitant medication included prenatal vitamins. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH, solution for injection, Lot Number: 301308A), via an unspecified route of administration, administered in the left arm on 03Sep2021 12:00 (at the age of 28 years old) as dose 1, single for COVID-19 immunization. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 27Oct2021 09:15, the patient experienced I have discovered I miscarried 2 weeks after my second dose of the Pfizer vaccine, and at that time I was 4-5 weeks pregnant. The mother reported she became pregnant while taking BNT162B2. The mother was 11 Weeks pregnant (Gestational period: 5) at the onset of the event. Last menstrual date was on 06Aug2021. All events resulted in physician office visit. Therapeutic measures were taken as a result of I have discovered I miscarried 2 weeks after my second dose of the pfizer vaccine, at that time I was 4-5 weeks pregnant and included with treatment DNC. The clinical outcome of the events was reported as recovered on an unspecified date of 2021.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-202101502504 same reporter/patient/product, different dose/event.
Diarrhea for 2 weeks after shot 1, now for 3 days after shot 2
Swollen and bright red around injection site (about 4 inch diameter across). site is warm to the touch.  patient first noticed when adverse event when she woke up the morning of 10/3/17 and symptoms have persisted.
Received Jynneos vaccine on 7/27 then developed rash on 7/30. non tender, small bumps on forehead, multiple vesicular lesions on L arm, very small  not pruritic. Had contact with person infected with monkeypox
Intense headache/pain in head in 5 minutes. By 15 minutes chest tight to breathe, intense pressure in head, tongue swelling, light headedness. All over lethargy.
Patient was given vaccine 9/28/10, a few minutes later a hard, bruised knot appeared at the site of injection. Gave pt ice pack. Followed up w/pt 9/29 swelling was going down. Pt takes PLAVIX.
She started to get hives around the injection sight. Bad joint pains which started in her feet up to her thighs. Called her dr and was told to take Benadryl for the hives and Ibuprofen for the pain.
14:30 received injection. 17:00 knot in throat (not sure if related, but was not eating), felt like something stuck in throat. 18:30 started to feel fatigued and uncomfortable due to throat, ate dinner. 20:00 started to feel weak and muscle aches, scratchy/tingling in back of throat; knot in throat gradually faded. 20:30 tried to go to bed, feeling severe aches and pains, took two ALEVE and dose of NYQUIL, hot bath, later took two TYLENOL. 22:00-01:00 severe aches and pains, fever-like chills (but normal temperature), mild sore throat, headache, bouts of nausea. Pain was on par with malaria, strongly considered going to hospital, but didn't want to get out of bed -- after 01:00 pain started to subside and I fell asleep. 11:30 woke up, tired and sore like all my muscles had been clenched through the night. Headache remained and scratchy throat, with slighty runny nose. Started to feel normal again about 18:00 the next day, with very slight hint of headache remaining
Headache, Myalgia, Fever, fatigue Narrative:  Fever 101.1 for about a day, headache, fatigue, body aches. Took Ibuprofen and Aspirin OTC x3.
23MAR93 pt recvd vax mom phoned & stated pt had t103, nasuea & vomiting & unable to retain food-fluid; c/o diarrhea also; advised to go to ER;
36hr post vax pt devel 99.7 ax cont temp through next 4 days;mom giving APAP;noted red area on rt leg size of nickel(not raised or puffy);on 29JUL97 noticed rash on chest;took to ER;no appetite,vomit, fussiness;rhinorrhea;
Body aches, chills, fever. I had every symptom that was on the paperwork except did not have diarrhea or nausea. I was fine right after the vaccine. The symptoms didn't start until 09:00. Then I had numbness and tingling in my opposite arm - my right arm. And then I got a red rash outside of my thighs (both) and then also where my elbows and knees are. The rash on my thighs was almost like shingles - almost like pin needle dots. The one on my elbows and knees was almost like hives/welts but smaller. Neither one of the kinds of rashes itches. I had all the symptoms, including the rashes, until Saturday afternoon. I still have the rash a little on my knees, elbows and thighs. The tingling/numbness on my arm went away. Today, I was getting a cramp in my right leg  - it wasn't even an hour - but it went away. On Saturday, around 03:00 pm I went to Urgent Care. I knew I was having some kind of adverse reaction to vaccine. If I get numbness back in right arm I am to go to ER. I feel better right now but I have had the leg cramping and rash is still a bit visible.
Severe pain in the left arm just below injection site with substantial swelling in the bicep area down to the left elbow. Also large area reddened.
tested positive after taking the first dose of the vaccine; tested positive after taking the first dose of the vaccine; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer. A patient of unspecified age and gender received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient tested positive after taking the first dose of the vaccine. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
(L) lateral deltoid injection site pain unable to move elbow and (L) wrist. The pain and ROM and strength; slowly improving. TX: hot pack and ibuprofen.
The individual was given 0.2mL of undiluted pediatric vaccine. The parent was contacted and notified of the error. The patient experienced a mild fever around 101 F, for approximately two days. Fever was controlled with Tylenol. No other symptoms were reported.
The patient began having diffuse myalgias and fatigue 3 days following the first injection on 3/17/21. Two days following the second dose on , the symptoms became much worse.   He continued to note weakness, fatigue and intermittent bitemporal headaches
This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness in hand), DIZZINESS (light headiness), VACCINATION SITE PRURITUS (itching around the injection site) and VACCINATION SITE PAIN (pain around the injection site) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included XYLOMETAZOLINE HYDROCHLORIDE (NASAL SPRAY II) for an unknown indication.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced HYPOAESTHESIA (numbness in hand). On 09-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itching around the injection site) and VACCINATION SITE PAIN (pain around the injection site). On 10-Feb-2021, the patient experienced DIZZINESS (light headiness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (numbness in hand), DIZZINESS (light headiness), VACCINATION SITE PRURITUS (itching around the injection site) and VACCINATION SITE PAIN (pain around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant Medications include Birth Control PIlls
Day one left arm slightly swollen and sore.  Day 2-3 redness present with soreness. small lump under skin. Headaches Day 4 redness growing in size (about size of quarter) with hard nodule under skin Day 5-10 enlarging redness (about 2.5inches by 2 inches diameter) dark red ring present with central clearing. Area is warm to touch.
This spontaneous report as received from a physician via company representatives and from a support services director, refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 06-JUN-2016, the patient was vaccinated with a dose of improperly stored VAQTA "10Pk 50U/1ml SD Llok w Caps Adult" with lot number L031196 and expiration date of 05-FEB-2017 (dose, route of administration and anatomical location were unknown), which was stored at the highest recorded temperature of 47 (8.333333333 Celsius degrees) for 24 hours. The storage criteria and the storage type were reported as "Refrigerator(R)". The vaccine status was reported as "in excursion". No adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
1. Right after I got the shot, I got dizzy and felt a little faint but then was fine after that - it only lasted a couple of minutes. 2. I had a sore arm for 2 days, but just a dull pain right after the shot. 3. I was fine for the past week but then 8 days after my shot, my arm got a small red rash at the injection site, it was itchy, and a little sore - I got the so called "Covid arm" or "Moderna arm".  It came out of nowhere.
No additional AE; MMRII was administered to a patient that expired on 04DEC2021; This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.  On 13-DEC-2021, the patient was vaccinated with expired measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (rHA) (M-M-R II), 0.5 ml (milliliter) (Expired product administered) (lot # S039319 has been verified to be a valid lot number, expiration date was reported and established as 04-DEC-2021; , dose number, vaccination scheme, route of administration and anatomical site of vaccination were not reported) for prophylaxis. The measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (rHA) (M-M-R II) has not had any temperature excursions.   No additional AE was reported.
Pt mother states leg has a large area of redness, warm and inflamed. Appointment with Provider to assess. Treatment cool moist compress.
Throat swelling 4-5 hours tongue swelling 5-6 hours treated w/BENADRYL after consult with physician.
**Note: I believe patient had symptoms of adverse effect to COVID-19 vaccination but later on also symptoms of viral infection**  Patient received second dose of COVID-19 vaccine on 5/4/21 on left arm (Pfizer). That night, patient had chills, headache, fever to 101.5 F (oral), fatigue. On 5/5/21, fever to 100.5 F, headache, fatigue. No chills. Fever, fatigue resolved by the afternoon on that day. On 5/7/21, +postnasal drip. Headache continued until night of 5/8/21. Patient took OTC tylenol for headache. On 5/8/21, patient began to cough. Had visit with telemedicine physician, who prescribed azelastine nasal spray and prednisone. On 5/9/21, cough continued and nasal congestion and chest congestion began. Yesterday, no postnasal drip, but cough and nasal/chest congestion continued. Patient has also taken tylenol PM. The prednisone and azelastine have not really helped except perhaps for the postnasal drip.  No pain in the throat with swallowing, loss of smell/taste, nausea/vomiting, diarrhea, rashes, body aches.
Patient had redness on the right thigh. She was prescribed Keflex in case of cellulitis and Zyrtec for the local allergic reaction = dx.
This case was reported by a pharmacist via call center representative and described the occurrence of therapy non-responder in a patient who received ENGERIX B for prophylaxis. Co-suspect products included ENGERIX B for prophylaxis and ENGERIX B for prophylaxis. Concurrent medical conditions included immunocompromised. On an unknown date, the patient received the 1st dose of ENGERIX B, the 2nd dose of ENGERIX B and the 3rd dose of ENGERIX B. On an unknown date, unknown after receiving ENGERIX B, ENGERIX B and ENGERIX B, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown. It was unknown if the reporter considered the therapy non-responder to be related to ENGERIX B, ENGERIX B and ENGERIX B. Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported that an immune compromised patient received a 3 dose ENGERIX-B series and did not develop antibodies. The health care professional had no patient or vaccine information such as dose dates lot or expiry dates. Lab Comments: On unknown date, hepatitis B antibody test was performed.