chrisvoncsefalvay/vaers-outcomes huggingface dataset:
big lump at the injection site; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site lump in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced injection site lump (Verbatim: big lump at the injection site). The action taken with Shingles vaccine was unknown. The outcome of the injection site lump was unknown.   It was unknown if the reporter considered the injection site lump to be related to Shingles vaccine.     It was unknown if the company considered the injection site lump to be related to Shingles vaccine.   Additional Information: Additional Information: GSK Receipt date:19-JUN-2023 This case was reported by a consumer via interactive digital media. Omg got round one the other day because my mom presented with by her eye. She's on the mend and patient have a big lump at the injection site.
Fever followed vax which persisted for 4 days; Anorexia; No other sx; Seen x 1 by MD during rxn;
Rash at site 5-7 4x5 cm. Temp 102 5-6 with stomach ache and headache and low energy. (+) Bullae 5-7 (R) thigh. Resolving rash-
some liquid (Moderna vaccine) was fell on his bare skin; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL EXPOSURE TO PRODUCT (some liquid (Moderna vaccine) was fell on his bare skin) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, the patient experienced ACCIDENTAL EXPOSURE TO PRODUCT (some liquid (Moderna vaccine) was fell on his bare skin). At the time of the report, ACCIDENTAL EXPOSURE TO PRODUCT (some liquid (Moderna vaccine) was fell on his bare skin) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-107772 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-107772:For sister
Around 2pm on 1/9/21, I started to have mild abdominal discomfort. Later on that day started to have a headache. Took Tylenol 1gm, which helped with headache. Approximately at 1:45am on 1/10/21, I started to feel chills body aches, fatigue, abdominal pain, headache, arm pain on the injection site. Took Tylenol 1gm with Benadryl 50mg. Felt my body sweating. Woke up still with chills, and fatigue. Headache was intermittent throughout the day. Took Tylenol 1gm one time at night woke up on 1/11/21 without symptoms except for the arm pain.
Pt developed low grade temp & URI sx; To ER w/rash, otitis med & red eyelids w/conjunctival infect; tx Amoxicillin trihydrate (Augmentin); Pt hospitalized because of dehydration, temp of 102.3, s&s of measles;
Information has been received from a physician concerning a 70 year old female with a history of chickenpox as a child and mild case as an adult who on 07-JUN-2007 was vaccinated with 0.5 ml dose of Zostavax (Oka/Merck) (lot # 652947/1411F).  On 16-JUN-2007 the patient developed a rash on the left forearm and scapular area of the back.  The rash was described as erythematous and had clear vesicles with 20-30 lesions.  The patient did not experience pain, fever or general malaise.  The physician planned to perform a direct fluorescent antibody test for varicella and perform a zank test.  Unspecified medical attention was sought.  A product quality complaint was not involved.  Additional information is not expected.
Fever (100.8) 12 hours after injection. Still present at time of reporting (33 hours post vaccine)
COVID arm; The site of injection started itching; Site of injection has red mark; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID arm), VACCINATION SITE PRURITUS (The site of injection started itching) and VACCINATION SITE ERYTHEMA (Site of injection has red mark) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced VACCINATION SITE REACTION (COVID arm), VACCINATION SITE PRURITUS (The site of injection started itching) and VACCINATION SITE ERYTHEMA (Site of injection has red mark). At the time of the report, VACCINATION SITE REACTION (COVID arm), VACCINATION SITE PRURITUS (The site of injection started itching) and VACCINATION SITE ERYTHEMA (Site of injection has red mark) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information provided. No treatment information provided.
Burn underneath my armpit,bit burn under the armpit,terrible burn under the armpit, left armpit, muscle on the left arm,errible burn under the armpit and a little further down,terrible burn under the armpit; Move the arm and stickiness; Little bit of chills; Arm sore; Slight headache; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burn underneath my armpit,bit burn under the armpit,terrible burn under the armpit, left armpit, muscle on the left arm,errible burn under the armpit and a little further down,terrible burn under the armpit), LIMB DISCOMFORT (Move the arm and stickiness), CHILLS (Little bit of chills), VACCINATION SITE PAIN (Arm sore) and HEADACHE (Slight headache) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067F21A, 036A21A and 026A21A) for COVID-19 vaccination.     The patient's past medical history included Pain in thigh (In September or October.) and Leg operation in January 2020. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL]) for Anticoagulant therapy.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced BURNING SENSATION (Burn underneath my armpit,bit burn under the armpit,terrible burn under the armpit, left armpit, muscle on the left arm,errible burn under the armpit and a little further down,terrible burn under the armpit), LIMB DISCOMFORT (Move the arm and stickiness), CHILLS (Little bit of chills), VACCINATION SITE PAIN (Arm sore) and HEADACHE (Slight headache). At the time of the report, BURNING SENSATION (Burn underneath my armpit,bit burn under the armpit,terrible burn under the armpit, left armpit, muscle on the left arm,errible burn under the armpit and a little further down,terrible burn under the armpit) and HEADACHE (Slight headache) had resolved and LIMB DISCOMFORT (Move the arm and stickiness), CHILLS (Little bit of chills) and VACCINATION SITE PAIN (Arm sore) outcome was unknown.            she got a surgery on Nov2019 and in Jan2020 got a leg surgery (right leg) product of a clot for the previous surgery.  Since the surgery she tales a full aspirin, 325mg and Excedrin 250mg to make the blood thinner.   This case was linked to MOD-2021-395886 (Patient Link).
Sore arm and extreme Fatigue. Sore Arm lasted 3 days Fatigue alittle over 24hrs. No meds taken
Breakthrough covid: on 12/18/21 had sore throat and unusual bad fatigue. Got worse each day. On 12/21 I went to an out door clinic and got tested, was negative. Continued to feel worse so tested again on 12/25/21 as I was going to be flying home. After I got home got much worse each day. Sinus and ear congestion, dry cough, earaches, chills, fatigue. Had a televisit with an urgent care on 12/30/21  and was given Augmentin . Was not tested for covid.  By 1/3/2022 I was significantly more sick with chills, fever, ears still hurting and could not hear well, cough, and everything tasted weird and lost most of smell. Was tested for covid which turned out to be positive. I told him I have MS and am on Ocrevus so immunocompromised. He sent in an order to hospital for sotrovimab. It was not available until 01/09/2022 at which time I received the infusion. In about 3 days I started to feel better. Note: I started the Ocrevus on 04/30/2021 and received again 11/01/2021.  (I had been on it before vaccination but stopped when pandemic hit until vaccinated. Last infusion before vaccination was Oct 2019. Started up again 04/30/2021)
9/24 (morning after vaccination) pt woke up with pain and swelling of knuckles of left hand; mainly middle and ring finger. Her left elbow was also "creaky", upper left arm was also red and somewhat swollen. Reported to pharmacy on 9/26, mostly resolved but knuckles still a bit swollen. As of 9/29 pm patient says swelling and pain resolved.
Sore jaw - painful "clicking"/Jaw pain; Sore jaw - painful "clicking"/Jaw pain; This is a spontaneous report from a contactable consumer. A 69-years-old female patient (Non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN5318) intramuscular, administered in left arm on 02Feb2021 17:00 at a single dose for COVID-19 immunization. Medical history included ongoing autoimmune Hashimoto's disease, known allergies to sulfa, osteoporosis and she had 2 oral surgeries. Concomitant medication included levothyroxine sodium (LEVOXYL) and probiotics. On 02Feb2021 18:00 The patient experienced sore jaw - painful "clicking"/jaw pain. No covid prior vaccination and No tested covid post vaccination. The caller said that she started taking Fosamax for osteoporosis. She stated for the first 4 doses it caused her joint pain and on the 4th week she got jaw pain. Patient took it once a week. Patient was advised to stop taking it and she did. The caller said that she has had the clicking in her jaw since taking Fosamax and this has been ongoing. She is not a medication taker. She said that she did take Advil for the jaw pain and then she read the next day that you should not take it before or after the Covid vaccine. The caller said that all of the other information that she read said that it was ok to take it after the vaccine, just not before. Her second dose was scheduled for 23Feb2021. Treatment was given for the events. The outcome of the events was recovered on 07Feb2021.
This case was reported by a consumer via call center representative and described the occurrence of chills in a 66-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included Flu vaccine (received in August 2018 (unknown manufacturer)). On 17th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 18th October 2018, 1 days after receiving SHINGRIX, the patient experienced chills, fever, muscle pain, diarrhea, abdominal cramp and fatigue. On an unknown date, the outcome of the chills, fever, muscle pain, diarrhea, abdominal cramp and fatigue were not recovered/not resolved. It was unknown if the reporter considered the chills, fever, muscle pain, diarrhea, abdominal cramp and fatigue to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX in left arm. The patient called her physician but did not go into the office for a visit. The patient had consented to follow up. The patient provided contact details of the physician.
pt recvd vax 27OCT94 & was admitted to the hosp for treatmnet of thrombocytopenia; pt is currently in the ICU, receiving steroids, gamma globulin & plasmapheresis;
This case was reported by a consumer and described the occurrence of gluten intolerance in a female patient who received FLUARIX. Previously administered products included FLUARIX and FLUARIX. In 2011, the patient received FLUARIX. In November 2011, an unknown time after receiving FLUARIX, the patient experienced gluten intolerance (serious criteria GSK medically significant). On an unknown date, the outcome of the gluten intolerance was not recovered/not resolved. It was unknown if the reporter considered the gluten intolerance to be related to FLUARIX. Additional details were provided as follow: The patient had no family history of gluten sensitivity, celiac disorder, nor any other chronic condition, autoimmune disorder, etc. She was an employee at a hospital and received FLUARIX in 2009, 2010, and 2011 distributed at the hospital as part of the hospital benefit/program. In November 2011, she was diagnosed with gluten sensitivity. Since being diagnosed with gluten sensitivity, her life had been turned upside down. Her health had continually deteriorated to the point where she was currently unable to work and she currently had zero quality of life. This is one of the three cases reported by the same reporter for the same vaccine.
memory care patients received Pfizer-BioNTech covid vaccine, and then were diagnosed with COVID, all three had COVID symptoms; memory care patients received Pfizer-BioNTech covid vaccine, and then were diagnosed; This is a spontaneous report from a contactable other health professional. This reporter reported same events for three patients. This is first of three reports. A patient of unspecified age and gender received BNT162B2 (Pfizer BioNTech COVID vaccine), via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The memory care patient received Pfizer-Biontech Covid vaccine, and then was diagnosed with Covid and had Covid symptoms on an unspecified date, the patient was scheduled to receive monoclonal antibody. Event took place after use of product. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event of positive for corona virus infection for the lack of efficacy of the vaccine. However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to possibly short number of days passed since the vaccine is given. Case will be reevaluated based on follow-up information,Linked Report(s) : US-PFIZER INC-2021004747 same reporter/product/event, different patient;US-PFIZER INC-2021004748 same reporter/product/event, different patient
10 year old with no past medical history and no known allergies. 10 minutes into observation became diaphoretic and pale, c/o blurry vision and nausea. Told mother"I am not feeling well". He was placed in modified tredenberg, ice applied. Pulse and HR monitoring remained stable. Remained awake, oriented and verbal. Colour return within two minutes. EMS called to patient side. Continued monitoring Vision return  normal, no longer diaphoretic, denies nausea. Tolerated juice and water. Patient told mother he was anxious about getting the vaccine. Observation time 30 mins. Went home with mother in stable condition. Instructions provided to call 911 and report to ED for further event.
sore arm; chills; sinus was inflamed; viral infection; This is a spontaneous report from Pfizer sponsored program from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (UNSPECIFIED TRADE NAME, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date in 2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included stroke in Feb2021, thrombosis in sinus cavity. The patient's concomitant medications were not reported. In 2021, the patient experienced sinus was inflamed. It was a virus actually. No effects after the first shot, just a sore arm, got the chills (2021). Started to feel better. Thought it was sinus but a viral infection. It was completely gone. The outcome of the events sore arm and chills was recovering, of the other events was recovered on an unspecified date in 2021.  No follow-up attempts are needed. Information about Batch/Lot number cannot be obtained.
Patient stated "I feel some pressure like I need to burp."  Patient was taken back to medic area where vital signs and EKG were done.  Manual v/s 138/98, O2 98%, HR 70, EKG results normal.  Patient burped and stated, "I feel better now."  EMT released patient to go home.
RECEIVED VACCINATION ON 2 SEPT 03 IN THE EARLY AFTERNOON. BY NIGHT, HE BEGAN TO RUN A LOW GRADE FEVER OF 100.3 AND C/O TINGLING ALL OVER HIS BACK.  NEXT MORNING HE WAS FINE. THE REASON I AM REPORTING THIS IS BECAUSE I HAD 2 ODD REACTIONS FROM THIS SAME LOT, SAME VIAL.
Hit my head; Dizzy; This is a spontaneous report received from contactable consumer, the patient. A 71-year-old elderly [non-pregnant] female patient received the first dose of BNT162b2 (solution for injection; Lot EN6201 expiry not provided) via unspecified route in the left arm as a single dose on 19Feb2021 at 09:00 AM (at 71-years-old) for COVID-19 immunisation. Relevant medical history included Congenital heart failure, and pancreatitis. Concomitant medications sans posology/indications included alprazolam, atorvastatin, bisoprolol fumarate (BISOPROL), and escitalopram. The patient denied any allergies to medications, foods or other products. The patient denied receiving any other vaccination within four weeks prior to the COVID vaccine. The patient also denied being diagnosed with COVID-19 prior to the vaccination. The patient reported that she woke up to go to the bathroom at 03:00am on 20Feb2021. The patient explained that she was dizzy and hit her head on her dresser. The patient stated that once in the bathroom she was still dizzy and hit her head on the wall as she could not sit up straight. The patient explained that she went back to bed and awoke at 09:00am with same things. The patient exclaimed that it is now 4:12pm on 20Feb2021, and she feels felt exactly the same. The patient has not been tested for COVID since being vaccinated. There was no treatment received. The outcome of the events, dizzy, and hit her head was not recovered.
All symptoms started 4/13 around 11:30pm  Fever Stuffy nose Congestion Sore Throat Cough Headache nausea  fatigue dizziness muscle pain body ache chills
This spontaneous report was received from a registered nurse referred to unspecified number of patients of unknown ages and genders. On unspecified dates in 2014, doses of GARDASIL (Lot# and expired date unspecified) and other vaccines were administered to unspecified patients (dose, frequency and route unspecified), after exposed to temperatures of 10 C degree for 37.5 hours/ temperature excursions with other vaccines on 08-AUG-2014, 13-AUG-2014 and 28-AUG-2014. No adverse effect has been reported. This is of the several reports from the same source. Additional information has been requested.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 15-FEB-2017 at 14:01, the patient was vaccinated with improperly stored VARIVAX injection (lot # M035142) (expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA008441: US-009507513-1704USA000389: US-009507513-1704USA000390: US-009507513-1704USA000392: US-009507513-1704USA000393: US-009507513-1704USA000394: US-009507513-1704USA000395: US-009507513-1704USA000396: US-009507513-1704USA000397: US-009507513-1704USA000398: US-009507513-1704USA000399: US-009507513-1704USA000400: US-009507513-1704USA000401: US-009507513-1704USA000402: US-009507513-1704USA000403: US-009507513-1704USA000404: US-009507513-1704USA000405: US-009507513-1704USA000406: US-009507513-1704USA000407: US-009507513-1704USA000408: US-009507513-1704USA000409: US-009507513-1704USA000410: US-009507513-1704USA000411: US-009507513-1704USA000412: US-009507513-1704USA000413: US-009507513-1704USA000414: US-009507513-1704USA000415: US-009507513-1704USA000416: US-009507513-1704USA000417: US-009507513-1704USA000418: US-009507513-1704USA000419: US-009507513-1704USA000420: US-009507513-1704USA000421: US-009507513-1704USA000422: US-009507513-1704USA000423: US-009507513-1704USA000424: US-009507513-1704USA000425: US-009507513-1704USA000426: US-009507513-1704USA000427: US-009507513-1704USA000428: US-009507513-1704USA000429: US-009507513-1704USA000458: US-009507513-1704USA000431: US-009507513-1704USA000432: US-009507513-1704USA000433: US-009507513-1704USA000434: US-009507513-1704USA000435: US-009507513-1704USA000436: US-009507513-1704USA000437: US-009507513-1704USA000438: US-009507513-1704USA000439: US-009507513-1704USA000440: US-009507513-1704USA000441: US-009507513-1704USA000442: US-009507513-1704USA000443: US-009507513-1704USA000444: US-009507513-1704USA000445: US-009507513-1704USA000446: US-009507513-1704USA000447: US-009507513-1704USA000448: US-009507513-1704USA000449: US-009507513-1704USA000450: US-009507513-1704USA000451: US-009507513-1704USA000452: US-009507513-1704USA000453: US-009507513-1704USA000454.
pt phoned 30OCT92 w/c/o erythema & edema 3" x 8" lt arm just distal of where Td was administered on 28OCT92; pt c/o itching x 24 hrs & mild h/a 30OCT92;
Area of vaccination (arm) became red and sore.  Area of redness, swelling and soreness increased for about 7 days.  Redness, swelling and soreness was significant.  It remained about the same for almost a month.  It took about another 2 months for the redness, swelling and soreness to completely go away.  I did tell my doctor who felt it was a very unusual reaction.  I had no shortness of breath in the reaction.   When I had the vaccination I told the pharmacy who administered the vaccination about my allergies.  I didn't know it should be reported until I had my H1N1 vaccination and mentioned the reaction to the pharmacy (Walgreens)
Patient reports receiving his injection at 4:45 p.m..  He went to the local exercise facility and had walked 1 lap which he estimates as 1/9 of a mi.   Approximately 15 minutes after his vaccine he experienced tingling and numbness of the bottom of his jaw.  He then felt like he was wearing a turtleneck shirt with a feeling of throat constriction.  He then reports probable lower lip swelling.  He did not take any photographs.  He returned home, 8 dinner and symptoms completely resolved after 2 hours.   He reports going to exercise the following afternoon.  After being on an elliptical exercise machine for around one minute he felt the onset of throat constriction.   He apparently discontinued his exercise and symptoms resolved after 30 minutes.   No symptoms recurred.